307 



64 - 



III. STATEMENT OF LEGAL GROUNDS 



A. LOW TAR ANO L OW NICOTINE CIGARETTES ARE "DRUGS" WITHIN THE MEANING 



OF T HE repgRAL FOOD. DRUG, and casHnrwrr 



Section 201(g)(1) of the Food, Drug, and Cosmetic Act (21 U.S.C. of 

 321(g)(1)) defines a drug as: 



"(A) articles recognized in the official United States 

 Pharmacopeia, official Homeopath'!': Pharmacopeia of the United 

 States, or official fonmjlatlng, or any supplement to any of theai; 

 and 



(B) articles intended for use in the diagnosis, cure, mitigation, 

 treatment or prevention of disease in man or other animals; and 



(C) articles (other than food) Intended to affect the structure or 

 any function of the body of man or other animals; and 



(0) articles intended for use as a component of any articles 

 specified in clauses (A), (B) or (C) of this paragraph; but does not 

 Include devices or their parts, or accessories." 



It is the intention of petitioners to establish that the manufacture, 

 advertising, promotion and marketing of low tar and low nicotine 

 cigarettes falls under the definition of drugs under clauses (B) and (C) 

 and of Sec. 201 (g)(1) which defines drugs as articles intended "for use 

 in the diagnosis, cure, mitigation treatment or prevention of disease," 

 and "articles (other than food) Intended to affect the structure or any 

 function of th« body of man or other animals." 



Petitioners contend that the manufacturing, advertising, sale and 

 promotion of these products has led consumers Into believing that use of 

 these products will mitigate and prevent diseases caused by the use of 

 the higher tar and nicotine cigarettes and that the marketing of 



