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It was clear to us several years ago that the tobacco industry's entire low tar and low 

 nicotine market was and should be subject to section 201 of the FDC Act, in that these 

 products were developed, manufactured, and marketed with an intended purpose to both 

 "mitigate and prevent disease," as well as to "affect structure and function of the body." 

 Last spring, the Coalition contracted with the Gallup Organization to determine what the 

 public's perceptions were about these products When asked what message the industry 

 was trying to get across by using such terms as low tar, low nicotine, and lower yield, almost 

 two-thirds of those surveyed (including both smokers and nonsmokers) believed that these 

 products were in some way safer and/or less addictive. 



I think the message is clear. The tobacco industry manufactures and the public buys these 

 cigarettes for the overwhelming reason that they believe these products are safer. These 

 products are, in our view, "drugs" under the Food, Drug and Cosmetic Act. Such a 

 conclusion is consistent with all the legislative history of the Act, the FDA decisions, as well 

 as the case law on when cigarettes can or should be treated as drugs. 



As Judge Meany stated so eloquently in a 1953 FDA/cigarette case: 



If claimants' [tobacco companies] labeling was such that it created in the mind 

 of the public the idea that these cigarettes could be used for the mitigation or 

 prevention 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 



