Tobacco Documents Online

Statement of Charles O. Whitley on behalf of The Tobacco Institute to the Subcommittee on Health and the Environment Committee on Ene~gy and Commerce United States House of Representatives July 29, 1988 Mr. Chairman, .~istinguished members of the Subcom- mittee and former collea.~ues. I appreciate the opportunity to appear before you today on behalf of The Tobacco Institute to discuss the 20th Report of the Surgeon General, "The Health Consequences of Smoking: Nicotine Addiction," and the nature and extent of the Food a~d Drug Administration's authority to regulate cigarettes. With me today nee Theodore H. Blau, Ph.D., a practi- cing clinical psychologi!~t, and Stephen M. Raffle, M.D., Assistant Clinical Profe~sor of Psychiatry at the University of California at San Francisco. Dr. Blau and Professor Raffle will address the Surgeon General's assertions with respect to cigarettes and addiction from a clinical and scientific stand- point. Although this hearing has been called as an oversight hearing, both of the matters to be considered are subjects of pending legislation. Rep. Slattery has introduced a bill TIMN 0025797

PRIV[L~ ~D AND CONF~DEN~IAL lh'o~uced as required by the Court's March $~te of Minnesota, et ~. _ Court FUe No.: C1-9~8565 (H.R. 4793) to require a new Surgeon General'~ warning to appear on cigarette pack.ages and in cigarette advertising, stating that "nicotine ii~ cigarettes is an addictive drug." Repo Whittaker has introduced a bill (H.R. 3294} that would authorize the Food and Drug Administration "to Eegulate ciga- rettes in a manner similar to its regulation of food and drugs." Mr. Chairman, The Tobacco Institute opposes both bills. To call cigarett.e smoking an "addiction" trivializes the serious drug problem faced by our society and undermines efforts to combat drug abuse. This is the Surgeon General who, in all seriousness, publicly proclaimed in 1982 that youn9 people are "addicted'* to video games. The escalation of antismoklng rhetoric by the Surgeon General in his latest Report is similarly withDut medical or scientific foundation -- as a number of public health officials have recognized, and as the 41 million Americans who have stopped smoking attest. Neither is there any justification for establishin~ a special regime of regulatlon of cigarettes by the Food and Drug Administration. The FDA has not treated cigarettes as "exempt" from regulation under the Federal Food, Drug, and Cosmetic Act but has asserted jurisdiction when health claims have been made by vendors or manufacturers. Subjecting ciga- rettes to speclal FDA regulation in the absence of health claims would impose substantial new burdens on the agency, TIMN 0025798

State oi IVimn~"'.'.., - Court File No.: C1.94-8565 fragment its regulatory focus and divert scarce resources from such essential tasks as approval of new medicines. When the Surgeon General released his 20th Report this May, comparing tobacco with "other addicting drugs such as heroin and cocaine," the critical response from public health figures and others was instantaneous. Professor Albert Hirsch, author of the foreword and conclusion to an extensive 1987 report on tobacco to the French Minister of Health and a vocal critic of the tobacco industry, condemned the Surgeon General's conclusions in a May 18 interview on French radio: "Tobacco cannot be compared to drugs, espe- cially hard dru~s like heroin or other narcotics. It ~s always bad to fight an evil with misstatements or distortions of the truth. * * * Talk of 'addiction' would mean comparing tobacco to something which com- pletely alters the personality of the sub- jects, turning them into anti-social indi- viduals, which we know is not the case with the overwhelming majority of smokers. We should resist the kind of discrimination and witch-hunt that can be observed in some of the excesses of the antitobacco campaign in the United States." In voicing this criticism of the Surgeon General's claims, Professor Hirsch echoed, earlier findings of the World Health Organization. As the Surgeon General himself acknow- ledges, WHO long ago drogped the term "addiction" from its lexicon, concluding that the term is so misunderstood and misused that it lacks any useful meaning. 20th Report, p. 248. TIMN 0025799

- 4 - Se~ WHO Expect Committe~ on Addiction-Producing Dcugs, Thir- teenth Re~rt (1964). Editorial writers across the country also immedi- ately registered sharp disagreement with the Surgeon General's addl~tion report. The Hoston Globe noted that "[s]moking bears no resemblance to drug abuse or alcohol abuse. Smoking does not affect mental acuity, nor temporarily derange a per- son, nor produce so much as a lull in anyone's contact with "Classifying the dangers of nicotine with the horrors of heroin or cocaine is misguided zealotry. It downgrades, even discredits, the nation's campaign against hard drugs. * * * [TJhe Surgeon General's latest attack on smoking is ~tself generally irresponsible .i,..nthusiasm has turned to zealotry and is on ~ts way to .~anaticism. His concern for the people's health is no longer mixed with a healthy respect: for individual rights and individual responsibility." The.Kansas ~_ City Star called the Surgeon General's contentions w~th respect ~o cigarette smokfn, and addiction "r~d£culous~" and the Orange County ~CA~ Register commented: "What we need is a differen~ warning, to be stamped on every federa~ document and on every paycheck given to governmen~ workers, reading: 'WARNING~ Power is addictive. Once you start abusing your office and wasting the taxpayers' money, you,my not be able to stop.'" Dr. Blau and Professor Raffle will comment in detail on the medical and scientific aspects of the Surgeon General's TIMN 0025800

- 5 - Report. I would note, however, that the Report is merely a compilation of existing literature. No new research is oon- rained in the Report. Indeed, significant portions of the data in the Report actually cqntradict the Surgeon General's conclusion that cigarette smoking is "addictive." The Report ~cites, for example, a 1985 National Health Interview Surve stopped smoking. According to the. survey, approximately 90 percent oZ these former smokers quit smoking without formal treatment programs or smoking cessation devices. If the difficulty of stopping use of heroln or cocaine is the measure of an "addiction" -- a step usually requiring hospitalization and outpatient treatment and the wholesale restructuring of the former addict's lifestyle_ -- then the comparison of nicotine to such hard drugs is clearly absurd. If the effect of heroin or cocaine use on the user is the measure of an "addictive" substance -- impairing the indi- vidual's ability to think clearly and otherwise to lead a normal everyday life --~hen, by this standard as well, nico- tine cannot be considered "addictive." On the other hand, if the mere fact tha~ some people find it difflcult to quit smoking is enough to make smoking an "addiction," then any habitual behavior may be considered an "addiction." People who have trouble controlling their eating may be considered "addicted" to food, and some people may be TIMN 0025801

considered "addicted" to television. Similarly, if the mere cigarette smoking produces some pharmacological fact that effects is enough to make smoking an "addiction," then coffee drinking is also "addictive." Once the term "addiction" is so political document. Its conclusions conform with the Surgeon General's political goal of a smokeless society, and undoubtedly were reached long before the Report was drafted. By branding cigarette smoking an "addiction"--a term with- deepl~ pejorative moral and social connotations -- the Surgeon General obviously hopes to strengthen the antismoking cause generally and, undoubtedly, hopes to make it easier for plain- tiffs to prevail in tobacco product liability cases. The "addiction" claim, of co~rse, was not accepted by the jury in the Cipo~one case in New Jersey, even after the Surgeon General's Report was introduced into evidence by the plaintiff. In sum, there is no medical or scientific basis for viewing cigarette smoking as an "addiction," and no justifica- tion for legislation requiring any new warning label of the sort that Rep. Slattery has proposed. The effort to disparage cigarette smoking as an "addiction" can only detract from our soolety's attempt to meet its serious drug problem. TIMN 0025802

-7- II. The other purpose of this hearing is to "review the nature and extent of the Food and Drug Administration's authority to regulate nicotine Containing products such as the ~o-¢alled 'smokeless cigarette.'" We understand that the ~ eEerence to the "sm k le i " " " ~'~._~r o e ss c'garette is a reference to a ~cernlng that product. The Tobacco Institute is not in a posi- tlon to discuss particular products of individual member compa- nies. The Tobacco Institute, as stated earlier, opposes any proposal to establis~ a special regime for regulating cigarettes under the Federal Food, Drug, and Cosmetic Act. The proposal of Rep. Whittaker (H.R. 3294) in this regard -- like the proposal of Rep. Bates (H.R. 2376} to confer upon the Con-. sumer Product Safety Co~,ission authority to regulate ciga- rettes -- appears to rest on the premise that tobacco and tobacco products are essentially "unregulated." Rep. Whittaker has flatly stated that tise FDA is "powerless" to regulate cigarettes. These suggestions are unwarranted. The claim that cigarettes are somehow unregulated (or underregulated) Ignores, among other things, the many statutes and regulatlons that govern virtually every aspect of the growing, manufacture, marketing and use of tobacco and TIMN 0025803

-8 - tobacco products -- including cigarettes. In my testimony at the September 16, 1987, hearing on H.R. 2376 before the Subcom- mittee on Commerce, Consumer Protection and Competitiveness of the House Energy and Commerce Committee, I discussed in detail the extensive regulation of tobacco and tobacco products at every level of government -- federal, state and local. o£fe= my prepared statement at that hearing for your considera- tlon. As you will see, tobacco and tobacco products already are among the most intensively regulated products in America. Any suggestion that the FDA ~iews cigarettes as "exempt" from. regulation under the Federal Food, Drug, and Cosmetic Act ~s particularly mistaken. The FDA in fa~t has asserted jurisdiction over cigarettes when health claims were made by the vendors or manufacturers, and the COUrtS have sustained the Agency's assertion of jurisdiction. (See United States v. 46 Cartq~@., More or Less, Containing Fairfax Cigarettes, 113 F. Supp. 336 (D.N.J. 1953); ~nited States v. 354 Bul~ Cartons * * * Trim. ~educin@ Ai~ Cigarettes, 178 Supp. 847 (D.N.J. 1959);. see also FTC v. Liggett & Myers ToSacco Co., 108 F. Supp. 573 (S.D.N.¥. 1952), all'd, 203 F.2d 955 (2d Cir. 1953).} Absent such health claims, the FDA has concluded that cigarettes are not a "drug" within the meaning oE the Act, and the U.S. Court of Appeals for the District of Columbia Circuit has upheld the FDA's position. (Action on Smo~In~ and Health v. Harris, 655 F.2d 236 (D.C. Cir. 1980}.) TIMN 0025804

-9- Antismoking advocates recently have petitioned the FDA to institute proceedings to regulate low-"tar," low- nicotine cigarettes as "drugs" under the Federal Food, Drug, and Cosmetic Act, contending that such cigarettes are promoted as a means of reducing ~he alleged health ris~s associated . with smoking. The FDA denied a similar petition in 1980. The most recent petition has no more merit. In the Comprehensive Smoking Education Act o~ 1984 to "conduct and support research on the effect of cigarette smok~n~ on human health and develop materials ~or informing the public of such effect." 15 U.S.C ~ 1341(a)(I) Congress • . also directed the Secretary to "coordinate all research and educational programs and other activities within the Department • * * which relate to the effect of cigarette smoking on human health." I__d. S 1341(a)(2). In addition, cigarette manufac- turers are required by the Comprehensive Smoking Education Act to disclose annually to the Secretary all ingredients added to the tobacco used in cigarettes. The Secretary, in turn, is required by the 1984 Act to report to Congress on any such ingredient that, in his j~dgment, "poses a health risk to cigarette smokers." I__d. S. 1335a(a), (b)(1)(B). There is no evidence that the Secretary is unable to discharge these responsibilities, and no basis ~or transferring those responsi- bilities to the FDA, as H.R. 3294 effectively would do. TIMN 0025805

- 10 - Mr. Chairman, the FDA is a beleaguered agency, with scarcely enough resourcE~s to perform such essential functions as approving new medfcir~es. The historic policy of focusing FDA regulation on foods, drugs, cosmetics and medical devices is a sound one, and sho~id not be f~agmented by expanding the agency's jurisdiction ad hoc to encompass products that do not fall within those categories. Congress should not establish special systems of FDA ~egulation for products that are not foods, drugs, cosmetics or medical devices. I would be ple.ased to answer any questions. I~KIVILEGED AND cONFIDENTIAL Produced as required by the CouPs March 7,1998 Ord~ State o[ Minnesota, et al. v. Philip Morris, et ak Court File No.: C1-94-8565 TIMN 0025806