309 



. 66 



affect, and contained a component which affected structure or functions of 

 the body, and therefore constituted "drugs' within the meaning of the 

 Food. Drug, and Cosmetic Act." 



The Food and Drug Administration's jurisdiction over tobacco products in 

 appropriate circumstances has also been reaffirmed by the FOA in testimony 

 before the Congress. In 1972, FOA then Commissioner Charles C. Edwards 

 testified to the Consumer Subconmittee before the Senate Conciilttee on 

 Commerce as follows: 



"Cigarettes and other tobacco products would be drugs subject 

 to the Federal Food. Onjg, and Cosmetic Act If medical claims 

 are made for the product. ...We have on occasion proceeded 

 against cigarettes recooaended for use in controlling 

 appetite or otherwise reconmended as a weight reducing aid. 

 ...However cigarettes recommended for smoking pleasure are 

 beyond the Federal Food, Drug, and Cosmetic .Act. (Hearings, 

 "Public Health Cigarette Amendments of 1971", Consumer 

 Subcommittee, Senate Committee on Commerce 92nd Congress, 

 1972, Serial No 92-82 page 239) 



This position was reiterated In December 1977 by then FOA Commissioner 

 Oonald Kennedy In a letter of denial to a petition filed by Action on 

 Smoking and Health et.al., that had requested the FOA to exercise 

 Jurisdiction over cigarettes containing nicotine as a "drug" under the 

 Food, Drug, and Cosaetic 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 cigarettes 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 



