563 



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.^ 



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 



> To Amend the Federal Cigarette Labeling and Advertising Act to Require The 

 Federal Trade Commission to Establish Acceptable Levels of Tar and Nicotine 

 Content of Cigarettes. 1972: Hearings 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). 



- See, e.g.. FTC v. Liggett and Mvers Tobacco Co. . 108 F.Supp. 573 (S.D.N. Y. 1952), 

 affd on op. 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 Smoking & Health v. Harris . 655 F.2d 236 (D.C. Cir. 

 1980). 



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