318 



75 - 



Filters of vtrylng types have been introduced to reduce tar and 

 nicotine delivery, chemical additives and flavorings of all kinds have 

 been Introduced into the product to restore flavor lost by tar 

 reduction. Variations in tar and nicotine levels, primarily for health 

 reasons, have become important, if not critical consumer determinants 

 on whether to quit smoking. (See "The Changing Cigarette," Report of 

 the Surgeon General 1981.) 



Today's low tar and nicotine cigarettes and the advertising and 

 promotional micerials that go Into their marketing requires that th€ 

 FDA classify these products as drugs under Section 201 (a)(1)(C) of the 

 FOCA. 



In U.S. V. 354 Bulk Cartons Trim Reducing Aid and Cigarettes , 



178 F. Supp 847, (D.N.J. 1959), the Government filed a libel action for 

 tlie seizure and condemnation of articles alleged to be drugs which 

 consisted of 354 bulk cartons (more or less) of cigarettes labeled 

 •Trim Reduclng-Ald Cigarettes." In ruling that the products were drugs 

 aider the FOCA, the Fcdtral District Court held that they were Intended 

 ts affect tlw structure or functions of the body by reducing the 

 ippetlte for the Ingestion of food. Drawing from an earlier decision 

 Itwolving cigarettes ( U.S. v. 46 Cartons, More or Less. Containing 

 Fairfax Cigarettes, supra ) the Court stated: 



"To contend that the claimant's labeling In 

 the case at bar would not create in the mind 

 of a weight conscious potential purchaser the 

 Idea that Trim cigarettes could be used for 

 reducing his or her weight, is to speak with 



