189 



This position was reiterated in December 1977 by then FDA Commissioner 

 DonaJd Kennedy in a lener of denial to a petition filed by Action on Smoking and 

 Health et.al. . which requested that the FDA exercise jurisdiction over cigarenes 

 containing nicotine as a "drug" under the Food. Drug and Cosmetic Act and in the 

 alternative, as "devices " under the Act. In his letter. Commissioner Kennedy 

 concluded that the judicial opinions stood for the proposition that cigarenes are 

 "intended to affect the structure or any function of the body of man " within the 

 meaning of the Food, Drug and Cosmetic Act only where manufacturers or 

 vendors of cigarettes intend such effects (emphasis added) and that such intent 

 must be shown by heaith claims or other represenutions by cigarette 

 manufacturers or vendors. (Brief of Action on Smoking and Health v. Joseph 

 ralifann Case No. 79-1397, U.S. Court of Appeals for the District of Columbia p. 

 2-3). 



To date, the FDA has brought action against traditional cigarette products as 

 ""drugs" on two occasions. A third case, relevant to this petition and discussed in 

 greater detail elsewhere, concerns an action brought by the Federal Trade 

 Commission which employed the Food and Drug Administration s defmitional 

 standards for "'drugs." 



The first case relevant to this portion of the petition. United Stat es v 46 Carton. 

 More or Less, r^n'^^"'"? P"'*^" Cigarettes. 113 F. Supp. 336 (D.N.J. 1953), 

 involved the introduction into interstate commerce of 46 cartons of "Fairfax" 

 Cigarettes. The cartons were accompanied with 51 leaflets entitled, "How 

 Cigarettes May Help You." A Ubel action was brought by the United Stotes 

 alleging that the cigarettes were drugs and. as such, were misbranded. The issue 

 addressed by the court was whether or not "the seized article is a drug within the 

 meaning of the Food, Drug and Cosmetic Act." The Court noted that "in a field 



