208 



B. THE TOBACCO CVDISTRY HAS CONT)LCTED EXTENSFVE 



RESEARCH FSTO T HF \TFnir AL RA-VPFICATION OF CIGARETTES 

 ■AS WELL AS ON THE IMPORTANT ROLE THAT MCOTINT: PLAYS IN 

 THE ADDICTTON TO CIGARETTES. HAS INTENTIONALLY 

 ■VL\NTPLXATED THE NICOTINE LEVELS IN TOBACCO PRODUCTS 

 DESIGNED TO AFFECT THE "FL"NCTIONS AND STRLCTLTtE OF THE 

 BODY." ANT) HAS USED THIS KNOWLEDGE AS PART OF ITS 

 PRODUCT DEVELOPMENT AND MARKETING STRATEGIES 



Petitioners have already established that tobacco products can be "drugs " under 

 Section 201 of the FDC Act. This section will provide factual evidence that the 

 tobacco industry is no longer selling cigarenes for "smoking pleasure only." but 

 has for some time in fact conducted extensive research and marketing activities 

 on nicotine, and cigarette products in general, including developing sophisticated 

 processes for extracting nicotine from tobacco products, and adding the nicotine 

 back into the product (Reconstitution processes). This calculated, scientifically 

 based effort to "control" the nicotine delivery of a cigarette prtxluct, coupled with 

 a marketing strategy often designed to promote low nicotine cigarettes as safer 

 and less addictive, warrants FDA expeditious action to classify all tobacco 

 products as drugs under Section 201(g)(1)(B) and (C) of the Act. 



Over the last several years, new evidence and documentation has been brought to 

 light which establishes that the cigarette industry has for many years recognized 

 the central role that oicotine plays as part of the smoking habit, and that it 

 deliberately and intentionally conducted (and continues) extensive research into 

 nicotine, its effects on functions and structure of the body, and has used such 

 research to develop and market new cigarettes designed to both affect functions 

 and structure of the body and to mitigate and prevent disease (addiction). 



In addition, tobacco industry documents made public in the case of Cipoilong v. 

 Li^yett Group. Inc. . CivU Action No. 83-2864 (D.N.J. 1988), a product liablUty 

 action brought in the U. S. District Court in New Jersey, reveal cigarette 



