181 



TABLE OF CONTENTS 



I. PRELCVONARY STATEMENT page I 



n. STATEMENT OF LEGAL GROUNDS page 6 



A. Cigarettes are "drugs wuhin the meaning of the 

 Federal Food. Drug and Cosmetic Act. 



B. Legal requirements for establishing intent. 



C. FTC V. Ligg ett is consistent with the legal arguments 

 made by petitioners to classify all cigarettes as 

 dnigs under Section 201(g)(1)(C) of the Food. Dnig, 

 and Cosmetic Act. 



D. FDA has on numerous occasions regulated as drugs and/ or 

 food other nicotine or tobacco containing products. 



E. FDA's failure to take action against tobacco products 

 is arbitrary and capricious. 



in. STATEMENT OF FACTL AJ. GROUNDS page 23 



A. Tobacco products are a major cause of disease in the 

 United Sutes and are addictive. Nicotine is the dnig 

 in tobacco that causes addiction. 



B. The tobacco industry has conducted extensive research 

 on the important role that nicotine plays in the 

 addiction to cigarettes, has intentionally mampulated 

 the nicotine levels in tobacco products designed to 

 affect the "functions and structure of the body," 



and has used this knowledge as part of its produrt 

 development and marketing strategies. 



IV. 



rONCLUSIGN page 3^ 



