Jump to:

Anne Landman's Collection

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 Jursisdiction to Regulate and Therefore Ban Cigarettes

Date: 14 Apr 1994
Length: 29 pages
TIMN0046266-TIMN0046294
Jump To Images
snapshot_ti TOB01921.61-TOB01921.89

Abstract

This is the famous 1994 testimony by the R.J. Reynolds Tobacco Company (RJR) to the House Committee on Energy and Commerce, where the company compared the addictiveness of cigarettes to that of tea, coffee, Twinkies and even carrots. While not stated, presumably the statement was given by James W. Johnson, CEO of R.J. Reynolds from 1989 to 1996. Mr. Johnson should not be confused with another former CEO of RJR named F. (Frederick) Ross Johnson, who was quoted that same year in the Wall Street Journal as saying the following about tobacco: "Of course it's addictive. That's why you smoke the stuff." [Eben Shapiro, "Big Spender Finds a New Place to Spend," Wall Street Journal , October 6, 1994, p. B1.]

Six years prior to this testimony by RJR, the 1988 U.S. Surgeon General's report focused on nicotine addiction and stated clearly:

"Cigarettes and other forms of tobacco are addicting. • Nicotine is the drug in tobacco that causes addiction. • The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine." (http://www.cdc.gov/tobacco/sgr/sgr_1988/1988SGR-Intro.pdf)

Fields

Quotes

[Starting at the bottom of page 17 of the statement, under the section entitled, "The 'Addiction' Hypothesis"]:

In 1964, the Advisory Committee to the Surgeon General recognized that cigarette smoking did not meet well-established criteria for "addiction." In 1988, the Surgeon General altered the definition to fit the existing data on smoking. In essence, the Surgeon General moved the goalposts after he located the ball on the field. We categorically reject the claim that cigarettes are "addictive", and we know that an objective review of the facts and science supports our position.

Dr. Kessler defined "addiction" in terms of four elements:

-- compulsive use -- psychoactive effect -- reinforcing behavior -- withdrawal symptoms

When each of these elements is carefully analyzed in an unbiased manner, it becomes clear that cigarette smoking is no more "addictive" than coffee, tea or Twinkies. 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, has 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 defines 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. [Footnote: Using similarly vague definitions, researchers claim to have discovered addiction to love, jogging, television, credit cards and even eating carrots. See e.g. Peele, S. Love and Addiction, 1976; Hailey and Baily, "Negative Addiction in Runners," (1979); Winn, M. The Plug In Drug (1977); Parade Magazine, April 5, 1987, p. 28; Wright, MR "Surgical Addiction: A Complication of Modern Surgery?" Archives of Otolaryngology: Head adn Neck Surgery, 112: 870-872 (1986); Cerny and Cerny, "Can Carrots Be Addictive? An Extraordinary Form of Drug Dependence," Br. J. Add. 87:1195 (1992)] The desire is overpowering and leads to criminality and violence, if necessary, to satisfy the need for the drug.

Company
R.J. Reynolds
Author
R.J. Reynolds Tobacco 1
Johnson
Recipient
U.S. House of Representatives 2
Region
United States
Litigation
Minnesota Ag
Type
STATEMENT/TESTIMONY
Subject
addiction
testimony
FDA jurisdiction over tobacco

Annotations

1. R.J. Reynolds Tobacco Author
  • Affiliation:

    R.J. Reynolds Tobacco

2. U.S. House of Representatives Recipient
  • Affiliation:

    Committee Energy Commerce, Subcommittee Health Environment

Document Images

Text Control

Highlight Text:

OCR Text Alignment:

Image Control

Image Rotation:

Image Size:

Page 1: TOB01921.61 Log in for more options!
Statement of R. J. Reynolds Tobacco Company Before the U.S. House of Representatives Committee on Energy and Commerce Subcommitlae on Health and the Environment Concerning Whether lhe Food and Drug Admini.~;,-ation Has Jurisdiction to Regulate And Therefore Ban Cigarettes April 14, 1994 TIMN 0046266
Page 2: TOB01921.62 Log in for more options!
R.J. Reynolds Tobacco Company ("Reynolds Tobacco") welcomes this opportunity to respond to the inaccalrate 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 modificatio~n 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 dgarette 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 dgarette 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. Pl'9~ess 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 TIMN 0046267
Page 3: TOB01921.63 Log in for more options!
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, dgarettes recommended for smoking pleasure are beyond the Federal Food, Drug, and Cosmetic Act."1 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 dgarettes are 'drugs' within the To Amend the Federal Cigarette Labelimz and Advertising Act to Require Federal Trade Commission to Establish AcceDtabl’ l.~v’l~ of Tar and Nicotine Content of Cigarettes. 1972: Hearings on S.1454 Before the Consumer S~bcQmm. of the Senate Comm. on Commerce, 92nd Cong., 2d Sess. 239 (1972) (statement of Charles C. Edwards, Comm., FDA). See. ~ FFC v. Liggett and Myers Tobacco Co.. 108 F.Supp. 573 (S.D.N.Y. 1952), ~ 203 F.2d 955 (2d Cir. 1953); Letter from Donald Kennedy, Commissioner of Food and Drugs, to John F. Banzhaf, HI, Dkt. No. 77P-0185 (December 5, 1977); Action on Smoking & Health v. Harris. 655 F.2d 236 (D.C. Cir. 1980). TIMN 0046268
Page 4: TOB01921.64 Log in for more options!
meaning of the Federal Food, Drug, and Cosmetic Act." A/1 cigarettes sold are "n~cotine- containing cigarettes," and indeed the tobacco plant is known as ~ in recognition of the fact that it naturally contains nicotine. Moreover, the facts relevant to whether FDA has jurisdiction over cigarettes today are substantial/y the same as when Dr. Edwards testified in 1972 and when the FE)A 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. 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 dgarettes over the last forty years - an evolution that, in its purpose and effect, differs significantly f~om 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 discnssion of the history of cigarette design will illustrate why these recent claims are mBguided. Early cigarettes were primarily cut tobacco (much like pipe tobacco) wrapped in paper, with flavorings such as the oil of citrus peels. The quMity of a cigarette depended TIMN 0046269
Page 5: TOB01921.65 Log in for more options!
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 differem 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 dgarettes 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 (F'rc). (The FTC methods became offidal in 1969). A number of watershed developments in the early 1950s led m 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 a.fleeted 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- TIMI 00462"70
Page 6: TOB01921.66 Log in for more options!
constituents in tobacco smoke and development of technolo~ 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. 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 palming 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-19S0s until today, a succession of constituents has been targeted by the biomedical community. Even today, however, the biomedical community has been unable to a~ree on which, if any, of those constituents is responsible for the reported association be~een dgarette 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, ~ 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 flit-at.ion mech~ni~n~s 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 TIMN 0046271
Page 7: TOB01921.67 Log in for more options!
commonly increased another constituent. In general, efforts to reduce individual constituents have not been successful. Gener_al Red~lction During the snme period, Reynolds Tobacco and other cigarette manufacturers also directed their research to attempt to reduce levels of all constituents. This approach, also advocated by resemchers 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 ~hase. Since the mid-1950s, cigarette manufacturers have devoted extensive resources to 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 • Exp_anded tobacco .. • • • Filter ventilation Design chan_r;es such as the development of more porous cigarette paper, improved filtration, and the ,_,~e of expanded (or "puffed") tobacco and reconstituted tobacco made TIMN 0046272
Page 8: TOB01921.68 Log in for more options!
general reduction po:~sible. By utilizing one or more of these techniques, cigarette manufacturers can off..~r smokers a variety of cigarettes with a range of "tar" and nicotine levels. Cigarette desig.aers have been so successful in their efforts to respond to the demand for these reductions tltat 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? 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 Io ~'er yields of "tar" and other smoke constituents. The earliest de-~elopments 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 yiel, ls had been reduced dramatically. After 1965, the principal design See, ~ Fedel'al Trade Commission, "Far," Nicotine and Carbon Monoxide in the Smoke of 207 ~/arieties of Domestic Cigarettes 2-3 (1985). Public Health Service, U.S. Department of Health, Education, and Welfare, Smoking and Health: ~, Report of the Surgeon General 14:110 (1979) ("1979 Surgeon General's Rep,_~rt"). The techniques identified in the 1979 Surgeon General's Report were genetics r~ad breeding of tobacco plants, planting density, nitrate fertilization, applying agrieu ttural chemicals, topping the tobacco plant at different stages, altering the type of tobacco, alteriiag the position of thestaiN changing the nitrate content, ..... i .......... selecting tobacco with specific constituents (g~ proteins, carbohydrates, resins), curing, homogc:nized leaf curing, grading, fermentation, solvent extraction, tobacco expansion (fre-.~ze-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'~ng the cigarette paper, smoke filtration, and perforating the filter tips. Id. at 14:108-1-l. TIMN 0046273
Page 9: TOB01921.69 Log in for more options!
breakthroughs were ~xpanded 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 ciga~'ette 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 withless tobacco, there is less tobacco available; 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 196:1. In fact, Reynolds Tobacco licensed this process to others in the industry for commerc'~al use throughout the world. In the late 196 3s, scientists discovered that perforating the cigarette filter allows air to mix with the mains~: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 t, ~ be burned per puff, thereby further reducing the "tar" and nicotine yields. Perforated filters were first sold commercially in about 1972. By 1981, approximately 50% o ~ all cigarette brands sold had perforated filters,s 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 Public Health Service, U.S. Department of Health and Human Services, The Health Conseauences of Smoking: The Chan~ng Cigarette. A Report of the Surgeon General 209-10 (1981) ("1981 Surgeon General's Report"). Id. at 209-10. °8° 00 6 ' 4
Page 10: TOB01921.70 Log in for more options!
tobacco was used to a much greater extent to reduce the weight even more dramatically.7 Thus, as part of the ,lesign 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 dgarette 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"i This effort involved government, tobacco i adustry, public health groups, and universities. Reynolds Tobacco and other dgarette manutacturers participated in this program. The NCI program evaluated 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 eritici:;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 commer,_,~al 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,Sng the previous twenty-five years in response to the smoking and ................... health~ controversy. /dl of the papers presented at the. Banbu~ conference were. published, 7 This point is ,;spedally significant because it addresses Dr. Kessler's "surprise" at finding that, f{)r 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. - TIMN 004 27

Text Control

Highlight Text:

OCR Text Alignment:

Image Control

Image Rotation:

Image Size: