n REGIMTION OF TOBACCO PRODUCTS (Part 3) Y 4, EN 2/3; 103-171 Regulation of Tobacco Products^ Ser. . . HEARINGS BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENIHIRONMENT OF THE COMMITTEE ON ENERGY AND COMI^IERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRD CONGRESS SECOND SESSION JUNE 21 and 23, 1994 Serial No. 103-171 Printed for the use of the Committee on Energy and Commerce if^lUi f^AY 10 REGUUTION OF TOBACCO PRODUCTS (Part 3) HEARINGS BEFORE THE SUBCOMMITTEE ON HEALTH AND THE EXMROXMEXT OF THE COMIITTEE ON ENERGY AND COMAIERCE HOUSE OF REPRESENTATR^S ONE HUNDRED THIRD CONGRESS SECOND SESSION JUNE 21 and 23, 1994 Serial No. 103-171 Printed for the use of the Committee on Energy and Commerce U.S. GOVERNMENT PRINTING OFFICE 86-463CC WASHINGTON : 1995 For sale by the U.S. Government Printing Office Superintendent of Documents. Congressional Sales Office, Washington, DC 20402 ISBN 0-16-046954-6 COMMITTEE ON ENERGY AND COMMERCE JOHN D HENRY A. WAXMAN, CaUfornia PHILIP R. SHARP, Indiana EDWARD J. MARKEY, Massachusetts AL SWIFT, Washington CARDISS COLLINS, Illinois MIKE SYNAR, Oklahoma W.J. "BILLY" TAUZIN, Louisiana RON WYDEN, Oregon RALPH M. HALL. Texas BILL RICHARDSON, New Mexico JIM SLATTERY, Kansas JOHN BRYANT, Texas RICK BOUCHER, Virginia JIM COOPER, Tennessee J. ROY ROWLAND, Georgia THOMAS J. MANTON, New York EDOLPHUS TOWNS, New York GERRY E. STUDDS, Massachusetts RICHARD H. LEHMAN, CaUfornia FRANK PALLONE, Jr., New Jersey CRAIG A. WASHINGTON, Texas LYNN SCHENK, California SHERROD BROWN, Ohio MIKE KREIDLER, Washington MARJORIE MARGOLIES-MEZVINSKY, Pennsylvania BLANCHE M. LAMBERT, Arkansas Alan J. Roth, Staff Director and Chief Counsel Dennis B. Fitzgibbons, Deputy Staff Director Margaret A. Durbin, Minority Chief Counsel and Staff Director DINGELL, Michigan, Chairman CARLOS J. MOORHEAD, Cahfomia THOMAS J. BLILEY, Jr., Virginia JACK FIELDS, Texas MICHAEL G. OXLEY, Ohio MICHAEL BILIRAKIS, Florida DAN SCHAEFER, Colorado JOE BARTON, Texas ALEX MCMILLAN, North Carolina J. DENNIS HASTERT, IlUnois FRED UPTON, Michigan CLIFF STEARNS, Florida BILL PAXON, New York PAUL E. GILLMOR, Ohio SCOTT KLUG, Wisconsin GARY A. FRANKS, Connecticut JAMES C. GREENWOOD, Pennsylvania MICHAEL D. CRAPO, Idaho Subcommittee on Health and the Environment HENRY A MIKE SYNAR, Oklahoma RON WYDEN, Oregon RALPH M. HALL, Texas BILL RICHARDSON, New Mexico JOHN BRYANT, Texas J. ROY ROWLAND, Georgia EDOLPHUS TOWNS, New York GERRY E. STUDDS, Massachusetts JIM SLATTERY, Kansas JIM COOPER, Tennessee FRANK PALLONE, Jr., New Jersey CRAIG A. WASHINGTON, Texas SHERROD BROWN, Ohio MIKE KREIDLER, Washington JOHN D. DINGELL, Michigan (Ex Officio) WAXMAN, California, Chairman THOMAS J. BLILEY, Jr., Virginia MICHAEL BILIRAKIS, Florida ALEX MCMILLAN, North Carohna J. DENNIS HASTERT, IlUnois FRED UPTON, Michigan BILL PAXON, New York SCOTT KLUG, Wisconsin GARY A. FRANKS, Connecticut JAMES C. GREENWOOD, Pennsylvania CARLOS J. MOORHEAD, California (Ex Officio) Karen Nelson, Staff Director WiLLL^M SCHULTZ, Counsel Phillip Barnett, Counsel Mary M. McGrane, Minority Counsel (II) CONTENTS Page Hearings held on: June 21, 1994 1 June 23, 1994 131 Testimony of: Bell, Griffin B., King and Spaulding, Atlanta 138 Kessler, David A., Commissioner of Food and Drugs, Food and Drug Administration 4 Sandefur, Thomas E., Jr., Chairman and CEO, Brown & Williamson Tobacco Corporation 138 Smith, Gordon A., King and Spaulding, Atlanta 138 Witt, Ann, Special Assistant to the Deputy Commissioner for Operations, Food and Drug Administration 4 Material submitted for the record by: Coalition on Smoking OR Health: Letter dated June 20, 1994, from Scott Ballin to Hon. John Dingell, and subsequent letter to Hon. John Moakley, Committee on Rules 126 Lancaster, Hon. H. Martin, a Representative in Congress From the State of North Carolina: Statement 255 Subcommittee on Health and the Envirorunent, hearing exhibits: Nicotine Quotes 256 Nicotine Studies 284 Project Aries 374 Project Janus 383 Project Truth 405 Project Wheat 437 (III) REGULATION OF TOBACCO PRODUCTS TUESDAY, JUNE 21, 1994 House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment, Washington, DC. The subcommittee met, pursuant to notice, at 9:47 a.m., in room 2123, Raybum House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. Waxman. The meeting of the subcommittee will come to order. It is hard to believe that it was less than 2 months that Dr. David Kessler, Commissioner of the Food and Drug Administration presented his testimony to this subcommittee about the investiga- tion as to whether nicotine and tobacco are drugs subject to regula- tion under the Federal Food, Drug and Cosmetic Act. Since that time, this subcommittee has engaged in the wide-ranging investiga- tion which has included the critical issue of whether cigarette com- panies intend that tobacco have drug-like effects. This morning, we will hear testimony from Dr. Kessler on the current status of his investigation. On Thursday, we will have Thomas Sandefur, a CEO, back before the subcommittee. Before calling on Dr. Kessler, I want to see if any members have opening statements and recognize Mr. Bliley first. Mr. Bliley. Thank you Mr. Chairman. Gk)od morning Dr. Kessler. I must say, as I review this room, that there seems to be a good bit of media interest in this subject. Brings to mind a ver- sion of that old question concerning the tree falling in the forest. If the media was not here, would we be holding this hearing today. Four months ago. Dr. Kessler dropped a bombshell that made all the papers. For decades, the Food and Drug Administration had de- clined to assert jurisdiction over cigarettes as drugs as long as the manufacturers promoted their products on the basis of smoking en- joyment and not for some effect cigarettes might be thought to have on bodily structures or functions. In his famous letter of February 25, however, Dr. Kessler sug- gested that FDA would now be considering regulating cigarettes as drugs if the Agency found that the manufacturers intended that people buy their products to satisfy a "nicotine addiction." With the stage properly set. Dr. Kessler then appeared before the subcommittee on television cameras to describe the mounting evi- dence that nicotine is addictive and that cigarette manufacturers deliberately manipulate the amount of nicotine in cigarettes in order to "produce a sustained addiction." (1) With coverage in the evening news guaranteed Dr. Kessler exited the stage. Since then, the subcommittee has learned that nicotine is actually lost in the manufacturing process and that cigarettes that are sold contain less nicotine than is found in the raw tobacco used in its manufacture. We also learned that the nicotine yield in the average cigarette today is one-third what it was in the early 1950's. Although the av- erage nicotine yield fell by two-thirds over the last 40 years, Dr. Kessler is now accusing the cigarette manufacturers of adding nico- tine to their cigarettes in order to keep smokers "hooked." No matter. On to the next hearing. Today we will hear more from Dr. Kessler on the subject of tobacco. We will hear about the Brazilian tobacco and chemical analogs, and based on the turn out today, it will make the nightly news. Where does that leave us? For those of us who insist on basing policy on facts and reasons, this hearing will leave us cold. Much like the street sweepers after a parade, long after the cameras are gone, we will have to sift through testimony to separate the facts. Mr. Waxman. Mr. Synar. Mr. Synar. Thank you, Mr. Chairman. First of all, let me thank you for this very important and timely hearing and also welcome back Dr. Kessler. The testimony we are about to hear today is beyond fascinating. It is going to add to my disbelief, as well as my colleagues, about the tobacco company's un- willingness to allow public access to the truth. The CEO's of the seven largest tobacco companies stood in this very room and swore that their companies did not manipulate nico- tine levels in cigarettes. Today, the FDA will tell us that in fact Brown & Williamson, whose CEO took an oath before this sub- committee, developed a genetically altered tobacco plant and used that tobacco in a blend to manipulate and maintain relatively high levels of nicotine in cigarettes. The FDA will also tell us today that they found that Brown & Williamson adds some of the compounds on the list of 599 chemi- cals to the domestic cigarettes to increase their nicotine potency levels. Other tobacco companies have refused altogether to tell the FDA why they use chemical additives in their cigarettes. America and the consumers of this country remain in the dark as to how the other nearly 600 chemicals in cigarettes interact with tobacco and with each other when they are lit. I lament that it is the government instead of the tobacco industry that has to inform the public of the dangers of these cigarettes, but I laud the courage of Dr. Kessler and other health officials who have not cowered in the face of the tobacco industry's power and influence. This is an important hearing and I am glad to be here today. Mr. Waxman. Mr. Wyden. Mr. Wyden. Thank you, Mr. Chairman. Let me join my colleague, Mike Synar, in commending Dr. Kessler again for an excellent job. We are going to hear another chapter of the tobacco industry's hidden history this morning. In the prepared testimony I have read, it is clear from Dr. Kessler's standpoint that one major manufacturer. Brown & Williamson, bankrolled the development of a high nicotine tobacco plant in Brazil. Later, that specialty tobacco which was far more potent in nicotine content than normal cigarette tobacco was incor- porated into a small number of Brown & Williamson cigarettes. There appears to be no reason for the development of this tobacco plant, labeled Y-1, other than to artificially maintain the level of nicotine in Brown & Williamson products. I think it is important to note on page 3 of Dr. Kessler's testi- mony that industry representatives have repeatedly stated for the public record, according to our transcripts that they don't manipu- late nicotine levels in cigarettes. Yet now there is a very clear, very obvious direct attempt to manipulate nicotine. It seems to me, Mr. Chairman, that raises serious questions about whether the tobacco executives when they appeared before our committee deliberately and intentionally misled the Congress regarding the manipulation of nicotine in tobacco. Those executives were testifying under oath. This committee, in my view, has an obligation to make sure that oath stands for some- thing. I think this is an issue we are going to have to review fur- ther. Finally, let me make a point with respect to ammonia. Like you and other colleagues, I pressed for years to try to get out the list of chemicals that are added to cigarettes. We heard from the tobacco industry at the time that these chemicals were in effect much like those that you eat in a cookie or drink with soda and that the American people should not be con- cerned or alarmed. In effect, right before our hearing with the ex- ecutives, they put out a list of the chemicals and said that the case was closed. Now what we are learning with the testimony that will be of- fered today is that there are much more significant health effects in these chemicals. In effect, what cigarette consumers are getting amounts to a chemistry set in a tube, and I think it is important that the American public had a chance to know exactly what the health effects were of smoking these chemicals. Those effects are not known. The tobacco industry has worked hard to say that when you sim- ply eat a foodstuff in our country, that is like smoking a cigarette, but the fact is that the scientists are saying that is not the case. When you smoke a cigarette, you are sucking in these chemicals. Dr. Kessler's testimony raises important new issues with respect to the use of chemicals and additives in our cigarettes as well. This is an important inquiry, Mr. Chairman, and I commend you and look forward to Dr. Kessler's testimony. Mr. Waxman. Thank you Mr. Wyden. Mr. Kreidler. Mr. Kreidler. Thank you, Mr. Chairman. I appreciate your hold- ing this hearing today on tobacco regulation. As we learn more about the contents of cigarettes, the addictive nature of nicotine, and extraordinary steps the tobacco industry has taken to conceal the truth, it becomes clear that the FDA regulation is needed. We can't expect the industry to tell the truth. The attempt one company made to intimidate you through a subpoena shows how far they will go to keep the truth hidden. Now, another company is running full page ads to mislead the American people. They claim that regulating tobacco will lead to bans on alcohol, caffeine and fatty foods. The fact is that all those products are regulated now much more than tobacco. The fact is, tobacco is the only product that kills peo- ple when it is used as intended by the manufacturer. Intent is the key issue in determining whether the FDA should regulate a prod- uct as a drug. In this case, the intent is to use nicotine to addict people to a deadly product. I look forward to hearing from Dr. Kessler about his progress with his investigation. And again, Mr. Chairman, thank you for holding these hearings. Mr. Waxman. Thank you, Mr. Kreidler. Mr. Greenwood. Mr. Greenwood. No statement. Mr. Waxman. Dr. Kessler, we want to welcome you back to our subcommittee hearing today. I want to inform you that at the table are the applicable rules of the House and the rules of this commit- tee that apply. They indicate the limits and the power of the sub- committee and the extent of your rights during your appearance today. Do you desire to be represented by counsel or advised by counsel during your appearance today? Mr. Kessler. We will have counsel from the Food and Drug Ad- ministration join us. Mr. Waxman. There is a switch on the base of the mike, if you would push it forward. Mr. Kessler. Counsel from the Food and Drug Administration is with us. Mr. Waxman. Do you or those who you have asked to accompany you object to appearing before this subcommittee under oath? Mr. Kessler. No, we do not. Mr. Waxman. If you have no objection to appearing under oath, I would like you to rise and also have those that will be furnishing testimony rise as well to take the oath. [Witnesses swom.l Mr. Waxman. Please consider yourselves to be under oath. Iden- tify yourself for the record. And include those who are accompany- ing you as witnesses. TESTIMONY OF DAVID A. KESSLER, COMMISSIONER OF FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION, ACCOM- PANIED BY ANN WITT, SPECIAL ASSISTANT TO THE DEPUTY COMMISSIONER FOR OPERATIONS Mr. Kessler. Thank you very much, Mr. Chairman. My name is David Kessler. I am commissioner of the Food and Drug Adminis- tration. With me today will be Catherine Lorraine from the Office of Policy; Margaret Porter, Chief Counsel; Mitch Zeller, Office of Policy; and Ann Witt, in the Office of Operations. Mr. Chairman, in my last appearance before this subcommittee on March 25, 1994, I raised the question of whether or not the Food and Drug Administration should regulate nicotine containing cigarettes as drugs under the Federal Food, Drug, and Cosmetic Act. According to this act, a product is a drug if its manufacturer in- tends it to be used to affect the structure or function of the body. Because of the enormous social consequences of such a decision, we have asked Congress for guidance as we try to answer this ques- tion. The information that I presented about industry control and manipulation of nicotine at that hearing was suggestive. Today, as a result of an extensive investigation over the past sev- eral months, I am here to provide you with actual instances of nico- tine control and manipulation in the tobacco industry. My first example involves the deliberate genetic manipulation of nicotine even before tobacco seeds were planted in the fields. A major American tobacco company spent more than a decade quietly developing a tobacco plant with exceptionally high nicotine levels growing it in Central and South America, and ultimately using it in American cigarettes. My second example involves the addition of chemical compounds to tobacco. Based on our investigation, I will describe the use of chemical compounds to manipulate nicotine delivery. Let me begin with the story of a high-nicotine tobacco plant that was code named Y-1. The story begins in Portuguese with our dis- covery of a Brazilian patent for a new variety of a flue-cured to- bacco plant. One sentence of its English translation caught our eye: "The nic- otine content of the leaf of this variety is usually higher than ap- proximately 6 percent by weight, which is significantly higher than any normal variety of tobacco grown commercially." In fact, this Y-1 plant has almost double the nicotine that natu- rally occurs in flue-cured tobacco. The holder of the Brazilian Y-1 patent is the Brown & Williamson Tobacco Corporation. Let me tell you why this discovery interested us. Industry rep- resentatives have repeatedly stated for the public record that they do not manipulate nicotine levels, that they do not design for nico- tine. Moreover, when we asked company officials whether plants were bred specifically for higher nicotine content, we were told that this was not feasible. We were told that tobacco growers and cigarette manufacturers have an agreement that the nicotine level of new varieties of tobacco grown in the United States can vary only slightly from the levels of standard varieties if they are to be sold commercially. Nevertheless, we learned that interest in developing a high-nico- tine tobacco plant dates back to at least the mid-1970's. In 1977, Dr. James F. Chaplin then of both the USDA and the North Caro- lina State University, stated: "Manufacturers have means of reduc- ing tars, but most of the methods reduce nicotine and other con- stituents at the same time. Therefore, it may be desirable to de- velop levels constant or to develop levels higher in nicotine so that when the tar and nicotine are reduced, there will still be enough nicotine left to satisfy the smoker." In fact, Dr. Chaplin had actually begun work on genetically breeding tobacco plants to increase nicotine levels. Dr. Chaplin re- ported that tobacco could be bred to increase nicotine levels specifi- cally by cross-breeding commercial varieties of tobacco with Nicoti- ana rustica, a wild, high-nicotine variety that is not used in ciga- rettes in the United States. Over the next several years, Dr. Chaplin continued these efforts, but he never succeeded in developing a plant that would grow prop- erly. During that time, an employee of a Brown & Williamson affili- ated company, that employee told us that he requested and re- ceived tobacco seeds from Dr. Chaplin. From what we can gather, there was no formal release of this high-nicotine tobacco variety for commercial use. In the early 1980's, Brown & Williamson grew a number of different high-nicotine plant lines on its experimental farm in Wilson, NC, selecting those that had the best agronomic characteristics. In 1983, Brown & Williamson contracted with DNA Plant Tech- nology to work on tobacco breeding, including Y-1. Much of the Y- 1 work took place in the laboratories, greenhouses, and fields owned by DNA Plant Technology. A few years later. Brown & Williamson also hired Dr. Chaplin as a consultant. The scientific work on Y-1 involved a combination of conventional and advanced genetic breeding techniques. These include traditional crosses and back crosses between dif- ferent plant varieties and more sophisticated state-of-the-art breed- ing techniques including anther culture, tissue culture, hybrid sort- ing, and protoplast fusion that resulted in cytoplasmic male steril- ity of the plant. The genetic makeup of Y-1 was verified by using genetic engi- neering techniques involving restriction fragment length poly- morphism, RFLP[s]. The story of this high-nicotine plant continues in Rio Grande do Sul, Brazil. DNA Plant Technology and Dr. Chaplin both told us that they saw Y-1 growing in Brazil on sev- eral farms in the 1980's. These farms were under contract to Souza Cruz Overseas, a sis- ter company of Brown & Williamson. We do not yet have all the details of how Y-1 came to be growing in Brazil. We do know that until December 13, 1991, export of tobacco seeds or live tobacco plants was prohibited without a Tobacco Seed Plant Export Permit from the U.S. Department of Agriculture. Such a permit could be granted only if the shipment was for experimental purposes and then only in amounts of a half a gram or less. Brown & Williamson and DNA Plant Technology have each in- formed FDA that it believes the other may be responsible for the shipment of Y-1 seeds outside the United States. We have asked both countries to furnish copies of any export permits for Y-1. Ulti- mately, Brown & Williamson succeeded in developing a tobacco plant with about double the nicotine content of the standard vari- ety that grew well and could be used commercially. To obtain commercial protection. Brown & Williamson, filed a U.S. patent application and a Plant Variety Protection certificate application for Y-1 in 1991. The company also deposited samples of Y-1 seeds with the National Seed Storage Laboratory in Fort Col- lins, Colorado. The plant certificate application was withdrawn about 3 months ago on March 14, 1994. Brown & Williamson also removed the Y- 1 seeds it had deposited. The patent application was rejected ini- tially but the company filed an appeal on February 28, 1994. However, 2 weeks later, on March 16, even before receiving a ruling on the appeal. Brown & Williamson abandoned the patent. On Friday, June 10, 1994, DNA Plant Technology told us that it had been authorized by Brown & Williamson to tell FDA that Y- 1 was never commercialized. Mr. Chairman, I wish to submit for the record two invoices filed with the U.S. Customs Service in 1992. Mr. Waxman. Without objection, that will be received for the record. 8 v;_--..-.. r-":"v cs I c: I o K c X o 0> S) 0- a r. N ~ IN ra ^ • c o « C VJ Z 2 = c = I- 3 C ^5* w — c: -c ^ •- J- - C T c _; o = = 'J -►^4 ^ 52 c - li •K - 5 I 25it I c: 0. (0 o c ; =1 IT a = -] II O I 'r r- -% , o ^ o (J CJ c r- IT. ^ PJ O <3 ■J> ^ •E 1^ « > •-4 > i: ,_J « '-I 41 » l- 77 u: := _; K _j l«! O ^M T 3 ■ 1 O O C •=. 21 ■ O ■.-i 23 a. _! — - >- =: a >- _J 3 \ V X — •. XXX •_: :l a: a: ar Co o: a: = .:. = D = = IT -J = L. -;■ LJ ■c .-s c d c = o- c - ^^ c <: fT; o ■- ^i 1 _i r,' u 2: c c r- = C ^ -r O -I ( - O -<: — ^■ =; r^ ■. ^ ^ ►^ t- 2: — i 3 C: T C _i r: r i-" r.' >■ 3 - ^ c; CK 5 = C CJ rj C i. r< X c .- T _< S c -» en 2 r 3 ^^- #* „ c = ? ? = E s .- < "^ < 3 ^ ^ 1? !£ " 5 ; = o 5 •• a "i ^sr" s . El S. K ^ >■ &i » *-' o - i 3 ■ = 3 r; t - u 5 I I?] I •CO >- =3 C o u o f 1 C) •c (T O )- rj ~ C-; o •o (.-; •c c O V »-t o- ^ _I o -1 »- b i—t n u 3 -J X _) •« ►H c :> -2. CT -• ■ C o ^ ^ :; 2(33 o u. ■ CVJ ^ o C — :p3 LL 13 ^ i 10 Mr. Kessler. This was like looking for a needle in a haystack. The invoices are addressed to Brown & Williamson Tobacco Cor- poration, Louisville, Kentucky, from Souza Cruz Overseas. They refer to 'Tour Order Project Y-1," and reveal that more than a half a million pounds, more than 500,000 pounds of Y-1 to- bacco was shipped to Brown & Williamson on September 21, 1992. Late last Friday, once it became clear that the agency already knew about Y-1, Brown & Williamson told FDA that 3.5 to 4 mil- lion pounds of Y-1 tobacco are currently being stored in company warehouses in the United States. More significantly. Brown & Williamson revealed that Y-1 had, in fact, been commercialized. Mr. Chairman, these brands of cigarettes, Raleigh Lights, Rich- land Lights King Size, Viceroy King Size, Viceroy Lights King Size, and Richland King Size, were manufactured and distributed na- tionally in 1993 with a tobacco blend that contains approximately 10 percent of the high-nicotine tobacco called Y-1. Company officials explained that one of the reasons they devel- oped Y-1 was to be able to reduce tar while maintaining nicotine levels. Let me now move on to the second area, the chemical manipula- tion of nicotine. In April of this year, the six major American ciga- rette companies released a list of 599 ingredients added to tobacco. Among those chemicals were several ammonia compounds. Many people have wondered why the cigarette industry would add ammo- nia compounds to tobacco. In fact, there are many uses of ammonia in cigarettes. One is denicotizing; two, strengthening the adhesive matrix of reconstituted tobacco; three, it is used to react with sug- ars to produce certain flavor compounds; four, investigation has re- vealed another important use — to affect the delivery of nicotine to the smoker. Let me refer to one company's 1991 handbook on leaf blending and product development which describes this use. The handbook states: "Cigarette smoke ammonia is entirely dif- ferent from the way ammonia reacts with sugars in tobacco. It can liberate free nicotine from the blend which is associated with in- creases in impact and 'satisfaction' reported by smokers." The handbook also describes ammonia as an "impact booster." "Ammonia, when added to a tobacco blend, reacts with the indige- nous nicotine salts and liberates free nicotine." As a result of such change, the ratio of extractable nicotine to bound nicotine in the smoke may be altered in favor of the extractable nicotine." "As we know, extractable nicotine contributes to impact in ciga- rette smoke and this is how ammonia can act as an impact boost- er. Ammonia's role is further explained elsewhere in the handbook: "This means that at the same blend alkaloid content, a cigarette incorporating ammonia technology will deliver more flavor com- pounds, including nicotine, into smoke than one without it." Understand, Mr. Chairman, that only a fraction of the nicotine in the tobacco gets inhaled by the smoker; ammonia technology en- ables more nicotine to be delivered to the smoker. How much more? It is our understanding, based on smoke analysis described in that company handbook, that an experimental cigarette made of recon- 11 stituted tobacco treated with ammonia has almost doubled the nic- otine transfer efficiency of tobacco. How widespread is ammonia use in the industry? The company handbook states that many U.S. tobacco companies use ammonia technologies. Until we have access to similar documents from other companies, we will not know whether other companies inten- tionally use it to affect nicotine levels. Mr. Chairman, the control and manipulation of nicotine I have described raises important questions. Why spend a decade develop- ing through genetic breeding high-nicotine tobacco and adding it to cigarettes if you are not interested in controlling and manipulating nicotine? Why focus on the enhanced delivery of free nicotine to the smoker by chemical manipulation if you are not interested in con- trolling and manipulating nicotine? These questions are even more important in light of the indus- try's repeated assertions that it does not control or manipulate nic- otine. Now, let me discuss why the industry pays attention to nicotine. We have learned that at least one company has identified target levels of nicotine necessary to satisfy smokers' desire for nicotine. Furthermore, we now know about industry research into nico- tine's physiological and pharmacological effects. Let me give you one example of how a company identified specific levels of nicotine necessary to satisfy smokers. A company document describes consumer preference testing on "impact," which the company correlates with nicotine. The docu- ment states that impact is a "high priority" attribute of cigarettes and is "controllable to relatively fine tolerances by product develop- ment and product intervention by manipulating nicotine in blend and in smoke." This document goes on to describe an elaborate model shown on the chart for establishing the minimum and maxi- mum nicotine levels tolerated by consumers. It states that the model provides "a median ideal point level for milligrams nicotine in smoke," and a range of tolerable nicotine lev- els around this ideal point. The document notes what happened when this testing method was applied to a group of European smokers: "It is clear that con- sumers are less tolerant of decreases than they are of increases in nicotine delivery. By the time nicotine levels fall to approximately 0.35 milligrams, 50 percent of consumers will be saying that the level of impact is so low they would reject the product." Mr. Chairman, this document makes clear that at least one com- pany is aware of the need to target nicotine delivery to levels nec- essary to satisfy smokers. In fact, as one tobacco flavor specialist has written, one of the most important goals of cigarette design is to "ensure high satisfaction from an adequate level of nicotine per puff." And that even cigarettes with reduced levels of nicotine and tar must have this property. Mr. Chairman, let me turn to the industry's knowledge of the drug-like effects of nicotine. I will first describe several studies commissioned by the tobacco industry. As I go through them, ask yourself, are these the kinds of studies that would be conducted by an industry interested only in the flavor or taste of nicotine? 12 On May 16, 1994, Brown & Williamson released results of re- search conducted more than 30 years ago. The first report known as Project Hippo I, discussed the effects of nicotine in the body, in- cluding its effect on the central nervous system. Let me quote from the final report on Project Hippo II, which focused on the newly evolving field of tranquilizers: "The aim of the whole research 'Hippo' was to understand some of the activities of nicotine, those activities that could explain why cigarette smokers are so fond of their habit." The document goes on: "It was also our purpose to compare these effects with those of the new drugs called tranquilizers which might supersede tobacco habits in the near future." These studies represent a serious commitment by a tobacco com- pany to a scientific examination of nicotine's pharmacologic prop- erties. The comparison of the drug-like effects of nicotine and tran- quilizers was not exactly a well-kept secret. Even in the 1940's, Mr. Chairman, you could pick up a magazine and see an advertisement like this: "If upset by a 5 year old, why be irritated? Light an Old Gold." Another report released with Hippo called "the Fate of Nicotine in the Body" presents the results of studies on nicotine metabolism in a group of smokers. The report states, 'The numerous effects of nicotine in the body may, at first, be conveniently measured by var- ious physiological and pharmacological experiments." Such re- search is inconsistent with the industry's representation that it is only interested in nicotine's flavor and taste. Mr. Chairman, we believe that the studies released by Brown & Williamson are relevant to the determination of whether nicotine- containing cigarettes are drugs for purposes of the Federal Food, Drug, and Cosmetic Act. And thanks to this subcommittee's work, we now know that Phil- ip Morris also studied the pharmacological and reinforcing effects of nicotine. We are also aware of research utilizing electroencephalographic measurements to monitor the biological effects of nicotine on brain function at both R.J. Reynolds and Philip Morris. Let me also quote some of the recently reported statements in the media of officials from one company that reveal a recognition of nicotine's drug-like effects: "Nicotine is not only a very fine drug, but the techniques of administration by smoking has considerable psychological advantages." Nicotine is a very remarkable beneficent drug that both helps the body to resist external stress and also can, as a result, show a pronounced tranquilizing effect." These statements were apparently made by Sir Charles Ellis, who served as science advisor to the board of Brown & Williamson's sister company, British-American Tobacco Company. Dr. Ellis made another statement in 1962: "Smoking is a habit of addiction." But perhaps the most striking statement attributed to him is one from a meeting of company scientists in 1967: "Sir Charles Ellis states that this company is in the nicotine rather than the tobacco industry." These statements are echoed by those made in an internal com- pany document of another senior scientist at a British tobacco com- pany. "There is now no doubt that nicotine plays a large part in 13 the action of smoking for many smokers. It may be useful, there- fore, to look at the tobacco industry as if a large part of its business is the administration of nicotine in the clinical sense." Other scientists are quoted in a May 30, 1963 paper that is re- ported to have been produced for the British American Tobacco Company and labeled confidential, a tentative Hypothesis on Nico- tine Addiction. "Chronic intake of nicotine tends to restore the nor- mal physiological functioning of the endocrine system, so that ever- increasing dose levels of nicotine are necessary to maintain the de- sired action. Unlike other dopings, such as morphine, the demand for increasing dose levels is relatively slow for nicotine." Other statements reportedly made in this paper describe what happens when a chronic smoker is denied nicotine: "A body left in this unbalanced state craves for renewed drug intake in order to restore the physiological equilibrium." "This unconscious desire ex- plains the addiction of the individual to nicotine." The information that we have presented today has been the re- sult of painstaking investigation. We now know that a tobacco com- pany commercially developed a tobacco plant with twice the nico- tine content of standard flue-cured tobacco, that several million pounds of this high-nicotine tobacco are currently stored in ware- nouses, and that this tobacco was put into cigarettes that have been sold nationwide. We now understand that several tobacco companies add ammo- nia compounds to cigarettes. Further, one company's documents confirms that an intended purpose of this practice is to manipulate nicotine delivery to the smoker. And we now know that some in the industry have identified target ranges of nicotine delivery. These findings lay to rest any notion that there is no manipula- tion and control of nicotine undertaken in the tobacco industry. It is equally important to lay to rest, once and for all, the indus- try's assertion that nicotine is not addictive. Up until very recently, the tobacco industry was able to claim that it does not believe that nicotine is addictive. The release of company documents and the testimony of company scientists before this subcommittee have opened a window on what some senior to- bacco officials knew about nicotine's physiological and addictive properties as much as 30 years ago. Mr. Chairman, members of this committee, one important thing that every teenager in this country needs to know before deciding to smoke his or her first cigarette is how one cigarette industry of- ficial viewed the business of selling cigarettes. "We are, then, in the business of selling nicotine, an addictive drug." Thank you, Mr. Chairman. [The prepared statement and charts of Dr. David A. Kessler fol- low:] 14 STATEMENT BY DAVID A. KESSLER, M.D. COMMISSIONER OF FOOD AND DRUGS In my last appearance before this subcommittee on March 25, 1994, I raised the question of whether the Food and Drug Administration should regulate nicotine-containing cigarettes as drugs under the Federal Food, Drug, and Cosmetic Act.' A product is a drug if its manufacturer intends it to be used to affect the structure or function of the body.^ Because of the enormous social consequences of such a decision, we have asked Congress for guidance as we try to answer this question. Mr. Chairman, the American public owes a huge debt of gratitude to this subcommittee for its tireless efforts to focus attention on this most important public health matter. Let me begin by summarizing the information that I presented at that hearing. I reviewed the evidence that supports the scientific consensus that nicotine is addictive. I also reviewed the evidence we had at that time on the ability of the tobacco industry to control nicotine levels, including numerous industry patents for technologies to manipulate and control nicotine content. I described activities of the cigarette industry that resemble those of pharmaceutical manufacturers. I presented information that raised the question of whether tobaccos were blended to manipulate and control nicotine levels. And I provided data showing that over the last decade, nicotine levels have not dropped in parallel with tar levels -- in fact, they have risen. Since March 25th we have continued to focus our analysis and investigation on the physiological and pharmacological effects of nicotine and on the degree to which cigarette companies manipulate and control the level of nicotine in their products. The information that I presented about industry control and manipulation of nicotine the last time I testified before you was suggestive. Today I am going to provide you with actual 15 instances of control and manipulation of nicotine by some in the tobacco industry that have been uncovered through painstaking investigational work over the last three months. We have discovered that manipulation of nicotine has been carried out by some even before tobacco seeds were planted in the fields. We have discovered other forms of manipulation that occur later, in the design and manufacture of cigarettes. Today I want to discuss two examples of nicotine manipulation in some detail. First, we have discovered the deliberate genetic manipulation of the nicotine content in a tobacco plant. It is the story of how an American tobacco company spent more than a decade quietly developing a high- nicotine tobacco plant, growing it in Central and South America, and using it in American cigarettes. Second, I will discuss how chemical compounds are added to cigarettes to manipulate nicotine delivery. I. GENETIC MANIPULATION OF NICOTINE CONTENT The project I am going to tell you about led to development of a tobacco plant code-named "Y-1." (Chart 1) It has been an enormous task to piece together the picture of Y-1. Confidentiality agreements have made getting the facts very difficult. The story begins in Portuguese with our discovery of a Brazilian patent for a new variety of a flue-cured tobacco plant.' (Chart 2) One sentence of its English translation caught our eye. "The nicotine content of the leaf of this variety is usually higher than approximately 6% by weight. . .which is significantly higher than any normal variety of tobacco grown commercially."' (Chart 3) Prior to our discovery of the patent, an industry executive had told us that "flue-cured tobacco naturally contains 2 . 5 to 3.5 percent nicotine."^ (Chart 4) Thus, this new specially bred plant would contain approximately twice the nicotine that naturally occurs in flue-cured tobacco. 16 The holder of the Brazilian Y-1 patent was Brown & Williamson Tobacco Corporation, maker of such cigarettes as Kool, Viceroy, Richland, Barclay, and Raleigh. Let me tell you why this discovery interested us. Industry representatives have repeatedly stated for the public record that they do not manipulate nicotine levels in cigarettes. The plant described in this patent represents a dramatic attempt to manipulate nicotine. Moreover, when we asked company officials whether plants were bred specifically for higher nicotine content, we were told that this was not feasible. We were told that tobacco growers and cigarette manufacturers have an agreement that the nicotine level of new varieties of tobacco grown in the United states can vary only slightly from the levels of standard varieties. Under this agreement, a new high-nicotine tobacco plant that varied more than slightly from the standard variety could not be commercially grown by farmers in the United States. Nevertheless, we learned that interest in developing a high- nicotine tobacco plant dates back to at least the mid-1970 's. In 1977, Dr. James F. Chaplin, then of both the USDA and North Carolina State University, stated: "manufacturers have means of reducing tars but most of the methods reduce nicotine and other constituents at the same time. Therefore it may be desirable to develop levels constant or to develop lines higher in nicotine so that when the tar and nicotine are reduced there will still be enough nicotine left to satisfy the smoker." (Chart 5) In fact. Dr. Chaplin had been working on genetically breeding tobacco plants with varying nicotine levels. In a 1977 paper, Dr. Chaplin indicated that tobacco could be bred to increase nicotine levels, specifically by cross breeding commercial varieties of tobacco with Nicotiana rustica. N. rustica is a wild variety, very high in nicotine, but not used commercially in cigarettes because it is considered too harsh. Dr. Chaplin has told us that his specially bred plants were not commercially viable because they did not grow well and literally did not stand up in the field. Furthermore, he was 17 surprised that he could not get the nicotine levels as high as he anticipated. In fact, in his 1977 paper, the highest nicotine level he reported in these specially bred lines was 3.4 percent total nicotine, within the normal range for flue-cured tobacco. At the same time, international efforts focused on controlling and manipulating nicotine by alternative methods. For example, the use of reconstituted tobacco: "... [LTR, a maker of reconstituted tobacco] which homogenises tobacco for various European cigarette houses cannot only reduce the tar in the sheet it sends back to clients; it is able to work into client's scrap and waste new tobacco of the rustica type, rich in nicotine, in order to change the relationship of nicotine and tar in the sheet. It is able to do the same by the alternative method of adding salts of pure nicotine into the slurry that eventually becomes tobacco sheet. This is an operation parallel to, though more exact than, that on which US geneticists are engaged, in seeking to develop types of ^ tobacco that are low on tar but fairly rich in nicotine." Over the next several years Dr. Chaplin continued his efforts to breed a tobacco plant with a higher nicotine level. During that time, an employee of a Brown & Williamson-affiliated company asked Dr. Chaplin for some of his seeds. Some of Dr. Chaplin's original plant varieties were used as a basis for Brown & Williamson's work. From what we can gather, there was no formal release of this high-nicotine tobacco variety for private use. In the early 1980 's, Brown & Williamson grew a number of different plant lines on its experimental farm in Wilson, North Carolina, selecting those that had the best agronomic characteristics. In 1983, Brown & Williamson contracted with DNA Plant Technology to work on tobacco breeding. Much of the developmental work on Y-1 took place in the laboratories, greenhouses, and fields owned by DNA Plant Technology. After he retired from USDA, in 1986, Brown & Williamson also hired Dr. Chaplin as a consultant to work on Y-1 and other projects. The high-nicotine tobacco variety Y-1 was developed by a combination of conventional and advanced genetic breeding technicjues. (Chart 6) These include traditional crosses and back crosses between different plant varieties and more sophisticated 18 state-of-the-art breeding techniques including anther culture, (Chart 7) tissue culture, (Chart 8) hybrid sorting, and protoplast fusion (Chart 9) that resulted in cytoplasmic male sterility. The genetic makeup of Y-1 was verified by using genetic engineering techniques involving Restriction Fragment Length Polymorphism (RFLP) .' (Chart 10) The value of Y-1 to Brown & Williamson is reflected in the fact that Brown & Williamson had DNA Plant Technology make Y-1 into a male sterile plant. This procedure ensures that when a plant is grown it will not produce seeds that can be appropriated by others. Brown & Williamson characterized its achievement in a patent filing as follows (Chart 11) : "By the present invention or discovery, applicants have succeeded in developing a tobacco plant that is agronomically and morphologically suitable for commercial tobacco production, i.e. it closely resembles SC 58, and provides a pleasant taste and aroma when included in smoking tobacco products, vet it is possessed of the N. rustica high-nicotine attribute. So far as we know, this has not been accomplished before..." [emphasis in original] What was accomplished was the development of a tobacco plant with a high-nicotine content — about 6 percent — that grew well and could be used commercially. The story of this high-nicotine plant continues in Rio Grande do Sul, Brazil. (Chart 12) DNA Plant Technology and Dr. Chaplin both told us they saw Y-1 growing in Brazil irv- the 1980 's. These farms were under contract to Souza Cruz Overseas, a sister company of Brown & Williamson. We do not yet have all the details of how Y-1 came to be growing in Brazil. Until December 13, 1991, export of tobacco seeds or live tobacco plants was prohibited under Federal law (Chart 13) unless a Tobacco Seed Plant Export Permit (Form TB-37) was granted by the United States Department of Agriculture. Such a permit could be granted only after satisfactory proof was offered that the seeds or plants were to be used solely for experimental purposes and then only in amounts of a half a gram or less.^^ Brown & Williamson and DNA Plant Technology have each 19 informed FDA that they believe the other may have been responsible for the shipment of Y-1 seed outside the U.S. We have asked both companies to furnish copies of any Tobacco Seed Plant Export Permits for Y-1. In reading the Brazilian Y-1 patent, we discovered that two related applications for the Y-1 variety of a tobacco plant were filed in the United States. Brown & Williamson filed a U.S. patent application and a Plant Variety Protection Certificate Application in 1991." *' The company also deposited samples of seeds from this plant with the National Seed Storage Laboratory in Fort Collins, Colorado. When we attempted to obtain the Plant Variety Protection Certificate Application from the U.S. Department of Agriculture, we learned that the application was withdrawn about 3 months ago, on March 14, 1994. We were told that Brown & Williamson also withdrew all seed samples for this variety from the Seed Storage Laboratory. We learned that the U.S. patent application had been rejected by the patent examiner," but that Brown & Williamson had filed an appeal on February 28, 1994.'' However, two weeks later, on March 16, 1994, before receiving a response to their 16 appeal. Brown & Williamson expressly abandoned the patent. (Chart 14) On Friday, June 10, 1994, DNA Plant Technology told us that it had been authorized by Brown & Williamson to tell FDA that Y-1 was never commercialized. Mr. Chairman, I wish to submit for the record two invoices filed with the U.S. Customs Service in 1992. The invoices are addressed to Brown & Williamson Tobacco Corporation, Louisville, Kentucky from Souza Cruz Overseas. They refer to "Your Order Project Y-1" and reveal that more than one-half a million pounds of Y-1 tobacco were shipped to Brown & Williamson on September 21, 1992.^' Four days ago, on Friday June 17, after our questioning of 20 DNA Plant Technology, and following our letter to Brown & Williamson indicating that Brown and Williamson had not been cooperative with our investigation. Brown & Williamson told FDA that, in fact, three and a half to four million pounds of Y-1 tobacco are currently being stored in company warehouses in the United States. More significantly. Brown & Williamson revealed that Y-1 had, in fact, been commercialized. Mr. Chairman, these brands of cigarettes — Viceroy King Size, Viceroy Lights King Size, Richland King Size, Richland Lights King Size, and Raleigh Lights King Size — were manufactured and distributed nationally in 1993 with a tobacco blend that contains approximately 10 percent of this genetically- bred high-nicotine tobacco called Y-l. (Chart 15) When we asked company officials why they were originally interested in developing a high-nicotine variety of tobacco, they told FDA that they wanted to be able to reduce tar, while maintaining nicotine levels. II. THE CHEMICAL MANIPULATION OF NICOTINE Let me now move on to the second area. In April, the six major American cigarette companies released a list of 599 ingredients added to tobacco. Nicotine is not one of the additives listed. But Mr. Chairman, a number of chemicals on that list increase the amount of nicotine that is delivered to the smoker. Around the time the list was made public, a great deal of interest was directed toward substances on the list that sounded particularly toxic. Among those frequently mentioned was ammonia. Many people may have wondered why the cigarette industry would add ammonia to tobacco. In fact, there are many uses of ammonia. Our investigations have revealed an important one. Let me refer to a major American tobacco company's 1991 handbook on leaf blending and product development. The handbook describes two ways that ammonia can be used in cigarette 21 manufacture. One way is to interact with sugars in the tobacco. But it is the second way, the effect of ammonia and related compounds on the delivery of nicotine to the smoker, that is most striking. Let me quote from that handbook: "[The ammonia in the cigarette smoke] can liberate free nicotine from the blend, which is associated with increases in impact and 'satisfaction' reported by smokers." (Chart 16) The handbook goes on to describe ammonia as an "impact booster" : "Ammonia, when added to a tobacco blend, reacts with the indigenous nicotine salts and liberates free nicotine. As a result of such change, the ratio of extractable nicotine to bound nicotine in the smoke may be altered in favor of extractable nicotine. As we know, extractable nicotine contributes to impact in cigarette smoke and this is how ammonia can act as an impact booster." (Chart 17) This important role that ammonia plays in the liberation of free nicotine is also emphasized in other parts of the handbook. "This means that at the sane blend alkaloid content, a cigarette incorporating [ammonia technology] will deliver more flavor compounds, including nicotine into smoke than one without it." (Chart 18) It is important to emphasize here that most of the nicotine in the average American cigarette is in the bound form. By that I mean it is not going to readily make its way to the smoker. Mr. Chairman, I am not going to go into the details of acid-base, and vapor-phase chemistry, or the bioavailability of nicotine in the protonated versus the unprotonated form. Suffice it to say that only a fraction of the nicotine in the tobacco gets inhaled by the smoker. The handbook indicates that this ammonia technology enables more nicotine to be delivered to the smoker than if the ammonia technology is not employed. What are the ammonia compounds used in this technology? The company handbook lists a number of different chemical compounds that can act as "impact boosters." Ammonia compounds known to be used include diammonium phosphate (DAP) , ammonium hydroxide, and urea. In those countries, such as Germany, that do not allow DAP, other proprietary formulations are used. To what are these compounds added? One of the most common places the ammonia and ammonia-like compounds are applied is to 22 reconstituted tobacco. When the cigarette is burned, the reconstituted tobacco serves as a source of ammonia in smoke. The amount of reconstituted tobacco can be as high as 25 percent of the tobacco in the cigarette. And we've seen ammonia compound levels as high as 10 percent in the reconstituted tobacco. Thus, as the company handbook goes on to state, the benefits of the reconstituted tobacco: "come from being an ammonia source, as well as incorporating sugar-ammonia reactions. As a low alkaloid blend component, it also absorbs nicotine from higher alkaloid-containing components. [It thus becomes]... a positive blend contributor rather than merely a filler." The handbook also says that ammonia can be applied directly to the tobacco' that goes into cigarettes. How much additional nicotine does this technology impart? It is our understanding, based on smoke analysis described in the company handbook, that an experimental cigarette made of reconstituted tobacco treated with ammonia has almost double the nicotine transfer efficiency of tobacco. How widespread is ammonia use in the industry? The company handbook states that many U.S. tobacco companies use ammonia technologies. Until we have access to similar documents from other companies, we will not know whether other companies use it directly to affect nicotine levels. To determine how well nicotine content is controlled in cigarettes, FDA laboratories compared the content uniformity of drugs in either tablets or capsules to the content uniformity of nicotine in cigarettes. What is striking is how little the nicotine content varies from cigarette to cigarette, suggesting tight and precise control of the amount of nicotine in cigarettes. In fact, as this chart shows, the nicotine content uniformity of the cigarettes tested meets drug content uniformity standards set by the U.S. Pharmacopeia. (Chart 19) Mr. Chairman, 1 have presented information on the control and manipulation of nicotine because I believe it raises certain important questions — questions that are even more important in light of the repeated assertions of the cigarette industry that 23 it does not control or manipulate nicotine. Why spend a decade developing through genetic breeding a high-nicotine tobacco and adding that tobacco to cigarettes if you are not interested in controlling and manipulating nicotine? Why focus on the enhanced delivery of free nicotine to the smoker by chemical manipulation if you are not interested in controlling and manipulating nicotine? III. THE GOALS OF CONTROL AND MANIPULATION Why is there such interest in controlling and manipulating nicotine in cigarettes? Senior industry officials are aware that nicotine is the critical ingredient in cigarettes. Some in the industry have identified target levels of nicotine necessary to satisfy smokers' desire for nicotine. And the industry has undertaken research into nicotine's physiologic and pharmacologic effects. Target ranges Let me give you one example of how a company has identified specific levels of nicotine necessary to satisfy smokers and focused on how to achieve those levels. A company document describes consumer preference testing on "impact," which according to the company correlates with nicotine. The document states that impact is a "high priority" attribute of cigarettes and is: "...controllable to relatively fine tolerances by product development/product intervention. .. (by manipulating nicotine in blend/smoke...)" (Chart 20) This document goes on to describe an elaborate model for establishing the minimum and maximum nicotine levels tolerated by consumers. It states that the model provides "a median ideal point level for mq nicotine in smoke" for the population tested and a range of tolerable nicotine levels around this ideal point. After applying the testing method to a group of European smokers, for example, the document concludes: 24 "It is clear that consumers are less tolerant of decreases than they are of increases in nicotine delivery. By the time nicotine level falls to approximately 0.35mg, 50% of consumers will be saying that the level of impact is so low they would reject the product. To reach the equivalent stage of 50% of consumers rejecting the product as having too high an impact level, a nicotine level of approximately 5 . Omg would be required. Again, it is important to note that there is a clear upper as well as lower rejection limit for nicotine in smoke." It is thus clear that at least one major cigarette manufacturer is aware of the need to target nicotine delivery to levels necessary to satisfy smokers. In fact, as one tobacco flavor specialist has written, one of the most important goals of cigarette design is to "ensure high satisfaction from an adequate level of nicotine per puff," and that even cigarettes with reduced levels of nicotine and tar must have this property.^' Physiologic and pharmacologic effects of nicotine Publicly available information, including recently released documents, reveals much about the industry's knowledge of the drug-like effects of nicotine. I will begin by describing several studies commissioned by the tobacco industry. As I go through them Mr. Chairman and members of the Subcommittee, ask yourselves: Are these the kinds of studies that would be conducted by an industry interested only in the flavor or taste of nicotine? On May 16, 1994, Brown & Williamson made available previously unreleased results of research that had been conducted more than thirty years ago. A review of this research, known as the Project Hippo studies, documents that the industry was interested in the physiologic and pharmacologic effects of nicotine as early as 1961. The first report, known as Project Hippo I, contained an extensive discussion of the effects of nicotine in the body. This included, for example, the effects of nicotine on the central nervous system. Project Hippo II is an interesting study of what was, in the early 1960 's, the newly evolving field of tranquilizers. Let 25 me quote from the opening paragraph of the summary of the Final Report on Project Hippo II: "The aim of the whole research "HIPPO" was to understand some of the activities of nicotine - those activities that could explain why cigarette smokers are so fond of their habit. It was also our purpose to compare these effects with those of the new drugs called "tranquilizers", which might supersede tobacco habits in the near future." (Chart 21) The comparison of the drug-like effects of nicotine and tranquilizers was not exactly a well-kept secret. Even in the 1940 's you could pick up a magazine and see an advertisement like this. (Chart 22) What seems to be new about the Hippo study was that it represented a serious commitment by a tobacco company to a scientific examination of this pharmacologic property. Another report released with Hippo and conducted in the 1960 's is called "The Fate of Nicotine in the Body."^' It reviews the state of knowledge about the distribution of nicotine in the body and presents the results of studies on nicotine metabolism in a group of smokers. The report states: "The numerous effects of nicotine in the body may, at first, be conveniently measured by various physiological and pharmacological experiments." (Chart 23) The studies involved the use of radio-labeled nicotine in both humans and animals, which provided very sophisticated knowledge of the absorption and distribution of nicotine in the body. This included a knowledge of how much nicotine is present in the blood of smokers; how this nicotine is distributed; how it is excreted; and what variables affect the duration of a nicotine blood level. It is clear that such research would be of interest to the industry only if the industry were concerned with the physiological and pharmacological effects of nicotine. Certainly, this is not consistent with the industry's representation that nicotine is of interest to it only because of flavor and taste. Mr. Chairman, we believe that the studies released by Brown & Williamson are relevant to the determination of whether nicotine-containing cigarettes are drugs for purposes of the 26 Federal Food, Drug, and Cosmetic Act. And Brown & Williamson is not the only company that apparently has been involved in research on nicotine's physiologic and pharmacologic effects. Thanks to this Subcommittee's work, we now know that Philip Morris was conducting nicotine addiction research. We are also aware of research utilizing electroencephalographic measurements to monitor the biological effects of nicotine on brain function 27 26 20 30 31 at both R.J. Reynolds and Philip Morris. Major projects undertaken by at least two companies to develop cigarette alternatives also demonstrate that the industry understands that nicotine is the critical ingredient they are delivering to smokers. It is widely known that in the late 1980 's R.J. Reynolds Corporation developed and test marketed a cigarette alternative called Premier. It was smokeless and virtually tobacco free. It was essentially a nicotine delivery system. To make sure that Premier would be an acceptable alternative to smokers, R.J. Reynolds conducted human studies to determine whether the nicotine from Premier and from a standard cigarette was absorbed into the blood of research subjects, metabolized, and excreted at the same rate. Recent reports in the media reveal that Brown & Williamson, too, launched an effort to develop a cigarette alternative. It was referred to as "Ariel." Brown & Williamson's own documents reportedly refer to Ariel as "a nicotine delivery device." One of the applicant? for the patent for Ariel was Charles Ellis of British American Tobacco, Brown & Williamson's corporate parent. Ariel was composed of two parts: a source of nicotine and aerosol, and a heating material such as tobacco that served to heat the nicotine and cause the release of the nicotine and the aerosol. Mr. Chairman, we further believe that recent reports in the media also may be relevant to the determination of whether nicotine-containing cigarettes are drugs. Let me quote some of the recently reported statements of 27 officials from one company that reveal a recognition of nicotine's drug-like effects: "Nicotine is not only a very fine drug, but the techniques of administration by smoking has considerable psychological advantages."* (Chart 24) "...nicotine is a very remarkable, beneficent drug that both helps the body to resist external stress and alsp^ can, as a result, show a pronounced tranquilizing effect." (Chart 25) These statements were apparently made by Sir Charles Ellis, a member of the Royal Society of London, who served as science advisor to the board of British American Tobacco Company. He was responsible for advising the establishment of the company's research and development center at Southampton, England. He was also responsible for advising on the research operations of BAT's associate companies." Two of his recently reported statements are particularly striking. One statement was made in 1962: "Smoking is a habit of addiction." (Chart 26) But perhaps the most striking statement attributed to him is one from a meeting of company scientists in 1967: "Sir Charles Ellis states that BATCO is in ^^ the nicotine rather than the tobacco industry." (Chart 27) These statements are echoed by those made in an internal company document by another senior scientist at a British tobacco company: "There is now no doubt that nicotine plays a large part in the action of smoking for many smokers. It may be useful, therefore, to look at the tobacco industry as if for a large part its business is the administration of nicotine (in the clinical sense)." These statements are consistent with the quotes from William L. Dunn, an official of Philip Morris, that I cited for you in my testimony last March. (Chart 28 and 29) "Think of the cigarette pack as a storage container for a day's supply of nicotine." "Think of the cigarette as a dispenser for a dose unit of nicotine. " "Think of a puff of smoke as the vehicle for nicotine." "Smoke is beyond question the most optimized vehicle of nicotine. . . " other scientists are quoted in a May 30, 1963 paper that is 28 reported to have been produced for Brown & Williamson's sister company, the British American Tobacco Company, and labeled 39 "Confidential. A Tentative Hypothesis on Nicotine Addiction." As reported, it contains a number of statements regarding the powerful effect of nicotine on the body: "Chronic intake of nicotine tends to restore the normal physiological functioning of the endocrine system, so that ever-increasing dose levels of nicotine are necessary to maintain the desired action. Unlike other dopings, such as morphine, the demand for increasing dose levels is relatively slow for nicotine." (Chart 30) Other statements reportedly made in this paper speak directly to the addictive nature of nicotine. The report goes on to describe what happens when a chronic smoker is denied nicotine: "A body left in this unbalanced state craves for renewed drug intake in order to restore the physiological equilibrium. This unconscious desire explains the addiction of the individual to nicotine." (Chart 31) IV. CONCLUSION The information that we have presented today has been the result of painstaking investigation. We now know that a tobacco company commercially developed a tobacco plant with twice the nicotine content of standard tobacco, that several million pounds of this high-nicotine tobacco are currently stored in warehouses, and that this tobacco was put into cigarettes that have been sold nationwide. We now know that several tobacco companies add ammonia compounds to cigarettes, and that one company's documents confirm that one of the intended purposes of this practice is to manipulate nicotine delivery to the smoker. And we now know that some in the industry have identified target ranges of nicotine delivery. These findings lay to rest any notion that there is no manipulation and control of nicotine undertaken in the tobacco industry. It is equally important to lay to rest, once and for all, the industry's assertion that nicotine is not addictive. Up until very recently, the tobacco industry was able to claim that it did not believe that nicotine was addictive. The release of 29 company documents, and the testimony of company scientists before this Subcommittee, has opened a window on what some senior tobacco officials knew about nicotine's physiological and addictive properties, as much as 3 0 years ago. One important thing that every teenager in this country needs to know before deciding to smoke his or her first cigarette is how one cigarette industry official viewed the business of selling cigarettes: "We are, then, in the business of selling nicotine, an addictive drug . . ."*° (Chart 32) Thank you. REFERENCES 1. Kessler, D.A., Statement on Nicotine-Containing Cigarettes. Testimony before House Subcommittee on Health and the Environment. March 25, 1994. 2. 21 U.S.C. § 321(g) (1) . 3. Republican Federativa do Brasil, Institute Nacionel da Propriedade Industrial, PI 9203690A, "Variendade de fumo geneticanente estavel e planta de fumo", issued to Brown & Williamson Tobacco Corporation, June 4, 1993. 4. Brazilian Patent No. PI 9203690A. U.S. Department of State, Official English translation. 5. Letter of J.W. Johnson, Chief Executive Officer, R.J. Reynolds Tobacco Company; to D.A. Kessler, Commissioner, Food and Drug Administration; R.J. Reynolds Tobacco Company, Winston-Salem, N.C.; February 28, 1994. 6. Chaplin, J.F. Tailoring Tobacco Plants to Meet Future Demands. World Tobacco October 1978;62:145-9. 7. Chaplin, J.F. Breeding for Varying Levels of Nicotine in Tobacco. Proceedings from a Symposium on Recent Advances in the Chemical Composition of Tobacco and Tobacco Smoke," Raleigh, N.C., 1977:328-39. 8. [Unidentified Author]. Evolving Techniques of Making Cigarettes Milder. World Tobacco April 1979:93-101. 9. U.S. patent no. 761,312. "Filing of Utility Patent Application," Figure 1. 10. U.S. patent no. 761,312, "Appellant's Brief on Appeal," at p. 6. 11. 7 U. S. C. §516. (Tobacco Seed and Plant Exportation Act). 30 12. 7 CFR 34.4(b) . 13. DNA Plant Technology did provide a copy of a Phytosanitary Certificate. This document, which certifies that exported plants or seeds conform with phytosanitary regulations of the importing country, was issued to DNA Plant Technology by U.S. Department of Agriculture, Plant Protection and Quarantine, to facilitate importation of 20 grams of tobacco pollen into Brazil. March 20, 1990. 14. U.S. patent no. 761,312, filed September 17, 1991. 15. Plant Variety Protection Certificate Application, PV No. 9100119, filed February 21, 1991, U.S. Department of Agriculture. (referenced in U.S. patent no. 761,312, "Filing of Utility Patent Application," at p. 1 - unable to obtain copy of application from USDA) . 16. U.S. patent no. 761,312, "Rejection of Claims," July lo, 1992. 17. U.S. patent no. 761,312, "Appellant's Brief on Appeal," filed February 28, 1994. 18. U.S. patent no. 761,312, "Express Abandonment of Patent Application," filed March 16, 1994. 19. Redacted copies of United States Customs Service Invoices for Brcwn & Williamson, dated September 21, 1992. 20. For example, ammonia has been used in efforts to de- nicotinize cigarettes (U.S. patent no. 4,215,706) and, in reconstituted tobacco, for its adhesive properties (U.S. patent no. 5,159,942). 21. Reconstituted tobacco can be made (one of several methods) by mixing tobacco stems, dust, and other scraps, adding a liquid solvent to form a "slurry," and then extracting the liquid and pressing the remaining mixture into a flat sheet. Almost all U.S. cigarettes contain some reconstituted tobacco. (Vogues, E. Tobacco Encyclopedia, published by Tobacco Journal International 1984:389-90.) 22. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Analysis. Report on analysis of packages of cigarettes. April 4, 1994. 23. Hertz, A.N. The flavourist's role in the cigarette design team. World Tobacco March 1985:97-104. 24. Herach, J., Libert, 0., Rogg-Ef front, C. Final Report on Project Hippo I. Batelle Memorial Institute, Geneva, for the British American Tobacco Co. Ltd., January 1962 (released by Brown & Williamson Tobacco Corp., May 16, 1994). 25. Haselbach, C.H., Libert, O. Final Report on Project Hippo II. Batelle Memorial Institute, Geneva, for the British American Tobacco Co. Ltd., March 1963 (released by Brown & Williamson Tobacco Corp., May 16, 1994), 26. Geissbuhler, H., Haselbach, C. The Fate of Nicotine in the Body. Batelle Memorial Institute, Geneva, for the British American Tobacco Co. Ltd. , May 1963 (released by Brown & Williamson Tobacco Corp., May 16, 1994). 31 27. Gilbert, D.G., Robinson, J.H., Chamberlin C.L., Speilberger, CD. Effect of smoking on anxiety, heart rate, and lateralization of EEG during a stressful movie. Psychophysiology 1989;26:311-20. 28. Pritchard, W.S. Electroencephalographic effects of cigarette smoking. Psychopharmacology 1991;104:485-90. 29. Pritchard, W.S., Duke, D.W. Modulation of EEG dimensional complexity by smoking. J Psychophysiology 1992 ;6 (1) : 1-10. 30. Pritchard, W.S., Gilbert, D.G., Duke, D.W. Flexible effects of quantified cigarette-smoke delivery on EEG dimensional complexity. Psychopharmacology 1993;113:95-102. 31. Meeting. Food and Drug Administration officials; William K. Dunn, former researcher for Philip Morris, Inc. ; and counsel to Philip Morris, Inc. Law Offices of Hunton & Williams, Richmond, VA: May 10, 1994. 32. R.J. Reynolds Tobacco Company. New cigarette prototypes that heat instead of burn tobacco. Chap. 7 ; 1988 : 457-459. 33. U.S. patent no. 3,356,094 Cl:8-10. 34. Sir Charles Ellis, Scientific Advisor to the Board of British-American Tobacco Co. , July 1962 (as reported by Hilts, P.J., in the New York Times, June 16, 1994). 35. Sir Charles Ellis, Scientific Advisor to the Board of British-American Tobacco Co. , July 1962 ( as reported by Harris, R. , for National Public Radio, June 14, 1994). 36. Hutchison, K. , Gray, J. A., Massey, H. (chapter authors). Biographical Memoirs of fellows of the Royal Society of London: Chapter on Charles Drummond Ellis. by the Royal Society 1981 ;Vol . 27 : 199-233 . 37. Sir Charles Ellis, Scientific Advisor to the Board of British-American Tobacco Co. , July 1962 (as reported by Harris, R. , for National Public Radio, June 14, 1994). 38. Excerpt from a British-American Tobacco Company research chronology from June of 1967 (as reported by Hilts, P.J., in the New York Times, June 17, 1994). 39. Excerpt from a May 30, 1993 British-American Tobacco Company internal document entitled "Confidential: A tentative hypothesis on nicotine addiction" (as reported by Hilts, P.J., in the New York Times, June 17, 1994). 40. Excerpt from a July 1963 Brown & Williamson Tobacco Corporation internal document, authored by its General Counsel Addison Yeaman, analyzing whether the company should acknowledge the hazards of cigarettes or remain quiet (as reported by Hilts, P.J., in the New York Times, May 7, 1994) . 32 33 34 c 1^ ^ c § o c ^ (0 o 1^ 0)£ M^ 03 0) 0 by wei igher t G) O O o (0 O ercent lantly h o 15 o c o 3 (0 o 3 ^ c ^ s 0 c ■ ■■■ o o (0 5 V) c — mal va rcially. < o o> «o CO o ■ ■■■ c (5 > "ii o g QL o (/) II > E a. c H ■^^ c o .2 CO (0 o m 1 1 1 35 in CNJ 0) o (0 ID o c 03 0) > s (0 'in 3 . ■■■■ o o c o o 0) (0 lU o ^^ O C o LO 3 CO U. O LO £ c 0) H C W Csj 8 ^s ^ m W (0 ^ g o D CL N 8 o 5 2 o (0 a Q. (0 c c> c o o < o o> (O CO o CM O) •<5Q- OS S '5 4-1 (0 Q. QQ 36 0 c c 0 ■ ^^ ducing o o c 0 0 E a o 0 > 0 O) c o o c 3 " - o S; lo- co o ■ LL. 0) o o 3 ■D 0 0 E OS 0 o (0 0 c T3 c (0 D (/) ^ (/) 0 c5 0 o (0 c cn 0 a *^ II still be y the sm ■^ OS 0 E 0) > ■D O 0 E jd S 0 "D o 0 > 0 -a 0 c 0 ■ a 1 (0 0 c 0 3 0 o 1 there wi to satisf oo CO 0 3 O "oo c > 5 o c OS o o o O o o o o ■^^ "S) 0) u o •5 *5 E 3 0 0 o c o o 0 c o 0 0) O — 3 0 ■o C re n .2 w O (0 n o 0 (0 o 0 -^s • ^ E ■ ■ ■ (0 3 (0 0 0 > 0 c *- O 0 O <5 "c q> 1 37 in o O z Q. cc 1 > Tetrapioid Progeny ler Cultui Sorting X # O) Nicotiana rustica c o Q. edin X # X 0) 00 in O C/) 2 ? TheB X # ssue Cul ast Fusic 00 in O Ti Protopli c (0 o Q. O u o o c £ u c « D. < C (0 < o n o CM c m a. N CO CD SP 38 m 3 3 o 0 < t ! ^==^- CO c .2 '■B UJ c (0 E Q> O a. c o c £ o «r a. o o c ■■5 a> a> w CD 0) 3 O CO 39 0) "5 O 0) 3 0) (0 lij o m CO c ■■5 lU c 09 E o Q. c o o -s w Q. O o 'il at c '■5 Q> Q> k. CD (l> J» 3 O to 40 41 Y-1 : Restriction Fragment Length Polymorphism DNA Differences Bgl II Bam HI Pvu II 1234 1234 1234 Tobacco mitochondrial DNA fragments identified by hybridization with mitochondrial probe pMNS 198. Lane DNA Sample 1. P.P. Y1#26 2. Y1 3. SC-58 4. NC-95 5. Molecular Weight Markers (kilobases) {Source: U.S. Patent Application # 761,312) CHART 10 42 CO CO f- (0 o 4irf CO 0) ■ ■■1 .\ ■o .V c -o <0 E c o to O 3 O »- o >eals an o > o o evelop ally an mmerc ly rese taste a ig toba theN. CO a . aj of Patent App ruary28, 1994 (0 o c o ■ ■■■ c [needed in d agronomic Lable for coi i.e. it close a pleasant d in smokir assessed of (0 •2 o en plished bef speal before the Board er. No. 07/761,312, Febi 0) suc< at is suil ion, des 0) o 3 E o o CO < w > c 3 CO 12 c "5> ief on tter of c CD ^ ^ 3 o c -- cS o CO o CD £ "By the prese applicants ha tobacco plant morphologies tobacco prodi SC 58, and pr aroma when i products, yet high nicotine c 0) o n o c (0 CO (emphasis in (Source; Brown & Williams Interferences in tl 43 Where Y-1 Was Developed and Grown CHART 12 r^-^ 44 < "O c O "C o o S5 X ^ nj Oil !-■£ (Q o (A .£'5 o c (0 "O 0) 0 (0 o o o (0 o (0 t o a X 0 o 1 c 0) n >.t: - ^ I- c £ o (0 o Si, 8 2 « o o % (Q U r ^ o c/) (ft x: c -^ S 5 5 « o.^ '•^ E r * «^ ti ^ r^ O V «^ E il u .= » O «ii ■o Q^ Si S ^ 3 c a> f °^-o o o c *" •Q (0 2> w o ,- ^ «^ (ft (ft C c *- 0 TO £ £ a = o 3 3 (ft (0 go 0 0 c (0 0 iT 3 Q..2 •C (0 o o 3 = CO Q. Q. 11 iS 3 O) C Q. Q.< O O ■o 0 0 . o c 3 O (ft 0) 2 CO Am 0) E (o 8 o ^ ^ CE 45 c O w 13 .9 a, < o o> CO c o o o ^ 0) CO > i> S (0 CO O (J LU ^ O IE ■ CM c • MM ^ c 00 -t^ Q. Q. < c 0) o c o t> CO o CO o c CO ica 0) Q. c o Q. c o *-• o . CM ■ CO nif (/) Q- E > Q. ■ (0 N 0) o re (A CO 0) o O) .2 0) C/) ■ (0 (0 (0 Q. of Si ^^B S^BB m (0 o ■D >« ■D * &Wi ntVa (A 0) en 0) 0) a Q. (0 Q. Q. < CO c CO aban ation > 66 5 5 C en 5 o ffi o CD * QQ CD (L m CL m < o ■ ■ ■ ■ ■ ■ CNJ ■ ■ ■ ■ O) ■ ■ O) o O) O) (O J^ v^ 1^ w ^Mk o S 00 CM O o 12 Q. Q. ^ ^■M JBtf 0) 0) o 0 CO (B • (0 • CO • • • 1 • 46 ■ ■■1 o 0) N 0) "O N K N 0 (0 ■ ^^ ■ ^^ (0 O) CO O) ^k c D) 3 0 c o N (/) N ^ 5) (/) ^ (0 o o o CO c 0) G) C3) c T3 U) G) >» > C c £ o o TO TO O) (0 ■ ^^ 0) o 0) o o O 0 TO o ■ ■■■ ■ IHM ■ ^^ > • > • • • • 47 o n E o o o G) C) ■o.s « o C c C ^ i^ E — ^ CO CO ^ Ci CO = o (/) o 0) cu ^ 0 o a O 0) c £ 'c ■ ^^ o S o T3 CO 0) C/) (0 ■ ^^ O CO O CO (0 — (0 CO c ■ CO CO o CO o CO CL o g E ■ ■■■ 0 O -^ O " « a E.E o "o r " S S o i2 I 5 n o O — > ♦-CO) < O -D 0) .iii :: 48 c lend, ts and O 3 o o 0 0 o c o 03 03 o 03 c o -^ o o c 2 -Q 75 (/) c 15 0 o. o « Q. acco ine Si o "5 o o c 0 5 < o E 03 a o) E.E O T3 -S d to a tob ous nicot (/) 0) 03 < 0 o 05 en E 0 o E 0 c o o c (0 0 D n c o ■ ■■■ ■ 0 oil " -Q ft ■^ C 0) < O T3 1 Q> C ■ X 0 (/) o XI s^^ ■O 0 0) 0 0 o ^^ o o "O O) ^ 0 "D o o o o c C 03 0 — ■ ^^ ■ M ^ ^ 03 o 0 o -c a> c cS 0 o ^ 03 5 £ 0 ">< O Q. 0) 0 o 0 0 /) E ii (0 o 0 *o O > 03 0 03 E i2 ^ (D £ 0) c 03 C 3 o (0 0 c5 03 JQ ^ O ">< c3 ^ ^i^ ■ ^■1 o n 0 o 03 49 1 ? ^i 0) O c ^ 05 ".^ **- o 5 o ^ S S2 I — m 0 3 c o C CO C3) CO f (0 •s a. o ° (0 0) Q. (A 0> E r re V (/) re O) o> 3 O Q II o lO CO c^ ■a O — > »- ■Si = E I o £ E £ 1 = 8 O 3 in in (S3|duies |e}0) p %) Aouanbajj u (0 c ■= > £ o Q o c •o « w Jo's o *0 .^ D) C C 3 iS « -s cfl E ^ ~ ^ 0) S 0 ^ 3 0 0 ■ ■ ■ .D "O ^ 0 (0 ^ c ^ o roduct ventio o E c o o ■ ■ ^ byp inter c 0 ^ c V E 3 U o c (0 a E o u o o o (0 o < I N 52 - -^ 2 I O 3 = CU O o ^ +- o -^ C CO iS *- ^ O) (O O) CD ■ ■^ f- c o ■ ■■■ ■ ■^ CO t^ s r\ CO M ^ C/) o 0 o N o ■^ CO 3 13 o CO 0) ■o *^ 0) CO ■o 0) 0) Q. 0 CO 3 O CO CO 0 c £ E = 1 2 o am .2 w ft « Ol ^ _ (O O) (0 m o ^ w ^Z n o S Q. > Q. 2 if Ij ♦^ , u o V o o o Q. o C ra O ^ o ^ Q. c 0) ffi QC o 'l. 75 0) c E LL < q> u ^ 3 O W 53 If upset by a five-year old . WKy be Irritated ? Ligk an Old Gold Ir» tho»r txtra touchee ihal make OM Cold ynur ^xtra friendly ciparclltr. A|»|ile ^Hot»c%,*** for inKUnrr, fiivrs you inorc<-lhan- Qkual frc*line66. l^e vorlH'k most Lrrasurccl lolMCrun «rr bleiiUcd whb extra care. Kore, importtfJ LjiUikia lolHireo arldn lis OH-n »I>erial luxury (^flavor. Evrn rbe fiue, fnou-y Hparelle |wpcr . . . mode frotn virgin purr Jinx . . . coiilrilHiles it» euperfiuc quality. r,ri fricuHly vt lih *Hrl Colilft — they're your kiud of eiparrllp! *^IuA l'uf>. tArjiurr cf ftmk affect, o tftnal n*-Mirim ^mijt^f e^nt ur ••M l^/Jf -ISvtify' hr'pt trrp OU CvliL frn Ji-jf •t/ftinir 4'j USrtH TO F8ANK SINATRA •nd MET MC a puirs CHART 22 54 0 .9> o o o (/) o 7 (Q 0 > o o n to 0) (/) o E c o ^ 0) (0 o "5) = £ iH .2 c (/) 0) >E 3 X O 0 03 CO E (0 (0 > o >* O) n o -a o 0 o (0 3 (0 0) E (5 E a ^ O) o> ^ T~ (rt re (U ^— c 0) i O 00 6 c *•* 3 5 ♦- o '*- w W CO c >> ^— ^ re ^ ■o o 0) E re u 0) S V 0) CC ^3 V. (U n (O re O) m O re OQ - a> c _i ^^ c 6 0> o c o '^ o o o u re n z o ,^ >- o c 0) re re o u. E < oi u k. 3 O CO 55 ^ (U > o *rt _ ^ 3 c o "5) o o His, Scientific Advii of British-Americar , July 1962 (as repo ork Times, June 16, 0) c s • ■■1 c o (0 Q. > (0 ■ ■■■ E (0 0) (0 0) r Charles E the board tbacco Co., the New Yi >% o "U ^S{i.£ c (0 "<0 1 o (1) c 4^ 3 o o ■ IBM o c c 0) ■ (0 £ (0 (0 ■ ■■i o ^ 0) 0) o moking G) (0 ■ MB o o 0) c (0 > z "3 T3 i3 (0 (U 56 - >. c ^ ^ 0) k. «l o r\ r o c Si ■ ■■1 00 4-> 3 ■ .<« c > to O T- c (/) 0 ;^ ^ 0) to 0 Ijz ■^ E li n 0) ^ 0 If CM-' 0) o CO (0 1^ i5i JQ (0 "n ■ ^^ ■ ^^ (5 E o (0 o 3 TO -Q > £ i2 "(0 ^ Q) E CO ■D 0 O 1 (0 (0 c 3 O , >§■■ o 0 c 0 n ^ o C (0 laa ■ ^^ ^"^ Q. 4^ (0 ^^ O (0 CO o 4^ c ■ ■MB c ■ 3 o o ■>< £ ■o 0 (0 57 ■ CO 0) ^ .5 o c (A (D }^ s >.y ^ ■ 2 o O < c^ ^ ■ BB S £ to ^ ^■irf .Si w a> e Q ■■■■ ■D .<2 2 5 1- (0 o (5-Q m 0) .,» ■■^ •^ o (0 iz a> n 1 H w-3 05 1 H (0 (0 ■ ^■B D) C ■^^ ^ o E c (A O o 0 O o ^mi BM^ ^m OS c o (0 (A O ^ (A £ BHiM o rfi = a> lU — (A.i2 *■' arle tco c (0 ■ £ > o m 0) str ^ 4-' 3 > n W ^ ■D C/) £ (0 C V ■c o a ca (0 c 0) o w d O o o o (0 o h- c CO E ?J < . = 1 O to E S 0) ^ r- >• ID ^ C Q) Si a o 59 "Think of the cigarette pack as a storage container for a day's supply of nicotine." Think of the cigarette as a dispenser for a dose unit of nicotine." William L. Dunn Jr. 1972 CHART ?8 60 "Think of a puff of smoke as the vehicle for nicotine." "Smoke is beyond question the most optimized vehicle of nicotine ..." William L. Dunn Jr. 1972 r-!.'.PT 61 ^ o" o> ds to restore ioning of the -increasing essary to 0) o 0) "E o c CO E 0) ■o 0) vely slow for "Confidential. A Tentative lew York Times, June 17, 19 ne ten 1 funct at ever o 0) c ■ c o 0) c "co o (0 May 30, 1963 rted in The N ■+: CO _c CO Jl ^ JZ pi ronic intake of nico normal physiologic ocrine system, so t 0) c o o c o u> 0) > 0) 0) o CO ■D 0) "55 0) ■o 0) c ■2 c ings, such as morp easing dose levels 0) c o o c itish-American Tobacco Co. paper date pothesis on Nicotine Addiction," as re = ^ 0) o '5 E o o c ffl X a 62 CO o» o> o (0 c 0) 1- ^^ £ o c « ^ ^— ■ ■■i .2i 0) o 5~ o ^ 1- o A body 1 o 0) > (0 0) O to 0) o (/) c o o c c 0 ?; British-Americ Hypothesis on o ^■^ 3 o 63 o c ■ 1^ (A o 3 ■o n ■o o (0 £ c *^ (0 c VN ■ ^■i 0 c c the icot 0 c nj (0 0 ■ i^H ^ 0 (A o 0 "w £ E O 0 gl V (A !>! c-55 (0 E c (0 3 §2 M (I) 0) if E 2 .2 w w 1= ^ Q) 1^ C t- (0 ^ 03 -9 is ^ <0 64 Mr. Waxman. Thank you very much, Dr. Kessler. I have to tell you that I thought your testimony was riveting and I want to com- mend you on the investigation that you and the people at FDA have conducted at least to this point. We have heard over the years and eveii very recently in this sub- committee from the executives of the tobacco industry that they don't think smoking cigarettes is addictive. Now, they certainly know that nicotine is a property of cigarettes. You've said it in your testimony. You want to lay to rest once and for all the industry's assertion that nicotine is not addictive and you go on to say that the release of company documents and testimony of company scientists has opened a window on what some senior tobacco officials knew about nicotine's physiological and addictive properties as long ago as 30 years. Is that correct? Mr. Kessler. That's a correct statement. Mr. Waxman. So, in other words, you are telling us that tobacco company executives and those in the tobacco industry have known for three decades that the nicotine in cigarettes is addictive and is causing a pharmacological reaction in people which causes them to smoke. Mr. Kessler. I was reading their words, Mr. Chairman. Mr. Waxman. What is it in the tobacco or the nicotine that keeps people smoking. The executives told us it is not addictive and, in fact, nicotine is solely a function of giving people a taste or a flavor in the cigarettes themselves. In your investigation, is this the conclusion that you have reached as well? Mr. Kessler. Mr. Chairman, when you smoke a cigarette, within 8 to 10 seconds, that nicotine travels through the lungs into the blood stream and starts affecting the brain. It is that portion of the brain and those chemicals that nicotine affects that result in this nicotine psychoactive effect, and that psychoactive effect makes it addictive. Mr. Waxman. If that nicotine were administered through an oral dose, a pill, or a patch or an injection, would it be any different? Mr. Kessler. No form of nicotine delivery is as potent that I know of as smoking. Inhalation results in very rapid transfer of nicotine from the delivery agent to the brain. Eight, 10 seconds. Mr. Waxman. Now, you've indicated that when you first looked at this issue of whether there can be a genetic manipulation of the tobacco plant to increase its nicotine level, you were told that it couldn't be done. Who told you that? Mr. Kessler. Let me turn the microphone to Ms. Witt who was at one of our trips. Mr. Waxman. There is a microphone she could use right there. Just push the button on the base forward. Ms. Witt. Mr. Chairman, we visited the Brown & Williamson fa- cility on May 3 of this year. Several representatives from FDA vis- ited Brown & Williamson and, at that time, company officials told us first that it wasn't feasible to increase nicotine levels in tobacco because of voluntary agreements that the industry had entered into 65 that would preclude them from growing and selling this nicotine in the United States. We also asked them as part of our general investigation into whether they were manipulating nicotine levels whether the com- pany had engaged in any breeding of tobacco for high or low nico- tine levels. At that time, they told us the answer was no, they had not. Shortly thereafter, their in-house counsel offered the qualifica- tion that they might have provided some unrestricted grant money to universities that might have been engaged in breeding research. Mr. Waxman. In other words, you asked the company officials whether they could breed and plant for higher nicotine levels. When was that first question posed to them? Ms. Witt. On May 3 of this year. Mr. Waxman. And their response was that they could or could not? Ms. Witt. That they did not and that it would not be feasible to do so in any case because they couldn't grow it in the United States. Mr. Waxman. And that was this year they told you that? Ms. Witt. This year. Six weeks ago. Mr. Waxman. Now, as of last Friday, after they learned all that you now know about the Brazilian operation and the commercial use of this genetically altered tobacco plant, Dr. Kessler, did they have any explanation for their inconsistency? Mr. Kessler. Ms. Witt also met with them on this Friday. Let me let her comment. Mr. Waxman. OK Ms. Witt. The explanation that they offered was that they thought we were asking whether they had genetically engineered tobacco and that the answer to that was no. Having been present at the original meeting, I can tell you that I had no idea that there was any genetic engineering going on and that the only question we asked was whether they were breeding tobacco for high or low nicotine levels. Mr. Waxman. That sounds like a pretty deceptive or misleading way of answering the question unless you knew what you later found out, that they had gone through this whole elaborate system of genetically altering the plant and using a ranch or farm in Brazil to produce that plant, their answer would have stood. Mr. Kessler. Mr. Chairman, I am not here to characterize any statements. We would be happy to provide the committee with the factual basis. Mr. Waxman. All right. I appreciate that. I think we can draw our own conclusions as to whether they were being helpful to you when you inquired of them whether they were able to ao this sort of thing. But they not only, like a lot of these patents you discussed last time you were here, were theoretically able to increase the nic- otine levels through genetic change, it wasn't theoretical, they in fact did it and it was added to cigarettes in this country in the last year or so; is that correct? Mr. Kessler. That's correct. Mr. Waxman. And in this genetically altered tobacco plant, how great was the increase in nicotine levels? 66 Mr. Kessler. Andrew, do you have — ^there is a chart that com- pares the flue-cured with Y-1. We were told by the industry in a letter that we received, it wasn't from this company, but it was a gen-'jral statement about industry practices, that flue-cured tobacco natursdly contains about 2.5 to 3.5 percent nicotine. Patent claim number 6 of the Brazilian patent states tobacco plant and they were referring that patent for Y-1 in accordance with claim five characterized by the fact that the nicotine content is approximately 6.2 percent. Mr. Waxman. So they are able to double the nicotine level in to- bacco through this genetic alteration. Mr. Kessler. They were able to double it compared to flue-cured tobacco, yes, which is what Y-1 is. Mr. Waxman. How did this transfer into the cigarettes being at a higher nicotine level if it was in fact at a higher nicotine level? Mr. Kessler. What the company has told us, what their purpose was to be able to lower tar and maintain nicotine. We are not here stating that the issue is putting an enormous amount of nicotine beyond traditional ranges, but what was important was to keep the nicotine, I believe, in that traditional range and that traditional range as we said is more than enough to be able to create and sus- tain an addiction in my opinion. So what they wanted to do was maintain the nicotine while lowering the tar. That was their intent as they told us. Mr. Waxman. So the nicotine is not just simply a by-product of whatever the tobacco might be. It is a carefully calculated level in every cigarette that is sold in this country? Mr. Kessler. Mr. Chairman, the story of Y-1 is one example of nicotine being, as you said, doubled compared to the standard flue- cured variety. We have spent a lot of time looking at the Y-1 story. The reason why the Y-1 story is important is not for the sake of Y-1. The reason why the Y-1 story is important is it goes to the heart of the assertion by some in the tobacco industry that they do not control or manipulate nicotine. I don't know how you design a plant, you genetically alter a plant, and spend a decade doing that and say you are not inter- ested in controlling or manipulating nicotine. Mr. Waxman. Thank you very much. Dr. Kessler. Mr. Bliley. Mr. Bliley. Dr. Kessler, I listened to your discussion of the nico- tine plant that Brown & Williamson apparently developed which has a somewhat higher nicotine content and a somewhat lower tar content. You appear to be suggesting that B&W did something to the cigarette ana possibly detrimental to human health. Don't you know that the Federal Grovemment, through its Cancer Institute proposed just such changes in tobacco? Specifically, I wanted to ask you if you are aware that in 1980, Dr. G.B. Gorey, the director of NCI's smoking and health program, proposed just what you are now accusing B&W of doing surreptitiously. I would like to introduce for the record and read a quote from Dr. Gk)rey's presentation. He stated that NCI, that is the Federal Government, as late as 1980 was considering just that relationship of nicotine to tar as follows: The end of this review, one cannot avoid a special consideration for nicotine which, besides being a 67 major contributor to the taste and smell of smoke, is the most im- portant pharmacologic principle in the complex relationship be- tweerf the smoker and the cigarette. Most commercial cigarettes in the United States have maintained a ratio of approximately 1 to 10 between nicotine and tar delivery in cigarette smoke. But in the last few years, new generations of cigarettes have begun to appear on the market where the ratio of nicotine to tar has been pushed to as low as one to five or less. Thus, it may be possible to reach levels of nicotine concentration in the smoke that are still pharmacologically satisfactory but so low as not to pose significant concern. Dr. Grorey then went on to explain exactly how this change in the nicotine to tar ratio might be achieved. The progressive reduction of nicotine to tar ratio in commercial cigarettes is a feasible but not a simple proposition. It may require changes in tobacco varieties, and agricultural practices in the field of tobacco processing and blending and fine tuning of filtration and ventilation practices before the ratio could be favor- ably altered for the majority of cigarettes on the market. In other words. Dr. Grorey was explaining that perhaps it would be useful to increase nicotine delivery relative to tar delivery an- ticipate that it might be useful to try to do that by changing to- bacco variety which, as I understand it, is exactly what B&W ap- parently did. My question to you. Dr. Kessler, do you believe that it was wrong for the Federal Grovemment through the National Cancer Institute to encourage the tobacco companies to try to change tobacco vari- eties in order to increase nicotine relative to tar delivery? Do you believe it was wrong for NCI to work on these sorts of things with the tobacco companies in the 1970's before Secretary Califano pulled the plug on the government's less hazardous cigarette pro- gram, and do you believe it is now fair for you to accuse these com- panies of some type of insidious manipulation when all they were doing was precisely what the Federal Government suggested that they should do to yield a cigarette that still had the taste and smell of smoke produced by nicotine but had somewhat lower tar deliv- ery? Mr. Kessler. Mr. Bliley, I am not here to say what is right or what's wrong. I am simply here to say that if what Dr. Grorey said in fact was what was going on, then I believe that is evidence of manipulation and control of nicotine. If you are doing what Dr. Grorey is suggesting and you understand the pharmacological ef- fects of nicotine, then I believe that is relevant to the Food and Drug Administration's determination of whether nicotine is a drug. It may well be that people addicted to nicotine need nicotine in some form, but if you are going to have a nicotine delivery system and you are going to have what Dr. Grorey is suggesting, then the question for this Agency is whether that system should be regu- lated as a drug. Mr. Bliley. You apparently, Dr. Kessler, have not read your Sur- geon General's report before claiming that the FDA has made a "startling discovery." Let me read to you from page 50 of the 1981 Surgeon Greneral's report which clearly stated that scientists were actively involved in the genetic manipulation of tobacco plants to yield a wide range of nicotine levels. 68 A substantial collection of tobacco lines is available to plant ge- neticists. These include 63 species related to tobacco and about 1,000 different tobacco varieties. The wealth of this term permits genetic manipulation of leaf which could be used selectively to en- hance or reduce the content of specific constituents. Among flue- cure tobacco lines available at present, the nicotine concentrations varies from two-tenths of 1 percent to 4.75 percent. Among various barrier lines, the concentration varies between three-tenths of 1 percent to 4.58 percent. The ranges should be ex- tended by agronomists should that be desired. Did you not read this report written 13 years ago before making your statement here today to suggest that B&W variety was some sinister genetic plant. Mr. Kessler. Mr. Bliley, not only have we gone through to 1981, I have read an enormous number of papers on genetic breeding, I cited papers that go back even earlier than the 1981 Surgeon Gen- eral's report. I cited Dr. Chaplin's work in 1977. This cross of 6.2 percent is higher than any commercially viable — it was higher than even Dr. Chaplin initially thought he could get. I asked when I read this report, I asked in fact Dr. Koop who was Surgeon General back in the early 1980's, what he thought about a high nicotine, medium nicotine, low tar cigarette, and his answer to me was if in fact companies developing a medium or high nicotine cigarette ^vith low tar and are doing it by manipulation, that is, in his opinion, a nicotine delivery system. Now, that was not in the 1981 Surgeon General's report, but that's what Dr. Koop told me very recently. Mr. Bliley. You mentioned Dr. Chaplin. When he started devel- opment of the strain of Y-1 tobacco, was he not an employee of the Federal Government? Mr. Kessler. He was an employee of the Oxford Research Cen- ter of USDA. And he also had an appointment in North Carolina State University. Mr. Bliley. Thank you. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bliley. Mr. Synar. Mr. Synar. Dr. Kessler, again, thank you for this very important testimony and with it, I think we may come to a close of this de- bate with respect to whether or not tobacco companies do indeed manipulate nicotine. Not to oversimplify, but to summarize what we have learned today — manipulation really takes three forms — one, planted breeding, second, chemical charging and third, targeting levels of nicotine. What I am interested in is the motive behind this and I think you may have given us that with chart 21, and if I could ask the staff to put that up. I am particularly interested in the last sen- tence, "It was also our purpose to compare these effects with those of new drugs called tranquilizers which might supersede tobacco habits in the near future." Does that sentence read to you as it does to me? Which is one, it is an admission that nicotine in tobacco is indeed a drug and that, second, the entire manipulation may have been because of their fear of the competition of future tranquilizers? Mr. Kessler. It is a statement that certainly reflects the concern about their market share versus tranquilizers. Mr. Synar. That's all I have, Mr. Chairman. 69 Mr. Waxman. Thank you, Mr. Synar. Mr. Greenwood. Mr. Greenwood. Thank you, Mr. Chairman. Dr. Kessler, your testimony has been fascinating and interesting in that it has helped us to better understand a fine point in the debate about the ability of tobacco companies to affect the amount of nicotine in their product and whether or not they can somehow inject it into the process or whether they actually manipulate the tobacco leaf itself. But it doesn't really go at all to the central question which you raised in the first sentence of your testimony which is whether the Food and Drug Administration should regulate nicotine containing cigarettes as drugs under the Food, Drug, and Cosmetic Act. That's really the issue. This is interesting, but the issue is whether we ought to change the law in some way to give you the responsibility to do that. Let me make it very clear that I don't have any interest in de- fending the tobacco industry. I think the world would be a lot bet- ter if no one smoked another cigarette and tobacco companies went out of business. We would all be healthier, and that would be fine. The question is what is the government's role and specifically what would the FDA's role be in controlling and regulating tobacco prod- ucts if we gave it to you? Would tobacco companies be in the business of advertising that their cigarette is guaranteed by the FDA to have the highest nico- tine levels possible? Do we want to see the tobacco company saying that Dr. Kessler has certified that the tobacco in this cigarette is the safest cigarette on the market or that this has been approved by the FDA to contain no higher levels of tar and nicotine? I don't see that this would be progress on public policy with regard to smoking. What would be the Fed's role? Would it be to limit nicotine in cigarettes, to set some sort of level and say, "All right manufactur- ers, you can't have more than this amount of nicotine in your prod- uct and tar and so forth." If that is the role that the FDA should play, where in Grod's earth would you set that level? Who wants the assignment to decide what is the lethality or the habituating quali- ties of cigarettes? So I guess my question for you is, flat out, do you want the re- sponsibility to regulate tobacco products and, B, if we gave it to you, what would you do with it? Mr. Kessler. Congressman, I think those are all excellent ques- tions. Please understand that the current Federal Food, Drug, and Cosmetic Act has a definition of drug, and without any other con- gressional intervention, then we as an agency are left with the question of deciding whether nicotine-containing cigarettes, and it is a nuance here, but we are focusing on nicotine in the cigarettes, nicotine containing cigarettes rather than just the cigarettes, whether the nicotine containing cigarettes are drugs for the pur- pose of the Federal Food, Drug, and Cosmetic Act. If Congress does nothing, if Congress is not in a position to be able to give us guidance, then we have a responsibility to answer that question under the law as it is presently written. 70 Let me go to the broader question because, under the law as presently written, it is fair to say that the tools available to the Agency are relatively crude. We can decide it is a drug. We can look at different levels, but they are relatively crude tools to look at nicotine in cigarettes. I believe that if I were sitting where vou are sitting, what I would focus on and I would ask myself tnis question, how can I prevent the next generation of teenagers or at least some in the next generation of teenagers who are going to decide, for whatever reason, to start their first cigarette, how can we reduce the num- bers of them who are going to get addicted to cigarettes? Prohibi- tion does not work. Mr. Greenwood. Let me interrupt you. I think that is a good policy question, and I think that question is probably largely an- swered by saying that programs in schools that my little girls have been exposed to are very clear about that. We have all sorts of pub- lic service announcements, role models, and certainly the role of the parents is first and foremost. The question is: What is your agency's role, and if you were me, you would probably ask the head of the FDA what do you want? What responsibility do you want in this process? What do you think would be good public policy in terms oi the FDA's role? Mr. Kessler. I believe steps that would reduce the risk of a teenager from becoming a Mr. Greenwood. Let's be more specific. How do you do that? Mr, Kessler. The current cigarette Mr. Greenwood. You get the authority, then the tobacco compa- nies have to bring their product to you, and you have to say some- thing about it. Mr. Kessler. There are many things that could be considered. One, you can consider restricting access even further. Two, you can consider looking at nicotine levels, the current cigarette has mul- tiples as far as amounts of nicotine that will create and sustain an aadiction. Wouldn't it be great if a teenager who is going to smoke a couple of cigarettes didn't get hooked on that nicotine by the amount of nicotine in that cigarette. It is a very difficult question because, ob- viously, we have 40, 50 million smokers. Mr. Greenwood. We give you the authority, and you could limit the amount of nicotine in cigarettes, and then the cigarette compa- nies could go into Sports Illustrated and advertise that Dr. Kessler says, "This cigarette won't get you addicted." Smoke it. Mr. Kessler. Congressman, you could also restrict the advertis- ing in the magazines. There are many things that could be done. What I would focus on is how do we reduce the demand for ciga- rettes and the way to do that- Mr. Greenwood. I have a hard time imagining Mr. Kessler [continuing], is to reduce the number of people who are going to become addicted. Mr. Greenwood. I agree with that, and I want to see it happen. I just don't see what the chemists at the FDA have to do with it. If it is a pharmacological product that is FDA approved, your job is to say, yes, this has the right dosage to cure what ails you. It is not too high, won't have these side effects; not too low, won't be 71 ineffective. That's the role of the FDA in many regards. We can pass laws about advertising, we don't need the FDA to get involved in that. Mr. Kessler. Congressman, we will convene in early August, one of our advisory committees, the Drug Abuse Advisory Committee, to look specifically at the question of what are addictive levels of nicotine in cigarettes. When we have those scientific answers, I would be happy to come back and share that information and con- tinue this dialogue with you. Mr. Greenwood. OK Well my time is short and I think it is running out. But let's get right to the question: Do you want us to give you the authority to regulate the content of cigarettes? Mr. Kessler. I think the Congress should give us guidance under our current authority of whether we should regulate ciga- rettes as drugs. Mr. Greenwood. I would like you to give us guidance as to whether you want that authority. Mr. Kessler. I think when you look at caffeine and alcohol and other things that the cigarette industry is currently putting out there in the news, those products are regulated. I see cigarettes as much more hazardous by orders of magnitude and I don't under- stand why all those other substances are regulated and cigarettes are not regulated by the Food and Drug Administration. Mr. Greenwood. I take that as a yes, at this point, you would like us to put your agency Mr. Kessler. I would like you. Congressman, to do — for us to fig- ure out the right policy steps based on the right scientific answers so that, together, we can reduce the demand to reduce the future generations from becoming addicted. Yes, I think that is scientif- ically possible to do by focusing on the nicotine in cigarettes as well as considering other policy options such as you raised, advertising such as restricted access. But prohibition won't work, we are going to have to do this by reducing demand. Mr. Greenwood. OK. My guess is that kids that smoke ciga- rettes don't smoke them because they are addicted early on. They smoke them for a lot of ridiculous social notions about what is cool. Mr. Kessler. Congressman, exactly Mr. Greenwood. FDA ain't going to fix that. Mr. Kessler. But what we can talk about is if they are going to smoke cigarettes, is it going to deliver the kind of doses of nicotine that are sure to get them hooked. That's what we need to focus on. How can we prevent that teenager who's going to smoke because of peer pressure or because someone in the family is going to smoke, how can we reduce the risk of that teenager getting hooked on cigarettes? You are right. They think they are going to get hooked. They smoke because — they smoke one cigarette, they think they can stop. They don't know that once they start smoking regularly, it be- comes very hard to quit. Mr. Greenwood. Thank you. Dr. Kessler. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Greenwood. Mr. Wyden. 72 Mr. Wyden. Thank you, Mr. Chairman, and thank you very much for an important presentation. Dr. Kessler. I think the people of this country should not be mistaken at this point. It seems to me that the Food and Drug Administration is now building an ad- ministrative record that would require that tobacco be regulated as a drug in our country. For example, look at what you have said. Tobacco companies have patented the technology to manipulate nicotine content. The tobacco companies have bioengineered tobacco plants specifi- cally for higher nicotine content. Tobacco companies have added chemicals to enhance the nicotine effect of cigarettes. It seems to me that you have already built what amounts to an undeniable proposition with respect to requiring that tobacco be regulated as a drug. My first question to you is: Do you have evidence that the nicotine content of cigarettes tested in your laboratories meets the drug content uniformity specifications that are set out in the U.S. pharmacopoeia? Mr. Kessler. Andrew, could we have the USP chart? My staff always jumps on me when I refer to this chart because it is very complicated. So just indulge me for a second. Congressman. Our St. Louis drug laboratory tested over the years more than 11,000 drug samples and tested many different tablets within each of those drug samples, and we also tested 10 different cigarette brands and tested a lot of different cigarettes within those 10 brands. The bottom line is that if you fall, as you see all cigarettes fall, within either the yellow or blue areas of that chart, you meet USP, United States Pharmacopoeia standards for drug uniformity and drug delivery. You even see that some drugs don t meet that standard but all cigarettes meet it. Now, this, again, shows very fine control, very precise uniformity. It is a measure of Quality control. It may iust be, hey, we just want every cigarette to be exactly the same, out when you get to this level of uniformity, it is striking to us that the uniformity is — does meet USP drug delivery standards. Mr. Wyden. I have heard reports that there is evidence that Eu- ropean manufacturers are using other means of manipulating nico- tine levels in cigarettes. My question to you is: Have you all picked up this evidence? If so, can you share with the subcommittee what information you may have about other approaches being used in Europe to manipulate nicotine levels and whether or not those ap- proaches are used in our country? Mr. Kessler. I have seen certain other additive, certain humectants. For example, I have seen a patent for the use of cer- tain percentages of chemicals, other chemicals that are called humectants, that are used in an attempt, according to the patent, to alter nicotine and t£ir ratios. We would be happy to submit that, Mr. Wyden, for the record. [The information follows:] 73 ■•-=)r»ir>c . aScf—— -*-» •^crwC MORE OR LESS NICOTINE r^s.^-.-r* :f — .octrr. ii^Arrr-es ?*.-Jc-jiA.-rv t.**.c>e an.-, .c-rr ••.a.*" isj-.»re» T^-.e ■' —.f^'y-C-:M-)t tcttccc r-.er.:s Tr.ea* a- -^:Ize^.*J »-„ r.oi aiTtr: the GCer ■ :;=ac^= pr^*l.c?c a: LTR .SZ^ST^ZS Lew ^ar de- ccr.-.T-/ :rgar.c.er-_c .T-ac-''.ca-rr.a We car. Jieip ycu ,^^ii'^- NDUSTRIES Get more tobacco from all vour tobacco LTH ;N3'_ STPJIS a subsidiarv ir. France of © KIMBERLY-CLARK Ccrcrcrcr. 74 R4mjmA. L*arAni»t(«atlon du tabac rvcon«lllu4 I ar/WfM (J(t :aDOC r»con«mu« • «t* un tujttt 09 OlOCuwwi w»'id»ni da aombrou»»« %nnmm^ C'*«1 pour C0ttor«>«en qua LTmndu«lr<»«ii tJ6- v*4oppi !«■ T*ohrlquoo roquiocs pour rr>odlft«r rii''nma <1* mi ga^ii^a da produ^. Co0 1»ctv>t- QiMt oo^lDrftn'^anf it TiooiTirjimrt rtu mftiang* de* maii'MioJi bruia. I •edition oea siuc«] ff I'fp corporal ton dt dift4rsrt> ardmet. D« uiua. (toux lulraa p'^oo>6d6a. nioot^na forttflAa ot >*»- ronsTlTUTion da* cOTa«. ir\f1iionc9nt d temo >rom(id»( t«t>»cohomooert»noo ko* aata i^uva. LT« tiiJuauhm ^« 0«a«rfOll»do loa mft- lodo* corrft«pond>artas para 'a modircacl6o dal troma dtt toe D''op'o« produotoo A aotoa m*todoa p^lanacar* ta v»r aolAn <*a las max- eiBB da niaTarta pnna la aaickdn oe aaiaaa y a •■"UdMiiAa >J« >uala"Uas irLMnatlcaa A«amte. otroa tfoa proc««oa Influyai d-rsttam^nla an ta caiMted oai humo da lo« produoloa tabaoaio ro» la concentracidn ae rucotww y la r acona"- Zu»«mm9nfaaaung: Aromattelemng von rakonadtuJaiiam Tabflk Da» Thama ^roma d«rt. Aua d!aM/n Grunda nal LTP mduainaa Jo zur Mo flifTl^'iiriQ rta^ A/omaa car eiganan bfiai,g- riraa4 0tTcMOa>[li.riaM Maihooan antwlcka'l '■> (jl«»ar MoThoaor aa'^txan dia Andarung Odr Roharonryleohungon. a«r ZuwmU von SoOa*^ ond dia ZoQatea von Afor-aaletfan Aulardam wlrlcw^ aicr /wai irdara pf^n^eaaa. dot Par tat -notM) 'a L'P irviiaim*« f^ iiia»*n I maroli a^' p rroOT'cara 1 aroma 0« propr prooont Finno oaria d) «' maiodi a modinca^lona dalia nlacala \M ma- tana gragga. nor.oha laagi-"" d) conca a dl soatanja aro'^iaticna. Oicracci6, dja attr . pr-o- oadmanrt rmaia arnonfar^ntri *r» mrOT.na a la rtcoadUuiO'^a Jal^a ci^tuia »( th«ma .-4at ■rorttattaa'^n van go^O mnQ«irii»««'rte r«&»»' mfO^fJT ainos ar^^ |ara«> ^f^dU^wawati J. Daafu'M •^•mU LTB rnduatr'aa matbotfaa onrwflbcald. dl« »«r w.|zi«rfrxi van hat aroma «birnan bawarkaiaiitga-« Tot dozo marrwiMi rtah<%pv> (ia verarxlaring van grond- Btoftnangaaia loi loavoagan van aautan tf\ da toagawa van eto~*aioffar Bcrvandla^ wai kan Twaa andoro proooaaon diroot in pp da rookvwa<>t«i1 win am tao»*r«produ«tan ni da nlaollna»«r'l)he stresBBd thai no chwnneal BOd'.- Itvea are required in iniB op*'Btion rne nerea ara tnan dispareea Bui;u aalract li corx:entra!ed tor later addition to The Oa»« sheet i he result ng reconati- tuted tobacco le then dried and cut into atrip 3 Tnough me fexibnity ot the BxaluoJvc Km bony ClorV prooBBB of*BrB marry possibili- tlca for the modlftCBtlon of ihe v^herrilcBl and physica D'ooanlaa of tl>a raw ma tarlals a compiprp mvcuasKjr of tnia arpe ia out of mo scope o' thli article. How- ever, It la tnis extreme tloxibillly w^ich a'- l0W8 LTR lndJStrlB» to modiN lie tlavour of Its products. T«chnlqu« 1 . Raw MalBrtal Modincatlon The two ate p reoonetltutlon process a' lows for the separvtior of the irvater ai- tractot^le conipo-wnia Irom rria inaoiuoie "ibrp Sinna II l» tne exiract wruch conta'na t^s voiatiis aromatic flavour oompoClar1i) procsca alluwB LTR Induatrlaa to taka special eara In coniarvinQ tna true tlavour of Iho ttsrt- lr»g tobacco malonaiB in other worda. tno flavour portion of ths tobacco la not ma- nipulated will- the tlbrev during uroteis- ing Thp ro»ult Is > flnianBd reconatitured tobacco shBBt witn tna asrpa flavour ofwr- aotor ae Iho starting tobaoco raw matorl- als It Is therefore obvkiua that our (ligl tachmuue for tlavoui modlfliatlon la vta the sai action nf -he raw metena; oisnd " one Dogin* wvitn 100 per cant Virginia. 100 par cent oriantal. or a blond o' Vtrglnis and BuMay materials, ttie flavour of tfio lln- lahBd orodUCI will CW either Virou .ut orloo- lai or oHinopd, fpecttvafy i/ae 75 Flavouring. M 26 1 I BKi'^ff tii» pcirr one st»p tui^r&r. e^ojld one widh to inp«r! an onertai robacco noie lo a VlrginlayBurlfty bl^nj. iiiw acd'- Ucx' or cnantat r»w matonim in mp ^ror ing Di»ocNw*li prcdLtC« thrtreajtt. Thio lo luot ooc cxemolc o* t^e n-i«rv fla vojr nodrficBions which cer tie mace Dy prop»'fy rrodIty(r>g trie oimnc o' raw maie- 1918 ooelireo 'o^ 'oconst tuTicn ' Addlrlonaify, the excJuslve erly-Cl»rV rocu'sLilu; ufiyfut;e&&'BQui^BinoctiBm rjj ogom rn •o^'ti r^* Tinianoil QnoQi Tni« It of portiCL ar tmportanc* from a flavcu' poJni of-vlcw beocuA* th« flavour of t^n *tniaTod ar^et l6 noi ofected by T^e TecNnlqiM 7- Cpaing Addition T>ic acoonfl tconntquc fc modftylng th« f!«vojr CT* r»con&titu:©d tobacco 5 via the ■ddttlon df CBBlnga In ihls ease ihe ab HCtjancy cnarnr'Br.a' c^ o* reconaT 'jiPd tob»cco tn»«t ptay an l-nponant ro*o. Tobio t ohowo T^o ponotrotion of propy lera ufYCC>1. a» a f jnc: ori of tirr.o. 'or ! Vee '.sDaccoft and a reconsriuteJ louaccu shoat T>7i»s« CfitB cnr Pa assuned to dp rBproaontsTivQ o* trg panetrstion of a oas rg oeuca. It l6 dearry iius: ated ti^at tacodotiiulvu tobacco sha«t Is stgnntcanrry mcB aDaor 08*^1 aunng the flr«t t'lrTy rri nut»» attar tha apphoatlor orf propytcno glycol This o«n bo axoUtned by a moro open physica' Birurtim of Th» '^ccnj'tnu'ed tobacco Curranry. ^IH induBtrtox appiioa caotnge during rbc rooonatttLr'O'^ proooaa Thooo caairga are ollhor pramlxod aad sant to La by our dlarts or davaicpsdsnd aaded m gh^n proportions Dy our atan Tn»t« eating compoaltlona rnay Includa the oIaooIooJ oorrpononta such aa cocoa. I CLOrtco a^ara. acKJfr. tiul exTrocia aruj humerrianr* Thmy n-^py ilao IndLXJo ftona Ipss cnnvantlcnw' matoraia. notaofy lt>a '^■^i,:v■ ...iMf"'- 1 L^ . ■/ .-.1 I >■>•.; • 1, * ' * w^' . -^;>^o inoal by care'ulty cortrolbr>g tho variooo prodccUort poremeiers. Th« comptnctlon of "m ocooalilu.od Lut>ac- cc 9 a3»orb«ncy cn»raTeri(itiri a nng %vTThlha special Lm inoj«rr'i09 impregna- tion tachniqjoo y eld 0 * noi produol with a oeoicig, wtiich has penerraTcd t^m ortine intarrvl o^ee! atructuro Dtis IscIciiciub 1& Twira offwiv* rher a simp e aurrac? ap- pticatKJi py aprayir^ TabI* 1 Propyl© no Glycol P« n Pvf C9nl. Bt 30 n«1ratlon c Timo (Mm.) TurWoh Flue- Cured CasBd BaconatiTjleo Tobscco Tobacco 8url»» SflBOl 5 233 27 : 24< .SI 7 10 ?8 « je4 40 2 W2 ao 46.4 39< 46.6 88' » S0.8 643 57.B 78 3 45 534 M/ SI 3 98* ao S98 (O ? ftS7 80 / 90 884 71 9 IW.4 7-1 0 lao m 70 1 78.0 70 6 ISO es.4 788 71.0 842 (FromP C Ba*tlo k»c0mzi'vdA.S-h ■rmor Convr^un io«'io-«iothe33rd1 rCnC. Lexington 187* ) Tscfinlqu* 3. riavourlng Incorporation 7ho third toohrKj JO for mod'tyng tho flo vour of reconartnjiad tobacco le via the irv clue uii of riavtjui't'oo. Tbeoe rna'.ertalodlf- tn'tTDTi r:a^r\(}« hpraii*« m«y len/i tr^arto TOfO pfonot-rced flavour nolei. Tie uie of botorlool OKtroolo ouo^ 03 door Tor^gue fe~'^Breek. 8t. John a bread and Ifm beiBan-.a adu very ntoa. awfip' end aliQ^Tiy apicy rtci'^9 to ff^o smplfo chorto- ler ot reconetituted tobeooo. Naturai ox:r»ct8 of tobacco may bo ue«d •o onhoroo the Inhoront toboooo notoo of tlo row molorialo. AdOrt'Oialhr thoOO ox- f^rt** fT'Hy hR usptl rn arirl re-iair lohacco rotes to the aboot virMon the raw moterial coTvpoolTfon locW3 0 porioulor typo of ro- beuco. Aromeiic chcrr^lcalaand corr.pound^c fla* wtJL*ra fruiii IFia »«t:rlj& many Suppltera can po uftod xci moflffy the smoko cnertc- tor r almoot arry ' avojr di'octioi. Sorro oxoripioo ct !ho uoe of Thooo meTOf laio In- cIlJo vanllBn. maltof and coumoiEn *o* sweat noma iho pyrn/ noK for IncrMTsad rooKleo/TooRtert notoR onfl Rorr^ pheno- lic compounca fc ircroooJng rho amo»«i unml lum Unm'jm Itnt l: :k. tin L:^i«ro fmofoB-LTfi »nd (lultvchoratt^rof tne smoko flavour. TTiesa «(« ;U3t a fewof tho alrroot ondleso numoer or poftsibllltlBS at the dl3pasai of today a tooocco fiavourisl ADon ^om triGso tnrae i«cnrMqu«B Tfwra are two otnor importonr polnti rofatoo to the flavour of raconatitutad toboooo «nd the amoka quality of a tlnlaf^ed tobacco produCT 6l»ni A«conitlTutlon "he tobacco manufacturer haa two baalc procaises for rraatlnq tho alema or'or to IhB'f vjijiiiuri inlu hta proJuct cutting. and 'nirinQ (C«S). andraconstltuttor. Tn» racon«ttTjtion of Btamd ntfpr^ The ao- vontaga of aasIFy modifying tn^ir flavour via the add(t>o^ of oaclngc arid flavour- iiiga. Hero, '.ho flavour and Irritation oro ^rTlR<4 nt s^atna i^n ba TioOlttod to Im- provo inair STioka qimllly Thp^^o moUKi- cotiOfTB aro ot primary imporrancg when :oolg at tho tlovqor qjollty or tho •^nai c aar«:ta or tobacco product. Nlcotln* Fortificfltlon Tha navirtitTy of ina two-arap Klmbony- Ciark proca»« oilowa fcr iiany mango* in the ohomloal propartloa of tno finlshad reconAthutcd tobacco ohoat 0n4 ohango ihaT inouiu bet diacuasad when bpaaking oT !lavo*jr '9 tne rorrtncation of !h<« nlrntlnp oontcnl of tho fmehod shoot. Though atandard raconatttutad tobacco produots cor lain 0 7 — 1 Cp*i cent nIcotlno.LTR In- c]uP:'"U>a nffftrs tna poaalbllity of Incraaa- Ing t*ia nicoUna content or tho nnal 8h««i toamoxIfTium of 3.6 por cent. Thia natural- ly ha5 a mator 'mpact on the nicotin« con- tant cf Ttip final latjaiJL.u bland Howovar. an additiOrtai ofivanTaga to this nifx^Tio»» tortrtlofltlon te an inor«aa« of tho tooacco (tavour and body In tho -ocongtitutad to bacco amoKo uuaMy It naa haon Trwnnrad by many ra«aarch- ora that ntcotina. a'ong wnn rna otnar aU k0lold3 In toboooo. oot aa precuraora for known aron^tlca found (n tobaCOO aitK>ke TI1I1 point la auoported by amok- ing svaluatlons wtilch coniooro a alartO«r J raconsiitviTon rnnarco anaoT 10 ona which haa boon fonillad witn nicotine A drama- tio inorceac In toboooo taste and amoke body is notac In tho nicotlno-fortifiod ro- ranstltulaU tub«tCCO Along with an irt- croaaff in rr© nicotina r;ontanT nf rha to- bacco blend, rriia incraaaac tooacco flo- vour adda an oxtra quality 'ootor to the firMt^oJuct. Conolu«t«n« Aluiig with the flavour modiflcailon poa- Slbllltlas alraarty cllacusaod. LTR lodus- tnea orrorc a lina of opodaiTy rocorsT'ru- ted tobaooo produotc with flavouro da- St^ned TO meet the IndMdual neoda o^ various rnarkBiplaca&. Trieev piiXiuCla In- cicdo the Krstatc-type ni>vfujrs, modinad olgorette odour and modifiad ogarotte sidestream odour. AddlTlonflUy, boloni caifl rruiy ba Included In the starting raw mRtwifil tiipnO 60 as lu itipar! oartah^ tia- vourtuinotaa In order to moot tho neede Of t^ta looacco induat^Y world-wide, LTR Indualrlaa main- talnb a tiavuui laboratoiy and a apeciellzed f>lint plan? 'fv navounnga Its R i D spa- claiiatB in conjunction wtth tha tiavoor apaolollato orour>d the globe hav« dovo- loped and will cont'nua to devetoo new Mnrl mrKP ftsvourful fBeunalilulrtd lobac- co products 'or tha yeart to come ■ ^^ Yes! S\ Sodim ♦ synonym for modern, etticient Quality control equipment tor all phases of tobacco products ^^^-f^ manufacturing ^ycrdXAAA. SOCI£t£ Q& 01FFU6I0N O APPARfelLS D£ MESUnE rtUrMONr (30) aa ri 42 TtvrM too 004 AQCNCE cowwKitUALE MA AKTrtu - ci^ irS^d acmcounT (auia«ci r^L (oai 76. as aa ct ts sa.jo tcux 34 sxa botfc cm 29 77 Mr. Wyden. Have you found Brown & Williamson Mr. Kessler. There is one other, Andrew, can we just — there is an LTR quote that I think is interesting. This is from a quote in World Tobacco and it talks about a European maker of reconsti- tuted tobacco essentially using the dust and stems to make a sheet. And they talk about how various European cigarette houses cannot only reduce tar in the sheet it sends back to clients, it is able to work into client's scrap and waste new tobacco of the rustica type, which I mentioned earlier is rich in nicotine in order to change the relationship of nicotine and tar. It is also able to do the same by an alternate method of adding salts of pure nicotine into the slurry that eventually becomes to- bacco sheet. The article goes on that this is an operation that adding purer nicotine into the slurry into the sheet is an operation parallel to though more exact than that on which U.S. geneticists are engaged in this seeking to develop types of tobacco that are low on tar but fairly rich in nicotine. Similar processes. Mr. Wyden. Now are you investigating these issues? Mr. Kessler. We are. Our investigation continues, sir. Mr. Wyden. All right. Has Brown & Williamson been forthcom- ing in your requests at the Agency for documents that would clear up these remaining questions you have? Mr. Kessler. I am not in a position, Mr. Chairman, to editorial- ize in any way on Mr. Wyden. Let me ask specifically. I understand that the Agen- cy requested a number of documents about 6 weeks ago in early May and which the Agency felt that those documents were nec- essary for its inquiry. My reports show they have not been forth- coming; is that correct? Mr. Kessler. On I think it was — it was early May, two of our two senior counsels for the Agency requested after reports in the press of documents that we believe sound relevant regarding the pharmacological and physiological effects of nicotine, we asked out- side counsel for those documents on the physiological and pharma- cological effects of nicotine. Those documents have not been pro- duced to the Agency as of this 6 weeks later. Mr. Wyden. They would be relevant to your inquiry with respect to knowledge and intent concerning manipulation of nicotine? Mr. Kessler. Absolutely. Mr. Wyden. My last question that I had, Dr. Kessler, concerns the nicotine enhancement effects of ammonia. I have long been con- cerned about these chemical additives. Now, you told us that this will increase the effect of this drug, which, I think you are moving to categorize as a drug, as I noted administratively. Have you looked at the adverse health effects that may be part and parcel of smoking these chemicals such as ammonia? Mr. Kessler. Congressman, I think it is very important for the industry to release certainly all its inhalation studies and all of its pyrolysis studies. I think it is disingenuous to simply state that 599 chemicals that are on the list, are used in foods digested. The issue is not what the effect of those compounds are when they are di- gested. 78 The issue is what compounds will be formed through combustion and pyrolysis. What other compounds will be formed. We know when you pyrolyze a compound, other compounds are formed. I think it is very important for the industry to not only make avail- able the list of compounds but to make available its — any pyrolysis studies that have been undertaken as well as any toxicity studies on the inhalation products either of the direct additives or any newly formed compounds by combustion or pyrolysis. Mr. Wyden. My understanding is that at this point, there is very little research data along the lines that you are talking about that the tobacco industry, after it put out its list of ingredients said look folks, everything is fine. Because you can see these kinds of chemi- cals in that cookie you eat, that ought to close the debate. We got letters from Federal agencies saying that they wanted the kind of information that you are talking about, the health effects of these chemicals being smoked or burned and my understanding there is very little research to date on that; is that correct? Mr. Kessler. It is very important. We are certainly restricted in our analysis by simply looking at that list. If you go to just the published literature, you don't get all the answers on what are all the possible pyrolysis products of those additives and it is really their products and their toxicity that needs to be examined, Mr. Wyden. Mr. Wyden. Dr. Kessler, this has been very helpful. It seems to me crystal clear where your Agency is headed, whether or not Con- gress acts on this issue whatsoever. I, for one, think it is very help- ful that the Food and Drug Administration is calling this on the basis of science and not politics. I think there is a serious question about whether the tobacco ex- ecutives, when they came before this subcommittee deliberately and intentionally misled this subcommittee with respect to the in- dustry's ability to control nicotine levels and, fortunately, you all at the agency are setting aside these kinds of considerations and letting the scientific facts fall where they ought to as part of an ad- ministrative record and I think the American people ought to be very clear where that record is heading this country in terms of smoking policy and I appreciate your testimony. I yield back, Mr. Chairman. Mr. Waxman. Thank you, Mr. Wyden. Mr. Franks. Mr. Franks. Thank you, Mr. Chairman. Dr. Kessler, I, too, have found your testimony and charges very intriguing. However, I am always somewhat skeptical when I only hear one side of the story and Dr. Kessler, thougn I have a concern for the entire tobacco industry for various reasons, commerce, indi- vidual rights and also having family members in North Carolina that once grew tobacco, I have a particular concern about the smokeless tobacco industry since I have a major manufacturer based in my State. And my question to you would be: How much of your comments would be applicable to the smokeless tobacco industry? Mr. Kessler. Congressman, I talked a little about that in my last testimony — some of the promotional activities and some of the evidence that had been released over the years that relate to nico- 79 tine. We have yet to visit any smokeless tobacco company and begin a face-to-face dialogue, but I would welcome that and I would certainly reauest the smokeless tobacco industry to produce for the Agency all documents relating to nicotine, nicotines physiological and pharmacologicEd effects and any documents relating to control and manipulation of nicotine. I welcome that. I have not seen them, but we would ask them to do so. Mr. Franks. I am sure they would be happy to provide that in- formation, but getting back to your earlier point, obviously when you are talking about smoking tobacco, and most of your comments were obviously directed toward that industry, cigarettes, is there anything that you can mention at this point that would be applica- ble to the smokeless tobacco industry? Mr. Kessler. Sure. Andrew, do you have the chart on the "grad- uation process." Mr. Franks. Maybe I shouldn't be asking this question. Mr. I^SSLER. This is a — actually part of a — I guess it was a pro- motional campaign document, an advertising campaign document, a company document that came out that we saw Mr. Franks. Do we have a copy of this in here? Mr. Kessler. It was attached to my previous testimony and we would be happy to submit that. I would be happy to bring it closer. Congressman, if you want. Mr. Franks. I can't see it. [The chart referred to follows:] 80 TABLE 1 COPENHAGEN SKOAL WINTERGREEN SKOAL/KEY NATURAL fiber b9ard plastic" ' (A (A Ul O o ac a. z o < O < o SKOAL LONG CUT WINTERGREEN SKOAL LONG CUT MINT SKOAL LONG CUT SWEET HAPPY DAYS MINT LONG CUT HAPPY DAYS SWEET LONG CUT SKOAL LONG CUT NATURAL HAPPY DAYS NATURAL LONG CUT V) Vi m O O E a z o < a < oc o SKOAL BANDITS WINTERGREEN SKOAL BANDITS MINT SKOAL BANDITS SWEET SKOAL BANDITS NATURAL Source: Marae* v. US Tobacco Co., Plaintiff* Exhibit 100 (Provided by Plaintiffs Attorney) 81 Mr. Kessler. Let me just describe it. This was part of a pro- motional document, and other witnesses talked about this. It was an exhibit, Plaintiffs Exhibit 100, Marsee v. U.S. Tobacco Com- pany. You see various different products and you see products that start on the bottom and move up to the top. It talked about the graduation process and how you graduate from one product to the next. We have done some analysis that we would be happy to share with you. Congressman, if you look at nicotine bioavailability and what is being suggested, is that you start off with those products that have the least amount of nicotine. And as you get to the top of the whole graduation process, as you graduate, you go to products that have higher and higher nicotine. Again, you need to focus on nicotine bioavailability. I am aware of that document. Again, we would very much welcome the smokeless industry providing us with all documents on any nicotine manipu- lation, all nicotine control, all nicotine's physiological and pharma- cological effects. Mr. Franks. I yield back the balance of my time, Mr. Chairman. Mr. Waxman. Thank you Mr. Franks. Mr. Kreidler. Mr. Kreidler. Thank you, Mr. Chairman. Dr. Kessler, I am just kind of sitting here trying to figure out why the industry kind of responds the way it does. It kind of re- minds me of back in the 1960's with the first Surgeon General warnings, when there was denial on the part of the industry that there were any harmful health effects from tobacco smoking. They only acquiesced under pressure to the warnings finally being put on cigarette packages and so forth. I am curious, is the reason right now that, if you have a kind of a gut feel or what do you think the reasons are as to why the tobacco industry right now is so adamantly fighting this connection with addiction with their product? Is it because they feel that the admission will lead to FDA or some kind of controls on nicotine and how it is delivered with other chemicals, if they admit to addiction, in the same way they were so apprehensive, perhaps for liability and other reasons, to admitting to health effects? Mr. Kessler. Congressman, I would very much appreciate if we were not asked to comment specifically on motives that we can't de- termine factually. We asked Congress for guidance and I feel obli- gated to present you with the facts we have determined in our in- vestigation. I would not like to go beyond those facts in any conjecture. I apologize. Congressman. Mr. Kreidler. I can appreciate that. I guess I am sitting here thinking about somebody who would be sitting out there wondering why there is this reaction on the part of tobacco companies. I mean, I think we have all recognized for an awful long time that nicotine was the means of getting people hooked on tobacco. Mr. Kessler. I certainly would agree with that statement. Con- gressman. Mr. Kreidler. You know it is interesting to me as I look at the recent ad campaign that has just started out here that — and you have probably seen these full -page ads right now that RJR is run- ning— R.J. Reynolds, that is — running claiming that we are trying 82 to prohibit smoking and abolish cigarettes. It compares cigarettes to alcoholic beverages, caffeine, and to high-fat foods as targets for prohibition if you ever turn toward cigarettes. How does FDA regulation affect alcohol, caffeine, and fatty foods, and how would you compare tobacco with alcohol, caffeine, and fat from a health standpoint? Mr. Kessler. We regulate caffeine, fat, fatty foods, and with our sister agency, BATF, we regulate alcohol. We do not — there is no prohibition of any of those three others. We do not regulate nico- tine— nicotine in cigarettes. We do regulate other forms of nicotine. There is no question, by orders of magnitude, cigarettes are much more harmful. You know, caffeine 2ind fatty foods and alcohol in excess could be harmful. Cigarettes are harmful, period. Mr. Kreidler. I appreciate that. I am sure there is a good analogy of what this kind of represents of trying to grab on to — I am surprised apple pie isn't listed or something like that, and try to come up with and say, look it, this is Cjod, motherhood, and apple pie and so forth. Mr. Kessler. Congressman, I do not personally believe that pro- hibition is the answer. And we are not focused on the regulation of cigarettes. We are focused on the regulation of nicotine in ciga- rettes. And it is a relatively crude tool, the current Food, Drug, and Cosmetic Act as we are looking at it. I would focus on the policy questions. As I spoke to Congressman Greenwood, I would focus on tnose policy options that really would reduce kids and teenagers becoming hooked for their life. Mr. Kreidler. Well, I think you are very appropriate to point that out. I don't know if anybody, at least among my peers here in Congress, are talking about prohibition and I have certainly never heard it from the FDA or anyplace else. I only hear it from the tobacco industry which is trying to raise some kind of specter here to avoid appropriate regulation if there is a health risk. Mr. Kessler. Congressman, I need to point out that we are talk- ing about under the Food, Drug, and Cosmetic Act that nicotine, if the Agency were to conclude that nicotine in certain doses were in fact a drug in cigarettes, then that could affect the nicotine in the cigarettes but that would not affect the other parts of the ciga- rette. Mr. Kreidler. Good point. Let me just switch here going to the issue related to Y-1. Have you asked the Department of Agriculture whether they ever issued an export permit for Y-1 tobacco seeds and do you have any information from USDA on this? Mr. Kessler. Congressman, we've asked the companies, as I mentioned in my testimony, for copies of their export permits and, yes, I have been in communication with the Department of Agri- culture and I have some information and I would be happy to sup- ply that to you privately. Mr. Kreidler. Great. I appreciate it. Do you have any informa- tion on or reasons to believe that Y-1 variety tobacco has any other properties besides a high nicotine level that would make it desir- able or useful to cigarette manufacturers? Mr. Kessler. Congressman — ^Andrew, you have a chart on the characteristics of Y-1. As I read the English translation of the For- 83 tuguese patent, and these are some of the characteristics in Y-1, that patent stresses that the significant aspect of Y-1 is in fact its high nicotine content and the ability to grow that plant agronomically. That is the major characteristic of Y-1. The other issue with regard to Y-1 was and I had to learn some plant breeding, Congressman, was I had to learn about cytoplasmic male sterility which was one of the things that DNA Plant Tech- nology was asked to do for Y-1. You undertake cytoplasmic mail sterility for a number of rea- sons, but as we understand it, CMS, as it is called, is undertaken when you have a seed of value, for example, that you don't want others to be able to use. If I just hand you a seed, then you can go and propagate it, but if in fact the seed is male sterile, then you can't grow further generations without my giving you more seeds. It is a form of protection of commercial protection. It is probably as good as a patent or it may in fact be better than a patent. So the other characteristic of Y-1 was in fact the pollen free Y-1 that is stated and talked about in the patent. Mr. Kreidler. Very good. Thank you very much. Dr. Kessler, I wish you well in your endeavors. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Kreidler. Mr. McMillan. Mr. McMillan. Thank you, Mr. Chairman. I don't think that it does much good to go back and retroactively browbeat people for this or that, what they knew and when they knew it. I think that most of us in our lifetime have been aware of the potentially harmful effects of smoking, drinking, abusing al- cohol or tobacco or other products for that matter. And we certainly know a lot more about tobacco today than we did when I was a kid. I don't know that we know much more about alcohol. We certainly don't focus on it to the degree that we are focusing on tobacco here today, and I think that is an important thing for us to focus on. Dr. Kessler, you have talked about the regulation of alcohol as that it was some paradigm that we should follow with respect to tobacco. What is it we do regulate about alcohol and do you have anything to do with it? Mr. Kessler. Yes, we do. We share that regulation with BATF. Mr. McMillan. What specifically is it? Mr. Kessler. What we deal with is both adulteration and mis- branding. There are both of those provisions. We deal with adulter- ation of alcohol. We also Mr. McMillan. Would you explain that, please? Mr. Kessler. Any additives or any compounds that are added. Mr. McMillan. Isn't most alcohol? It is not pure alcohol, like no cigarette is pure nicotine. It includes a number of ingredients and a lot of different products that include alcohol. Mr. Kessler. We regulate the adulteration of alcohol, compounds may render the product adulterated. We also, in our agreement with BATF, I believe it is below 7 percent, we regulate the labeling. They regulate the labeling of Mr. McMillan. Would you say that most alcohol products or many of them manipulate the alcohol content in that final product? 84 Mr. Kessler. There are some fortified alcohol — fortified wines for example Congressman that have been of concern to a number of Mr. McMillan. What is the natural alcohol content of a malt whiskey. Mr. Kessler. Congressman, I would be happy to supply that for the record. I don't have that. Mr. McMillan. Is there a natural content of alcohol. Isn't that manipulated by the manner in which you distill it? Mr. Kessler. I have talked to our colleagues at BATF about the process and with the exception of the alcohol fortified wines, they don't view, in fact, the distillation process, as far as adjustments to alcohol levels, but I would be happy to supply that and look into that question. Mr. McMillan. I would submit to you that the general public understands there is a wide difference in the alcohol content of dif- ferent products that they have a choice of consuming and Mr. Kessler. But as I understand it, that is a natural result of the distillation process. Mr. McMillan. But over time, these are things that we have manipulated to achieve a desired result and no one would drink a so-called alcoholic beverage if it didn't have alcohol in it. Mr. Kessler. Congressman, the issue on manipulating, the ciga- rette industry has come before you and said they do not manipu- late or control nicotine delivery in cigarettes. If what Mr. McMillan. I don't think they have said that exactly. Mr. Kessler. Again, certainly the record could stand. Mr. McMillan. You said did not control. I think they basically said that they do try to control it. Mr. Kessler. That they do try to control. Mr. McMillan. That was in response to a question that nicotine content in a cigarette does not exceed what occurs naturally in the product of which it is made, the blend of which it is made. Have you found evidence that they have exceeded in a total blend of a cigarette, a nicotine content that is in excess of the constituent products that make it up? Mr. Kessler. Well, obviously, the sum is going to be the total of what makes it up. Congressman. The question is how you — let me show you some cigarettes over time. Actually, let me show you one variety Mr. McMillan. No, just answer my question. Do you have evi- dence of a cigarette being produced that has a nicotine content in excess of the constituent blends of tobacco that make it up? Mr. Kessler. Obviously, your sum can't — ^your total can't be more than the sum of your products, Congressman. Let me show Mr, McMillan. What standard, then, are you measuring them under. Mr. Kessler. Let me show some examples, Congressman. Could we go to the percent figures? Mr. McMillan. I can't read your writing. Mr. Kessler. I will be happy to read it. Mr. McMillan. Just zero in on one. 85 Mr. Kessler. Here, for example, is percent nicotine concentra- tion over time. This is percent nicotine in certain cigarettes over time. In 1952, a Chesterfield was tested in FDA laboratories and the average nicotine concentration was 1.66 percent. Mr. McMillan. Was it a filter tip or nonfilter tip? Mr. Kessler. I'm sorry? Mr. McMillan. Was it a filter tip or nonfilter tip? Mr. Kessler. I don't know. I would be happy to go back Mr. McMillan. Does it make any diff'erence whether it is a filter tip or nonfilter tip? Mr. Kessler. We can discuss it. Let me just show the nicotine concentrations if I may. In 1952, Chesterfield was 1.66. In 1969, a Reference cigarette was 1,56 nicotine. One variety, as I mentioned in the laboratory of an ultrsdow brand cigarette had 1.98 percent nicotine. Mr. McMillan. OK. What is good or bad? Mr. Kessler. I'm sorry. I can't hear you. I apologize. Mr. McMillan. What is acceptable, what is good or bad. What does 1.66 mean relative to 1.96. Mr. Kessler. I think there are two issues Congressman, that goes to the issue of whether there was control as you talked about of nicotine levels. If you are going to Mr. McMillan. Since you regulate it, is 80 proof bourbon worse than, what, 12 percent alcohol content beer? Mr. Kessler. The issue. Congressman, is whether there is ma- nipulation and control of that level. Mr. McMillan. All these are manipulated. How do they end up Mr. Kessler. And in fact, the issue with alcohol is that alcohol is regulated in certain instances as a food and in certain instances as a drug. Mr. McMillan. Well, that brings me to my final question, be- cause the question here is, I don't think it is whether or not there are health hazards to smoking or drinking or whether or not mis- use can be habit forming or addictive, if you will. Clearly they can and they have very different effects. Some have enormous behav- ioral effects you have tried to — alluded to the behavioral effects of nicotine as being a tranquilizer. If that's the case, do you think that affected the ability of Win- ston Churchill and Dwight Eisenhower to conduct operations on D- Day? They were heavy smokers. Mr. Kessler. Congressman, these were not my words. Those were words of the tobacco industry in comparison Mr. McMillan. I think it gets down to what it is we are trying to consider here. I think if you think there is some level at which this needs to be addressed, I think it is up to you to come up with a recommendation and make a proposal and we have not heard anything specific in that respect. Mr. Kessler. And we are looking at the question of whether nic- otine is a drug for the purposes of the act. We recognize that as a large question has enormous societal consequences and as we look at that question, we wanted guidance from the Congress. Mr. McMillan. WTiat are you going to do, arrive at some point at which nicotine becomes addictive and draw a line at that point? 86 Or are you going to try to regulate the number of units of a product one consumes in a day? You say we regulate alcohol. We don't reg- ulate the amount that one consumes unless we do it through driv- ing under the influence legislation. Mr. Kessler. Andrew, could you just show the backup chart on nicotine and alcohol, please. It is chart N, please. Mr. McMillan. Well, forgetting the chart for a minute, what are you — what do you anticipate you will come back to us with in the form of a recommendation? Mr. Kessler. Congressman, I would be happy to answer that in a second. Let me just finish for just 2 seconds. There is a vast dif- ference in percent of people who use alcohol. You can use alcohol and only 8 to 15 percent end up the estimates are that they are addicted; 74 to 90 percent of people who use cigarettes end up ad- dicted. You can use Mr. McMillan. There has to be a concern about why we come up with addiction. It has been said to me by plaintiffs' attorneys that perhaps as many as 90 percent of those incarcerated in jail today because of a crime are there because of a crime related to drugs or alcohol. Would you include cigarettes in that category? Mr. Kessler. Congressman, you are correct, our focus and the focus I think of this committee is not the fact that cigarettes are simply addictive, the problem is that cigarettes are addictive and they kill people. Mr. McMillan. So does alcohol. Mr. Kessler. Not when used in moderation. Mr. Waxman. Mr. McMillan, your time is expired. Before recognizing Mr. Hastert, I want to point out for the record that the tobacco industry has made public statements that they do not manipulate the nicotine levels. They have made those state- ments. They tried to be very careful when they testified under oath. They have tried to say specifically they don't spike the levels, but there have been public statements that they don't manipulate the level, they don't control the levels. And I just want you to know that is a reality that you indicated they didn't make those statements, but they have. Mr. McMillan. If I may respond, Mr. Chairman. Mr. Waxman. Yes. Mr. McMillan. I think it depends on your definition of manipu- lation. On any product that you make and you have control over the contents you could charge manipulation. I think the important thing is to go back for-the record and hear what they said in re- sponse to my question that said, do you know of any cigarette maker who has produced a product in which the end product con- tains a higher nicotine content than the constituent tobacco that was put into the cigarette and they all said no. So Mr. Waxman. I will be pleased to furnish you a transcript of the statement made by Brenda Dawson on behalf of the tobacco indus- try on Face the Nation where she explicitly stated they do not ma- nipulate in any way the levels of nicotine and nicotine levels for the tar. 87 Mr. McMillan. They said in here that they work at nicotine con- tent to try to hit a standard target and in no case did it exceed the natural percentage of the constituent product. Mr. Waxman. I guess the point is they do control and the ques- tion is for what reason do they control. Mr. Kessler. Mr. Chairman, could I just add one statement. The reason, Congressman McMillan, that control and manipulation, that we raise that issue is, again, when you look at the definition of a drug and that is: an article except for food intended to affect the structure and function of the body. I never thought that there would be direct evidence, direct information, that the tobacco in- dustry intended to affect the structure or function of the body. We have used the issue of control and manipulation as a surro- gate as one of the elements perhaps of intent. I think the docu- ments that I have referred to in my testimony that this committee has worked very hard to make sure that the American public have as part of the investigation, those documents may be relevant, di- rectly to the question of intent. When I see a statement that is reported from a general counsel of a major American tobacco company that says we are then in the business of selling an addictive drug, that statement may go di- rectly to the issue of intent. We may need not be focused on control and manipulation. I would ask. Congressman McMillan, Mr. Chairman, that those documents as well as any other documents regarding nicotine, its physiological properties, its pharmacological properties, control ma- nipulation or drug-like effects or research on nicotine be made available to this Agency so that we can thoughtfully and analyt- ically determine whether when, in fact, nicotine is an article in- tended to affect the structure and function of the body. Mr. McMillan. Would you also recommend that the committee have access to all documents of your Agency with respect to this issue? Mr. Kessler. Congressman, I have Mr. Waxman. Mr. McMillan, I really don't think it is important what Dr. Kessler recommends for the committee. It is up to this committee. Mr. McMillan. I think that's why he was here. Mr. Waxman. What documents we think are appropriate are the documents we are going to pursue further. It is Mr. Bilirakis' turn and I want to recognize him. Mr. McMillan. With the privilege of the Chair, I ask unanimous consent that the documents of the Agency be made available to this committee. Mr. Waxman. We will give the unanimous consent agreement to documents that are furnished to us by the FDA and we will make them part of the record. Mr. McMillan. I thank the Chair. Mr. Waxman. Mr. Bilirakis. Mr. Bilirakis. Thank you, Mr. Chairman. That was going to really be my first request. You have talked about your investiga- tion. Dr. Kessler. I wonder if you wouldn't please provide this com- mittee for the record all of the memoranda prepared by your inves- tigators on their interviews and any memoranda or draft memo- 88 randa on the possible details and implications of potential FDA regulation of tobacco products. I have a number of those types of questions and I am going to read them into the record and ask you and the FDA to respond. You will let me know whether 2 weeks is too short a period of time? Mr. Kessler. Mr. Bilirakis, I would be very happy to work with the chairman so that the chairman can or the chairman's designee can verify that I have quoted from any document accurately and completely. Mr. Bilirakis. Dr. Kessler, frankly, over the years, you have tes- tified before this committee and I have been very impressed with you. And now you say you are going to work with the chairman. Well, that's fine. We all like to work with the chairman, believe it or not. But if you have any memoranda prepared by your investigators on their interviews or any memoranda on the possible details and implications of potential FDA regulation of tobacco products, then I am asking that you furnish them to the committee for the record so we can all look at them, not just the chairman, but all of us. Mr. Kessler. Congressman I need, respectfullv, and I appreciate your comments, but I need to respectfully make it clear to this committee that if we were in a situation where I could walk in and get information — one second, please. If I can get information freely and fully and have full cooperation and I don't have to be reading about Brazilian patents, if I can get information on all documents walking in through the front door of any major American tobacco company, then I would have no prob- lem making available our records to you. We have had to rely, un- fortunately, on sources and confidential information. Mr. Chairman, I am willing to allow the Chair to verify the au- thenticity of anything I have said, but I am not willing — I am not willing to make available any document or any memo or any infor- mation that could possibly jeopardize a confidential source. Mr. Bilirakis. I believe I am talking about memoranda within your agency as one staff member to another or memoranda to you regarding this entire issue. Dr. Kessler. I mean is that unreason- able? I don't understand. Mr. Kessler. We deal with document requests all the time. I just need to underscore when one has information from confidential sources, again, those confidential sources, as you could understand, need to be assured of their confidentiality; as well as, I follow the same general rule Mr. Bilirakis. So there is information that you have received from confidential sources that you have not made charts of and that you have not shared with this committee? I don't understand, Mr. Chairman. Mr. Waxman. Let me pose it this way: It is not uncommon for us to get documents from the Executive Branch, but if there is any confidential information on it, to have that information deleted. But you want memorandum within the agency, and I think it is ap- propriate for us to get memorandum, so long as we don't infringe on any confidentiality. Is that acceptable to you, Dr. Kessler? 89 Mr. Kessler. I cannot put any confidential sources at risk, and I am sure you would understand that. Furthermore, I am — again, I would be happy to work with the Chsdr Mr. BILIRAKIS. No, sir. Forgive me; as I said before, we are all happy to work with the Chair, but I am sure the Chair would be the first one to tell you that this is a subcommittee hearing and we are all members of this subcommittee and you are talking about working with the Chair. I don't think the Chair would ever hide from the rest of us any information that they have; the Chair would make that available. So you are sharing information with the entire subcommittee. I didn't think this was a combative tjrpe of thing that I am ask- ing for. Mr. Kessler. Congressman, any documents that you are entitled to, I would be happy to provide that. We would be happy to work with you on that. I am not prepared to release documents that could, one, jeopard- ize any further investigation, because yes. Congressman, there is information that we have that we have not yet presented that we are still investigating. Two, there is information that could jeopardize sources. Three, I think that I tried to follow a rule here in today's testimony — and I hope you would appreciate it — that unless the name of a company was public or the document was a public document, that I did not mention that company by name. Mr. BILIRAKIS. I noticed that. Mr. Kessler. And I try to stay away from that just as I did last time. Mr. BiLiRAKis. In your continuing investigations, are you telling us that there — Mr. Chairman, you know, I am trying — ^you know, you have never known me to be militant, but I am trying to under- stand here. Are you saying that there is information that would ba- sically be in conflict with your charts and some of the things that you said the other day? Mr. Kessler. No, I am not. I am saying that there is additional information we are investigating. We have an established proce- dure for handling requests of Members of Congress and we will use that process to consider any requests. Mr. BILIRAKIS. Well — in other words, we are talking about, this is a subjective thing on your part? In terms of you will decide what documents you think are in order for this committee? Mr. Waxman. Will the gentleman yield to me? I think what Dr. Kessler is saying is that if there are cases where documents are submitted voluntarily in a cooperative way by the companies or anybody within his jurisdiction, that would be made available, but if there is information being furnished to him by a whistleblower or confidential source, neither you nor I would expect him to give us that information or information submitted by a company with the expectation that the information be kept con- fidential. He has to respect that, and that means he has to respect that with regard to you and me and other Members of Congress. Mr. BILIRAKIS. There is no distinction here between majority and minority? 90 Mr. Kessler. I am willing to follow established procedures. Mr. BiLlRAKlS. Now, those are the things that bother me, Mr. Chairman; words like "established procedures." Would you in the process of furnishing information to us make it known to us without divulging this "confidential information," that you apparently are going to be subjectively the determining factor in what information you are not furnishing to us? I don't want that to come across the wrong way, but what I am trying to say is that while I am not going to — ^without divulging the specific information, I would like to know and I think this subcommittee should know, that there is information regarding a particular sub- ject that you are not divulging because you have subjectively deter- mined that it is confidential and it is not in order for the majority or the minority of this committee. Can you do that? Can you add that to this submittal? Mr. Kessler. No, Congressman. What I am prepared to do is that in anjrthing that I have brought before this committee, to make sure that I have quoted properly. I am not prepared at this point to make investigative files — I am not prepared to make those investigative files that could jeopardize either an investigation or jeopardize certain confidential inform- ants. That is why we have, Congressman, established procedures and I am willing to follow those established procedures. Mr. BiLlRAKls. Do we know what those established procedures might be? Mr. Kessler. Congressman, we have worked with this committee for a long time and I would be happy to have staff go over the es- tablished procedures of what documents Mr. BiLiRAKis. Do you have — yes, sir? Mr. Waxman. Would the gentleman yield? Mr. BiLiRAKiS. All my time is being taken up, Mr. Chairman, and I haven't intended that, but yes, I will yield, obviously. Mr. Waxman. I do want you to understand that we want to work with you and make available information to you consistent with protecting confidential information. I think that is what Dr. Kessler is saying and oftentimes that is just a matter that has to be protected and certainly you would see it that way as well. Mr. BiLlRAKls. But, Mr. Chairman, this is the first time — I am flabbergasted and I have learned a lot in this hearing so far. Mr. Waxman. I am glad. Mr. BiLiRAKls. That is what a hearing is all about. We should be coming in as open-minded as we possibly can be. Unfortunately, that is not always the case, but this is the first time that I have heard anything about confidential sources or anything of that na- ture. I am just flabbergasted. Mr. Waxman. Well, where have you been? Don't you think people come in with information they don't want given to the tobacco com- pany or some other group that is being investigated? Don't you think that people come forward when they know they are going to be respected and their confidentiality — don't you think that indus- tries will say to us very frequently, "We want to help you with your investigation, but we don't want this information out because we don't want our competitors to have this information?" 91 Mr. BiLlRAKlS. Mr. Chairman, we have held executive sessions in^ a number of cases to maybe get some of that confidential informa- tion which is not available to the general public, but it is made available to the majority and to the minority. Mr. Kessler. Congressman, I think we can certainly — I think if we shift into a mode — and I would like to suggest that we shift into a mode whereby we can get all relevant documents directly from the tobacco companies, then there is no issue here. Why don't we shift into that mode so that the Agency has access to these documents, any documents Mr. BiLlRAKlS. Yes, but that is not — Doctor, that isn't really my question. I don't know that it has anything to do with my request. Mr. Kessler. Congressman, it does because when you are in an investigative mode, as you know, and people are not going to give you information directly, and we will move into that mode and we will move into that mode today. We will start asking for documents directly from the tobacco industry so that we don't have to have this and it will be much easier. But honestly, you have to understand that when you conduct an investigation the people who have control over information are not sharing that information freely with you, then you rely on certain established investigational techniques, and people end up — who co- operate with an investigation — Congressman, are scared. Mr. BILIRAKIS. But, Doctor Mr. Waxman. Mr. Bilirakis, your time has expired. Mr. Bilirakis. I know that, Mr. Chairman. Mr. Greenwood. Will the gentleman yield? Mr. Bilirakis. I am not sure. My chairman is telling me that my time has expired. Mr. Waxman. Mr. Greenwood, did you Mr. Bilirakis. Mr. Chairman, forgive me. I have a number of questions that I wanted to ask the gentleman. Mr. Waxman. We will have a second round. Mr. Bilirakis. I have been stuck on the first one. Mr. Waxman. We will have a second round, if you want to stick around. Mr. Bilirakis. I am going to ask unanimous consent that all these questions be given to the gentleman and that he has a period of 2 weeks and if he feels that is not adequate, that he can furnish the answers to those questions to the committee, not just to the chairman, but to the committee. I would like to put these questions into the record orally, and if I can hang around for the second term — for the second round — I will. Just in case I don't, I want these put into the record. I ask unan- imous consent, Mr. Chairman. Mr. Waxman. I will put it this way: We will ask unanimous con- sent that all members have an opportunity to submit questions in writing to Dr. Kessler and that he respond in writing for the record. Mr. Bilirakis. But within what period of time, Mr. Chairman? I don't think this should be open-ended. We are going to be called upon to make decisions on some of these things and we should have all of these answers. ^2 Mr. Waxman. Two weeks seems a reasonable time. Without ob- jection, that will be the order. Mr. Greenwood. Would you yield? Mr. BILIRAKIS. I can't yield. Mr. Greenwood. I ask unanimous consent to pose a question to the chairman about process. Mr. Waxman. Any objection? If not, Mr. Greenwood. Mr. Greenwood. As a new member of this committee, if the members of this committee knew that Dr. Kessler and his agency were in possession of all the documents that he has revealed to us, and we want them as part of our study here, and he refused to yield them to us because of his need to protect confidentiality, what would the Chair and the members of this committee do in an in- stance like that? What are our procedures? Would we subpoena those records? Mr. Waxman. Dr. Kessler? Mr. Greenwood. My question is to the Chair. Mr. Waxman. There are evidently procedures. Mr. Kessler. Mr. Greenwood, the information I can furnish you on Y-1, we have. Mr. Greenwood. I know that you can do that. My question is, what do we do? Mr. Kessler. We have asked the Patent Office and received the patent application. Mr. Greenwood. That is not my question. My question has to do with the access of members of this committee to documents that you have and I want to make sure that we are not selectively mak- ing sure that the documents that are useful arrive at the commit- tee and the documents that are not useful don't arrive because we don't have a consistent policy. I need to know what is the policy that determines how we get documents that we want? Mr. Waxman. Mr. Greenwood, if there are documents that we are requesting as a subcommittee that are not given to us, we will have the option of subpoenaing those documents. I think that is some- thing that the members of this subcommittee need to talk through, because there are times when confidentiality ought to be respected and there are times when the committee just should know because it is our right to know. But let me use as an example, not something that is theoretical, but Brown & Williamson in May of this year told Dr. Kessler and his people that there was no feasible way to develop a genetically altered kind of tobacco that increases the nicotine level. Through Dr. Kessler's investigation, he found out that was not true; that he was being misled by Brown & Williamson, and then finally Brown & Williamson, once the information was laid out to them, admitted it as of last Friday, in anticipation, I presume, of Dr. Kessler com- ing before us. Would any member of this panel want Dr. Kessler to not be able to get that information because he couldn't protect the confidential- ity of sources? I would hope nobody on this committee would want that result. Mr. McMillan. Would the Chair yield? What is the difference between Dr. Kessler protecting the confidentiality of sources and 93 then several weeks ago, we were having a hearing that was based on information that was illegally obtained by someone who had a client relationship with one of the subjects of the discussion, which was clearly a violation of confidentiality it seems to me. What is the consistency there? Mr. Waxman. We have not had a hearing on anything along those lines. Mr. McMillan. There was a lot of information delivered in testi- mony that was illegally obtained. Mr. Waxman. I am sorry the gentleman is not correct. That is an inaccurate statement. It is Mr. Hastert's opportunity to ask questions. Mr. Hastert. I thank the chairman. I am listening to this and it is kind of surreal. You are saying that you think that — Members of Congress, this subcommittee, the whole committee, have to make intelligent decisions. But you are going to give us only that information that you are going to spoon- feed us. You are not going to give us all the information that is available to us. You come up with decisions and predetermine what things ought to be. Maybe you shared some of that information with the chairman because you have some type of an agreement here. Is it that you don't think the rest of us should have that information because you don't trust us? That is contempt. I think that is contempt of Con- gress, sir. Mr. Kessler. Congressman, there are established procedures, and we will follow those established procedures. Mr. Hastert. Tell me what those established procedures are. Tell us. What are the established procedures? Mr. Kessler. Congressman Mr. Hastert. What are they? What are the established proce- dures? You are telling us mumbo-jumbo. Tell me what the estab- lished procedures are. Mr. Kessler. Congressman, we are engaged in an investiga- tion Mr. Hastert. No, no, no. Wait a minute. Don't go around. Either you tell me what those established procedures are, or I think you are in contempt of Congress. You said there are established procedures. We should know what they are. What are they? Mr. Kessler. I would be happy to tell you. Mr. Hastert. Tell me. Here we are. No; you, sir. Your established procedures, what are they? Mr. Kessler. Congressman, I have very good people at the Agen- cy who are trained professionals and know those procedures, if you would like to know the procedures. I rely on them. If you would like to hear the procedures Mr. Hastert. Do you know what they are? You can't tell us what those procedures are? I think you are in contempt. Mr. Waxman. Gentleman, as a Member of Congress, do you know the procedures? Mr. Hastert. That is why I am asking. Evidently, we are in the dark. We don't know what those procedures are and the gentleman is not willing to tell us what they are. 86-463 95-4 94 Mr. Waxman. I think if you will give him a chance to answer, you will find out what they are. Dr. Kessler? While he is looking it up, if the gentleman would yield to me. Mr. Hastert. Sure. I would be happy to yield to the chairman. Mr. Waxman. You seem agitated about it. Mr. Hastert. I am sitting here, sir Mr. Kessler. Congressman, let me read a letter dated June 20, 1994: "Dear Mr. Chairman, this letter is in response to your re- quest that I appear before the Health and Environment Sub- committee to testify regarding the Food and Drug Administration's ongoing investigation of nicotine-containing cigarettes. I am pleased to have the opportunity to appear again before the sub- committee on this subject. "Since my testimony will relate to an ongoing investigation, I feel it necessary to apprise the subcommittee of the limits that I must impose on the scope of my testimony. As I am sure you can under- stand, I am not in a position to disclose the names of confidential sources or any information in my judgment that could lead to the identification of those sources. I believe that this limitation is es- sential to protect the integrity of the agency's processes and its ability to effectively investigate important public health issues. "Moreover, this is consistent with past agency practice when we have been called upon to discuss matters under investigation in a public forum. "I appreciate your sensitivity to the importance of preserving the Agency's responsibilities regarding investigations. We stand pre- pared to continue to work with you in your deliberations on this issue." Mr. Hastert. Thank you. Thank you for reading it. Those are your standards and procedures; is that correct? Mr. Kessler. That is the letter dated that date. Mr. Hastert. These are the standard procedures that you are re- ferring to? That is complete? Mr. Kessler. No. There are a lot of established procedures and I would be happy to have other people Mr. Hastert. But you agree that all Members of Congress, if they have to make votes on this, ought to know what the informa- tion is. Not just the information that you are willing to give us, but all of the information. How do we make intelligent votes if we don't have hearings and get information? Mr. Kessler. Congressman, I have no problem with a process that determines the veracity of the quotes that I am saying. I think you have every right — I would like to assure that what I am saying is that those quotes, that I am quoting accurately. I cannot — please understand. I don't want to get in a back-and- forth with you. I respect your need to know and have information, but please understand, when you go into the front door and you are told one thing, and in the end — again, I don't want to characterize that statement, but when you go into the front door, and you are led to believe certain things, you rely on certain investigative tools and there is a balance, sir. Mr. Hastert. Let me tell you what my balance is and the reason why I guess I was a little bit upset. When a person who works for the taxpayers, such as you do, and who has some responsibility to 95 Congress and its Members, tells us that he can't give us this infor- mation to make decisions on, to me that is contempt. Mr. Kessler. Congressman, I am very willing to work to make sure that you can check that the quotes that I have said are accu- rate. Mr. Hastert. And will you give us the rest of those procedures? Mr. Kessler. We would be happy to share those. Mr. Hastert. Thank you. [The information follows:] 96 j|: ;;;^:;;;2:Z: -:::2' Fooo anfl Drug AoiiiHiaujiiu<> nockviiie MO 20S7 June 20, 1994 .The Honorable Henry A. Waxjnan Chairman, Subcommittee on Health and the Environment Committee on Energy and Commerce House of Representatives Washington, D.C. 20515 Dear Mr. Chairman: This letter is in response to your request that I appear before the Health and Environment Subcommittee to testify regarding the Food and Drug Administration's ongoing investigation of nicotine-containing cigarettes. I am pleased to have the opportunity to appear again before the Subcommittee on this subject. Since my testimony will relate to an ongoing investigation, I feel it necessary to apprise the Subcommittee of the limits that I oust impose on the scope of my testimony. As I am sure you can understand, I am not in a position to disclose the names of confidential sources or any informa- tion that, in my judgment, could lead to the identification of those sources. I believe that this limitation is essential to protect the integrity of the agency's processes and its ability to effectively investigate important public health issues. Moreover, this is consistent with past agency practice whenever we have been called upon to discuss matters under investigation in a public forum. I appreciate your sensitivity to the importance of preserv- ing the agency's responsibilities regarding investigations. We stand prepared to continue to work with you in your deliberations on this issue. Sincerely rugs 97 Mr. Greenwood. Will the gentleman yield? Mr. Hastert. Let me follow up. What will you do, then, if you get jurisdiction over the tobacco industry, and nicotine is viewed as a narcotic? Would you want to regulate that or do away with that industry? What is your long-term view? WTiat is your goal here? Mr. Kessler. Congressman, I think that obviously is a key ques- tion. We are very much and we have been very much in an inves- tigative mode and we continue in that mode. I think we are shift- ing somewhat. There are some scientific questions that I think I raised with Congressman Greenwood; what is the level of nicotine in cigarettes that would create and sustain an addiction? I don't know exactly what that level is, but we want to ask our scientists what that Mr. BiLlRAKis. Will the gentleman yield? Doctor, you are still continuing an investigation. What is the source of that chart, "Percent estimate of all users who are ad- dicted?" I don't see a source on there. Mr. Kessler. We would be happy to provide the source. [The information follows:] 98 Percent Estimate of All Users Who Are Addicted 100 90 80 70 60 50 40 30 20 10 0 74-90 1 8-15 ■ NICOTINE ALCOHOL /" "-"^ 99 Epidemiologic Bulletin No. 27 Prevalence of DSM-III-R Alcohol Abuse and Dependence United States, 1988 Bridget F. Grant, Ph.D., Ph.D.; Thomas C. Harford, Ph.D.; Patricia Chou, Ph.D.; Roger Pickering, M.S.; Deborah A. Dawson, Ph.D.; Frederick S. Stinson, Ph.D.; and John Noble, B.A. Nearly 9.0 percent of adults surveyed in the 1988 NHIS met DSM-UI-R criteria for 1-year alcohol abuse and dependence, with males about three times more likely than females to experience these problems. However, there was evidence of a convergence of prevalence rales between the sexes in the younger age groups, suggesting that females may be catching up. This Epidemiologic Bulletin pre- sents detailed prevalence and population estimates of alcohol abuse and dependence for the United States for 1988 The diagnostic categories of alcohol abuse and depen- dence were based on cnlcria from the Diagnostic and Statistical Manttal of Mental Disorders, Third Edition, Revised (DSM-III-R) (American Psychiatric Association 1987). One-year prevalence estimates of alcohol abuse and depen- dence were derived from self-reports of symptoms of alcohol abuse and depen- dence on the 1988 Alcohol Supplement of the National Health Interview Survey (NHIS) The figures presented in this re- port are the first estimates of DSM-III-R alcohol abuse and dependence to be re- ported at the national level. Backcjroiind and Procedures Prevalence and population estimates of alcohol abuse and dependence were based on data from the NHIS. a nationwide household interview survey conducted by the National Center for Health Statistics and sponsored by the National Institute on Alcohol Abuse and Alcoholism (NI- AAA). For the survey, direct interviews were conducted with 43.809 respondents, aged 1 8 years and older, in all 50 States and the Distnct of Columbia. The re- sponse rate for the Alcohol Supplement was 85.5 percent. The NHIS featured a complex multi- stage sample design (Massey et al. 1989). Primary sampling units (PSUs) were stratified according to sociodemographic criteria and were selected with probability proportional to the size of the sample. There were approximately 2,000 PSUs in the 1988 NHIS sample, 52 of which were self-representing — that is, selected with certainty. Within PSUs, geographically defined secondary sampling units, known as segments, were systematically select- ed. Oversampling of the black populaoon was accomplished at this stage of sample selection. Segments were divided into clusters of approximately four to eight Vou IS, No. 1, 1991 91 100 Table 1 Prevalence and Population Estimates o( DSM-III-R Alcohol Abuse and Dependence by Age. Sex. and Ethnicity: United States. 1988 Alcohol Abuse Only Alcohol Dependence Only Prevalence Ethnlclty/Sex/Age (%) S.E. White Males 4J0O (0.19) 18-29 6.25 (0.47) 30-44 457 (0.29) 45-64 2.78 (0.29) 65 and Older 0.94 (0.19) Nonwhite Males 2.33 (0.31) 18-29 2.21 (0.53) 30-44 3.30 (0.67) 45-64 1.89 (0.55) 65 and Older 0.48 (0.32) Total Males 3.77 (0.17) 18-29 SS7 (0.41) 30-44 43B (0.27) 45-64 2.66 (0.27) 65 and Older 0.90 (0.17) White Females 1.23 (0.08) 18-29 2.88 (0.26) 30-44 1.13 (0.14) 45-64 0.57 (0.11) 65andOtdef 0.14 (0.06) Nomvhite Females 0.49 (0.10) 18-29 0.68 (0.21) 30-44 0.46 (0.19) 45-64 0.34 (0.16) 65 and Older 0.33 (0.23) Total Females 1.12 (0.07) 18-29 2.49 (0.22) 30-44 1.03 (0.12) 45-64 0.53 (0 10) 65 and OWer 016 (006) Total 2.38 (0.09) 18-29 4.00 (0.24) 30-44 2.67 (0.15) 45-64 1.55 (014) 65andOldef 0.46 (0.08) Population Prevalence Estimate * (%) 2.903 237 1.193 5.14 1,079 2.25 530 0.77 101 0.57 267 2.31 86 3.03 128 2.34 48 222 6 0.00 3.170 ^36 1,279 4.78 1,206 2.26 578 0.94 106 0.52 979 1.25 569 3.22 274 1.04 116 0.51 21 0.04 66 0.91 29 1.44 21 0.99 11 0.42 5 0.29 1,046 1.20 see 2.90 294 1.03 127 0.50 27 0.06 4;216 1.75 1,877 3.62 lAM 1.63 706 0.71 133 0.25 Population S.E. Estimate (0.15) 1.722 (0.44) 981 (0.23) 531 (0.13) 149 (0.16) 62 (0.33) 265 (0.70) 117 (0.52) 90 (0.69) 57 (0.00) 0 (0.14) 1.967 (037) 1.098 (Oil) 622 (0.14) 206 (0.14) 62 (0.09) 996 (0-29) 635 (0.13) 250 (0.13) 105 (0.03) 6 (0.15) 124 (0.34) 61 (056) 44 (0.18) 14 (054) 5 (0.06) 1,120 (055) 696 (0.12) 294 (0.12) 119 (0.04) 11 (0.08) 3.107 (021) 1,794 (0.12) 916 (0.09) 325 (0.07) 72 housing units, and all occupied housing units were included in the NHIS Because of the complex design of the NHIS sample, variance estimation proce- dures thai assume a simple random sam- ple vvere inadequate Research has shown that clusienng and suauricalion of the NHIS sample typically result in standard errors at teasi 20 percent larger than those thai would be obtained with a simple ran- dom sample of equal size To take into account the NHIS sample design, all standard errors of the estimates presented in this report were generBied using SUDAAN (Research Tnangle Institute 1 990). a software program that employs Taylor series linearization to adjust for sample design characteristics. DSM-III-R Classificatios The 1988 NHIS included an extensive list of questions designed to assess the presence of symptoms of alcohol abuse and dependence during the preceding year. These questions were developed by the principal author of this report specifi- cally to operationalize DSM-IIl-R crite- na for alcohol use disorders. Corre- spondence of the DSM-ni-R criteria with individual NHIS questions is shown in the sidebar. According to DSM-UI-R. a diagnosis of alcohol abuse requires that an individ- ual exhibit a maladaptive pattern of alco- hol use demonstrated either by continued use — despite a persistent social, occupa- tional, psychological, or physical prob- AiroHOL Health & Reseakch Wokld 101 Epidemiologic Bulletin No. 27 Table 1 Prevalence and Population Estimates of DSM-III-R Alcohol Abuse and Dependence by Age, Ses, and Ethnicity: United States, 1988 (continued) Alcohol Dependence with Abuse Total Alcohol Dependence and Abuse Ethnicity /Sex'Age White Males 1&-29 30--t4 45-64 65 and Older I Nonwhite Males i 18-29 i 30-44 45-64 65 and Older I i Total Males 18-29 30-^*4 45-64 65 and Older White Females 18-29 30-44 45-«4 65 and Older Nonwhite Females 18-29 30-44 45-64 65 and Older Total Females 18-29 30^»4 45-64 65 and Older ; Total 18-29 30-44 45-64 65 and Older Prevalence (%) 7.63 14.74 8.06 3.61 1.22 4.65 5.27 5.16 3.87 2.67 7.22 13.14 7.65 3.64 1.36 2.20 5.35 2.17 0.69 0.17 1.10 1.73 1.21 0.71 0.00 2.04 4.71 2.02 0.70 0.15 4.50 8.83 4.78 2.10 0.65 S.E. (0.24) (0.67) (0.40) (0.32) (0.24) (0.52) (0.93) (0.9S) (0.93) (1.24) (0.22) (0.59) (0.37) (0.30) (0.25) (0.11) (0.35) (0.20) (0.13) (0.08) (0.18) (0.37) (0.34) (0.32) (0.00) (0.10) (0.30) (0.18) (0.12) (0.07) (0.12) (0.33) (0.21) (0.16) (0.11) Population Prevalence Estimate (%) 5.541 13.99 2.813 26.14 1,903 14.87 694 7.14 131 2.73 533 9.29 204 10.50 199 10.79 99 7.98 31 3.15 6.075 13.35 3,017 23.50 2,103 14.30 793 7.24 162 2.77 1,746 4.68 1,056 11.45 523 4.33 142 1.77 25 0.34 151 2.50 74 386 54 2.66 23 1.47 0 0.62 1,897 4.36 1,130 10.10 577 4.07 165 1.73 25 0.37 7.972 d^ 4,147 16.65 2,680 9.08 958 4.36 186 1.37 S.E. (0.34) (0.91) (0.54) (0.42) (0.35) (0.69) (1.26) (1.19) (1.31) (1.27) (0.31) (0.78) (0.49) (0.40) (0.34) (0.17) (0.53) (0.27) (0.22) (0.10) (0.26) (0.55) (0.46) (0.39) (0.33) (0.15) (0.45) (0.24) (0.19) (0.10) (0.18) (0.46) (0.29) (0.22) (0.15) Population Estimate 10,176 4,S87 3,514 1,373 293 1,065 407 417 204 37 11,232 5,394 3.931 1.577 330 3.722 2,260 1,047 363 52 342 164 118 49 10 4,064 2,424 1.165 412 62 15.295 7,818 5,096 1,989 392 'AN population e£lln>ates ara m thousands. Note: Components may not always sum to the totals displ3y«d In 1h« tatila Iwcause ol (wjndlng. lem ihai is caused or exacerbated by alco- hol use — or by recurrent use in physical- ly hazardous situations. A diagnosis of alcohol dependence requires that an indi- vidual meet at least three of the nine cri- tena defined for dependence (see sidebar)- To be classified as an alcohol abuser, a respondent must have expenenced one or more symptoms in at least one symp- tom group during the preceding year. To satisfy the DSM-III-R duration cntenon for abuse — that is, that some symptoms of abuse persisted for at least 1 month or occurred repeatedly over a longer period of time — at least one symptom of abuse must have occurred two or more times during the preceding year. Similarly, to be classified as alcohol dependent, a re- spondent must have expenenced one or more symptoms for at least three depen- dence criteria, and one or more of the symptoms of at least two of these criteria must have occurred two or more times during the preceding year. The diagnosis of dependence present- ed in this report was further qualified in two ways. First, since the withdrawal cn- tenon of alcohol dependence is defined in DSM-III-R as a withdrawal state or Vou IS. No. 1. 199t 93 102 1988 National Health Interview Survey: DSM-III-R Alcohol Abuse and Dependence Diagnostic Criteria and Associated Questionnaire Kems Diagnostic Criteria for Alcohol Abuse I Diagnostic Criterion: Continusd to dnnk despite a persistent so- ! cial. occupational, psychological, or physical problem that is caused or exacsftialed by drinking. j Questionnaire Itenu: * Continued to dnnk even though it was a threat to your health. \ ' Kepi drinking even though it caused you emotional problems. ! * Kept drinking even though it caused you problems at home, 1 wofK or school. I * Had a spouse or someone you lived with threaten to leave you because of your dnnklng. I * Lost a job, or nearly lost or)e, because of drinkir^. * Had your chances for promotion, raises, or better Jobs hurt by ' your drinking. Diagnostic Crlterton: Recunent drinking in situations in which alcohol use is physically hazardous Questionnaire Items: * Drfven a car after having too much to drink. * Done things when drinking that coukf have caused you to be hurt. ' Done things when dnnking that coukj have caused someone else 10 be hurt Diagnostic Criteria for Alcohol Dependence Diagnostic Criterion: Drinking in larger amounts or over a longer penod ttian intended. Questionnaire Items: ' Ended up drinking much more than you intended to. ■ Found it difficult to stop drinking or>ce you started ■ Kepi on dnnking lor a longer penod of lime than you intended to. Diagnostic Criterion: Persistent desire or unsuccessful efforts to cut down or control drinking. Questionnaire Items: * Tried to cut down or stop drinkir>g and found you coukjn't do it * Wanted to cut down or stop dnnking and found you couMnI doit. Diagnostic Criterion: Spent a great deal of time obtaining alcohol, dnnkjf^, or recovering from dnnkir>g. Questionnaire Item: ' Spent a lot of time drinking or getting over tfie effects of dnnking ' Diagnostic Criterion: Frequent intoxcation or witt>drawai when expected to fulfill major role obligations, or wtien drinking Is physically hazardous. Questionnaire Itema: ' Stayed away from work or gone to work late because of drinking or from a hangover. * Gotten drunk Instead of doing ttie thirtgs you were supposed to do. ' Been so hung over that It Interiersd with doing things you were supposed to do. * Driven a car after having had too much to drink. ' Done things wtwn dnnking ttiat couk5 have caused you to be hurt. * Done things wlien drinking tfiat couk) have caused someone else to be hurt Diagnostic Criterion: Important sodal, occupational, or recre- ational activities given up or reduced t]ecause of drinking. QtMStionnaIre Itema: * Given up or cut down on activrties or Interests like sports or assodatkins with friends. In order to drink. * Lost ties with or drifted apart from a family member or friend because of your drinking. Diagnostic Crttarlon: Continued to drink despite a persistent or recunem social, psychokjgical. or physical problem that is caused or exacertjated by drinking. Questionnaire Hems: * Continued to drink ak»hol even though K was a threat to your health * Kept drinking even ttvxigh it caused you emotk>nal problems. * Kept dnnking even though It caused you problems al home, wort<, or sdhoct ' Had a spouse or someorw you lived with threaten to leave you because of your drinking. Diagnostic Crttarton: Tolerance. Questionnaire Hems: ' Found that the same amount of akxihol had less effect than before. * Fourid tt^ you had to drink more than you once did to get ttte same effect. Diagnostic Criterion: Charactaristk: withdrawal state. Questionnaire ttsms: ' Been sick or vomited after drinking, or the rrraming after * Felt depressed, irritable, or nervous after drinking, or the momir^ after. * Found yourself sweatng heavily or shaking after drinking, or tfw morning after. * Heard or seen things that weren't realty there after drinking, or the morning after. Diagnostic Critarlon: Drinking to relieve or avok] withdrawal symptoms. Questlottnaire nam: * Taken a dnnk to keep yourself from shaking or feeling sick either after drinking or the morning after. 94 Alcohol Health & Research Wosld 103 Epidemiologic Bulletin No. 27 syndrome (i.e., a cluster of symptoms), at least two symptoms of wtihdrawal wei^ required to meet the duration critenon. It should be noted, however, thai the pres- ence of withdrawal is not required for a DSM-III-R diagnosis of alcohol depen- dence. Second, any reported symptom of tolerance satisfied the duration criterion for alcohol dependence, because toler- ance constitutes a less acute and episodic symptom of dependence relative lo the other dependence criiena. Table 1 presents the 1 -year prevalence rales, standard errors, and population es- timates of DSM-lll-R alcohol abuse and dependence by age. sex. and ethnicity. The DSM-lll-R alcohol abuse and de- pendence groups formed from the 1988 NHIS were mutually exclusive: that is, respondents classil'ied as alcohol abusers did nni meet criteria for alcohol depen- dence, while those who met criteria for jIcdIioI dependence were classified as lo tiKtnchrr F. Chanj. Ph.D.. Ph.D.. is chit/ oj ilw Bioiiii'fry Branch. Divixiwi nf Bionicfty ami EpuU'n)iohi\'\\ National hixiiniic an A/cahttI Ahuxc anti AUahaUsui (NiAAA). RackvUle. Manfand TiiiiMAsC. H.\HH>Kn. Ph.D.. i\ director oflhc Divi.sam itj Bamwiry and Epidcnnolafiy. NIAAA. pATKtciA Chov. Ph.D.. /.? a .wnry .T/n/f.T- tician in ihc Biometry Branch. Division of Biometry and Epidemiology. NIAAA ROCKK PtChEftiNC. M.S.. IS a computer programmer nt the Biometry Branch. Division of Biometry' and Epidemiology. NIAAA. Deborah A. Dawson. Ph.D.. is a survev statistician m the Biometry Branch. Division of Biometry and Epidemiology. NIAAA. FREDERtCK S. Stinson. Ph.D.. IS project manager for the Alcohol Epidemiologic Data System, operated by CSR. Incorporated. Washington. DC. under contract to NIAAA. John Noble, B.A.. is deputy director of the Division of Biometry and Epidemiology. NIAAA. 18-29 30^W 45-64 Age Group in Years 65 arxl older I White male n White female Nonwhite male Nonwhite female Rgure 1 Prevalence of DSM-lil-R alcohol abuse and dependence by age. sex. and ethnicity: United States. 19B8. whether ihey also met the criteria for al- cohol abuse The I -year prevalence for total alco- hol abuse and dependence in the NHIS .sample was 8. 63 percent, representing 15.295,000 Americans (Table 1) More respondents were classified as alcohol dependent (6.25 percent) than alcohol abusing (2.38 percent). Among those re- spondents meeting the DSM-III-R diag- nostic crilena for dependence, an overwhelming proportion also met the cnlena for alcohol abuse Tlic dominance of the dual abuse-dependence diagnosis was generally consistent across each age. sex. and ethnic subgroup of the population. One-year prevalence was even more dramatic for males, with 13.35 percent meetmg cntena for alcohol abuse or de- pendence. The prevalence rate for fe- males was much lower, 4.36 percent. Prevalence also was greater among whites (9 13 percent) than among non- whites (5.60 percent) (Table I). Rales for white males and while females exceeded the rates for their nonwhite counterparts by 33 6 percent and 46,6 percent, respectively. Prevalence rales were higher among males and females under the age of 45 years than among those aged 45 and old- er (Table 1 ). For males, the 1-year preva- lence rate in the youngest age group (18 lo 29 years) was 23.50 percent The rale fell lo 14.30 percent among 30- to 44- ycar-olds. and was only 2.77 percent in those aged 65 and older Among women, the highest prevalence rale was also found in the youngest age group ( 10.10 percent), and the rates fell steadily to 0.37 percent in women aged 65 and old- er Possible reasons for the decline in al- cohol abuse and dependence rates with age mclude the artifact of recall, lower survival rates among alcoholics, and re- sponse styles. Alleraatively. the age gra- dient may reflect a true cohort effect; that is, that alcohol abuse and dependence is more prevalent among the more recent generations of Americans. Ethnic groups (i.e.. whites and non- whites) showed striking patterns of age- related I -year prevalence rales of alcohol abuse and dependence (Figure 1). As shown in Table 1, among the youngest males, the prevalence rate in whites (26 14) was 2.5 times greater than in nonwhites (10.50). In the next age group (30-44 years), the rates for whites and nonwhites were more similar, with a slight predominance in whiles. This pre- dommance in whites disappeared in the 45-M age group, m which rates of alco- Voi.. 15. No. 1.1991 95 104 Table 2 Male to Female and Nonwhite to Wtitte Ratios of the Prevalence of DSM-)ll-n Alcotio! Abuse and Dependence: United States, 1988 EthnlcHy/ Male to Nonwiilte to Abo Female Ratio Sex/Age Whita Ratio White Male 18-29 2.3 18-29 0.40 30-44 3.4 30-44 0.72 45-64 4.0 45-64 1.11 654. 7.9 65+ 1.15 Nonwhtta Female 18-29 2.7 18-29 0.34 30-44 4.1 30-44 0.61 45-«4 5.4 45-64 0.83 65+ 5.1 65+ 1.80 1 liol abuse and dependence were quite similar (7 14 for whites. 7.98 for non- whites). Finally, in the oldest age group, the rates of alcohol abuse and depen- dence among nonwhice males were 13.3 percent greater than those among white males. The pattern for nonwhite and white females was similar to that for males, as demonstrated in the nonwhite to white ratios in Table 2. Although alcohol abuse and depen- dence was greater among males than among females, there was evidence of convergence of the rates between sexes in the younger age groups. The male to female ratios were lowest in the 18-29 age group for whites and nonwhites (Table 2). Thus, alcohol abuse and de- pendence was more prevalent in the younger age groups, particularly among young women. This trend is highlighted in Figure 1. where rates for white fe- males are shown to exceed those for nonwhite males in the youngest age group. Discussion Nearly 9.0 percent of adults surveyed met DSM-III-R cnteria for I -year alco- hol abuse and dependence. Males were about three times more likely than fe- males to suffer from alcohol abuse and dependence. However, the fact that the difference in prevalence between males and females is least in the youngest age group suggests that females may be catching up. The decrease in the white to nonwhite ratio of 1-year prevalence wich incivasing age suggesu that at least part of the decline in prevalence with age observed in this sample may be due to a true cohort effect. If the de- cline in the prevalence of alcohol abuse and dependence were due entirely to faulty recall in the older cohorts, one would have to make the unlikely as- sumption that nonwhites have twtter re- call than whites, especially among females. The overall prevalence estimates and corresponding population estimates of alcohol abuse and dependence present- ed in this report do not differ greatly from those for the year 1984 (Williams et al. 1989), even though these earlier figures were based on diagnostic crite- ria from the DSM-llI (American Psychiatric Association 1980), and not the DSM-III-R. The prevalence of DSM-Ill alcohol abuse and dependence reported by the 1984 National Survey on Alcohol Use was 8.58 percent for the total sample, with a corresponding population estimate of 15,100.000. Although this figure is nearly identical with the prevalence of DSM-lll-R al- cohol use disorders found in the 1988 NHIS sample, caution must be exer- cised in assuming the stability of these rates between 1984 and 1988. Because the definitions of alcohol use disorders differed between the two surveys, no conclusions can be made concerning trends in (he rates of alcohol abuse and dependence over time The next major opportunity to up- date these national prevalence and pop- ulation estimates will occur in 1993 when the data from Wave I of NlAAAs National Longitudinal Alcohol Epidemiologic Survey (NLAES) become available The 1991-1992 NLAES contains a compre- hensive list of symptoms measuring def- initions of alcohol abuse and dependence from DSM-III. DSM-III-R, the proposed DSM-IV (unpublished memorandum, DSM-IV Substance Abuse Committee 1990), and the International Classification of Diseases-Tenth Revision (ICD-10; World Health Organization 1990) Representation of multiple definitions of alcohol use disorders will facilitate di- rect comparisons between the NLAES DSM-llI estimates and the DSM-III es- timates of the 1984 National Survey on Alcohol, and between the DSM-lll-R prevalence estimates derived from the 1988 NHIS reported here and the 1991-1992 NLAES It remains to be seen whether the consistencies in preva- lence and population estimates of alco- hol abuse and dependence, found between earlier reports and the present report, will generalize to newer defini- tions of alcohol use disorders (i c . from the DSM-IV and ICD-IOi appeaiins: in the NLAES ■ RllH.RKM i;,s AiiKncjn Psycliialric A-VMH.ijliim. OitiK't""!!* anil StalislHiit Mtiiuuit nfMciiutl thxitrtlvrs. Tfiiiil Etiitiim. Wa.sliinj:loii. DC: llic AsHdcialiim, I9KII Aiilcncjil Psytllialrit A\S(>i.iJlltin, 0(c(t;""v"< (""' SialtMuol Mouiitil i'/Mixt'ntvis. Tliiiil Ednnm. Rei'i.\ril. Wusliin|;lon. DC. IlK AsMKialitiii. I9S7 M*sst\ . J T.. M(X)Hi;. T F . Pak-Siins. V.L,: ,^N^» Taoros. W OcvHif'f mill EMniintimi fnt llu- Null: / Hrud/l /iilt-rvin.- Jiin-i-v, IVXS-IVH Vilal jiHl Hcjilh Slullsllt.^ Rtfpiwl Scrio 2 1 1 nil, Hyall^vilie. MO' Nalional Cenler I'lW Hollh Slall■.llt^. l')H'» Rc-Ncaivh Tnaiigle liislilulc it'llwiire fur Siincv Dala Aiinh-iiiji ISUOAANI. Vtrxiiii f.lO RcNC.tah Tnan^k Park. Ihc InMtlulc. IWI Williams, CD.; Grant. B.F.; Hahfsord. T.S.; and Nonui. i Populalion pmjecliitns using DSM-III tn- lena: Alcohol abux jihJ licpcodenctf. 19911-211(10. Aluiliol Heollli Jl Rexeanli World l.lUl:,l&<)-}70. 1989 World Heallti Orgjnilunion. Tlie Prtifuiicd lillenuilitmal Cluxiif'ii tilioii of Dncu^es. Tenllt «?r(j(mMlCD-IOl. Geneva. SwilEcriand: the Organi7.al(On. 1990, ALCOHOL Health & Research World 105 CDC July 9, 1993/Vol. 42/No. 26 MORBIDITY AND MORTAUTY WEEKLY REPORT 501 Imported Cholera Associated with a Newly Described Toxigenic Vibrio cholerae 0139 Strain — California, 1993 504 Smoking Cessation During Previous Year Among Adults — United Slates 507 Availability of Comprehensive Adolescent Health Services — United States, 1990 516 Salmonella Serotype Tennessee in Powdered Milk Products and Infant Formula — Canada and United States 517 Update: Hantavirus Infection — United States Emerging Infectious Diseases Imported Cholera Associated with a Newly Described Toxigenic Vibrio ciiolerae 0139 Strain — California, 1993 Epidemics of cholera-like illness caused by a previously unrecognized organism occurred recently in southern Asia ( 7 ). This report documents the first case of cholera imported into the United States that was caused by this organism, the newly de- scribed toxigenic Vibrio cholerae 0139 strain. On February 5, 1993, a 48-year-old female resident of Los Angeles County sought care at a local outpatient health-care facility for acute onset of watery diarrhea and back pain. A few hours before seeking medical care, she had returned to the United States from a 6-week visit with relatives in Hyderabad, India. Her diarrheal illness began in India on February 4 and increased in severity while she traveled to the United States. She reported a maximum of 10 watery stools per day but no vomiting, visible blood or mucous in her stools, or documented fever. The patient was prescribed trimethoprim-sulfamethoxazole without rehydration treatment and recovered uneventfully. Duration of illness was approximately 4 days. No secon- dary illness occurred among family members. When the patient sought medical care, the physician suspected cholera, and a cul- e of a stool specimen obtained from the patient at that time yielded colonies suspected of being V. cholerae. This was confirmed by the Los Angeles County Public Health Laboratory. The isolate was identified as V. cholerae non-01. The isolate pro- duced cholera toxin by Y-1 adrenal cell assay and latex agglutination in the California State Public Health Laboratory. Testing at CDC identified the isolate as toxigenic V. cholerae serogroup 0139, resistant to trimethoprim-sulfamethoxazole. Before this illness, the patient had been in good health. In Hyderabad, she stayed with relatives and did not travel outside the city. Although the source of her infection was not confirmed, on January 30, the patient had eaten fried shrimp and prawns purchased from a local market and prepared by relatives. She also recalled drinking a half glass of unbottled water in Hyderabad on February 3. Reported by: M Tormey, MPH, L Mascola, MD, L Kilman, Los Angeles County Dept of Health Svcs, Los Angeles; P Nagami, MD, Southern California Permanente Medical Group, Los Ange- les; E DeBess, DVM, S Abbott, GW Rutherford, III, MD, State Epidemiologist, California Dept of U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES / Public Health Service 106 ^ 3 O »n "c — O) ft o £t O - ID (= "C « ^ « ■ ? 3? 2 o a^ ^ o _ »- in 5 Q. « 2 - xs ® -r "^ 5 oi __^ TJ 5 £ : 5 s 1 1 o c z « s t mo — ^ CO a, I ■o o 5 = =5>s e E == S ■ z r. "- tN 11 I i s C o = •> a ai *- 5 •- ffl o 2t- C ■" O ^ — OJ . O a! ° -D I O "O ^ < «•>. = ; s * ° *£ = ; o o 6 ' ■g C 5? c Q. 12 3 «) 2 « > o = e 5 o = ^ S = _? g ■o _ ^ ■i J? « S- « o t« > T3 3 |"S. a _ CB © (O C -c .SO" ;; c o> « 5 c ■— < "C 13 ^ 3 *^ — to . g o — a. -3? c « a? > c 2 o i 5 fas : -= i: a> t o aj >n - <^ 5 - ? E a ; 2 £ . o ® -" • a> S S o = « ° E c > « ^ c ^ ^ o 0) > c t: ^ tr o c _ 0) M O ® > *- C € S » E E .9 « c o 'o S c O CO ^ £ c 5 •I * 5 B „ -a ' T3 « C O ^ o ;; JC C .0 10 O cog £u, B W ^ w CI i2> 2 SG EG Q. j< >■ t -5 ■» = ° o » • O - 5 ? E S 3. I i 5 5 to E » !l ^ E O o ci.i J V c a» -! . •- *~ ^- o * ~ H > 5 = , 2^1^ £ o * ^ • — e - = 5-^5 -s ^■S ? Q 5 £ = c i: ^ . *- OS w S ^ rt ' c ;r o „- 2 >. ^ a, c S 9 S - 3 ^- £ " ^ o £ F S - -c - ■ ; « ° tc « « ^ — ^S = S 5-0 One >• c c o 3 "_ .a g c i " -c = ■3 3 0).— ■o P S ^ y i 5 2 5-1 £ ; » ^ S o c a. £ ^ OS O eo — 2 -g 2 y 2 « ? ^ « O .r S rj-g Q. O 03 c G. »- C c 2 o " C 2 c ° O .c o © a - ~ u E ■= « £ c — o * <- ™ => © ^^ o 0) 3 C S"° „ ^ o © ".go S- « E 2 x: ■ I 5 i- " .c 5 ■= ffl © c g « (0 O X3 — wj ffl C «- 2 ? S. .?? 5 "3 — 3 C V) (/) CI U 5 "c __. O (D m c) S" sis •r - I : 3 1 ul < 2 i j-c — o o ; © o o * "o 'E ^ ', - i. si 00 - , .S © ^E — ■ if I ; *. « tt — o -On© ;= «• S -O o 2 E r- 4> S) A( J< ■D °« © c 3 o 3 2 «> » a? £ .2 © CSI E .2 5 •«■?■? ? o ^ In « o oi ci * -£ <= ^ m o • « £ « O UJ c -^ • © > > © c « m £ © ■— o 9 > " '^ — « i3 C P = ™2 » ° "^§ 5 i £ s I.E ° ; a m © E .S 5. U 4U ' <0 (0 3 « O o, O n 0) 3 0) in >■ £ CO « AJ J< O) T3 - .E - ® W O £ ? _ ® f- ® £ .= ■ y £ £ ^. O u» > E P O ffl g is s © 2 C — C " II T3 <» 3 ■o < c o < O) s s I S ^ ! I ■ '^ - I e II «)t*K,3c£tS««c«» 2 d ^ £ ? S 5 II »- ! £ ^ .= -h O) Q. — B .^ 00 — t- S-oJ^g.co.| g,«S? •2-2ScX = ,ola.©Jg -• = £'='>.Sr!) = a-S O.CW©23S — -c,].?^© - 5©ti"'"©o px" — SS^oi'lo-EZSe "^riiliirs^i © o 2 -S 3 © c-Dt°'c£|-.l £5iS;2£gES 3S,s£^fS»«-g3:»©03-2 S » 5 o S o s -5^.? c .9 .S C .Em S3 U « >- " o c OO.pC—dia, »- ©AjoiaS© °- £-a£a>c£|.2 £ oiat;crZ(2g-2' E2s5S/^3:o.So-g^ r £ 0-5 o^Z- © |Ie ^ — — 2Po» — oOffl©© ^ - g S I 2 i E S £ S ■- i £ i s s ^-^i a*:;-© .ffgoiSo)©.?© l"- © © ■- 01 je ^ 5 5 o Jfl j: © 2 •- £ t o o a, © t -g £ " ffl © « -g _.. o £ ^ - I 5.3 i o o » J « -c " c © -S _ J ■« ^ ^ o _ ; 0 o ; c 3 5 - -c E CO o > 1 5 S 2 I .1 ■S S - £ ~ £ © o ° » .5 • c .c 5- .? ■= c i ►— « O © — 2. -o © ; o ffl g s c ? © ■° c 2 5 - ■= c « © © -i •" O ;^ — — P -O o=£-"oS .--'--O.c'Offl " 5 g » <= © £ ffl ^ 5 s 5 g 5 £ ; - £ ?- ?E o'2 jr i E£ « E ? ® r " c^ * " c £ e « 2 ^ t CB _o ? g £ o o — — tn ^ — c . _ 5 .'5 >• o 2 ^ w) w « M 2£5 ffl c ^ 2 3 >. c _ U) u _ - ^ £ oj « .0 — — Q. © © £ O o E 5 « ;d 3 C o- o ^ £ 5 I o .t © "O © E o i 0.-0 — ^ c © il5l I o 2 i.E £ I o 5 « '" " o ^ „ 5»©P5i 2^" "££©••5 g-°8^o£-© c '"«»—>. «Ci-fflffl©©-r: |5li£ii S-Ssi»-S3§ t „ '^ ffl Jr 3 M O _ > CT >. ^ o ■= ~ I I 1. I E 1 £- • I 00 ;£ „ -o >• © 5 ; -a O CT 5 © o I- >.£ ■o f = t: ■§ c © E „ o .0 © JC O © Q. 1- j; W Q. .C 2^ © £ E — « -£0» = &£© ^ £| 0 g » E ■° E o E ffl 3 j- o ^ *" - O (_) ■a <" — © ffl « « £ ffl .= ^ £ ■o o © ffl M ^ © =■- 1!: (/) 0) a> ^ o > o c * « « 5 « = < O (D O L > O ■^ ^ ^ ^ " - 3 o .E . o 5 ® « O i; I « 0> CO j; O ^ Q) (J " c: ■;;; ^ - £ ? o s«i| i - " S "J ■^ f § 5- ^ £ < 2 © © S .^ " ■i f ! ^ © s (A EC .„ M C © 2 -D .^ 5 „ ■- - 5. ■" c 2 5 ^ ffl ; «. © ffl © " Q. i © hr * " "> - i T £ - ffl 3 tf* .0 o £ 3 £ f>i G ~ ^ c in □, • ffl — — i ? »Z : E c < ; w. © < O .■5 Q = O O) I £ o - o -o -?■« — ffl © .? ^ — ' -- Si © 2 ffl 5 = > .i Q i: >- ffl ^ T3 ffl Q. 2 "^ 5r'° ° .2 £ " S o «rx J3 © C "D ; .2 i e c ,^ 2 * :2 o = o "^ " I r ■; = I o = > -O u c $ a> _ w sj; •- »"• w w in 2 "D := [; 2 ■o <0 Q. — < fn £ a-§27 3 © -D ffl -O ..p £ .2 ^ g ^ -Si. - £ - '" — „ ffl t s» >. ffl s-D < 2 -Si; 5 c - ^ - o> n O M a> I 107 3 S S T3 C C c fi E Q> c S o 8 S a. U a> ® — « cr c o 5 T) .- © E c c (_) a c ^ « r o ^ ceo 2 = a ■D s Tl n o u O o © V 5 (0 e 3 © c (0 ■o o s s = O (R — g e = ■O 2 i: 1 1 « 3 ■D 9 O « c o "5 9> < 5 is « E = « o © '5 > © a "3 c o s . a ffl O O C o 1 z 2 c fO 3 C -Z d O S „ '^ a c o o a (A CM en fir* ftl £ • 2 — T - ^ ^x = I |o ^ D O 00 ^ JIJ f^ O C CD " S ' O C7» ■- 2? S "O C ^ ■o . t^ e CTi ,9 » S Sec o5-£? = 1 5 C! " ? ■? > a ^ m ^ ^ X T3 dr: !? C 3 2 O — ■= 0. •^2 >i-o „■ e o e is t E S< o S II •S 2 ' "S n E " » 2 « c c C •- = (A 5 o c © O C -S ^ 3 D S • » c w c c Q.Z = < ^ O • = c" f 2 r ^ - -£ o • • o£ - ° S c >. . »i . E c o e j< •=■=§ «£ E £ S sfg g « o<« »i- • •» := E " ^ ^ &(_) S'OS "'-•5 — - u = | exU) i 2 0 CTO » *= u • 2 5 E ° • £ .i= >■= coEy-cSg^i) Ej=»oxo3^2 5 = o • • "Z o "> O I. O S — 5Z2a, o • j< 1^ a 3 ^ c •- a £ B £'^i '= ^ i o o °- ££2^ o t -O « , - s n.- g : - a— " c U « « o > " • O- ' -D £ S • 22 E -^^ S 5) Q-— • •■ CO (A 0> at » " £ « ^ O °- • J* -O *? '<^ .^ • -Sop*" : T-. O U C " -) .5 'S|gS§E^I o •< < ■» -D c e an f c £3 a E o u -c .9 J= c (B = >? " .E S -E © ■" .^ O Ul © ^ ^ "i — °Z£85---£.9e&. — ©©««^ ._'-^(d" tf) C^3©--ai©'--DC--> « <-P"d£o— «ffl©^©ru©°c3„ a O • s := -D « ;;; i2 21^5 c -, x; "5 "^ 3 ^^f£ p (B C © ;. £ « 3 £ o^ £ * r c = c ^ i J 8 •■§ s £ = -5 c o I s 0 u n e V 13 1 5 - » o - > o £• =^ o > « .= =•; *. a •> S O" • ■S " = at u 0 " E M o . .S _ ^ " £ £ ° — S c • »> »> "> 5 S T3 W o — " C S £ I o ■D O -S .= ^ — 1 .§ = I Is =- S -"' f ■5 "t c 5 - > ? £ • » "° 5 E .5 c > o 2 5 5 r - 5 I Mill ■D o a-? c — ■ "E *o 3 u "D (J a E -i c c .«; O U5 © to .5 q: 2 I !:; E o «> S •» • al O • c = ^ ^ • 2 • J S S c a -DC ■s • • = c • o c " ^ = • • « .Z £ o ■ « s^ .2 Q.2 ■D ■= • ■o ' a » 010 •i .E c _, • 3 • ) c fn C CM P^ c o> 00 -» c ;a"n> 1^ ® --; • - CnI ^ 10 ^ (D *7 7 7 1" £i^ si, 0 n = 2 l°z c S2 2 Sz-d. • c 2 6 f>i C I I <= 9 at ,?op: c r) ^ ^ o o •- in c CO •- C CD 10 fO c tc cs 0 E - ol ifere S-0. 3-0. 4-0. • ^* ^ N e ■ • flc C _ c 2 2 S • ^ ^ ^ 0 « lO 0 r) (D tQ ^" -^ a-: -^ 0 0 d -^ -^ .-: -^ C 00 ^ ,500 X o o •= • S e I £ i Eg < » si £ u So 1 = |E £ o c S c .- O) E -^ P e _L I 2- 3:5 c 2 u. ■ > m X o>7 7 » • CO in i • > o < a- o c o o i Q. « C raphic varlal ce; race/elhr status, pad by the i by family s li demogi ble. own ra cation develo at vary V c £E 0 « c 3 tn ^ — CT t: ~ -^ "O c — •■rf 21= ?ll ^ 0 •Se each es In her 01 know dafin resho lad for variebl< Is of 01 ndenls. s of un sed on ome Ih a « 5 = 0 « EieiSlSg E-g S pres( jraph pond ir res. }ond( 1 ere It of 1 . <-B )» 3 C^ ** « » o E o E-se - • ©s 5S o-« ^ rj — rw S • • « "D 2-D ~ S c ' = " C 5 » 5 ^ >'mi -11. in ■^-to at : LU 3 L 108 Some Interesting Results from an April 1993 Gallup Poll Smokers are interested in quitting In 1993, 66% of smokers stated that they would like to quit smoking. No time period was mentioned in the survey question. We know from Federal surveys that about 4 0% of everyday smokers (17 million people) quit for at least one day in a recent year. However, more than 90% of these will eventually relapse. In any given year, about 2.5% of smokers quit permanently. Most smokers believe that they would be able to quit smoking if they made the decision to do so In 1993, 69% of smokers (74% of male smokers and 63% of female smokers) stated that they believed that they could quit smoking if they decided to do so. About 18% of smokers stated that they would use the nicotine patch if they decided to quit 21% of females and 14% of males would use the patch. Most (68%) smokers stated that they would try to "stop cold turkey". 74% of smokers believe that they are addicted to cigarettes 72% of males and 77% of females report that they are addicted to cigarettes. Fifty-six percent of smokers state that they are addicted to cigarettes and that they want to quit. Nineteen percent state that they are addicted and that they don't want to quit. Fourteen percent state that they are not addicted and that they do want to quit. Twelve percent state that they are not addicted and that they don't want to quit. If they had to do it over again, eight of ten adult smokers report that they would not have started smoking in the first place 86% of females and 77% of males would not start smoking, if they had it all to do over again. 65% of smokers believe that their smoking has already affected their health 69* of males and 61% of females so report. 78% of smokers believe that it is very likely or likely that they will have serious health problems from smoking if they continue to smoke 82% of males and 75% of females so report. 77% of smokers believe that they could avoid or decrease serious health problems from smoking if they quit 76% of males and 78% of females so report. 90% of smokers felt that smoking was harmful to their health 90% of both genders believe that smoking is harmful to their health. • Source: Thomas RM, Larsen MD. Smoking Prevalence, Beliefs, and Activities by Gender and Other Demographic Indicators. Princeton, NJ: The Gallup Organization, Inc., 1993. 109 Receipt of Advice to Quit Smoking in the Past Year by Amount Smoked — United States, Ages 18+, 1991 50 40 30 20 10 Cigarettes/Day* 1-14 ■ 33.6 1 ■ 1 15-24 ■ 41.4 1 ■ 1 25-^ ■ 46.3 *Currant Smoker* Onty Sourc*: mi National Haaltti InUtvlaw Sumy CDC Prevalence of Cigarette Smoking by Frequency of Feeling Depressed in the Last Two Weeks, by Sex — United States, 1991 Men B ».9 1 WomenCD 21.4 1 ■ 1 M«i ■ iiJt WomenQ ZI2 § 1 Men ■ 41.5 33J Rarely / Never Sometimes Often / Very Often Source: SciKMnhom & Horm, 11/4/1993 1991 Natiorwl H«alth Intarviaw Survay CIX 110 Prevalence of Cigarette Smoking by Frequency of Feeling Bored in the Last Two Weeks, by Sex — United States, 1991 50 i30F § 20 a. 10 0 E "«" B Men__H >Vomen[J" B Men Q Women 32.3 2».e 428 Rarely/Never Sometimes Often/Very Often Source: Sctwanhom & Harm. 11/471993 1991 N«tk>nal H«*tth knarvicw Survey ccc All Things Considered, Would You Like to Give Up Smoking, or Not? 80 70 .60 r 50 c e 40 o. 10 Yes 30 -•••••••« 20 No |19T7 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 Yes— ' 66 66 75 77 68 63 74 76 66 1 No •• 29 30 22 20 27 33 24 22 30 Ill Smokers' Opinion of Addiction 1990 1991 1978 1993 1978H 1 ■. 1 1990| 61 1991 ■ 70 1993H 74 Souro*«: 1978 - Rop«r Organaation Survey 1990.1991.1993 - Galk^i Pol CDC 112 Mr. BiLlRAKlS. Have you come to a conclusion? I have never smoked in my life. I don't have any idea in the world how the smoke affects an individual here. I am trying to learn here. I don't know whether you have ever smoked. Mr. Kessler. I smoked a pipe for a little bit. Mr. BiLlRAKiS. Have you come to a conclusion? You have shown this chart to us, "Percent estimate of all users who are addicted," and yet you don't have a source. Mr. KESSLER. We would be happy to provide that. You can see my last testimony had an excess of 70 footnotes. There is no short- age of footnotes. I can assure you that kind of information from the scientific community Mr. BILIRAXIS. Dr. Kessler, you have appeared before this com- mittee so many times and we have talked to you one on one. Your testimony is tempered by virtue of the fact that you have come in here with testimony which would indicate completely one way inso- far as this issue is concerned. You haven't come in with any testimony the other way, whether it be 90 percent here and 10 percent the other way. It is all one way, and yet you say you can't give us information and yet you say the investigation is continuing. You have come to conclusions which would indicate a completed investigation and yet you say the investigation is continuing. Maybe that is not your fault because you have been called in here to testify, but you certainly have not made it clear that Mr. Kessler. Let me make it clear, if I can. Congressman, so we can end the confusion, where I think there are conclusions that have been reached and where there are not conclusions that have been reached. On scientific conclusions, things that are in the med- ical literature, for example, the issue of whether nicotine is addict- ive. When you have every medical organization saying it is addict- ive, yes, I think that you have a consensus and you have the con- clusion that nicotine is addictive. The questions for which we do not have a conclusion today, but which is before the agency, is whether nicotine, as you look at that definition of a drug — an article intended to affect the structure and function — whether nicotine-containing cigarettes meet that defini- tion. That is an issue for which there is no conclusion as I sit here be- fore you today and one for which we are asking your guidance. Mr. Greenwood. Will the gentleman yield? Mr. Hastert. I yield to the gentleman. Mr. Greenwood. Dr. Kessler, will you provide the minority members of this committee all of the documents that you have pro- vided to the chairman and his staff or other majority members of this committee with regard to this investigation? Mr. Kessler. We certainly will treat absolutely both sides the same. Mr. Greenwood. I am asking you to supply me a copy of every document that you have supplied the chairman with regard to this investigation. Will you do that today? Mr. Kessler. I have no problem suppljdng documents fairly across the board. I think that is absolutely certain. 113 I would ask the committee and the Chair that if you want to ver- ify something in Mr. Greenwood. I am asking you a very specific question. Mr. Kessler. And the answer to that question: Absolutely we will treat Mr. Greenwood. Listen. I would like you to supply to my office within the next 48 hours a copy of every document that you have supplied to the chairman and his staff with regard to this inves- tigation. This is not a prospective question. Mr. Kessler. Absolutely. Mr. Greenwood. Thank you. Mr. Waxman. The gentleman's time has expired. Let me assure all the members of this subcommittee that I didn't get any documents that you didn't also get. The members have had them available to them. Second, I want to — I am just sort of amazed at the attitude of the members here. I don't want information that is confidential from Dr. Kessler. I don't want to hurt — I don't want to hurt the whistleblowers in coming to him and getting information and get- ting the facts out. And I would hope that members of this sub- committee would feel the same way that we want to get the facts and get them on the record and we want to get them in a way that will enable people to feel that they can come forward, sometimes taking a risk, and talk to Dr. Kessler or any other Agency of the government in confidence. If they talk to Dr. Kessler in confidence, he is going to respect that vis-a-vis all of the members of this subcommittee. Mr. Greenwood. If the chairman will allow, the problem is that our staff has told us that they have not been able to obtain infor- mation from Dr. Kessler's people that your people have been able to obtain. Mr. Waxman. I think your staff is misrepresenting to you the re- ality of the situation. We did not get Dr. Kessler's testimony until late yesterday. As soon as we got it Mr. Greenwood. We are not talking about testimony. Mr. Waxman. In terms of any documents, any documents I have received, your staff has received on the minority side, other mem- bers have received as well. Mr. BiLlRAKis. Will the gentleman yield? Mr. Chairman, you haven't said whether you would yield. Mr. Waxman. I am not going to yield and I want my second round and I am going to go around and others can jump in and say what they want to say. OK I am going to yield. Mr. BiLlRAKls. Dr. Kessler has emphasized that he would furnish the chairman with information. He has emphasized that. He said it more than once. So you know that I think any reasonable person could conclude that some information has been furnished to the chairman that hasn't been furnished to the others and will con- tinue to be. Mr. Waxman. He has said that if there is something of a sen- sitive nature that he is willing to talk to the members of the com- mittee to verify a statement that he made and why he has come to that conclusion, but he does not want to submit documents — is 114 this correct, Dr. Kessler — to you or to us or the committee that would violate confidential information? Mr. BlLlRAKis. In the process of the committee working with him to determine the merit of the confidentiality of those documents, does that include the minority? Mr. Waxman. As to whether it is confidential or not? Mr. BILIRAKIS. Yes. Mr, Waxman. I think we ought to work together. Mr. Kessler. Mr. Chairman, could I— just so the record is com- plete, yesterday I think we briefed both the minority and the ma- jority. In fact, as I was told this morning, the minority actually asked more questions and had more information before this hear- ing than the majority, in fact, in those briefings. So we briefed at the same time. We did not share documents with either side yesterday in those briefings. Mr. McMillan. Mr. Chairman, if you would yield for just one comment. Mr. Waxman. Yes. Mr. McMillan. I think what we are concerned with here, there has been a pattern on this issue of selective documents being brought to the hearing room without prior knowledge on the part of anyone else as to what was going to be considered. Mr. Waxman. Mr. McMillan, that has not happened. I think if you have been led to believe that, you have been informed incor- rectly. Mr. McMillan. I have been sitting here in the room, Mr. Chair- man. And all I am asking is that we have equal access to the same information, if we are going to respect Mr. Waxman. The gentleman is absolutely correct in what he is requesting and I think he ought to have and has had equal access to documents that any member of some subcommittee, including the chairman, has received. Now if I could, I am going to ask my questions and then we will recognize Members on a subsequent round, but I do want to make one point clear. We did not get any documents that the other mem- bers of the subcommittee didn't get, and as far as briefings, they were given to the Republicans as well as to the Democrats. I do want to point out and I do want to underscore that what is being missed is that Dr. Kessler has been misled by a company and through his investigation found out that they tried to mislead the FDA. And I don't think he ought to be misled or that we should be misled. But let me talk about times when people have been misled. The industry has asserted that nicotine is not addictive. They just made that assertion even as of a couple of months ago when the chief ex- ecutive officers testified. The industry has asserted that they don't manipulate nicotine, when in fact, they do manipulate nicotine. Brown & Williamson said that it is not feasible for them to de- velop a genetically altered tobacco product that would be higher in nicotine levels and that assertion was a few months ago and now we find out that assertion was incorrect. The industry has also as- serted that we didn't need to know about all of these additives be- cause these additives were only for flavoring and what we are learning today is that two of the additives were not just for flavor- 115 ing, they were to give a jolt on the nicotine when the smoker smokes. So, I think that we ought to find out, if we are going to talk about credibility, the credibility of this industry that has attempted to mislead the American people and their Representatives, both in the Congress and in the Executive Branch. Now, Dr. Kessler, there are 599 ingredients added to tobacco. Few people have any idea what most of these ingredients are for. You have now told us that ammonia and substances related to am- monia are applied to reconstituted tobacco for a variety of pur- poses, including to increase nicotine transfer efficiency and you say that ammonia is added directly to the tobacco. Can you describe for us the mechanism by which ammonia would increase the nicotine received by the smoker? Mr. Kessler. Congressman, without getting into the complex- ities of acid-based chemistry and vapor chemistry, let me explain it as I understand it. Nicotine in tobacco, in most instances, is in the salt stage. Am- monia, when it gets released into the smoke, according to the infor- mation that we have learned from the industry, when that ammo- nia gets in the cigarette smoke, it changes the pH of the smoke and it changes the nicotine from the salt state to the free state and that free state has changed the bioavailability as it gets into the body. That is a simplified version. I hope I haven't misstated it. Mr. Waxman. Do you have information on industry-wide prac- tices with respect to the addition of ammonia? Is the addition of ammonia an industry-wide practice? Mr. Kessler. It is on the list. There are a number of different ammonia compounds — diammonium phosphate, ammonium hy- droxide. Urea is on the list. From the documents that we have seen, in fact, many companies use ammonia compounds. Only one company document that we have substantiates that company is using it specifically for that in- tended purpose. Until we have access to other documents, Mr. Chairman, I can't tell you how widespread it is. Mr. Waxman. We were told by industry representatives that the FTC tests would measure whether there was an increase in nico- tine or not. Have you verified whether ammonia added to the ciga- rettes in some way or other increases the level of nicotine that comes into the FTC test? Mr. Kessler. We have had to rely on industry studies. We don't have that capability. I just want to add one note of caution here, Mr. Chairman. The FTC measures do measure what the machine measures, but they don't measure necessarily what humans are consuming. We have seen information that would suggest that there are human smok- ing measurements as well as machine smoking measurements. We don't have access to that information. So until I have access to all information and all smoke analj^icals from the cigarette in- dustry, I am not going to be in a position to answer that question. Mr. Waxman. Brown & Williamson, you indicated to us, applied for a patent on this Y plant or whatever it is called, the Y-1. They applied for a patent. They seemed to have trouble with it. They 116 were appealing the decision. They were pushing forward to get it. Perhaps we could get that chart up. Mr. Kessler. I think it is Chart L, Andrew. That is the chro- nology to the best of our knowledge. Mr. Waxman. So that is the chronology as you understand it at least at this point. They filed this Brazilian patent in February of 1992. In February, they went to appeal rejection of U.S. patent ap- plication. That was in February of 1994. Less than a month later, March 14, Brown & Williamson with- drew their application. Do you know why they withdrew it? Mr. KisSLER. I don't know why they withdrew that application. Mr. Waxman. That coincidentally was 12 days before you testi- fied before us for the very first time about the issue of whether there was a manipulation of nicotine levels in tobacco. I would be interested to know from the Brown & Williamson representative, from Mr. Sandefur, the CEO next Thursday, if there was any con- nection between the two. The last question I wanted to ask you was: In this country, we don't control tobacco additives. There is no requirement that the company show that additives are safe or that they even disclose what the additives in cigarettes are for. Do you have any information as to whether other countries con- trol additives in tobacco? Mr. Kessler. Yes, sir. As part of our reading of what industry practices were, other countries, for example Germany, we believe restricts the availability of certain additives and has much tighter regulation. In fact we believe other alternatives to certain ammonia compounds have been used in other countries because they do, in fact, regulate the additives that are added to tobacco and ciga- rettes. There is much tighter regulation, Mr. Chairman, in certain other countries. Mr. Waxman. Dr. Kessler, you have been asked repeatedly as to what your recommendations were to be as to the level of nicotine. If you were to give us an answer without getting all the facts, I am sure that members of this committee would be justifiably jump- ing all over you. I think that you are doing what we expect of you; develop the record, establish the facts, and then give us some thoughts on this subject of what the levels ought to be. Of course, to criticize you for giving levels or not giving levels when you don't have the legal authority to set them, or may not have that legal authority, seems to me a very peculiar way to raise this issue. /^ I understand, you are going to have some conference on nicotine levels? Mr. Kessler. We will, Mr. Chairman. I assure you, yes, we're going to have an advisory committee meeting this summer, but I assure you that we will proceed thoughtfully, and analytically as we address this question. Mr. Waxman. Thank you very much. Mr. McMillan? Mr. McMillan. It is my understanding that this patent applica- tion was disapproved; is that right? Mr. Kessler. The initial application, yes. I think we said that it was rejected, yes. 117 Mr. McMillan. And the language — the reason for the rejection was that it was not remarkable? Mr. Kessler. I have read the appeal. I have not read all the pat- ent documents. The issue, I believe for the patent examiners when they ran the computer searches, they had seen that there were cer- tain crosses made back in the forties and fifties. What Brown & Williamson appesded and what they said was unique in their appeal was the fact that for the first time, this plant could be agronomically viable; that it could actually be grown. Other people had done some genetic breeding, but no one, to my knowledge — according to the company, this was the first time that anyone was successful in actually being able to grow a plant. Mr. McMillan. I thought when they turned something down that was not remarkable, that it really offered nothing significantly new. Mr. Kessler. Again, I am telling you what was in the patent ap- plication and what Brown & Williamson appealed. Brown & Williamson made the case that this was the first time that this plant was successful, could be successfully grown. For example, when we talked to Dr. Chaplin, Dr. Chaplin said yes, there had been crosses, but he couldn't get the plant to actu- ally stand up. It just didn't grow. It was not agronomically feasible, and so the real value, according to the company and Dr. Chaplin, was the higher nicotine that could be grown that was agronomically viable, sir. Mr. McMillan. Is there anything wrong with experimenting to find out how you could deliver a nicotine product witn less tar? Mr. Kessler. There is nothing wrong with research at all. Mr. McMillan. Isn't that in fact why the industry, through re- se£U"ch, developed filter-tip cigarettes, for example? Mr. Kessler. The issue. Congressman — I think the question is still out. What I have asked experts in the area is does low tar, in fact, reduce your health hazard compared to a regular cigarette? There are different opinions. The evidence is not concrete. There may be Mr. McMillan. This is a lot of legislation on the assumption that is the case. Mr. Kessler. Again, the issues — ^you need to inquire about com- pensatory mechanisms. How people smoke, elasticity of nicotine and tar, and what actually gets into the smoke, before you can con- clude that, in fact, the low tar cigarette is any less hazardous. There are certainly those who believe that there may be a small benefit for the low tar cigarette if you are addicted and you have no other choice. But on the other hand, there are certainly those experts who say that in the end, you are going to get as much, and in fact, there is no benefit to you from a health perspective. What could be of use is if vou want to quit smoking, how do you do that? What information do we get? And perhaps shifting — first of all Mr. McMillan. I understand that very well. I have done it a thousand times. Mr. Kessler. As far as quitting smoking. The question is did that— do the very low tar, are they helpful in getting you to quit? 118 For some people, cutting in half the deliveries at periodic intervals really does help them get off cigarettes. Mr. McMillan. Well, you seem to be hung up on addiction. The question is what is harmful and that is what we need to address. In order to do that intelligently, we need facts and what we are getting here is speculation, so I would urge you to get on with the development of whatever it is that you are prepared to present. And then we should come back and take a serious look at it and try to make some intelligent choices, because we are basically up here debating a lot of speculation and emotion rather than the facts. I think it is the facts that you perhaps are in the best position to sift through and provide us with a recommendation on. Mr. Kessler. Congressman, I certainly understand the need to move on to the policy aspects, but let me make sure the record is correct. We are interested in addiction, first of all, because of the definition of drug. But leave no doubt, it is not just the addictive potential; it is the harm that addiction causes. I think there is no question about that harm. Mr. McMillan. But what are the facts that we really need to get to? Mr. Kessler. Congressman, I think that there is no disagree- ment in the scientific and medical community. When you see 420,000 people die each year Mr. McMillan. I would like you to get the facts up here. Dr. Kessler, so that we can make some decisions instead of rehashing the same statistics over and over again. I thank the Chair. Mr. Kessler. Congressman, those facts are in fact what ciga- rettes do. We can't deny their hazard. Mr. Waxman. Thank you. The gentleman's time has expired. Mr. Synar? Mr. Synar. I can't let that go unattended. I am disappointed by the tenor that this debate has taken, at least from the Republican side. I think that Dr. Kessler has taken pains to say — in the last 3 hours, we have seen one of the most comprehensive presentation of facts related to this issue, unlike what we saw when we had our CEO's in here under oath — who at best skirted or stretched believ- ability beyond any form. There has been no hiding of documents here. Documents are pro- vided both to the majority and minority and as the chairman said, they have been provided. You have been very forthcoming. I have no criticism. I think those who are criticizing you would like that to be the debate. The fact is that we have been here for 3 hours and not one fact that you have presented has been refuted by either the tobacco in- dustry or those people who would attack your credibility. That said, let me go into specifics. You said that nicotine re- leased from cigarettes can be increased by adding ammonia; is that correct? Mr. Kessler. I am relying on what we have learned from the re- view of the industry information available to us. I am not asserting it for the truth of the fact. I am only stating — I am just repeating, Congressman, what we have learned. 119 Mr. Synar. Adding ammonia in a way is really a way to adjust the acidity or the pH level of the tobacco smoke; is that correct? Mr. Kessler. What, we have seen is ammonia as an impact — as an impact booster and that impact is correlated with nicotine and nicotine's effect. Yes, I believe that — the chairman asked me about the biological mechanisms. From my basic chemistry understanding, putting one and one to- gether, it has to do with ammonia as a base. It does affect pH chemistry. Nicotine in the protonated and unprotonated forms, they act differently. I am putting one and one together. Mr. Synar. So what we have learned today is that the tobacco industry has been manipulating the nicotine by adjusting the pH of the smoke; correct? Mr. Kessler. They have been adding ammonia and in their words, that affects nicotine, the liberation of free nicotine to the smoke. Mr. Waxman. Mr. Bilirakis, do you have questions? Mr. Bilirakis. Well, Mr. Chairman, if I may quickly read into the record — when I asked the general question previously, I didn't think I was going to start a small war in the process, and that question still stands subject to the discussions that we have had here, but these are more specific. Near the end of your March 25 testimony, you discussed the legal question of whether nicotine as contained in cigarettes was a drug for purposes of regulation under the FDA Act. It occurs to me, how can it not be that this is the kind of question that you or your predecessors would have put to your advisors? Will you please provide to the subcommittee for inclusion in the hearing record any memoranda that have been written on the sub- ject of the regulation of cigarettes under the FDA Act, specifically the question of the possible regulation of cigarettes on the grounds that they contain nicotine that may have been written by anyone at the FDA over the years to the present? That is the question for the procedure. Next question, on page 27 — and I will furnish these to you. You don't have to worry about writing them down. Mr. Kessler. Thank you very much. Mr. Bilirakis. On page 12 of your March 25 written statement, you acknowledge that there is the possibility that, "regulation of nicotine in cigarettes as drugs would result in the removal of nico- tine-containing cigarettes from the market." Isn't it true that under current law, if the FDA asserts jurisdiction over cigarettes on the grounds that they contain nicotine as a drug, you would have no alternative but to eliminate all nicotine-containing cigarettes from the market because they would not be covered by any new ap- proved drug application on file? [The information follows:] We are continuing our investigation and evaluation of public health and regu- latory options under current law. While immediate removal of all tobacco products with addictive levels of nicotine might be one regulatory alternative, I am not con- vinced it is the only one. We are continuing our internal deliberations and consulta- tion with other agencies on that issue. When we have completed those deliberations, we will be pleased to share them with the Congress and the public. 120 Mr. BlLlRAKlS. You also state that there might be other possibiH- ties such as limiting the amount of nicotine in a cigarette. You did that today, too, I believe, to such so-called non-addictive levels, surely given the monumental societal consequences of your pro- posal, someone at the FDA must have made some type of analysis or proposal as to what those levels might be and would you provide those to the subcommittee for inclusion in the hearing record if they exist. [The information follows:] We have evaluated published research on the subject of addictive levels of nico- tine. We believe strongly that this subject requires full scientific exploration. As a next step, we are presenting this issue to a panel of experts, the Drug Abuse Advi- son^ Committee, scheduled for August 1. A copy of the notice of that meeting is at- tached. We will have a number of scientific presentations and will ask the commit- tee members a series of questions designed to elicit scientific opinion on the issue of addictive levels of nicotine. Afler that meeting, we will determine what additional scientific development, if any, of this issue will be necessary. Mr. BiLlRAKlS. You have acknowledged the dramatic effects on society that FDA regulation of cigarettes as drugs would have. Surely you have outlined the precise steps that you would take if you asserted such jurisdiction. Would you give the subcommittee all memoranda from your staff or anyone at FDA concerning these steps. [The information follows:] Clearly, when a product used by 45 million Americans is at issue, assertion of FDA jurisdiction could have dramatic effects. As I have stated repeatedly, that is why I have asked Congress for guidance. The precise steps that we would take would be based on the results of our investigations into manufacturers' activities, which are ongoing, as well as our continuing scientific exploration of the precise ad- dictive effects of nicotine. We are also exploring with other agencies which regu- latory requirements and other government action, both within our jurisdiction and which might require additional legislation, would be best designed to produce desir- able public health outcomes. Some alternatives we are exploring are additional ad- vertising and promotional restrictions, more restricted access to minors, and reduc- tion of nicotine in tobacco products to nonaddictive levels. To the extent possible, we want to be sure that the regulatory scheme we arrive at serves valid public health objectives and has public and Congressional support. Mr. BiLlRAKlS. The next question, you state in your March 25 testimony that FDA might otherwise restrict access — ^your words, "otherwise restrict access" — ^to cigarettes unless the industry could show that nicotine-containing cigarettes were "safe and effective" — your words. Do you expect this subcommittee to believe that there is any possibility that you could be convinced that any nicotine-con- taining cigarettes are safe and effective for some therapeutic pur- pose? I am sure you could take probably the rest of my time to answer that and therefore I would ask your response be in the record. [The information follows:] At this point in our consideration of this issue, I would not predict what any ciga- rette manufacturer might produce in response to a request to submit a new drug application for cigarettes. They have never had to do the detailed assessment of risks and benefits that such an application would require, and I would not want to prejudge that effort. I want to stress, however, that we have not in any way con- cluded that new drug applications would be required if we determined that tobacco products containing addictive levels of nicotine are drugs. Mr, BiLlRAKls. Next, Dr. Kessler, I assume you have considered the manner in which FDA might restrict the sale of cigarettes. For 121 example, would you require cigarettes to be sold only with a pre- scription from a doctor, indicating that it was his or her best medi- cal judgment that the person should smoke? Would you please provide the subcommittee with any memo- randa that you may have concerning restrictions that might be placed on the sale of cigarettes other than removing them in the market? That is the end of that question. [The information follows:] One alternative under consideration would obviously be to consider nicotine-con- taining tobacco products as prescription drugs because of the health risks they pose when consumed as intended. There are very complex public policy and medical is- sues that would need to be resolved before we might decide to impose such a re- quirement. We would not do so without a full airing of these considerations. 122 33738 Federal Register / Vol. 59. No. 133 / Wednesday. luly 13. 1994 / ^Jotices Food and Drug Administration Advisory Committee; Notice o( Meeting agency: Food and Drug Administratioa. HHS. *CTio«: Notice. summary: This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administiation CFDA). This ootice also summarizes the procedures for the meeting and methods by which interested persons may participate in open public hearings before FDA's advisory committees. MErriNG: The following advisory committee meeting U announced: Drug Abuse Advisory Ccmmltte« Date, time, and place. August 1. 2. and 3, 1994, 9 a.m.. Holiday Inn. Plaza Ballroom. 8777 Georgia Ave.. Silver Spring. MD. Type of meeting and contort person. Open public hearing. August 1. 1994. 9 am to 10 a.m., unless ptiblic participation does not last that long: open committee discussion. 10 a.m. to S pjn: open committee discussion, August 2. 1994. 9 a.m. to 1 p.m.; open public hearing. 1 p.m. to 2 p m., tinli^^s f>ublic partidpatioQ does not last thai ong: open committee discussion, 2 p.m. to S p.m; open public hearing. August 3. 1994. 9 a.m. to 10 a.m.. unless pubUc partLCipatioD does not last that long; open committee discussion. 10 a.m. to 5 p.m.: Ennona B. McCk>odwin or Isaac F Roubein. Center for Drug Evaluation and Research (HFD-009). Food and Drug Administratioo, 5600 Fishers Lane. RocVville. MD 20857. 301-443- 5455. General function of the committee. The committee advises on the scientific and medical evaluation of information gathered by the Department of Health and Human Services and the Department of Justice on the safety, efficacy, and abuse potential of drugs and recommends actions to be taken on the marketing. Investigation, and control of such drugs. Agenda—Open public hearing. Interested persons may present data, information, or views, orally or in writing, on issues pending before the dtnraittee. Those desiring to make formal presentations should notify the contact person before July 25. 1994. and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments. Open committee discussion. On August 1. 1994. the committee will discuss the abuse babiUty assessment and related issues of the new drug application (NDA) 20-385. nicotine nasal spray. Kabi Pharmacia. Inc., an aid to smoking cessation. On August 2. 1994. the committee will discuss issues related to nicotine and smoking, including the relationship between nicotine dose and addiction in smokers. On August 3. 1994. the committee virill djscuss the abuse liability assessment of NDA 20-281. Ultram® (tramadol hydrochloride tablets). R. W. Johnson Pharmaceutical Research Institute, for treatment of pain. FDA pubbc icTvisory committee meetings may have as many as four separable portions: (1) An open public hearing. (2) an open conur'tee discussion. (3) a closed presentation of data, and (4) a closed committee deliberation. Every advisory committee meeting shall have an open public hearing portion. Whether or not it also Includes any of the other three portions will depend upon the specific meeting involved. There are no closed i^rtions for the meetings announced in this notice. The dates and times reserved for the open portions of each committee meeting are listed above. The open public hearing portion of each meeting shall be at least 1 hour long unless public participation does not last that long. It is emphasized, however, that the 1 hour time limit for an open public hearing represents a Tninimnm rather than a maximum time for public participation, and an open fiublic hearing may last for whatever onger period the committee chairperson determines will facilitate the committee's work. Public hearings are subject to FDA's guideline (subpart C of 21 CFR part 10) concerning the policy and procedures for electronic media coverage of FDA's public administrative proceedings, including hearings before public advisory committees under 21 CFR part 14. Under 21 CFR 10.205. representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. Meetings of advisory committees shall be conducted, insofar as is practical, in accordance with the agenda pubUshed in this Federal Register notice. Changes in the agenda will be announced at the beginning of the open portion of a meeting Any interested person who tvishes to be assured of the right to make an oral presentation at the open public hearing portion of a meeting shall inform the contact person listed above, either orally or in writing, prior to the meeting. Any person attending the hearing who does not in advance of the meebng request an opportunity to speak will be allowed to make an oral presentaboo at the bearing's conclusion, if time permits, at the chairperson's discrebon. The agenda, the quesbons to be addressed by the committee, and a current Ust of committee members will be available at the meeting location OD the day of the meeting. Transcripts of the open portion of the meeting may be requested in writing from the Freedom of InformaUon Office (HFI-35). Food tr. " Jrug Administrabca. rm. 12A-16. 5600 Fishers Lane, Rockville, MD 20857. approximately 15 working days after the meeting, at a cost of 10 cents per page. The transcript may be viewed at the Dockets Management Branch (HFA- 305). Food ana Drug Adminislrabon. rm. 1-23. 12420 Parklawn>Dr.. Rockville, MD 20857. approximately 15 working days after the meeting, between the hours of 9 a.m. and 4 p.m.. Monday through Friday. Summary minutes of the open portion of the meeting may be requested in writing from the Freedom of Informaboo Office (address above) begiiming approximately 90 days after the meeting. This notice Is issued under section 1 0(a)( 1) and (2) of the Federal Advisory Committee Act (5 US C app 2). and FDA's regulations (21 CFR part 14) on advisory committees. \ Dated. July 7. 1994 Linda A. Suydam. \ tt.tenm Deputy Commtmoner for Opentions. IFR Doc 9+-159:6 Filed 7-8-94. 12 48 pm| • 'LUMC COOC *^tO~Ot-f 123 Mr. BILIRAXIS. Finally — and I appreciate the Chair's indul- gence— on pages 27 and 28 of your March 25 written testimony, you stated that a black market could develop if the FDA asserted jurisdiction over cigarettes and either removed them or restricted their sale. Has anyone at FDA made any type of analysis of the likelihood and the problems with such a black market; and if so, will you agree to provide any memos relating to such analysis? Dr. Kessler, those are the specific questions which obviously, if you respond adequately to the first general question, they would probably all be covered therein. Dr. Kessler, as I read Chapter 2 definitions, the term drug means an article recognized in the official United States pharma- copoeia, et cetera; and then B, articles intended for use in the diag- nosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and then Article C — ^Article (c) goes on, "Articles other than food intended to affect the structure of any function." I guess my question is, have you received any testimony that would show intent consistent with the definitions of the term drug in the FDA regulations? Mr. Kessler. Testimony? Mr. BILIRAKIS. Testimony, evidence, et cetera. Mr. Kessler. There are certainly statements that are appearing in — ^that have been reported, a statement that says, for example, we are then in the business of selling an addictive drug. A state- ment that says, and I can't quote it exactly, that we are in the nico- tine business, not the tobacco business. With nicotine's physio- logical effects, those statements. Congressman, may be relevant to the question of intent. But, we need to see all those documents, see them in full context, the full analysis, before we can reach any de- cision. Mr. BiLlRAKis. All right. So what you are saying, you have not reached any decision as yet? Mr. Kessler. On the question of intent, that is correct. Mr. Bilirakis. Well, that is the key question. Mr. Kessler. Absolutely. Mr. Bilirakis. It seems to me as I read the Mr. Kessler. Absolutely. I don't want to leave any misunder- standing. Mr. Bilirakis. You will share all your investigative reports and all your information to us to the extent that you Mr. Kessler. We will go through questions and, again, I appre- ciate all the questions and we will respond. Mr. Bilirakis. But even in those circumstances where you do not deem it fit, you are going to get together with majority and minor- ity, so we might help you determine whether or not you are in- deed Mr. Kessler. Congressman, as you know, we have very good working relationships with this committee and personally, and we will make sure that you can do your job and that we can do our job. Mr. Bilirakis. Thank you. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bilirakis. Mr. Wyden. Mr. Wyden. Thank you, Mr. Chairman. 124 Let me ask a slightly different question, Dr. Kessler. If the Con- gress says we as a collective body are interested in a new Federal policy with respect to smoking, that would in effect have the Con- gress working with your agency and other health agencies to gradually lower nicotine levels over an extended period of time, say 10 years, to help smokers in this country defeat this horrible addic- tion, what would you say some of the policy issues would be in looking at something like that and would in fact something like this be an area that you think would be fruitful for the Congress to work on? Mr. Kessler. Congressman, it is a complex question. That re- quires very thoughtful analysis. There are those scientific experts who do believe that perhaps a way to reduce ultimately people's de- mand for cigarettes and people's addiction, is you actually deal with the level of addictive substance in the cigarette. There are also other ways that are beyond any consideration for this Agency but you have — in fact, this committee has discussed. There is the issue of advertising. There is the issue of restricting access even further. So there are many different ways. Looking at nicotine levels and reducing dependence on that level is certainly one way that needs to be reviewed and thought about and dis- cussed and debated. We will engage the scientific experts on that question over this summer. We don't have all the answers. Mr. Wyden. Does research show, for example, that if you reduce nicotine levels, smokers will just smoke more of the cigarette, suck harder on them, et cetera? Mr. Kessler. I have read some of those studies, certainly for a short period of time there may be certain compensation, but if you took nicotine down, if there wasn't the kind of elasticity that there is, if you really took the nicotine down so you couldn't get out more, then perhaps you can overcome those compensatory mechanisms. They are complex questions, they need to be addressed scientif- ically, and then the policy aspects of those questions need also to be reviewed. Mr. Wyden. Is your agency looking at those issues now, or do you consider those issues the province of another public health agency? Mr. Kessler. Obviously when one looks at the question of whether nicotine containing cigarettes are a drug for the purposes of Federal Food, Drug and Cosmetic Act one has to ask the ques- tion in what dose would nicotine be considered a drug for the pur- poses of the Federal Food, Drug and Cosmetic Act. Perhaps it is all levels of nicotine. Perhaps there is a range. We need to look at that question. Mr. Wyden. Well, I am interested in exploring that with you be- cause, along with my colleagues, I share the view that a ban on cigarettes would cause great chaos, but I think this question of in effect gradually lowering nicotine levels over an extended period of time is an important public health issue that ought to be looked at. Let me ask you about just one more matter, and I have my friend, Mike Bilirakis here and m.aybe we engage in this together. On the matter of an agency request for documents from a tobacco company, if a tobacco company denies an agency, your agency spe- 125 cifically, documents that you feel are necessary, what can you do about it? Mr. Kessler. We could proceed — you get into the issue of juris- diction to determine jurisdiction, and that would involve us going the route of an administrative warrant to get those documents. We have not gone that route as of this time. Mr. Wyden. I ask this question because, as you noted to me ear- lier, you all made a request for documents May 8 of this year that you felt would really flesh out and clarify questions with respect to manipulation and control of nicotine that those documents if they were forthcoming would resolve the matter. And I think that what is really important on this, and I have worked with Mike Bilirakis on many occasions on lots of issues, is that majority and minority members work to make sure that docu- ments are received from the best source, which is the tobacco com- panies. And, historically, it has not been possible to get these docu- ments from the best source, which is the tobacco companies, and that is why these whistleblowers have been so important. I want to assure my friend from Florida that I am going to work with him on all of these issues. And that is the way we have done it in the past and we will continue to do it in the future. Mr. Chairman, I yield back. Mr. Waxman. Thank you very much, Mr. Wyden. This committee is conducting an investigation. We intend to get the information we need pursuant to that investigation. And by "we," I mean Democrats and Republicans alike. We expect to get them from anyone, whether it is a government employee or the to- bacco industry, and we will work together, I expect, to get the in- formation. And if need be, we will work together by way of sub- poena to get the information because we are determined to follow this investigation to where it will lead and to get the facts out. The American people deserve to know what is going on in the area of cigarettes, tobacco, and tobacco products. Dr. Kessler, I want to thank you again and commend you for your testimony and for your diligent work in this area, and we defi- nitely want to work with you. Thank you very much. Mr. Kessler. Thank you, Mr. Chairman. Mr. Waxman. That concludes our business for today. The sub- committee stands adjourned. [Whereupon, at 12:47 p.m., the subcommittee was adjourned, to reconvene at the call of the Chair.] [The following letters were submitted:] 86-463 95-5 126 AMERICAN V CANCER rSOaETY t AMERICAN LUNG ASSOCIATION American Heart % IE Association " Coalition on Smoking OR Health MfCTiiift* Biwmww* June 20, 1994 Mxiueir llCT-in .\i(W«ifi t 'dicer iHXictv AdwIwUlfMor - Sll* Utmt The Honorable John D. Dingell Chairman Committee on Energy and Commerce U. S. House of Representatives Washington. D.C. 20515 Dear Mr. Chairman: I tKtitoiK« A4»lMr» VmtmtH Vncntafl Vvtdcnn ,>rFam))v t^^Mcuni VnefK*n At*deni% .f Pedumo \mc«»n AiWKua.-'fl f'" \rt»^-rH*ni'.'U«w»>li \nwiKin ■ olkBC i>n hctr Ph) w wcuiu Amcnc«n Public Mnkh .UMcuqon XmcfUtfi S>ur4*utm«nScrvxoi.>nuiu/jDoruii. USSMM' S.H.'n.'n •'K'oAin-uculv ^ 1nilo)i> The American Cancer Society, American Heart Association, and American Lung Association, united as the Coalition on Smoking OR Health, are pleased by your statements that you support efforts by Food and Drug Admmistration Commissioner David Kessler to work with Congress to develop legislation authorizing the regulation of tobacco products. The Coalition supports such legislation and would like to work with you and members of your committee in this effort. We also share your view that action to ban the sale of cigarettes would have negative consequences and is not desirable. As you know, the Coalition and more than 70 other national organizations believe that it is time that tobacco products be held to the same regulatory standards as other legal consumer products. Because we strongly believe that FDA has the authority to regulate tobacco products, we supported the effort to obtain a rule to allow an amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Fiscal Year 1995 Appropnations bill to instruct the FDA to use its authonty. In your June 13 letter to Chairman Moakley concerning the proposed amendment on tobacco product regulation to the Agriculture Appropriations bill, you note two concerns about FDA resources which we would like to address. First, you ask for vigilance in assigning to FDA resource-intensive obligations that it will find enormously difficult to fulfill. And, second, you question whether increased resources made available to FDA would best be used to further the public health through a new regulatory activity. The framework for a specific regulatory authority dealing with tobacco products is already pending before your committee. The Fairness in Tobacco and Nicotine Regulation Act, MR. 2147, would establish a separate chapter under the Federal Food, Drug, and Cosmetic Act that will regulate the manufacture, sale, labeling, distribution, and advertising and promotion of 1 1. 'id ConnctlKul Avenue. NW. Suite K2II Wavhinglcin. DC 2(X1.'6 Telephone; (:(i:i 4i:-l 1K4 FAX i2():i45: UI7 127 tobacco products in a way comparable to that in which other legal products are regulated, but will prohibit any regulations banning the sale and distribution of a tobacco product solely because it causes disease. TTie issue of the availability of resources within FDA to administer new regulatory authority for tobacco products is addressed m H.R. 2147. The bill would require manufacturers of tobacco products to pay an annual fee to cover the costs of implementing the new requirements. The fees would be credited to the FDA"s salary and expenses appropriation account and could be used only for the costs of implementing the new authority. A similar "user fee" is in place for certain regulatory requirements for pharmaceutical manufacturers. You also raise the question of whether tobacco product regulation is a good use of scarce FDA resources. Preventing the death and disease caused by use of tobacco products is a very high public health pnority. Tobacco is the greatest preventable cause of disease in this country, killing 420,000 people a year. Compared to other very important major initiatives undertaken by FDA, tobacco product regulation would not be a huge burden. Cigarettes and smokeless tobacco products are manufactured by seven companies. Only about 65 brands of cigarettes are currently on the market in this country. The pharmaceutical and food industnes, which are already regulated by the FDA. include hundreds of manufacturers and tens of thousands of products. The payoff in public health benefits would more than justify the expenditure of resources to regulate tobacco products, especially if the manufacturers paid the bill through a user fee. We would be happy to discuss these issues with you in greater detail. A proposal is ready for committee consideration and we urge you to do what you can to move forward with legislation for tobacco product regulation through the committee process. For 30 years the tobacco industry has surrounded itself with a fortress that has protected it from government oversight and regulation. The public supports FDA regulation of tobacco products. The public's health deserves such regulation. / Sfhcerely^ §tottb. Ballin" Chairman Deputy Managing Director Coalition on Smoking OR Health Amencan Lung Association Vice President for Public Affairs American Heart Association ). Ballin ^ Fran Du Melle A-^ Michael F. Heron National Vice President Advocacy and Relationship Management American Cancer Society cc: Members of the Energy and Commerce Committee Ctl -oMCac^ 'Mt«oc:-«iCaiit 128 jO*»h D C***CiLi. i«iC<*irnwi* c*-4c it ccxiMt ..ic: I «.-■■ WVOfM C«Mn .iM coot* vttiMtttat T>4>MU < uufTD« Hiw mm. IOOtf««U4 tnwWK liit«W rQM CM>0 * i«AtKMI OMiQ MfCI CMItOUl «AtMtl*OTQM MaAjcm tfAi;cK>(SM(fv>ittT »t*i4tn« T*nMC< i to.** • .•rn.i* tiCMAii G oecif ically prohibited from regulating any product which, in its judgment, meets the definition of "drug." The question of whether nicotine in tobacco products meets that definition is one with which FDA's legal counsel -- and legal counsel to both the tobacco industry and consumer groups -- have grappled for a number of years. Just within the last several months, the agency responded to a petition from the American Heart Association and others, indicating that while It believed a legal case could be made for defining nicotine in tobacco products as a drug, it. preferred to work with the Congress to achieve legislation specifically authorizing r.h* rugrulat 1 on of such nicotine and defining the parameters of the regulation. I supported this 129 The Honorable John Joseph Moakley Pace 2 responsible approach co an excremely controversial and difficult matter, as did the Chairnan of the Health and the Environment SubcommittGG, in public comments following FDA's statements. It is clear -■ and FDA emphasized this point -- thaL if FDA were simply to consider nicotine in tobacco aa a drug and regulate it as it regulates prescription drug products, lu would be banned from sale. This is because, once defined as a drug, nicotine in tobacco would not meet the fundamental test lux FDA approval -- that it has been shown to be "safe and effective for its intended use." PDA's only option relative tu the marketing and sale of an unapproved drug is to take legal action to remove the product Troni the niaiKet. Thus, under this scenario, FDA would be required by law to remove from the market cigarettes, smukeless tobacco products, and cigars, while many in congress might agree that this action would be beneficial to our health, I am certain they also would acknowledge the enormous social consequences of such an action -- consequences reminiscent of alcohol prohibition. hor many weeks, the Health and the Environment Subcommittee has held hearings on matters associated with nicotine and its potential addict]. ve properties, the health effects of using tobacco products, and various activities of the tobacco industry. The hearings have been detailed and exhaustive, and have laid groundwork for consideration by the Subcommittee and the Committee of whether additional legislation to regulate nicotine would be appropriate. This is the proper way to deal with this matter -- not by a legislative amendment to an appropriations bill that, in an area as complex as this, lacks thorough consideration. With respect to use of FDA appropriations for the purpose intended by the proposed amendment, let me make two points. First, because of the enormity of its public health mission and the increasing responsibilities assigned to it by Congiress, FDA is sorely and sadly underfunded. This is a fact acknowledged and lamented by Chairman Durbin. Though he works mightily to alr.^r the situation, he, like all of us, is constrained by spending caps and deficit reduction goals. "Vhmrmfnrti, we annually faes a situation where w« know full well that Congress cannot provide FHA with the full resources it nssds to lcs«p up with its work. Because of this, we must be vigilant not to assign the agency highly resourcs-intenniva obligations that it will find enormously difficult, if not impossible, to fulfill. Second, if it were feasible to increase FDA's resources, the Congress should sxamine closely to what purposs thooe reoourccs should be put. Should those fiinds go, for example, to improving the agency's •xieting seafood regulation program, controlling the entry into the U.S. of contaminated and misbranded foreign 130 The Honorable John Joseph Moakley Page 3 products, implementing the Maamography Quality Otandairds Act, continuing to reduce review times for medical devices and human and animal drugs, or fully implementing congressional requirements related to the safety of medical devices? Or would it be in thft best interest either of FDA or the public health to assign the agency's increased resources to an altogether new regulatory activity that, because of its controversial nature, would be tied up in litigation for years and consume enormous agency ancl othar govarnnont funds in the procet>»? I an not persuaded that the latter course is best. It may be theoretically possible, I suppose, for the author of this nmAndment to construot it so that it tevlinically would not violate Rule XXI. In that event, I obviously would not be in a posit Inn to argue that the amendment should not be made in order on that basis. Irrespective of how such an amendment is phraBAri, however, itc underlying intentiuii clearly is to authorize the PDA to conduct business it heretofore has declined to conduct, baood on an argument that Congress has not enacted specific authorizing legislation. For the reasons set forth above, I boliove auch an amendment would be no less ill-advised on an appropriations bill than if it did violate Rule XXI. Thus, in either oaae, I raapecCfully request that tne araendnent to authorize FDA to use appropriated funds for the regulation of nicotine in tobacco products not be made in order under the rule for House consideration of the FDX appropriations bill. With every good wish JOHN D. DINGELL CHAIRMAN cc: The Honorable uavid R. Obey, Chairman Committee on Appropriations The Honorable Richard J. Durbin, Chairnan Subconnittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agenda The Honorable Mike Synar Member of Congress Mr. Nm Holmes Brown Parliamentarian REGULATION OF TOBACCO PRODUCTS THURSDAY, JUNE 23, 1994 House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment, Washington, DC. The subcommittee met, pursuant to notice, at 10:06 a.m., in room 2123, Raybum House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. Waxman. The meeting of the subcommittee will come to order. Our hearing today is with Mr. Sandefur, who is the chief execu- tive officer of Brown & Williamson Tobacco Company. Mr. Sandefur, I want to welcome you to this hearing and I appreciate your willingness to testify as well as your cooperation in submitting many of the documents the subcommittee has requested from you. This hearing will provide you with an important opportunity to explain Brown & Williamson's position on the many tobacco issues that are before this subcommittee. I am very interested in your perspective and hope you will be as specific and detailed as possible in answering questions this morning. Full and open disclosure is especially important because the in- formation you and others in the industry provide is essential as we develop legislation, especially when we look at the impact of smok- ing and kids. Three thousand children started smoking yesterday, 3,000 chil- dren will start smoking today, and another 3,000 tomorrow and the day after. In all, over a million kids will take the first step to ad- diction this year. The sad fact is that tobacco is winning the battle against common sense with many of our kids. Congress, the tobacco industry, and the public have to face this reality. And the only way this subcommittee can craft effective poli- cies that will reduce the number of kids smoking is to know as much as possible about your industry and how to make the best policy with that knowledge. The knowledge we gain in this and other hearings about health impacts, addiction, advertising, and other issues is invaluable to our work. And I hope you will join us in this effort. I look forward to listening to your testimony and I want to thank you for being with us. But before I call upon you, it is the tradition of the subcommittee to recognize members for opening statements, and I want to call on Mr. Bliley first. Mr. Bliley. Thank you, Mr. Chairman. (131) 132 I, too, would like to welcome you, Mr. Sandefur, to this hearing, particularly because we had a hearing a couple of days ago in which charges against your company were made regarding a to- bacco plant called Y-1 and its use in nicotine and the like. I hope you will use this opportunity to enlighten this subcommittee and this Congress on the history of Brown & Williamson and Y-1, so that we can separate fact from fiction or maybe it is better to say smoke from mirrors in this debate. I thank you for coming and I thank you for what I know will be your candid answers to the subcommittee's questions. I am also glad to see and recognize our colleague from Georgia who represents your Macon, Georgia plant. Congressman Bishop. Sanford, nice to see you this morning. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bliley. Mr. Synar. Mr. Synar. Thank you, Mr. Chairman. And Mr. Sandefur, welcome back to the committee. America and the Congress really can no longer talk about the need for health care reform and at the same time bury our heads in the sand when it comes to the oversight, regulation, and control of tobacco prod- ucts. It is time to stop this vicious cycle of addiction, disease, and death. The documents involved in today's hearings will bear wit- ness to the tobacco industries' 40 year deceptive campaign of misin- formation which has resulted in the unnecessary and premature deaths of 10 million of our fellow Americans. We now have over 60,000 scientific studies showing that ciga- rettes cause death and disease. We have had over 20 Surgeon Gen- eral's reports reach the same conclusions. The time for action is now. As we commemorate the 30th anniversary of the release of first Surgeon General's report, we have to ask ourselves, when we will fulfill our responsibilities to protect the health of the American public. Today's hearing will help us along that way. Thank you, Mr. Chairman. [The prepared statement of Hon. Mike Synar follows:] Statement of Hon. Mike Synar Dr. Kessler's recent testimony on Y-1 and the documents involved in today's hear- ing bear witness to the tobacco industry's 40 year deceptive campaign of misin- formation which has resulted in the unnecessary premature deaths of 10 million Americans. Brown & Williamson, although under the spotlight today, only has sales amounting to 11 percent of the cigarette market. This subcommittee is still waiting for Philip Morris and RJ Reynolds, which control 80 percent of the market, to dis- close the internal and company financed research and marketing research which this subcommittee requested 2 months ago. The Congress can no longer seriously talk about the need for health care reform and at the same time bury our heads in the sand when it comes to the oversight, regulation and control of tobacco products. It is time to end this vicious cycle of ad- diction, disease, and death. Unlike other legal products in our society, tobacco prod- ucts which cause 420,000 deaths each and every year are products which are not regulated in any way. In spite of the industry's public relations campaign to con- vince the Congress and the American public that it is a responsible inaustry, its ac- tions have shown that it has one motive and one motive only — to sell cigarettes to maximize its profits. Are we going to have to witness the next generation of children seduced by the billions of dollars of seductive advertising? Is the American public going to continue to be denied information they are entitled to about this deadly product? Will the 133 Federal and State Governments continue to neglect their responsibility and duty to ensure that State laws restricting cigarette sales to minors are enforced? We have had over 60,000 scientific studies showing that cigarettes cause death and disease. We have had over 20 Surgeon General's Reports that have reached the same conclusions. The time for action is now. As we commemorate the 30th anniver- sary of the release of the first Surgeon General's Report, we have to ask ourselves why has it taken so long for Congress and the administration to fulfill its respon- sibilities to protect the health of the American public. Mr. Waxman. Thank you, Mr. Synar. Mr. McMillan. Mr. McMillan. Thank you, Mr. Chairman, for holding yet an- other hearing on the issue of tobacco, and I am pleased that Mr. Sandefur of Brown & Williamson has agreed to voluntarily come before this committee again. It is my understanding he is here of his own free will, and I applaud his desire to respond to some of the allegations that have been made in hearings held by this com- mittee. I am concerned that there not be a misunderstanding about Mr. Sandefur's testimony today. I hope that he will not only answer the allegations that have been leveled against Brown & Williamson, and perhaps some against the industry, but also will be quite clear about any reasons why he may not be in a position to answer such questions. I think we had some of that with Dr. Kessler here ear- lier this week in which he was unable to answer questions and there may have been some confusion as to why. I believe that this committee should have a full understanding of the issues surrounding Brown & Williamson Tobacco Company as well as the industry. I am also hopeful that the subcommittee will not get overly emotional today. Some of our previous hearings have been rather heated, something which I think in rather dif- ficult circumstances does not benefit us or the public who may have an interest as well. I would also hope that the media will not only report the loaded questions but also the answers to those questions. The process is aifficult for all concerned and it is important the committee and the public understand the facts, not just the charges. I know that the chairman is interested in factual information as well, and we will try to get that as we proceed today. I would merely ask that as we do this, the public be exposed to information in a balanced manner. Not everyone is watching this on C-SPAN. Some are dependent upon the print media and the electronic media, and I would hope that we achieve a level of bal- ance in what we do. Finally, I hope that whatever legislation is proposed, and I am not sure that we have had a serious proposal on this subject yet — Dr. Kessler did not describe specifically what he would do — that we would go ahead and pull it up and get on with it. I think that most of us are prepared to deal with something that is sensible. We have spent extensive time and resources pursuing this issue. There are other matters before Congress, as the gentleman from Oklahoma has said, the issue of health care reform is before us and I, for one, am in the middle of that as is the gentleman from Vir- ginia on my right. We are trying to work out satisfactory com- promises and I would rather be there than here because, frankly, I think that is more pressing at this point. 134 So I would urge that we get on with it and get to the bottom of the facts and the charges and consider what constructive action may be necessary and move ahead. And I thank the Chair and yield back the balance of my time. Mr. Waxman. Thank you, Mr. McMillan. Mr. Wyden. Mr. Wyden. Thank you, Mr. Chairman, and let me also say, Mr. Sandefur, we appreciate your being here, and the staff has reported that you and the company have been very forthcoming with respect to giving us the documents that we need and I appreciate that. I am going to be very brief, and let me start, Mr. Sandefur, by saying that if one believes the reports of the U.S. Surgeon General, as a tobacco company CEO, you have your hands on the controls of an addiction machine. Apparently, from news reports, several executives at your own company have thought exactly the same way as long ago as the 1960's. As you know. Dr. David Kessler came to the committee here a couple of days ago, essentially said the same thing, updated us on these very serious matters. So what I am interested in today especially are two substantive areas. One would be any new evidence that you could give us that would contradict what the Surgeon General has said, what your own executives seem to have said in the 1960's, and finally what Dr. Kessler said even a couple of days ago. And second what I would be interested in today, Mr. Sandefur, is talking about sensible regulation of cigarettes and how we are particularly going to ensure that young people in this country don't get started smoking. That's what this debate is all about for most of us. That's what this fight is all about. I can tell you, with all due respect, I don't know of a member of this committee who thinks that we ought to ban or prohibit ciga- rettes, but all of us feel that there must be a significantly more ag- gressive effort to keep young people from smoking, and I'll be ex- ploring that with you as well this morning. And, again, we appre- ciate your cooperation. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Wyden. Mr. Bilirakis. Mr. Bilirakis. Thank you, Mr. Chairman. Mr. Sandefur, I too add my welcome. And I also welcome, I might add, your courage and your willingness to cooperate with what we are trying to do, whatever it is up here. Let me begin by saying I am not here to promote cigarette smok- ing. I have never been a smoker, and none of my family members use tobacco products. Probably one of the reasons I never smoked was because, when I was a child, everyone told me that smoking cigarettes wasn't good for me. Obviously, cigarette warning labels were not required when I was growing up. Obviously, too, the public education campaign of the last 3 decades has had an impact on the number of people who choose to smoke. It should come as no great revelation that smok- ing is not beneficial to your health. Most Americans have known this for years. I daresay, all Americans who could read and write 135 and understand have known it for years even before, long before the initial Surgeon General's report. This being said, I believe that we must view some of the issues before us as a matter of personal choice. We hear that word in the halls of Congress constantly, except we use it when it is convenient for us. Millions of Americans now do smoke with knowledge of the risk involved. They have adopted smoking as part of their lifestyle and there is only so much government can and should do, in my opin- ion, to protect people from themselves. Our government can never become so omnipotent that it tries to dictate the habits of individ- ual Americans. Our government has no intrinsic right under the Constitution to tell people how to run their lives. Ours is a govern- ment of limited and enumerated powers and we should be ever mindful of that fact. We should also be wary of the slippery slope we place ourselves on when we try to regulate the food products, vitamins, drugs, and other items that people consume. Of course, we must regulate some of these items because government does have a valid role in pro- tecting the public health and in guarding against harm, but then we have to ask ourselves, where is the line drawn? In the name of public health, should the government decide how much milk, butter, eggs, bacon or hamburgers a person can consume? Can the government do this simply because those prod- ucts have a high cholesterol content and we have evidence linking cholesterol to heart disease and other illnesses. Should people be penalized because they are overweight — and I would be one of the first probably to be penalized for that — and refuse to exercise? These questions are not so absurd as they may seem. Once we begin to actively regulate products on the basis of their perceived health risks or because they may or may not meet the legal defini- tion of a drug, we set a standard for intervention that is realisti- cally applicable to other products. In other words, if we regulate one substance because we have evidence it is in some degree harm- ful, how can we not regulate other items where there is evidence of significant harm. Let me quote from a recent Roll Call article by Morton Kondracke, "The Center for Science in the Public Interest claims that 445,000 Americans die prematurely each year from poor diet and lack of exercise compared with 420,000 per year from tobacco use. Guns kill around 40,000 a year. Alcohol abuse kills around 100,000. Drug abuse kills 20,000. Dangerous sexual behavior, 30,000, mostly from AIDS. And auto accidents, 44,000. Abortions claim 1.3 million fetuses per year. "These are too many deaths and the government should step in to do something about all of them mainly to make clear to citizens what the dangers are and to invoke reasonable regulation to pro- tect the public health and innocent lives." Mr. Chairman, it is my belief that our citizens appreciate that there are risks associated with smoking. It is also my belief that our citizens have the ability to make choices for themselves. During the Flag Day weekend, I spoke at two different Elks Clubs. Many people there — and I can't tell you how many — approached me and said, don't take my rights to smoke away from me. 136 But continuing on, it is also my belief that our citizens have the ability to make choices for themselves and they don't want to be continuously protected by government which thinks it knows better than they what is and is not good for them. So let us approach these issues reasonably and hopefully without the rancor that has pervaded some of our proceedings. Let us fulfill our subcommittee's responsibility to seek the truth and let us be divided by common sense. We do not need to be a vehicle for cru- sades or witch-hunts. Let the facts speak for themselves and let our witnesses answer the questions in a meaningful way with time to explain fully their answers. Let us treat our witnesses with the same respect we expect from others. So let us, in brief, act reason- ably and with equal respect for both the breadth and limits of our legislative power. We should remember both the terms and import of the 10th amendment to the Constitution. We should fully appreciate its dic- tate that the powers not delegated to the United States by the Con- stitution nor prohibited by it to the States are reserved to the States respectively or to the people. Thank you, Mr. Chairman. I look forward to the testimony today. Mr. Waxman. Thank you, Mr. Bilirakis. Mr. Bryant? Mr. Bryant. I do not wish to make an opening statement, Mr. Chairman. Mr. Waxman. Mr. Kreidler. Mr. Kreidler. Thank you, Mr. Chairman. On March 25, this subcommittee received a statement from Brown & Williamson To- bacco Company claiming that its processing techniques reduced the amount of nicotine in cigarettes. On April 14, we received a statement from Mr. Sandefur denying that Brown & Williamson adds nicotine to its cigarettes. But this week, we learned that Brown & Williamson developed a special high nicotine variety tobacco and added that tobacco to five brands of cigarettes. We have also learned that Brown & Williamson dropped that project shortly after the FDA began investigating nic- otine in tobacco. On April 14, Mr. Sandefur told this subcommittee that he does not believe nicotine is addictive but, according to the New York Times report of May 7, the General Counsel of Brown & Williamson wrote a memo more than 30 years ago stating that, "we are in the business of selling nicotine, an addictive drug." This is a record of distortion and deceit that should embarrass even a tobacco company. We have to cut through the fog of decep- tion the tobacco industry is spreading across this country and get at the truth about nicotine and tobacco. You and your staff are doing that with great dedication, Mr. Chairman, and the American public should be grateful to you. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Kreidler. Mr. Paxon? Mr. Paxon. I don't have a statement. Mr. Waxman. Mr. Franks. Mr. Franks. Thank you, Mr. Chairman. 137 What we are doing in these hearings, if taken to its possible con- clusion, could result in the erosion of freedom for some 50 million Americans who exercise their personal choice and who accept the responsibility of smoking cigarettes. Whether one would think it is the most disdainful practice in the universe and some people I be- lieve would believe that smokers would represent that description, we in Congress need to be very careful about removing that or any freedom. We have made mistakes before this august body, the most nota- ble of this sort probably being prohibition. And that obviously was done with the great deal of zeal and, unfortunately, without a great deal of thought, obviously. With that, I would urge all of us and all present to consider the issues being raised fairly and with an open mind and with a close eye on the possibility of diminishing unnecessarily the freedom that all of us cherish and hold so dear. And I yield back, Mr. Chairman. Mr. Waxman. Thank you very much. Mr. Greenwood. Mr. Greenwood. No statement. Mr. Waxman. Mr. Sandefur, I do want to acknowledge the pres- ence of your representative. Congressman Sanford Bishop, who is not only your plant's representative, but I think your own personal representative in the Congress, and we are delighted to have him here. And I want to extend to you the greetings of Congressman Roy Rowland who is a very important member of this subcommit- tee. We have at the table in front of you the rules of the committee in the blue and white pamphlets, and they will inform you the lim- its on the power of this subcommittee and the extent of your rights during your appearance today. Do you desire to be represented by counsel or advised by counsel during your appearance here today. Mr. Sandefur. Yes, I do. Mr. Waxman. Do you or those you have asked to accompany you object to appearing before the subcommittee under oath? Mr. Sandefur. No, sir. Mr. Waxman. If you have no objection to appearing under oath, I would like to ask you or anybody else who is going to give testi- mony to rise and raise your right hand. Mr. Sandefur. Yes, sir. Mr. Waxman. Do you swear that the testimony you are about to give is the truth, the whole truth, and nothing but the truth? Mr. Sandefur. I do. Mr. Waxman. Please consider yourself to be under oath. [Witness sworn.] Mr. Waxman. Identify yourself for the record and include the names of those who are accompanying you. Mr. Sandefur. My name is Tommy Sandefur. I am chairman and chief executive officer of Brown & Williamson Tobacco Com- pany. Accompanying me is Judge Bell and Gordon Smith, law part- ner of Judge Bell. Mr. Waxman. Before you begin, I just noticed that Congressman Ralph Hall has entered the room and I do want to give him a 138 chance to make an opening statement if you would withhold for a minute. Mr. Hall. Mr. Hall. Mr. Chairman, I thank you for the courtesy extended to me and to Mr. Sandefur. On behalf of Congressman Rowland, whose constituent Mr. Sandefur is, I would welcome him to the committee and would request unanimous consent to put a state- ment submitted by J. Roy Rowland into the hearing. Mr. Waxman. Without objection, that will be the order. Mr. Hall. Thank you. [The prepared statement of Hon. J. Roy Rowland follows:] Statement of Hon. J. Roy Rowland I am pleased to welcome Tommy Sandefur, chairman and chief executive officer of Brown & Williamson Tobacco Corporation, the Nation's third largest tobacco com- pany. Brown & Williamson is one of the largest employers in my congressiontd dis- trict with over 2,000 workers at its Macon manufacturing facility. Mr. Sandefur is a native Georgian from Perry and a graduate of Georgia Southern College. As you know, I have announced my retirement from Congress this year after IIV2 years on Capitol Hill. I have no personal or political motivation in my remarks here. Tommy Sandefur is being asked to appear today to discuss a series of issues relat- ed to nicotine, smoking, and health. I hope that the testimony and the questions surrounding the testimony will be conducted in a tone of civility and mutual respect. Since I am a medical doctor, and a member of this subcommittee, and the fact that one of the largest employers in my district is a tobacco company puts me in a unique position. I will also point out that the manufacture, sale, and distribution of tobacco prod- ucts is a lawful activity in this and other countries. While I might discourage indi- viduals from smoking, more than 45 million Americans use tobacco products. As a major employer in my district, there are some things about Brown & Williamson related to the impact this facility has in middle Georgia in terms of em- ployment and community impact that are important. The manufacturing facility at Macon began production in 1977. Since then the fa- cility has grown to about 2,200 employees. This makes Brown & Williamson the largest private employer in the Macon area. The economic impact of the facility at Macon is more than $180 million annually. Statewide, the plant makes contribu- tions in payroll, taxes, purchases, and civic support of more than $425 million. It is my understanding that contributions to the United Negro College Fund through the employee payroll deduction plan is also the highest of any company in the Na- tion. While there is controversy about tobacco, Brown & Williamson has been a fine employer in my district, not only treating its employees fairly but supporting many social and civic causes in Macon. So, Mr. Chairman, I welcome Mr. Sandefur today and express my good wishes to him and his employees in Macon. Mr. Waxman. Mr. Sandefur, we have your prepared statement. We would make that part of the record in full. I want to recognize you to proceed with your testimony and to tell you that as much time as you will need to present that testimony will be accorded to you. STATEMENT OF THOMAS E. SANDEFUR, JR., CHAIRMAN AND CEO, BROWN & Wn^LIAMSON TOBACCO CORPORATION, AC- COMPANIED BY GORDON A. SMITH, AND GRIFFIN B. BELL, KING & SPALDING, ATLANTA, GA Mr. Sandefur. I appreciate that, Mr. Chairman. Mr. Chairman and members of the subcommittee. On behalf of Brown & Williamson Tobacco Corporation, I'm certainly glad to have the op- 139 portunity to present our views on the issues raised by this panel and to hopefully set the record straight. Mr. Chairman, if I may start by addressing several issues raised by this subcommittee on April 14, 1994, and highly publicized in the news media following those proceedings. First, my statement on the record of April 14 that I believe nico- tine is not addictive. In a letter following my testimony, you, Mr. Chairman, advised Brown & Williamson counsel that, "knowingly deceived," this subcommittee because I stated my belief. I repeat, I do not believe that nicotine is addictive. I certainly be- lieve that I am entitled to express my views even though they may differ from the opinions of others. My opinion is based on my com- mon sense understanding of the major differences between tobacco and drugs in terms of the way people behave and how many people have been able to quit smoking. You know, people use the addiction term very loosely. I'm sure I have people in my company that use the addiction term very loosely. Much as I believe, the Surgeon General did in 1988 report addressing this particular subject. Based on that definition in 1988, I would submit that the enjoyment derived from drinking coffee or cola could also be considered addictive. In addition, if we were to rely on the scientific definition applied by the Surgeon General in his report of 1964, cigarettes would not be addictive. The Surgeon General at that time labeled cigarettes as a habit. And I certainly agree with that. To put the enjoyment of smoking cigarettes on the same level as addiction to drugs in my opinion defies common sense. If cigarettes were in fact addictive like cocaine and heroin, as is currently being asserted, there would be no way that 40 million American smokers would have been able to quit smoking, 90 percent of them with very little help at all, if any. I might add that the mere existence of old documents in the files of a tobacco company doesn't prove addiction either. Scientific ad- visers working in Brown & Williamson today advised me that none of the research, I repeat none of the research which apparently prompted the allegations that I see — that I deceived this sub- committee establishes that nicotine is addictive. I've learned noth- ing, nothing that would change my view. One final point relating to nicotine, and that is the allegation that the level of nicotine in the cigarettes that we produce, or our competitors produce, or manipulated, or that the cigarettes are somehow spiked. I want to assure this subcommittee that we do not spike our products, nor do we manipulate the nicotine in our cigarettes to keep people hooked as the FDA alleges. In fact, over the last 40 years, the nicotine levels have been reduced substantially. Why? Because that's what the marketplace wanted. That's what the con- sumers said. Unlike drug addicts who require higher and higher levels of the drug to attain satisfaction, smokers require less. They asked for less and we responded. And that's a fact. Mr. Chairman, I would like to briefly address three other issues: The relationship of smoking to health, the regulation of the tobacco industry, and the accusations of Dr. Kessler and the FDA. 140 First, smoking and health. I and other chief executives of tobacco companies have somehow been cast as living in the dark ages when it comes to being aware of studies on smoking and health. I state for the record that I believe there are health risks statistically as- sociated with smoking, and that the same illnesses statistically as- sociated with cigarette smoking also have been tied to other human conditions, including life-style, diet, and heredity. And the public has certainly been aware of the risks of smoking for a long, long time. That leads me to my next point and that is the regulation of the tobacco industry and to be more precise, in my opinion, back door prohibition of tobacco sales. Because, again, in my opinion, that seems to be where we are headed. It has been contended, and "tobacco products are the Na- tion's least regulated consumer products, with tobacco products being exempt from every major health and safety law." Nothing could be farther from the truth. In fact, our industry is probably the most regulated in U.S. commerce, from the sowing of the seed in the seed bed to the sale of the finished product at retail. The following agencies regulate tobacco products or have issued re- ports that have the same impact as regulations. The U.S. Depart- ment of Agriculture; the Bureau of Alcohol, Tobacco, and Firearms; the Federal Trade Commission; the Environmental Protection Agency; OSHA; the U.S. Department of Health and Human Re- sources; pardon me. Health and Human Services; the Consumer Products Safety Commission, including the National Institute of Standards and Technology, as well as the Surgeon General. In addition to these Federal agencies, various States or every State and various counties and local municipalities have laws on the books regulating the sale, the distribution, and the marketing of cigarettes. There are literally thousands of regulations. There- fore, I believe it is totally misleading to paint the tobacco industry as business that is run unbridled. And given the fact that we al- ready are heavily regulated, I have concern that we now are head- ed down a road of putting this industry out of business. There is certainly no doubt about it in my mind. That's clear— that's clearly the intent of giving the FDA super- power jurisdiction. I recognize that the legislation proposed by Con- gressman Synar purports to prohibit the FDA from banning ciga- rettes outright. The words in that legislation make it perfectly clear. My concern is that we need to keep an eye on the back door. Let me explain why. Because the FDA's jurisdiction — because of the FDA's jurisdiction, the Agency could make it absolutely impos- sible for us to sell cigarettes because of the reach of their regu- latory powers. For example, the FDA can say you can sell a cigarette but it can't have any nicotine or they could say it is OK to sell cigarettes, but they can't emit any secondhand smoke. I think you understand my point. It is like telling a company it is OK to sell a beer as long as it doesn't contain any alcohol. The pathway to FDA regulation is the pathway to prohibition and we need only to look to the past to understand the consequences. Over the course of 19 — of 1895 to 1921, more than a dozen States enacted legislation banning tobacco products, banning the sale of 141 tobacco. It was not until 1925 that the last of these prohibition laws against cigarettes was repealed. People in this country, in our country, are against banning ciga- rettes. In a recent CNN-USA Today Gallup Poll, 86 percent of the people interviewed said smoking should not be made illegal. One finsd note, and this is in more of a personal nature. I've been in the tobacco business for more than 30 years. I'm proud of the qual- ity of products that we make. I'm proud of the thousands of people that we employ. And I'm proud of the livelihoods we provide to hundreds of thousands of others, from the farm families to the mom and pop stores around the corner. Mr. Chairman and members of this subcommittee, if I sound con- cerned or even alarmed, it is because I am, not because of the in- formation being brought before this committee. The issues being resurrected here relate to nicotine and so-called safer cigarettes and health risks associated with smoking are not new issues. These issues have been played out in courts over and over again. And when we are given a forum of fairness, judges, juries, and equitable rules, common sense has prevailed. Juries have always decided these issues in our favor when the facts are presented in a fair forum. No, I'm not concerned about the information itself. I'm concerned about the process. Saying it's OK to steal, saying it's OK to accept stolen property, saying it's OK to violate the rights of confidential- ity with legal counsel, saying it's OK to return to an age of McCar- thyism when blacklisting and vilification of honest and reasonable people were sanctioned for the sake of advancing a political agenda. I'm concerned about our government regulating the lives and life- styles of the American citizen. I am not alone in my concern. Col- umnist Richard Baker — Russell Baker writing about this congres- sional proceeding, said, "we have here a crusade in its second phase. Crusades typically start by being admirable, proceed to being foolish, and end by being dangerous. The crusade against smoking is now clearly into the second stage where foolishness abounds." Mr. Baker later adds, "this is an illustration of a crusade enter- ing the dangerous stage." Dr. Kessler's efibrts are a perfect example of a crusade by the FDA which is clearly in its dangerous stage. I would now like to respond to the false allegation also made against Brown & Williamson last Tuesday by Dr. Kessier and his staff concerning Y-1. First, the testimony implies or implied that Brown & Williamson developed some new variety of a tobacco plant which we didn't want the government to know about. In fact, the U.S. Department of Agriculture actually developed the breeding line which became Y-1. Three Federal agencies responsible or having the responsibility for public health issues, the Surgeon General, along with the FDA — pardon me, along with the USD A, and the National Cancer Institute, all recognized that it was appropriate to consider the de- sign of cigarettes which would deliver lower levels of tar and mod- erate levels of nicotine. The development of Y-1 was consistent with this approach. 142 Second, it was suggested that there was something sinister or se- cretive about Y-1 because it was patented in Brazil using the lan- guage of Brazil which is Portuguese. In fact, it was grown in Brazil to prevent our competition from using it and because the growing conditions in Brazil were very good. I'm told that the Brazilian pat- ent application file contained a certified copy of the American pat- ent application in English. So Dr. Kessler didn't have to go to the trouble of obtaining an English translation as he asserted. For Dr. Kessler to suggest that thev had to uncover this secret by translating Portuguese into Englisn, in my opinion, is nothing more than grandstanding. B&W has never attempted to hide the existence of Y-1, and in fact, we sought to have a U.S. patent issued which would have made the existence of Y-1 a matter of public record. Third, Dr. Kessler not only misled in my opinion this committee by what he said, but why — ^but by what he failed to say. He made absolutely no reference to the actual nicotine deliveries in the B&W brands which use Y-1 in the blend. In fact, as we told the FDA, the brands that use Y-1 delivered essentially the same nicotine as the products they replaced. Some of the brands contained — contain- ing Y-1 actually delivered less nicotine than the non-Y-1 blends for those same products and some delivered a little higher nicotine. Fourth, Dr. Kessler stated that B&W authorized DNAP to state that Y-1 had not been commercialized. This is false. When DNAP called Brown & Williamson earlier this month and asked if it could discuss Y-1 with the FDA despite his confidentiality agreements with my company. Brown & Williamson gave permission to do so. We never told DNAP what to say. In Wednesday's Washington Post, Mr. Evans at DNAP is quoted as saying that his company assumed Y-1 had not been commer- cisdized. Now, that's a far cry from Dr. Kessler's allegation that Brown & Williamson told them to make any such statement. Once again. Dr. Kessler's exaggeration, in my opinion, of the sit- uation fits his personal or political agenda. Fifth, Dr. Kessler has attempted to dramatize his investigation by stating that he uncovered the Y-1 story through, "investigation work over 3 months," which took him to Brazil to find, "a needle in a haystack." Again, this is nothing more than grandstanding. If Dr. Kessler had been sincere or sincerely interested in getting the facts, all he had to do was ask Brown & Williamson. In fact, the FDA never asked Brown & Williamson a single question about Y-1, and never asked Brown & Williamson to produce a single doc- ument about Y-1. When we learned through a third party that the FDA was inter- ested in Y-1, Brown & Williamson contacted the FDA and set up a meeting which took place this last Friday. The FDA did not confront Brown & Williamson with its evidence of Y-1. Instead, Brown & Williamson took the initiative to set up the meeting to discuss Y-1. Finally, Dr. Kessler and one of his staff members made the high- ly offensive misrepresentation that a Brown & Williamson em- ployee falsely answered questions about crossbreeding during a meeting between the Brown & Williamson representatives and the FDA. 143 I wasn't at that meeting, but one of Judge Bell's law partners was Gordon Smith, and he will address those allegations. In fact, it now appears, at least to me, that the FDA may have known about Y-1 early on and may have intentionally engaged in a course of conduct that avoided asking questions about Y-1 in an effort to set Brown & Williamson up for the assertion that we failed to dis- close information about Y-1. Dr. Kessler's boast — Dr. Kessler boasts that Brown & Williamson did not make concessions about Y-1 until after confronted with the FDA's evidence is highly misleading and grossly unfair. The FDA did not ask Brown & Williamson a single question on this topic until Brown & Williamson initiated a meeting to discuss it. Furthermore, contrary to Dr. Kessler's allegations, Y-1 is not a genetically engineered leaf. Crossbreedings — crossbreeding tech- niques similar to those used with food crops were used. This was fully explained to the FDA in our meeting last Friday. Mr. Chairman and members of the subcommittee, my fear is that Mr. Baker's quote about the crusade against smoking is correct. We are entering the dangerous stage. Where the rights — pardon me. We are entering the dangerous stage where the rules are good for some but not for all where the rights apply to some but not to all, where the freedoms to make choices apply to some but not to all. Herein lies the danger. We have all seen it in the past and I cer- tainly pray that we are not going to see it in our future. Mr. Chairman, I'm here to answer the questions of the sub- committee. I want to be cooperative and I will be cooperative. Please bear in mind, however, that my personal knowledge of my company. Brown & Williamson, and its history and activities is somewhat limited given the fact that I only joined the company over 12 years ago and that my area of expertise is marketing and sales. I am not a scientist and will not be able to speak to scientific issues, particularly those in 30-year-old documents. Otherwise, I will do my best to answer your questions. Thank you. Mr. Waxman. Thank you very much Mr. Sandefur, we appreciate your testimony. I want to assure you, because you mentioned it and others in your industry have mentioned it, that I don't know of any Member of Congress that is for prohibition of cigarettes. Prohibition is a ter- rible idea. It failed with alcohol, it would fail with cigarettes. It would be impossible to be enforced and, to the extent that we did enforce it, it would be a cruel punishment for millions of Americans addicted to nicotine. There are, however, other measures that we may want to look at, and that will depend on the record of these hearings. And I also want to give a response to your statement that I accused you of knowingly deceiving the subcommittee, and that was based on a letter sent to your attorney dated May 17, 1994, and I want to read the complete quote. "According to reports in the Nation's leading newspaper and tele- vision news programs, your client may have knowingly deceived the Congress and this subcommittee in particular about the dan- gers of smoking and the addictiveness of nicotine." 144 I did not make an accusation as was represented in your state- ment, Mr. Sandefur, when you were here on April 14 of this year with the other CEO's from the tobacco companies, the panelists — your panel of CEO's seemed to feel strongly that nicotine was in cigarettes for taste. And I want to ask you about this this morning. Does Brown & Williamson believe that nicotine is present for taste or is it in cigarettes for its drug-like qualities? Mr. Sandefur. Mr. Chairman, we very strongly believe that nic- otine is a very important constituent in the cigarette smoke for taste. Yes, sir. I would further add that the consumer tells us that when asked why they didn't smoke a denicotized cigarette that Philip Morris marketed, the reason they didn't smoke it is because it doesn't taste very good. Now, that's what the consumer says. Mr. Waxman. Now, just so we have the record clear, you have submitted certain documents to us and among those remain the chronology of the relationship of Brown & Williamson to British- American Tobacco. And am I correct that BAT is the parent company of Brown & Williamson? Mr. Sandefur. British- American Tobacco Industries is our par- ent, yes, sir. We are a wholly-owned subsidiary of that company. Mr. Waxman. So BAT completely owns Brown & Williamson? Mr. Sandefur. That's correct, yes, sir. Mr. Waxman. And Brown & Williamson has input into BAT's re- search? Mr. Sandefur. Mr. Chairman, my chairman along with several other sister companies report in to BAT industries. From time to time, there will be discussions by our R&D people, our scientists with our sister company scientists, but it would be misleading you if I told you that we made those decisions. Mr. Waxman. I'm not suggesting that. I just want to know if you have input into that research. Mr. Sandefur. We do have input, yes. Mr. Waxman. And your employees participate in BAT research conferences? Mr. Sandefur. Yes, sir, that's correct. Mr. Waxman. In fact, in 1961, Brown & Williamson entered into an agreement with BAT to pool their research efforts. Mr. Sandefur. Mr. Chairman, I was in college in 1961. I can't speak to that subject, no, sir. Mr. Waxman. Well, the documents you submitted to us indicate that. Mr. Sandefur. I haven't read those files. Mr. Waxman. In 1969, Brown & Williamson and BAT entered into a cost-sharing arrangement under which Brown & Williamson would help fund the research conducted at BAT laboratories. Mr. Sandefur. Same answer, yes, sir. I was in college during that time. I don't know. Mr. Waxman. Well, if it is a cost-sharing arrangement, do you know whether you are still sharing the cost. Mr. Sandefur. Let me put it this way, Mr. Chairman. The par- ent sends me a bill and I pay it. It is like — it's like asking me what dividend I'm going to pay. They tell me and I pay it, yes, sir. 145 Mr. Waxman. I want to evaluate this statement about nicotine being for taste and not for drug-like purposes. In 1962, Sir Charles Ellis, who was scientific adviser to BAT, presented a lengthy paper at the BAT research conference in Southampton, and Sir Ellis de- scribed the issues relating to smoking and health this way. If we could have the statement up there. I want to draw your at- tention, and I will read the bold type provisions, "it is my conclu- sion that nicotine is a very remarkable, beneficent drug that both helps the body to resist external stress and also can, as a result, show a pronounced tranquilizing effect." And then further down he says, "nicotine is not only a very fine drug, but the techniques of administration by smoking has consid- erable psychological advantages," In other words, Mr. Ellis, or Sir Charles Ellis who worked for your parent company, seemed to rep- resent a view about nicotine being a drug. Do you disagree with that, with his views? Mr. Sandefur. Whatever that says, it says, sir. Mr. Waxm.\n. Would you disagree with his view that nicotine is a drug? Mr. Sandefur. Yes, sir, I would. Mr. Waxman. OK. Mr. Sandefur. I absolutely would. Mr. Waxman. OK. Now, you do acknowledge that it does rep- resent a view of an important person at BAT at least as early as the 1960s? Mr. Sandefur. Sir Charles Ellis was a scientist in BATCO, yes, sir, I understand that. But we have scientists in our other sister companies as well. Mr. Waxman. OK. Now, let me give you some similar quotations from people involved with your company. Chart number seven, if we could have that put up. The quote was that "nicotine interacts with specialized sites in the body termed receptors or (nicotinic colinergic receptors)," that was "in its simplest sense puffing behav- ior is the means of providing nicotine dose in a metered fashion." And then in 1984, further, a BAT researcher at a conference on own smoking and marketing, Rob Ferris said, if we have that also on that statement, "it is apparent that nicotine largely underpins the contributions through its role as a generator of central physio- logical arousal effects which express themselves as changes in human performance and psychological well-being." Let me ask unanimous consent to place all these articles and conferences on nicotine and health effects discussed at the hearing as well as all the charts used in the questioning in the record. Without objection. [The information follows:] 146 The following documents are part of the official record of this hearing. They are available for review by the public at the office of the Committee on Energy and Commerce and the office of Representative Henry A. Waxman: Studies on the Effects of Nicotine by Brown & Williamson and Related Companies Final Report on Project Hippo I. British-American Tobacco Company Ltd., January 1962. Report No. 1 on Project Hippo II. British-American Tobacco Company, June 1962. Final Report on Project Hippo II. British-American Tobacco Company Ltd., March 1963. The Fate of Nicotine in the Body. British-American Tobacco Company Ltd., May 1963. Further Work on "Extractable" Nicotine. British-American Tobacco Company Ltd., September 30, 1966. The Transfer of Nicotine from Smoke into Blood using a Perfused Canine Lung. British-American Tobacco Company Ltd. , February 28, 1967. Relation Between "Extractable Nicotine" Content of Smoke and Panel Response. British-American Tobacco Company Ltd., March 17, 1967. The Absorption of Nicotine Via the Mouth: Studies Using Model Systems. British-American Tobacco Company, Ltd. ,May 9, 1968. The Retention of Nicotine and Phenols in the Human Mouth. British-American Tobacco Co., Ltd., November 22, 1968. The Effect of Puff Volume on "Etractable Nicotine" and on the Retention of Nicotine in the Mouth. British- American Tobacco Company, Ltd., August 21, 1969. The Absorption and Effects of Nicotine from Inhaled Tobacco Smoke, University of Melbourne for British-American Tobacco Company, Ltd., January 20, 1970. Nicotine in Smoke and Human Physiological Response. British- American Tobacco Company, Ltd., March 26, 1970. Effects of Nicotine on the Central Nervous System. British- American Tobacco Company, Ltd., January 12, 1971. Relative Contributions of Nicotine and Carbon Monoxide to Human Physiological Response. British-American Tobacco Company, Ltd., November 15, 1971. Preparation and Properties of Nicotine Analogues. British- American Tobacco Company Ltd., November 20, 1972. Further Studies on the Effect of Nicotine on Human Physiological Response. British-American Tobacco Company Ltd., June 5, 1973. Preparation and Properties of Nicotine Analogues — part II. British-American Tobacco Company Ltd., November 11, 1973. 147 Acute Effect of Cigarette Smoke on Brain Wave Alpha Rhythm — First Report. Brown & Williamson Tobacco Corp. , October 31, 1974. Interaction of Smoke and the Smoker Part 3; The Effect of Cigarette Smoking on the Contingent Negative Variation. British-American Tobacco Company Ltd., December 12, 1974. Some "Benefits" of Smoking. British-American Tobacco Company Ltd., January 26, 1977. The Study of Human Smoking Behaviour Using Butt Analysis. British-American Tobacco Company Ltd., August 7, 1978. Preparation and Properties of Nicotine Analogues--part III. British-American Tobacco Company Ltd., June 20, 1973. Method for Nicotine and Cotinine in Blood and Urine. British American Tobacco Company Ltd., May 21, 1980. Nicotine Studies: A Second Report. Estimation of Whole Body Nicotine Dose By Urinary Nicotine and Cotinine Measurement . British-American Tobacco Company Ltd., March 31, 1981. II. Conferences on Nicotine and Health Effects Held by Brown & Williamson and Related Companies A. Group R&D Research Conferences Smoking and Health--Policy on Research, Southampton, 1962. Research Conference Held at Hilton Head Island, S.C. September 24-30, 1968. Research Conference Held at Kronberg, June 2-6. 1969. B.A.T. Group Research Conference, November 9-13, 1970, St. Adele, Quebec. Group R i D Conference — Chelwood, October 14-19, 1972. Notes on the Group Research & Development Conference at Duck Key, Florida, January 12-18, 1974. Notes on Group R 4 D Conference Held in Merano, N. Italy, April 2-8, 1975. Notes on Group Research & Development Conference, Sydney, March 1978. Notes on the R. & D. Policy Conference, 1979. Notes from Group R&D Conference, Part I, February 5-9. 1979. Preliminary Minutes of Group Research Conference, London, October 30-November 1, 1979. Notes on the R&D Conference, October 29-November 1, 1979, London. Research Conference, September 15-18, 1980, Sea Island, Georgia. Research Conference, Pichlarn, Austria, August 24-28, 1981. 148 Research Conference, Montebello, Canada, August 30-SepteBber 3, 1982. Research Conference, Rio de Janiero, Brazil, August 22-26, 1983. Research Conference, United Kingdom, 1984. B. Smoking Behavior Conferences Conference on Smoking Behaviour, Group Research and Development Centre, Southampton, October 11-12, 1976. International Smoking Behaviour Conference — Chelwood Vachery, November 1977. 1983 Smoking Behaior Conference: Overview Human Smoking Behavior Conference, July 9-12, 1984, Methods for Monitoring and Assessing Consumer Awareness of Smoking and Health Research Conference, United Kingdom, 1984. C. Smoking Behavior Marketing Conferences Proceedings of the Smoking Behaviour-Marketing Conference, July 9-12, 1984, Session I, Montreal, Quebec. D. Meetings of Biological Committees Minutes of Biological Testing Committees Meeting Held in Millbank, July 8, 1963. Biological Testing Committees Meeting Held in South Hampton, June 18, 1969. Minutes of I7th Biological Testing Committee Meeting Held in South Hampton, January 27th, 1970. Minutes of Special Meeting of the BTC held in Millbank, October 19, 1970. Minutes of the I9th Biological Testing Committee Meeting held in Millbank, February, 1971. Minutes of 22nd Biological Research Committee Meeting held in South Hampton, May 11, 1972. E. Biological Research Meeting Minutes Minutes of Meeting held in South Hampton, October 8, 1975. Minutes of the 28th Biological Research Meeting, July 29, 1976. Biological Research Meeting, October 11, 1976. Biological Research Meeting held in Chelwood, November 27, 1977. Biological Research Meeting held in Chelwood, November 27, 1977. Biological Meeting held at GR i DC, May 20, 1983. 149 III. Projects by Brown & Williamson and Related Companies A. Project Wheat Project Wheat. Brown & Williamson Tobacco Corp., January 10, 1974. Project Wheat: Manufacture and Analysis of Cigarettes for Consumer Tests. British-American Tobacco Company Ltd., September 24, 1974. Project Wheat Part 1: Cluster Profiles of U.K. Smokers and their General Smoking Habits. British-American Tobacco Company Ltd. , July 10, 1975. Project Wheat Part 2: U.K. Male Smokers: Their Reactions to Cigarettes of Different Nicotine Delivery as Influenced by Inner Need. British-American Tobacco company, January 30, 1976. B. Project Aries Proceedings of the Smoking Behaviour-Marketing Conference. Montreal. Quebec. July 9-12. 1984. Brown & Williamson Tobacco Corp., July 30, 1984. C. Project Truth The Smoking/Health Controversy: A View from the Other Side. Brown & Williamson Tobacco Corp., February 8, 1971. D. Project Janus Biological Testing: Short Term Hyperplastia Test. British-American Tobacco Company Ltd., June 24, 1966. Long-Term Skin Painting Experiments — Progress Report: July 1967 . British-American Tobacco Company Ltd. , August 2, 1967. Janus Airferm Sample Anaerobic Yeast Fermentation. Brown & Williamson Tobacco Corp., September 13, 1968. Further Results of Work Aimed at the Development of a Goblet Cell Test. British-American Tobacco Company Ltd., January 6, 1969. Project Janus Quarterly Report: July-September. 1969. British-American Tobacco Company Ltd., October 7, 1969. Project Janus Annual Report. British-American Tobacco Company Ltd., October 7, 1969. Project Janus Quarterly Report: October-December. 1969. British-American Tobacco Company Ltd., January 5, 1970. Evaluation of Filters Containing Water Capsules Submitted for Project Janus, British-American Tobacco Company Ltd., January 29, 1970. Project Janus Quarterly Report: January-March. 1970. British-American Tobacco Company Ltd., March 18, 1970. 150 Long Term Skin Painting Experiment General Report on Project Janus. British-American Tobacco Company, Ltd., June 1970. Project Janus Progress Report: April-August 1970. British-American Tobacco Company Ltd., September 14, 1970. Project Janus Annual Report 1969-1970. British- American Tobacco Company Ltd., October 16, 1970. Project Janus Progress Report; September-December 1990. British-American Tobacco Company Ltd., February 12, 1971. A Survey of the Janus Mouse Skin-Painting Experiments. British-American Tobacco Company Ltd., April 7, 1971. Project Janus Progress Report: January-April 1971. British- American Tobacco Company Ltd., May 10, 1971. Quarterly Report April-June. 1971. British-American Tobacco Company Ltd., July 14, 1971. Analysis of Janus Condensate Solutions. British-American Tobacco Company Ltd., July 29, 1971. Project Janus Progress Report: May-August 1971. British-American Tobacco Company Ltd., September 1, 1971. Project Janus Annual Report 1970-1971. British- American Tobacco Company Ltd., October 14, 1971. Project Janus Progress Report: September-Eecember 1971. British-American Tobacco Company Ltd., December 23, 1971. Project Janus Progress Report: January-April 1972. British-American Tobacco Company Ltd., May 5, 1972. Project of the Mutagenic Effect of Inhaled Smoke from two Cigarettes (B8-1. B8-3> on Mice Using the Dominant Lethal Method. British-American Tobacco Company Ltd., June 1972. Project Janus Status Report Memorandum. October 3, 1972. The Promotion Activity of Tobacco Smoke Condensate to Mouse Skin: Cigarettes B9-2. B9-3. B9-4 and B9-5. British-American Tobacco Company Ltd., January 19, 1973. Carcinogenicity of Smoke Condensate to Mouse Skin; Experiment B-1. British-American Tobacco Company Ltd. , March 197 3. Carcinogenicity of Smoke Condensate to Mouse Skin: Experiment B-3. British-American Tobacco Company Ltd., March 1974. 151 Carcinoaenicity of Smoke Condensate to Mouse Skin; Experiment B-4. British-American Tobacco Company Ltd., September 1974. Project Janus Status Report. Brown & Williamson Tobacco Corp. , March 1975. Analysis of Progressive Lesions Programme Description/System Definition for JANUS/OPTIM/TRANRA Programme. British-American Tobacco Company Ltd., March 1976. A Study in the Tumour Promoting Activity of Tobacco Smoke Condensates Applied to Mouse Skin: Cigarettes B13 1-8 . British-American Tobacco Company Ltd., September 24, 1976. The Promotion Activity of Tobacco Smoke Condensate to Mouse Skin: Dose Dependence and Interaction of DMBA. B9-1 and B9-6 Condensates. British-American Tobacco Company Ltd., April 197 7. A Statistical Analysis of the Incidence of Tumour- Bearing Animals in Janus Promotion Study B30-31. British-American Tobacco Company Ltd., August 31, 1977. A Comparison of the Tumorigenic Activities of Janus Condensates BO. B2 and B4 . British-American Tobacco Company Ltd., October 24, 1977. Carcinogenicity of Smoke Condensate to Mouse Skin Experiment B-9. British-American Tobacco Company, Ltd., October 1977. Carcinogenicity of Smoke Condensate to Mouse Skin Experiment B-10. British-American Tobacco Company, Ltd. , March 1978. Carcinogenicity of Smoke Condensate to Mouse Skin Experiment B-11. British-American Tobacco Company, Ltd., March 1978. 152 CHARTS Prepared by Majority Stafi^ Subcommittee on Health and the Environment June 23, 1994 L Drug Effects of Nicotine 1. The Tobacco Industry: Nicotine is for Taste 2. 1%2 Statement on Nicotine 3. 1968 Statement on Nicotine 4. 1972 Statement on Nicotine 5. 1976 Statement on Nicotine 6. 1980 Statement on Nicotine 7. Statements on Nicotine at the 1984 Smoking Behavior-Marketing Conference 8. 1984 Statement on Nicotine 9. Studies on Effects of Nicotine by BAW and Related Companies 10. The BAW-BAT Relationship n. Nicotine Mam'pulatioa 11. The Tobacco Industry on Nicotine Manipulation 12. Project Wheat: Smoker Reactions to Cigarettes of Different Nicotine Deliv«ry as Influenced by Inner Need 13. Project Wheat: Proposed Model of the Market 14. Quotes From Documents on Extractable Nicotine and pH 15. Relation between Nicotine Retention and Smoke pH 16. Addition of PEI to Boost Nicotine 17. Project Aries 18. Session Vl-Product Modification for Maximal Nicotine Effects 19. Data from Dr. Ncal L Bcnowitz, Professor of Medicine, Chief, Division of Oinical Pharmacology and Experimental Therapeutics m. Health Effects of Smoking 20. Project Truth 21. Project Janus 22. The Legal Strategy 153 • • I « o ^ H V3 01) 'I ZS (0 s 2 O Of) o o B o ^ o .=E |E E o _ o ^■§ i| 2 I LU C O LU r 0) ■^5 ll lii CD I— n 0 c cB ^ CO 1 I iS o c S o a CD -^ c ♦-- ® ."^ > LU S^ T3 1^ C ^ CO 5 (0 ^ _ o £ CO "co 0) CU CO T CC CD - :£ £ CD »■ ent efor • S X3 ^ CO . B Pre tion "* o Vice rpora CJ> _- o '^" -♦i- -c o r- o ^ (D ^ ^ ■Si. CD O (0 t* ul s ^ c s o C8 © "3 00 J3 c <•>• o o o W) o CO ** J3 J2 |2 ^ c V3 CD •o CO • ?J ii o > C8 c: *j o C« CO 5 (/} rt ^,_^ C3 Q '^ ^2 CJ) c G) -v^ CD NM c c K • Q) C\J "^ m ^ tC o c o CO c ^ V) CD c> E "c CD .9 CO Z *-C o o c o . » • ^^ ^^ ■ ^ cd O -^ :£ c -^ 03 cS ^ © 2 c/a cs "« C o 22 S; N a • — ^ -5 03 c o B C/5 C/5 s © ■^^ (C :3 a* :=: c is o a > 3 *^.§ q^ CO TO -J •^ o O ^ ;=: o V) « 5 -?-= -^ V3 o o C/3 £ C CO O j^ -co _^ CO -3; " o N O CO C O c o o ^ ^ •- _- e 2 ^ -r. CO c o O 03 ^ 2 c o c o o C IS O CO -^ O X o Q. CO CL O c 2 S c CO C c •- Co — J^ O o .sa o o O C CO - "^ ^ -3 (D ' o CO c J3 O £0 © -o © -^ 3 03 a3 o O c :3 ;5 .§ S "3 ^ g. ^ CX X ;» C o CO 3 CO -*-• cd O D *^ ^ — 03 CO C Vh O ■*— > O ;. CO -^^ ex ^ 03 a> « o i ^ o S Qa .S W (D :i. CO ^ 03 © ^ ■5 g en C O O CO c5 ^ o 03 c o ■*— ' CO 3 03 -4— » o c 03 C s o c CO O CO 0) CO E <^ i CO •c a> 03 03 O •o (0 o CQ c 0) = ID CO ^ ■g s. 03 CO (D C3 > CO ug CO ^ •i ^ c -^ § - c > (U 03 (/} 3 o3 (U t« -^ CO a> 03 — Ofi "^ ^ c CO 01 3 3 c C C (D 2 o ^ ^ - ■? O CO "^ i i-8 ^ CO CL ■'■' E o 5 -Q ^ o > O ^ CD > S c^ CO CO c 9 o CO 05T o CO E = w LU o d. Q. CO CO 03 C O O O .fi 05 L. C CO O c o Q. .i= c o C/) LLI 05 155 ^ a o ^ .s e o B 00 c o U c ^c o o (0 (0 o DC o o o 03 c ^-^ CO 00 O 00 c "^ O T- E 9 ma "co oo" ^ > — O . CO o DC CO CO "O c c O (0 w « C CO O 0) O I 156 (U 'So o o a -2 s a a> S OX) Su c^ CD ^ <=> £ on S >> O 03 S ^ 2 S s o '■♦-• o o CO 0 Q. O T3 C CO c g To CO 2^ CL V ^^ ' T— c . CO O) .9 ^ I E CJ) m=co o § Q. CO 0) C DC < 157 C4-H a> c 0^ © 0 O • T-H -d o o ^ o -S ^ o t^ > C/3 WD .2 a a c o o ^ o o CD (D ^ CO >. m T- -O CO C\J - CD O '^- ^- ■ Q. CJ ^ r^ CD O 05 r^ CJ T- - -^ c o I— 2 ^ S c 0^ F 3 c 5 o .i= < O) o jc - .9 w S BCD ^ °=l ? .9 O CD c ^- 2 2 CD CD 5 £ C f^ o o Poo 158 a © o 0^ o 00 ^ i o o 'oi) o CM ^ QJ O = i o S c o ^ o >» B ^ ■> c Oh O 0^ o .fi 2 (D C o O •o c c o o o o ll E e. o ^^ ^5 o o o o o ^ (C . XJ CO 1 1 ° ^ DC m a. .2 ;Z5 159 C« • 5« v. £ £ ^ O © , t: « CA VI W3 Q^ '^ 0<^ c o ■a 0) V e« *W3 -^ s; — « ^, ?« S £ = ^ 'as u ^ > « 2^ o ^ c iZ e 2 ? ^ « s U © c •7 .M « c nj ,o '^ £ < x: (0 m o ■^ x: (U CD O E C/5 0) ■o ^^ CO CJ (U -^ 3 CO ii CO o 9 n3 > O) ' o «5 © «£ W) S ^ © — ;S &i) o s 0^ tf3 ;X3 S 13 2 ^f © © ■ CD e(3 © < " % byG., ipany Vi s ^© ^ t o 15 S c« V a> |8 j3 ;« •*j "O (0 (0 K c 0) X} Dl) a C u 3 (^ ■^^ c © Vi Vi C ■* © Dj) V3 OJ c 03 O) £ 3 O c, -r s s i '5) o s C 03 DJ) u E 3 o o o (0 c CO o '^- (D E < x: CD c£ O O >^ D) O O x: o (0 0 (0 c CO Vi — , ^ C\J X) 9 §:% 0 Q. CO F 2 O CL O 160 o o a 00 as C3 §2 o s o C/3 o c o o o c -5 top o o a. a o O (DX) ^ •PN (/) o 2 C o o o .2 ^ c .2 o e CO 0} (0 0) CC O Q DC CO O o O cvj o o O ' F $ c m 03 •— ' O ^^ OJ CO E 05 I pq H o c2 CO c o 2 o & o U o u CO s2 o S pa On CO £ o U o o e2 o o o c CO u ■c m CA I CA ID ^ ^ '5 .22 ffl I ,i; ii "2 >^ 6 CO -^ c ^ CA O o b S C ^ Oa < .22 T3 CA CO Si es 'S o o § H £ g o CO 2 o f^ S ed C " CQ « 1a *- a o «« g o ^ O R3 0) " .S -i c y o CQ g -§ •£ ffl S ^ pa .£ ^ ON c ^ •£ -^ S OQ 00 3Q -^ C ;« •* C *^ 1-1 pa « 3 c u U Q a, 3 a o CO CA '£ CO £ o o -o (L> .2 i oa ^ . 2 § II -^ -'- p G 53 2 p S CO *s C ^ i^ .S 2i s e o 164 fl u o £ • pM^ n o ^4^ _>^ (/■ ,u T3 CS "oJ _c c c *E C CO ^a^ « CQ ■k' £ nipu 0) V3 W3 "(8 3 VJ •a B 3 1 u X 2 c« £ .s > 0) ^^ V 3 -^^ J3 ^ u ■o ** "u . ^, 3 O R « 0) •♦-< u JS 3 u a. -4-^ •■ 0> 3 C o 1 B (0 o o o ■^^ E "? o CO 1- o 4> o o '3 o 4> > ^ .2f 4> C "t. ^H '3 5? 3 G O ha '3 1 3 O > <*- O B ' .2 u 3 o '^ .2 in C CM ^ "O o o B >. to C/5 DC 3 'S (*• o e 3 > o > O E w E © »9 o E E _B (0 ^ O CO O e .2 *5 E E o U J3 — O - ^ E § CO tu 0> JS H i?5 •^ >■ ■a o e E u «2 ■o >, 2 O ■a >, « B _o O a, ■a B DJ) B o U o . ii H q r J2 CM x: p c o CD O 03 c o B _c o o o CO ,o 0) 0 o c o en S CO Q c CO c c: CD c CD E « 55 u QQ o a o .E a o J= B *- O E 2 -b g i 2 -O _OJD 3 Is O 3 ■a g 5 *• .2 >• 3 = ? ? - « B O >-> 4^ CQ 'S U OX) 02 '3 ui •M CD u I- o B OI TO c CD CO (D I o o »^ l cfl E .i: «^ C« ;F= 3 ^ O CO o Z 2 c ID E c o 5 g CO LU 3 O S O o B V "T3 B a. 0> •a O E o B o ■o c (D E c 2 ■> c LU T3 C CO CO CD X CD O < CO ID CO x: Q. O O LU O a, =■ .- CD a. u r a. C CO 1- -^" CO Q. = < ll CD O 2^ CO CO f*i 165 Project Wheat: Smoker Reactions to Cigarettes of Different Nicotine Delivery as Influenced by Inner Need (Jan. 30, 1976) "The purpose of the survey was to classify smokers into a number of categories showing distinct patterns of motivation, and different levels of so-called Inner Need, as a first step towards testing the hypothesis that a smoker's Inner Need level is related to his preferred nicotine delivery." [BW-W2-01587] "This hypothesis, in turn, is seen as part of a general approach to the problem of designing cigarettes of increased consumer acceptance." [BW-W2-01587] "In considering which product features are important in terms of consumer acceptance, the nicotine delivery is one of the more obvious candidates. ... The importance of nicotine hardly needs to be stressed, as it is so widely recognised." [BW-W2-01589] Project Wheat had two phases. In Part 1, the attitudes of over 1,000 male smokers were surveyed to assess their "inner need" to smoke and their attitudes toward health risks. In Part 2, the smokers were given experimental cigarettes with a range of nicotine deliveries. In the study, "inner need" is characterized as smoking to achieve psychological benefits such as "to relieve stress" and "to aid concentration." According to the study there are "positive relationships" between "the inner need score on one hand and daily cigarette consumption, the depth of inhalation and the anticipated difficulty in giving up smoking on the other." [BW-W2-01591] 166 Project Wheat (cont.) • "As predicted by the hypothesis, High Need clusters tend to prefer relatively high nicotine cigarettes, their optimum nicotine delivery being higher than that of Low Need clusters." [BW-W2-01676] • "A model of the market is now proposed in which two major determinants of the type of cigarette which best suits a smoker's requirements are Inner Need and concern for health. This model leads to the conclusion that there is a substantial potential for a range of cigarettes which at present is not available. These cigarettes range from some with low tar and medium nicotine deliveries to others with medium tar and high nicotine deliveries, and are visualized as attracting those smokers who combine average Inner Need with above average concern for health." [BW-W2-01677] • "Three of the cigarette types shown in the model are not currently available ... but are technically feasible ... In terms of definitions used in Project Wheat, consumers in these three categories accounted for some 40yo of those who took part in the first product test. This figure is quoted in order to give some idea of the possible potential for cigarettes of the three types indicated in the model." [BW-W2-0 1726-27] 167 u ST ^ O 'O MH Q^ o (« O o f ^ 4) I s ON 08 O ^Z -J © ^ eg OS .= H ^ 3 Z 10 OD Sic "PPTTS Q +. ^ ^ "* ffi QO u 3 0 a> C« fi £ e C ^^ Q Q. M £ C9 9J 0 0 U § flQ o E c o U < ffl S ^ V- — «> 3 O 168 On G o s: o c o © ii s ^ 12 o &X) a> :: ^ &£ OH = Z^ Si o a> s c o c c 3 o « g a> -:^ *= — o o _5 o -oS •r" ® ^ "i -= *- O «« rub. C Q oC CC d O o o o (0 JQ c CO E < CD 0) c o o LD = CO jQ ^ o > UJ CO c o 2 ? O) c 0) E 0) .^ »- 03 I? W = LU "Si «| c ■o c o o B o E 05 o .2 u Q. Q. S C5 (DJ) ^ C3 05 c •■C o C O 5 ® o o © *s a u 3 © ► a-. «^ 2 2 .fl & © © a> *a.*c 0^ o 2 c Q. ^ S" ^ 1 = = 1 <1> >*! C > oi" C , — , % i^ O CD - ^ LU CD c ^ o -^ -^ c O CD 0) .^ :£ 5 t^ CO a ,:^ o C/3 s © .9- *C a -^ c -o c a .Q V3 a a. . « ^. c c o ^ c © c © LU -^ O Z s c CO CD E < I CO •^ CO >> 3 O . *4 I I 70 ■ I i 75 —f- C/ -0-4 I'/ -0-6 \ X). ■^ ^. -0-7 -Oft -0-9 H-O NICOTINE RETAINED IN THE HUMAN MOUTH Log Mr • L«g N» Source: "The Retention of Nicotine and Phenols in the H™ Mouth," by British-American Tobacco Co. Ltd., R&D Estabhshment (1968) a-0 170 £ a -a ^ 73 w > § ^ 9 O nn 1 1^ Ml c^ o jn • -3 & (D (U o -a -ti CO - O ,fi ^ ^ o u e *^ *-C o m .2 -o M 1 i^ \ 9i ^^p^^^p^ O o « s Im « -^ o. k. ^ 01} ^Qli^^hSi e vw^K^l .2 E^I^Q o ff S C8 -Q V) >. O a> o .Si "Z VI O H £ .fl OD C 1/3 Qi ^ > <1> « -2i B EH ^ O JS PHH ^^ ■4i^ ^ a> s i^s CQ oS Ki ;« >« ^ s O. o ^ 1=1 C/) v^ s • ■M E ^ O V M o •^ Cm = s O -i^ o a. ^ o s = o c c .S -2 OX) ® 3 k. a, 3 o 0£ ID 8 '•S O V GO on e '2 o E o U f2 E ^ 3 3 = (» o O Oh o t: «d > >. s Lh cd c ^ O GO U a ■3° 00 C/3 D -is P3 (U c o • pa ga S ^ «^ ts B 3 O ••■ 5 ® S 2 jC ^ m es ro a -(— > ■imi 4> c« A (U S '3 •^^ o o t s% 175 CO o S ^ -C 1) U c« fc Q. (U X) r? X 52 3 U. 1) 3 00 3 C «3 o r'-i ^ ^ e ^ ^ u, -s •■^•5 5 &£ 00 g .£ c/i <=> .2 g,m t- 2 -a 3 "^ "■30 y O C/2 3 C CO 3 C a, c 1> 1> o a. S ^ i ^ o oa c u c o C o >^ D. O (+^ = 4) CX o «* 2^ C o it: 3 CO CO C (U > u O 00 o _ = .S D. ^ O 73 c OS < < o O O o 1/3 CT3 t: o Oh (D 00 C2 cd (73 cd »— > (D -4— > J^ (D c« • 1-H I— I 'O *© o ^ ^ ti _2 ■*-* »3 V. ^ c 2 o cd (D u -a cd O — 4^ -fi (D O E S o u ^ o (D CO 5 ? t>H ?^ =^ H o ■— ' ^ (D Q> (D S (D V9 '^ ?. cd « W g td t ^ a (D XJ to « (D J3 w) e o o T5 51! o .'^ ^ 5 "C e o ■t-H bX) » -"^?pr«du^ offfct. on th« e«itr«l Mrrovli tjtxt^.^^ f i*ohM»«t«?;^tie of tr*a^uiUl«la« or itiTOlfttUi* -.y.^ 'v. di^^« ^ad,"^ »o, to M« If "^ch Mtrnty It *»• '^ - - ^' v« attach «i foch liportaaet to til* '- Mpoct of our r«M*T<«jtUt wt *r« pr«pcilij« • •- to %\%x\ actlT* voxk »t J^«»t« with OUT o«a 1 -i:-. fP^ h"aiA/-i (^'?A"?-. To h*T» .H porMMot staff. ' ■ 4jrT»n«c*t? to work oa th« ph*rm*eol»or oi^W», »ad w« a« fortMMto la h»Tla< th« '4lftlii«Mi«^4 !»• *«" *» act u eon.«lt*nt »ad adrlM «fl oaSft« dlr^etloa . . ■. , jI/'. / • of thlf work, ^ u ■ ^ . .-- •; .-. •• ':-r. -' '_. I h*T» ^tn hunria* ay •«««iat la oc^or to haTo tlM to do JuBtle* to %omt ■or* ««o*r^ r«scarch«s, our tupport for which arlMO out of - th. polat of Tl.w I r«f«rr.d to .•rll«r, that progr^i* In taiowl«4«t of l^ia* caac«r aay "tU arise from ooa* fund»««ntkl adTaae* la •tM4jrlB« eanctr generally. c c to I o 262 .0 " ." .^ .S.. . r lgtJ> AT IPLTQM HEAD ItUWP. g.C. ....... : . . • J'>Jt4th . I»h 8«M.mbf . IIMT y'.. rr«*«nt: tci- *••• (CJi«lm«n» -,-• . Mr (px«rl^ rUl* "^. (y V, '-:> Ox lU A. Mn/ord .''X '6> : '^iu CenfartAM «•• oooc«i>«< with UuM M)or t)t^t: ;^A^«) liBolUiW and RMlth ^ ^ TtMraWrt iBUntlya 41»oit«tont b«ii U »•• (frvad M r«pc(t enlr eotKlgilon* and p«itlcl|>«^rt undertook, •♦xf* rktettury, W proYld* tnr b«Ck(reuM dHOilltO* lor liq^r/«ip«ctlv« ■«n*9«m«iH ceUM9M««. I.. B u elMr tS«t • MMb«r of^Mrv* •< elf«r««t«i eat MOdUr tlM Meloglcal «cUv1tr •( •aokVboi>d«nMU. Th«M includ* Uk« ^ li,eoivot*U«* et rCL %M auC^ form et t>>« tmekinq ^hieU (itnt petilbty niun; ««nHl«UM «te.>> t>>« (YV* •( ta«*eao, th« pr«««(M« c< tddttlv** tad t^• *o1«a« •( pw(t.(»Ua la tawklaf th« elearaiu. Th««« Uct«rt wUl bd«nMia ara iNowtnf a btole«(ap1 actlvlir lAwardi awut»-«kJa of tSa aaaia erdar a* ihat a( aula een^anaata, i«««««>ln« Om* <)^ biological aciivitr la not ttM-4«par4att aad that th« lata ««UtU« ee«iUtu*«ta a< tb« vapour ikaaa ar* «4r^ aicaptlenaltr acUw«. "^-v <. T>a elaar poiiiblUtf of pr«d««cln9 cl«ar%«iaf with iodvca« wuM'' Vl. P BW-W2. 01486 263 % ■■ ^c • » - eo«b«01c~, eeap«Utori' predueti ihould U. Bcaltorvd for Out "^ > 10. In v1«w of U%pr«'**lft«iUi)e«i lo««th«r aay tjc*n tStctt V'^ larger than allhar itf^ri^Hpf (f/n«lrj1»cO ihow'jd b« irudlad and 'v . li aAcaaiaT tha attaniloa 6< VUrkailag Dapartoantt ahouJd b« '/. dnwn to tSaw pottlblUiUiTV^, O .c^ ' It w«i, how«v«r, afraad that nle6ably uipla, tUtan. Ioom rlik wou^ ta lAvolvad in Iha Introduction of a nrm trp* ol (lUar ialna thir'wa hMlth o«ltnut*d. It »ai a«r««d that tha dauitad 1n'T "^"^S^. ate.) with tha peiilblllty that appUcatioe o^ th« fiadiagi p^ld b« uiad to tdanutr with graatar carta lary |><«nio«lar aarta« •«gBanti la ordar to gulda pr«-Barfc«( ta-rvy tBokiag r>«Juattoa^ Canada, D.t. A. and C«r«a>r «ro«ld w«Wmm laltUtlcB into tha WOODItOSt laehnlqua of laeka aiMttBaMMd wlU coruldar tar^tng tOB'Moa to tha U.K. for rUt pvpo^y kaeognltlng that '.ho raiiooi why poopW taoka trVP*'^ phamacoloqical and pantr prychologlcal, tha Conf*^«hc« agr««d that ihara la a naad for axport advlea oa tba pf7«h$legleal aipaeta, and tha afTactt oa thata of ihapa, e«)e«r, ate.l^ttha taoUng vvhlcla and tho paeiiga should ba ryttvaatlcaUr / ^^ ajcplorvd. '^ .- /<• \ BW-«2-0^*®® 264 rs I • 1 #4 5 i /f^ 0 ^. ■X — %-^:- ^ rwf*wni iticuTiJtCANikiiiomi REW«T HO; W.nj-« - .i.W.Wi. . • \ Ceatpe — BWnSH- AMERICAN TOeAOCO COMPANY UMfTEO • ■ 1 •• lESEAlCa UB^Alt ^-'A^ BrowttiWinUmiott ''^ ^. Thit csnTidtmal i«pan a ih( pgpcrtT i< Mish -Aranc» lobKta Compaq UiM4d. ird nd w te copM « tf^ 8W-W2-I207S /O 265 /• • wicuryfi. AHA LOCUM XEPCtT HO: IU).«33-I ' , ', 9.11.1*72. /. " ■ ■ ■,-- "^. AOTROHS: CD. Mtbun X • . ■ ..-. C, JC. Ood.rvoo^ -Q ^;n ... ^^ ." % ''■^ ^ ■ .-;^)»»i'«y. ,. . .'KTfiai..*?/?* .o ■-.,... C- . Ml I. •> '.r" . Dirnu»m«. C>. , 5 es^ I.J. CT«tm ^e«»y U. 1, 1, J, 4, Or. I.». nu»bM -.* • • ' - l.v, •■ Br, I. A. Iwfor* ^-O " 7, • I.I. w.4t, (■«. '-^ " », JO, n »Un««tr, 1. * D.D., AuttttlU " '.12. 1) nerr 1. SnttotC " ^ >i, IS Bt. D.e. Feltoa " ' ti . tlkr«ry " • l?r"ll cnnr «>i "] riu lo. -' ■ • • l» •,• V ->- 8W-W2-1207- 266 •2> • ttti th*t • ceint<«fgM> »t»f«tf aDtlfitlon to ceattiBH ^n^ii"* - tf thlt yt«v U c jr«itot imI* of th* toUteo taiuttty It l«tt«ly 4«p«Bd«B"t-^ tl^f l»fa«tp» u4 a«c«r« •( Ui* rh«rMe«la(le«l •etlsa ot atc«ttn>. ~ > --/ •. •• J ■ ' .c- : .». A CMMrctal chrMC m«fi «rlM If ctthM aa altUMtl** rroAiec 'J ■ ■ 'i^. - -i, ... . ;.. .- . Ao •Icarnactv* proAict c«al4 e«Ma tnm tk« fhataacMttcal tAAjtety. ■-..'"'■•■ - - i» With « aocUlly aceapttkla rvaca far aiatAXtcratlas, aal «ttk aadtcal - aaiertcMBC, tha proAact co«l4 b« f««caii(*l«' "-^'^ Tha affact af alcatUa eoaU k« UkUltaC 9 aa au«NtK, m4 clpt^aa would tatt4 ta bee«aa U«lpt4. tocV aa aMafaaUt aavl4 arlM tgr acelM(^ ar daalga (i«« tka p(ui«a«aacleal Uiuatir;.^ tt atiM k* uta4 caatleM>v to a4«aaca Umc laAiatcy'a altanaclra pre^t, av tJU ^ A" ■ * (onerat %— eouV ^ a««ocata4 by tha astl'Msklag lobby, vttlTer wttVav* 'c^ ■ •■■" tovaiiMiiit aafport.-V Oia ebvlaa^ atartni^peUit o( • aaareh, altkar far altarmatlvaa ar Mtaionlata ta aiaatlaa,'^ tha alcettaa aalaevla ta4 aUia aitalefaaa o( tt. na prctcfM rifart 4110^^4 alMtlna aa4 *o«a «( Iti aAil»|ua*, •s4 4a*crlbat fynthatU «t«4Ua at li^h Dittrarallj 4urtat • pott-4octatal (eUawihlp (uppoita4 ly l-A.ti '' • <^. S«N-cral antleguat u( ntcoilna h«Ta bte« a^fncholtrd prtvloualy (t, }, 6) and rhe pbarvacoloor o( other ralatcd iUUJaldi found t/i (paelc* <^ BW-W2-I207S 267 /C CO^fEtlMCE ->r- O R S M 0 K I R C /,-« E I I T I O 0 I % % Q-, ^. Croup Kcsttreh k D«vilopiMDt Southiaptoo lltb ao4 13th Octol>«r 197C tb« ^ARtiolquci thit bt** b««a Had It^tb* MOurtncot o( buau taokl tvlour^^M^ to <1^** tb«lr *«la* ^^ \^ To coBtldar tb* toplleatna* of aaisurod saokiai bcbavlour o« pro^o* 4«tlfi.^»»4 o« ■l«»fu«" ■^^ ttbUs \ ^. o. ». fbtt ibould w* do ocxtT % irS^ & Willi] cuoo RSSEjUtClTj^CRARt c .M o IS) 268 /O O^ COWremtCt OW SMOKIMC BCHAVIOW C^-, Hth and Hth October, H7t ur9 Olr. Tob. 01*. M lUOO, Mlllbuk Mit. Coord., M'bok. Woking R. 4 D. b»i»*^' "C- Q>, V ^ MISS J. PR£SS:y (Secretary) ^N c c o 269 A> T'o ■ tea PARAtCTXRS OF S7CXIHC SEHAVIOOR U> BE OlSOREO? C«Der&I Inc>o^uctlof and Iclcooe. Dr.S.J.Creen The Saoklac Htblt: *o4f euri^at views on tbc role of olcotlae ^/y •C) Dr .R.E.Tborotoi («• Ttblaa : k !t«vi«« ^-^r.O.f.lUtoa Mrs. A .Co^rj Bcoeflt* of Saokii( _» ^ c«"- 'V Dl««stloa »r» c c M o 270 3: a>T>RE.viC'V;EW3 on TTIE ROLI OF NtCtyTlfE H ■^ , Sl#5«I!»C 3EMAVI0LR V_. It Is ay loteotloO', io tblt tilk, to revir* (be literature wblcb fives 10 iodlctiioa of the Utportmce of aicotine la deteraioio( bo> and «br people sooke clfarettes. lo dolof so, I bcpe to provide some Just 1 f icattoo for tke laportance wblcb Is (Ivea to the deterBiottloD of tbe vbouots of aieotlae which people obtalB froai clfarettes. I a1«o bop« to indicate that ■ ^* sbould oot lose slfbt of the fact tb^ other (actors are also loportaat Is sBokioc behaviour. /^ " ,r*lll start br coBslderlOf the 'historic^' arp«ct* o( to^cco^if^suaipt Ion. Q "Q ft V. fobaccd^^^e has fluctuated b«tw«es chrvlBf, sauKt^c *^ snoklat. kat oQ%, adopted by a tocletf It baa sever been fives up. It tb« present t la* clfarette cBoklaf Is tbe aost popular for* of tobac«« usa^S, but clfarette saokers «bo are (orblddea to saoke, tor 4llVt*b"~^ * lumber alll or dovs a aloe, alll resort to chevl^l i4|acco'^La(tead of saoktaf ■ Tbe coenoa factor la alV^e types of tobacco usafe neetloned la alcotlB*. either abiarb«tf tbreteh tbe luofs or tbe Ualsf of tbe aoss or aoutb. Takes la tbcsr^^rs alcotlae «111 quickly •atsr a dlract route, is tbe blo«d, t^be brala. Tobacco has sever bees used as a substa/ice •( lafesaoa. Tbe probable reasos for tbls la that «hes It Is absor^ad la taer «to U BlcotlDe travels la tbe blood to the U icb or latestloes ^ 9 c c O hi I 271 ^ a %- WTHOD FOR WICOTIWE AW> COTIVIKE IN BLOOD A>JD URINE /-. tPORT SO. RD.1737-C -V_ y- '/, 21. S. 1980 ._J ^6> '^^ *^/-- G "<>, -%.. % o. fir 0iiiP ^ Heseapeli' aniBevslopmat CeatPB ^/j y/ SCWTHAMPTON EKiLANO '>/'. c^. .V BRITISH - AMERICAN TOBACCO (^OMPANY LIMfTED ''^ Brown & Willli^msoQ .*uN 2 S 1980 R €f D LIBiUi;i / /. c c IV* o o w OB This unfKJeniialnpons the property of British -A/T^icanTbtxcco CoTipanyLmted.afld must not be copied or shown to m«;ihor>sed peran 272 •- /. ^C^ WTHOD FOR NICOTINE AND COTINIKl ^'^r. IN BLOOD AND L'SINE -''■' . tlPORT KO. RD.1737-C /.■ ■ -'^^ ^ '^ •/ j 21.5.1 980 '>-, ^. 'c-. '4 % AUTflORS: C.A. tt^i, I. CM. MAj^rsom CTOUP UAJER: R. Blnni r\ •< ISSUED BY: C.I. t" %. PROC. REP. t«.07.000 '/'. '/ '>/ DISTRIgLTTION: t>r. L.C.r. BlicluMn Copy >e. Dr. I.W. Hughei M Dr. R.A. Stnford •• R.M. Clbb, E»q. M c f A R.S. U»d«. t%n. ft 6. 7. 8 OD R.C. Mlcholli, Etq. n 9, 10 v.- c Rerr E. Rictcrshaus N '/ c Dr. P. Seehofer n ^>. 1 Dr. C.J. P. d« Slquelra «f o o Dr. D.C. FeltOD H Library m 15. 16 - 'r 'V COPT tJO. tj 273 -2- INTROBOCtlON Wlca^a* i« an extreaely blolo|tc«lly «ctlv> eo«tx>m>d C4p«blt •t ellcltlRy«Tifi re i8t» of pturtt«£ologtc«l, bloche«le«l and phytiolotlcAl tpontei /i^ivo (I, 2, 3). Ourlnj •aoklog It 1< rapidly and alaoct quantltatlvely'^sorb^d by lung Clctue fro« the particulate phase af 0- _ whole cigarette smo4(« befer* entering the blood ctreaa (4). In aoae Instances, Ihe pharmacological response of emokora to nicotine is believed to be respoosl'bl* for an Individual's taoVlng behaviour, providing the moctvatloo for arwl'the degree of satisfaction required by '"y the snoker (S, 6). ■•/^;^ ' ^ There are numerous reports in the" iKeratura Indicating a direct or iDdlrwOf relationship between nicotine and £^-rang« of in vivo psycbologlcal, blochealcA and physiological responses. -p Dm (rln^le blochealcal and physiological tuicts 4ir*ccly attributable to orl^clne are changes In haeaodyoSJ^cs, platelet function, A'. vascular tone and hen^th 3Utr. 1984 ■ / ^ ''^. y. V/^ -^/r. V-. "^^ «5) •'<^.. ^. Ci/ C \ •'/-J DISTRIBUTION: Or. L.C.F. Blackflvan Mr. A.N. Heath GERMANY : U.S. AUSTRALIA : U.K. CANADA SO X ^o e. Ko«hn R. W«rn1tz T. RteM A. NellMn T. WHton J. Brennan C.I. Ayres 6.0. Brooks ITL Library (4) '^ ^o. o ^A '6: ^u ^t c>. July 30. 1984 ''^ 9 C % C-^, C <>. O ■',0 w ^■sr 9 276 IIST Of OeittATES ATTEWDIW6 THC 1904 SW0ICIK6 6tHAVICXJR/WAm{TIN6 COwrggENCE "%. 'b ; ' Or. C.I. (Ian) AyV^^ - Sesearch Manager, GR & DC Graham Read "-Q^ - Group Leader. Smoker Behaviour, 6R & OC Rob Ferris -^y - Product Technology 4 Technical Services -^ - Manager Psychology Group Geoff Brooks ^■^ - Product Development and Marketing ^-"- Planning Manager Colin Pendry ",-- Manager Market Research BQ&urq ~' - Maoafer of Pro<3uct Development - Reseat^. Scientist - Manager l^ethods Development - Market RestA/ch - Manager Market'^estarch - Section Head Sensory JivaluatlOfl - Division Head Product QeVelopaent - Marketing ^V f - Deputy Manager Research & Development '^0- Manager Market Research % Dr. P.J. (Pat) Dunn - Vlcr^esldent Research & Development Wayne Knox - R«rke?>1);a Director Bill Sanders - Olvlslon-^^ad Product and Packaging Group, Mar<^lng Jim Unlacke - Division Head Aarketing Research Bob Bexon - Marketing P1am>Vng Associate Or. S.R. (Stewart) Massey - Manager Research i Development Herb Roublcek • Group Leader SubJe^Vve Evaluation Catherine McBrlde - Research Scientist Kw^n Smoking Behaviour •". Karen Brecknock - Conference Secretary. ,' C c ^^ i '^ - N I o w e> m "6f> Erhard Koehn Or'^yOIrk Fangrltz Werner- Huelmann Ralner w^mltz U.S. Aust W.H. (Bin) Oe1i<<:f Tllford R1«hl 0~ Andy Mellman ^^ ralla '-*• T.I. (Tas) Wilson Jin Brennan Cana > da 277 -14- CURRENT STATUS Mt FUTURE OIRECTIOW OF SUCKING BEHAVIOUH RESEARCH O 6. A. READ SUMMARY :- The presentation will outline smoking behaviour research In general, Identifying the elements of the smoking process that collectively constitute the eonplete smoking process. An attempt wttl be aade to identify the relative significance of these elements for tXe smoker \n relation to product design, acceptability and smoking satisfaction. Smoking behaviour 'fesearch Is highly dependent on the a^l.llty to monitor and characterise the smoJ^Ing process. In addition, the ability to monitor the smoking process has co'iMl^lerable laportance for product deslgrv-^nd 4SSisstKnt In relation to satisfying « smokers needs from the product. ^^ Over many years of research a ndBiber of reasonably consistent observations have emerged In terms of a saokers iuponit to a product and indeed probably reflects a measure or means of obtalnlf^satlsfactlon from the product. In addition to the physical way the product U smoked It Is of equal Importance to establish wtiat happens to the smotrf after puffing and identify the relevance of smoke Inhalation In this process.'^. The relationship between Puffing and Inhalation has significance for product acceptability and « smokers needs from the product. ' y The quantification of the smoke dose taken from the cigarette, the interaction of the smoke with tne smoker both within the mouth and respiratory system has » significance for smoke quality assessment, product acceptability and future c cigarette design and these areas will be presented for discussion. ^ w M 278 NICOTINE INTERACTION WITH THE BODY 1 ,'-^ » • . • - - Nicotine Interacts with specialised sites In the body termed receptors (nicotinic cholinergic . receptors) '- . :^ -: 1^^ ■.■■' rl o -^ -^ - - . JO-:'^ -Body communication usually through nerve ,:;. fibers .V, *t .',-r.. .C^. ■ ■ Ll •:... ..' v^ .V, V- •-. '. ' •■ — ' )!_ - --.r Regulation, interpretation transduction of V*"' Information occurs at specialised sites' termed •f- ganglia '■^.^,. '^ s^ Jnter-comm^unication by neurotransmitters ;- >^y^'COtlne ■:^'-^. ^=R^Vf^^Vr -^^ *»' M^ aaw ^^ SB a^ a^ ^i^ ^^ ^^ ^" ^N ^\ ^^ ft I ^\ ^* ^' t'ACE^TYLCHOLINE T-!r*.RBCEPTOR RESPONSE ^ 279 o I CO LU CO CQ o CO X LL O LJJ O z < g Z g CO UJ X g X X /" 0 « c S ^^ %■ O o o c i2 - w £ ^^ o c> E o c O 2 ^ o E 0) c o ■D C 3 I -/^ r-1 O (0 c (0 £ i/i > o CD C c t c o (A (0 •o w o £ c o (0 o ■o o c Q) '^♦- c o 9 c 0 (A a 0 o • AM c 0" »4M 4^ £ 0) o o c (ft c 0 (A '•5 (A 4^ > o «^ t^m 0 <0 (0 Hi c 1 a 75 3 o o c o (0 •D .C re. (A >0 o (A 4- C) Is ® (A (A o o 3 *- ^ i! o c a o o Q (9 a o o (0 o 3 T5 O (A O (A C o o I c I c N I O u* rs* M 280 -79. THE ROU Of SMOKING BEHAVIOUR IN PRODUCT DEVELOPMENT SOME OBSERVATIONS QW JHE PSYCHOL06ICAL ASPECTS OF SMOKING BEHAVIOUR >, R.P. FERRIS SUMMARY OBJECTIVE: To outlioe the functional sIgnUUance wtiUh tffloklng has wUhIn the context of the smokers' negotiation of everyday life, pladO) particular emphasis on human perfonuDce, stress coping and the Interactions of personality, arousal and behavioural jowklng style. ^^ Sowklng has suffered a hOjory of attentions fron sciences wtii(-i> havt adopted • very partial perspectives olT/^he behaviour. A psychological 1nt*f'ii''ttat1on of smoking takes a less fragitented perspective by considering the wttole person, the whole cigarette, and tht way ftt>ok1ng behaviour fits Into the Individual's repertoire of 'life skills'. A llfc^klll may be defined as a particular personal performance attribute which costrlbutes to an Individual's effectiveness or well being. Typical 11f*<<)i111s would be coping with stress; problem solving; social skills and similar behavioural situations. The contention of this paper Is that to understand taoklng. just as any other behaviour. It Is necessary to consider \t as a procest ^nbedded within everyday life. Smoking Is then seen as a personal tool used by the smoker to refine his behaviour and reactions to the world at large. 9 It Is apparent that nicotine largely underpins these contributions through Its * role as a generator of central physiological arousal effects wtilch express n themselves as changes In human performance and psychological well-being." " o -J w > 281 282 Re^orch Conferenct. September 1984 CTIPC Re$e«rch Pro^rt— e OPOSEO REVISIONS FOR 198S - 1987 Smoker Behaviour 'r The awjof objective of the V^up will be wlntalne^l. Howe^^Jhn^^i1d help behaviour data under n/njra11^^Afond1< AUetipU wnibewde liiuraljyi ro~"do mis, Barlet resear b« Initiated. fgcussed on Bicotinc to Identify butes. partKurariy acceptdbllltv -lad' ' otlnls!ed-LotoA£COL.bl^nds. supoleoented t^i 11 be prepared. These will be used »^ specific sensory properties of '-fcetweim tar and nicotine in -teiJtt-Q/ product acceptA])llltjC. The »ty4les (i»111 provide an initial oppor- tunlt/ to separate lamedlate ^rc*»^t <^eptabi11ty froa longer-tef» satisfaction. v ^^. ^l^y (c) Psjrchologicil research with Gale ha\ b»en ^^erned with the sig- nificance of smoking as a coping BechMlta aftt^its role in sociah Interaction. The programme Is being extendeo''^ investigate tN relationship between sacking, s«oke intake «nd tWe electro-cortical J correlates of the central nervous systea. Vt» reiVirch progra»t " will attempt to identify the 'psychological ititt' thijiprecedes a '* smoking event and the changes occurring during tiM saokI^ process. ^ . - ■ '7 n (d) The wrket segmentation techniques based on a smoler.'i •otivatlon 2 and attitudes to predict market place smoking behaviour will be "^ extended to include s«ok1ng behaviour monitoring as an obJ[ectiYe measure within these studies. c 283 - 2 •oker Intenctjofl r- 'v<-. 17\ese'^HMll«s win continue as planned. They vlll b« extended to Include^l^^les of aniaal studies to detemtne the distribution of up^r 7^Vi« tignlflcance of this for subjective product assessment Is be1r<§>deter«1fted. Joint work with the Saoke Research Group win attempt i^,dettr«1ne the relationship between particle size, numbers and subfeytlve assessment. However, product Improve- ment through aerosol nodti^catlon Is llclted by available resources. The experimental c1g«rettev«ed In 1(b) will also be used to Improve the efficient use of smoke >dtot1ne thr-Ouqh pH modification. These "-/y Studies wiTi «.^/»«nfi> »h* r»>itMnn«h*P between— MCQtlne dose-und /. n1cot1ne-relatid-*ubjectijrft_im£355nei^. This will further help to ^^iBFritTty the relationship b€tween'.:]^od(JCt acceptability and smoker '^^tlsfactlon. ^X . U) No'^eclflc changes are planned other t»Mn diewltplng aore tangible Hn'^s^^tween In-house research and cllfo^l '«Mles in terw of ci^M>d1f1cat1on and consutser response. O 3. sialtr^af («) irno^plogy The wort^ll 'ftJMI action w""" * ■■ '^' nue to IdenttlY-the Mechanisms of nice •»"»rffl fi'"'''""^ *y^tJ*- It will be ex! and changing brain concentrat1< sslon tomograpny technlguesT The human nicotine pha'^ co-kinetic study Is progressing welt» although sample anal^^ t9^ the rate-limiting step. Within this -Inmiie assay techniques will be evaluated (. e^ftgrTJ^' context, alternative •nd implemented where The human studies at the V.O.S. finical win be extended to establish tite that can provide Pharmacol oqicll snrttirvrn-5e part of 1(H) and t(b)) Pharmacology Department ke nicotine smoker (these be •l •at fiction fartT^e sa (b) (c) Ho specific mojiflcatlonj research prograxne. o. » planned for thAjqenol oharwacoloolctl / The salivary studies irt proceeding as planned, H^ver, within the programme of research, the relationship between smate. oualltv-and tillvatlon win be Included. Where sultaBly tensltfverpethods are developed, these will be made available to operating cavanles as a means of Improving specific product attributes. (d) Ho modifications. c hi I o M O 284 Ni62>V^cSW|i>S If • V .''T v>; ••i5»$02 ll V .. . - • • •. ^■•*v.^... ;■ _te 1 1 ^4t i- Vi« f • ■ -» -. • . • IV' .. .•.",:«■; PROJtCT KIPWi • '1 ' for tiM IrltUh AxmHcaa Tob4tc« Co LM If W««UaiA«ur Bo«s«, T Mn,1>>«iJr \,,ot,a»» t.w.i It ■ c •• « • ' '. ♦ •vv *■*?, .«' ♦ -••;. • . .r o •-;%. *..i».. • : . . ..-..-.;•*.'. . .^- ■ ■J'* ■' -T^^' •.. . •;•■.•.;... i- •■ • -.. '•'.*■/ * •• ; •■ . «■•. ••■-; •■>.•-*•<•..■■; i- • ... *. • ■ !■•*-'- ' • A-'- .J^' '--TiV--, •: \<*i:^\.-/- ^ . ^•.•_^. _-V. 1 i '-:-:. .♦'•■^1> 285 If ....:>:- If ' f if 11 .•A«-A.'^^ «... J - % .- ♦ W ' - . . , rXKAXUrOKT mojrcT HIPPO •- V. 3. n*nOi. O. Lrb«rt ^ad C. Ksu^CffrMt 5VMVAKY '* f- •• ;l to Ox Dlar«il« M«t)>MJrm ;?r *•• •.-.-•♦.«ivi 286 t. >8tlibl« IflfrftMwct of Wic^tin* In th« *5OM (ACTH). This t(T*ct v«( n«uur«4 fej tw« tt(t«. 4Ad Um rvtulu tfrttd v«i7 w«u. w* liiv«(Uf*t«4 a«rt UtervuftU/ tb« afrtct at mcoUm it om aC UMt* u«u (AAA£ u«t):> (•) Um UirtthaU vtlu« w riJi*4 tt O.S a|/k|, •ixtiy Uk« la Um »AU41«r«Uc UM. ft) Th« r«tpoA«« u aie«UM U UUt ttct vm lUfltU/ tfimiaUh«4 •/t«r •4miaUtr«UM wl rttarpiM u Om t««t wtimAU. («> Th« tfftct tt kicoUM «»« •UfltUr iAhlWtH *y orm*llr oa r»U lt(ton«4 la th« tatioty ctatr«. (%) NiceUM (Uaul*t«( »«i7 r«pi41y tht moblliMUoa •/ Uyidic d«p«ts: u (irly u 10 miavt«t aA«r 0%* kdeaiaUtmioa »f th« 4ni|. t)M Uyids ar« »obiIu»d ud f r«« f»R7 add' *PP«»r i> blood U fTtmr wao<«U. TW tkr««boJd r*l»» of ■leoUa* actirlty «w fottad oact BMr* u ta th« *«m« a« la tk« oUcr utu. (c) Whoa oa* vtitt wnil lu b««r« a/ur tho tdmialatratioa af aieouM. Um rr*« fatty tei4« prttoat U bloo4 ara «lAiAl»h«4. aai tlMlr «iia9»«aruc« U yro^rUoMl U tto «m« aC alc««lM a4mlfli«ttr«4. TU* fact (hava tXat aitaclaa aahaAcaa Om AartraeUaa af th* yrotfwcu af Ua14 aobOuaUaak. Wa vara tiMrafara U 1 yactua* u ahov that Bic« flcu: afltcu if tAMcco taotu, t*cUIiimmi— tf t««««e« UbitMtiM (t«Ur«*c«) 4ad/«r tddietlM (Latm* ct U. (IMO)). D«tAU»d kB9«l««r«/or« tt Tiul Uaporuae* W ta« teb*ce« latettry, aol «al7 ta e»M«cUa« vltk ta«lr ^tt«st $\A»Uri pro&9€U, tat alM wlUi fgtri W futv* potcatul ««•• af to6*«e« iBr»W>l4a. TW aaatrew •fl*«ti of aieoUM U th« be47 a*/, «l Orct. ta coov«alt«Ujr b«a«tu'«4 ^ nrlo«u ^tloloflcal Md pharmAcolofleU •x?4nmtau. B«v«T«r, UM tluei4»Uo« of U« Bo4« Um vui yJuaAUly 4tp«ad m blochtaieU aaaIt**! d«fclia4 «-llh th« b«- ^vt»«r ot th« aieoUA* iB«ltcul« «a. tad lu LauncUeaa vlth. tte $\r' '•et of pb/iielAfieUly kctiT*, BAcr«a»U««Iar c«U coMtltaoaU (taxTmot. jl 291 r«c«ptAn. tte.). Th» race*** «f avch amlIx*** 4«9«adt, la tarii. m • d«tAU«4 taMvW4«t of ttM fau of lieotlM U tA« be47. L •. af tte virioua B*«h«aittBJ which eo«Lr«) tk« tjrp* »ad tb« rmu if (•) Ab««r^ ttee. (b) dlnribwtioa, (e) br*&kdo«« vr trvAxfermAOaa. tad (4) •JX- Ai B«7 b« •««« fr«a th« r«yi«v of W«rU, Strt"W^ of t ctruxo ^\ULabt7 af aicetlM •otcnAf tb* movia of • SBoktr. Maoj af th* prtrieuj IffrirUptioM v«r« cArrltd evt wivb cb«mic«i Btt&od* vhiek ar« B«itter «*a«ltiT« taeufh to d«Uct tb« tr»e« qaajrtitl** of kikaloid Uvvlvotf, Dor ratTieltoUy tp^dfle to dlrUafvUh botvooa aicetljM »ad »»a« of ttt t&rl7 brtakdotn prodvcu (for 0T«mpl> Um e7*ao|«a feroai4« roactlaa; Corceru oi U. (Il3f). Wolff ot «1. (IMI); Taujlaote «t »1. (IH$)). U •^dltloa. vb«* owmliilf eortata phoaoaoaa aa a faaetlaa of ttsM, tta iMonralj eboooa la (h«o« oxp«rlB««U vary ofUa 4M aot taka Utta xcowt t&4 •fparaotiy txtroBaly rapid rvtao of dlatrOvUaa aad fcraaMon ttat ««r« to b« oipactod from pft7«iolo|lc«l o^«rlm«aU (Libat 4 OoraH (Itll); 0«ald«r«tu (IM})). Ttaaa bota klAod aad tUraa Wrala af Mca- tlaa vara »aa««r«4 la torma of fcaaii or •▼«■ daja afUr adaalatatraOaa (WtrU fc Oa«kaU (IMI); WaW at al. (IM*): OaM ot aL (IMt): Tn^aata «t aL (IMS)). Sack Utonrala, whiU aSavlaf eartala dadactlacM aj ti tte rat« of aliAlaattoa of tte itt^lwld. oortalalj 4e aat parmlt aa^ caaeiaalaaa with rafard to Uflod aad tUoaa caaetatratl aaa darta^ tte pariatf af aaU pti7«UUfle«J aetiTlt7. It U oaly mry raaaait;^ ttet aoAo aapacia of On rat* of aleatlM dUtrlterttaa aad feraakdavm. aapaalalfy la brala tloaaaa. kara te«a i-nmlaod la torma af aten tlaa latanralj (SckalUrlaa k Baaaoaa (IN}); Baaaooa 4 Schmltorla* (1M2); A«pal«r*a at aL (IMl)). 292 I flulta at M •xt4UiT« larvrttptioo 4«4Ubc vtth tbMrytio*. 4Utn^tlo«. br*&Uov« aad «UalA«UM o/ (iMtepicaJly liib«TUO aicotiM la tamu b«lAft tad aalm*la. Slae* th« eh«mieAl %s^*c\a if sl«otia« M«ub«U«a. L «. tb« rtractonl aodtfictUoaa br««^ •b««t ky tas7m«tlc trftMfora- •tio«a. tr« at prii«at uUMlvtlj «wml— <1 bj UcKcaaii ud hi* frwif (BevmAA, T«m>«a k Uct*aaX* (IMI). MelUa^*. Bovmu fc T%Tsb«n (IBIO) (IMl); McKtMl*. rw-nfr«U. Scbwra, TunAtt k B9vmM(>M2); MeK«aal«, T«rntoaU. BovmAA 4 S«irv«J-a (IMI), Bovmu 4 Mc)Unai< (1»C2)). eh*aie«l aAiJjr««« havt b««A Uiniv*^ to th* kppUettlo* of a«- thodi p«rmima4 dltUbctiea b«r*M« tb« ■achAa^td illrmlold aad aa^ar Ub«U«4 br«akdovs pr«ducta. U ordar to daterlb* tha prtaaat r«««lt« U a lofleal w%j. tfea g*' aara: pauiva/ ot alcvtlAa 1« Um bo^j af a oaeku' U acbamAtlcAOj \adi' eata4 aj foUovat 293 . 4 . Aecerdiaf to thl« •eh«B«, aieetlM U c*rn*4 Isu tte orvl tMr\ty AAd th« r««plrkt«f7 trftet ky fm«kt p«raelaB. A tmAU p«r««st&ft, vhieh th« tJ^AlAid hA4 b«ta »b«ert44 ^7 th« tur»t« UaLA( th««t tneu. It U tr»A«f«rr*4 Isto Om eircoUtorj •7ntm fblood •tr«4jB), wkich. la ton, diitribvtti It to th« TarioQ* erfuu tad UtiB«i tt th« b«d7. Tbcrt, tb« •Llkxloid mAjr prevok* Iti dUT«r«fft pbyuftloficki »>. '/? Wr*««« (tm) U •• uv*yl«UUfT. tkt« fttur Wr««M •«<«>•>•• z »»rfiaJ^ '*. niV^««AltM-ftt«u«y •ttaU«tt« fd UMtiM !• tt4 VMtftM^VI •••kAM <%l^y« >tu i(•«•, (Mk ta Mr^Ta^^; «*a taua far Ucraaata^ «ai« 1»>:a n'.taalM a/iita «ta Va ■•UteU*4 'itt^ kf aaattaaava altatua uiaaa. '^. / P wicr If m rtui tKAce i« «^ii" 8V-W2-0308C 295 /. X> T -Q ^ <<-. '6. r« nan. 4 li-«« UvaAt k7il«l>«lut ^ 4U-4«/ ti^rt««< ar t^ W»IU if wu^tnC^ fMU «• t^ "^IJNv \jLJty 4a4 >7t««IM. 1% u k »«U >!■■■ fMt i»'3«k«n^ •Htir) ^^»U1/ t«xa M Mfval rM4 UUta. U UtOUa It <1U- {n» Yyt UAlrt«uU, tt« Iw m MaiMVntlM U IM »!«•« • |iry 111 k«««' rt«iiM- t^* r*«>L>4 •<■ v* Mtu> ri<4 tt«k«tf% tx^^ty* rM4 U«^« ar V r«tM«4 «•»!•«• UWriuiT «t»irt»m« m«\k^r%U tMrm Ult aMtaaliti UJmU« •••4*Jl«4 'talanat r»M* •»«*« n^tla* af ataatl** avvltMUm rr«aa<><_t —jtM tsarataa t^ tmt uiala *t awlar*** rata*. aMak l»aT»»**'^V"'^ '• *"'*' •"' r«»i»a ta««). '->. '-V / If T« flUl IVwCI 11 UJI CLtM riAi n:» wtict It 11 out re m qoiijTi o» r«i »c-j«n MiK nu«s. BW-W2-03O8: 2% "^ "*. • » Ci o 6, V ''^ t -/■■ ^6. ^c. 9:). ">?. ->> ^a "^^ >c '^ 'O^ '^ 'c_ •>^ / ■ma ir m rim Mct ti ujt cuu na nil wi;ct. it ti an n T« qmtrrt of ru xicwrr u'jc riuci. BW-W2-03O8: 297 U(902 f J . . • : i {Ut.\ Wi- - -J:. "^ ♦; • : : i '. it:":, 0- '-^ .• • *•* HA."- - >*• •'•■■,■• .^ ■- -'^^y •;.'•: - . .' MOJCCT m^po n f I I . - " tor tte . . ■ - .T ♦ . / 1 '.•-■'.•'•■" v - ■ • ^^t<^^ «.W.l • f" ■ r :<".;*'.. 'Vi/** lATTtixx MEMOWAL wsTmrri •■■ .t' •*-»•• ;i--.'-^ - - ••-4.^. : I I I I I. 298 COHTtKrt Ptt* urrnooucnoN » I, Moot or ACTION or THA>*Qt'JUZlJ a. iKrtuEHCcs or omn PAATS or THE txAOt UPON HYPOTHALAMUS IK THZ COKTlCOTtOrai. ftEOUUATION MCCXAXISM II A. Ml*r«la U t. Hl|b«r krua W««l 1> OSCUSSION 1< USXAACa PtOCAAMia M r r I 299 UPOIlTIt* i noJtCT mrro n orrnoDucnoK T* UvtAloM vtM^teT cr M« alotlM •eu •• kr«ia N*ctlM« U U««« 4rv|t- U UU ruin Rapon *« ••4««T««r u r«Am«rU« ika Ms«r«u U vktck Omj U^ 1*4. At tlcvtlfM ••«B«4 «• Ut«rf«r« U Um kT^ihAUalt rttcUe* M mr9$: *« U«u«H tt Mcti(U7 t* UrrttUnt* •!•« I' *^ liMrttsrt viMtbtr M Mt tU* fcyp«Ul>i>i« Nac^m U 4«fM4«« ■»«• or«fr»aB« m «fU> WUh«4 U mu yTopot4L 11 300 rO«AL RXPOKT I .v.- rKOJXCT HU'PO 0 ■ .* -4 2 5^ 301 *• Jx-i;>J$T2fc- «v>«i4JUiY Aire OBCvssioir *-. • • >- - i [\^i'«a. covtrAAiiON Of na trrtCTS or NicoTDo: Axo • '-. . il;*-'?^ viff or nxszKrOft on thi wrcrriiALAMO-j-rrurrAjiY iV '^'5^>V^ ; U««hAAi«a k*4 M ite AJr«a«*«erUe»l fiacd** I •: XidX\'-i^'' *• Air«m*l AicorWc lti4 OvbUUm T*tt « / ■ •:' ; :. -U- C. ActlM M t*4j W«t|hl X«fMl»llM ■ . ; II I- J. ..'•>! vt3^■V-X•• -• '•;.•■.. .• . _ 302 •.V r . ,«k..v..-r«'>'B ' ^" ^ . . ..^ __ ^ - v»* u »a<«rit*»4 torn* Cf Dm tcUvMl*! tt •tcMlM • &«!• *«tlv1U«« tK«l CM14 u>l«U vkjr .'•°'. dikniu (atUrt k/« •• (Mi if thttr k&Mt. ft vu all* m/ ruf>«a« ,,, .. < I ? ■' Uf' *' altMlM U k««ir«r vtrj AXr*r«ai rr*« Ut« *ir«a^UltUf* tff«el f.-.-.-./:.:.»,.k«^//-:^-i.-.:-V.-, "-•.'. • • • -•• ^•- •iA.--.- 5 > to ;^/: •#.. a ^lr 4» ft i; fr\ •^ • '•. •'.. *. -» ". :-J\. "JJ'ii^ •» '•' • ^ •.'.' -iJ •• •'Jr *li ■viA- ••- /_^ -■i-T'J ■■» 303 f-^^'^f:--'^^'--: ■•••■■■•. V ■ ""Irl »«*« tt o»«r»etl»t •trekMlc sftUtatj »M, u r»c*. »r« UfftJjr «*•< U .-»-< L '4>v^ >47«iU4Lry: aleoda* U etrulAljr 4«v«i4 of raU tdteu. ■'■''-^'*yi^ -•-''"*• -.- • • ■■. '^-.^ r -.sj^- •««• (••♦ ow ru«t Rtyort OS Hiy*»0 n, p. J). Oh7 Ai«^(. fr9« thi* I < ..• ;'." ; Oxr LavitUfUlo* tt^^i»\r ihovt Out k«Ot tdadi W ini|i tet ' .^.V^^U ATftrtatl^, t/yi f^M ilc»aa« mtj W eoajldarttf (itt urfi** I * '^Ji^.TM««Ur t/ttct* M( b«lA« eeattoapUitd h«r«) u B«r« "Wacndkl* • - .''*■'« Ut( lA^ouJ • Oua tkM Mv iraaqolUUtn. rr«a ■•«• ^%rj txip«nAAt . ■ ..>^r:v — ■ y It KX-^n* i«*>cAn«4 *^Mfi•« •■ ^* ^t>atai7*»4r*a«l r«tp«M« u ttrtta: ... i^/dM Matrwr tWvt tt4«tl/ikU •i4a>«ctiaa« tiui ar« mi fl«M fey ■!«•• f 4 ?^:-*Ja*a. L«. 4 tuXr nmt\m kU«kA4a •< f «u«« tad flkjrwt* »«!1*lt«lf .'.*\^^! ,^yV/7 i7tt«a. «Uek aftrmADj c««tr«U all th« ta«etrU« tctlvldM. "I'^^O'' ''^ '^''' ■1 • ^' I ^m^ .i^i\- L . V-,- - ' TW« aanaal r»*«Uaa if u arraiUim w a •trttaf*! ilhJiUoa •• ...> .iyS^ -'r> tit^r y«7ehoI«|leal ar ^iltUrleaJ ta aAtvr« • U a •UmuUUaa tt .r.V^ '•*. U« ^rdtu7'kirta«l r«aal«a (a4rta«-cortlc»; -'/l'^ V'« 304 *a .- ' v«.-. -*:!• •- r r r I ycV'.toa af UU e«nu«l r%*pocM» %• •trtti. vtut ru4 vtrt i«bBltt*tf W VA*'-: bk aw a^iAlaa thU »cUaa t«^^14 W ««« «r th* txptkAAtleu •/ th« ^ 7-\* S. Bo»r Weight R4rj'»''oa ^' ■' ■ . if^j' •. ' TVj ♦««« iitA< t* b« ft ^•rj impcnxMt p^iM for lbb»ee« *■*' AAAa/ttturtrt: deo*;-^|:'U) ^ It* aatloaf^dta •er««i. I ,:^'it"^.i\C' (V) U B«WUtlA« Um U^4 4«f«; .-'•.>; I' • .<§V V*^ ^ "•• ***** •* ***• "**** '**'' ****** >*'"*^ ** atlmmUi* » .]^ ^ ^^ that tk« flaa^«rt af aaaUai U aeUftUjr gMpptu4 . .!ii*;..^ .; *:' 'i'rCr W BtiralalactealaSaeta af aic»tlM that caa ta roAcltf«r«4 u banaOetal ''■j'^'iT- I ^;* ^tf tka arfkAija. Maai K*^*^^- '^c'^ ^^t^^*^ *^*<^ "^ ^£!i *** '*4->'^ • .1^' «• atfjamUUaa af »4raM>«*rtle«tr«fkU pr«4«eila« »7 tha ^nUtafy. 'f v,'. jr^i:> 1 _^^iUt«AUy, Ifcl* bar»a«a asarta. fc/ lUaU. tha ^jralalaftcal (aalr«l «r ^ : -*'. "-,<• L'S'' (at BakUiaaUaa 4*4 af ra«4 UiAka aJ wtU u af tk* r«a«tlaa U atraaa. ^ . :'^ '^V ^■■'t' . ••- ..- .. ... ... ...... '>'.-i.».-- '-ttJi L 1. ■*■ -.' !• TU ^Itrrtattatlc r«BraaaftUtl«a aa pa^a I ta aa aa^ara«r M -. •' j[ fc- I . .;.'.-.•.•-.•.•*■• - '-. . . -■: "-• • • • '-V Vt t:.v M-.^'-S^ ' • .■S'^ 305 r r .■J^:jVv>-,; ...V. r "i>^»?5caui:^^^» •••■'■ -■ ' ■■" • *-> ■ •■'• i.i\»'^^fk\»ckA4» «f tU pii>atU7 tetivltiii). ICcoUm ttiawUui th* rtUut •(. ''^t^fr\t9prttii»* . •«yt*ti»« 4^ C**". »ll>io«i iK««-Ui« tar •a*ei M tlM rv,>4-^^/^ ■*■ • • '■' ;■ '..^/Tciectl rir»u ^^ <^* hjywhilaiwm. Froa kMLb«r ^«Ut •ftftv, U U .^'2 -^f^ttAX* (kAC vuo^rtitiM tA4 CKT art rtUi«4 La NaetlM ar u'boU* nlar ttnctvr*. b v*«u a^^aar tlui oleotiaa acu a^eiSeaUr «a tm« iJT -.'*-;}' T^aaa «o&aitftratiM« rai«« a vary la^rtaAt ^'•'tlaa: ^x**/'T VUt U th« raaaM Car tJOa c^cmdorf to U tkat liMaat acta .^y-S^"^ aa CB^ «la th« ralaaaa mt aaaa Waefcaaleal prt .■".'."**. - "Ohr ait«a»« ta t^lala •teouaa aetMUaa a« kraU Naeuaai aa akl»«k«aieal kaala vaa aat raccaaafvl. Om varba4 k7>«(iM(li »aa \' t *.'|« «t«^ vteihar aleatiaa laurfaraa U Um kraU ataraa af aaraiMU I *•' T^-vf * ** AAlaa^vW A U aaajifara< %• W aaacar«a4 «Uk Mrraw la^liaa ^'^ . ;->-^ I -^^^^t to kraU. ft U »tU ksaw aA tka aaa iaa4. Ikat atcaUaa ««»Utt( Uia ^'. -.7T*?[ \'^''"^- ftaraa af eatackalaxftlaa* •'9ih»r krala aaarotruuaitiart •'aa4. «• ^ ^'^^ I. "I'^S^'ika atkar kAa4, Out rattryUa «a»Uit* (ka krUa aiaraa afkaU fra«H '!r«- 5t r'-^'Yv^'tVasla«* (eaiackolaaalaaa a»4 aa raUAla ). Oaa af tka kgr>«(kaaa< ua4*^ ^':^| f / .It'#^ la a^UU ra(ar>iaa affaeta a« kraU r«»«Ua«# ttaa U ikU la^UtUf ^^^ ' '* 'l^]^**ctf«i9> Aa aa aaaUo. «« tk«w|W U ^aaCkla ikat aleatlaa al|W alaa '^7^ r ' V^'m Msla a itmlUr va/. to aar ax^rtaaata, uUf a aalaedira aatka^ far •^^^ 'lir^! ttM aauwrtaatt ar aarataai* U kraia. aleaUaa 414 aat ad U ftU vajr. vt3 I . ; _ Tka ^(imui/ raaaiaa *at thmr krala caaaUivaaia comU atAtaia tka .;j.*^ w^, .•*. '.'^ A t^iuultatlva U^tiUfUloa af tha rtUUaoa with Oat af aieaUaa * •.-!.:^ C' ' ' aa4 «t $9»* pataikU kraia aadlatara • aa adrtaa>c«rUeotra^c activity * cmU flvt aJ ik« ka/ ta ika arj^VaAaUaa af kath ^taeaaaa af taUraaca ,.:!' t' * ° 4a4 af a441«Uoa, U ako«v»4 tka aya^toai a( vUh4ra«al. > i M^C *. ° 4a4 af a441«tloa, U ako«v»4 tka aya^toai a( vUh4ra«al. > i'-^^^t^-ixr:', 306 H»;/ri. ; •; » .^. • ' : . • ."■" j ♦' ' Pt>fT>g>B>*Xie R«>r«n»t»>loB o^ t>>« tfTtctt »( Wcertfl* • ' '* ^-^ ■**^.^ ' • I ;'", WeetliK K«nrplft« Br«iA hifh«r rtfieos CaitcholuuMi S«roieruA ipltdea *i It]rp«ripMi ^^•^« M' AaUA ^ J:. • •»• J. • .'.■•• E ... . -••' V- V T»x BoblUdBf trraet srApptiiU C«rtleeiitrel4« ■Sutti r«*ca«« < 1 -'^ 0. ■•.■'-■■.■ ■• • •■ ■,■•■■ .X •• • . ,•.•■■ .. ■ • "•■•• • •-•• .■^•••^ • • • \ .•.■:..'< ••• r^ 307 : r 1 ^RITISH.AMERICAN TOBACCO CO. LTD. 9(gTH« tCBX OW 'gCTACTAWj* ri^^Ti ^ . ^^ -^^ % Research^>^ Development Est^lisbment v'"^. G Southampton V ^^ P^PERTY Of BROWN ^^/lUIAMSO/^ Research o^partkent -LIBR^Y- ' \ Tlib conBdeattal report b the propertit^ of Bridsb-Am«ricaa Tobacco Co. Ltd., *nd mtur^o^ he cooled or shown to unauthorised penoidr be copied or shown penoat^ c I c N t »^ 9t 308 R«t«Ar«h t Drr«lep«Mt Eattblii Brltlah'AMrlotA Tobaoeo 0». IM.. O^ (Mtport Ho. W).»JT-«) SL>»AFT AWP 00WCLD3I0W ^ X) It M«a •hom In in •«rU«r rO?rt th«t «»• r«4otloo of a n>ok«r to tbt »tr«n«t* otO^t «»ok« fro« * elfu-ttta oould t» *^Jr«Ut«d to th« 4*ount of "•xtp*eUW«* ftlaot^^ln tho nok*, rmthtr thaa to tht i%il nloctlfl* eonttnt. TM« r*Utlon«Mp hat DOW M«ae«nflrs«4 tqr an^tujii nation of fui\^ iMplta of ol(ar«tt«s. Altbou^lA ^< ^(B shoM t^^ *«xtraet«bl«*1pl«otlM wid nleotlno )u« «r« elostljr r«Ut«4. tljftr »r« not eo«pX«t»l/ tynongrwui, tn^t It ka aad fha*^aoua iMrfaca of tha ^"^^ raaplrmtery tract, or O^ (II) at tha iBtarfaca bttwian tha aquacua la/tr and tha^C^tt/ tlaa^M 1a tha raaplraUnr ayetaa. . /^ ^ On tha forMf vla«, a saoU with a higher 'axtraeUbla* niaoUn^v*^ b«n«4 \ L V. 309 / I "y. BITISH-AMERICAN TOBACCO CO. LTD. ' THE tfaiSFEU Oy WTCOTIHE FTX)M SM)KS DfTO ELOct ysrwo of British-American Tobacco Co. Ltd., and mast (i^ be copied or shown to unauthorised pertons. 9 C C isl Oi N 310 /O \, ^ ^':^. _ o- ^ TtC TRANSPEF OP KICOTTWE FWX SMDKZ IVTO EtjO£>D UST>« A PERnJSED C/WVE UW 'V REPORT «. RD.457^ :•.:. 0^"'. ^ % •/r s - ^/ Al/THOR: S.R. £y«lB» • %- xC; ■''/, ISSU'FJ) BY: I.W. fti«h«i '^,'- PROJECT: 1000 DisTPmrriOK: COMT »o. 9^^ D.S.F. Hobson. Cm). Sir ChArl*s ElUs ■ ■ 2 S Dr. %.). Crttn • "3 < Dr. R.B. Griffith ' ■ *• ^ ^ ' L.C. Uport«, Eaq. ' ■ ?; 8. 9 '^;~ V.W. Rtld, Eaq. ' • 10. XI ;, H«rm E.H. Sflrln* ' • 12, 13. H E.C. Meldsend, E*q. ■ • 15, 16. 17 R. 4 D.E. Llt>r»ry ' ' 18, 19 c R. & D.E. ni« No. «6d ' • 80 C.^. COPY »: V- '*'-''^-il«26 311 &ritlsh-la*rle*a T«btec« Co. 1X4., 30UrSA«T0«. THE TRAXSyB^.'Og MfCOTDC ?90H gOKE IWO gX>00 USINC A ^ . pgffcap CAKivE owe \^.- a^:^*SY A.VD cowcmsiOHS ^ ,- ^Uowlnc discussions wlthla T>Roi«» le L-. c c e Vs 314 ^ v%: ' EyT!^c^o^a^ kicctixe'_ 'C' ^ 17.3.1967. %, ^. AUTHOR; D.J. Th« h*lp rl8iv*l/>AMrlc«n TobMM Oo. U4., sooraAMnoM. 17U )Ux^^ : Th« T»«t« »ivd ?Uvour Vorklx4*>ijrt3r h»T« ttMssed th« caoke froa nu«r* i'l9f«4 elg»rett«8, ud« froa flu«-cur«5!]^|a08 U«nd) toUeeo, U which Kh» ' itlivi^ 9t "extrtctibl* nicotic*' »«• ■Ani[s^t«4, %o cover t convenient r».x<> toy" •ttit*"M*«ldltiofu of PEI (polyethylenelatnirij;^^ t^ flltert. Wl|Ms tMrj-ftAc* •njaln«d. the pr«doalnut tffm e^iMr«ul^Q< IrreU ^tlM* na ^0 lner«a«« the iaptet oKO^thal • of "•xtrt la thr««t Irritation were Clcarettet Bade irritant effeota sentl kL(h oonteat of 'extraetable throat and noae. Zt la hopad to extend thaae fl tloa Maa al«o dat'eotod. Wt south tobacco were vued la order to eonflr*^ ike frca theae «l«ar«tt«a had aa cauaed aarkad IrrlUtlen of tha fJ?^ jIoLoc the aenaory affecta produced bf "oon-extraotabla nlcotlaa". ^« wtlJi^iiaceaalUta traatoMOta tddah / produoe wbatantlal differancaa U *Doe-«xtraf««Ua n4«otlaa* deUvary but laaTap the "extractable tacotlne* delivery at a oonittnt Uval. '^^toerlaental dlffleultlea ara likely to be enoounterad In 4«hiarlj\« thla objectlTO. '^. <5^ <>. c N I 9 O 316 V I Q ITISH-AMERICAN TOBACCO CO. LTD. a %. c/ OP KicorrKB AKD PHacta ggaffTW OP KicorrKB am ^^^ n< THE HtfUK Kxrm •^^J 82. T1. 1968. ■^ 4- ^w o \ - ^o ^. '-i-^ V <^0, Researcifc>& Development Es^bifs^jment \ ^ Southampton '0 ^^ ^^-^^ Prc^^tv Of 3R0W.< & VVkUAMSON Research Depa^ment -LIB R AR^- \ o. 1 Thii confidential report U the prope^ of i Brituh-Americ*n Tobacco Co. Ltd., uA mosO^t I be copied or shown to unauthorised persohiL 9 C C 9> Oi 317 impor^^nt la 4^ phenol! (2) Uut"^ 1 wrtXm (1) taM lndlo«t«d «Moh ftctert mt b* th« proportloaa of nlootlaa ftUuloldJ (1) 4ad tagr asekirt. ne«tln« attrition «pp«*r XH r. t4 b« d«p«nd«nt prlnot^Vl/'lk asok* pR uid nleotln« e«nt«nt] «M1« tha retention of Individual ;n«a|^ la dependent oo their Tapour preijur* end bolUng point, end 1« oot ejected V|r laoXe pH. "'^^ ' A verjr soell panel of caokera TCae ti*«a vsed to eiuilne the retentloo ^ h-- • ^Ct. these coaponente In the Kuth. artd t^ retult« are dlecuesed la this Or "•O o^ A '^ the'^tet It Mj reellied that It would oi^^ be poaalble to undertaJrVdaJTiri^ts ualac aaodltlona t^eh wer« artX&elat^^kU«t the taokera M|r« fui^^^ware ef th« nature of tha experl*eMv,and eonse^entljr ■Ignt.Bftt s>V^ la • »or«el ■a/wer. However, phjrsloal reatralntt vera elcarette holder, Ith^^t si^ la ■Inil^^t*^ r, oonnaotlS^ta ta^tOacts a*okad throufh a laell pLaatla ^^ght flexible plaatlo tuba t« 2^^ piff recording derlee. Aeoilw MrCiUked to Uke a puff appr«xiaatel7 once per gdnute, to hold the aaoto la t^e-i ■^ for five scoonda and to blow aU tha aaoka Into a Ca«brld«« fllta^^^older. Prior to tha aotual tetta, panel Msbera wra aakad to Mke^^i a«M el(arattea throu^ a C4Abrld«a filter ualnc ^^ »*»• pufflnc i*«^^* TMa waa requeatad ao that tha flltraUoo afflolener of a ahort (7^5 ■■) filter plu« attached to all tha elcarettea could be Maaured. Oetern^tlea of ■- - - . .^^ theae flltratlen-efflelencles could be aade aora eonvenlentljr ualf^v V a puffnOK OP KIOOTDffi VIA WE XOOTV : A; ■"->■ RgQRT NO. ro.$^;j;>a _LVI5.6S ^> '-% '9 ^^ Development Es Southampton c sn^ent "", ^ PROP^jy Of -> ThU confidential report is the property of Britbh-American Tobacco Co. Ltd., and mus(^^ b« copied or shown to unauthorised persoiitX C c 319 ^'^ .6^:* Wk ^I^TBM OP yiOOTDd TU WE WOUTO; :^1VDIg liSUiG MCD£L StSTC^ -•- :^ ^ RgOW NO. HD.560-R*^-. 9.5.1^68 'C. •^ . Or ■" ^<1 AUTHOHi S.R. £y'^. S. '-^, /■J ISSVED BYi^ I.W. Bl^3^ OISTRIHmOU "^■^K. Dr. S.J. GrMO Dr. W.B. Ortfflth ^ L.C. t«port«, Eaq. O.A. frt«t«r, Ktq. H«rm B.H. SSrlAf I.e. Fi«ld««nd4 i:>4« K. * D.C. Ubru7 K. * D.E. ni« !ie. 46c Copy Ito. l.ci 3. 4 • 13, 14, 15 COPY MOj / e^ ^> '^c I c 320 \ TOE AasQppno»:'y Brttlah*Aa«rt«aa ftbMM Oi. 9U Mar* 1961. (Ai»ert No. R>.S60-K) w 4. /: Sl>>URY AXD COWCmSIONS v;. Th« tbaorpUoG of alcoUao 4iiic4^1d« rt» th« aeutb bJL« b««i eaoBl^«r«d '^ » MO otAgo proeeaa. flrttl/, nleoVStu La tlM caok* aoroaol auttto A^ >1 "'*"' W«jvt^rt«d to th« curfte* of th« south, i^t*^ 1% oax fora a aolvitl* la th« •«Itva. ^Mondljr. nlootlfi* eaa dlffuaa froa tx2« aolatlao throufb te ■ (^ tAto tlM Uood atraaa. ^>^ Iha aOMl^ of tho rt»ult« obUlood »lth tho iMdtX fit •- d«flA*d nltUwuM^. •CM dwlftUcru h4T« b*«n foujd. y«or axitaploj It •pp««TS thAt «4rbcB fil^r* ^'B ooui* » Mj-kod r«du«UaB la th« rvtMUoo y\ of nlCOtlBO. *;;^ "'-• It !• prcpcatd to eoBtlnuo" j(M« •tady >rlto Vv« ila of coapirlAf tho "rvr*^'*ntlOB of clcotlAO Ifi Um taua4n houth vttli Uut 1a tb« aodol. 'a \ 'V^ -r '^. / V c 322 ITISH-AMERICAN TOBACCO CO. LTD. ■/- > ^ ^- yiOOTTIg rx THE >CUTH '-^^ UaO? / ThU confidential report U the propertf^ of British-American Tobacco Co. Ltd, and must (tot b« copied or shown to unauthorised personlT s Oi w 323 /*_ •- -/^. C^ /. ^^ ■t-, 21 .8.1969 /^ 'Sir '^ '^^ '^500 ^ '(i?- X% Dis??virm H. Sottorf £.C. Flcldtcnd, £^. Or. B.C. Felton R. k D.E. Uta-4r7 R. A D.E. Pll« No. 4£C ^-^^^ y ■ 8. 9. % • U, 12 ^> • 13. 1» '^,^ ' 15. l6. 17 ^/. ■ 18 ■-> ■ 19, 80 • 2i c c / 61 / con C: a 324 lUsttreh * O»v«lop*«nt £rUbllsha«nt. BrUiifa-AaerleAa ToUcM Ce. Ltd.. SM/CaV*6c ^'i M«t Jki«ust 1969. \^ > ^ \ . lncre«s« with puff ^^^jua», th« proportloa 4«cr«44«(. For totacaea such «t thott uMd »oiiaec. huiMn sMldD^: for exaaple. It 1« possible th*t. If pipe 4xtd el|4r N Stivers take sit&ller puffs th4xi cljirette taoVers, the chAage In J 325 *ftv»lUbU* 9}Mtin« with puff TOluD* eouU ee.itrl%ut« to a higher retention In ^ Aouth. It Is A pUnMd, (t pr«s«nt, to •xiJdA* th* effMt of puff voluB« on *«v4fu^l«" Bioetla* In tny aor* dei«ll, tut lt« IsportAat* In terns of other ik^* e«a^ooents will be considered. - r- / '/*_ 4- C-, \.. ^ o.'v^.. . r, c I c I 326 /. SH-AMERICAN TOBACCO CO. LTD. gccoray pr s- oki A>rT) -rj.: hVr-ULV s-. y , R£FOST NO. sd.7;'.-:h <^^ 2c. 3. 1970. — &r^ '^.-. ^^. \ ^ >.% /^. C ^•^. Research & • -9. Pi:i=csT KO. ■'o.70i--t/-'. 26.3. 1970. ■/^ ^q. ^0 > O^ AUTHOR: D. Crelitim o. ISSITCD BY: ft.J. Woo^ '^ PPOJaCT; )^2<* ^0 ■ • DISTRIBUTION : % t ~ Dr. S.J. Green "Copy .Wqa^,!, 8, J. k Dr. l.W. Hughes V ^ t^ , Dr. R.A. Saaford L.C. L*port«, £sq. 8. S 10 11, if ^ Dr. W.B. Pordyc* Herr H. Sotusrf 13. U <.-, J.C. Burgan, Esq. 15. 16. it .- Dr. D.G. Pelton 18 ' R. 4 D.E. Library 19. 20 . 6 R. 4 D.£. File No. 1*6£ 21 '^ CO?Y NO: ' c - '• a c • 1 0 w 328 l(cs«*r;, ^^-■^ f . — ^^■^, (ft«P»rt Mo. RB.701-.'^) S'->y>RY A irl«l hia been completed -o lavkstlgat* the rel»tlon be*.-ec- pr>>Tl9- loii^l effect »r.d nicotine delivery. Tt'jl ph/«lelojle»l par»n«',• tof>H durlx^ and UcedUtcly &rter srekugxight ^pet of el;arettt by a pttnel ^ hLiAAn volunteers. Ihe results shoi^thAt tho aettureae.nt cf heart r«t* c^>u^ appeu-ed the aost r«ll4blt of the 'fiructar* and t^ie group Averafi rcsulT^ showed a.t Lr.dlcatlon of * relation- wtwew totAl nleotLne delivery and fairSrease Ln heart rate during the smoking period. The changes In sJcLn raslstaqr^ and ckLn teoperature were less erratic than previously, but sttll dld'o&t a^-o« a relation irlth nicotine delivery or Impact on Inhaling. v'. The experience gained durlnc Usls owl the previous trial has allowed the Identification of probable sourMS of error and varlane*. Hecomciendatlons are aade to Irprovc the InstruatevtAtlon. cj^perlacntal ■ y^ technique and envlronaental conditions. ''^^ ^> c I c o 329 ^ :K cooutnua X '/•_ trftsfi or Bfonia oa m ctvivk, jaxvocs ftsm ''V, ""o 'o. Q, ^. Oa -°^^- •% '^ JL44KIM*: '(^ VitfcOM: •airrct. i. ^e 'yV ". [■ ' Q o o 330 C -^ /^ t* «»t«r«Laa wtetJMff. LA «>«•• cttfx fcfcU t* tlk %^tum »rf«c^J pfcf«t*laf ic«l pr«e««a«« u»4 WMviourtl 4^w^ci,»A« «f t*« e«Btr«l •at^^m* «^t«« vf tka |ria«t«. T» Uiii «iW «■ 'A. f^ fTLMC* «« Ka«« «Ko*** t« m* is «te •fMtxrtl MAksr ^M tM •»tf«4a «• w MCiHf era ai (allMf*** '^'.^ I. Naaturaaant aC th* a«^>ut af «c«t7:efMl ia* fraa Um kraia awrtact aC * ^. I. tacartfiM ^^ US af conctf^^* »aUml«. 1. Iaear<*i«4 •! ^tantiala a^okM^tlr alacvricftl stiAtUtAaA a( artaa mt im Wa*a. ^ j< «. Aa»a«ta»ac af aftacta aa Oia Whavt^tfr af tfft&aai 4nt.^Lt- -^^^ A '^A- flkia rapart twaatariiaa raavlta a*4 eaacUttaf^^/M **(• t* «^«a axaac a( v5V**'*l^* "v* **taila« 4arar«atAaa aa tte — 1 1 ■ fH gajy »« 0««a ta tte AppaM.a. -n "O ex %, a> ^ ^.-, ^-^^^ ^.. «« ■•9g«it*4 IhiT*. IMI) c^At aie^tuM rtt«afelti fccttrletolus la Ita AO^^^fv* >«««••• It r*l««a«« *c«cylck«liii« tnm «tti« wtt«r« it la koaA TtM *ett»A|f.«f alcM&JM m»r t)Mr«r*r« W «»• ta Um r«l*«aa af acatf l«hAt LJa. « a^AkatuKa «*iM la %«««« t* yUy a ttajAc r«la la Wtui fwieti»«. Chanfas U ^ activity •< th« caatral k«x««w« rrita*. lueh t« t>Ma« accMrruk^ Avt^^ tW xranatttjft froa alaay to vikaNlMia. ^a«« ^aa c«rr«:j=ai vith wariatta^a va ftif apowtMnma ralaaaa •( a<•trlchcU.■^« fto« tte earatem. cartas. lUCtAceak t^d Qh^r la (IMS) firat iavaatifata4 lAa ralaaaa *t acatylc>MlkfM (ro« t^a fr^rf^ca 9f Om krain aM •rMto*4 *.Mt c>« ral««a« l« ralatad to tXa alaccncal 4>£i>Tit/ •! thm braia: luular -.achm^tt w«ra .«irt ^ RtccSall UMl) aA4 kr AJ%rr>9a ftll *c4 SalUra IIMII. r>>a«« ■^ihert ca'.Iaetad tM acatyleSol k-^« lK t^li rylLA^ic^l cvpa 7:*c«d oa tXa ■texfact ^ AODuac a( acatflcholuM w*iicfc .-^ Oia axpoaatf carabrtl eortaa. a^^ tea •<'ca4 tka 4 >■• ^ W4 accu«tUta4 trtkaa a^tli^rit^ W«V J a t aft I Ljih* -^ . Ik/aita^ at al. . (IMf) ■tw4ia4 i%m St' ac^ vf intrivaAdMi aicatiiM «■ /^ acacylcNAliiM ralaaaa froa t)M kraia a%r/acvo! WLaMU«tiia4 cati. tttc/ fa^ ^/^^ iXat wKaa KicetiAa (tat^l 4oaa t^f/V^) way^^d^** ^crwi^c^ta Vy at * 4eaa of ^ ^t^^l ta]acia4 awrr thLXty sacaA^a av«f a -^■pWo4 ^ M ftkAMtai. tkia oaMaltf ^5^ rai«lta4 la a* iacraa>a4 owt^t af acatylOAlV^C T^ »*• total 4D*a ia;on^ C^ ^at 4krfaraAt rataa cava«« «o«a vaxiakla a(f*cca^^ actty^^MUa raUaaa Ui4 (VM**tk*ai a«*a ro4Mca4 «^ aaovat ralaata4. O^ ^^ ' S A'aoiMtiMi a**a ro4Mca4 «^* aaowat ralaata4. O^ .^ 0,.^liUl*x AxyuUHata K«v* kaa« caxrk*4 flat ac ik* L^ ii^fS^ IbmucJi Cm fa/aat ratoa owar a >0 kiauto tmt\*A «i»an4^«jM>a4 a A»*0 ihiAoto*. At tJkij 4ea« a<^a*^la aa ivraaaa Utm M t* >oaB. waa a*ca4 ^» a^ary ai^rvaant. 5 Vi«l*f *^^^^ aayoriaMAta «^ ala« facor4»4 t^ CSC. aa^ally bat«««aa ^Lar^M hall >lattxo4aa p^a4 witJua Um «>«^ nk« uKtaaioa la aeatylctelLM ip^ar^ i« a«rr«L4M v)tA '^i^aa •( in«raaa*4 Wala artiTity, aa Aatarm4i-«4 ¥7 a c^i^ -^'' ', U ilM tn irt^ tJM fyrtL>f patiara t* ttet ••«« *rfuif c«rtual Mtk*atv«k ^^ Maoa a I«mw t*tal 4|^* •( alcaclM llCh««/M) «*• kA]acta4 at 4trrarajit ratat 9'*%t a yoriai •! 20 ^fWtaa tK« aaat «r«Al rar^lt wai an iAcra«ia4 •Mtpa • f acatyUMlLAa CS* • WOtMyytA %.hx» affoct waa «aa«ci«ta4 with cKaaifoa la tta nc c*Aafcataat «aOi wrt-Wal icuvaiiva. fV«a* c»aa»a» •ccrirra4 trrca^octi«« ^ t^ tr*^a«C7 of tW fti««>iA« iJl^f^iOAa. T^« UC cka'^ai wora oftaa of ahTi 4i.ratiaa a*4 laraly aJtr««Aa4 CM pv\M •! tJM aicoti.ta a^staittrjtioa, tot i* a«aa aji^riaaata cfe^ra ««« • ptalO'HfoA'jMcrto** la tte acatyUN*! 4n« .owt^t. Jkttaapta to ra^aat tfcia ^«r% M tK«Jf<^^M tatal 4»aa la*al a* co^aci***. ratkaf tKaa aAaaathatiaa4 a^s* irT«4 ■■•kaya^Kaao a*^ , aa rat. ^o<^a4 any 4ari*ita co'tflattoaa: th« i«pfaiai*« ^ift«« ^ tKat aicattaa raA^ai t'^a acftf IcKolLAo ralaaaa la a*«t «i^rl««MU ^t 4M4«torally raiiaa t.No la^^l of acatylcNalioo- TVtoaa •rpmt umntg a/a ^attw^ l-A/^^'»iajK aaviraASoat of a a««'4-«ttOAuata4 boa Aalnf Ck« costr^W aa aapar.UAt rart wa«k. aatM A^ffaraat aicatiao Aeaoa. ia ro^Lra4 Wtor « -^f init k«a co^aaat caa W aa4o — tKaaa taavUa. ^ 1 :. ^A ^ 8W.W2-10104 332 I. «vnt »'^mj'^ H i>« na ns <4mC4^'*< "T •••« • •«-^l» U>u<>^u L^lactiM OiWf* 4*4 DMiM. IMll *' " * "HQ t«>|i«i rria^mta •x4 OOKin. 1M». (((Ktt •« tiM (tc lu»« ch*nt«< c<>n«tft«4 •( HUi«tiAa or «aa)nwKr«u»ciM •( tka ae. >kick air k< Utcrii*4 '^~Jj_ njr»—l»^- of Um tie raeorC aii4 u< llUatr«t*4 la rtfu* I. Th« aai(Ti«^ *wr««« ««r« laiatM^ tl«a c«K«r>^ •lt«r««l«M U Om >u>aiu tn^Mn««» •( tIM ICC eouK ,> •• •« "C. •»• uj*>5j« f WiM »»1 tooU to aiukU •• la itaty fi* ««« l« -, "Kk fi««t«r 44t«>l. ?%• 4^»o4< w«'iMcri»«4 !-• t.\« ippa>4ii u<4 csnoit ' - boteallr •( int»-)e c.^.». %nt • (ra^^anc; lAalriar will " ' eontinuoxilr lupla u US racoril'a^ pra14a kararaatioa oa Oia pca;orlia« aC ■^.__ «ck (caTuaacr »an4 raauia«4 u> eon«Mtitiv« yar Ladj »t tiM ta »»c cxa 10 ,/^ lac^iwaal. V/^ ("J-, ' ' , '-'• , » ""^T •' e>>aat«« i^ «J>« alacuaa v:««Ka^a«iaa fWwrn^ tha •4>iiii>trtitM /• •( lacacuttaoc •asi.tat teaaa a( aicatina ll>«^ i ii i rn«i««il| Nai kaaa M«a ui /- aiM K<>a raiolti ■'J4la«i tfiM ik* »tlt\ a( mcatira "-v la ta ^9««ca aa tCC •.mIat t* 0«ai aaaa la 4a ^aoMl 1« tktt tlart ataca ^ fha UC la tha alvt ttata coaa^a/a* >ktk cha rvinxt n^M W tyrtdal %t •" fV'<***4 parcancafa actiavtr u Om ltlt^a> rr»«M><&Va aM « «Kra<>}>""«• actiTttir u !»• lOTMC (raquaiwiaa. n>>a Kaljli** *^*f'9* '" *^' /aa>iW^a»k)acta4 ta a teamiaacy aaalrata aflai ak.c*«taa''0 l>«/iMl4^*< Id auMM> 14 401MUI a« t« aa laeraaa*4 anaai la ik« raftika (Mlti^ MiaalaV])n bf/kf/Ka fM }0 ua^taa. Ite alar« auta tr^V^ trPkfU* hr • 4ai(k tka raatta* |haaa>V^ "c«tUk I***!* a( l>#^/aia IV )0 Kxaataa tki4 vas akaaxa*4 la lavi a»Qa aiM«t« •tvitUC At <>]^,lanU a( laif/kf/aaa all tA rifiuaa 1 aa4 I. Qtaofaa la tatal •cttaitr an *»>« V-'r^^waa « aa4 1. fha af ta^ W i lYl^ *f **• •' »caaa. \ Aa (lit Va aaaaSk tti/^r^haaalaty 4aacrtW4 la tha >rrait4». aa»t taar>aMalr tuUta *** '«'*■«' •' aa^ciaaaru «*iO caA ^ ^r (araa«. THa taaalta akla>na4 ta 4aia a>a .anr aaeitinf kHr>»na af tka actiana %l aicott-M. tka 4aaaa aaa4 ta tAaaa aayaXLaaitct an aattaoil. aaall aa4 tka affacta aatacva4 taa aaaaa aaa« ta tlaaa aayaXLaMitct an a a^U aa4 tka affacta aa axa caccaapaajinflr avU. rsarafara, it la K^tatarr ta te aavacal ra^a aifaCLaaitta at aack ^m Ia>al ta Ka'^ » kk't^Xltr ^t«t aa4 tka aanval aani^Utiaa a( tka a4 alv>>r>u^ cka««aa >a kraiK att< *>a ta aicatiAa. ta4 a kaltav* tkia \aa tlraa4r k«ai< t«te^a>««. »a aia ta lacaliia tka aiaaa .iik^ tXa krain at -nick cka»|aa ara ^tiata4. u a ~V ^ c c M Zi. Sr S 333 H} )«Ll '■*!■ •• «« •!« •Uctxodat u u«u •( tlM kr4l« <*i*»« • «««»«lit« •( nUMiM nek u "«i^^- *«•••••• «tO>oat> «« lu»« aMW Um Ue MUntkM fro4uc«« kr aintlM sitk tka» alicita^ kjr sOxr •rvfr'vta^ kr« kaoM t« 4Cr*ct cMCral Mr««u lytcM NactiM a. a. >■ >tt»cf|.a.^>»4 W alactrictl itiauLUo* at tha kr.i.. ^^ TKara lauj .»«iTr (•«'•«» to taiv4 u>a aaoei/naptic pathviyi la tuto>«aie ' -, ««'>tU« u cafraiaui lyi-.a.. -•- t>a •>•;'.•» an^ aoat ctsaaly ^jmalu ta t^ lanflisAie fraparawaa ■• iNa ' . t ^,-.,»* «>«-«av.roa. ke< ana cariaa ».ik 'f" ^._4v fy^walrieal petnca la if%* con crTtuaTaV fvrbaa. • " l' ■■ - ^ V , '« '■ pomkla u awka tcar<>«al raafoak*«a la tka caiabral cot-.aa o( '/- »«riwj« utuU kr alactrieal at laulat >«• at tS* oerT<l araa aa cKa ^-" tontralatai.l certax. Ran/ Irv^a )u»a k«A ttudU* tm t)iair a(r«»>tntU( cr^nfaa >« Nnctien ^^ within tha eantral a«4-««M4 ayatoA. y'' (" O % »J> "• '••« ">»« • "•«» •' tlva aira« tta piaciaa Cn* ka Wki< fractiaaa. ^/,P« taM.4»n« arataa Saa baan •ykjacta4 ta aa<^c>Y)»4. r .iaU«M *.riit . j», - t)«l^fV»«y k»t M ara CMfiAant tAaC «« aw kat>« a iratti/Xack to kaCiCiaatlr ^K.' 4«»«T\TW t* «atact (Mil chuwfaa la tka a<«a4 raaponaa. V_Litr.4* • ^ Ufi»»i%yi coal4 ka uc«rrarata« ta turaaaa t>a aaaiitiy£L«f tM n«Ma ^.nlU -"^yk... tkaaa ara not f.aaUla ..l.aa tNa 4at. ak.ain^.. j« » mm^ntiltUp-^tit m iIuuK aspKaaiu t^t a.'il, aaall c^aAtV; la caaM**'' caa to upacLtf ^M tkMafoca a »arr aanaitt>« «ata«tkoa ayiiaa ta aaaantitl, taKlr lanlW^Mfaat that «vita Ia>f« afa a 6a;iaita uiliikttian a( Ou a<«ka4 ntfaoaa. Lit^'aa Lataca^ttaatl; ta aaakiaf «aaal (Vf/kf/aaal um aftact ta UM fc»aatt£^y la attll aaaamkla. *♦» *•»»* *• •■•a»t>a»i^ Jua a rtMouaea4 af face aa tka a>aka4 raa^anaa ta itLwUtLaa aiv4 !• wacco^ t^ia ^aalaa »ttl aavicaa ta aiaii^. Wa^aa a( tkia prapacattaa >ill ka«ia aa •aaa aa tka afpcofriata «hb Ot(tc<;y(ttlkcataa ua aktalna4. >ra»aklf la tAa aaat faw waakj. V*^ \ e ''^- % ca 334 Ml*. CO t)M tKyttoa %| Om Waui ■■ofcir . tltia tjrya •( itWy Kai uavAlly b«M (KomftOA. iWV'f", traif^A tm4 Outt^. 1*70-. r^iAfvliata. C«ttanck tlMI),>'av* cArriad »ut itu^af to »«■•>■ iHa •ffactt of iiM^l ^t*! «( nicociaa. ofvily^ •AU^staxc^. aa :\a parfon^nc* of huA«a v«Lsjntc«ra t.a a vvriaty af labor^^«f-v *.aatJ. ?Sa f^Aaral hypothaaia i.ivaat ttataa ««a tJ\ac rttcotir%« in amil doaaa w*ut4 ^-a*a a poiitiva affact oa cortical ara«.»al «*4 an t>-m wtkola c^^>r ravalta a^pporiad thit >lypel^aata. V ^. Oka davaiopcLaat af J «ii*.i>lo tev.ca wn^c^ xo^jld p*tmn era tn:«.-&ittan( uic.-awaaoua in;a«tia«i of -itctfvwM croM^rMut a* ai^ri^ant. va ra;* could fr« eaxritd by ^''* ^^y^l- t«ot4a.'tt.*-f t>a d/wf ■Mvtiaa afkd al*etraA;.ca aacaaaAxy far ita c*r.ciAu»hir; t^tar oittaat apacattoa. AfQi aany falaa Twpaa had Vaan rai»*4. va ara caa f . ta'^O^ \a i nik • davica la >«c^^aitftkla aad aavaral aM»alt a/a •.rai/'ad ar >at^^caiA«d « thoo di^rarKf^aC^t .aAvAf acha^laa. TS^ acSa£ulaa lalac-.ad a/^t^ia OKMffcc Ukaly %# data«y^aall cSan^aa ui tiM baKavcvwral ^ttari >s.t t>.a »^%l^% ^ » »aad ia ^^jM* c^^ ^?Vxaaaai'«k ta aaraacila ajk4 caa y« adapca4 f aaay ^Mdwlad «tf o#«r«aa rtapQliiin. t* dato w« h«v« taatad AiC««iia ta tw* 4aub(1^ aa • Co-^^vtm^ iw«>^Aca. ri.i»d l-acLa acNa4-jla CA/ni «rd la •!** un^A^ a Fiiad Ist««*al.W^fcad tatia achatfyla ifurx). ?Sa a.'fac*. an tka ^L^ aOia^U vaa di.*tarMft la a^^ aauMl. In ar^. Oa i.^itial rata af la«ar pcaaain^ «•• ir^raaiad far a^^oi^^taly 10 a^»\a fittt accajioa it tacaiwad lacatifva <0. W'^ff ^^4ff ' ■ ^^ a.i^aao-a.-M tatta ra^alad >m actioa af tM drwf- TKa aac«Ad aAiaal a>-g>-»a y LCENdiata cSa^a la t9tpa\4ut^ (lavar yraiaiif) ^ahavkaar «*taa flv«> NicaCjM Cak.«/kt/>0 aac) ¥at i>a ^tta^ft aa tSm fatlovu^ PlcMiM (0. V«^k^ii •^mT^4 MM arpaar c« altar Ova kakorUw •( tJk« ■DAkay taatad aa tte Pf/ft acKadM^ O^viaualy cSaaa axa aatfly 4ar« &' t>.aaa tx^ti^mr^tt to«t aUaady «« caa %*» 9cm» atfact* af aic*ctca aa4 «• !»«« a^j>a>.^t t-\at t>aaa cKaafaa and tNoaa lA^wcad It WKavlOttf pattarna «• 9'^.^^r WtJ>«la«, vill. xAan ceapa/ad vitk cKan^aa i*^>cad by otKaf drv^a a *-(' Ualvaraity of ^^•l>OlU■n• ^. -vv rin«l rt^»rie rci^krck dir«ct*4 >r ^ro.'titor H.J. IUa4 4nd tusporf«4 \m 4 Ipf^t *ro3 th* trltii^ Tobacco C«ap4Af t>etion of s»okinf i^ciiin*. ' 3. E*v>«/. V V", «. D«vtlopaii (fftct*. ^^ I. tfttbllshaant of p«tt*rn of nicoTijra, i!M4 l«v«la \ ^'\_ durlAf ln>i«l«tion of tuce«s(lv« pufff^* aaaka iA /9 th« ^«nf^.' pl«sm4/e«llt dUtrlbution of nleetin* 1» bloc^^«v«lf withlji t^• r4n(* liktly to occur Curiae i*o><4((* % c. c c fsi "7 337 > Cj^ ^Q 1. to tttopt to •«t«>ll*k WtMtlMF th* tr4A«f«F Of ^' ^ aieotiAO froa InMltd el|ar«tt« taok* to tho bloetf ^' (.tr«aB if 4iffu*ioa or flow llaitod iy iiiin( aji Di&ie«tar dilution tce^ni^u* K44 ^ui ati«; • h:mi*rp et rt*y« 4r« ^Ln( t«)c*n to obttljs aero a<4.ii.*^Nl r«talC(. I. A ?ilot tturff ■'>!«• Mtoklithod tho proctiurtt •^ , Mccssory to itaJty tbtorytlsa of nieotln* fro« 'O, solutions of th« >"U^1eid, or »ao)c* h*14 in tho X •euth. '.-.^ t. A (tudy of eordlovticolAr Vriiont of sicotLno in p, I. A (tuay 01 eoraiov*ic\uar arm C^ Um rot with tpoeiol roforoned^o^nX^tlM'o O^ Utoractlono vlth soao «rv(« a*04'(^ tho trootaon ^)> . of eordiovtieulor aiiordori (•• »naT-r«e«pt#r '/A '''->loekiJ^J druft) hoi *o«« e4rritd out. 1. A aaltif lo ^looter dilution toehniquo wlU M oy^llod c« ee^»^o tho tro^ifir rotot of nieotln* fr«« inholod oUcol^ eigu laolco. odd ei(orotto Moko. and nteetloo to^oaola to t'.o blood ttrcoa (ef. t.l). y.- T^o aultiplo indieotor 411uttlA .*.- -^<^4u* will b« C •73" o w 338 i BRITISH-AMERICAN TOBACCO CO. LTD. ' V • 1 1 ^> - % - /, Murm contribi;tions of nicotivf and CAX*ON DONOXIDC TO Ht-MAN PHYSIOUXICAi R£SPONSE J» V. RXPORT NO. RD.839^»- ,, jj .,^ \ f- & % Research & Development ^PtaDl^shment •^5 Southampton ■5' Brown & ^^iamsoo NOV30i(j« RESEARCH UfiRAJKY v^. This confidential report u the property of British-American Tobacco Co. Ltd., and rrfuK not be copied or shown to unauthorised pei'sons. c O 339 H- H- 'a RtUTIVg COWTRIBin'IClWS OF NICOTINE ANP CAMOtnigW^IDE TO HUHm PHY SI Otoe I CAI. R£SPOWSE ' r V RZPORT HO, RD.839-R ^^/ 15. II. 1971. 4l. ■'<^, ^x- -Q^ Mill L. TCJteCmi»r«y CI V V ISSUED BY; D.J. Wf^ % X' DISTRIBirriOM: PMWICt: 3)20 ^/^ '<^ Dr. S.J. Crt«a Dr. X.V, Hu|hti Dr. R.A. S*aford I.S. V«-.i3 17 -^ IS, 19 20 -/ COPT NO: €:-. ''>. -^r r a c c C N Oi 340 R««t*reh I D«v«1op«MC Ett«bli«haeat, Irititli-Aaericao Tobacco Co. Ltd.. SOUTKMflTOll. DC/CA1,/46H VJ ^ I5tk Hoveiibtr 1971. KiUTivt coWTMBirriOHs OF Hicornre a; ■ 4 <« 341 ^; Si i>^0 xi ''0. - RtroUT HO; ».<5>-» -/ ' IdLiiU. v*i. X.. -c ■•5> ^. %- lAfy ^ Crow amiaevBlopiBeat %. Centre M '/^ 'c, SOUTVM^TON CN3UW mCANTOACCOl .. t . ■ ■^ o •^x. lESEAlCa UBlAlt .'A^^ BrowiiWantflttOtt <•- ■^-y. - r TKt car^d«iuririp«i«(N property ^8^la^-iUwiv1DteaCanpa^ftJ^^ oopiiri • *Mvn v ^«uUv«i4 imvL ■ 5'. 8W-W2-1207S 342 X 'O^ A0TIIOU| I.D. UtWn - ,-^ •■ Dinunrngti ^ . ^ ^ ^^]P ■•• |. «. ». «. ^< • t, JO. 11 lUr.fT ' ' " • P.V - ftu <">• ot*«* <:«*r <■•• i> *• )t 4t ) Br. l.A. ImfcH l.t. «*4«, lH< MjnMtr. ■. » t.«., A««tr*lU '_ \^\\, \\ ntrt 1. SACt*c( »T. ».C. PcltM ^/, 5'.. <> ew-w2-i207; 343 '^ Crvar Uittrck k Brr«lsr««>it Caacrt, \ Irltlik-AaarUa t»^»ce» e». U4., -J- v^. ng ..*«. '. ^ It 1( m II1II >1 tk«t tkli vork «Mtlsw* tfltk ««U«kl« MU*ker*t«t» r- '-^ <>A -5^. ( ' / BW-W2-1207J 344 y . >; > FOHTH£R'STVO'» <* THI IFfEa Of NICOTINE ON H'jn^ p>a >LSPOf 5.6.1973 '^t Si '\ Centre '^C SOUTMfMPTON ENGLAND "-^ '^ BRITISH - AMERICAN TOBACCO COMPANY LIMITED \ Irown ^ WiK.^mson^''^- / /L"^ 2 01973 6.. 1 c iltSEAktU LIukaKY S 1 o ^sr * Thij toe' d«r,i ji ttpcxi .s;^•« jijpcriyol 8'.(iSh-Ar4'caolbtwtco Co'-p^ny LT'ied »(i sScvi->*.'*irho<>»< jrvm: 345 \ ^8^^ /s^^ rCRTHZR StqoiES Oi THE ttnCl Of WICOTryg OH HivjQi yjorsrouxicA:. 'gsFoNsF y R£PCRT HO. W).l007-r V S. 6. 1973 /•^ ^O, ^. ■s^ '^^ <5^. AtTTBOKS: ^- Cc. ^Q O.C. Creich^^ Hri. B.M. WiCCl^ '^. % V> %^ ^ tSSUtp BY: I.E. TVortttocC?' % -9 PISTP-IBUTIOW; Dr. S.J. Crcea Dr. l.W. Bu(he( Dr. R.A. S«nford R.K. Cibb. E»q. «.S. Wide, E»q. R.C. .SichoUt, E»n. Htrr H. Soctorf Dr. C.J. P. de Si,ueir« Dr. D.C. FcUoa Librtrjr File Ho. 66B PROJCCT J % % Copy Hj:^ I. 2. J. 4, s ' • I0.?f£,l2 " " i>. u --'^ " " 15. 16 <- " - 17 " - 18 '^. " " 19. 20 " " 21 Og »_ 7 s c q5?» HO: 346 Croup t«*««rch I D«v«lofaeat C«aca, •rltUh-Antricao Tobacco C«. Ltd., SOVrHAMTTOa. E^ R CTPDirs on rm trrtcr or miootiwi om '•-- HUm« fHYSIOLOCICAL KTSPONSE ■ J! "i^ pUp•r^ Ho. W).1007-t) SfMMAJtY AKD OONCXUSIONS *^ /J. A tcic h«« be«a co^)l(Ccd with tn*Qbjectlv« of con(irmin| th« rclctionship between nicotiM iotak« and piryuolof leal chaoge, withis tb« consrniat th«t the noLera iot«k« of nictfcioe could only b« «scu3tcd. AMlytuC^ the rcculti ebowt th«t ther* is ^Oh a raUtioothip. Hovever, ««l7 coQrvatively larga dlffcrcecaa in the i^^rotin« lacaka result io sigttlficenff^ffetencca in the (ollowini physiological paraaetert:- heart rate ch^oga, akin lycfaca tcaparature and blocd pressure. Raatt rata change waa the rfe«C aea/bjjva of these paraaatera. Skin raslataaea • 'v ^ ^ shoved no correlatioo vith alcotiijit intake. Mo further studies of this kioo^^^ planned until puff duplicatiaa la available, when it should b« possible t« relate physiological chaafts to the exact anount of saoke, or saoka coaponaot, retained. -v. During the course of this work a new cootroilM environment rooa . \ vis evaluated. Noluithctanding the sorsewhat disappcii^Lng results obtained f' froa this experic^nt, the use of the roo« is considered t^h^vc rcsulud 9 in a sencral Lnprovcaent in the stability of the resulta. ■ '^ _ c r o 347 9 « '^.\ ^O, (y 6: y. mrMATiox mo fKoftPfg or ■loormr. AjuLOCuei UfOCTJIOjlO . IMS-* ^. < - V brown »• Wih)«niyig '^lJ H0V27«73 RESEAkLb LlilKAKY v.- ^A 6W-W2-12127 -pl 348 \ A C^. ^ Al/niOK : K.D. KlUwrn y. Vr J.C. Uo4-> •55 I.J. CTt«a ^^^ ^ »T. t.W. Ru(iM( I.H. Cikk, Em- I.I. W«*«, IM, " >0 l«rr a. Wtl*r( " * ^L, >> ■ 1^" A.J. Krutixntkl, (i^. »r. e.J.r. <• Si«i>*ir« " " u rt Dr. O.C. »«;i- • " M ' a" Li¥r»i7 " " U. l> O COrr WOi 1^ Til* H*. MC • " U •^'^ *~ ''^^ % BW-W2-1212? 349 Iritith-Aacrica T»k.»«» €•. U«., souTiwrrai. '^^ — ^ rug n V a«4 h*a >«• % % '6 ^> BW-W2-1213C 350 BROWN & WILLIAMSON TOBACCO CORP. <> t. C' y ^ O, Report Ho. 74-20 >-'■ d<>obcr 91, 1974 HUHU< 1>)()KII«: nuoiEs V . ACUTE EFFECT OF O^AJtCTTI SMOtCE OH BR>IN WAVE ALPHA imtTHl*^ FttST REPORT Author*: I. f<;erot«|« Dr. J.c.^^ Kean«4y 'C-c 'A ^(? ^. cv RE$£ARpi S DEVELOPMENT DEPAKJMEW. "<>. '^uisvillc. Kentucky -^b '-^r. * s^ "<> '^O, (y '\ I c O o e -^-^ z Vv ~^/ ''/% THIS CONFIDENTIAL REPORT IS TH€ PROPERTY OF BROWN h. WH.CIAMSOJH TOBACCO COW. AND MUST NOT 8E COPIED OR SHOWN TO UNAUTHORIZED PERSONS. ^>. ■s^ 351 \K o,- cy ^. ■sj. V. tftfojfj. Ro. 74-20 0 c I c N I N* o o a 352 Ittporc Ho. 74-20 0fha U teUcad to th« reltxed •c«c« la adulti. V« h««« nov found In a preUalnAry^^ipertMBtt ch«e three •aoker* shoved « ttrtklng lncre<«e In Che amounc «nchologlcal and physiological respons^ Co change In sooke characterltclct. Thi j'Sv&gescs chac sooe snokeri are relaxed. after receiving nlcoclne sciouladoc -'-a response which has been described bjf^«cher«. We will eoncCAue sCudles of this basic huaan responA^ Co ctgareCCe sawke. \ %. ^/. o, '0 %. ^1 '^A % 61. c I c ru I T M 353 't . m V a '^'>>j Q-^ DffttAcric?; or s>g)icg and the smokeh 3; IBE tFFTCT OF CICAJHTTE SMOKDiC ?1C COWTU-COfT KECATIVE VAJtUIION /: RtPORT NO. RB.Ttfe^-R 12.12.1974 -^-^iC A. i^, ^. -1 ■o. ">>. \. '%% EPOUp __ Reseaper% anilBevelopmiit SCX/THAMPTDN ENGLAND BRITISH - AMERICAN TOBACCO COMPANY LIMITED -^ •., ^ "y- Brown J W;i!'.jm.uo JAN fV^TS RESEARCH US^ARY CD C c o o N ii conr«;OHXC O-ywE O0MTL\ce:. c I OOTT ^0X7 o N O w 355 Croup tcjcarch I D«v«lo{>**flC Ccactc, KritUb-AacricM Tobacco Co. Ui., SOUTHAMnOa. V AKC/RTT/Ki/Uj 12ch D«ceA«r. 1974 Q Oy ^r DrtWACTiow or s^OKE ahd the smokik PAJy 3: rait EfTtCT OF CIC.^AETTE STjOKI'mC 08/^ IV^ COBTDiCENT >:iCATrVE VAJtlATIOW \(^port So. IU>.1164-R) /< . ^ X^ effects of cigarette siDokiQ( oil J^ectrical activity in the o ' ^ Vrain, W^sured bjr clectroeocephalography <^CK), ar« Wing investigated «s part of i^^study of the interaceioaa between a^ SBok«r and the cigircttt. Of^tn^ex Q^ brain activity ^ich has b«cn we»9vlti ^RLf%* cootiagenc negative variation ^^TV) , or expectancy wave. The OTV [a a sl«v potcatial •hift in the baseline t$iO which occurs in the interval bcCvctn two ■K .* Cu - •tiauli (*uch aa ool^iLor i>^c (lashes), if the sacoad one re^uirasX a decision or action by tba sub5V^- The aagnitude of the CKVwas d^^rained a nuober of tines before and after each subject saokcd a dgaretO^ Soae saokers showed an iacrcase and others a decrease after they had vaokc^^'^ This divergence of response can be Interpreted in two different ^ ways. Nicotine (which has been assuaed to b« the aAln pharmacologically •• f hi active component in ssioVe) say act in a bi-phasic Manner «^ v/^^ ^ ->>- '^^^ / '/. I 357 i i y- y . > ■:'. ^^ ^ ^ sowr "Bn>trrts" or smokiwc ■^^ C IXPORT HO. Ttp. 1461 UWCUSSIFIEP '^y 2(. 1.1977 "O \ \, ""a % % ''^^^ ^ ? 1977 - Brov/n u Willianuon TV.ij corf«) or showtl to i**."*© s«d pefvns 358 X >*. v'- tO^'trKrtlS' OF SMOKING /I' RXPORT K0.-1bD.U»l UVCUSS[fIFD "T— y . ?«.1.1977 O. \ 'O, ^.

5. R.E. Thorn too ^"5^1 N \ \ ISSUED BY: O.J. Uoo4 ^; Nv PROJF.CT JOB KOj DISTKIgtmOW; Dr. S.J. Cre«a Dr. I.V. Huch«« Dr. R.A. S4nfor4 K.M. Cibb, Esq. R.S. W4fp$s(klt "benefit*" \ - % Su '^'-- of saoking, «a4 bo*t^ then refer to ill-defined effeccjp^f saoking, reported «ubjcckl»oljf- vi; However, a nua^r *t oQ^ctivc studies luv* indicated tliat LaprovaHats in performance (ia laboV^ttvry tMjfLt) can occur a« a result of saoklne, "^ •od there it every reason (« b«licve that these effects also occur in real-life situations. Psychologlfal "b^ij^fics" can also occur, buC these arc necessarily aore diCf iculc to dcaonsfratt. Additional studies art being mode at t_nua' -t ,4 y. %. THg-'^TVPr or HUhA.y shokiwc behavioor USmC BUTT AKAJ.YSIS RCTOc'lg). M).160e RXSTRICTCT 7.8.197t ""^ ^. \ Oj, ^■\ 'b. %, % % imp ;o,><|, asilBsvelopniBitt ' '-;y- <^ -^ ■^r c N Thit confidential report Q the property ol 8iiish> American Habacce Company Imiei.and must not be cop shown to «authoriud prarti 361 H > /", THT jTUPt or HUMAN SMOKING BEHAVIOW '^L.. OSIMC BUTT ANALYSIS R£POKr>iO- M). 1608 R£STRICTED i v5) AITTHORS: J.R. Cojrt%, ' - ■ Cj< Mr*. A.K. Coa&s > ">>. DISTRIMTIO.^! ••. ^ Dr. S.J. Crcca Copy Mo. l-i Dr. I.W. Hughes n n ^ '^ Dr. R.A. S«nford " •« ia h • - t.M. Cibb, Esq. " " 12 - *^ R.S. W«<)«, Esq. » .. ij^ 14^ 15 'C. R.C. NiehoUs, Esq. " " jj^ j; H«rr E. Ritttrj'.uus " •• ij' Dr. F. S«ehoftr " "19 ~^/ _ Mr. A.J. Krusxynski " " 20 " ^ « Dr. C.J. P. d« Siqu«ir« " " 21 > C. Dr. O.C. FtUon " " 22 -^ ** '•i*"*ry " " 23, 24 COPT Nof£- It '*- rs> /. 362 Crogp t«(««rch I D«y«lop«Mac C«ncrt, lrleiih-A«tricu Tobacco Co. Le4., \- SOVTHAMTTOM. JRC/AXC/CAI./I4I .- ^th ^r*«S l»?«- V; ■ OF HUHAK SHOtCtWC tEHAVIOVI -v- VSIMG urn A-SALYStS (RepOi-c^. 10.1608 Kctcriccid) SUVMARY AM) COSCLUSIONS '/y .;BuCC «a«lytis of filter tips Kit b««Q.uie4 u • ooa-iavttiv* cechAi^uc to asscn. ch« tnokint behaviour of human tuQ;eo|^i Vy t(Ciaacia( cha delivary oP^icociae which cha/ obcaia fro« citd with chota datcrmioed fro* kachia«'*aoklas. It has been potiiola, {or^^ea paoalt of tubjacctt Co coaipara ^^ toolttat of cigaretctt of dtf fartaf^aicht and da*ita* and to coapara saokinf t* differaac external ••▼Icoaj&aACt. Theia f tudiaa, whi*^ Wva 9jp|o coaplatad by (roups of axpariMacars outside I.A.T, have shown ckat subj^^cs uaj aodify their saoking behaviour under a variacx of clrcuaatancM. Oaa^^soup of subjects was fouod Co saoke low aleotiae delivary cltarettas witV-f reater iacensity than aedita ■<< oicetiac dvlivsry ci|«recces during a mabar orpdiffcrent perCoraanee casks. In two studies subjects saoked "shorceaed" -citarettes but ia only one of these was there a tendency (or this aaalput^cion to affect nicocina delivery obtained by the subjects. There was soaa'^^dicaeioa * Chac saokin( behaviour aay differ between laboratory and work/no«a i( ... « •- conditions. — lO * 363 y. tfTBOtt K.D. UlVw» ^^^ Ditniigncn »r. (.i. CftM »r. t.«. »(tk«« »r. I. A. I4af*r4 I.M. CIM, U^. I.I. V(44. Ul. t.e. ■IctolU. IH- l«rr I. aUt«tiU«* »r. r. *.-«Ncf:f Hr. A.J. ftr««>/. -'^' <5^. ^>. \ BW-W2-1215C 364 V-4 ^^ CrM* U(««rck 4 BavaUyatat C«acr«, W-V, IriCltk^AMfieaa T»U**» Ca. Uf. >0 •OVnAMFTM. I»I7CAUJ«C^ v V lOtk J«a«. U7» hcnam wgA3UTio» Ajc flOfnntt or riooriia Amtocpo - y%Ta W«B •Cu4I*4 U M •> tUMt u tkrav U|kt aa tte aeltevlar ch«rtet«rl«tXc« Ma4«4 M ftMtt a alctclaa-lUa affact, tlkalt U tka r«ttrUtt4 atM* af U« •ftacc iff M^cla tlMaa. Tka vork 4aa«rtl^Tha raaalta Ma «smjlata«t »it», Ut U aat rr*»«. • »k«>a l^rfaifciiU ffO aieatUa «ul*t«a u •«( u M V ^(Mtlra aUl* far ateatlM tcia»^ A M« kU4 af alcatlM aaaUna la rt«»«i*4 aa tka W*l« af tka kgr*^^' U U »ror««*4 that tka mw aawU«gT80D FPU MICOTIWE AWP COTIKIWg •■:y . (y /^ 4 IN BU>OD AND URINE /• tt?ORT KO. RD. J737-C V . 21. S. 1980 ^O 0> ^. ^o. o ^. "^6, ^Q <>. -^v aifilBEvslopmttl % % SOUTHAMPTON ENGLAND BRITISH- AM ERtCAN TOBACCa COMPANY LIMITED Brown & Wini<»fn»oa '->^ c ..uN 2 5 1980 ^.^ » «r D LIBitAi;i ^>^ c 1 o o w This tarf^ttaal report s !)« ptcpenv of B(itsh-AmenanH«cco Company Umled.and must no( b( copied or jhoMm to PBu(*K>lnfla ^<>. Q.>- -^^ ':b % o. ISSUED lY; C.l. 4)Tm "^ ' rRoc. REf. ra.e7.000 V % '^^>. PISTRI»UTIOK: Dr. L.C.r. lltckaan Dr. I.U. Ilu|h«t Or. t.A. S«nfer4 R.H. Clbb, E«^. U.S. Vad«, Eaq. t.C. NlchoUt, E*^. R«rr E. Rlctcrihju* Dr. r. S«th«f«r Dr. C.J. P. d« Slquelr* Dr. D.C. Ftlto* library Co ■K .. ~s s «. 7. • ». 10 u 12 13 14 IS, 16 /- / "V cort no. c I c M I o o w w 367 CAJtyiOa/IU^«&D-2 21tc tUy 1990. Croup K«tetreh ( Davtlopacnt C«atr«, Brltl(h-A*«rle«a TebACce te. Ltd., SOUTHAMTTON. rtmioD rot micotime axp cotiwiwe in iux)d aw) unrnE — p- ^ '^.'^. (Xeporc Mo. W).1737-C) 5. xi ^^. t&D-LOJZ-ao e.4 -'' 7-^. An Imptovei ar.alyclcti Becho^hAS Veea developed for Che tlaltaneous 'fecasjreaenc of nlcocloe and codnlne,- it* ««Jor Betabollta In ■«■. In ■lci^kcts> Ac aethod couH facilitate tUfC4tvt].op%.eat of current Intereett In alcotlae, eotlnlnc and carbon aono^de la -t^atloa to dotlaetry and aaoke rccentloa U koth ' ^ • '^ ■ "• * anlaali aad la aan. ^. ■^^. e % Si. -'», c I o o 368 •a- IWTROOOCtlON Nica^M It aa •xtttmmlj bloloslejlly aetlv* coapouad c«p«bl« •( tlleltlnt^ n^tM of p)iir«««ologlc«l, blocb«alc«l aad ph]rslolotlc*l rccpoDCCS ^liyivo <1, 2, 9). tXirlnf •aoklnc It 1* rapidly and alaMt quantitativaly -^torb«4 bgr luns tltaut fro« tht partlculata phaac •( C' . whole clgarecc* %mb)t^ bcfer* cnterlni the blood ttreaa (4). /.■ In aonc Instancet,' the phar»acolo|lcal rctponsc of taokera Co alcotlnt It believed to be respoostbpe ior an lodlvldual't taokloi behavloor, providing Che aodvadoa for ao*^ clie degree of tadtfactloo required by ^'^ the tnoker (5, 6). '->.^ "^'^ There arc nunerout reporca la Che" I^teratura lndlcaclo| a dlrt ,' v ib« frln^iple blocbcalcal and phytlologlcal c^fi£ta^9^tly attrlbucabl* to nri^clM arc chan(ca In Kaeaodyntalct r^lacel4(c foKClon, vateular tone and her^ bloo^ presture chaoget, Increaaed cardiac Mtput . Incretted aecabollc rmcc.'^banget lo tbe whole body Intcr-rtlatloasuSk between lipid and glue«M m*t^^lltm. $o«* of thcta affcctt, not turprlalngly, have been la^llcaced^4.n the atlology of a nuabar of cardiac and vatcular dlteatea (7, g). ^ A large proportloe of th« blochcmlcal^nd phytlologlcal tffccu can be cither directly or ladlractly relatad to cK^a^et In the blood Ictclt of adrenalin (eplnephrlM) and ooradrenillo (nore^oephrlnc) follovlsg nicotine adalnistratloo (7, 8). The cbtnget In adrenil horaona le«- rtltMt of ttercd hooMM*. Ia4««4, Tlrtu«llr *^^ ^^ iJ> 'i^ •tltci$ of alcoClfH MA bt uUlMt«l7 r«l«C«d to the aeabrAo* tetlrt properties of '"^fe. Chit coopo MetuMll;'; j|«rln< aoj icodr of th« bloloflcal tffoet of olcotlat U It of p« r«iio«M^ la|»orC«oc* to «ccur«tcl]r attest the dote of alcotlec absorbed, lo pre^Uce this objective h«t beea difficult to tchleve. PrlMrlly because of i,£t aeabrase active properties, oicotlne It r%y\i\f lott froa the blood to otliikj; tlasuet. Average pUsu alcocine levcU In - swokers rarely Increase above-3J-50 m/al Irrespective of nicocloe ;l«ld -•f.^ of the cigarette or the frequency of tooklu^. To gala an Insight lato '■^^ ">). the netabolltn and hence the aetaboli^'^f fectt of nicotine in vivo ic It r<0^ssar]r to aonltor sequentially the 61>^d Icvcla of alcocine prior (o, durfftft^and after exposure. Thus plasma iM^lt of alcotloe aetakeUtes, Che ^t« oKli^earance of nicoelnc and aetabollt^^ tSt^lae aad hence tM t»te "^^learanee should be Matured. Addf^nalw, where the causal relattootht^ bftveen nicotine and Individual blochenlca^, physiological or ptychot^ical retpontet ar* to b« Invettigated, aeonte Infontatloa regarding iUcotuy dote It cttentlal. ^ If thete alas and obj«ctlvy> are to b« achieved, particularly asiag experimental anlmalt, it It SAcessa^to develop methods for taalyst^ numerous taall volume biological •aaplerfor nicotine aod its metabolites. Naturally the use of small voluae aaapZjM aecessttttes the use a( highly sensitive, reproducible and. If pottible^auantltatlve methods. Mo assays currently avallsble vere considered tultaMe to aeet these C c criteria. This report describes the developaeot of a aQlro-aethod for ^ measuring nicotine and cotlnioc levels. ^Q o 370 •^ /r MCWOt^ AHP HATtHIMJ NlcHlnt w«t lufr^i*^ ^T BDH with • •p«eifiH purity of 98X. T^« purity oP8Bk^a«ttrl«l vat ••••y«d by the •p«etrephoto*«trlc attb*4 of Wllllt* (43 a(4 t* 4«««rlb«4 In Appendix B. Coclolo« wa« obtained fro* C^ ■ Battel!* (FiSMfurt). Although no tpeclflc purity check wa« made, the ^^ Material chroaatojfr«ph«d aa a alntlc coaponcnt. *,4-blpyrldyl (99T pure), ~>> aodlua hydroxide (AAXaad aodlvn oxalate (AX) were all obtained tbrou|h BDH. "'*;.. V n-butyl acetate (A*), ctiU>j-ofor» (AX) and propan-2-ol (I?A; Ai) were ^'■. obtained froa BDII and redistilled before ose. Ucon HB 2000 and Chroaosorb wcrCaupplled by Chroaatography ■ X V> Supjirllct Ltd. A, Rn J} concentrate was aupplted by Cheat£4l Cooecatrate Ltd. ''^ Surety wai tupplled by Merck and pre pa red'^^tff^ ua( ky the pcoccdura - ^ o^ ^O^ X deacrl^4l() Ap^li B. 2) All gaata for ifiC «n«l;rsl* were tupplled by Air Products. Ca* Chroaatonr'apKlc Aftj^xtla A rackard *26 Mrtci g^ chroaatojrtph tqulpped with a tpeclflc nltrogen-photphorut detaetor (Hfo) was used for til nicotine and cottnln* •nalyaca. (^ The following colt«a and OC condltSoM were used for all routlae analyses: i> -^* Coluan; Class; 2a x 1.6 an l.d. coatalolng >J Ucon HB 20C0 plus 6Z /.- KOH on Chroaosorb AW, 80-100 aesh. The Ucon coluan yat prepared asd conditioned according to the aethod described In Appendix A. \ o o * 371 ■; y ^o. ■ /- ^ JO ficonn STTjDtES! A gcowD l^£^3^^T. O^ tCTPaiioM or wHou boot mcoriirt dose it ^JRimUtT KICOTIME AW) COTmtrt MEASUI>£HEKT -^ •• . . - C- RCTOtt WO. 1U).1792 USTHICnD 'J. R&D-L023 '.k-,..^ 31.3.1981 ■"/}' <. ^O, \ CrwK ^ anillleveloiimift ^ /C, SOUTHAMPTON ENGLAND \ BRITISH - AMERICAN TOaACC!a COMPANY LIMITEO <^,. l(fD LIBRAIY MAY 28 1981 BroAQ ^ Uiiuum»uii V- "/O ^^ / <>. ; I.C.H. ib^rso^ t.C. ChapdS^ CtOUP IXADEK: R. Blniu "'^. %. ISSUED It! C.I. kTT— Oy. % % <>/ DISTRIMJTIOW; Dr. L.C.r. Bl«ckAao Dr. I.W. Ilu«h«« Dr. R.A. $«n(ord R.M. Clbk, Etq. R.S. Wid«, Esq. R.C. NlchelU, E$q. H«rr E. Rlcc«rsh«u« Dr. P. $««hof«r Or. C.J. P. 4« Slqu«lr« Mr. W. ?«o Puctia R. Tudor, E*q. Dr. D.C. r«lCoa library 'cy. C 4) PROC. REP. 107, % Copy Ay4, 2 " "60 ,0, ll'' -V / ^^>. '•^V c I c o 19 COPY NO. 373 Croup t«ac«reh 4 0«v«lopa«sC Ctatra, lritl«b-AMrlC4a Tob4ce«. Co. U4., SOUTHAKPTOfl. CA>yia<^ 9thvj^th JU^T. lofti --o o-. V. •fe ^<^ % '/> '>. ^ 6>. G Q GERMANY U.S. AUSTRALIA U.K. CANADA O E. Koehn K. Wernlti T. »1«h1 A. MeHoun T. Hllson J. Brcnnin C.I. Ayrfs 6.0. Brooks ITL Library (4) -v o. % ^ ^ ^^i Q' '^. (9 <,, <^o. vv ^ Oi. ^^ ■^^ ^^A July 30, 1984 61. 375 LIST OF OeU^TeS ATTEHOIWS the 1984 SWOXIUS SEHAVIOUR/MARICETIWG CONFEtEMCE \LJL <~ ' Or. C.I. (Ian) Ay>4«_ - Research Manager. GR (, OC Graham Read -,^.^ - Group Leader. Smoker 9ehavlour. GR 4 X Rob Ferris '^^ - product Technology & Technical Services '-^ - Manager Psychology Group Geoff Brooks -> - Product Development and Karketlng flaiwilng Manager Raaii)urq Colin Pendry ~',-- Manager Market Research v<- Of^ Erhard Koehn - Manager of Product Oevelopment Or,;X)_lrk Pangrltr - Reseai^.SdentUt Werner. Huelmann - Manager Kethods Oevelopment - Market Rest^fch <_ narie: Kese^cn »*1n«r w^Tflltz - Manager Market.Nteseareh W.H. (BUI) Oel(<*n Smoking Behaviour C^ Karen Brecknock - Conference Secretary. ' ,• /- '>. S N 376 -M- ARIES: A CASE STUDY SHOWING THE INTERACTIONS BETWEEN PtyXKT 0ESI6N AND SWOKINS BEHAVIOUR /O T.r. RIEHL \ suwmRY >- ^ /^.oovel Cigarette mouthpiece was developed In response to a hypothesis that plaja end. or unflltered smoke representCthe ultimate smoking experience. TMs mouthpiece (coded ARIES) achieved tar reduction by ventilation alone and thus provWed unflltered smoke at low tar detlV^les. I ^- . i" Initial reactf»|»-of smokers to the ARIES product was favourable. However. upon sustalntd smoEtfig, ARIES was perceived as excessivi^ Irritating with a unique sensory -prof 1H1 ^^^ % ^O Limited smoking behaviour studies showed that consumers smoked AttTi5 differently compared t« conveK^nal cigarettes. Consumers smoked ARIES mort Intensely and were apparently unik^e to adjust to the novel product. Extensive sonkt chemical stud1*^d«Mn %. MORE INTENSE PUFFING ^. ARIES' SMOKE CHEMISTf^'DIFFERS" ^ STEEP DEL f^RY PROFILE NICOTINE ENR^CtjiMENT IN LATTER PUFFS LARGER SMOKE PAf^CLES \ ^ .-^ /r • /O - c --*, o 378 v: = -, -49- ■ >. HEW PRODUCT DEVELOPHEIIT Viiji. A.J. HELLMAN ^^i^ SUMMARY ^ An etamlndtlon of Marketlng/R ^0 coordtnatlon with examples featuring new y^ filter technology. "''^ ly- Marketing and R&D build product^ based on perceived consumer need, ^'^helr perspectives, however, alght %ffer an4 the problem, therefore Is ^ keep the courses parallel. t- \ %. II. e 4 W nana^ the process via regular reviews Vf6 t»r\^ Interface III. The process 1j vaH^^ed at every step, froa Initial d^lopmeat through final test marktt. (?> \ \ IV. Several examples irt pratetteo^ \> & % - % s 61 OB 379 \ -SO- > ■ \ V y DISCUSSION - ('♦VmUj taken by T. Riehl) To develop relent naw products. R & 0 and Marketing Initially proceed on separate pathways.^^ & t dtvelops new technology based on both perceived and Identified consuner n^s. Karketing, on the other hand, conducts appropriate market research to identl^ opftortunltles In the marketplace. When a potential opportunity Is Idelft^lfled, the required technology Is married to the product need. ^l- .. 9 C t C N I O IM t^ <« * 381 \ \ \ %^ 0-^ '-^ Vi ^-^ c '\ J 1 o '0? f>J ^ \ 382 /C> a K ^ 3 •^6. t- 3 ■>i^ 09 C ■I c N I o N 0> OBdttelle S*neOelnswuieV Frankiwt 383 ^fOxeJr ^^^% ^u Report Carcinogenicity of Smoke Condensate to Mouse Skin Experiment B1 OB C I c 09 384 Carcinogenicity of Smoke Condensate to Mouse Skin Experiment B1 Report for British-American Tobacco Company Ltd. England March 1973 frof«ct SoemHts Aitisunts L lUrbe )utu Kiendl C Konif smjnn H. Kramer W. ^T9^JU Inf eborf Schmidt Suiiltical Analyvs (Appendix) : E.B. Wiiket 385 Summary and Conclusion > 1) The prime aim of thH txper iment was to explore the effect o^ puff volume oo tSe tumonf enicity ol coo- denute from a sundard ofarene. 2) Three lime* per week from jSe ninth week o( IHe uniil death female ASl »Cl-ded treatment was 50 mg . Each experWncnui group orifi- naBjr induded 2S2 animah. 3) The f>umbef of tumour-bearing animab in the condemate- tTMted groups was 131 00 mJ). 170 (2S mi) and Kt (SO ml), seven of these m«ce exdusivYty showed tumours whkh regressed. The proportioo of artimab with perma- nent tumours rnferrt^ (o animab Mill alive at the end of experirr>enul week 20 Oust before the fint tumour occurrence) was practicany the same kn al three groups (72.9, 73-5; 74.2 percent) due »o *fl^ rent death rates. Higher lurrtortgefwary was recognised by earlier tp^mnct of tumourv Utcreasing puff volume reduced turrvxtgenicity from 10 ml via 2S mi to SO ml. The number of animab with malignant tumours was 92 no tr^. 115 (25 ml) »rxi 122 (SO m\\ Onreganjing the arMmab which died during the first 20 eiperi- mental weeks, the percenuges of arumals with malig- nancies were 52.0 (10 ml). S0.9 (2S ml) and 54J (SO ml). With this correspondence berweeo groups. the death rates after we«k 20 give *r\ indicaton of (he se<)uerKe of tumortgeoKity for tht condensates, whkh again demonstrates reduced carortogerMcity with inaeasing puff volume. 4) The rtumber of animab with permanent tumoon m the SO mg group (puff volume 35 ml) of Eiperimeni BO was 17i. Related to the number of anirrvils alrve at the 20th eipeenial week the inct^nce of tumour-beanr>g antmah was 73 9 percent, that of animals with malig- nar>oes S5 5 percem »vh»ch corresponds wuh ihe dau of condensate groups m this Experiment Judged from the ume the tumours occurred, the tumon|i«ntc effect was siifhily higher than would be expecieo from the resuhs of (hu Exper irr>ent assun-Mng rr>orK>tony-lype of respome with puff volume. 386 S) TV incklertcc of congested lung m 4 \e%ion »nd » oute ot death wm (unicubrfy freque«M in one |ro«p (10 rrJ) which K»d < hijh mop a tumour both within arid outs«de the pairMed area or on the irKidence 0/ non-turTX)urous lesiorv irtcrcasir^ with afe 0 For comparison with other experiments, additionai •wee of the tame type were treated with pure carano* |er« to esubiish reipomes to defined treatments. 7) Four calibration groups orif irvilly with 27 mice each were treated with the caror^of en in acetone on the iKived back during 13 or X weeks three times per week, ttartmf at the afe otf 9 weeks. The animak received a toul of OJt or \Sitngof JAbertao- Pr^tne or Ui,i-dibervLBnihraccne and were kept untreated until death occurred tponurteoui^ or was irtduccd in moriburvd arWnak. I) Wi the caBbratioo groups (he nymbcr of «iimab bear* inf tumours within the paiixed area was 2} ar^ 27 for *• titn beruopyrenc dosages artd IS and 23 for the two Aeruanthracenc dosac« grot^t. WScn dte Mnour regret. tions were exciuded the number of y^knak involved was 21 and 24 for the beruopyrene artd 12 and 21 for the tfberujnthracer^e groups; these resuNi ktdknt dose- ocpcrwcrtoe. TTte number of animals bearwg nfubgrwtf lumoun increased with the dosage wtd was 17 and 23 in the two bcnzopyrene groups. « artd 13 in the two dibena- artfhracer>e groups. f) A comparison of the results of the batch calibrttion groups between Ciperiments BO and II indicates great similarity for most eiperimenul groups; however, with regard to the 0.78 mg beruopyrerw group the number of aninuh with tumours eiduding rcgressioru increased from Upertment lO to SI from 14 10 21, the number of animals bearirtg malrxnani tumours from f to 17. The validity of companrtg the resufts of different experimenu remaim open to questM^n even ttwugh It was evident in most groups. 387 TO) from a »u«rsi>cal *fvi>yv» o/ tS« poo<«d resullJ oi the cjlibraioo groupt rt was coodud«d iKat the r«suhs of Eipenm«ni 81 couM vaiklly b« compared with tSoiC of SO. In order to compote rvimof»fe*^< ratio* for the corxJeniite* produced at diHefew puff voJumes ii was necessary to assurT>e that (he dote respoote reUt<>/»hip w\ tiperiment B1 wat paraM lo that of Expenrr^ent BO. 11) On the b*ws of the staiHtkal aruhrw) for ail tumoort »nd for matigrvani turrtours it it shown that the tumorTfentcrty of co- rkhmt of the puff voiumet over the range of puff volumct used. 09 c I c I o OB 388 .<', mSBHi^ > A- « • ■■',•. . «* ',• .I i V..!-,' ,,. . ,.V,V/'. i«r ; .• V tonj-t.r* Skla Palotlac •. ', •« • ; s,\ .; • J ',,», .;, .. : / VA .', - 1.- BATTELLE-INSTITUT FRANKFURT AM MAIN--1-: ;/: >/\H./ ■ ■ III ■ : • • ■ *- ' OD c I c M I o o Ul 389 Lonf'tara Skin Palntlnc Cxpcrimant Gaotrml Report on Projoct "JANUS" for Britiah-Aa«rlc«ji Tobacco Coapany Ltd. ■ngland JuBl 1970 Prejact Seiaatirta: Jntta Klandl 6. KSnlfaaano B. Kraaar CO c I c BATTCLLe-INSTITUTC. V. FRANKFURTAMMAIN f^ O o in 390 -2- I . Introduc tlon , . 1 . 1 "Janu»" Objectives and Team The General Report contain* all the inforvation that la generally applicable to all 'Janus B" long-term experi oients. Special details, which concern only specific "Janus 8" experlBcnts will be described in subsequent reports. In 1969, Battcllc-Instltut a.V., Frankfurt/Main, was requested to carry out lon(-terei skin palntlns expcriaents with solutions of tobacco-snoke condensate on nice. A duration of five year* was originally envisaged for the experlaents. Frosi literature It Is known that long-tera skin painting experi- ■ents have been carried out for some decades. Ever since It wa* possible to produce neoplasas on test aniaal* by the applica- tion of tobacco product* thla aethod was used la experisiental pathology to Investigate alao the carcinogenic effect of tobacco products. The project was aimed at first at testing and evaluating the ■carclnogeale action of cigarette saoke en aouse skla". The •xperlaeats were to be based on experlaeat* carried out by the Tobacco Research Council, Barrogata. England. la the course of year*, bowever, certain change* were aade, and the "Harrogate procedure" was aodlfled. To carry out the extenalra experlaental prograiaa, It «a* nece**ary to *et up an Independent working group and to erect a apeclal building. In 196$, the year of preparation, planning and trial runa for the long-tera experiments, the team Included four parsons: two scientist* (one chemist and one biologist) and temporarily two cheaical technicians. — (B C I C BATTen.e-INSTITUTe.V. .^RAUKFURTAMMAIN M I o o rs> 391 After having aovcd into th« new prcBlscs - four weeks before the first long-tera cxperiaents were started - the staff was gradually enlarged to include: a) 1 Project leader b) Aniaal husbandry 1 veterinary surgeon % aniaal keepers 1 cage washer e ) Condensate production and processing 1 biologist 2-3 cheaieal technicians 10-20 operators (woaen)*' 1 aechanic d) Docujientat ion 1-2 technicians 1-2 veterinary surgeons (of b and a) 1 biologist (of c) •) HistoleKT. pstholonr and ceding 1 veterinary surgeon i-K blotechnlcians f ) Laundry 1 woa g) Consultants (when required) 1 pathologlat 1 statistician *) The unqualified operators are part-time workers aostly working only a few hours, three tlaee a week; they have been trained frea the Battelle-Institut for the saoking procedure. OD C I BATTBLLt-INGTITUTE. V. FRANKFURTAMMAIN 5. I O o N IN* 392 to •) The project l«ad«r undertook orifinally •!! th« aupei-rlsloa and decision aakliis (stratecT-) concemlnc the project (iacludln( the plannlnc of prealsee). All experlBental reaults vare channelled ezclualvely to hla for Inspection aad statistical evaluation. Later on these actiTltles vera clearly divided into scientific and tachno-adminiatrat iva sectors. to b) In addition to the aniaal rooaa the vetarinar-jr aurgeon is also in charge of docuaentat ion. Hia responsibilitjr is to supervise the health of aen and aniaals and to send aonthly lists to the sponsor reporting on the aniaal stock. The aniaal keepers work ezcluslvslr in the field of 'aniaal husbandry". Th« cage washer washes only the cages af the aniaal rooaa where the aniaals are treated with tobacco-samka condensate . to c) The acabers of staff In this group aay also assist group b. The technicians aay be asked to keep the aniaals under observa- tiOD (weighing, tuaour search and inspection) and the woaea operators aay help in the painting procedure. This teaa carries out the docuaentat ioD of data concerning the saoke eandensatas used in the experiaents. to d) The technicians who are concerned with aniaal docuaentat ion, visit the aniaal rooa according to a fixed t iae table (weigh- ing, tuaour search and Inspaction) so that they are alao able to coapare the information on the punched carda with the real aituatioB. BATTELLC-INSTITUT C. V. -FRANKFURT AM MATIN CD c I c N I O O yi 393 -5- to •) Originally the veterinary Burgeon responsible for this area of work was also responsible for animal husbandry. However, in the long run, this involved excessive work for a single person. Therefore, the veterinary surgeons in groups b and s work in close cooperation. However, the final diagnosis is aade by the veterinary surgeon of group a. In April 1969, the project was aaalganiated into the Toxicology Division of the Biology Department. Thus, the overall responsi- bility for project "Janus" lies now with this division. 2. Janus Building Scope and problems involved In this long-tera project required the er.ectlon of a new building. Construction work began In August 1969 •»' tho nav building was opened to Project Janus In July 1966. This does oot mean that the building Is to be used exclusively for this project, but that It was primarily built for this purpose. Tba buildlBg hM» two floors and • flat roof, ^ring to the partic- ular ground configuration, It la poaslbla to ua* tha basement rooms aa stores and laboraterlaa. Tha layout plans shown In fig. 1 and 2 permit a clearer descrip- tion of the "clean" and "non-clean" areas, that la of the "closed system" and the "open system", respectively. 09 BATTCLLC-INSTITUTC. V. -FRArjKFURTAMMAIN , c ro I o o V f f 394 3 V \ I ^ BRITISH-AMERICAN TOBACCO CO. LTD. A_ajRVCT_OPJVEJW!US_M0USE REPORT NO: RD.773-R 7.i\.l9n. Research & Development Establishment Southampton ;^PR 2 3 1971 ..^'■^v '\ ■ fies.r ^^.^ ■^L -7 This confidential report is the property of British-American Tobacco Co, Ltd., and must not be copied or shown to unauthorised persons. CD c I c I o 395 A SURVEY OF THE JA^RJS hrOUSE SKIN-PAIMTDJG EXPERI.V3JTS REPORT NO: RD.773-R 7.'M971. AUTHOR: E.B. Wilkes ISSUED g: N.E. Wills PROJECT: 3500 DISTRIBUTION: Dr. S J. Green Dr. I w. Hughes Dr. R, A. San ford R.S. Wade, Esq. Manager, R. t D.D., Herr H. Sottorf. J.G. Burgan, Esq. Dr. D.C. Felton R. 4 D.E. Library R. 4 D.E. File No. Copy No. 1. 2. 3 4 5. 6 7. 8, 9 Australia 10. u 12. 13 14. 15, 16 17 18. 19 6D-2 20 COPY NO: ^ OB c I c M I O o 396 The key to understaivllng the reasons for s-ich things as the negative dose-respcmse relationship In the obsei-ved response rates In B6 Is to be found In Table 3 and Graph 3. where Is shc*fn plotted the number of animals dying before the appearance of the first tunour in each of the experiments. Now two distinct patterns of events can be seen. Experiments B2, BJ and B/i show little change in the number of deaths prior to first tumour as the dose level Increases; on the other hand in experiments BO, B6, and B7, the deaths Increase sharply with dose level. Comparison of Graphs 2 and 3 shows that It Is the experiDents m With this sharp increase of early deaths with dose rate (BO, B6, B?) which exhibit the most anomalous behaviour. This high initial mortality Is (usually) due to the toxicity of the codensate, and It has the effect of reducing the number of animals at risk of producing a tuoxjur; If the increase of death rate with dose level Is high enough, the number of animals producing tumours will decrease with dose level, rather than increase. This is whet happened in B6. Age standardisation is aimed at reaoving effects such as these, and generally speaking it does so quite well; the anomalous effects that remain in the standardised data arc not primariljr due to toxicity* effects. Cigarette smoke condensate does not produce instant tunours. The earliest tumours produced at Battelle have occurred about the 20th week of an experiment, and usually the time is about 28 to 32 weeks. Now consider BO. In the age standardised experiment 95$^^ of the animals survive to about the 28th week, so that even if every animal then became tumour bearing, th» standardised response rate would be 931^« In fact, the age stajxiardised BW-\i(2-01105 397 rate for BO (50 n«) is 805S, I.e. only 15% of tho animals escaped bcccalng tanourlng-bearlns during the remainder of xhe experiment. Ihls 15^ represents the majdnium amount by which any increase of the dose level above 50 ag no matter how great, can increase the steuTdardlsed response. It is no surprise that under these circumstances an increase to 75 mg can only produce a rise to 84Jb in the starriardlsed rate; this is about 25% of the maxlmuin possible increase. Oius it is unrealistic to hope that when the 50 mg dose is producing a 7O-8056 response, the 75 mg dose will produce an effect that is proportionally greater. To do so in BO, for example, the standardised response at 75 mg would have to be 9-• ^^ o 398 .18- APPENDIX A short description of the cigarettes used in Experiments BO to B? Is as follows: BO Plue-cured blerri (CNIOC), lamina only. B2 "Typical" U.S. K.S.P.T. cigarette. B3 PCL, based on CN1C2 lamina and Canadian stem hinder. B'+ Flue-cured la/nina (CN102) and Canadicin Stem (as CRS), in equal portions. B6 Yeast treated flue-cured lamina (CN102), ctrar.d widths m 30, 60 and i20 c.p.l. 37 Flue-cured lamina (CN102) control for B6; strand widths 30, 60 and 120 c.p.l. KO groups are control groups of mice which are not treated. KLm groups ^re control groups of mice which are treated with solvent only. OB C c M I o O 399 :19- TftBLE 1 Standardised values Dose Levels BO 25 50 75 J»7.7 79.9 83.8 B2 :j?.6 76.0 79.6 B5 16.9 54.9 65.2 B^ 51.1 68.2 75.8 b6 59.1 81.2 80,7 E7 62.2 81*. 9 83.7 TABLE 2 Observed values Dose Levels BO 25 50 75 ^i.:> 64.5 47.9 B2 33. <» 68.9 69.8 B3 17.3 55.4 67.8 Bh 28.U 62.5 65.9 B6 57.8 43.1 21*. 3 B7 56.2 57.9 43.8 C I c M 400 PRIVATE & CONriPt,fmALT "jJ?W^%ts«y*-: i (i^V ft i - !^^\ :>«ti' RESEARCH CONTERE NCE ii^,\i^^^'^'k>-*^'^ '^^ '^ 5 ■?*-►.■ -i;?^*-/ HELD AT ICBONBERG l^i^^^- 2nd - 6th TUNE. 1969. '"?«" Pr€sem*"> ■'srj'. Green (CI (Chair sir Charles ElUs- » ' '" V r: ^^ .r!./^^' .R. b. Gnif ith -r '. ; ; ■ ip: ■i'ii.' -^S:' V *?^?^ ■V; ^ J C^i'^J^#""- '^- A.,Sanford H. Sottorf R. "S. Wade , .. ., -^ , - , . - ^ V : r^jr. '.-'X-'r ' -f f . t . 'AV, : . ':-..,•' TT • • MINUTES In response to several requests It was decided to JS» ••'•>. % ';■'■ expand the minutes somewhat for this Conference, but each mernber*'" agreed to be responsible for presenting a fall story to his Company'* 1. .>;;;;}vfi • -i' > 0 ^.•;:^ -i •inanagement If this !s required. ^.•.': .. v c.-- ■ -i**..-^..^ «y.^.-\ACJi.-_- The Coticluslons of the previous Conference were revlewod.' '''^j- ~.~ >•'■ '''■■ It was'suggested that the the U.K. representatives should emphasise V, ''^V: at the T.S.C. 'SWn-Palntlng Conference" their Interest In the,~^,_" •%. ' /,'.. T4A29 comparisonr This appears to be a significant alteration In '-'•"' ''*i^. ^' mouse-sVln bloassay reaction brought about by an alteration in' 'i-^^' i-'.^*^ tobacco composition. 1' T. R. C. are hampered In following this up by^^' j^'.' -^t? Vthe practical difficulties of specifying the actual composltlons'of i* v''.i-'''rr"r ". T4 and T29. The Coi^erence agreed to Invite T.S.C. to communicate '•"■.'7.'^ /i' .'their findings to Dr. GtlffUh of the University of Kentucky, explaining lA-ry^S^. ,', why they could not follow them up and hoping that the Unlvers Kentucky would use the wide range of tobaccos at their dlsposa known genetic origin, to Investigate how great a variation In "mouse- \ skin reaction" could occur within a conventional classification, e.fl. ..' Virginian flue-cured, Burley, Oriental, etc. Following a discussion "/ of the differences In the bloassay results on T.R.C. samples T4 '\- and T29, Dr. Hughes agreed to produce a paper on the laboratory '" tests which could be made to Investigate this. ■''•.' '^■^. \ '■ :' . . ?iv '.-.-V"^' - '. ^ .•;;.. ?,>;.■ -.:.•'. ■ ^': vsV;>»--'- ■ • ;■" rractlonatTori experiments at Harrogate. The Conference devoted some time to considering the value of this line of research. They .(K took note of the T.S.C. paper E 1628, which attempted to s«t out • \ ll*^ p the objectives. The general opinion was that this work should be , •* ^J continued In the hope that It would be possible to Identify specific - "^ inlUators and promoters. ■- '- • •:;--•;•-' .-.f:-'^ -:'f f--'^':'> r Ity of ■• i. "'.':., A >* al, of ^''^^S:i:^ - .'V -s.- i Lv I^^^.VVjs — .J^'has'been Studied Intenslvelyand there Is a body of expert opinion "*'--'*?r'5'.>i§: ■ V?-. '.•^"x.:'' ■■-" which considers' that It Is possible that It may correlate closely jj;^- ^•'^';*^'^' "*,'. "' "^•'".%^'^_^;*;'wlth Idhger-lerm'carclnogenlc effects. The majority of the other •■ "'. i!'-*/^ JT ,.- :*t" • - ■;^"^ inariy blologYcal reactions that have been studied seem more "^ " • ^''\ '-^ -. '■.■>*---• -^ related to Immediate toxic effects than anything else. The '">=■• '^''''.'■^ '_^.',_: ,,_;':.■•' Conference took note with interest of B. A. T. (Hamburg) experiments '•./,•. "I' • . . .,_.-'-■. ■^'. and also of T.R.C.'s collaboration with Professor Latner on studying ^- .; 'T: i- * feefi-- -i-dX" the relative amount of. Lactic Acid Dehydrogenase Isoenzymes.^ ■-!_ , .«^ ■; : -^v ■■■= •»''C*-''«.^-'^-s -^»>■-'--i•'>^ * "^ • -■ ■-■■'.\-- - : ■' -v'- ■ - ■' r . . ■ In an attempt to take a broad view of this complicated situation, :.'.■ ■.•',■• the Conference reached the following conclusions: . . '. . ^^ •. '-'.'■< (a) ■ ' In the foreseeable future, say five years, mouse-skin painting would remain as the ultimate court of appeal on ' ' carcinogenic effects.""; - .' " ' '' t' '.'- • ' 401 There was a possibility that short-term cellular phenomena - ' such as hyperplasia, sebaceous gland suppression, alteration ■. i •._. '-.t^,^ in cell metabolism, reaction of chicken embryo membrane, "r-"'. '••';*: "might develop sufficient credibility to lighten the burden of .i'- -f. ■;*' ' '^xf^T'.l'* mouse-skin work by screening.' ^'•>.'-:-»-*-"/^-;' -;■••--- '. \' ■^ *■. 'i!-'*^.W'?-iJ^i <,!;■> '*K ■-' - ■ ! - ' - -• •-■'.-■ "^.'t:^- .-."■^; ' : l•^ .' '" ' .'•.■ t. ■•-'. "V' ''.(c) '-'However the pr'eceedlng decision developed. It was '.'~: .' . '{■ ■■«;'?;, •''^.' already clear that techniques such as hyperplasia, . ■,'• "^ .-|.j. ■ /•• observation of goblet cell activity, and anything that ■. **.i'.' -•' could be directly related to changes In cell behaviourism * :'■■.•'-'■: merited Intensive study In their own right. The Immediate ' -' J."."",' V •.*- ictlon agreed was: J. •-,"'/ ^'v" .:.•''■" 1- '1/ -f :t:.'.,j^^:^-^^'-'^'>r'^u:''-^- .-r-' :.*"-. ^v-v-. '-• - - ■• -,. •• . . -u- ^' -•. J-i'-S"-"-'- W .•' To accept and use hyperplasia as an empirical ■-.".. - -■ '. 'r.t>''^,i^i'-{', ■;■/;• - .- grading system of tobacco smoke under the proviso . '<"■ ':'■'■.:. ■^; J ■/'■'■-•'-:*»; -." '■ that this Interpretation of the results was the ' ^x•^-• ^ 'r^'-i.'.}-^ •>}''•''!''.''' ■ responsibility of the user, ."ii;: -.;• • f ' .-..■;■.. :■'■ :-^ ,;%'<^3Hfv i^-i-'A... / ■ •■-'•.■. ' '-"-ri- i:- ■ '.. ■■■■ . ' . ; . ■ _' .-^A . - .(11) To support research Into the meaning and ". '<:••''?/ T"v/-.' -' Interpretation at the cellular level of the various .^ -".V --.^-j'" "•■'•'.,".".7 short-term tests. ..•' ' "T -^ V . ; ""^ •'^ 11.'^^ .Dr. Green stated that hyperplasia tests could be made available to ' ,j >.'-:,.'•. V-' members for about $ 1,000 per test. Dr. Griffith and Herr Sottorf ^ 'j ■ Z. • ' * felt that greater sensitivity might be required beforo adopting this c >-,%.-•■■;■■' test rouflTiely but Dr. Fordyce was of the opinion that attempts at J5 ' " '.-.--..' further refinement would be a waste of time. It was agreed, however, ^ t -■i- ■■•:-". that, with a test of this nature. It would be wise to take samples - ■ 'J'- '■. with maximum differences in order to establish the trend Jlkcly vj ^^ »■ : to be found with commercial samples rather than submit proposed " .;■ •■'■"'"'' and cuaent brands. ;.' " '■- S^^2i2^^i^g>^ 402 PROJECT JAVUS ANNUAL REPORT 197O-71 l^t. 10.71 CONFIDENTIAL IV) I o o M 403 BRITISH-AMERICAN TOBACCO COMPANY LTD. PROJECT JANUS ANNUAL REPORT 1970-71 li*. 10.71 AUTHOR; S.R. Evelyn DISTRIBUTION; A.D. McCormick, Esq. Copy No. 1 Sir Charles Ellis (1 n 2 Dr. S.J. Greon iii(* holli rk in-p.< in V. in,-; .nti'l inli.i la tion lochniquos. It is aniicipa toil that tlie proinotioij test BW-W2-00228 405 406 THE sn;oking ^G/HEA LTH COiNTROVERSY: y. A VIEW FROM •T^if; OTHER SIDE 'V, o. ~/ 'o % N ^o. O^esented to: COLHIER -JOURNAL-'A.XD LOUISVILLE TIMES By BHyn & Williamson Tobacco Corporation Dat«: Fefif^^y 8. 1971 -/^ '-> Every s'atement in this presentation is fulW documented and the source and authority can be supplied upon request. r ''> c o /O 407 % ■ LUNG CANCERr'xThe •Utistical basis for this claim arises, ^ in large part, from two report<^ observations: first, an increase in ciga- '>ette consumption and an increase'tf) lung cancer through the years; and, secbnd, a greater Incidence of lung cane^r among smokers than among non- - C '^ »moker<^vi ->- ■ /^ ^ <^^ L^us make one point clear: we are not {rying to discredit the use of statistical ana^sis in medical research. When p/^i^r\y used, the technicae can be mostlMlsful t^ndicating certain relationships anA-\;»^so<^tiBf trends, ^•^ %. o' *- . and thus can play an impoMant role in the development of hyp<^eses. Like other research techniques, h^l^ver, the use of statistics has its limitattoits. One of these is, as the 1984 Surge^oGeneral's Report pointed out, the fact .; that "Statistical methods cannot cstabRs^ proof of a causal relationship in an association. " ^<>„ ^-/ There are numerous examples In the History of science where it *. >> was erroneously believed that one factor caused a dfit^ase because of a statis- tical association between the two. For example, because'of a statistical asso- ■'/■ ^ elation, it was once thought that malaria was caused by ''nigh<'air, " because people who contracted malaria had been exposed to the night air. ^fiswever,- 9 C further research proved that it was a microbe carried by mosquitoes which w o caused the malaria. In certain areas people believed pellagra was caused *" by eating corn, because fhose people who contracted pellagra had eaten a 408 2 - \x lot of corn. It was ||1jkf learned, of course, that pellagra was caused by a vitamin deficiency^ aWlh^ reason people got pellagra was that they were not eating other foods^il^ch voold have supplied essential vitamin require- ^O ' ■ ments. *-'-V If cigarette smoking^s.to be co/ivicted of causing lung cancer, a lot of questions must first be answered. These include the following as examples: ' ^'.. -.1. Why is it that the vast majority jb/ cigarette smokers don't get - j^ lung cancer^ ^ In recSflthearings before a Congressional G^rimlttee, Dr. Duane Carr, Professor «f SoMery, University of Tennessee Col^je of Medicine, \ ' . ^C O > and former presicJenl of tlr^^Southcrn Thoracic Surgical AssocraKon, ipoke %. ^ on this subject as follows: v]^ It ' ^ If only smokers ^evelopt^ lung cancer — which is not true— and if there ^t;* 70 m<^ion smokers — which is a Si pretty good estimate— then tHi^_p[ung cancer deaths reported in a given year would p^present about one case for each 1,400 smokers. I bebeve that figure is far higher. I think it is a typog^ap^ical error. If we consider only lung cancer specifier's originating In the lung the figure would be about one-ojft of every 3, 500 smokers. Such an incidence Is Incort^Galible with the theory that cigarette smoking causea^-^ncer. " The point here is not to minirr.ize the problem of WJg cancer or its importance as a medical problem. Certainly, it is a terrible' 4*:Sease but the hypothesis concerning cigarette smoking and lung cancer Is indeed difficult to accept when relatively few of the very, very many people who Smoke are stricVcr. with the disease. a c ^s ■ s o 409 - 3 - V .'•■ 2. If (rtprettes caug* lung cancer, why is it reportgd that 10 to ease 20?« of lung cancer ttpcors in non-smokera'> Why should they get the dls at all? This casts -^oth«r doubt on the claim that cigarettes cause lung \ cancer. ^c:^ 3. If a smoker geU lung cancer, why is it that the number of years he has smoked or the number of-"ci^ar«ttes he smokes a day seems to have so Dttle bearing on whether he gets it earlier or later in life? Light smokers, heavy smokers and even non-smokers — if ^^y are going to get lung cancer- tend to g4v it at about the same age. If cigarfir^es wer« the cause, surely J the smoker Wjji} started young and has been a heavy sipolcer for many years should be affecteit>Qpner than the non-smoker. c^^ 4. 'Also, g^jnedian age of lung cancer incidence >^ reported to be advancing. People seem f^ave taken up smoking at earlier ag€« over tt>e last 30 years. Yet the mediah'S^e at death from lung cancer for white males '^ in 1949 was reported to be age 61 aif^n 196S the median age had increased '^. to nearly age 65. If cigarette smoking eM^es lung cancer, should not the median age have decreased? "V-. 5. Men get lung cancer more often thair^women. The paradox here concerns the ratio. In 1950, the ratio of lung cancer -to, men as compared to women was 4.7-1. That is, men were reported to get luri^cancer almost 5 times more often than women. In 1965, that ratio had widened to 6. 1-1; ? 6 times more often in men than in women. This happened even thougr^the '^ proportion of women to men smoking had increased steadily for years. If o cigarettes cause lung cancer, then one would expect this ratio to narrow no: 410 widen. It is the r*»€rse of what one would expect. I 6: Anoth JiJ^r r»a r f»asoD to question the anti- cigarette theory is that the incidence of lung ca)>^er •bows little correspopdepce to cigarette consumptlop on a geographical basigi<->The »ccompanying chart (Fig. 1), based on ooe from the 1964 Surgeon General's t>port on smoking and health, shows the per capita consumption of cigarettes in IsMaod the death rate from lung cancer io 1950 'la various countries. The reason srooljing rates in 1930 are compared with lung cancer rates in 1950 is that the Surgeon GeneraJ's Advisory Committee in its l964 Report assumed a 20-year induction period for the appearance of V "'"• V lung cancer. Q /^ K» you"^*! see. Great Britain and the Dnitecf^tei h»ve rather high levels of>fr capt^ cigarette consumption. But look at<1^e Ab)^ cancer in these countries. The LTOted States, which has the higher raw of smoldsg. also has the lower rate of lung'^ncer. Great BriUio. with a lower smokinj rate than the U. S. , has almost t»i: ;i'"-: ■ jrx . r..: .:■ *;•■ ;■>,.•■, I^O ISO % < . e:;.T f-iiVM.*) UMIffi-.O \1 L-b V."- J (»»■.•■• a ^a. * ;.-;' r?/ J.o ^. 412 N= mlttee did. or one rfl5 or 30 years, as others have suggested, the reported rate of Incidence oj^u^R^cer does not coincide with cigarette sales. Has there r$#Uy Vxa any substantial increase in lung cancer? During the 196y,pb;ig'f«sSional hearings on cigarette labeling and advertising, a number of me^a^ authorities questioned that there has been ^»n actual increase. Dr. Milton Ro^oblatt, who is the President of the Medical Board, Doctors Hospital, in Ne»-york. said this before Congress: - *~ ' ' '^. In 1900, the combined crude deaOy^ate for respiratory 'Jliseases in the United States exceedejj^450 per 100, 000 bui,.there were no death rates recordetMor lung cancer. If Ofify a small percentage of the deaths a<«-ibuted to taberl^osis, pneumonia, bronchitis or Inftuenza bad be«n Incc^ectly diagnosed and were, in acti^ihiy. cases of l^fife cancer there would be relatively lOtle incressc ln"5^ prevalence of this disease during (^V '^V^ past haU csntu^r*' ^/V Then he goes on to say: '.c ^stics are based on death . certificates and nSk oo auf«^y findings. . . A recent Nfe 10-year study of cases dlagngfejid primary lung cancer on the death certificates reveif^d that in almost 60% of the cases autopsied, the origiftj^l clinical diagnosis of lung cancer had been incorrect. V, So Dr. Rosenblatt Is on record as sayi>>»<" lung cancer may have been "under"-diagnosed years ago and may be "over' ■'^gnosed today. "'^ Another medical doctor who testified before Congress was Dr. Thomas H. Brem, who Is Chairman of the Department of Medicljw at the c University of Southern California School of Medicine. Dr. BreroalCedis- ? ^ o V u cussed improved medical care and diagnostic techniques as the principal % o factors in the reported increase of lung cancer. He said this to Congress; 413 "ThQ^i that the rate - In addition, there is the Tj^pry that reported associations between smoking and disease may be rooted in Oie genetic or constitutional make-up of indfi^dyals. 'cv. ^* '. ' X l^rge and growing body of researchladicates personality, emotions. genetics, md sry^g. o^ l^f^ influence not only the healtX4xperlence of people but Both British afijjAmerican studies suggest that lung'^cer victims have a distinct personality ty^iljiextro verted, and characterized by a special also whether or not tltev become smokers. ^Q psychological pattern which can b^^ughly described as "poor outlet for emotional discharge"). Although mucrrfeore research remains to be done, it may very well be that smoking and lung caacer art associated in lung cancer victims with certain psychological and physiological fact^s which include the true source of the disease. ^ p EXPERIMENTAL WORK '''^'^ Much of the experimental work involves mouse -paintmg or animal / • * smoke inhalation experiments. In mouse -painting, smoke condensa(«r are c ■* . o painted or dropped on the backs of mice, and cancerous skin tumors have been w produced in this manner. 414 Howtytr, these cofxjgnsa'.es are artificially produced under laboratory copditions and, a» ao^. have little, if any, relation to cigarette smoke as it reaches the smoker. ^Bfelfer, the results obtained on the skin of mice should not be extrapolated \<0^i ^^P% tissue of the mouse, or to any other animal species. Certainly such'^^n re^uUs should not be extrapolated to the human lung. ^- ^ For many years various 4vbstanc*s in cigarette smoke or in ciga- '' - ' '/ ^ rette smoke condensates have been reporUed by some to be responsible for disease in smokers. One example is ben2o(aJj3yrene, which is a carcinogen; that is, a sobstance which has caused cancer in Animals under experimental conditiona. Tn Wyndfir, well known for his mouse-painting experi- ments. has repeatedly linked benzq-. ^^ However, io 1966, the siniificaKe of benzo(a)pyrene in animal tumor production was seriously questione^l. Irr October 1969. Dr. E. Cuyler *^ Hammond, a Vice President of the American Cance^^ociety, announced that after an extensive survey involving roof workers who nec9$.sarily must inhale large amounts of benzo(a)pyrene in their work, he had concl.j<^d that the t substance may have to be ruled out as a cause of lung cancer. C < Another area of experirr.entation is smoke inhalation. Animal '^ — —r o smoke inhalation experirr.ents have been conducted for well over 30 years. 3 415 with unifonair regative results. The nbnurtond-Auerbaob study of smoking dogs, notwithstanding, we feel that this st^l^Svit is still valid. In fact we believe its validity is. if anything, reinforcw.by ih» pecubar circumstances surrounding the Hammond- Auerbach work and its {^licatioB. Last February, n^ou will recall, the American Cancer Society held a news conference in New %s>t\. to announce: "For the first time scientl3ts ^ve produced lung cancer in a significa^ntly large animal as a result of heavr cig4Jr€tte smoking. " ACS added that the Tifj^ings "should have a significant imf>act on -the smoking of cigarettes in this ccKit)try. and will probably lead to a reassessment of advertising claims and policiess^y the cigarette indusirr. " Sbortly^hereafler and three times subsequeTiJ^ the Tobacco Institute asked the American Q^o^^t Society to make all materials irui^flatt from the study available for ev&luafcw by a group of independent experty^ith the understanding the Tobacco Insfi^te would pay the costs involved. On each occasion this request was r«fua«d. ^ r V' ^^ Then last summer, as I am stipe you remember, the Journal of the American Medical Association, acting on thfr^ecommendation of 18 independent authorities, decided not to publish the Hammona-Auerbach work, subject to major revision. The main reason reported for this dfe^sion was the poor ' r- quality of the slides submitted by Dr. Auerbach to substarrHate his claims. One cannot help but wo-.der why a scientist of Dr. Au^rbach's vear-s and experience, attempting to advance a controversial claim In one ^f>the m:st c prestigious medical journals in the world, did not submit his finest slirfes aad u microscopic materials with his work initially. 416 - 9 - One" •14*1 o'^o^ ^^P wondering why he made no attempt to satisfy JA-MA's objections tejtfa* study. Instead, late last fall he submitted his work with an entirely new set^nkdes. which by the way are quite excellent, to an entirely different and nui^ lft«* well-known publication. Archives of Envlron- mental Health, of which incl8bx>tal3* he happens to be a member of the editorial ^6 board. Archives published the «r&rl^ list month with no fanfare whatsoever. In fact, we no longer hear,much about scientists claiming to have caused lung cancer in large experimental'^imals "as a result of heavy ' / / cigaretiertrpokLng, " or much talk about the "si^ificant impact" such findings should have."^ Instead, what we have now is Dr. Ksmmond'e statement; "In our opinioo, you eaiwot prove that cancer is caused in 6jjtman beings by pro- ducing cancer in dogr-ift,any case, or mice, or ar,y other aTCinal, and this was not our purpose la thewsjcxperiments. " O^ In bringing this ma'(ifcr to your attention it has not been our intention to put down animal smoke inhilation^^periments. However, we feel that for ssch experiments to be truly meaningfbl they Ouist be designed using animal models ' ■'^ and conditions that closely resemble human ^;Boki.ng. and the results of such ->. experirr.ents must be subjected to careful scientific scrutiny m order to determine their true significance. ^ It seems to us that any well conceived hypotheQs should satisfactonlv account for all pertinent known facts. The h\-pot:-.e;!£ that cigarettes cause ■ a lung car.cer simply does not meet this criterion. .\5 we have seen.^^^r* ^r* * ^^ f quite a few observations involving cancer and cigarettes which the statistical i "< - o evidence for the anti-cigarette theory fails to explain. With regard to the vo 417 Xs-- - 10 - experimental ev^e^e for the theory, it is doubtful that any findings reported so far have aoy valid Afglication to the human situation. Taking aUOhe «b6ve into consideration, we believe there is sound % X ': evidence to conclude tlm£,the" atatemcnt "cigarettes cause cancer" is not a statement of fact but merely-^ji hjrpotfaesis. ^erely^j r>_ C Q-v ■■<: r. '-^'y %. '/t- a c >A c -'.-^ s o o ^e U1 418 11 HEART PI gBBt£. Nov. let's take a look at the cUim that ciga- rette smoking caus«f^;^art disease. You have heard this claim on TV. It is usually the implicatiorv'tp statements issued by the American Heart Asso- -6, ciation. Yet consider the foKoyirg statements from outspoken cigarette .critics: ^'j- . Dr. Lewis E. January appelr4»d before Congress in 1969 on behalf of the American Heart Association, ^which be is a former preside:- Asked whetlrer smoking had been established as4.cau8e of heart disease, he replied, "We gynot think- -we knov that an absolute-Vausal efleet has not been established. ^Ojl ^O ^r M? O ^>. Answers in t«f:.3ame vem were given by former Si«ceon Geoerai of ihe United States. Dr. Wfo^m H. Stewart, when questioned in another Congressional hearing. Bsr« ar^/^is replies: ". . .we have never said ca^^ and effect to the initiation of cardiovascular disease. neveTi55>"ce since 1955 when the reports started. . . I do not ttoinR^jne can make the statement that the scientific evidence support- it. We never have. " One of the problems that Congress enAijntered in considering < claims about smoking and heart disease was the sugg^fi^ed influence of factors other than smoking. Such factors include occupation, exrfeise. high blooi pressure, above normal blood levels of cholesterol, uric acioand sugar, <^ = w "excessive" use of coffee, personality, race, age, sex. weight, diet^ stress. C e.^vironment. and genetic make-up. 2 o 419 \. .^ - 12 V In the regw^ of the Congressional hearings there are quite a few scientific witnesscs^hol^bstimony questioned the charge that smoking causes heart disease. V5 ^c '■■ ^ One of them is D£/Jii\nt Cedorlof, of the National Institute of Public Health in Sweden. Profe^^r Cederlof has done extensive research using twins to study health problemSV'-As we mentioned previously, one prcbiem in determining the cause of hcartf disease is the many factors Involved^ Py using twins, one of -.vhom smok%> and the other does not. Professor Ceierlof can control such factors as rrrt,^ag«, sex and, more importantly, genk^(tc make-up. In recent years, he harfe«moloy«J this ■? \' technique to s^udy hea^and other diseases from the standf^pl ofJh«ir relationship to Smoking. K^has conducted studies in Sweden injjjlvinf 20,000 t'.vins and just recently Aijiplcted a study of 14,744 tv.ins in the ioll^e 0 U.S. . working in conjunctioH^|th tfvi?>.'ational Institute of Health and the \, American Medical Association.^ *"?^ In his statement to Congress. Dr.^-Cederlof said that his vork with non-smoking and smoking twins indicated thaV-the association between smoking and some symptoms of heart disease may be -jtajtrely statistical and not causal. He also observed— and this is extremely l«J»j;resting — that in a study of 3, 656 pairs of identical twins no "higher mcrt^lity among C ■ * the smoking twins" was found. '^/^ " ^ Scientists have reviewed t.vin studies and regard them hlg.'.ly.'T Dr. Joshua Burn, who is the former Head of the Department of Pharmacology, Oxford University. England, in discussing tv-in studies. 420 13 • S4id this in hi9 «tetement to a Concessional Committee: "These i^tfi^Us a/ford no support whatever to the view ^^^lfl|K>g causes increased coronary heart diseas^ThlObrtradict it. " They contr^^t! Afsin we have a situation where the testimony of experts prominent in the^^ field by virtue of achievement and long experience >" disputes the conclusions advanc^ by the U.S. Public Health Service. Again ' -ve have a situation where the hypotlvesis will cot accommodate all the facts, wh»r-e the case against cigarettes has bee;^ pverstated and conflicting evidexe ignorea.;^ -^r D^ Carl Seltzer, of the Harvard School^ Public Health, and also a consultant to t^ .^urgeon General's Advisory Commt^e in 1B64, said this about heart ^e»6e W-i 969: r\ \: It will be regi^able, if the impact of the prestige^ of the U.S. Publi^«ealth Service led scientists and the public to bebev^^^ and accept as firmly established facts which, oothe ba^|^ of current knowledge, are speculative and Ticking Ipc^cientific validity. The situation demands not spe^lki pleading but scientific truth, namely, what is reaswC'fcbly established. And, certainly, it has not been reasoMbly established that cigarette smoking causes corona£j»~^eart disease." % y \ OB c c <>. ' 15 1 o M w o IS 421 14 - EMPHYSEMA. qft,tertlnK>ny before Congress in 1965, the then U. S. Surgeon General told C^n^ss that in 1964 his Advisory Committee ijad determined "that a relationshifi'«jcista between pulmonary emphysema '. • . ahij cigarettes but it has not been establ/jhed that this relationship is causal.^ He further affirmed that "We hav&^ot been able to establish /^ an absolute "^use and effect between smoking afid-emphyaema. " And iSjb. President of the National Tubercutosis and Respiratorv Disease Assoclatiorf^ld Congress in 1969 that the cause'i'f emphysema is "unknown." \ Op <^/^ Although the Pubht-_^ealth Service has maintained that cases of /^ emphysema have climbed dramafb^Uy in the last 10 years, many medical - authorities in the 1969 Congressional nj^arings questioned whether the reported rise had in fact taken place. ^ As physician after physician explaineqpto Congress, the diagno£"ls of emphysema is a very difficult one to make corre^y. They said the reason ^^ is that the symptoms of the disease — coughing, shortnesS,of breath, diffirjlty .<- getting started in the m.orning, ar.d early fatigue in the evening— arc also ire c \/^ c symptoms of asthma, asthmatic bronchitis, chronic bronchitis, aijd^ variety "i* ".^ ««» of other diseases. '~V S w Other witnesses before Congress had revealing remarks to ma'-:» about emphysema. Dr. Edwin Levine. Professor of Clinical Medicine, Cr.icago 422 - 15 - Medical School awQ^pecialist in diseases of the chcsl since 1931, said: • I* is "iRni^H^fect to say that any attempt to determine causal relalionaip fVIncidence, occurrence, or death rate of emphysem Is based 4^r (\g»ms so inaccurate that even the trend is im- possible to »^ure. Consequently, when the question Is raised whether any prr^cultf ificnl may be responsible for an increase in emphysema onjn deaths attributable to emphysema. It must be answered by sa^fnA that there is no way of determining how many of these cases^iCre truly emphysema. It Is not possible to y say, on the available esj^nce, whether there is an Increase in ";_ either incidence or death fV^fii this disease. " - ^- It would thus appear that there u reason to Question not only the --, University (i^Manitoba. told Congress: "V There is no evident of which I am aware that constituents of cigarette smoke ha^pthe capacity to produce dissolution . . of lung tissue (err\^jrscm^." "V*- rie went on: '//i "Most authorities agree that eniph^ema presents a complex problem which awaits a scientific e.ifelanalion. " EXPERIMENTAL EVIDENCE? "^^ J ^ What about experimental evidence, which again derives from anir.al testing' Some scientists have reportedly succeeded in Inducing emphysem* gi "->.■ *■ experimentally In some animals. However, horses and cattle are tt^.only g . , <;' o Known animals besides man which spontaneously develop and suffer from this ^ o d;sease. This is interesting, because medical authorities say that th^ hors* 423 - 16 V. is the only anim^ i^se lung is similar to that of mar.. It was found that by reducing the bloodncto to the lungs, emphysema could be produced in the borse. This exp^LmteCal result in the horse was achieved by introducing small beads into the artecifs Qiat feed the animal's lungs. In a statement befifr,* Coofress relating to these erperiments, Dr. Levine said: s the "Morbidity Report." "^. The material for the stjdy cajj*e from a survey conducted by the Public-^alth Service involving 42. 000 famrtV«3. A member of each family, providing he^A^as 19 years of age or older, was t^Jjeyied as to his own smoking habits and heaulT-'coDditlon and those of others in theijDusehoId, The questions dealt mainly ^tb srrUldng habits, past diseases, amd dayiW dmDl^ity. Data from the study were useclljo produce a number of statements ^Ich hav* been reproduced and widely publiciied in anti-smoking pamphlets to suggest certain conclusions. Here are some «f 1X92^ conclusions: >^ • It is said that because of cigfJ^ttes there are 77, 000, 000 work days lost. -^--^ % • Cigarettes are responsible for 88. OD0.lere drawn. The Council for Tobacc^llesearch-U. S. A. requested Wasfitr^ton University to undertake an «naiysra)«f the study. The university consealkd wjfio so and it was agreed that Us findings would be made public and furnished* 1e the U. S. Public Health Service -ftLthie same time they were released to the Council for Tobacco Research. The^^fter Dr. Theodor Sterling, mathematicT%ji and head of computer science at Washington University, obtained the raw da'a from the Public Health Service and proceeded^Q evaluate the study and its conclusions. Another examination of the study wa»^erformed by Dr. John % Sawyer, Professor of Mathematics at Wake Forest Um^rsity. Both were highly critical in their judgment oi" the survey. '/ 0. Here Is Dr. Sterling's evaluation of the so-called "Mo^idity c ^^ • ? Report. " '7-r> •V "The report on cigarette smoking and health characteristics is based on most uncertain and inaccurate data, it is based on very inadequate analytic procedures, and it lacks con- \ viction that it really demonstrates any difference between smokers and non-smokers." V u o 426 '^•. - 19 - Here is ^f^^Dr. Sawyer had to say. 'In short^heSirbidtty Report was based upon a survey loosely corlttpctisij ««d interpreted so as to be wholly misleading 3(^urlr« liable. " Oj • .-» ■- Dr. Sawyer then^nt on to take the U.S. Public Health Service -^ severely to task for Issuing "a c^iense^ propaganda pamphlet entitled C. 'A^oking and Illness, '" and stated, *^ " '• , "... the further use and comprMjion of the Morbidity "Tr Report in this pamphlet (Smoking"and Illness) can only " ^be regarded as a dangerous and n-.t^ieadtixg deterrent ■£b further scientific study. " Dr. -^rllng appeared before Congress to^stify concerning '''^ .. ^% his critique of the "iftorbidity Report. " In his testimonJCUie described th« major faults ho fouiVQj^ith the survey. ^^ ■tr'-A First, the samplC'W^en by the survey was nonrandorr and not representative of the United States- non-inslitutionalired. civilian populatioiy M»st of the information on m>le» wayjpjbtained not from the males involved *v, but from someone else, secondhand. Coraider who is usually at home during normal working hours, when the survey was rS^e: housewives, children, retired or unemployed persons, the elderly, the H^nd temporar-.ly or \ permanently disabled people. As a result, informationVas taken directly frem or.lv 40'"; of the males, altliough 0 3T» of t;-e females wfre personally I f interviewed. N'ojie of the data carr.e from doctors of the respor^«flts. c This brings us to the second fault Dr. Sterling found withtH^ '-V Survey: namclv, that the method of counting diseases and Jisab:Httes o o ^es^Jltc:^ in large errors. N'o attempt was rrsdc in the sarvev '.s check diseases or disabilities with rr.edical records. .^ number of s-.ji;es have 427 shown that even it contains many i medical informatio is roughly double. 20 edical information is supplied by patients themselves es. Other studies have demonstrated that when from "proxy" interviews the rate of error Let us look at an e'^mjile supplied by Or. Sawyer of how the ififormation on smoking habits was^^jrganlzed in the report: - y "Consider a fifty year old m^r^'who smoked for one year '^l^ only while in college, but, durfla^ a part of that time, '"■y smoked in excess of one pack per ^^ ■ This was 31 •'^ears ago. He has not smoked sinCelhat time. How- ey^r, he v/as classified in the stiiay as A former heavy smcXer because the study did not distingi>^h between longtime exposure to smoke and casual elH&sur«. It contained absolutely no information about W^l ex- posure. O^ "^O V "Further, assd^e that this man, classified as s form«r heavy smoker, rS^tiirc from work last year after being scalded whcrfi-. safety valve fell from a radiator, allowing steam to escape. Tliis unrelated event would have (-loss days Smoked' n tfi^t^-40 cigarettes per day category. He would have beerf-4 statistic io Table 22. page 52, of the Report. In effect^/by the implied interpre- tation of this table, his injury, due36,a wholly unrelated mechanical accident, would be attribiiii^d to his smoking 31 years earlier! " "" X^ allowing steam to escaoc. Iius unreiatca event wc shown up in Mor^^fiU fc^port statistics as work-io by a person in the*4Bb64 argt bracket under 'Ever S and 'Former Smoked' In t«^^ -40 cigarettes per Not surprisingly, perhaos. the third fault fo(o>d with the "Morbidity Report" was that the data supplied in it did not bear out the jrublicizco conci-slons. / In this connection, Dr. Sterling ooinied out that the daieioc v/omen. 33To O! which was based on self-responses comoared tc only 40% for^^an, sho.ved that "female nor-5mokcrs often had more disease than female smokers. " This is tho ocnosite of what the renort clairr.s. 8W-W2-03105 428 - 21 Sterling said, the dau ui the report reveal that 'moderate smokers vll^^^en reported the least amount of disease. .. " Finally, a/^ysiVSf report statistics demonstrated that "former smokers consistently repwMed ^« highest rate of diseases and disabilities. " cy In this regard. Dr. 9terlfaig observed: "One of the major clairiviHhat smoking is a hazard to health is based on the argument t&^t stopping results in an apparent •'-^ increase in life expectancy. ^ Yet, t^ one finding consistent - -, for all sexes, categories of dijeafes, aod types of disabilities ' •- of the National Health Survey wa»l)iat to stop smoking was "^--associated with an increasing inciaence of illness. What Uftdmgs are we to credit'" "^^ Accojpling to Dr. Sterling, none. Here is')jt« conclusion: ^c -;a •J^ "If any l^»^n is to be learned from this issue/:^ is not that smoktag ca^^AS untold diseases and disabilities "aCRd loss from work,^ bbt thit^laims about such controversial topi<^>need te^ be very carvfulQ-and intelligently reviewed even if tJi^ are mads by p^Ue agv^ies or by other impeccable sourcev. Such claims lead to i6 429 ^ 22 - ■ N X OTHER ANTl-CIGAilETTE CLAIMS Let's \^ no doubt you are familiar, was'^vestigated by Congress during the 1969 -■Oiearings. In the course of that investigation. Congressman Richardson Prej'er, of North Carolina, had this to Siy; ~ r- r _ '-^/."This statement is based on a stat?«^al study by Dr. E. -Cpyler Hammond who has refused io-disclo»e the raw data (jvitis studies so as to p>€rnnit independeViVeviluation. " Bere ($« have a claim said to be a fact, baS4$il on information said to be a fact,*(|^XBD a ^entist who will not reveal how he ^9^s K.^ ^ *■ fact. . '^ X5 The "statistic*! stii^" to which Congressman Preyer referred is an extensive mortality Sto^y b^g^i* years ago by Dr. Hammond for the ^ American Cancer Society. As doubt leit^^^ou are aware, the Surgeon General's 1964 Report incorporated many of the (indmbs from this study. In view of .'a the magnitude of the controversy touched otf by ^bat report, and the pitch of intensity the dispute has since attained, it la imp>^^ble to understand this seeming reluctance on the part of Dr. Hammond to submit the raw data to open, impartial analysis. ^ ^ 5 6- c In any event, this work of Hammond's is nothing more ttfeg a ' ** ■ r m athematical calculation, and anv causal interpretation of it is subjected o 430 - 23 - ^. to the same'^Tticisms mentioned before. Also, the work is still subject to the criticisms t}Nilp|ve been leveled at it by such eminent statisticians as Dr. Leo Katz, Prof^J^ of Statistics, Michigan State University. Dr. Katz^^searM <^ing the 1969 Congressional hearings on cigarette advertising ajxf^poke'aj follows with regard to the figures on which 6, this claim is based: . y "A statement which has'.kecoroe a catchword ('the life expectancy for a tAvo-pack a day, or i*\Qjre, smoker at age 25 is 8. 3 years '. -^ less than that for the correffpocding nonsmoker. ') for broadcaste.'s "vC- IS the one on page 9 of the 1 96^^upplement, relating to estimates '~^-. of life expectancy by Hammond. :The figures he rer>orts are /^ unadjusted for physical, psychological, or genetic differences. "The implication is extremely strongr' 3a table S on page 10 and iir-"• Indeed, "m Or.'«tz went on to say, a study of Hamfrrond's flfbres suggests It is as conceivable Hr»t smoking may be merely a symptom of whatever the factors are 'imX C«use/<,^horter life span as it is that smoking ^6^f Is the cause. V/^ He concluded: Vy ■K "Actually, the suggestion is stroog thu. xather than the other way about, it is true that whatever causBi-Jhe life expectancy difference also leads to taking up of smoki/r^s psychological rebef. " -j^ % '' 300,000 Excess Deaihs Caused by Smoking"--This is a figure ^ (g. _ c that has been bandied around for quite some time. It has been featui^d in |^ % o news stories, used extensively in speeches, and even reprinted In scientific w o articles; vet the figure has no tisis in fact. How it came into existence is a fascir.ating story: 431 - 24 - In Janu»rr,: 1965, Emerson Foote, a former advertising executive. attacked cigarettes as^Blsing 12S.000 to 300. 000 deaths a year. He was at the time Chairmarfirthe ffational Interagency Council on Smoking and Health. G^ ■' 6. . .^ Soon a government -effvcial. Dr. Daniel Horn, Wrt ggjing In a speech that smoking was responsiM© for at least 125.000 ^5»#t»iTe deaths •5 '9 . ■ - * " a year. His source, he said, was the ^>\airinao of the Council. % "'■^ Mr Foote was asked In a hearing before the U.S. Congress, where he gothisfiMres. His reply: From the goveri^nt! 8o th<(jball was shot back to Dr. Horn, wtejhen OMUited up 138,000 '^"' o '"''^ "^ " dcaths-33, 5^ froM^^yng cancer, $0. 000 from coronary3isea»», 16, 500 from bronchitis and c'rnUiyse/!ia. and e.OOO from cancer of the oraC)fiavt^; esophagus. larynx and bladder. 'C^ .<■. To achieve thic^toire.Caf . Horn had arbitrarily included several ^ \ diseases which were not-claimed evertT^ the Surgeon General's Advisory Committee Report to be causally related fp-^moking. lAter^ the then 0. S. Surgeon Genec^ Dr. Luthlr Terry, under- took to explain tJTe 300, 0« Hfw-e. He did th4•J>y<^^ ' " " ^ - 1, Taking as his basis the unsupported esfpi^iwtlon of 138,000 deaths. -^•:, 9 - - ^, • ^ 2. Adding to it another unsupported 102,000 jdei^Pfcr \>, rS "from diseases where the relationship to cigarette ^ smoking, while not so obvious, is nevertheless clearly indicated. " o 432 - - 25 - 3. > AAd-Lng to this another unsupported but "reasonable estimaW'^Af 60, 000 excess deaths for women, who had c6in^< not bec6 in7Bin smoker. Blackening of lungs is from carbon particles, al^j^to^olung tobacco does not introduce carbon - particle S/Oto^M lung. " The whole que^i^n wa tumined up well by Dr. Irving Zeidman. "O Professor of Pathology at the"JJaiver8lty of Pennsylvania, when he was /■_. asked in Congress whether it was pSssible to tell which of two lungs was the lung of a smoker. He said: ~ ---. "I would estimate that of a thousMd pathologists in this country .^ J98 would say. 'I could not tell, ' afii* the other two would say, 'I 'cou)d tell, ' and those two who could teC^either bad some divine int. "V ^>, V,, 5, 9 434 - 27 V TUg iJEgP FOR FURTHER RESEARCH "o^ ■ It Is not llkaK that thg cause or cure of cancer, heart disease, and emphysema will be fouSJ through fear and Ignorance. Only by sclen- tific study and dedicated researfrf) arc these obiectlvea likely to be achieved. a'^ It Is through such efforts. ttjat progresj continues to b« made to- ward this goal. And progress is beJng'qjade. Results are especially cn- /. couragfng. In the field of cancer research. -^:.. Of^April 27. 1970. The Wall Street Jou)»(ial reported that researchers have found new «rjdence linking viruses with human'^ncer. According to the Journal.' l\ Is ncni^nown that viruses cause cancer Ih^nlm^ of almost every species. One of tn^^^lruses associated with human caWwr, the paper noted, is the EB virus, whlcl^as been linked to a cancer-like lung disorder called sarcoid. ^ The tobacco industry has piQed a leading role In tobacco/health research. *.';, V, In a roundlable discussion publlshed'^vember 17, 1969, in The Wall Street Transcript, Robert N. Stanton. Senior-^Pbacco Analyst for Dean Witter i Co. , made the following comments about resc^ch efforts In this area: ''' y II T' * There was about $14-$15 million spent for research-last year, 1 O • * and of that amount, close to $9 million was spent by the industry, aivs-out g of that S9 million. S4 rr.iUion v.as in unrestricted funds. In other words. ** 435 28 \ the money was gnwftut by the Council for Tobacco Research, and by the AMA through the Mu^pbnal Research Foundation, and no direction was A, dictated for the expcTtSHtu''* P' 'his money. " Oo It Is our opini(^andlh*t of many reputable scientists as well that the repeated assertion vfKhont conclusive proof that cigarettes cause ^0JECT tHEAT "/^ rs • BAClCCROnOT) ry The Croup R. t D. Cestre have be««; givet the objective ,v«f deslgalag cigarettes of Increased acceptability. While r^^lslag that nany lotaiitlble features ofjl^e product, sud^as brand name. Image and advertising, bav^- aii ljq>ortant lDfl^«earcb is rer^ulred Into the effect of var^s *■ clgareft* design^^eatures on consumer acceptance. In obVXi)tfs problem b«r« Is tl^ fonsuner tastes differ so widelf. eve*^ la the sane country ,,^Mlclng it necessary to Identify groups of consumers vltk 4ifrey}ng requireaeats. In recent yean t Buab^^^f authorities, «ho have Independently considered the /M^or* which motivate people to smoke, have broadly afxeod ttli^^he reasons for smoking are by no means the same for all saokers. and they have indicated which motivational tactors^dpear to be laportant for different groups of people. McKenneU, In particular, baa grouped people according to tbosoeds >rt>lch are satisfied by saoklng, and for a sample of O.K. sale sn)<1te^rs has given an idea of the relative sizes of clusters so del^iyed. UcKenneirit seven clusters are numbered la sscea^log order of the "Inner need" dimension. This "Inner need**" dimension measures the extent to which smokers use cigarettes In order to help them concentrate, to relieve nervousness, anxiety or boredom, to help them relax, as a substitute tor / c I c I o o< 09 438 eatlDf s«eeO^ ets. ; It ls,-coatruted vlth the "(ocial dlawDsloD" vhL^h iseLSur** the extent to vblcb cigarettes are SBolced in ordoc to eontorm with others la a group, to give BooetblDg to dtf with tb« bands when la coaipaiiy, etc. Theoretical considerations suggest that the product characteristics which a CQiisumer considers to be optlmuai would differ' widely between clusters. ?or lostaacc the "Inner need" dimension correljit«s with the extent of Inhalation, with the craving fdr cigarettes when these are not available, and with the difficolty wblch consumers anticipate in giving up smoking. \M a first approximat ion , therefore, one night postulate that smoker's la Clusters 1-3 tequire a low nicotine delivery, those is Clusters 4-6 a BCdluB nicotine delivery, and those in Clus'ter 7 a fairly higVaicotine deliverv. One aight further afpfr«ulat« that la th^ Jk^gber clusters the requireinent for olcotl^ coal4 b* ao gr«iU_that subtle nuances of saokc flavour ''^Icbt b* coaparatlvrlj^un import ant provided there were ao obje^ilonabl* characteristics such as a blgb level of irritation. ^'^^J flavour Might be'^st important ainong tbose wfao like to relax over a clg*reit.e, as in Cluster 3, or tbose who smoke aa a substit«t« lor food, as lo Cluster 3. V' % Based on these e«osla«f«tlons, the objective of the study Is to segment Q.K. conCMi^rs according to the needs satisfied by smoking, wsLiig Mcaunell's technique, aad to explore the requirements of thes^^gmeats for various product attributes so that the opt 1^(6, conbinatioa of attributes for each segment caa be dete'rvlaed. '' /\ It may be that no clear dlstlactlon M^Mcea the preferences of the various clusters will eaer^^ la which case this particular approach will be abaatened.'-^. If , oa the other hand, the experiment reveals an obvious lUkd logical relationship between the clusters and the pret«rred cigarette attributes, with wide differences betveea the / c I c . N I o <^ oa 439 - 3 . cigarettes •ftiroc;RAIOC FOR PRETTRENCE TESTING o (1) Project TOKAT •^ Tbe first exBArlBeafy^ode-naaed WHEAT, alns to test the hypothesis that }tieX»KL*Ti^ "Inner need" dlnenslon is correlated with the prefMxed ~»(eotine level. HcKeanell's questionnaire will be submitted, li^ a Market Research Agency, to a sample of O.K. male saokars. 'After completing McKennell's factor and cluster analysis," samples of four experimental cigarettes, with nicotine deliveries of approximately 2-0. 1-4. 0-9 and 0-6bc, will be presented to smokers la each of tbe clusters and tbelr order of preference determined. (See the Agency's propo«als for as outline of tbe placement design.) (2) Subsequent Experlirents Subsequent experiments will depend on the outcome of CD c I o ui 440 - 4 Project WHIAT, *a4 for thla reason tbey ctooot be specified 6o precisely. The JollCTrtnf are two possible lines. Assuming that a correlation Is found between preferred nicotine level and "Inner ft«ed" , It would be valuable to know to what extent the craving for nicotine overrides other considerations. Smokers in "high need" clusters who have chosen the highest nicotine cigarette as first preference should be asked to choose between this sane cigarette, modified to give it an unusual flavour, and a cigarette of hSwer nicotine delivery but unmodified it flavour. As a comparison, smokers in one of the "low need" cluster* who havk cbosen the O'Smg cigarette as first preference •hould b* asN< to choose between this same cigarette with oiodifltd flavour, am the O-fiog cigarette unmodified in fla«^^. Tb* hypothesis IrtM Id be that the "high need" caoker woutdTcrcfar to stick with tl^s high nicotine cigarette in spite of i^' noticeable flavo<^. change, whereas the "low need" smoker^^ would prefer to sv{tS AND THEIR CEKEPJkL SMOKING HADITS REPORT NO. Rr.l229-R 10.7.1975 / ■^r.' ^C '<:>> -r. ISSUED BY; C.l. kfcti/ AUTHORS : D.J. Wood ', E.B. Wilkes / r. PReJtCT JOa HO. 191 ^O X. DISTRIBUTION: ■^ < '/ Dr. S.J. Green , Copy No • I. 2. 3. 4. 5. 6 Dr. I.W. Hughes H II 7 Dr. R.A. Sanford If ft «. 9 R.M. Gibb, Esq. n M 10 ' R.S. Wade, Esq. m M U» 12, 13. R.G. Nicholls, Esq. II n 14, .15 Herr H. Sottorf n If '16 -y ^ Dr. F. Seehofer •1 17 CD A.J, Kruszynski, Esq. M 18 - C 1 Dr. C.J. P. de Sii queira II 19 c f>0 Dr. D.G. Felton II 20 1 o Library II 21, 22 **■ File No. 46D-6 II 23 COPT NO. \ a 443 Croup Research & Development Centre, British-Aaerican Tobacco Co. Ltd., SOUTHAMPTON. DJV/EBW/RA/46D-6 10th July, 1975 ^-^ PHOJDGT WHEAT - PACT 1 ClbSTER PgQFILES OF U.K. HALE SMOKERS AND THEU GENERAL SMOKIHG HA3ITS Okport Ho. RD.1229-R) A survey has been conducted in the U.K. aooog soiae 1500 male smokers of filtet-tipped cigarettes. The survey was based on HcKennell's questionnaire, which relates to the occasions when people saoke and the factors which inb^vate thea to smoke. Some additional question* were asked in order to give information about the concern felt^iry smokers for the possible health risks of smoking. The purpose of the survey w»a to classify smokers iato a titi^b^r of categories showing distinct pattenu A, of motivation, and different levels of so-called Inner Need, ac a first / step towards testing the hypothesis that a smoker's Inner Need level • is related to his preferred nicotine delivery. This hypothesis, in turn, is seen as part of a general approach Co the ^roblea of designing cigarettes of increased consumer acceptance. -v 09 C I - - c The answers to the survey questionnaire were submitted to factor i analysis. As a result, 9 out of McKennell's 10 factors emerged and g these included all the factors which he regarded as isportant}'* further 3 factors eaerged which were not observed by McKeaaell. Cluster analysis 444 -2- vas pcrforacd is order co cUtsLfy smokers iato groups with different patcems of necivacioo. Twelve clusters were identified, as coopared with 7 clustery ia MctCeonell's study. These 12 clusters were well spread A, aloog the loner )U«d dijEensioa and also along the Social dimension. In keeping with McKesnell, tb« Inner Need score was found to be positively related to cigarette consvunpcion, depth of inhalation and anticipated difficulty in giving up STuoking; it was also related to the extent to which smokers supplement their regular brand by smoking plain cigarettes and hand-rolled cigarettes. Inner Need showed no relationship with the nicotine delivery of the filter-tipped brand usually smoked, but this could Ve for reasons of brand loyalty coupled with the rather lioiited choice of o|.cotine deliveries currently offered hy filter-tipped brands in the O.K. . ~>^ The degree of ^oncem for health differed considerably between clusters, but was not delated to the level of Inner Need. Concern for health evidently influenced the brand choice of many different types of /- ^( smoker, particularly in the difftction of trying low tar brands. However in many cases their concern for health seemed to conflict with their desire for a satisfying cigarette. The marked differences between the 12 clusters which have emerged as a result of this survey, particularly in terms of Inner Need score, , suggest that the clusters should form a fim basis for testing the hypothesis that Inner Need is related to preferred nicotine delivery. The testing of this hypothesis, which involves obtaining the reactions of 11 out of the 12 clusters to a range of experimental cigarettes. CO c vn forms Part 2 of the present study and will be separately reported. oo 00 445 -3- INTRODUCTIOII One of tHa aain research objectives of Group R. A D. Centre is Co put B-A.T. in^4 position to design cigarettes of increased consuaer ^■. . acceptance. Thi« objective is confined to a consideration of product •'^ . -»- features, and the way these influence the consumer. Those factors which' may be termed the "imagery", including brand name, pack design, advertising etc., although obviously of friae inportance in marketing terms, fall outside the scope of Croup R. & 0. Centre. Even with this restriction the objective is still a very broad one, *nd leaves room for a number of different approaches. The particular approach to be discussed in the present report aims to produce certain basic Information, generated as a resulc of research among O.K. smokers, which can be of general utility in a vatiety of markets. C^ In considering which product features are important in terms of consumer acceptance, Coe nicotine delivery is one of the more obvious candidates. Others include ^ he taste and flavour characteristics of the smoke, physical features suCb as draw resistance and rate of bum, and the general uniformity of the product, to name but a few. The .importance of nicotine hardly needs to be stressed, as it is so widely recognised. Among numerous pieces of evidence may be mentioned an exercise conducted some years ago by the IcipeiLal Tobacco Company. As a result of extensive testing among U.K. stackers they concluded that the optimum nicotine delivery for the market was around 1.4 mg per cigarette, and that stepwise reductions in delivery caused progressive rejection by consumers (1). Since the above research was completed thef» has been i a general decrease in the tar and nicotine deliveries of D.K. brands, q *^ yi 00 RR^fi'i ac 446 -♦- includins tb« product! of Cb« ImpcrLal Tobacco Coopanj. The aarkeC leaders currenCly give nlcocine dellverie* o£ 1.2-1.3 ng, aivd chert Is s diversity of brcod* delivering less than 1 ag (2, 3). Siailar reductions in delivery hav«^eea evident in other countries, notably in the O.S.A. and Germany; in fade one of tbe^striking features of the German market ha« been the groving popularity of "low nicotine" brands. When attemptiog to understand the reason foe theso trends, one is left wondering whether the present-day smoker actually prefers the saoking characteristics associated with reduced deliveries or whether he has been influenced by his concern for the possible health risks of sanking and by the inplication, or even the direct allegation, that cigarettes with reduced deliveries are safer. One also wonders whether Che apparent attraction of reduced deliveries is true for all smokers or whether it is confined to specific segmeats. ^r\ L* These questions coctceming preferred nicotine level seemed so fuodaneatal chac Ic was decided Co Cry and answer Chea first, by direct consumer Cescing, beforo proeeeduxg Co consider ocher feacures of che cigarette. The argument here was that, unless the consumer was being offered approximately the right nicotiti^ level, it would be difficult to draw valid conclusions froa tests designed to explore his reaction to different taste characteristics, different degrees of draw resistance, and so on. Raving decided to investigate consumers' nicotine preferences in '' OB the first instance, and allowing for the possibility that dLfferent c '-• - c categories of smoker might prefer different levels of nlcotlo^, ,tbe ** ■• findings of McKennell (4, S) seemed particularly relevant. In bl*l«f , tji o 447 -5- McKsonell eo&ducced • survey among O.K. snokera, and on Che basis of ' their answers to a quescioonaire he classified thea inCo groups vich distincC patterns of sacking aocivation. Soae of the notivating factors, auch »k smoking JU> relieve stress, or sacking to aid concentration, appeared to represent vhat Hc<:ennell termed the "inner need" to sooke, and he was able to derivo a score along this dimension for each group of smokers. In a similar way he vas able to derive a second score along a social dimension which contrasted vitb the inner need dimension in that it represented the tendency to smoke in various social situations. He alsa demonstrated positive relationships between the inner need score on the one hand and the daily cigarette consumption, the depth of intaalatioft >nd the anticipated difficulty in giving up sacking on the other. O^ ^'^ The last-mencioned findings suggested to us that t»^ inner need dimension was probably. jdefiaing a requirement for nicotine.^'' The hypothesis was formulated that groups of smokers with a high inner need score would prefer relatively high nicotin^ cigarettes and would reject low nicotine cigarettes, whereas groups with a loy inner need score would probably find low nicotine cigarettes quit* acceptable and might well prefer them to those of relatively high nicotine delivery. It was realised, however, that these patterns of preference could easily^ be obscured when smoking branded products because of the influence of bran^ loyalty, image, published smoke deliveries, etc., and that to reveal tham would necessitate conducting consumer tests with unbranded cigarettes la plain j>acks. 1;; CO Accordingly it was decided to administer McKennell's quescionnaire to a i - . M saople of U.K. male smokers, to repeat his factor and cluster analysis ^ 448 •asigniag A^ch respoodenc to « eluacer, and tbca Co cest che hypochesia coaceming ch« rclacioashlp becveen loner need and preferred aicocine delivery. In addition it vaa decided to aak certain auppleaaatary questlona aliaed at exploring reapondenta* concern for Che health rlaka of saioking, becauac of the poaalbility chat thia mighc influence their brand choice and mighc Isdicat* a. need for apecific health reassurance featurea in product design. The project aa outlined above was given the code naae WHEAT; and if Chla project established a logical connection between Che needs of the sooker and hia preferred nicotine level further Investigations were envisaged to encocopass otber inportant. product features, vich che ulcimace aia of achieving a favourable combinacioa of accribuces co euic the needa of different ve^oenta. It vaa believed that cbe principlea eatablisbed by thia approach lo Che O.K. would apply, broadly, in other'piarketa. {_l Project VHEAT it>eing reported in two parta. Part t, the preaent report, covers che adainiscracioo of che McKennell quescionnaire co a r sample of U.K. siaokera, Caclfetir analyaia and cluscer analysis based on cheir answers, decaila of cbeir general sacking habics including che brands which chey currencly aaoka, and informacion abouc cheir concern for healch. Pare 2 will cover their reae'ciona co a range of cesc cigareccea offering differing nicocina levels* METHODS ~ ■ ''■;. I. The Survey ' " ( England, Crosse and Associacea Led. were cotomiasioned by Market ^ S£S«:arch Dept., Killbank, to handle this investigacion. They 'ia Cum i5 o employed a compucer bureau, Cybemecics Research Consulcanta. ~ vo 449 -7- Tba turvey vat conducced aaong male snokcrt oaly is order Co ac)uc«« cooqxrability vlch McKeonell't lecond study (5) vhlch was based on « sample of 2,000 aal* smokers. A further restriction was that the prodocC most often snoK«4 shoold be a filter-tipped cigarette, since in the ^/ subsequent productrC^stlng •tag'i respondents were to be asked to smoke, ' and state their preferaoce for, « range of filter-tipped cigarettes. A sample of 1523 male smokers of tipped cigarettes were interviewed using quota sampling methods vitb controls in terms of four age groupings (16-24, 25-34, 35-59, 60*) and four social class groupings (AB, CI, C2, DE). The quota control information was drawn from a Tobacco Research Council publication (6). Details of the saocle required to meet these quota controls and the sample actually obtained ^re shovn in Appendix I i > - > (page 40). l^ftrvieving was spread throughout the country using 100 sampling points, «^t each of 50 locations; these locaCicins are representative in terms of population^ and were selected by random methods'*- the full list of sampling locations is shown in Appendix II (page 41). Incervievs took place in the home* of ret<>ondents and were concentrated on evenings and weekends. The questionnaire used in the survey is shown in full in Appendix III (page 42). Questions 1-8 cover basic smoVisg information, including the number of tipped cigarettes smoked per day, oC,fu:r tobacco products smoked, the brand smoked most often, other'brands'^^moked occasicnally, the depth of inhalation, etc. Questions 9-20 are HcKetmell's 42 variables, and it is the answers to these which formed the basis of the factor *- oo analysis and cluster analysis. Questions 21-24 relate to the ^fficulty ^ ' • ■ . .. • ^- "J" in giving up smoking. > o •— • u> so 450 -8- 2. Factor AnalytU The nethod of deriving feccors vaa hy roc«ciag a telected number o£ principal coapoacntt uaing the well-known VArimax criteria, and thea obtaining an obliqua tolution b«sed upon the Variaax loading* uaing the y , Promax method (7). McKeimell'r anAljraia was based upon factors obtained by Variaax rotation; tb« Proaax method has the ability to define more specific factors (i.e. the varLsnce of the factor loadings is increased) but the factors so obtained are obllqua. This means that the scores obtained on any one Promax factor may be correlated to some extent with the scores on other factors. A range o£ factor solutions iron 2 factors CO \M factors was obtained; by visual inspection the one which aost closely matched HcKensell's 10 factors was the L2-f actor solution, and this was carried forward to the next stage of cluster analysis. 3. Cluster Analysis (_/^ A general description of the cluster analysis is givea in Appendix IV (page 54). The method used gave all 12 factors resulting from the r factor analysis an equal opp6^Cunity of contributing to the cluster / solution, and took into account tbe loadings of all kl variables on each of the 12 factors. This represents' a deliberate departure from the method adopted by McKennell (6) who only, carried forward 8 of his 10 factors to the clustering stage and ignored all factor loadings apart from those shown in Table 1. Tbe total sadt>le w»a randomly divided into two halves, and cluster analysis was carried out on each half independently producing solutions ranging from 2 clusters to 12 clusters. For each ^ c solution in turn the similarity between the cluster profiles in one half ^ IS* I of the sample and those in the other half was computed by means oE a o m 451 -9- cluscer cooiMrisoQ program. In addition the clusters from each half of . the sample ««• cross related to a range of external variables such as cigarette consumption, depth of inhalation, nicotine delivery of brand most often smcHted, ««•, social class, etc. The results of the cluster comparison prograS' Indicated ttet the two halves of the sample matched • well at both the low level (the 4 cluster solution) and the high level (the 12 cluster solution). Between these two extremes the matching became progressively less satisfactory at the 5, 6 and 7 cluster level and progressively more satisfactory at the 9, 10 and 11 cluster level. After taking into consideration the matching data, the profiles of clusters from the various solutions and the cross relation with external variables it was agreed that respondents should be assigned to clusters on the basis of a 12-clustcr solutioQ. y^ 4. Concern for ggalth v-_ ^X ' In order to obti^ some measure of the concern felt Jjy respondents / ■ for the harm which they aii^ht be causing to their own health by sswking, a battery of question^ ms i«l&U>ded for this particular purpose and is reproduced in Appendix V (page 66). The cigarette brands mentioned in Question 13 are those shown ia the Government Chemist's second list (2) as delivering 11 mg tar or less. The figure of 11 mg was chosea to include Silk Cut. as it was felt that this braod has a connotation of ^ "safety" by reason of the advertising attached to >t. Some of the questions in Appendix V are taken from McKcnnell's first study (4), others were designed specially for this investigation. The ^manner in ^ which the "health score" was derived from the answers to Questions 18 to 21 is indicated at the end of Appendix V. The questions In this 5'. c I O 452 -10- •pp«adLx vtre aoc la fact nslwd until the very end of the fiul recall Interview, efter ell the teat eigerettea had been aatoked and reapondenta' opiniona of thea bad been recorded. However for convenience the Infor^tioa fron theae que^ioai, as it relate* to cluater akeaberahip and general amoklag behaviour^ haa b«ea included in the preaent report. RESULTS AND DISCUSSIOR ■;., I. The Factor Structure . An important consideration in deciding between the various Pronax factor solutions which were computed was replication of the factor structure m found by McKennell in hia aecoad atudy (5). The aolut ion which best net thia requirement waa judged to be the l2-factor solution. Table I ahowi a eomparlfion between the l2-factor solution (co«ifined to items with a loading of 6.4^ or greater) and McKennell 'a lO-fad^C4r solution. The loadings of all «?, items on all 12 factors are shown i^^Appeodix VI (page 74) (this complete set of loadings waa used in the aubseqoent cluster analysis). It will be seen that 9 of McKennell 'a 10 factors have emerged, with much the^flme defining items; for convenience they have been given the same labela aa used by him. His factor DC, Occasional Smoking, has no real counterpart. However two of the items which defined that factor have appeared in two new facfora: "smokes when drinking tea or coffee" ia associated with "smokes when drioking alcohol" in a factor which haa been labelled Refreshment Sotoking; "stookea in a break between jobs" ia associated with "smokes travelling to work" and "smokes in the cinema" in a factor which has been labelled Idle Smoking. An interesting ^ point ia the emergence of the item "smokes most at the weekend" as a tsr o third new factor all on its own; it is to be noted that although '^'smokes ^ 453 ■"ii- vfaen vorklag hard" appearr in the same factor chese Cvo iteu have opposice tignSy Indicating that those vfao smoke aost at the weekend tend not to siBoke vdten voxking hard and conversely that those who smoke when working hard tend »ot Co aooke aost at the weekend. It would, of coerse, have been possible to choose a solution with a smaller number of factors, but only at the expense of losing some of those factors to which McKennell attached particular importance. At the 11-f actor level, for instance. Relaxation Smoking did not emerge as a separate factor. As it stands, the 12-factor solution shows ^ood agreement with HcKennell's factor structure, the replication being if anything closer than between McKennell's first and second studies (4, 5). Table .3 shows the laatrix of intercorrelatiens among the 12 Promax factors. The iirst five factors (1, 4, 12, S and 9); are those which McKennell Included 3a his Inner Need dimension, and the aodest positive correlations aacng then fit in with this concept. Three otner factors, those of Refreshment Ssokiogj Idle Smoking and Continual Stnoking, are also correlated with the 5 Iim©t Heed factors, and might perhaps be regarded as forming part of the s^ae dimension. The factor which is least correlated with all other factor* is Social Confidence. <^: 03 c I c 454 -u- X; TABU I -COKPAMSOW trtVEtH MeCHVEtL'S FACTCt SOmTIOW AMP ^ fROJtCt WHEAT rWELVE-PACTOR (PROMAX) SOLlfflOM (Id Ck« 12*facCsr •olucion Iteai vich lo4din(« of l«M thao .40 ar« doC chovQ) Hcfannell't Tea-Fieter Soluttoa I. Bervom Irriotioa Saokcf when irritable Saokei wheo acrvout Saokei vhea aoxlout or worried Saokct when engry $askef when bored Sooket whe(i doing toBechiof uaiatcretciog IT. Helejotion SBoking Saoke* whea ce>tia« efcer cxercite Saok«« ubea r«ljLzixi( Saoket wtwn h«p;>f Saokee vtaca readloj e bock Saoke* vhea w«tehiiia t.V. III. Saokltig tlovM O. Saoket when bjr self aad fe*^a( tlooe Sookei when eloae '/-^ Saoket when fceliag eloae ia A crowd .78 .76 .7* .7J .60 .64 .M .36 .I7« .14* .61 .59 .SO ly. ActlvitT Accoapeoiaent Saokce when working hsrd '• 72 Saokei when doing ioocchiog iacereicinf ~«^l Saokiof bclpt canceacrstiott '•*'. Project WHEAT Twelve-Fector Solution I. Wervom Irritetion 9Moket wtien enxiout or worried .M Saoket wfecn Irritable .79 Saokce when oervout .7S Saokee wtaen engry .(S 4, lUle*etian Sacking' Saoket wh«a reludaf .67 Saoket wheA vecchlag T.V. .66 Saoket when reeding • book .4S Saoket whea iiappf. .40 Saoking Alone ^Q 12 Saokei whea bjr t«lf tndl^eiiog eloae -.82 Saoket vhea elooe -.70 Saokei wtien feeling alone in a crow4 -.61 Cett aotc pleaiure tnokiog alone -.48 S. Activity Aecoapaniaent Saoket wttca working hard -.78 Saoket when doing toaething interettlag -.71 Saoking helpt concentration -.S2 Saokei wtico tired -.4S T. Food Subttitutton Saoket whea feeling hungry Saokee ineteed of eeting tweeti 9. ', Food Subttitution .64 Sa»kce Co etop eating too auch and .57 (aining walghc Saoket ieurcead of eating rwecct Saok««_wheQ feeling hungry .86 .49 *Thete two iteaa were included by McCennell in Fector It, ta tplM of their low loading*, becauec ia « previous study (4) they h«d high loadiagt M thit factor. / y 09 c I c N I o w 455 -13- TABLg I (CONTiyUED) VI. Social Spoking Sooket party Sookes in company Sookes when drinking alcohol Sookes most when out for the evening 2. Social Confidence More relaxed in a group when smoking Smoking gives confidence with other people Happier with smokers than non-smokers Snoking gives something to do with the hands in a group of people 6. Reluctant Smoking Sookes when not really enjoying it Sookes only because everyone else is but doesn't really enjoy it Sookes without really Chinking about it /-: '>0 11. .71 .65 .49 .46 .76 .76 .64 .45 .78 .75 .43 Continual Smoking ■/)y Sookes first thing in the ooming ■.bl^ Smokes last thing at night -.56 Sookes without really thinking about it 7. Refreshment Socking Smokes when drinking alcohol Sookes when drinking tea or coffee Sooking gi«es something to do with the hands in a ggroup of people 10. Idle Smoking Sookes travelling to work Sookes in the cinema Snokes in a break between jobs .81 .69 .40 .64 .57 .47 .79 .59 .57 8. Weekend S.tioking Sookes most at the weekend Smokes when working hard / .92 .41 6W-W2-01599 456 -14- TABLg 1 (COWTDniED) Items noc Included in lfcKennell'» Iteaj vich loadings of < .40 factor* on any factor Gets ooat pleasure sacking Alone Sooke* when bored SaoVces to stop eating Mo aoch and Saokes when doing sooething gaining weight '-J' uninteresting Saokes when talking ^'^ .^ Saokes vtaen resting after exercise. Saokes in the cineaa 'l*^. Saokes after aeals Saokes when tired Saokes when talking -0.. -0. '^> S 9 c c o o 45f -u- TA»U i Vattcouttixnms mvk otiiiKt tkhul rAcrou -^^ / I 4 12 s « i 2 t 7 • 10 11 Mtrvoui Irritatloa i.ea *«.2« •«J7 «0.2* ♦0.2J ♦0.20 ♦O.ll ♦0.10 ♦0.33 -0.12 ♦o.u ♦?.2» B«l4x«tlafi 1.00 •0.10 ♦0.11 «0.U ♦O.U ♦O.Ol -0.17 •C.Ol -0.1» ♦0.26 ♦0.32 12. SaDkinj kXoa* ,- 1.00 «0.3) ♦O.JO •O.IO ♦O.Oi ♦0.15 ♦0.26 ♦0.06 ♦0.41 ♦0.27 Accivicjr Accoap^siacoc 1.00 ♦0.27 ♦O.U ♦O.02 ♦O.IJ ♦0.21 ♦0.21 ♦0.3S •0.20 Food Sub*ciCutiOB _ » 1. 00 •0.07 ♦0.05 ♦0.06 ♦0.17 -0.12 ♦0.32 •0.33 Social Sasklng 1.00 ♦0.16 ♦o.oe -0.0* -0.02 ♦0.27 •0.0* Social Coofidcaca 1.00 ♦0.11 -0.03 -0.10 ,.0.12 -0.09 laloccaec SofckUt 1.00 ♦0.1* ♦0.25 ♦0.12 -O.U t«(re9haeot Saokia^ 1.00 ♦o.ot •0.27 •0.08 Vackaad SackiAt x • 1.00 -0.0* -0.28 10. Idla S»kla« ^S\. •^/y ^^r 1.00 •0.22 U. Coodaoal Saokint O 1.00 C ''A ' > ^o X X. ■-^/, V e V- / /

. - — 0 0 0 0 0 ♦ ♦ ♦ Activity Accompaniment - - 0 - - 0 0 - 0 ♦ ♦ 0 *-4 Food Substitution - - ' m ' 0 0 — 0 0 • 4- ♦••♦■ *■ Social Smoking _ 0 0 0 — 0 0 0 ♦ 0 0 0 Social Confidence - - 0 0 . " 0 0 ♦ ♦ ♦ ♦ 0 ^ Reluctant Smoking 0 - ♦ 0 0 ■ ♦ - - ♦ 0 ♦ 0 Refreshment Smoking - - ~ 0 ♦■ 0 — 0 ♦■ 0 ♦ Weekend Smoking 0 0 ♦♦ 0 = 4- .0 -- 0 0 0 0 Idle Smoking — - — - 0 0 * 0 0 4^ 0 ♦• Continual Smoking ~ 0 •• " ♦■ ' 0 ♦ •♦• 0 ♦ 01 c £ - t O O 459 -17- The first five fscCort In Table 3 are those referred to by KcKeooeU, «• Inner Need {acton. Considering solely the scores on these five factors, the ^tal nuaber of "low" assignaents (i.e. — or -) per cluster can be calculated; siallarly the total number of "medium" assigruncnts (i.e. 0) and "high" assignaents (♦■♦■ or ♦). These totals are shown in Table 4 below. '■ TABLE A DISTRIBUTIONS OF LOW, MEDIUM AMD HIGH INNIR NEED FACTOR SCORES -c 1 7 3 9 2 6 4 5 8 '"■ 12 10 I Low 5 4 4 4 2 2 0 1. 1 0 0 0 I Medium 0 1 1 1 3 3 3 3 4 1 2 0 I^High 0 0 0 0 0 0 2 1 0 '4 3 5 Inspection of Table 4 reveals a natural grouping of clusters according to the Inner Need dimension: Low Inner tfe/t^ xT; .^^ Medium Inner Ncei. 2 3 9 4 5 8 High Inner Reed il^ 12 10 There could be a case for classifying Cluster 4 as a High Need cluster. However on balance its inclusion with the Medium Need clusters is preferred, and it is interesting to see from Table 3 that scores on - the Smoking Alone factor perfectly predict the allocation of Low, Medium and High Need groupings as shown above. 09 c I c N I o o» o w HcKennell (5) preferred a 7-Cluster solution for his jytmple, and gave cluster profiles based on the first eight factors. Comparison between the two studies shows that some of the WHEAT clusters are broadly 460 -18- equivaleot to soaa of McKcan«ll't eluateri whereat others have no rc4l equivalent. 1h« Cvo sets of clusters are coopared la Table 5 belov. TABLE 5 I COMPARISON -^0 Elf PROreCT WHEAT CLUSTERS AND KcKENNELL •S CLUSTERS Project WHEAT Clusters Nearest McKeonell Equivalent CI uster Kuober of Respondeacs Z Cluster Nuaber of Respondents Z 1 50 I 310 16* Low Inner , 7 163 11 II 273 13 Low > Inner ^eed 3 65 III 248 12 Need ^ 9 102 in 248 12 #■ , " 2 119 - ;- - - " ^ 6 118 . "^ ■': - - Mediua -" 279 '; Inner Need a 184 124 12 IV VI 19 44 Kediua/ High 11 -^54 10 VI 279 14 Inner Need High V 209 10 Inner \ 12 123 C^^ 8 ' Need 'a / VII 309 16 10 16« ^w - - 1 1 Deciding which of McKennell'a cloiters came closest to each of the WHEAT clusters involved plotting and comparing the cluster profiles. These are reproduced at the end of the report.. The more complex cluster solution agreed for Project WHEAT appears to have Resulted in the sub-division of two of McKennell's clusters (III and^I) , and the plotted profiles show a fairly good match between McKeonell HI and^the average of WHEAT 3 and 9, likewise between McKennell VI and the avera^^of WHEAT 8 and 11. On the other hand WHEAT 12 seems to contain elemints 09 c I c N t O o 461 -19- o£ two McKttinell cluscert,. ▼ and VII, which tgaia can b« seen by cooparing Che profiles. Four of Che WHEAT cluacera (2, 6, 5 and 10) have no close HcKennell equivalent. An ioportai^ difference is Chac only 2SZ of che WHEAT sample was classified as Low Seed at ooop'a'red wich 41Z of HcRennell's, Che biggesc disparity being in Cluster 1. A possible explanation could be the different age distribution* of the two samples, with S3Z of McKennell's sample being 4S or older as against 37Z of the WHEAT sample. This could affect the size of Cluster 1 which ia both cluster solutions was considerably above the average age of the sample. -; McKennell laid emphasis on the distinction beCwecn the Inner Heed component, (comprising information from the first five factors as already stated) and ~the Social component (containing information from the two '^A 'O factors Social Snibving and Social Confidence). He predated « diagram showing the dispersion of his clusters in these two dimensions. The precise way in which he treasured these two cooiponents was not followed /^ in the WHEAT study. Bowever'^$Q approximation to his method of presentatioa can be arrived at by plotting the mean of the factor scores on the first five factors against the aean bf the factor scores on the two social factors for each of the 12 clusters. This plot is shown m Figure 1, which also gives the positions of "MpKennell's clusters after caking the means of the factor scores in the same way. Although much of the distinction between clusters is lost, this oteckod of presentation ^ c does facilitate an overall comparison between the WHEAT clusters and c O McKennell's clusters in terms of these two dimensions. FiguT^' I shows O' Chat Che clusters in each sec are fairly well separated from one toother ° 462 -20- and tbac cIm WHEAT clusters cover ouch the same part of the graph as . McKeonell's clusters. Points of deull are that, in the Social diaeosion, Clusters 1 and 8 «r« respectively lover and higher than any of HcKenncll's clusters; in tl»$ Inner Meed dunension Cluster 3 has the lowest score of either set, while VfcKennell's CTuster VII has the highest score. The distribution of certain external variables over the clusters is shown in Table 6. Inspection of the results indicates that some of the external variables (average cigarette consvjsption, depth of inhalation, difficulty in giving up) are related in a meaningful way with the level of Inner Need. The three relationships are shown in Figures 2 to 4. When it is remembered that the external variables of cigarette consumption, depth of inhalation and difficulty in giving up jjmoking are quite independent of the data fcda which the Inner Need scores were d^^ived, the correlations , -y -- - depicted ara ratJi^ striking and support the content iou(jthat th« factors on which the classification of smokers has been based real Cluster 4: Mediua Need- Idle, k tendency to smoke while travelling to and from work and between tasks distinguishes this cluster from other^ Medium Need clusters. High scores on the Nervous Irritation and Relaxation factors place the overall Inner Need level 'of this cluster CO rather above that of others in the group. This cluster, which is the ^ !5 largest of any (12. 2Z) is lacking in the GO-t- age group but is otherwise i o well distributed throughout the age and class dimensions. g 466 .24- • Cluster 3; Mgdium Wged-tow Rafreahnxnt. Aiooag Medium Need «Bokv«,. Cluster 5 neab«ra are the leaac reluctant and are least likely to toioka more at veeke^^s or vfaile drinking. They smoke for reasons of Social Confidence and tt^ quit* likely to sooke first thing in the morning and last thing at night. This is the cluster vith much the highest average age, 4SZ of members being over 60, and it is heavily weighted towards class C2, D and E. '^" Cluster 8: Medium Need-Social, High scores on both social factors, particularly Social Confidence, distinguish Cluster 8 not only from. the other Medium Need clusters but indeed frea all other clusters. Members of Cluster 8 are also the oust reluctant of any. Apart from a rather high percentage of smokers between ages 16 and M^ and a correspondingly low percentage~'&«tween 35 and 59, the age/class discribuclons of this cluster are nner.ce^ional. Q Cluster 11; High Weed-Social Confidence. This cluster is the only one of the High Need group tp show a high Social Confidence score. Among the Inner Need factors tb^ conmonest form of smoking is as an accompaniment to activity. Member* ^f this cluster tend, more than any others, to smoke while travelling to work or in a break between jobs, and they also show high scores on th« Kefreshment and Continual factors. X They anticipate greater difficulty in giving {)v^ffmoking than any other - ■/ cluster. The members are evenly distributed throughout the age range but are strongly concentrated in classes D and E. Cluster 12; High Need-Food. Of all clusters this has 1)y far the highest association between smoking and Food Substitution. Thi* is almost entirely due to one item in the questionnaire, 89Z of members OD c I c IM I o o» o 467 -25- clsiaiag tb«e Chey snoke "to ttop e«tiag Coo much and gaxDlng veighc". Clu«cer 12 i$ aore reluccant thAn the ochet two High Meed cluatert. It la evenl/ distributad throughout the age and class ranges. Cluster KyTyigh Weed-Low Social Cottfidence. This has the lowest Social Confidence score of any cluster. Its profile is othervise very similar to that of Clusc^tr 11, with slightly higher scores on the first four Inner Need factors. It Is the second largest cluster, accounting for 11. IZ of the sample, and overall has the highest cigarette consumption (32 per day). Like Cluster 12 it is evenly distributed throughout the age, an 1.2 ng 16 12 20, 20 13 19 15 11 13 17 20 14 Tar Delivery; < 12 mg 7 8 7 10 9 7 7 3 4 • 3 7 9 12-18 og 43 A6 44 37 45 36 44 44 47 56 38 39 • '-^19-22 Dg 51 44 49 55 44 56 50 56 51 44 58 54 >2ZBg 0 2 0 0 o' '\ 0 0 0 0 1 0 Price per Pack: 28p ♦"^-. 13 8 16 18 17 18 'y^ « 9 10 19 14 26-27p >3« 34 39 39 52 45 35' •^ 39 31 43 39 23-25p U 22 12 16 5 9 15 16 20 18 8 11 21p 18J-20P 28^ 8 6 25 .7 23 25 6 23 3 25 3 24 11 28 17 29 6 32 12 2t 10 29 7 OTUEU PRODUCTS SMORtD Plain Cigarettes 12 6 9 10 8 14 13 6 11 21 18 17 Hand Rolled Cigarettes 10 8 9 4 ,4 10 10 6 U 14 13 18 Cigars 38 34 40 40 38 40 .34 36 27 37 44 40^ 40 Pipe 12 18 13 11 18 13 ' % 13 17 10 10 12 8 r a c 1 c N • 469 -27- " TABLE 8 • .• ■OSMAL SMOKING BEHAVIOUR OF ACE AND OASS CROUPS ■ • Total Saaple Age Class %- 16-24 25-34 35-59 60+ AB a C2 DE BRAND MOST OFTEN SMOKED Nicotlae Delivery: < l.O ag 9 6 6 11 10 14 10 7 7 1.0-1.2 m« ■ 76 81 75 73 78 58 72 81 83 > 1.2 ag 16 14 18 17 12 29 18 13 11 Tar Delivery: < 12 mg 7 5 5 8 7 11 ' 7 6 5 ' - 12-18 Dg 43 53 42 40 39 33 35 44 55 19-22 mg 51 44 5> 54 55 57 58 52 43 T ^ > 22 og 0 1 0-; H 1 1 0 1 0 2 Price per Pack: 'cJ8p ♦ rt^7p 13 38 14 32 17 36 43 ^ 9 2' 27 44 17 46 11 38 8 30 23-2SP ,. 14 13 15 13 16 14 14 12 15 2lp 'C V" *. 39 26 25 20 14 18 32 37 18J-20P 5 8 8 16 2 8 8 13 OTHER PRODUCTS SMOKED ''/. Plain Cigarectes 12 14 10 9 8 11 13 15 Hand Roiled Cigarettes 10 16 '■' . 11 8 5 4 5 12 14 Cigars 38 37 38 29 46 39 38 32 Pipe 12 8 11 14 15 20 13 9 10 - / r r > c 1 c 470 -28- Ther* li no obvious rclatiotuhip becvecn cb« nicotine delivery of Che brftod noxaally snoked end Che level of "need" of the cluster. In fscc ehree of the Lov Need clusters sre more inclined to saoke high nicotine cigarettes (i.«. 1.3 Big nicotine delivery and above) than are clusters 11 and lO'which come «t the top end of the Inner Need scale. On the other hand there it a relationship betveen nicotine level and social class, the higher t^ social class the greater the tendency to smoke high nicotine cigarettes. But a complicating factor here is that a high proportion of those F.T. brands which deliver 1.3 ng nicotine an^ above are King Size cigarettes, and these are wort expensive than Chose 9f smaller size. Looking at the breakdown by price shown in Tables 7 and 8, the 28p * category consists exclusively of King Size brands. TherC is a close correspondence betveen tn«-£roporCxons of the various social cl^i^es smoking brands in this Cop pric4-category and the proportion svokin^^high nicotine cigarettes, so the apparent relationship ' ' < ... between social class and ttie smoking of high nicotine cigarettes is " Of mainly a reflection of aeonooui^^actora. To a sxull extent the smoking ^^ of lov nicotine cigarettes is als« class dependent. A possible interpretation '/. is that the upper social classca are optc adventurous in their stacking behaviour, being prepared to try a vide diversity of brands, whereas . the lower social classes are more conservativ^. This is borne out by considering the cigarette brands most comaooly safoked by various categories of respondent. The two most popular brands are Eabasiy F.T. and Player's No. 6 P.T., this being true of every cluster, all four age groups and all four social class groups. The former delivers^iS. og tar, the latter 18 mg tar, and both delivery 1^2 mg nicotine (2) .'""Table 9 BW-W2-016U 471 -29- bel'ov show* Che percentage o£ retpondeatt wbo snoke oae or other o£ these two braadt as their £lrsc choice: . . TABLE 9 /', ^O. BRAND SMOKED MOST OFTEN Total Sample Clasa AB Class CI Class C2 Class DE Embassy Player's No. 6 Other Brands 26Z 241 50Z 25Z 12Z 63X 30X 57X 30t 27Z 43Z 20Z 33Z 47Z . A greater proportion o£ respondents in the two upper social classes sraolie brands o'tXer than Embassy and Player's No. 6 as first choice than do those in the two lover social classes, which indicft.es Chat the upper social classes ici$. less conservative in the natter o^-^^nd choice. Embassy is ia a bighex price category than Player's No. fr^':and this is clearly reflected in the relative popularity of the one to the other for the different social elates. The extent to which product^ other than filter-tipped cigarettes are smoked does provide some eviden6€ for a link between Inner Need and preferred nicotine delivery. Plain cigarettes currently marketed in the U.K. deliver, on average, appreciably more nicotine than do filter- tipped cigarettes, and the same is broadly_tnie V>£ hand-rolled cigarette's. Table 7 indicates that the tendency to smoke each of these products ia addition to filter-tipped cigarettes inc^reases along with the level of Inner Need. For plain cigarettes this tendency is shown in 'Ticure 5. Information on consumption levels is not available for plain cigarettes, but for hand-rolled cigarettes the reported consumption ranges from CO e yi 472 -y>- 16 per week for chose la Cluacer 3 Co 51 per week for those In Cluster 12. So it CAii be said chat t proportion of respoodeots suppleoent their snokiag of filter-tipped cigarettes with other cigarettes of higher oicotinc delivery, tb« proportion who do so and the level of coosuapcLoa increasing along wltb. Inner lecd. Cigar and pipe smoking is also indulged in hj a .fair nuaber of '^lokera,. but consumption levels are low averaging 2-3 cigars per week and on^ ounce of pipe tobacco per week and not varying appreciably between clusters, ^e incidence of cigar and pipe snoking is related more to age and social ^lass than it is to cluster membership. A^^, Concern for Health ^''y Aa aientioned in the section on Methods^ that part of the questionnaire relating t< concern for the possible ill-«f fec(4 pf ssuking was not asked until respondents had smoked the various expe(^ent«l cigarettes and had been questioned about them in the final recall^v^^ervicv. It was felt that any earU^ exposure to the health-related questions ai^t bias their opiniona of thif experinental cigarettes. Naturally some fall-out of respondcn?* oecurr^ between the initial survey and the final recall interview, added to which %ft«^%fhole of Cluster 2 was deliberately '^. eliminated from the cigarette Ccating'^rt of the exercise for reasons which will be explained in the subsaquent Veport (i.e. Tart 2). Tb« . result was that the health-related portion of^ihe questionnaire was administered to a considerably reduced sample of respondents (1023, compared with 1523 in the initial survey) and there iay have been soae ^ / c shift in cluster profiles because of the fall-out. • c The answers to 7 of the questions were scored, as explainad at the o ff> end of Appendix V, to give an overall score for health concern for each '^ 473 -31- tetpondeat oa « scale raaging fron 7 (aialnja concern) to 35 (maxiauv concern). Th« sooret for the toc«l taaple oo S of Che 7 quesdont were ooc slgnificuitly different fros 3.0, the aid-polat on the 1-S scale, indicating that Che ntober of respondents expressing an opinion in one direction was roughly balanced by the number expressing an opinion in the opposite direction.'- however in the remaining two questions the answers were very unevenly split and the score differed significantly from 3.0: in Question 18a only 17Z of the sample had bought a brand because of its favourable position in the Government list, and in • Question 20c 83Z of the sample agreed either strongly or mildly that tipped cigarettes are healthier than non-tipped_ cigarettes. After sttidying tfeft resulting distribution of scores for Che 7 questions, respondeotswei^^classified in one of three ranges: -'hl9 (low concern) 20-24 (mediua conotni), 25-35 (high concern). Table 10 Sbows the percentage of respondents in eacn'M these three categories broken down by cluster, age, social class, cigarette- consumption and nicotine delivery of regular brand. 'y Based on the percentages in t>v^2S-35 bracket, those clusters which tend to be the most concerned about tfae'^ealth effects of smoking are Numbers 9, 6 and 12, in other words on* Low Need, one Medium Need and one High Need cluster. Those which tend to b^ ^east concerned are Numbers 7 and 1, both of which are Low Need clusteT». On this evidence it would appear that no relationship between health concern and Inner 08 Need has been demonstrated. This is contrary to what was expected, ^ though views differed as to whether those most concerned about h»«ltl risks would logically be expected to be low in Inner Need or high in 474 -32- Inner Need. According to the first view those vith irwr''— " coocem would already have rcdoced their saoking consimption and aighc even have ceased to snoke on petals types of occasion; they would thus have low scores on the Inner N«t4 factor*. The alternative view stems fron McKennell'a findings in respect of dissonant and consonant smokers (4). Dissonant smokers he defined as Chose who tend to accept the arguments against smoking and say they would like to give up smoking if they could easily do so. Consonant smokers he defined aa those who tend to reject anti- smoking appeals and express no wish to give up smoking. Ue showed. that disMoant smokers were high in Inner Need and made frequent, hue largely , O ■ unsucceijful, attempts to give up smoking.' Consonant smokers were low in Inner ^ed, hut when finally persuaded abouC'jbe dangers of smoking were able to ^ve up with comparative ease. Inese findings would seen to support the vfM^that snokers who are really cone em- Health Coacera Score 7-19 20-24 25-35 , Total Sample^ 27 34 39 Cluster: ' :' I 33 37 30 : 7 37 37 26 ■'Ji 28 34 38 ' "•'.'. 17 28 ii * 6 S^ 13 36 51 4 22 36 42 . 5 40 : 2B 32 5i, 8 % 26 29 24 32 30 '- 34 40 ^4 Age: '-.- 16-24 26 41 33 O^ 25-34 19 28 44 35 28 33 46 43 23 Social Clasa: AB vy, CI ^ 19 ,24 28 28 S3 48 C2 ^l- 35 34 DE 2^; , 40 31 % Cigarette! per Day: 1-9 10-19 20 24 r 33 46 *3 20-29 30+ 2S 36 35 33 / 40 01 c 1 c 1 Hicotine Delivery: < l.O og 20 25 55 o o> 1,0-1.2 mg 28 35 37 V0 > 1.2 Bg .29 32 39 476 -34- profile of Cbose who curr^ncly snoke « low c«r brand (I.e. 11 ag t«r delivery and 1«m) and those vto formerly tookcd a low tar brand but DO longer do^. The information la given in Table 11. The colufflQ J^aded "current ♦ former smokers" represents those who, at one time or another, have been sufficiently attracted to a low tar brand to smoke it regularly. It is seen that 22Z of the total sample comes into this category, and that the percentage is much the same across the various age and social class froopings. Even among the heaviest smokers as many as 17Z have, at some time, smoked a low tar brand , regularly. Concern for health, on the dther hand, does seem to exert some itvfluence in the direction of smoking low tar brands. Among the clusters ~ST)ffle fairly appreciable differences a'f^ apparent, although their explanation d^ not be imokcdiately obvious: Clustel^3 and 4 show the greatest tendency' to take up, albeit temporarily, a lo^^ar brand. Cluster 5 shows the lekat. The columns headed "eurrent smokers" and "former smokers" present a rather different picture.' ". 18 15 60+ 24 <■ 9 15 Social Class: AB 24 - 12 CI C2 23 21 <■% 17 17 DE 22 17 Cigarettes per Day 1-9 27 13 14 ' 10-19 22 16 20-29 25 20 30* 17 12 9 C I c N) I o 9> 478 -36- to »ocUl classes A or B, «nd to be light smokers. These trends, bovever, do not resllr explsio some of the differences betveen clusters. For Instance Cluster 10 eontsins one of the highest percentages of low tar smokers, and yet 09 average members of this cluster are not specially health conscious, not apprtciably older than average, nor upper class, and they are certainly nat light smokers. The explanation of this could be that one is dealing vith very small minorities of each cluster, and that the profiles of these minorities in terms of health concern, age and so on are rather different f^oa the overall profiles of the clusters to wiiich they belong. •- ^ • As-'flready indicated, most of chose who have at some time smoked '■'.; ■ > . a low tar brand regularly finish up as "former toftokers" of such s brand; ^ O "^"^ in other words '^hey give it up in favour of a braa unsatisfying and, after • pevlod. change to a brand which is less mild and has more taste. GENERAL CONCLUSIONS "y. Thii first part of the exercise has Reduced results from factor analysis and cluster analysis which are broadly comparable with McKennell's / ^ ■ results, in spite of some deliberate differences in statistical methodology. The twelve clusters which have resulted show wide separations both in the Inner Need factors and in the Social factors. External variables 09 c such as cigarette con&uzption, depth of inhnlation and the anticipated n' o difficulty in giving up smoking are all positively related to the Inner ^ IS) 480 -38- H*ed scor«, «■ was found by McKennell. The cluscers which have resulted froa Chi* sozvcy should thus provide a souad basis for cescing cbe hypothesis coDceming Inner Need and the preferred nicotine delivery: the results of this testing vilL be separately reported. The hypothesis is not supported by consldera'tloa of the nicotine deliveries of respondents' regular brands, but this could be a reflection of the influence exerted by brand loyalty together with Che rather limited choice of nicotine deliveries currently offered by filter-tipped cigarettes on the U.K. aMrlcet. The hypothesis does, on the ocher hand, receive some suppprc from Che extent Co which respondents supplesieat their regular brand by •fltokiof plain cigarettes or hand-rolled cigarettes. Conc«ra for the possible health risks of saoking, chough unrelated to Inoer Need^yis shown to influence the brand choice of a ainority of smokers, probably^^f Che order of 1S-20Z. This minority is drawn from all clusters, from all age and social class groupings, and from heavy smokers as well a* from tijjht smokers. Specifically this concern influeaces smokers' willingness Co try i^y C«r brands, but there is evidence of a conflict between Cbcir concern for bealch and Cheir desire for a sacisfying cigarette. 'V/', OB e c 9\ 481 3 I 3 y , 7^ A. PHOJICT WHEAT - PACT 2 ^K. HMZ SHOKERS: TKEIR R£ACTIOM$ TO rSjgrres Of MfrtRzyr Hico-rua ptiivEtT AS ttgUTNCED BY LVXIR NEId R£?. 1.1976 -/ , X ''-i. ^>l o 'O^. v^ SrouH ._ HessspctiK CsntPB Ay SOUTHAWPTON ENGLAND BRITISH - AMERICAN TOBACCO COMPANY LIMITED Brown Jfe Wliriam30Q,' FEB23197S RESEARCH LIBRARY ■5- > 9 C c htfori al r^cw! s !l* soperty o( fr.t.sh -ine'ca" Totacco Cofrpany I ir -s) jn<3 -'^.si xi M C'x«! o. sVwt. -o ^•>».'V «^ ;e-vjr$ 482 Croup Rctc«reh t D«vtlop«cnc C«acr«, BricLib-AacricAS Tob«cco Co. Lc4., SOUTHAMPTOf. f DJV/ltA/46&-( 30ch jAauary, 1976 C< FWUtCI WHEAT - PACT 2 D.K. mMAS^^OPI^: their REACTIONS TO CICAJtTrreS OF DIFFERENT ^^tqetlMt DELIVERY AS LNFLl'ENCED BY LNNER NEED (Re^c^ Ho. U).I]22 Retcricced) SpiMARY AS'D RECOMMENDATIONS '.;-. ', U.K. aale smokers, previously classified into < ouaber of cluscers vith different levels of Inner Need as alre/ify ^f epotCcd, have Cakea pare la cwo-^roducc cescs in which cheir detailM. opinions of experiaeacal : '5) "'^^ cigaretCet rang^g in oicocinc delivery froa 0.7 mg~g^ l.S ■( per cigarette wtrt recxj^ed. The object of this p«rc of thi^iavesclgetioa was to test cht hypoch^is ch«t a siaoker's Inaer Need level is relacod to his preferred nicotine delivery. The hypothesis has b«cn dSl^ partially confirmed, as the distinctiea between cluscers of differeat Inn«r;5 483 -2- trouad l.S CO 2.0 ag ar« b«tc«r suited Co Bigh Heed cluatert. Cl(arecc«« deliverias l*M ctua 1.0 ag ere probebly coo low ia alcotlae Co tuie evce Che Lov Ri^ «lutcert. Althoush elaeelflceeioa by laner Heed mj aoc give at go^ aa ladicecioo of che preferred aicodne delivery m bed beeo aBCicip.^««di claeaifiCACion Into deaographic groups, or laco group* based on Che tiuvbers or Cypet of cigaretce chac are sacked, gives -^''■ evea less indicacion. . -^ IC is believed that Innet ^eed is a sufficiently useful Measure lor inclusioa in further iavesci^cions. However a grcacly sioplified Vay of decermining che Inner Need le^l of respondents is proposed, whidk would make use of a shortened questionnaire and would eliainatc Che necessity for factor and cluscer analysis. ; Concerm for che possible health cisH »f smoking was shown in Che earlier Report to have an ioportaat laflv/e^e on consumers ia che direccion of^crying lew Car brands, and to be lopepcndenc of Inner Need. Ic was als^^howa chac, in many instances, smokies' concern for health evidently conflicted wich their desire for • satisfying cigarette. A model of the market it now proposed in which Cwo mifd^ dccerminancs of Che cype of cigarecce which besc suvcs a smoker s re^uLreaencs are Inner Need and concern for health. This model leads to th« conclusion tKat there is a substantial potential for a range of cigarecces which *c /resenc is not available. These cigarecces range froa some with low Tar an^ mediua nicotine deliveries to others with medium tar and high nicotine deliveries, and are visualised as attracting those smokers who coabine'4bove average c I c Inner Need with above average concern for health. It is reto^oended that this otodel should now be verified by classifying a further. «4mple 484 -s- of retpoodMC* lo fern* ol tU cvo diMatioos oC Inner N««4 ana conctn for health «a4 obe«iain| th«lr rMcelona to tjq>«riatnt4l clgaratt** of tho tTpot Mnt{0M4.iibov«. SiaulCMcously it 1« •u«ic*t«4 th«t th« 9u«atlons rtl«^| U thei« tvo dlaentlona mlcht b« locorporattd Into ongoing aarket re>Wrch, with ch« ala of ahoving bov far tha Liportanca of these two types of'fflflueocn is likely to vary fro. aarket to urket. ^% y V. '// X v^ ^'i c ^J' >: '9 v' % c t c ^> 2 485 'i N Tb« r>|Wt oa Pare 1 of ProjtcC WHEAT (1) d«*crib«d ch« r«e 74 on C ciearettes, so their nicotine deliveries were deliberately somewhat , . '> o • - . "* higher on a per cigarette basis but comparable on a per puff b4Jis. ot 486 -5- la order t* Mic cbt deilfn of cb« placcBcot c«»t each of the olshc eigtrcccti vat sroduccd vich thr«« dlfftrcot cod* mabcrt. Onforcuatctly clgAreet* D vhico m* plaaatd ce hav« ch« hithotc aicoda* dollvary caac well below !^r|Ct, ad waa licel* it taj higher chaa clgaratc* C. Thia aituation waa r^eal«d too lac« to cancel Che cooauaar teac which wenc ahead a< planned. -Sybiequcacly chc regular aise veriiona of cigarectea C and D were re^MaufaeCorcd to differeat apeciflcacieaa; a aeparate consuaer teat wai th«]i conducted uaiag the rcaulting cigarettea E and F. The aaoufacturc of Cheat various ezperiaental cigarettea haa already been reported (T,^^). For cooveoiencc, their code nuCbert and average nicotioe deliveries are auiAarited in Tabic 1 b«low. -/: '<: ^S; TABLE 1 ^-V CODC'IrVMBEHS AMD AVERACE MICOTmE DElIVtHtti OF 7? THE £KPERLgWTAl. CICAitZTTES ^^'v" <^ — /D Typa 1-^ JISFT K5FT €o4« ItWocmc Cod* Nicotine Mui*«r (•i^cig) Nuaber (■g/cig) A C52 O.lC^ . C5< 0.94 H38 , HS2 ICS6 -^>i B L45 o.n L4f. 1.12 P69 P45 ' N46 N43 ' "^y- C J52 1.44 JS« 1.71 R49 R4S '. T43 . T36 *. , D M36 F58 S43 1.53 M49 F52 S36 1. 68 ' E J 54 1.37 - - F M4 7 1.73 - - / > c I c ISI I o 487 PUCEMENT OF CIGARETTES ^' Th« «bev« alcocin* d*livtri«t art averages aa a rasult of aaokiaf 40 elsarttcat •( each aaapla (8 pores, S cliaratcas par port). Mora recently, saaplctjr^nd P bare b««a axaaiacd la (rcatar detail in ordar Xa ^ *• to give iofonri^oQ about the distribucion of nicotine deliveries vithia each sanpla. For t^s purpeae the nicotine deliveries of M individual cigarecces drawn at raOp> froa each laoiple were deccrvioed. Detailed .^ ■ results are given in AppeiMF^ I. The averages, which arc considered nore accurate than the figures quoted la Table 1, were: I - l.JATac/cig y F - 1.81 ag/ci^ Of 'difk 12 clusters identified in the surV^ (1) it was decided to include all c^ept Cluster 2 in the consumer test'.J^Clustar 2 was eliainated b«cau£^the cluster comparison program indicated a rather low degree of aatchiif^ between the two halves of the ssnpie in respact of this cluster; It was,'^ other words, a very diffuse cluster. With 4 products (il« t/d, Xi) to be inter-compared in the first consumer test, and with the stipu^tion that every respondent should smoke all 4 products, it vat necessary to carry out successive paired comparisons. Ideally, every respondent s^uld have smoVed the products in all possible combinations of pairs (AB. XC» AD. BC, BD, CD). As it was felt that three paired comparisons was the absolute maximum that respondents would agree to it was decided to adopt an incomplete design and to analyse the results, insofar as preference was co<(cerned, using ^ the "Round Robin" approach (see next section). This necessiUt^ed m' o dividing the sample of RSFT sooVers, and also the sample of KSFf ^.smokers ^ CB 488 -7- eacb lato 4 tub-tuiplct aauhcd 4t ftr •• pottiblt by eluiccr. Th« eo^ofidofl of chest 8 tub-tuiplcs It tbow la Appeodix IX. In ch« pltceaeoc dttlfft (latllx tdopccd (tct App«ad{jt til) tach product vas btltnced ovtr^ch Cttt (caking che 4 tub-Msplet togechtr), tad by Che end of che 3t^£eic etch retpondenc htd taoked til 4 produces. Tbc ouaber of peeks of etal^ prodoec chac were |iven co t respondenc depended on his norvtl cigtrecce cwuumpcloa: respondencs snsking up Co 4 cigarettes per day were given one pack of each product ac each placeaenc; all ocbert were given two packs of each. Foe any given paired cooparison, for liucance Sub-saaple I comparing A and ^.ac Cb« first placemenc, half Che'rt^pondents sacked A first and half npked • first, the appropriate IntCruction appearing on the pack. ' v^ Thlt f ic^c consuocr test took place over che period June- July 1974. Soae 4 snachs haf^lapsed since complecioo of che sur^^ and taevicably ere was so«* fall<$h£ of respondents during this period^'in addition th to those in Cluster 2 wKa were deliberately excluded. Out of 126} saokers theoretically tvtila^e for the coosuacr test 240 did not ttke part; of these, 33t had given up" smoking, ISZ had aoved house, 14Z were either on holiday or out after rcpeactd calls and 17Z were unwilling CO parcicipate. Froa the reaaining 10Z3 cespondents 32 dropped ouc after che first paired coaparison and t further 33 after the second, leaving 958 who coapleted all three stages of tVe test. Only 3 ssokers discontinued the test because they disliked che cigarettes. At the placement interview, i.e. when cigarettes for. the first c paired comparison were left with respondents, certain ^uestlof^ were o asked relating to their usual brand of cigarette. On couplet ioA iBf o» 489 -a- cach p4tt«A coap«risoa, rctpoadcaei vert qu«sciooaed about the cvo •aaplct ch«7 k«d (aoktd. Th^ queaciooiuire* uae4 la cheat iacervlcw* arc reproduca/^^pcadix !▼. The aecoad. coQS\mu ccsc cook place la July 197S, approxiatfcely a jear after che cigarettes per day, 4 packs of. iach Half the re'sgQndents sookcd E first, half siaoked~,<- firtC. Saokers of king sis* elgaM«,tes were excluded froa the test in'~C>pdfr to avoid having to prod«tce ^j^riaencal cigarettes in two differe^ sizes. Atteapts were aad* to ci^cact all respondents, apart froa king size saokers, who had takaa parfc'in che flrsc consumer test 12 aonths previously. A total of 607 ref^ndcncs coapleted the second test (E Afid f), che fall-ouc b«ia4 lar^ti^ accounted for by chose who ha4 ■<> given up sacking (. i additional question was included at the end of che recall incco^i^cw •' * OS *• > 490 -♦- la which tMpoaaeot* v«r« ,»*kcd Co rAok cb«lr ujual VrAoa tod Mch of ch« tvo tctt cls^cct** iB cb«lr order of prtf«r«nc«. KOUHP ROBIM AMALWl Round Robtfr-Analyrla it a aucliclcal tccfani^uc which iofcrt a relation«hip becv^^^ in cbia cla«, cvo cigarcccca of different olcotiM delivery which were noc^^etted againac each ocher. la aiople ccraa, it ia assuffled Chat if a smojter preferred A to B and preferred B to C then the net preference for A>9«r B plua the net preference for B over C will equal the net preference for k over C to within the li«ita eMected from the variability of the todividoal aeasureoeDts. The result is that the effective sample size La increated provided the V "'' acatistic4l test for additivity iodicatea that this ia a valid calculation. ^? ^/ Ia this ^rvcy it was impossible to ask •■vtif respondent to try ■ ^'y 'C all cofflblaacions^'Of the four nicotine levels against c^^ oCb«r, so Che Round Robin was 4«jtd to naxiaise the data use. The aOicivlc/ test indicated that this was Cvalid test using the current data. Round Robia Aralyala wx1r;applied only to Che prefereoce resulcs and not to any of the attribute '^Mles (i.e. strength, smoothness, etc.). The variables used arc shown la Appendix V. ipe RESULTS AND DISCUSSION V r I. FIRST TEST - PRODUCTS A. B. C, 0 Regular Brjnd Data '7^^ In order to have up to date information on thoit who actually smoked the test products, some of the questions relating to regdlar brand usage ^ that had already been asked 4 months previously during the "tiain survey •*•* •V - o were repeated. It was found that 91Z still smoVcd chc saata regular ^ o 491 -10- brtnd «t frcvloualy recorded, Aod chit pectcra wm« fclrlj eeatitccoc •Croat til ebw^r*. Abouc tvalf ch« chAnca rcpraaented aovcaaac fro« klat aisa coxe|iiur als* braada aad vlca vcrs«. Tb« aala reaaoa for ehan(c (43Z) i^M^iviB M Che need co ecoooaiae wbea Che price veac op. The overall diacrnEOCioa of braoda by Dicotiac delivery and by price remaioed virtually unct^ged. The average coeauapcioa of cigaretcea had increased tlighcly, aad^ chia «■« aoac oociceable aaong che low aecd clutcera vhere che iacrease vaa ^l>out 2 cigarecces per day, Che 3 high Deed cluster* remaining at cheir prcyioua level. . ^y' . In order cKac cheir opiaiona of tb« experiaental cigarecces could be relied co cheir noraal saoking experieQce, recpondeacs were asked •C Che p(t.. 1 O -i^-. 91 492 -II- TABLE 2 1 V opiniONS or R£cm>R cioatrrTE brakd CC O.- Strength otl6^ Slightly saooch . Oj Slightly harsh Moderately harsh Very harfh Taste A very good taste Quite a good taste A rather poor taste /^ very poor taste ^A. %- ^^. %. 5 ' k 2 1 * '? 3 ^ X Total Saspl* 3.3 3.4' 4.7 licotine Delivery of Regular Brand Low <1.0 ■ 2.2 2.4 '6. 5.1 "^ Speed o( Burning Faster than I want About the right speed Slower than I want Degree of Satisfaction Completely satisfying Moderately satisfying Quite satisfying Rather lacking in satisfaction Completely lacking in satisfaction ♦I 0 -I 3.2 ♦0.29 3.9 3.1 ♦0.35 Mcdiua 1,0-1.2 as 3.* 3.4 4.6 ^c. 3.6 >0 3.2 ♦0.29 3.9 r, tigh >1.2 a 3.4 3.6 4.8 3.3 ^A. ♦0.22 4.1 ■^^ m c c 9> OB 493 ria- C«n>ril Product Of A vtry l4^t* BAjorlcy of Ch« Cttt elfartce«« th«C w«r« tuDdtd out var* A vary t«r^ aajorKj ec cd« caac cigaraccaa caac vara naoaaa ouc •aoktd. Jot AMh produce Cria4 ovar half cba raapoodcaca raporc«4 thac chaj had ^\td fll cba clgarattas eheaaalvat aa4 cba reaaiodar had aaoked a raatob^le at^bar. Xa total oaly 2Z of cha teat cl|arattaj reoaioed uasaokad, and^-ti)i( figura scarcely varied becweeo che 4 product!. .\ Although aott respoo^«ttcs raported that they taoked the test cigarettes to a aonul butt leQJgth, a aloority left a longer butt thaa vhen seeking their regular brand. 'This mioority was greatest for cigarette A (2SZ), least for B (20Z). 'Other apacific changes in their aor«al-v$aoking behaviour were each mentioned by leas than SZ of respoodeots; S2X repcrjbid no change apart froa the iacreas«Jl|i bate length already aeat toned. . ^y ^>- Test Cigaretcys - Likes and Dislikes C^ '- ^ 'O. 'Aj. Sponcaneoua lik«^ and dislikes of the four cigareccn' are tabulated */ « ia Table 3 (oaittiag a ti^ cooaaents that were only aentioned by a very /^ small percentage of r««pendenj) . Cigarette A, with the lowest aicotiaa delivery, was cha lease llkad jucjging froa the percentage of respondents recording "nothing particularly like4*Laod "generally disliked/poor taste"; it was the aost criticised aainly oa the founds that it was too aild, too loosely packed, had a poor taste aad was^oot satisfying ("did not feel you'd had a saoke"). The coanents laply tt(((t cigarette A was loosely packed compared with B, C and D and CbAC it burned aore quickly, . . . ' / 08 though these criticisas cannot be substantvated by physical aeasureaentt C ^- i Cigarettes C and D were clearly seen as stronger and aore sa4fi5fying *^ ' Z ® than A and B which is in line with the nicotine deliveries; spontaneous ^ o» >4 494 ^13- ■■-•.>. \; TABU 3 SPOWTAMEOW ^JKES AHO DISIICTS Of TEST CIGAJUmTS A. B. C. D (X) ?^ r/ A B C D Sponcaneous Mket Nochiag parcicul^ly likad C«Q«r«lly liked/fouhd eojoyabl* 28 20 17 23 30 31 Easy to draw ^->. 24 28 30 Liked speed of bum/lasc«d a loog cLae 21 24 25 Firmly packed/not too loose TT , 19 25 2S Mild/not too strong '»<> Soooth/oot harsh "^'/-^ 19 22 14 14 18 15 Did cot nuke ac cough/did not burn/cool ScrOpg/mediua strength/right strength S«ti»^iog/fclt you'd had a saokc 11 \9 12 12 11 10 18 15 iik«d .at^iiailar to regular brand Spone«neo^JS BxAlikes Nothing pArticuI^rly disliked Too Bi Id/not «noughr;:castt 1-: - 10 '0. 10 9 17 26 28 20 ^28 Burned away too ^icklj Too loosely pack«4 /y 21 20 20 18 10 10 Too harsh 'V Too hot/burned ay tongue/lip* ^ ^ 17 IS 13 11 19 13 Made »c cough/irritated thro«c ^/y 13 9 14 Generally disliked/poor taste v^^ 17 13 11 Did not feel you'd had a saoke \l 10 5 Bitter/sharp taste/af ccrtaste '^V 8 10 Too strong/would prefer wilder 9" 7 15 0) c I c N I o- « OD 0» 495 approval of C aad D oa tccoonc of chtlr •crca(Ch allihcly outcuab«ra4 •poQCaaeouf llMMroval for b«Laf coo tcroot. Claarccta B was parecivai aa baLag cha tao«i$Me aod cha leaac Irrleaac to cha chroac. The covataSf. aate ky Lodlvidual clutcera vera broadly la Hat vitk chose suaaarited li^abta ), aod did ooc fall iaco aay obvious paccera related co Inner Need.O- Teat Cigarettes - Preftreoe* ^' The preference results ca'a^be expressed la two ways: (a) the results -' of analysis by the Round Robin prog'r%a which increases the effective HB^le sise by including indirecc or ioferred preferences as well as direc^^^^eferences; (b) the stralghtforvaf< preferences without Round Robla analysis. C^ (a) Rpaa4 Robin toalysis C^ For Cba varC^lcs listed la Appendix V (i.e. the €»al Maple, the 11 clusters, aad che'^nokers of specified categories of (^aretta) che Round Robin prograa calculates Che order of preference for the & produces and the statistical slgnificaAoe of the difference between any two products. The result, as applies ;-co question lib (i.e. where respondents were forced to state a prefereoc«) v» shown in Table 4. The order of preference for the four cigarcttaa readi ^oa left to right, and cigarettes have to be two cells apart (or aore) for the difference to be significant at the 951 confidence level. Aa exaaples of how^^ interpret the table, Cluster 1 significantly preferred D co both A and C, With B occupying an inceraediace position; Cluster 7 preferred D, C aod B Co A, differences , anong the first three being snail and statistically uareliaSViv Cluster 11 ' i ; - had no significant preferences, although there were distlocc inds^ations g vo 496 -ij- TABU 4 >. V \ BOUND ROBD AMALTSIS FOR fiETZHEHCZ ^■ to be significant. a c I c 9> O 497 -16- tb«c C cad D vcrc aor* ftvourcblj viewed ctua B «a4 4. Ic should b« eaph««lie4 that che dUteace tp«rc of «af two products la Teble 4 dcaote* tb« •catittie«l tlfalflcAnce of cb« difference becwcea cbea end it Boc oee^terily « relUbl* Indlctdoa of cbc caounc hj which ^^ ooe wet preferrec^ ctw other. For IntCAacc, because of Che l«rs« ouaber of respondeat! ^ cb« total saople the standard error of the differences was saall acd^eir •Lxolflcancc was thereby increased relative to the individual clstccrs and other sub-saaples, wtrlch y explains why cigarette A for thc^tjtsal aaa^le is placed so far to the r^ht. ^^^ ^ The aost strikias feature of the results ia Table 4 is the fact chat ciaarettc A, with the lowest nicotine d*(avery (0.7 m%) , was the ~ r- ^ '^ - lease ptefer^^ not only by the saaple as a wholr but by alaost every ■^ . "C- . aroup of aaokerSTi Cluster I waa the only genuine except lon^ tyen che 3 (roups who failed^TO distinguish significantly between/jpny of cIm cigarettes placed k dir^ prefer B wich a delivery ik(.0.9 ■(, but directionally A wai again tha least preferred cigarette even ^or these svokera. The coopiratively snail difference between A and B iooicotioe delivery coupled with the a^arent rejection of A by nearly all ^tegori«s of smoker suggesta some v^duct deficiency in addition to ibylow olcotine delivery, though Ic is noi ^lear from the "spontaneous dislikel^ (Tabl* 3) exactly what this daficie«^ could have been. "^ ^6 o (b) Straigftiorward Preference (^ \ '^, -^ It is possible'^ show the influence of variables wtGch war* aot included in Che Round R^^i" analysis by considering the overall preference <^ distribution of the foul teil) cigarettes (the total number of tiaes that each cigarette wes prafer('«d when coopared wich the ocher three cigaretces in turn, expressed •■ a 'percentage of che Cotal nuaber of tests). The preference discribucioo ia^pfyivn in Table S, which for comparison includes two of the variablea fr<>4 che Round Robin analysis. Coopared wich the tocal sample, staokers wt(> a high degree of concern for healch (score 25-35) have a slight cendervcy to prefer A and B (lower nicotine) ac Che expense of C and D (hithe/ nicocine). * This cendency is also seen among chose aged 60 or over, chos^ belongiag ^ Co social class AB and those smoking fewer chan 10 cigarettes pi<4e day; 9> 499 ^-"' .-i«- X TABU S PEItCEKTACg PK£FtREWCT DIST»IBUT10W >.. Tott^AapU Heal eh "b^cernt /-. 7-19 2D-24 25-35 Age: y. W-24 25-'S4r 35-59 60* Scial CUss: X: %, >> '^. V. -O. AB CI C2 DE CLg«recce« per ^y 1-9 ^. yo-i9 20^9 30+ '-/-. ReguUr Brand Nicocinc: Low Clusccr 10 19 19 18 20 A la 19 20 17 19 20 20 18 19 23 19 25 23 25 26 25 25 25 •88 -5^ Vr- 28 23 2<. V 23 2? 24 2i t^27 a r -J O >0' 30 7 ^> c I c 9> 500 -i>- bovcvar ib»«* tbovios tb« fructac C*n paee«r» In which praftreaca iocraaaai aloag vlch ch« nlcotiae dalivec^^C^^ C^ eifaretca; howrvar thla pactara ia aora clearly aeea in Cluster 10. ^y The poasibilicy chat aicotine, sod it is |g>s*ible that the inclusion of A nay ^\5vc bLassed the relative placiags of B, cj^< 6 >iaea ■ll«r in nicotioa ^Jkod D as computed by the Round Robid^ p^gras. In Table 6 tha only rasul^ fif>nsidered are tbosa in which B walgcpaparad with C and with D; «od si^^ tha latter tvo cigarettes were va^^ delivery th«s« two nired comparisons have been coabine'i^^to show ch* percentage of s«ok«rs ^Aferring B when coapared with C/D. TABU 6 PERCEIVTMZ P ^|CB R£NCE FOR B ACAlNST C/D ■^ Cluscar »>?- C/D ss r^» 43 52 45 57 43 45 SS 47 ■ 53 38 62 11 44 56 12 40 60 10 41 59 /-> '> y^ 9 C I C N I 0-- * 501 -ji- ATnilgTt KATCTC5 Of ClCOmH A. I. C. D A. ?^ U* SmA ■^iua l«^ U(kB«rf 1 1 7 3 9 ( 4 5 8 11 12 U, tt|ul4r .*•• S.l U 3.5 3.0 3.4 1.5 rjt. 3.0 ,2.» 3.1 3.S 2.1 S.« 2.9 2.9 3.3 3.0 1.1 1.0 ^ - 3.> 3.1 3.» 3.1 3.9 3.1 3.2 3.5 2.9 3.7 1.0 1.8 « A 3.4 $v7 4.1 4.0 3.8 1.8 SMDOTlCrtSS UgviUr 5.0 5.a~ 4.6 4 . 8 4.8 4.5 4.6 - ^ *"■ c 3.9 4.2 3.9 4.0 A. I 3.4 3.6 A° 4.1 3.8 4.1 3.9 3.7 4.0 3.6 4.0 4.0 3.5 -X " *.0 3.7 3.4 M-, 3* 5 3.7 3.4 3.4 3.3 2.2 3.1 2.5 3.3 2.3 'i^. 3.1 3.2 2.4 3.2 2.3 3.2 4'. 2.i 2.7 2.7 2.7 2.5 2.7 2.5 2.7 2.6 2.7 2.7 2.8 2.S llLt 1.6 1.7 2.« . . 1U1U4S TOO FAST A /li N « .23 .41 .4) .34 .47 .30 .32 .17 .:} ^•^« .26 .34 .30 .27 .39 .25 .32 .40 .n >23 ^ •*• .30 .33 .29 .34 .28 .31 .27 .23 n .21 .32 .26 .38 .26 .34 .35 .n CAS2 OF DKAU UfMUr 3.5 ; 4' 3.3 J.3 3.4 3.2 3. 1 3.0 3.0 31 1.1 i.ffy J.O 3.0 3.1 3.0 3.1 3.1 ^.^ 3.2 3.2 3.2 3.2 3.3 1.1 i^ • 3.2 3.2 3.2 SATISfAaiOB lUfuUr 3.* 3.0 3.9 2.6 5*. 2 5*^ -, , 3.8 2.7 3.9 2.6 4.0 2.4 3.0 2.8 2.9 3.7 2.8 2.9 3.0 2.9 3.2 3.0 J.3 3.0 3.0 3.0 3.1 3.2 >A 2.9 3.2 OVEIULL OFUtlOM UfuUr 3.« 4.0 . . 4.1 ;* 4.1 3.0 2.t 2.7 2.5 3.1 3.0 2.9 3.0 "j" • 3.0 3.0 3.2 3.1 3.3 3.3 3.0 3.0 0 ' 1 3.3 3.0 3.0 1 3.0 J. 2 3.1 9 C C 9- 502 •22- Ch«a A, U4 *itt> c^M txctptloo* til rtced D t^oal to or illihclj tCroQctr tKan C. Ttau« (W r«cln|t for itrtnsch rtfltcced ooc only ch« ordtr of the alcocln* ^Uvtftti buc alto ch« laccrvalt bctvcca cltar«ct«« vitk rctpece to aicoCW* JtllTtry. Tbi« It thown la Fifurt 1, where th« average ratiogt foirjCi^rengtk given by Che cotal saople of rcspoo^eact are plotted against th«^cocln« deliveries of the regAjlar size versio&s of Che tetc cigarettes. Ortbe oth«r attributes, the ratings for taste and satisfaction showed some sigfis of c relationship with nicotine delivery, but there were aany except/oos aaoof individual clusters.. It 'C^ '< . wcMllil therefore appear that respondent^ >«i th« whole were sensitive to ■ ^^ 0- -^ ■-* ^ cbe di/fereoces in nicotine between Che teM;-cigarectcs, even in soiae catet CO eke very saall interval separating D tij^ C, and that they used prlocipaVVv the scale of streagth-mildnets to'-£DdicaCc Che differeaces ch they percerv^^ In addicien Co cheir relative pva^ngt of the "^- .A wh 4 cigarettes, elaacersTV^re in fairly good agrecnent as to their «bt«l«tc levels of strength. For 1^t clusters the strength of their "ideal" cigarette fell within (h* ran|^. for A tl)4n for the other 3 cigarettes (2),. indicating that A had MrgiMlly V "">' tb« aloweir^ burn rate. There are two possible ejcplaoatxons for the ratings given, by respondents: either they were aii^aken about the burn rate of A, bat betause they disliked it for other reasoOf tKfj tended to give it a lov ratl« for all attributes; or they to\ini/$f. untatiafyiag and subconsciously puffedlat it harder or sore frequently so that it did indeed burn faster. Thet^ was a slight tendency aoong sose clusterv to find A harder to draw thaa ttUTothcr cigarettes; this again suggests that sookcrs Buy have found It unsaf i'sfying and subconsciously tried , ''"^^ to get oore out of it, because physical o^isureaents show that A was /^ <^ cooparable In pressure drop with C and D and" SAsewhat lower than B. - ~~'?- Finally, the ratings for overall opinion grflveri«s; » •^ f o» however the preference results calculated by Round Robin Analysis gave * Notable exceptions are Clusters 1 and S. The overall opinitfn^of both /• . 504 ordtrt 4(p, I, k, C for (iMtcr t aod D, I, C, A tot Clvft i, both of which trA.tOBBvhAC lUofictl la t«cma of aieoeloo. B«e«uat of this taoMlx ch« prtlwii^* r««ulca for ebot* c«e ela«c«rt ahoaU b« rt(«r4«4 vich (oaa tutpiKloa. ^ •. Ia;1..9 og rscher chaa l.S ag nicocine. The second consuaer cesc, resulcs of wbich are discussed *^ c below, WIS ia effect an acceapc Co rectify this situacioc. '^'^y * \P ' ^^ O 9k /, 505 -25- 2. St<1«*"' regular brands, probably «9 a result of the price increase; th'fi'.was trr** of all clusters, but '^. ^>%. was^eatest for Cluster 6. v^^ Inlioly 1975 a further tar and nicotine ^'V^gua table" was issued (4), which "sSoy^d that certain major brands on th^^^^.K. aarket, notably Players No. 6 ani^^J^abassy Filter, had increased in oi?'(^nc 4«llvery froa 1.2 Bg to 1.3 n^^Using the previous arbitrary definitions of "low" (less than l.O agj^^jiedium" (1.0-1.2 tg) and "hUh" (1-3 «« *»^ above) this caused a ^sid«v»>Jile shift froes the "sediua" to the "high" category when respondent*' reguW brands were re-classified on th« new data. Table 8 shows the percentage "dUtribution of respondents' regular -/; brands across the three nicotine and f out' Jar delivery bands at the /*! <; tvote of the 2nd test. - ^/^ As in the first test, respondents w«ra"ask^4;>{o rate their regular brand for a range of attributes. The ratings are shd^ in Table 9 which classifies the brands into three groups of different nicotine C ^^ -- delivery. J' ^ • -^^ 2 o 506 ^ -2»- ^. ^ TABLE 8 ' ^ UCULAt BRAND DATA BT CUISTEt >a^.„ loeal Sample Lov R*«d ttedlua Need High Sc*d I. . 7 3 9 6 4 5 8 11 12 10 Nicocine Delivery < 34 <1.0 as 1.0-1.2 Bg 11 32 0 37 16 35 7 33 6 31 8 34 7 37 6 39 8 35 9 32 >1.2 a« S« 70 ^Z 63 49 60 63 58 56 55 57 59 Tar Delivery ''■/,■ y'<;2 mi 7 0 9 0 ■>-. 7 6 6 6 6 8 8 12 < 8 mg 29 20 30 26 27^ -;p M 25 25 34 27 27 >2J « ■ -5^ 63 75 61 74 59 5^ ^ 64 68 59 65 65 I S 0 0 0 2 % co I I 0 0 • ^^C opisros! ( TABLE 9 > or R£CUI-*R CICAR£rrt BRX^D -0. \-*. ' M Total-: Saaplc Nicotine Delivery of Reg ular Brand '^ Low <4-jj^ mg Medium 1.0-1.2 Bg High >1.2 Bg Screngch 3.6 3.5 3.7 Ideal Strength 3.6 2.S 3.8 Sawothoeif ft. 5 5.1 4.4 Taste 3.3 3.1 3.y:. 3.3 OB c Speed o£ Burning •0.39 ♦0.54 ♦0.39 ^. ♦0.36 c Degree of Satisfaction 3.8 3.2 3.8 /i.8 o "»— T o 507 -27- •^^ ii> CoaptrUoQ vicb Tablt 2 ibovs ctuc, •• b«for«, Ua noktra o( low * nicoda* brAa4« viewed ch«lr rtgular brand ractMr diffaraatly Croa •aoktra of oebat lucca» (ixkdlAC ic aildar, >tb«r, lata aadaf/laf. aotDcvtvac pooravia cMt* aod burning dacldedly coo faac. General Pro. ^>. butt 'when they sacked the test cigarettes ^*n when they sacked their recular ^-and. Overall this ninority aaounted "^o 32X with cigarette E ■S' '^^ and 28Z vit'fi^c^arette F, with *o«« eoarked differ^es b«tveea cluster* o; as shown lo Tabr^O. X> ^O TABLE 10 \ PERCENTAC8 OF Rt^OSDENTS LEAVING LONGER BUTT THAN USUAL O Clust*ff 1 7 3 9 4 6 5 8 U 12 10 Total '<^ rctte E rr 18 27 2« 30 39' 29 33 29 29* 38 37 32 /j '6 O^ .< 32 >35 Cigarette F / 7 > c I c N I o o 508 V^ 'It' Th« vti|b(«4 STtrtitt tboy.cbsc sort Low M«*4 taolMrt ttaitd to 1mt« • loag«r butt «hM moklog P Cbaa wticn taokiof I, vUtm* vlch Blfh ImI ■■Dkcr* ch« r«T< • tru*. Ap«rc froiMhit dU f ^<(4ni ■otbin^!!^rcicularly liked ea«7 CO i^AW Firaly pacfc^^wcll packed Liked spaed tf^ burn/lasced a lon( cioe Mild S^ Snooth/DOC harsh "'/^ Saciifyiai ^_ /l o W 509 '^^ -29- Proa t^ti tpoatuieoua coancnCt ic would app«ar th«c eltarttt* t vtt |ec«railT (Ma as •troctt«r aod aort •acitfyias, ei|artcc« t vat ««c a* mildar, •llg^i|^aoocb«r and rachar fate buraios. Coamtatt that t vat liked became of it« ttreagcb and tacisfaccioo vcr« Co b« found at all Itvelt of Inn^-^eed, %ac inrcicularljr aaoos Clutters 4 and 10. Coaments that E was I'ixfd bacause it was aild caae particularly froa the Low Need clusters. /. /. Test Cigarettes - Pref*reil<;^e y ^ -■'. Consumers were asked two queations ralating to preference: "Which "^ the two cigarettes did you preferrr (referred to below as "free choTo^" - i.e. they were allowed to say ctjat cHey had no preference) Ay w> and "If "Qau had to choose one which would you ^efeirt" (referred to as "forcad chofca^'). Table 12 shows the answers to"^:fe>th qnettions, by cluster. la ehi^ree choice" situation the pcrceDCn»-^^ra£arance hat been calculated on ru^basii of those who expressed a prej^renca one way or the other, ignoriRj chose who had no preference. PERCESTAa TABLE 12 RRIVC E OR F BY CLUSTER ^^ Cluster Free Cholca "O^ Forced Choice i Base Prefer E Prafar F Prefer E Prefer P 20 4S 55 -iz : 41 59 50 50 57 ^'^51 49 44 56 27 x_ 52 53 47 37 49 45 55 44 45 ■•";- 55 35 65 72 35 -<'36 4>, 41 59 66 44 56 44 66 58 11 47 53 86 47 5^, 12 42 58 49 43 57 "^ 10 42 58 78 41 59 Total S71 45 55 604 45 54 a c c N I. b O x: 510 -30- V-- Ovtfl^^l, BoaM SSX of cb« (uiplt «xprtiic4 « pr«f reporc (1) which '^ •ueeesced a conflict between concern for. Che haalch ei{«ccs of smoking v ** -^y e and Che desire for a sacisfying cigarecce. Ic is al*a int<^ting to C note that, aotong che group of abouC 200 saoker* wich a high siforV for 2 health concern, 56X preferred cigarette F with a nicotine delivery* yt considerjbly hi»hi^r chAn any of the iMJor br.md* on th« U.K. inarkec. 511 -31- /. y \ ■^ TABLE 13 ^n^airrACT PKimota ahomc vakious COSSUMEE CW )UPS ^^ B«a« 1 f Bcslch'^ccrmi ., 7-19 V 4. 25-35 170 212 198 42 50 44 58 50 56 kit: ^>, 16-24 102 47 53 '';v 25-34 Ci5r59 129 39 61 283 48 52 '^ 90 47 53 Social Class: AB ^^ 79 47 53 Cl %. 129 49 51 t. *7 41 53 59 — «-'0/ t«jut^ Brand Nicotine: <1.0 ag Q^ 1.0-1.2 mg %- >1.2 Bg 46^ 203 %. it 347 49 ^ ■^51 Cigarett«f p«r 0«Br: 1-9 35 37 63 -^ 10-19 199 47 53 %20-29 193 176 47 44 53 56 Brand Most Often Swkcd: "^/^ Benson i Hedges Range -^ 53 38 62 Embassy Filter ^ . 122 55 45 Eabassy Regal ^-^, 33 67 Kensitas Range Players No. 6 360. 138 47 ~49 53 51 a c c Players No. 10 24 rt/ 71 Silk Cut Range 25 40 ^'^ ■^, ^v I 512 -J3- TASU 14 ATTHBtfTt lATtMCS Of CIOMTTTS E AKP f N^. Low U»d (todtua lead ai(k Rt«4 1 %. > >' « 6 4 3 • a U 10 STRfNCTH Id««l J. 4""- '^. S.O J. 4 J.i 3.8 J.J J. 7 J. 7 4.0 RetuUr }.4 ).0 J. 4 J.J 3.8 J.J J. 6 J. 7 J. 9 ).) J.l^- 'J. 4 }.2 J.O 3.2 2.9 J. 2 J.7 J.i y 3.1 J.J J.f J.« 3.9 J. 6 J.l J. 8 J.7 SNOOTRJCSS Regul«r 4.6 4.9 4.6 " |W 4.3 4.4 4.6 4.jk 4.4 4.4 ..- 4.2 4.1 J. 5 4'.t' 4.0 J.S 4.0 J. 6 J.7 J.J ^. 4.0 J. 8 J.J J.J' "».« 3.6 4.2 J. 9 J. 9 4.0 TASTE NleguUt J.J J. 4 J.J J. 2 j.r ^ » 3.2 J , 2 J.J J.J J.l ■"'. 2.« 2.S 2.7 2.7 2.7 2.5 2.9 2.7 2.6 2.8 t.l JO 2.3 2.6 2.6 2.8 2.7 2.8 BUMS TOO FAST \ .41 .27 > • OO .22 .24 .41 .JO .12 .23 .24 .24 . .22 > .JO .26 .JJ .JJ .JO .24 CASE OF DRAW RecviUt }.> t;^ J.J J.l J. 2 3.3 J.J J. 3 J.J J.J 2.« '•' i J.l 3.1 J.O 3.0 3.2 J.l 2.9 2.9 2.8 ).i H J.O J.J 3.1 J.J J.J J.J 3.2 SATISFACTION RcguUr it J. 8 ,.."■-. J. 7 J. 7 J. 7 J.S ).» J.; 2.< J. I J.l 2.9 2.7 2.9 2.7 2.9 2.8 J.O l.l J.l J.l-^ '^i' J.l J. 4 J. 2 J. 4 J. 2 OVERALL OPINION ReguUr *.J J. 9 4.5 J. 9 »•*. 4.1 4.2 4.1 4.1 J. 9 J. I J. I J. 4 J. 4 IJ5 J.8 J.l 2.8 J.l 2.9 J. I J. I J. 2 3.2 S.O »•'*:. J.S J.J J. 4 J.J 1 ^> 513 Attrtb*C« Rattngt Th« tccrt^u raclast «r« %iva In Tabl* 14 which follovt eh* t (ormac «• TabU^^ilb. k» b«forc, 31\ cl««t«r* iodictccd chat tb«ir regular brand cac« C^-. ' • ■^ close CO thair "Iddu-" In tarsa of acreogch; cwo of cha Hith Need and Cvo of Che Medlua Need ^i^scer* would appear co prefer a cigarette •oaevhat stronger than then^-rcgular brand. Host clusters perceived ^- cigarette F as beiag stronger flvio cigarette E, which is in line with C- c , - their nicotine deliveries. There wrfe, however, two exceptions - ^ 'V/ Cl^^ters 1 and 11; why this should be sp-^s difficult to understand becaus^n the first product test these tw^ij^ustara, in company with all the o^^rs, found cigarettes C and D stron^ffi^ thaa k and B. Satlafactlbn, which was defined as "the extcnC;

>4 ■"^ 5 514 Th« ntlncs for chrtt of cb« accrlbuttt - taoochnctt. Utct aad ««tt of 4r«v • Ihov « dUciocc rclacioashlp vlch ch« l«v«l of lanor Uichouc ozeopcloC %t High R«od eluttort r«c«4 P «• Uccor chaa f for •II chrco Accri^tes, wtMreai ch« Lov Heod clutctrt raced C •• •qutl t» or better chaa F n^ all three. Phyalcal ■easureaeoci (3) tbowed ch«c F had a loaewhac lover ^esrare drop than E and aighc therefore have been margiaally easier to dMv. A potiiblc explanacioo for thi* apparcac difference la perception betveW Low Meod and High Need naokert aight be that respondents first decided^vbich of the two cigarettes they liked ind then rated that cigarette higher nr, a mabar of attributes, including physHal attribunes for which there was no-r^al difference. On this basl* LoW^eed smokers would have liked E bette> thaa P, High Seed snoker* would, E^vc liked F better than E. The scdr^s for overall opinion, 'o« « sca^ ranging fro* "excellent" to "a verjQkoof .«l$jrette", lend support to this'v^w: of the four Low Need clusters 6^ gav* a higher score to B, two tc&rcd tbea equally; all three of the High Nead clusters gave a highoc tcore^^^ P. The picture in tcras of ove^ll opinion docs not exactly tally with that based on percentage preference, further analysis, described la the next section, was perforaed In order^xa clarify the situation. *^ Further Analysis of Results -" ^ When the second product test was inlcfated 0)e computer was prograaeed to carry out certain analyses and to print out the <1($vers as a series -'a of tabulations. The results discussed so far represent V'suciaary of 9 those tabulations. Attempts to Interpret the results reveate^two areas |^ o where additional analysis was required: the computer was progranta^ •• accordingly, and the results of those additional analyses are discussed ■* below. 515 ^ -35- x • Logleatl^, CO* would txpMt ch« p«rc«aus« prtf«r«ac« (or om clt«r«CC« ov«r ^S»ir to rtfltct ratpond«nc«* eT«r«ll oplnioo of ch« oa« r«l«tlv« c^-tht o(h«r. As already lodicaccd chit wa« ooc ch« e««« with ton* clutter^' To (•ciliVats coi>p«rl«OQ b«tw««a p«rccatag« preference aod overell jinxes Figure 3 (hovt a plot In which the overall opinion ratings fo^igarattc E have been subtracted froa those for cigarette F to give the "L Oyerall Oploion": where this Is negative cf - ' . ,- respondents had a higher opinion off, where it is positive they had a higher opinion of F. Comparison of Flgore 2 with Figure 3 shows a Dufflb^ of anomalies: for iostince, S6J of'<(Ujster 3 said they preferred clgarettcC^f SQ<) ycc oo average this sane clus^«£ had • higher overall oplntoo of ci^ette E; only 532 of Cluster 11 saTtf^hey preferred F compared vlth ^t^T^ Cluster S, but In terns of overal(]>}piiUott Cluster 11 favoured '^^o a slightly greater extent than d^ Cluster S. There are two possible explanations for this apparent anomaly: Explanation 1 - A considerable proportion of respondents gave the non-preferred cigarette a Hu^er overall rating than the preferred cigarette. r$ Explanation 2 - The percentage prenMace figures may conceal the strength of the preference for one or ot^er cigarette. For lostaoee, those respondents in Cluster 3 who preftrr^^igarette F (S6Z) may have preferred it only slightly, whereas cniose who preferred E (44Z) may have preferred it strongly. / ^ ^C^ c To decide between these two alternative explanations, a^'ltional is* o computer analyses were undertaken in which the stated prcferenctT^ ^ 516 "it- \ lodlvlda^ t«ipoa4tact, irlchia elta«C«r«, mt eo«p«rt4 vich ch«lr overall oplaioaa of Um cvd clgarocCM. Tb« rtsulea art tmrnttlfi la Tabla IS. Ifoorlag ch« ^- loo laco elo«c«ra, tba saapla haa b«ca dlvidad Into Choia who /«rtfacT«4 clgarttc* B, chott who prafarrcd P and choa* who had oo prafarMb^ altbct way. Vlchia cheaa grouplaga the overall oplnioQ of each retpotn^c for B has b«en lubcracced froa his overall '-^z. oplnioa Cor F co give a di^rcoc« rating which cao range froa *A to -A: positive values indicate cXighar opinion of F, negative values indicate a higher opinion of E. ^. -/■^ C PREFERENCE /kND OVERAU. OPIHIOK OF |TaDIVtDOAL RESPONDENTS c ■"^ vr ?A Overall i ic N I o 517 -37- Of t^M vbo mU tti«7 pctftrrcd eigtrtcc* C oolj 6Z (16 ouc of V . 2S6 r«ipoQdc«C«) s«v« « blglMr ovcrtll rtclos Co 7, tad for Cho vtsc >C chctii ■Ajorlcy of chcf^JlS omC of 16) cbo diff«r«ac« la ridns vsa ooly 1° u&ic. Of cboce vbo lui} cb«y preferred P oolj 5X gavt a higher overall raclog CO E, and for Che ^jorlcy of efaesa (11 ouc of 14} cha dif fareoca vaa O only 1 unit. For Cha coaparaClvely snail nuaber of retpondeaCi who expressed no preference all-^uC ooa raced Che cigarecces elcher equally or differing by one unic. "*■>%, These results would sees Co ?ivposa of Explanacion 1. '^^ To seek evidence for Explanacion {.ic la necessary co look at Che resuC^a by cluster. Table 16 shows, for '^l^h cluaCcr in turn, Che average Mwrall racings given Co che Cwo cigarit^es by chose who preferred E, and Che »M) for chose who preferred F, wich Lfl(i>^ach caac Che dif fcreaca between th« Cwo-'' outweigh the positive A acoraa, indicating that che strength of preference for respondents in chesa chree eluaters ^ho preferred E was greater Chan che scrength of preference for chose wtis preferred F. For the High Need clusters (11, 12 and 10) the coov«rse<>^ true, those who preferred F doing so nore decidedly than thost who preferred E. These results support Explanation 2. '•'^ 9 / C I C ^>. o -'-. t* ir "4 9* N 518 ■3«- tABU U CLUSm AVOtACES FOR OVtRAU OPINIOV /.Clu«t«» /^, c^. \. <9 ^ ^ '(y 6^ "6. 10 rr«f«r B 4.1 4 3.7 4 c I c rs> I e ^ST 519 -i9- (b) ]Mm1 Screnith. f«rc«ivd Strtoteh %tx4 fT*t*t*nc% R*fer«ae«hM tlrMdj bcco mtd* Co eh« eoae«pc of "idMl scrcofch" by which 1$ mtMai^Jafk aa«v«rt gives by rtapoodsncs eo ch« ^u«»cioa: "Which tctCeaeaC-bese 4Mcrib«$ bov •croag or sild a ei.(4recct should b« if it it to •uifc^u pwfoccryT" la th« Mcood product ceic eh« average score* for "idMj atrwifth" given by the various clusters ar« included io Table U, and PJ^ure 4 abovs these scores plotted agaiasc X the Inner Need level of each cl««ter. Clearly there is a positive ".■ relationship between the two, the'^i^l strength" of a cigarette iHcteasing along with the level of Inn*r. Need. In both the first aod • '"• ''r the second product test it was shown that,>^ and large, the average racings f^ strength given by clusters reflecte^ the nicotine deliveries of the test ciArettes. On the basis of the resufi* ploCC«d in Figure « one could «rtue,^x^r«fo'^«» '**' '•>« nicotine delivery^ th* "Ideal" cigarette differs subMantially between clusters and is poiltively related to the Inner NeedcTl^vel. Whether a cigarette which cones close to the "ideal" in strength i»,;>in practice, preferred over another cigarette which is not so close <^l presumably depend on the relative importance of strength/nildnesa when^fat alongside other attributes such as taste, saoothness, ease of drav, t^ter^t burn, and so on. In the present instance the data for cigarettes E «n^" 8 44 18 12 2 i ^!^ 6 25 8 10 11 9 - "% 12 33 20 Total 134 63 60 65 175 \ 309 128 Although, on average, cigarette F was perceived at befilB stronger than cigarette E it is apparent from Table 14 that siany individ^l ^- respondents must have had the opposite opinion. Further analysis was 8W-W2<-01715 521 underCAkW tt UeaciCj ChoM ladlvidtult wbo found t tcroastr ch«a B, ChoM vbo foMi E •croogtr chaa T «n4 cboM «^m (ognd eh« Cvo ei|ar«cCM cqu«tlr acroog, ^1^ tb«a co ••« wbleh eC ch* eve eltAr«cc«« Mch lodltrlioal preferred. Th4^Te«itt« «r« thovn La T«bl« 18 which groupi retpoodcou ^^ by clutccr «ad by te^«l •' Heatth coQc«r«. A turprltlng feaCv^ of Ch* r«tulcs it Che lerge ainorlcy of respondeac* (31t overall, ^-41S U iadi^iduAl clu*ccr«) who perceived cigtrecee E «• tcrooger then F- A«tplt« Ici lower nicotine delivery. ~ A* shown la Appendix I Chit cenxMt ^setblf b« etcriboted Co Che upper eW of Che nicotine d iter ibut ion for ifjpple I overlapping the lower cad of cKe nicotine distribution for aaaple F-tecauee Che extent of overlap % ^<> >. w»a aown^^ near sufficient. Product characteiMStlee OCher than nicotine delivery do r^A provide a satiafactory explanetiot^either. A possible clue auy %• Couo^Nry exaaining the detailed results u)r1(abl« II. Nearly YtalC che<^mplc (47X) reported F «s being stt4>gcr chaa E, which is in line wlcb th^r nicotine deliveries. Asong this sectioo of respondents all four L0« Me^ clusters preferred C on balance, all three High Need clusters preferred F d^balance, and the Hediua Need clusters splic two and two with regard CO pret^rencc. So on this basis there was a distinction between Low Need and Uign'^fcd clusters in the directioa predicted by the hypothesis concerning preficred nicotine delivery. However aaong the 31Z of the sample who, s3rpr i .<$ VJI « I IS 20 l« 11 20 « II U 2 T 1 '^ 4 121 1 t 3 I ^'K 4^^ %" z^. 41 *. <^ "o. o ^A ^. % '-->> •/^. 6.- c I c M I o I 523 -*3- pr«f crcncs^ Cad luvlo< firit 4 In terms of the percentage of respondent* preferring the cigareCJU nhicv^as raced a* ailder Che weighccd averages for Ch* chree levels of loaer Meel^^^re as follows: Uw Need ^^66X Kediua Ke«4 ^9^ High Meed 532 ^,< Overall, 58Z of respondencs preferred the cfgarec^ which they rated as being ailder, a result which is in turked contrast co')he face chac S5Z of respondents preferred the cigarette which, in terat of nicotine v delivery, was in fact the stronger. ^/v {^ OS 524 -*♦- Iad{e»ttont fro* S«con4 T««C Bai«4 put^y on eh« aua6«r of rtspoiulne* •xprcttlai « pr«f«rcnc« for oa« ci|ar«tt«^ivcc ch« other Ic would appear chat jute ovar half the saapU pitfii^t clfarctta dcliveriag about 1.8 ■( aleodaa to on« delivcrioi about I.IM nlootinc, tha lattar balag the delivery of th« two Bosc popular cigareucs o« th« U.K. ourket. Contrary to the results of the first test there Is B$,loog«r any iadicatioa that light saokera ^-'_ and those who oormally smoke a 1^ nicotine brand are likely to favour - - ^ i • a cigarette delivering around 1 mg oLlotiaa; indeed both these categories ek^ressed a distinct preference for the'J^S ag cigarette. Again, as is the firat test, there is little indication^^XTpo the preference figures that the Kffc^fcd nicotine delivery increases O^ng wick the level of Innar leedii^ 0-^ Bowevsr it liyclear that the crude preference perc^magM ettly tell part of the story. ti(^t are sooe coaplex interactions involving th« /A perceived strength of a ctMrettc, its nicotine delivery, its acceptaae« by the siaoker, and the saokcr^i level of Inner Need. Answers to tha • . '^ question: "Dow strong or aili shcn^ a cigarette be if it is to suit you perfectly" varied between clustery and as the Inner Need level of the cluster increased so too did tha strcn^h of the cigarette which S was regarded as "ideal". Of the two test cigifettes, the one which was - '^fc^ judged closer to the "ideal" in strength vat pref»^ed by a substantial ^^ majority of all clusters. On average, cigaretta F wir^jrated stronger '.^^ 00 than cigarette E, as would be expected froa their relative^nicotine C ^ k deliveries; but 31Z of respondents actually rated E stronger if^tp F '^ >r ifvas for reasons which arc not obvious. Irrespective of whether C or i^as >i «o 525 -45- x: e«Qtl4tr*< Cb« tcroascr chcr* waa aa ovtr«ll ctadtac/ co prtftr th« clg«r«Ct« vftUk was raced Cb« aildcr of ch« cvo, aad Chi* ccodcocy loectatad at Ch4l l|9«l of Inner >««d dcre would prefer relatively high nic6flne cigarettes and would reject low hXcotiae cigarettes, whereas groups wl^ a lov Inner Need score would probably find low nicotine cigarettes qui^ acceptable and aight well frefer rhqa to those of relatively high oicoc$&f delivery. In also asked a set of specially designed questions aiaed at exploring their concern for the possible A. ^^ health risks of snoking, because of the possibitTay that this aight influence their brand choice and their cossBeats on tt^ test cigarettes. In the earlier report (1) it was aentioocd that, soo^ years ago, the laperial Tobacco Coapany concluded that tha optiaua oicAiae delivery for U.K. sookers was around 1.4 ag per cigarette, and that any S^staotial q C 527 loMrlng ff tbt dtUvtrj b«lov this f Igurt r«iule*4 ta r«j«ctloa by eoofuaert, t^m r«Ct of rtjccdoo lacreatlai cbc aort ch« dtUvtry w«« reduced. Th«r« If •»chias la ch« ?ToJ«ec WHEAT re*ulc« Co •ut(**c Chae ch« optioua aictfune 4tllvcr7 for che average of a >«aple of O.K. aala "^ •Boker* is, aov •&/•{«<■ thaa l.€'ag, despite cbc general reduction la dellveriei which has c'^to pla«« since the I.T. Co. survey was carried out; indeed it aighc be coa^uded froa Che second produce Cesc that che opciaua is soaewhac above 1.4 a^, perhaps as high as 1.6 mg. These '~ findings, of course, are based oa ^ licuacloo in which respondents had n$ knowledge of the deliveries of che elgarcccas that they were smoking, and tbe figure might be different when saotclag branded products for wlilch chp4eUveries are published in "league r^^les" or even printed on the pack. ^ 0^ The Vraocherri concerning che link between Inner ^^fM nA Referred nicotine delivery is «(dy partially confirmed. Taking accent noc only of the actual perceatagc ^ference figures, buC also of other mcasuras of the coaparative deuaa of'-^klng for the test cigareccea, ic can b« said that High Need cluscara cenf^ prefer relatively high nicotine cigarettes, and that cheir opclaua ntratine delivery is certainly higher Chan is that of the Low Keed clusccra. ^V(^c other hand Che lowcsc nicotine delivery cigarette that was casced f0^7 ag) was rejected by a aajority of all clusters, and tha next lowaic dei^ery (0.9 ag) was probably rather too low even for the Low Seed cluster^. In other words the separation between Low Need and High Need clusters vtv'terms of a c preferred nicotine delivery, although in the direction predic^d by the -^ ^^ N hypothesis, was not at large as expected. However clisslf tcatiotf>f o «4 528 -A9' ch« reipoo4«mc< iaco deaographic croups, or Into groups b«st4 oo cb« Dumbcri or cypM of el|araCt« Out thmj taok«, gav« «vca saalltr ••paratioa In cerms of pr«f«|(r#4.°'-cocia« l«v«l than dU elaaslflcatiott Into InaiAr Reed groups, ij^is 'oot ^ssibla Co put praclsa figures to Che preferred aicodne deli.ver7 fin, dif{«r«at-«luscers, buc th« indicacions are th«c cigarettes delivering Wround 1.0 to l.S mg arc better suited to Low Need clusters and cigarettes del^i^criag around l.S to 2.0 ag arc better suited ^ to High Need clusters. The iaajf^. of « cigarette la tcrvs of streogth/ - - nildness is perhaps nore related t'O* Iqner Rccd than is Its actual oicotioc delivery, the lower the Inner Need the^^eatar Che tendencT to prefer • ci^^ette which is considered alld. '^. Conaajrn for the possible health risks of s^i^iag Influences coosuaers in th« dlrectiqA of trying low delivery brands. J^l^ concern for health is largely ladepdnifnt of Inner Need, is present la hnW^ smoktts as well as in light staoV^ji, and is spread across all deBogr«^vj.c ^roops. However there is cvldenca^f a conflict between concern for health aad \ ^ the desire for a satHfjring ^^&*rctce, froa which It follows that lov tar brands would be auch aora vii^y accepted if their nicotine deliveries could be brought within the taaga rehired by groups of consumer. Although the Inner Need sco^« any gi9* <'"^y * rather diffuse indication of the level of nicotine which suits aeab«rs'of,a given cluster, it does correlate well with other aspects of snoklag bch^v^our such as cigarette consumption and depth of inhalation, and also vith t^.dif f iculty, either anticipated or actually experienced, in giving up sacking^ It is considered _ a Sufficiently isiportant influence for inclusion In further kpvpstigations. r At the sase tine auch of the inforaation which was used In assigaOtg o '^ •M ig u -<.» 529 -4>- r*«poBdeae« Co clutters •««■• eo b««r oo ctUcloo to cbot* Mp«cct of eh«ir taokiaf VAaviouc ch«c v«r« •xuu.aed. Sp«eieie«ll7« Ch« faceorc elue vtr« Ub«ll«4 fbcUl Sivklac, SocUl CooCU«ae«, ttlueuac Swkla( «ad Veckead S«^^^g 4e aoc ataov «ay «vl4cac« oC b«Ln$ rclttad «lch«r Co (aokiac eoatuapt^^/dapck of iiih«l«cLoa or eo ropoadeaet' opUloaa of ch« cetc ci(«c«ccc*»<^'\J%is bouig ch« cas* ic would b« prtf«r«blt Co poticioa reapoadencs aloof ctlj^ atagl* dLseaaloa of loner Heed oo cb« bacLt of cheir respoasct co a Hi^ocly oiaplif led quetciooaaire coopoacd -of chose items with high loadiogs m Che toner Seed factors. This fora '■> oc-classificatioa would clLaioate all factor oad cluster aoslysis, together with the expense iovelved io perf^^iag soch aoalytes, and by o«itci4k items which appear irrclevaat it mipAC lead Co Inner Meed grouplof* ot'^ofter definition than the present "(^T cluccers. Tb« •uggestio* U ven^^uch in liae wich that made by KusWLi^ (6) «ho, after Isolating six differeih,^factors as a result of a rather similar tmcise Oy '^ • relating to aotivea for inkiag, concluded that it might prove more "^ useful to classify saofevts scC^ding to their position on a single dimension of phamacologTbel addk^ion rather than io terms of their profiles on the six types of saoki.ngV9 '^ When designing products Co aooc the'^auirea»ents of specific types of consumer, classification of Che latter on 'ihe Inner Kced diaentioo could prove a useful indication of the nicotine delivery to be aimed at. However thac by itself would only be an acteapc to me^ one particular requirexent, and it is Suggested Chat, acche very leJiti^^t would be g c important co regard consuaers' concern for the possible heal^risks of c SBtoking as another rcquireacnc which has co be sacisficd. These' .C^ o '*' ^ 530 -50- x: iimtaaicmM of Inner Head and coocaro for h««lth could. In face, k« retarded aa tvo azaa, cha tecood of which Inf luencea coaauaara to avitch CO brands of lov«f t^r dallyarr (and probably. In the future, to braada vith lover delif^rict of other coostltuentf such aa carbon aonoxida when theae feature In '^t^a|ue tablea*). The aodcl below conalders the aarfcat in terms of these two a^s, and aug^ests the kind of cigarettes which should, checrctically, aatC^ various combinations of loner Need and concern for health. *"•<-, '/-> '<^- y. ^ 'c. § 8 X o 3 s low tar, low oicocinc brands ■^ •^ low ta»^^-^ Bed i urn ^'/-^ nicotine fairly low tar, fairly high nicotine ^ \>{ifiAt wich " Bodrcnxc deliveries of botic car and micotineQ 9? medC(A.tat high W^ottM -v o. <^/> '^ ^o. o ^ high delivery brands, both plain and r.T. increasdk; ik^jer need o, ^, Three of the cigarette types shown in the model af^ not currently aveilable, 'A-^ certainly in the U.K. market, but are technically feaii]blc. In the top v^. right-hand corner of the nodcl cigarettes described aa "fairly low tar, ' a fairly high nicotine" are intended for consumers who combine a^osiderablc ' C Mportions of conauacra in each of tne^atftforiea. Alto Che proporciooa foun^vt Che U.K. aighc be very diffcrent^oa Cfaosa in other narkets. Tta« BodeC^^s in any case over-siaplif ied, and the diffarenc Cypea of cigarette shoald pm^rly be shown tt aerging into ooe anocher racher Chan separated by rigid b%)odariea. What is iaportant ia not ao Wich the precise detaila of aarkac <{^eoc aiaea and cigarette deliveriea but racher Che general concept tlwt Che Q^ separate influences of Inner Need and concern for health together create ^n opportunity for producta < >■ which, at present, are virtually non-cxiscAc. i^/ It is suggested that the nexc stage of lnvesti|i«ion should concentrate on verifying the broad principles of the nodel. A aimpl^ied questionnaire relating to Inner Need should be constructed by exaisinacion-O^ the existing Project WHEAT data. Following this, a further sample of U.K. rei^ondenCs, hi i o N 9t 532 •S2- BOSTON PUBLIC LIBRARY 3 9999 05706 6787 z^-- poxibljr laeludint feaal* «< v«ll •■ ult (sokcri, tbould'b* clatsiflcd In c«r«j of th« tvo diBensioni ted chtlr rMctioot obcalntd Co «xpcrlaeDtal clgtr«tc«< of th« type* indicactd. D«(ifnla| and aaaufacCurlag suleabl« cigarettes villr' inevitably take aoac aontba. While Chia la proceeding Chera could be con^t^crabla ad^Xncagc In incorporating Che queationa on Inner Need and concern ^or health into ongoing narket research, with the aia of showing how far the Itportanca of these two types of influence is likely to vary from surket to 'aarket. /^ '^4. '^■\ -V O, ^O ^. R£FTR£NCtS % •o 9d, ^. %, 1. B-A.T. Report «o. R£r>|229-R, 10.7.75. 2. B-A.T. Report No. \..l*h4^ 24.9.74. 3. B-A.T. Reporc No. L.4M-R, f\l.l%. 4. Tar and Nicotine Yields of Cigarettes. Depircmcnt of Heal th and Social Security, July 197S. 'O ^A KcKennell, A.C. A Comparison of Two Sooking Typologies. Research Paper 12. Tobacco Research CSunciU London, 1973. Russell, M.A.H., Peto, J. and Patel, U.A. The ^assif ication of Smoking by factorial Structure of fk>tives. J.R. StdCist. Soc. A., 1974, 131, 313. ^'^ c I c o ISBN 0-16-046954-6 9 780 60"469541 90000