200 



As *e will clearly establish in the Sutemem of Factual Grounds, the Surgeon 

 Generals Reports (particularly the 1988 Report on Nicotine Addiction), the 

 FDA's own actions in regulating nicotine containing products as drugs, as well as 

 the industry's own research, documents, and marketing strategies, reveal a 

 component of the tobacco product (nicotine) which is today recognized as a 

 powerful and significant determinant on smoking behaviors, and one that has 

 significant intended effects on functions and structure of the body. The tobacco 

 industry's deliberate attempts to remove other dangerous substances in the 

 cigarette product is further evidence of its efforts to produce products intended to 

 effect structure and function of the body, and/or to mitigate or prevent disease. 



Clearly the health claims, research, and development of nicotine and cigarene 

 products in general, which have been and continue to be conducted by the 

 industry are the primary i^esult of scientifically and medically established health 

 dangers (including nicotine addiction), associated with cigarette smoking, that 

 were obviously not known in 1952 or more importantly not cited in the 1952 

 Li ggett case . It was not until 1953 that the first significant scientific evidence that 

 cigarette smoking was causally connected with cancer came to public attention. It 

 was not until 1964 that the first Surgeon General's report on cigarette smoking 

 and cancer was released to the public. The scientific and medical knowledge 

 about the dangers of tobacco, coupled with the tobacco industry's strategic 

 responses to such knowledge, have changed so dramatically and significantly since 

 the 1952 decision that we are obviously no longer dealing with a product that 

 merely "stimulates" in some insignificant degree, but which is a proven cause of 

 major chronic diseases and is as addictive as cocaine and heroin -- issues which 

 were obviously far from the mind of the court when they considered and ruled in 

 Liggett. The basis upon which petitioners seek action on the part of the FDA 

 under section 201(g)(1)(C) is therefore wholly consistent with the LiggfiH decision. 



