315 



72 



th« Statute's definition, furthermore clearly points 

 out Congress' intention of going beyond the medical 

 usage.* 



This construction of the definitional scope of "drugs" under the Food, 

 Drug, and Cosaetic 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 Cosaetic Act of 1938 

 (Copeland Act) (52 Stat. 1046, 7Sth Congr<fSS, 3d Session, June 25, 1938) 

 that the definition of drug was expand-d to be broadly interpreted. The 

 Senate Coniilttee Report to the 1935 Act stated: 



"The definition of "drug" has been expanded to Include, 

 first substances and preparations recognized In the 

 Honeopathic 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 cosaetlcs intended to 

 affect the structure or function of the body. Such 

 expansion of the definition of the tern "drug" is essential 



if the consumer is to be protected against a multiplicity 

 of devices and such preparations as "sienderlzers*, many of 



which are worthless at best and some of which are 



distinctly dangerous to health. " (Emphasis added). Senate 



Report 74-361 "Food, Drugs, and Cosmetics', 74th Congress 

 1st Session, p. 3 1935. 



The fact thtt aeny tobacco products are not considered to be drugs does 

 not limit 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, 



