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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