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FDA seeking to classify all nicotine containing cigarene products as drugs. While 

 the petition was denied, it was denied on the basis that ASH had failed to show 

 any evidence of vendor intent , that these products were being sold as products 

 intended to affect function and or structure of the body. ASH had relied solely on 

 consumer intent. While consumer intent was useful evidence to bolster "intent, " it 

 was in and of itself insufficient for the JTDA to assume jurisdiction absent a 

 showing of any vendor intent. 



Petitioners believe that after a review of evidence that has come to light since the 

 ASH petition was decided, a clear and convincing argument can now be made to 

 establish that cigarette manufacturers have in fact been selling cigarettes not 

 "merely for smoking pleasure only, " but have for some time embarked on a 

 calculated, intended strategy to alter the fundamental characteristics of tobacco 

 products, including but not limited to, the manipulation of nicotine. The tobacco 

 industry has turned its research endeavors into the implementation of marketing 

 strategies in order to sell a product that is designed to "affect functions and 

 structure of the body," as well as "mitigate and prevent disease." The industry's 

 extensive research, its development and manipulation of the cigarette and the 

 nicotine in its products, its calculated labeling and advertising campaigns to 

 convince smokers and nonsmokers that there are safer, less addictive products, 

 and its deliberate efforts to withhold important health related information from 

 the public wanant FDA jurisdiction over all cigarette products. 



