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Tobacco products have traditionally not been subject to the Food. Drue, and 

 Cosmetic Act unless they have been determined to meet the legal standards of the 

 Act under Section 201 (g)(1), (B), and (C). The petitioners were pleased to 

 receive your lener of February 25, 1994, recognizing that cigarette products can. 

 in the view of the FDA. fall under the agency's jurisdiction as "drugs " and that 

 evidence exists that clearly points to the fact that these products are being sold to 

 mitigate and prevent disease and to affect function and structure of the body. 



As long as tobacco products and particularly cigarettes were sold merely for 

 smoking pleasure onlv and were not intended to affect function and structure of 

 the body or to mitigate or prevent disease, the FDA has not viewed itself as 

 having jurisdiction over cigarettes or other tobacco products. The history of the 

 food and drug statutes and case law, as well as testimony and other FDA actions 

 governing tobacco products do, however, make it clear beyond doubt that tobacco 

 products, like any other product, can be subject to the act when the manufacture, 

 sale, labeling, and promotion of the product is deemed to meet the legal 

 requirements of the Act. 



The earliest cases which affirmed FDA jurisdiction over cigarettes as "drugs " were 

 decided in the 1950s. Those cases remain the law today, supplemented by 

 numerous other cases that have reaffirmed the FDA's statutory authority. 



Petitioners believe that there is now more than ample evidence to establish that 

 today's cigarettes and other tobacco products are "druss" within the meaning of 

 Section 201 of the FDC Act. 



This proposition to regulate all cigarettes under the FDC Act was first advocated 

 by the Action on Smoking and Health (ASH) in the late 1970s in a petition to the 



