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Statement of R. J. Reynolds Tobacco Company Before the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health and the Environment Concerning Whether the Food and Drug Administration Has Jurisdiction to Regulate And Therefore Ban Cigarettes April 14, 1994 TIMN 0046266

RJ. Reynolds Tobacco Company ("Reynolds Tobacco") welcomes this opportunity to respond to the inaccdrate and misleading attacks that have precipitated these hearings. For the past several weeks, Reynolds Tobacco and the rest of the tobacco industry have been bombarded with spurious and inflammatory claims. Our responses to these charges are simple and straightforward: . Does Reynolds Tobacco add nicotine to its products? No. . Does Reynolds Tobacco manipulate nicotine yields to create, maintain, or satisfy "addiction"? Again, the answer is no. . Does Reynolds Tobacco hold patents for technology that relates to modification of nicotine yields independent of "tar" yields? Yes. In fact, for years some governments, smoking and health critics, and international public health scientists have encouraged such developments in cigarette design. . Is Reynolds Tobacco using such technology commercially? No. . Is cigarette smoking an "addiction"? No, cigarette smoking is not an "addiction" under any meaningful definition of the term, including the new definition presented by Dr. Kessler before this Subcommittee. There is no factual or policy basis to regulate or ban cigarettes as drugs simply because they contain nicotine or simply because cigarette manufacturers have the ability to reduce the nicotine yields of their products. This company is not engaged in some sinister plot to deceive the American smoker. Progress or Prohibition If this Subcommittee fairly and objectively evaluates the true facts about cigarette design, it must find that the efforts of Reynolds Tobacco and others in the industry demonstrate a remarkable record of achievement and progress. This company is justifiably proud of those accomplishments and of the dedicated and talented employees who have TI117N 0046267

contributed and now contribute to them. We regret that others seek to advance an agenda of prohibition over progress. Today, we are here to discuss whether there is a basis for FDA regulation of cigarettes as drugs. Contrary to many reports, this issue is not novel. In fact, the question has been advanced and rejected many times before. For example, twenty-two years ago, the Commissioner of the Food and Drug Administration (FDA), Dr. Charles C. Edwards, testified at a hearing similar to this one before the Consumer Subcommittee of the Senate Committee on Commerce. Dr. Edwards stated, "Cigarettes and other tobacco products would be drugs subject to the Federal Food, Drug and Cosmetic Act if medical claims are made for the product .... However, cigarettes recommended for smoking pleasure are beyond the Federal Food, Drug, and Cosmetic Act."' Dr. Edwards was echoing a conclusion that has been consistently reached - both by FDA and the courts prior to and after his statement Z Three weeks ago, FDA Commissioner Dr. David Kessler appeared before this Subcommittee and testified extensively concerning the "task facing the FDA," which he characterized as "to determine whether nicotine-containing cigarettes are 'drugs' within the I 2 e The Federal Trade Commission to Establish Acceptable Levels of Tar and Nicotine Content of Cig,arettes 1972: Hearinp,s on S 1454 Before the Consumer Subcomm of the Senate Comm, on Commerce. 92nd Cong., 2d Sess. 239 (1972) (statement of Charles C Edwards, Comm., FDA). 4gg, g,& FT . v. .iegett and Myers Tobacco Co., 108 F.Supp. 573 (S.D.N.Y. 1952), afPd on oR, below. 203 F.2d 955 (2d Cir. 1953); Letter from Donald Kennedy, Commissioner of Food and Drugs, to John F. Banzhaf, III, Dkt. No. 77P-0185 (December 5, 1977); Action on Smokine & Health v. Harris. 655 F.2d 236 (D.C. Cir. 1980). -2- TIMN 0046268

meaning of the Federal Food, Drug, and Cosmetic Act." All cigarettes sold are "nicotine- containing cigarettes," and indeed the tobacco plant is known as nicotiana tabacum in recognition of the fact that it naturally contains nicotine. Moreover, the facts relevant to whether FDA has jurisdiction over cigarettes today are substantially the same as when Dr. Edwards testified in 1972 and when the FDA rejected petitions to regulate cigarettes in 1977 and on other occasions. At those times, as is the case today, a variety of cigarette brands was available to consumers which yielded a variety of "tar" and nicotine levels. Through advances in cigarette design and in response to consumer preferences, however, the average cigarette sold today yields one-third less "tar" and nicotine than when Dr. Edwards testified. Cigarette Desi¢n How and why have these reductions in "tar" and nicotine yields come about? To evaluate these questions completely, it is imperative to consider the evolution in the design of cigarettes over the last forty years - an evolution that, in its purpose and effect, differs significantly from the grossly inaccurate allegations and misrepresentations by our critics in these proceedings and recently in the press. In short, Reynolds Tobacco designs cigarettes to respond to consumer demand and to attempt to address the many scientific and other criticisms that have been leveled at our products for more than forty years. Today's cigarettes reflect the enormous efforts to respond directly to consumer demand and those criticisms and suggestions. A very brief discussion of the history of cigarette design will illustrate why these recent claims are misguided. Early cigarettes were primarily cut tobacco (much like pipe tobacco) wrapped in paper, with flavorings such as the oil of citrus peels. The quality of a cigarette depended -3- TIMN 0046269

primarily on the single type of tobacco it contained -- Turkish tobacco was used in premium cigarettes and domestic air-cured or flue-cured tobacco was used in less expensive cigarettes. The first American blend cigarette, which combined both Turkish and domestic tobacco, was Reynolds Tobacco's Camel brand, introduced in 1913. Although slightly different blends and different materials were used in cigarette manufacturing, cigarettes remained largely unchanged until the early 1950s. At that time, most cigarettes produced in the United States were made from flue- cured, burley and Turkish tobaccos. They were 70 mm long and unfiltered. When smoked, these cigarettes yielded an average of 40 mg of "tar" and 2.8 mg of nicotine by methods comparable to those used by the United States Federal Trade Commission (FTC). (The FTC methods became official in 1969). A number of watershed developments in the early 1950s led to another evolution in cigarette design. Several epidemiologic studies published during the early 1950s reported that there was a statistical association between cigarette smoking and lung cancer. Also, in 1953, Dr. Ernst Wynder and others published the results of a mouse skin painting experiment in which the researchers observed skin tumors on the backs of mice exposed to cigarette smoke condensate. All these studies were widely publicized in the general media and the media coverage affected consumer demand. Reynolds Tobacco in turn has made extensive efforts to respond to these scientific theories and demands and the tastes of its consumers to produce a broad array of products. Since the 1950s, Reynolds Tobacco, among many other lines of research, has pursued two basic lines of research and development in this area: (i) identification of individual -4- TIMN 0046270

constituents in tobacco smoke and development of technology to attempt to reduce or remove those of potential concern, and (ii) development of new technologies to reduce yields of "tar" and nicotine generally. The first line of research has had limited success; the second line of research has been remarkably successful. Selective Reduction During the 1950s and early 1960s, many researchers focused on one chemical constituent of smoke (or a family of constituents) in the search for a "cancer-causing" agent that would explain the epidemiologic and skin painting results. This focus turned to disappointment, as reflected in the 1964 Report of the Advisory Committee to the Surgeon General ("Surgeon General's Report"). From the mid-1950s until today, a succession of constituents has been targeted by the biomedical community. Even today, however, the biomedical community has been unable to agree on which, if any, of those constituents is responsible for the reported association between cigarette smoking and lung cancer. Cigarette manufacturers and others explored and published numerous methods to reduce or eliminate individual constituents (or a family of constituents) in cigarette smoke, 14. reducing the temperature at which the cigarettes burned, breeding tobacco plants to change the chemical composition of the tobacco, and adding different types of filters or other filtration mechanisms to the cigarette. Unfortunately, manufacturers faced a moving target as the focus changed from constituent to constituent. Constituents of concern at one point in time were later determined by the scientific community to be of no significance. Moreover, techniques that might have selectively reduced a constituent in the laboratory -5-. TIMN 0046271

commonly increased another constituent. In general, efforts to reduce individual constituents have not been successful. General Redii tc ion During the same period, Reynolds Tobacco and other cigarette manufacturers also directed their research to attempt to reduce levels of all constituents. This approach, also advocated by reseaLchers such as Dr. Ernst Wynder, offered advantages over selective reduction because it led to the reduction of total smoke yields and the levels of individual compounds more or less proportionately. To understand the concept of general reduction, it is essential to understand what smoke is. Smoke is a complex mixture -- it consists of a particulate or "tar" phase as well as a vapor or gas 3hase. Since the mid-1950s, cigarette manufacturers have devoted extensive resources io achieve a general reduction in "tar" and the vapor phase components of cigarette smoke. Techniques incorporated in cigarettes over the last 40 years which reduce "tar" include° • Filtration • Reconstituted tobacco • Paper porosity . • Redu- ed tobacco • Expanded tobacco • Filter ventilation Design chan~-;es such as the development of more porous cigarette paper, improved filtration, and the l>;e of expanded (or "puffed") tobacco and reconstituted tobacco made -6- TIMN 0046272

general reduction po:;sible. By utilizing one or more of these techniques, cigarette manufacturers can off rr smokers a variety of cigarettes with a range of "tar" and nicotine levels. Cigarette desig iers have been so successful in their efforts to respond to the demand for these reductions ti tat today there are commercially available cigarettes that yield "tar" and nicotine at levels so low they cannot be measured reliably by the FTC's standard procedure 3 In 1979, the Surgeon General listed more than 25 different design techniques that reduce yields of "tar" and nicotine 4 Each of these techniques has been well-publicized and known to the gov=;rnment, public health, scientific and even lay communities. A brief analysis of these design achievements demonstrates the effectiveness of general reduction methods to achieve lo wer yields of "tar" and other smoke constituents. The earliest de-ielopments included the cellulose acetate filter, use of porous paper, and use of reconstitu_t-:d tobacco. Each of these developments was in place by 1965, and "tar" and nicotine yields had been reduced dramatically. After 1965, the principal design 35gg, g,g<, FedeLal Trade Commission, 'Tar," Nicotine and Carbon Monoxide in the Smokeo_f_207 `Jarieties of Domestic Cigarettes 2-3 (1985). 4 Public Health Service, U.S. Department of Health, Educa.tion, and Welfare, m kin and Health: _ A Report of the Surgeon General 14:110 (1979) ("1979 Surgeon General's Reptirt"). The techniques identified in the 1979 Surgeon General's Report were genetics = nd breeding of tobacco plants, planting density, nitrate fertilization, applying agricu ltural chemicals, topping the tobacco plant at different stages, altering the type of tob acco, altering the position of the stalk, changing the nitrate content, selecting tobacco with specific constituents (gg,, proteins, carbohydrates, resins), curing, homogcnized leaf curing, grading, fermentation, solvent extraction, tobacco expansion (fre-me-drying), additives, blending, changing the amount of tobacco, changing the amount of tobacco stems, utilizing varying amounts of reconstituted tobacco, using expanded tobacco, varying the tobacco cut, using porous cigarette paper, perforat ing the cigarette paper, smoke filtration, and perforating the filter tips. id. at 14:108-1• ~. -7- TIMN 0046273

breakthroughs were cxpanded tobacco and air dilution through perforation of cigarette filters. Expanded tobacco resulted from the search for ways to reduce the volume of tobacco in each cigaLette in order to reduce "tar" and nicotine yields. The tobacco is "puffed" or expanded in order to allow the same amount of tobacco to occupy more space, much like popping popcorn. As a result, each cigarette is filled with less tobacco, there is less tobacco availablo to be burned, and the yields of "tar" and nicotine are therefore reduced. Reynolds Tobacco developed expanded tobacco and was the first to introduce it commercially, in 196-L In fact, Reynolds Tobacco licensed this process to others in the industry for commercial use throughout the world. 0 In the late 190s, scientists discovered that perforating the cigarette filter allows air to mix with the mainsi:ream smoke, thereby diluting the smoke and reducing the total yields of "tar," and nicotine. Air dilution also reduces the burning temperature of tobacco and causes less tobacco w be burned per puf~ thereby further reducing the "tar" and nicotine yields. Perforated filters were first sold commercially in about 1972. By 1981, approximately 50% o F all cigarette brands sold had perforated filters 5 By 1981, the tobacco content by weight of the average cigarette had declined by 23.8% through the u:;e of expanded tobacco 6 In some ultra low-"tar" brands, expanded 5 Public Health Service, U.S. Department of Health and Human Services, The Health Conseauences_ of Smoking: The Changing Cigarette. A Report of the Surgeon n r 1209-10 (1981) ("1981 Surgeon General's Report"). 6 id. at 209-10. -8- TI-M-N 0046214

tobacco was used to a much greater extent to reduce the weight even more dramatically.' Thus, as part of the design techniques to achieve lower yields of "tar" and other smoke constituents, the amount of tobacco in cigarettes has been reduced, with the corresponding result that the smoke nicotine has also been reduced dramatically. The cigarette d --sign efforts discussed above have been reviewed and commended by government and other scientists. For example, from 1966 through 1978, the National Cancer Institute supported a program to develop a "less hazardous cigarette". This effort involved government, tobacco i 1dustry, public health groups, and universities. Reynolds Tobacco and other cigarette manutacturers participated in this program. The NCI program evaluated G over 100 different ci~;arette designs -- many of which had already been incorporated in commercial cigarettes by the major manufacturers. The results of this program indicated that the general redu-;tion approach as described above was the best approach to respond to the scientific critici:;ms of cigarettes. Importantly, virtually every design variable that was evaluated by the NCI group had been developed by the United States tobacco industry and utilized in a commerc:ial brand. In 1979, scientists involved in the field of smoking and health came together at the Banbury conference. This conference reviewed virtually all work that had been done to modify cigarettes du-ing the previous twenty-five years in response to the smoking and -health- controversy. ,"11 of the papers presented at the Banbury conference were published,. 7 This point is ~specially significant because it addresses Dr. Kessler's "surprise" at finding that, for some brands in the ultra low-"tar" category, the percent nicotine in the tobacco it;elf might be the same or slightly higher than the percent nicotine in the tobacco u-,ed in higher-yield cigarettes. Reducing the amount of tobacco has a major influen,;e on the nicotine yield to the smoker. -9- TrMN 0046275

together with all the d-.bate and discussions. The consensus among scientists participating in that program was that overall "tar" and nicotine reduction was the most effective and most appropriate approach. Several scientists, including Dr. Dietrich Hoffmann, acknowledged the responsiveness of the tobacco industry: I do thiak the tobacco industry, voluntary or not, adjusts very well to i.he demands of the logical reasoning of the scientific commurity and that we should continue on this path 8 In Dr. Kessler's March 25, 1994 statement, he asked the cigarette companies to address the intent of cigarette design developments. The clear intent behind cigarette design developments %as been and remains to manufacture and market a broad range of cigarette products in -•esponse to the demands and tastes of today's adult smokers and to ensure cigarette to cigarette and pack to pack consistency within a brand. Within the universe of cigarette p roducts, there is a range of "tar" and nicotine levels. As noted earlier, reducing "tar" yields automatically results in roughly proportional reductions in nicotine yields. That is seen by the dramatic reduction in both "tar" and nicotine achieved by Reynolds Tobacco an 3 other cigarette manufacturers since 1955. In 1957, Dr. Emst Wynder and others called for efforts to reduce "tar": [F]or practical purposes, a filter-tip capable of filtering out 40 percent of the tar would be a step in the right direction .... "Such a filter-tip ... placed on a regular-size cigarette which normali y yields 30 milligrams of tar in its smoke, would reduce the smoker's tar exposure to about 18 milligrams. A reduction to that level, as shown both by animal experiments and human 8 Dietrich HolffIaann, Discussion in "Risk Reduction Achievements", Banbury Report 3 - A Safe Cig arette?, pp. 155-178 at 174 (1980). -10- TIMN 0046276

statistical studies would be a significant reduction in cancer risk."9 The tobacco industry Ids accomplished this objective -- and has gone much further. The vast majority of today's cigarettes are 85-100 mm long, have filters and yield an average of 11.5 mg of "tar" and 0.3 mg of nicotine. Some cigarettes now available yield less than 1.0 mg of "tar" as measured by the FTC method. These "tar" and nicotine reductions have largely been achieved through innovations in cigarette design - in-lovations pioneered by Reynolds Tobacco and other members of the tobacco industry. Sinc= the complexity of smoke provides a cigarette with its taste and other sensory properties, mawy of these reductions in "tar" and nicotine have come at the expense of flavor. Some smo'.:ers are unwilling to sacrifice flavor for reduced "tar." This has prompted a continuing effort to develop new cigarette designs. It is ironic that in the face of the overwhelming recommendations of just such an approach, certain publ .c and private critics of cigarettes have decided once again to attack the industry - and to -;eek to stop, if not to reverse, the extensive design innovations that other public and prival;e critics have encouraged over the years. 'Tar",/Nicotine Ratios Reynolds Tobacco does not manipulate the nicotine in its products to create, maintain, or satisfy "a, ',diction". Claims to that effect are false. As "tar" yields have been reduced over the years, nicotine yields have also been reduced, roughly in proportion to the "tar." The fact that "tar" to nicotine ratios are not exactly the same for all cigarettes is not 9 Mattox, LL and Monahan, S., "Wanted -- And Available - Filter-Tips That Really Filter", Reasiert. Diest, pp. 43-49, 44 (August 1957) (quoting Dr. E.L. Wynder). 'I'IMIVIN 0046277

news to anyone familiar with tobacco products or to anyone who has reviewed the extensive "tar" and nicotine reports published by the FTC. Reynolds Tob;.cco's cigarettes contain approximately one and one-half to two and one-half percent nicortine, depending upon the tobacco blend. When burned, these cigarettes yield varyii.g amounts of "tar" and nicotine. 'Tar" to nicotine ratios, while not constant, are very clo~zly linked because both are found in the particulate phase of smoke. As "tar" yield is reduced, through filtration, paper porosity, expansion, and other design parameters, nicotine 4eld is also reduced. Filters, however, are slightly more efficient at reducing "tar" yield vian nicotine yield. This is due to the fact that cellulose acetate, the primary filter material used by Reynolds Tobacco and others, was developed to reduce "tar" yield. The ability of ihese filters to reduce the gas phase constituents is somewhat limited. Since a small amount of nicotine (unlike "tar") is found in the gas phase of cigarette smoke, as well as in the p=irticulate phase, slightly more "tar" is filtered out of the smoke, proportionately, than nicotine. Thus, as yields are reduced, the ratio of "tar" yield to nicotine yield is redu ced slightly. In response to the fact that "tar" and nicotine yields are so closely and naturally linked in cigarette swoke, many public health officials and others have suggested that the tobacco companies s~ould attempt to develop cigarettes which break that link. In other words, we have been encouraged to develop cigarettes with reduced "tar" while maintaining nicotine yields. Not able among officials who have encouraged such development is the Independent Committee on Smoking and Health of the United Kingdom, which recommended in 19'_3 that ". . . there should be available to the public some brands with -12- TIMN 0046278

low levels of tar and a proportionately higher nicotine yield.i10 According to one recent publication cited by 1--1r. Kessler in his testimony: One proposal has been to develop tobacco that is high in nicotine but low in tar. This is not easy to do naturally; nicotine and tar are highly correlated in the tobacco leaf. One method would be to add nicotine to a low tar, low nicotine cigarett ;.11 The fact is many scientists, government and/or public health officials have suggested reducing "tar" to nicodne ratios as a way toward potential progress in cigarette design.12 Much as the iiidustry responded to calls to reduce "tar" and nicotine yields in the 1950s and 1960s, Reynolds Tobacco has devoted research to responding to these calls to reduce the "tar" to n icotine ratios. Out of the hundreds of patents issued to Reynolds Tobacco personnel o`er the years, Dr. Kessler referred to nine Reynolds Tobacco patents during his recent tesLi-nony to this Subcommittee. These patents reflect work that Reynolds has done in this area. As Dr. Kessler recognized, however, patents do not necessarily reflect what is being used i-i practice. While Reynolds Tobacco has been able to develop a cigarette which d_isas-rociates "tar" and nicotine in the laboratory, it has not been able to achieve an acceptable commercial product. As stated above, this is not easy to do because 10 11 12 Third Report of the Independent Scientific Committee on Smoking and Health of the United Kiagdom (1983). Schelling, T.C._ "Addictive Drugs: The Cigarette Experience." i n Vol. 255:430- 433 (1992). Sgg, g,&, "UICC Tobacco Control Fact Sheet 3," Tobacco and Cancer Programme, International Jnion Against Cancer (March 1993); Editorial, "Monsieur Nicot's Legacy," Irancc-t H (8249): 763 (1981); Russell, M.A.H., "Smoking and Society (There Is No Questioii)", Rehabilitation, 32 (1-4): 41-42 (1979). -13- TIMN 0046279.

"tar" and nicotine are :;o highly correlated. If we could develop such a cigarette acceptable to the consumer, it would apparently be welcomed and encouraged by European governments and public health officials, rather than being characterized as some sinister plot by tobacco companiess as Dr. Kessler appears to characterize it.13 In fact. none of the nine ReXllolds_'I'obacco-Da :ents cited by Dr. Kessler has been used commercially. Published FTC '"Tar" -ind Nicotine Yields The amount oi nicotine present in a cigarette is in large part a result of the choice of tobaccos used in tle cigarette blend, which are chosen because of their taste and other properties.14 It is noi, present as a result of a decision to "manipulate" nicotine levels to some carefully contro lled "addictive level." The concept of an "addictive level", raised but not defined by Dr. Kessler, is not a concept known to or understood by Reynolds Tobacco. Neither that concept ior any similar concept is used by Reynolds Tobacco in the design of its cigarettes. We do not know what the concept means, and we are unaware of any data 13 14 In 1988, Reynolds Tobacco introduced Premier, a cigarette that heated rather than burned tobacc). That cigarette addressed many of the scientific criticisms that had been made ao ).inst cigarettes for many years. It virtually eliminated "tar"; it vastly reduced environmental tobacco smoke; and it reduced cigarette ignition propensity. Desp.ite these attributes, certain U.S. government officials, public health officials and, of course, ani -smoking activists launched a vigorous attack on the cigarette -- in terms that solmd strikingly similar to the anti-smoking rhetoric surrounding this current debat=;. European health officials, on the other hand, and some United States scientis rs recognized the attributes of Premier and, indeed, encouraged the development i +f similar cigarette technologies. ~gg,g,&, "Smoking Pleasure Without the Danger of Fire and Risks To Health," Die Neu Aerztliche (December 19, 1988); Hoffmann, D=, gl ,d., "Cancer of the Upper Aerodigestive Tract: Environmental Factors and PL evention," Journal of Smoking=Related Diseases 3(2): 109-129 (1992). A variety of agricultural factors and practices influence these properties, including, for example, nbacco type, stalk position of the leaii curing practices, and crop year. TIMN 0046280

that give it meaning. Further, what is relevant is not what is present in the cigarette, but what is present in the ~moke. Dr. Kessler has made much of the fact that the FTC numbers do not necessarily reflect the precise "tar" and nicotine yields for every smoker. This is certainly true, just as EPA mileage estimate.5 do not reflect the precise fuel economy that will be achieved by every automobile driv= r. The important point is that in spite of broad variations in how individual smokers may smoke any given cigarette, the fact remains that the lower the yield by FTC numbers, the 1)wer the yield will be to any given smoker. The yield for any given smoker will probably te different from the FTC yield; for some smokers it will be higher, for some it will be lower, but overall, the FTC yields are generally predictive of the yield to smokers as a group. The statement, however, that "in reality" low yield cigarettes do not yield low "tar" and nicotine, is not true. In work published by members of the Swiss Federal Institute of Technolo gy, lower yield cigarettes were associated with reduced smoke absorption.15 Another iindica ion of Dr. Kessler's misunderstanding of cigarettes relates to his statements concerning low "tar" cigarettes. He stated that from 1967 to 1978 eighteen brands of filter cigarei tes underwent increases in overwrap width, resulting in less tobacco being smoked by maciiine smoking in accordance with the FTC method. Since the FTC _ method specifies that the cigarette is smoked to within 3 millimeters' of _the - tipping overwrap, and Dr. KeF-sler stated that the tobacco within the overwrap was still smokeable '5 Hofer, gJ Al., "wicotine Yield as Determinaht of Smoke Exposure Indicators and Puffing Behavi m." Pharmacolog,y Biochemistry and Behavior, Vol. 40, 139-149 (1991). -15- TIMN 0046281

(and would be smoked by the consumer), he concluded that these brands deviously "cheat" the FTC method. Tha : is not true. First, Reynolds Tobacco uses standard tipping overwrap and has not increased the width because that would reduce puff count and the value to our consumers. But, mor.- importantly, the tipping overwrap simply is not smokeable. No smoker would conscioiisly smoke the overwrap more than once. The tipping paper, because it is not intended to b--. smoked, imparts a significant off-taste to the cigarette smoke. Finally, in his t -.stimony before this Subcommittee, Dr. Kessler used several charts (which have since been widely publicized) to support his contention that the nicotine/tar ratio for the lowest "tar" cigarettes has increased since 1982 on a sales weighted basis. This 0 allegation surprised JL:eynolds Tobacco as much as it surprised Dr. Kessler. Company scientists immediately tried to duplicate Dr. Kessler's charts, using the identical FTC data and the only publicly-available brand sales data of which this company is aware. Despite applying the same cjata allegedly employed by Dr. Kessler's staff, our scientists cannot duplicate these findings. In fact, our results show exactly the opposite -- nicotine yields and nicotine/"tar" ratios ir. the lowest "tar" category decreased slightly between 1982 and 1991 - - the time period co-~ered by Dr. Kessler's charts. We have, in fact, asked FDA staff members to provide its data and complete methodology. We would welcome the opportunity to review the data and methodology used by FDA staff to prepare these charts, so that vae would havP-a,fu11 opportunity to understand and review the _procedures used and evaluate the conclusions reached. -16- TIMN 0046282

The_"Addiction" Hspothesi A major premi~;e of the charges against the cigarette industry today is the claim that cigarettes are "addictive". Dr. Kessler and our other critics rely on selective and incomplete evidence to support this claim. They ignore significant and meaningful differences between cigarettes and truly 'addictive" drugs. When long-established criteria for labeling a substance or activity ?s "addictive" do not permit our critics to fit cigarette smoking nicely within the existing cri :eria, these critics resort to a simple tactic to further their agenda -- they attempt to lower the standards and change the definition of "addiction" and its alleged components. G In 1964, the Advisory Committee to the Surgeon General recognized that cigarette smoking did not me._.t well-established criteria for "addiction."16 In 1988, the Surgeon General altered the d-.-finition to fit the existing data on smoking. In essence, the Surgeon 16 The 1964 Advisory Committee Report to the Surgeon General defined "addiction" as follows: "a state of periodic or chronic intoxication produced by the repeated consumption of drug (natural or synthetic) whose charact-:ristics include: "(1) -,n overpowering desire or need (compulsion) to ,ontinue taking the drug and to obtain it by any means; -"(2).- A tendency to increase . the dose; "(3) A psychic (psychological) and generally a physical dependence on the effects of the drug; "(4) Oetrimental effect on the individual and on society" The Report _ :)ncluded that tobacco smoking was properly classified habituation. 1964 Surgeon General's Report, 351, 354. as a -17- TIMN 0046283

General moved the goalposts after he located the ball on the field. We categorically reject the claim that cigareti:es are "addictive", and we know that an objective review of the facts and science supports mr position. Dr. Kessler de fined "addiction" in terms of four elements: compulsive use psychoactive effect reinforcing behavior withdrawal symptoms When each of these e lements is carefully analyzed in an unbiased manner, it becomes clear that cigarette smoking is no more "addictive" than coffee, tea or Twinkies.l' Further, in spite of the efforts to expand the definition, it still does not properly encompass cigarette smoking. 1. Compulsive use. This concept of compulsive use, like the definition of "addiction" itself, h_n:; undergone a redefinition in an attempt to encompass cigarette smoking. The classic definition of "addiction", as used in the 1964 Surgeon General's Report, properly de__fi ;ies compulsive use seen with hard drug addiction as "an overpowering desire or need (compulsion) to continue taking the drug and obtain it by any means." This is precisely what is seen with truly "addicting" substances like cocaine and heroin. The Using similari y vague definitions, researchers claim to have discovered addiction to love, jogging, television, credit cards and even eating carrots. 5=, Peele, S., Love and Ad 3ic ion, 1976; Hailey and Bailey, "Negative Addiction in Runners," (1979); Winn, M., The Plug In Drug (1977); Parade Magazine, April 5, 1987, p. 28; Wright, M.R., "Surgical Addiction: A Complication of Modern Surgery?" Archives of Qtolar_vnaoloev: Head and Neck SurQerv, 112: 870-872 (1986); Cerny and Cerny, "Can Carrots Be Addictive? An Extraordinary Form of Drug Dependence," Br. J. Add. 87:1195 (1992). -18- TIMN 0046284

desire is overpowering and leads to criminality and violence, if necessary, to satisfy the need for the drug. In the 1988 Suigeon General's Report, the term "compulsive use" was expanded to include behaviors driven by "strong urges".18 There is a world of difference between the irresistible need of th : hard drug addict and a "strong urge" to engage in a pleasurable behavior or activity. I I'eople have strong urges to eat sweets, drink coffee and watch their favorite soap operas. It is misleading to label these types of "urges" as compulsions. Smokers are frequently in situations where they resist the urge to smoke. They are not in the throes of an overFowering desire to use and obtain cigarettes by any means. They do not remotely resemble cocaine addicts whose very real compulsion to take this highly intoxicating drug total [y disrupts their lives, their families and their occupations. Smokers are now constantly characterized as addicted and thus unable to quit. Common sense belie- that conclusion. Since 1974, more than 40 million people have stopped smoking perVaanently without any outside intervention or assistance. As one ex- smoker has candidly acknowledged: 'To quit, you have to decide you want to quit. Then you quit "19 ig The full definidon states: "Highly controlled or compulsive drug use indicates that drug seeking a zd drug-taking behavior is driven by strong, often irresistible urges"; It provides no :riteria for determining when a strong urge becomes "irresistible". In fact, no such criteria exist, as admitted by the American Psychiatric Association. "The line betw-.-en an irresistible impulse and an impulse not resisted is no sharper than that between twilight and dusk. . . ." Sgg "American Psychiatric Association Statement on "['he Insanity Defense", .Am. J. Psgchiatrv. 140(6), 681-688, 1983. 19 Leonard Larson, Scripp Howard News Service. -19- TIMN 0046285

This is not to say that stopping smoking, or changing any well-liked, habitual behavior is easy. It takes effort and commitment. But, the process is not different from successfully losing several pounds and maintaining the weight loss or developing a regular exercise program. It is completely different from successfully recovering from hard drug addiction or alcoholism. The true addict must overcome severe physical withdrawal, rebuild every aspect of his life, lea -n new value systems, and approach life without being constantly intoxicated. None of :hese impediments is present in stopping smoking. 2. P-sychoa,;tive effect. Originally, the scientific community described the term "psychoactive" to include, as a necessary component, distortions or disruptions in cognitive and motor performanee, i.e., intoxication. Those concepts were in effect for decades and were included in the .964 Surgeon General's Report.2Q Smoking/nicotine, however, does not produce intoxicati 3n. To eliminate this inconvenient truth, the 1988 Surgeon General's Report redefined "psychoactive" to mean anything that gets to and produces effects in the brain. Based on this imprecise and revised definition, nicotine is psychoactive. So too is the caffeine in chocol_r,te, coffee and soft drinks. Sugar, warm milk, cheeses, and many other everyday substances a-id common pleasant experiences (such as watching sporting events or listening to music) also produce psychoactive effects similar to those from smoking. They are quite unlike the pLofound effects caused by hard drugs and alcohol. It is the intoxication of hard drugs and alct ihol that sets them apart and causes muddled thinking and loss of self control. 20 Robinson, J.1':. and Pritchard, W.S., "The Role of Nicotine in Tobacco Use." Psvchonhat'macoloQV, 108, (4): 397-407, 1992. -20- TIMN 0046286

Dr. Kessler tesiified that nicotine contained in cigarette smoke releases a certain chemical (dopamine) i i the "pleasure centers" of the brain, resulting in similar effects as addicting drugs such a- heroin and cocaine. Dr. Kessler failed to acknowledge that many different pleasurable and not so pleasurable experiences and activities also result in the release of dopamine ~n these "pleasure centers". Once again, the attempted analogy becomes meaningless :vhen viewed objectively and without blinders. Dopamine release is one part of the neuro,:hemical response to both pain and pleasure. It will occur if one receives an electric sl,ock or slap in the face and also occurs in response to pleasant experiences of all kind:;. Attempting to mystify a basic physical reaction and implying that it only occurs with addicting drugs is misleading at best. 3. Reinforc inQ behavior. Dr. Kessler's third criterion, reinforcing behavior, provides yet another e=.ample of the attempt to invest commonplace concepts with scientific mystique, combined ::ith an erroneous implication that the condition only occurs with addicting drugs. Such s not the case. As presented in the 1988 Surgeon General's Report, reinforcing behavior - aerely refers to the fact that a pleasant experience will likely be repeated, whether it involves a chemical or activity.Zl Dr. Kessler cites two lines of evidence as support fcr his claims regarding reinforcement from nicotine: 1. That animals can be trained to self-administer nicotine; and 2.- The experiments which claim that nicotine causes activation of "pleasure centers" in the brain involving dopamine. 21 The report arti Mally attempts to separate reinforcement involving chemicals from those involving activities. In reality, it is the magnitude of the effect that is most important, not the source. Further, we reject the notion that the reinforcement, or pleasure, derivod from cigarette smoking is solely the result of ingestion of nicotine. -21- TI1Vj.N 0046287

Although it i _s true that animals will self-administer nicotine under certain very limited circumstance3, this does not imply that the effects produced by or the motivation for ingesting nicotine ar; in any way similar to those of truly "addicting" drugs. Scientists at the Bowman Gray School of Medicine, in association with a Reynolds Tobacco scientist, recently published a peer-re:iewed study demonstrating that nicotine and caffeine are very weak reinforcers when compared to cocaine and methylphenidate (Ritalinn ).22 Their findings were in line with the overall weight of the scientific evidence, which has consistently found caffeine and nicoti-te are both weak reinforcers.23 Animals can be trained to self- administer a wide variety of substances. Animals have been trained to self-administer very painful electric sho6s, and morphine addicted monkeys have been trained to self-administer opiate antagonists, p-ecipitating very painful withdrawal symptoms. However, none of these self-administration behaviors proves the existence of an "addiction". Moreover, animals do not have to be exte isively trained to self-administer cocaine or heroin. Once they start receiving either drum, they quickly become hooked and self-administer it to the exclusion of food and water and until death if not stopped. 4. Withd; awal skmn_ toms. Although nicotine withdrawal was defined in 1987 by the American Psych `.atric Association (DSM-III-R) as an element of tobacco dependence, 0 22 23 Dworkin, gl _d., "Comparing the Reinforcing Effects of Nicotine, Caffeine, Methylphenit late and Cocaine." Medical Chemistry Research, Vol. 2:593-602 (1993). Griffiths, R.R.., Brady, J.V., and Bigelow, G.E., "Predicting The Dependence Liability of Stimulant Orugs" in Thompson and Johansen Behavioral Pharmacology of Human Drup-Deven( ence, NIDA Monograph 37, 1981, p. 92. This position has not changed. Griffiths, R., American Psychiatric Association Annual Meeting, San Francisco, CA, (1991). -22- TIMN 0046288

the associated sympto _m_ .; were identified in the 1964 Surgeon General's Report: restlessness, anxiety, trouble concelitrating, and other "mild and variable symptoms". 24 That report stated that these symptoms were the same as those seen when any well-liked behavior was suddenly stopped. Not iing new has been established in this area. Caffeine withdrawal is much more well-established and well-defined, including the physical symptom of the "caffeine headache." Under Dr. Kessler's definition, caffeine and heroin should be treated equally. Smoking cessat on never involves any of the severe physical and behavioral disruptions involved in withdrawal from truly addicting drugs such as heroin, cocaine, and amphetamines. In faci, the symptoms of hard drug withdrawal normally require medical treatment. With man ( drugs (g,g, barbiturates and alcohol), the addict can die from withdrawal if not medi :ally treated. An addict undergoing withdrawal from hard drugs is unable to think clearly or control his actions while in the throes of withdrawal. This is never the case with cigarette smokers who quit. They continue to attend to their responsibilities and lead normal lives. The symptoms reported by cigarette smokers when they stop are of the same kind and maynitude reported by dieters and people changing sleep patterns (gg,., changing from the first to third shift at work ).25 0 24 25 1964 Surgeon (-eneral's Report, supram at 352. It should be noied that DSM-III-R states that there is no evidence that, even at its most severe lev-;1, tobacco withdrawal prevents a person from successfully stopping. The same can n:)t be said for barbiturates, alcohol or crack cocaine. Diagnostic and Statistical Manual of Mental Disorders (Third Edition - Revised) American Psychiatric Asst iciation, (1987), 151. -23- TIMN 0046289

Cigarette smoking is more like drinking coffee and eating chocolate than like using cocaine, heroin, or any truly addicting hard drug. Cigarettes, however, are unpopular, which is why our critics strain so mightily to demonstrate that smoking is "addictive". The plain truth is that, under any objective scientific (or common sense) measure, cigarette smoking should not be considered "addictive". Dr. Kessler and others support their assertions by repeating a deluge of facts that, in their judgment, prcve their conclusions. Let us examine just a few of these "facts": . First, D r. Kessler quotes a 1993 Gallup Survey reporting that 75% of smokers say they are addicted. What Dr. Kessler does not report is that the same survey found that 69% of the same smoker= said they "could quit if I wanted to." Moreover, this survey :vas conducted after the well-publicized 1988 Surgeon Genera°'s Report, which equated cigarette smoking with cocaine and heroin addiction. Does Dr. Kessler not believe that such publicit•r could affect responses to this survey? . Dr. Kes sler states that "By some estimates, as many as 74 to 90 percent are addicted." He relies on a paper by Hughes, = al. This paper also included the comment, "In addition, the fact that thi:; definition [referring to DSM-III-R] classified 90% of the tobacco users in this study as dependent suggests that it is over in-;lusive and thus may lack diagnostic discriminability". . Dr. Ki;ssler makes repeated references to how certain percent ages of people "may" or "might" possibly behave in certain circumstances. In one example, he discusses patients who coatinue to smoke after surgery or a coronary event. Some continu -. to smoke; most quit. Some also follow their doctor's advice and eat less fat, exercise regularly and lose weight. Some don't. -'Fhe fact that-human behaviors run a.wide gamut.. when f iced with similar situations tells us something about human behavior and little about smoking or nicotine. . Dr. K=isler's "experts" tell him that most smokers reach for their fu st cigarette within 30 minutes of waking. He concludes that this fact is "a meaningful measure of addiction". By this measur-. most coffee drinkers should be considered addicts. -24- TIMN 0046290 ~

Manufacturers of coffee makers have even developed machines which have coffee prepared by exact times to ensure that the coffee "addiction" can be satisfied immediately upon awakening. It should be pointed out that Dr. Kessler's "definition" of addiction would classify most coffee, cola, and tea drinkers as caffeine addicts. Caffeine is psychoactive and the effects last longer tha- ~ those of nicotine.26 Many people experience a "strong urge" for a cup of coffee each mo -ning. There is a well-established physical withdrawal syndrome for 2-3 cups a day coffee drinkers who suddenly stop drinking coffee. Is caffeine similar to cocaine and heroin because of this? Neil Benowitz, one of the editors of the 1988 Surgeon General's Report, ad.~utted that caffeine meets their new definition of addiction: c Many pil ysicians have treated patients who continue to drink large q? [antities of caffeinated beverages in the face of informan ion that caffeine is harmful to their health and advice to quit. Such behavior suggests that these people are addicted to caffei ae. Addiction liability can be analyzed according to criteria recently presented by the United States Surgeon General. The three major criteria for addiction liability are psychoattivity, drug-reinforced behavior, and compulsive use. That e.a.lleine is psychoactive and that some people consume caffeine compulsively is clear. That caffeine reinforces its consump,tion has recently been demonstrated in people, although reinforcement is highly dependent on the dose, with excess doses producing dysphoria. Minor criteria for addiction liability include the development of tolerance, physical depende nce, and recurrent intense desire for the drug, all of which ai e characteristic of regular caffeine consumers. Thus, there is i. group of coffee drinkers who appear to be addicted ~Sgg Jaffe, J. a-A Kantzer, M., "Nicotine: Tobacco Use, Abuse and Dependence, Subst. Abuse, 0(0): 256, 1981. S, ee also Sawyer gt al., "Caffeine and Human Behavior: Arousal, Anxiety and Performance Effects, J. of Behav. Med., 5(4): 415, 1982. "Caffei-n_-, is, without question, the most commonly used psychoactive drug in the World." -faffe, J.H., Com_prehensive Textbook of Ps cy hiatry. Chapter 13, Psychoactive Si Lbstance Use Disorders, 1(0), page 683, 1989. -25- TIMN 0046291

to caffeme, although the extent of caffeine addiction in the populati on is unknown.27 If the same "standardi"' are applied to caffeine, should the FDA also be considering (or should you suggest th_at it begin) regulating coffee and soft drinks as drugs? One final point is important. Essentially every claim made about manipulating nicotine in cigarettes :)y Dr. Kessler can be made about alcohol in beer, wine and spirits. Spirits manufacturers constantly monitor the alcohol content of their products throughout the fermentation process to precisely control the level of alcohol. Beers and wines are offered to the public with a wide range of alcohol content. Alcohol is added to fortified wines. High alcohol IIialt liquors are also available to the public. While no one will dispute that alcohol can be a truly "addicting" substance under any definition, there is no move to regulate alcohol as a drug, and we do not believe there should be. 3ft Peovle Choose _io Smoke Dr. Kessler d_i_;misses the issue of why people smoke by concluding, as the anti- smoking supporters he relies upon conclude, that smoking is an"addiction' and smokers would quit if they could break this "addiction". In the current climate of social disapproval and "political correc-t. ~ess", it is unpopular for smokers to honestly state that they smoke for pleasure and enjoym= .nt. Yet for hundreds of years smoking has been accepted as a social custom, providing a p.easurable, enjoyable break from normal activities. Smokers enjoy the taste and other senso-y aspects of smoking. A few moments with a cigarette can be a break 27 Benowitz, N_j.,, "Clinical Pharmacology of Caffeine." Ann. Rev. Med., 41(0) 277-288, 1990. -26- TIMN 0046292

during boring or intensive tasks, or a nice complement to a meal. All of these highly subjective reasons for ;moking have found support in scientific publications. Dr. Kessler pejoratively refers to "top tobacco industry officials" when referencing internationally respect=:d Reynolds Tobacco scientists who have published widely in peer- reviewed scientific journals because they do not believe that tobacco is addictive. He then goes on to mischaracte -ize their data. In the journal article referenced by Dr. Kessler, Drs. I Robinson and Pritchar 3 summed up the evidence concerning addiction and tobacco use: We believe that Warburton (1990) has developed a balanced, function_=1 theory of nicotine use that recognizes the beneficial psycholo:oca1 effects of nicotine. This "resource" or "psychok_igical tool" hypothesis holds that people smoke cigarette:i primarily for purposes of enjoyment, performance enhancement and/or anxiety reduction. This theory also passes the com. ion sense test of why people smoke. They smoke, not because =hey are addicted to nicotine, but because they achieve some benefits from smoking, enjoy these benefits which are totally cc-mpatible with everyday tasks and stresses, and choose to continue to enjoy these benefits .... We believe the distinctions are clear and cannot be stated more clearly t1,an what was said in the 1964 SGR [Surgeon General's Report]: "the practice [smoking] should be labeled habituation to distin guish it clearly from i i n, since the biological effects of tobacco, like coffee and other caffeine-containing beveragcs, . . . are not comparable to those produced by morphin_-;, alcohol, barbiturates, and many other potent addictin-; drugs" (p. 350, emphasis in original). If we lose this common-sense perspective of the role of nicotine in tobacco use, thoEe of us who enjoy the "lift" we receive from that first cup of coffee in the morning or that cola drink in the late afternooa may find that a few years from now a small group of research-:rs have equated our coffee/cola-drinking behavior to that of a hard-core crack or heroin addict.28 28 Robinson and Pritchard, suFra, at 405-6. -27- TIMN 0046293

No scientific Lreakthrough has occurred since the 1964 Surgeon General's Report to warrant classifying ci;;arette smoking as "addictive". All of the essential facts describing the behavior have been well known for years. The only thing that has changed is the political climate surrounding cigarette smoking, and with it the ability of anti-smoking critics to develop a new definition of "addiction" solely to include cigarette smoking within it. Conclusion The facts are clear: • Reynolds Tobacco does not add nicotine to its cigarettes. • Reynolds Tobacco does not manipulate nicotine yields in its cigarettes in order tD create, maintain, or satisfy "addiction". • Cigare=:te smoking is not an"addiction" under common sense and honest compa-ison with truly "addicting" drugs. Simply put, there is Ido factual basis or policy reason for the FDA to regulate cigarettes as drugs. The result of FDA regulation, moreover, would be a ban, or prohibition, of cigarettes. Dr. Kessler made this point clear in his recent statement before the Subcommittee. Me1i ibers of this Subcommittee have stated that a ban or prohibition is not their intent; the Am-_:rican public resoundingly rejects the prohibition of cigarettes as well. We encourage a dialogue that will lead to progress rather than prohibition. -2s- MN O046294 TI