192 



II 



This construction of the broad scope for the word 'drugs ' under the Food. Drug 

 and Cosmetic Act was set out by the Congress beginning in 1935 It was under the 

 legislation first considered during the 74th Congress and enacted in 1938 under 

 the Food. Drug and Cosmetic Act of 1938 (Copeland Act) (52 Stat. 1046, 75th 

 Congress, 3d Session, June 25, 1938) that the definition of "drug " was expanded to 

 be broadly interpreted. The Senate Committee Report to the 1935 Act stated: 



The definition of "drug" has been expanded to include, first substances 

 and preparations recognized in the Homeopathic Pharmacopoeia of the 

 United States: second devices intended for use in the cure, mitigation, 

 treatment or prevention of disease; third substances, preparations and 

 devices intended for diagnostic purposes, and fourth such articles other 

 than food and cosmetics intended to affect the structure or function of the 

 body. Such expansion of the definition of the term ""dmg" is essential if 

 the consumer is to be protected against a multiplicity of devices and such 

 preparations as "slenderizers."" many of which are wonhless at best and 

 some of which are distinctly dangerous to health. (Senate Repoit 74-361 

 "Food, Drugs and Cosmetics,"" 74th Congress 1st Session, 1935, p. 3.) 

 (Emphasis added.) 



The fact that tobacco products "'sold for smoking pleasure only" are not 

 considered to be drugs does not limit the FDA's authority to regulate those that 

 do fall under the statutory definition of "drugs." It was also Congress' intent that 

 product definitions not be mutually exclusive. As the Senate Report to S.5 further 

 noted in 1935: 



The use to wbich the product is to be put will determine the category into 

 which it will fall. If it is used only as a food it will come under the 

 definitioa of food or none other. If it contains nutritive ingredients but is 

 sold for drug use only, as shown by labeling and advertising, it will come 

 under the definition of drug but not that of food. If it is sold to be used 

 both as a food and for the prevention or treatment of disease it would 

 satisfy both definitions and be subject to the substanuve requirements of 

 both. The manufacturer of the article, through his representations in 

 cormection with its sale can determine the use to which the article is to be 

 put. (Senate Report 74-361, 74th Congress 1st Session, 1935 p. 4. See 

 also, U.S. V. Article— Sudden Change . 409 F.2d 734. 739, 1969.) 



Both the Congress and the courts have clearly spoken and the tobacco industry 

 cannot legally claim that their manufacturing, advertising, promoting and selling 



