202 



conventional cigarene smoke and thereby prevent lung cancer.' The regulatoi^ 

 letter goes on to sute that " Cigarettes marketed as containing the N-Bloctin' 

 additive such as Optima and Spectra Brands are also dmgs under Section 

 201( g)(1)(B) and (C) of the FDC Act . When one or more of these uses for 

 cigarenes containing N-Bloctin' is recommended or suggested in the labeling they 

 would be 'new drugs' as defined in Section 20 1 (p)...." This case is analogous to 

 the situation in the case of low tar and nicotine claims in that the product that is 

 being used is also the product that causes the diseases to be avoided, an issue that, 

 in spite of tobacco industry assertions, is obviously not relevant in the application 

 of Section 201(g). (Emphasis added.) 



The Food and Drug Administration has reviewed and approved new drug 

 applications for a variety of nicotine containing products including gums and 

 patches which are designed to assist the public in reducing their risks of disease 

 and addiction caused by cigarene smoking. 



And most recently, the FDA sent a regulatory letter to the maker of JAZZ 

 cigarettes indicating that the claims made by the manufacturer constituted 'drug" 

 claims under the FDC Act and since the product is a new drug for which no 

 approval of an application has been filed, the product was prohibited from being 

 sold in interstate commerce. JAZZ was advertised as a revolutionary product - 

 nicotine free , tar free , and noncancerous , a message clearly analogous to the 

 tobacco industry's messages in their low tar and nicotine promotions, and clearly 

 comparable to the industry research and development initiatives to develop safer, 

 less addictive products. 



