25 



DEP\RTVtENTOF HEALTH & HL MAN SERV ICES 



Puonc HatitA Sarvica 



Food and Drug Administration 

 Rockvill« WO 20857 



February 25, 1994 



Scott D. Ball In, Esq. 



Chairman, Coalition on Smoking OR Health 



Vice President for Public Affairs 



American Heart Association 



1150 Connecticut Avenue, NW. , Suite 810 



Washington, D.C. 20036 



Dear Mr. Ball in: 



As you know, the Food and Drug Administration (FDA) has 

 before it several petitions from the Coalition on Smoking OR 

 Health seeking to have PDA regulate low-tar and low-nicotine 

 cigarettes and denicotinized cigarettes as drugs. Rather than 

 respond formally to the petitions at this time, I think it more 

 appropriate to frame the issues for the broader public debate 

 that will be necessary to resolve them. 



In its consideration of the petitions, the agency has 

 examined the current data and information on the effects of 

 nicotine in cigarettes. The current data on the highly addictive 

 nature of nicotine and other evidence now available to FDA lead 

 the agency to take a different approach from that urged in the 

 petitions. The structure of the Federal Food, Drug, and Cosmetic 

 Act (the Act) , and sound public health policy, suggest that the 

 focus should be on the presence of nicotine in cigarettes in 

 amounts associated with addiction. 



As you note in your petitions, FDA has traditionally 

 refrained from asserting jurisdiction over most cigarette 

 products. This has not been based on an interpretation of the 

 Act that cigarettes cannot be regulated as drugs. There is no 

 exemption for cigarettes from the Act's definition of a "drug," 

 and some cigarette products have been regulated as drugs. See 

 United States v. 46 Cartons . . . Fairfax Ciaarettea, 113 F. 

 Supp. 336 (D.N.J. 19S3); United States v. 35 4 Bulk Cartons Trim 

 Redueina-Aid Cigarettes . 178 F. Supp. 847 (D.N.J. 1959). 



Under the Act, products are subject to regulation as drugs 

 based on the intent of the product vendor. If the vendor intends 

 that the products be used as drugs (for therapeutic or diagnostic 

 use or to affect the structure or function of the body) , FDA may 

 regulate them as drugs. See National Nutrition al Foods Ass'n v. 

 Mathews ■ 557 F.2d 325, 334-6 (2d Cir. 1977). Although it has 

 been well-known for many years that some people smoke for the 

 drug effects of nicotine (for example, for stimulation and/or to 

 satisfy a dependence on nicotine) , cigarette vendors have in the 

 past been given the benefit of the doubt as to whether they 



