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n. STATEMENT OF LEGAL GROfNDS 



A. CIGARETTES ARE "DRUGS" WmilN THE VtEANTNG OF THE 



FEDERAL FOOD. DRUG ANT) COSMETIC ACT 



Section 201(gKl) of the Food, Drug and Cosmetic Act (21 U.S.C. of 321(g)(1)) 

 defines a "drug " as: 



(A) anicles recogiuzed in the official United Sutes Pharmacopeia, official 

 Homeopathic Pharmacopeia of the United States, or official National 

 Formulary, or any supplement to any of them: 



(B) articles inteaded for use in the diagnosis, cure, mitigation, treatment or 

 prevention of disease in man or other animals; 



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

 function of the body of man or other animals; and 



(D) articles intended for use as a component of any anicles specified in 

 clauses (A), (B) or (C) of this paragraph; but does not include devices or 

 their pans, or accessories. 



The manufacturing, advertising, promoting and marketing of cigarettes on the 

 market today, fall squarely within the definitions of drugs under clauses (B) and 

 (C) and of Sec. 201 (g)(1) which defmes 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 the body of 

 man or other animals. ' 



Petitionen contend (and have contended in previous petitions filed with the 

 FDA) that the manufacturing, advertising, selling and promoting of low yield 

 prtxlucts will lead consumers to believe that use of many of these products will 

 mitigate and prevent diseases caused by the use of the higher tar and nicotine 

 cigarenes and that the marketing of cigarettes is conducted in a calculated 

 manner with the intent of affecting the function and structure of the body of man. 

 Thus, for reasons set out in this petition, as well as reasons set out in prior 



