337 



- 94 



C. CIGARETTE MANUFACTURERS HAVE FAILED TQ MEET THE REQUIREMENTS OF 

 SECTION SOS OF THE FOOD. DRUG. ANO COSMETIC ACT (21 U.S.C. Sec. 

 321(p)). "NEW DRUGS." 



Section 20l(p) of the Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 321(p)) 

 defines "new drug" as: 



"(1) Any drug (except a new aniiwl drug or an animal fc .<» 

 bearing or containing a new anIiMl drug) the coiiposltlor. uf 

 which Is such that such drug Is wt generally recognized, aiso.r, 

 experts qualified by scientific training and experience to 

 evaluate the safety and effectiveness of drugs, as safe &rv< 

 effective for use under the conditions prescribed, recooniended, 

 or suggested in the labeling thereof, except that such a drug 

 not so recognized shall not be deened to b« a 'new drug" If an 

 any time prior to the enactment of this Act It was subject to 

 the Food and Drugs Act of June 30, 1906. as amended, and If at 

 such time Its labeling contained the same representations 

 concerning the conditions of Its use; or 



(2) Any drug (except a new animal drug or an animal feed bearing 

 or containing a new animal drug) the composition of which Is 

 such that such drug, as a result of investigations to determine 

 Its safety and effectiveness for use under such conditions, has 

 become so recognized, but which has not. otherwise than In such 

 Investigations, been used to a material extent or for a material 

 time under such conditions.* 



Petitioners contend that manufacturers of low tar and nicotine cigarettes 

 have failed to meet the statutory requirements governing the introduction 

 or delivery of new drugs into Comnerce under Section 505 of the Food. 

 Drug, and Cosaetlc Act (21 U.S.C. Sec. 355). Section 505 requires among 

 other things that prior to the introduction or delivery of a new drug into 

 Interstate comnerce an application of approval be filed with the Secretary 

 of the Department of HHS. Such application shall by statute Include such 

 Information as: 



