492 



In conclusion, the interviews and inspections of these four Philip 

 Morris manufacturing facilties provided us with the information to find 

 that the nicotine content of cigarettes is not intentionally controlled 

 by the manufacturing processes, nor is nicotine added during the 

 process of preparing reconstituted tobacco nor as part of a flavoring 

 agent. The nicotine content of cigarettes results from the natural 

 content of tobacco leaves and stems, with the exception of an 

 insignificant amount contributed by the denatured alcohol used as a 

 flavor carrier. 



The question of FDA's authority to regulate tobacco products is clearly 

 a legal matter. This question has arisen previously, including during 

 my tenure as Deputy Commissioner at the agency. It hinges on a 

 marketer's intent and representation to consumers. The agency and 

 the courts have held that, in the absence of representations that the 

 tobacco product is intended to affect any function of the body, the 

 product does not fall within the statutory definition of a drug (2 1 USC 

 § 321 (g)(l)(C)l. The definitive court holding on this issue was in the 

 case of Action on Smoking gmd Health v. Harris in 1980 [655 F. 2d 

 236. DC. Cir. 1980i. Considering this and other provisions of the 

 FD&CAct, nothing I have learned during my service at FDA or since 

 changes my understanding of the Act and its applications in this area, 

 including the recent FDA consideration of cigarette regulation. My 

 recent inspections of the Philip Morris facilities did not disclose any 



