193 



of cigarenes. intended to atYect the structure and function of the body or 

 containing implied or direct health claims, are purely for smoking pleasure. 



What the Federal District Court said in Fairfax some 30 years ago, in applying the 

 provisions of the Food. Drug and Cosmetic Act. remains fuUy applicable today 

 and should be applied with the full force of the law against all cigarene products. 

 The Court in Fairfax observed: 



If claimants labeling was such that it created in the mind of the public the 

 idea that these cigarettes could be used for the mitigation or pr;vention 

 of the various named diseases, claimant cannot now be heard to say that 

 it is selling only cigarettes and not drugs... The ultimate Impression upon 

 the mind of the reader arises from the sum total of not only what is said, 

 but also all that is reasonably implied. If claimant wishes to reap the 

 reward of such claims let it bear the responsibility as Congress has seen 

 fit to impose on it. (113 F.Supp. at 338-339.) (Emphasis added.) 



B. LEGAL REQUIREMKNTS FOR ESTABLI SHING INTENT 



Petitioners have established that cigarettes and other tobacco products can and 

 have been legally classified as "drugs" under the Food, Drug and Cosmetic Act 

 when they are manufactured and marketed with an intended purpose to affect the 

 structure and function of the body, or when they are marketed to mitigate or 

 prevent disease. Additional attention, however, should be given to the legal 

 requirements needed to establish "intent" under section 201(g) of the Act. It was 

 Action on Smoking and Health's failure to show.aoy "vendor intent" that led to 

 FDA's denial of ASH's petition to classify all nicotine containing cigarettes as 

 "drugs." The legal authorities most frequently cited for establishing "intent" under 

 section 201(g) of the FDC Act include: 



Action on Smokiny and Health v. Harris . 655 F.2d 236 (1980) 

 U.S. v. Donerwich . 320 U.S. 277, 280, 64 S.Ct. 134, 88 L.Ed. 48 (1943) 

 U.S. v. An Article of Drue.Bacto-Unidisk . 394 U.S. 784, 22 L.Ed.2d 726, 

 89 S.Ct 1410, reh den 395 U.S. 954. 23 L.Ed.2d 473. 89 S.Ct. 2013 (1969) 

 U.S. v Hohensee . 234 F. 2d 367, 370 (3 Cir. 1957), cert, den., U.S. 967, 77 

 S.Ct. 1058. I L.Ed.2d 1136 (1957) 



