14 



STATEMENT BY 



DAVID A. KESSLER, M.D. 



COMMISSIONER OF FOOD AND DRUGS 



In my last appearance before this subcommittee on March 25, 

 1994, I raised the question of whether the Food and Drug 

 Administration should regulate nicotine-containing cigarettes as 

 drugs under the Federal Food, Drug, and Cosmetic Act.' A 

 product is a drug if its manufacturer intends it to be used to 

 affect the structure or function of the body.^ Because of the 

 enormous social consequences of such a decision, we have asked 

 Congress for guidance as we try to answer this question. 



Mr. Chairman, the American public owes a huge debt of 

 gratitude to this subcommittee for its tireless efforts to focus 

 attention on this most important public health matter. 



Let me begin by summarizing the information that I presented 

 at that hearing. I reviewed the evidence that supports the 

 scientific consensus that nicotine is addictive. I also reviewed 

 the evidence we had at that time on the ability of the tobacco 

 industry to control nicotine levels, including numerous industry 

 patents for technologies to manipulate and control nicotine 

 content. I described activities of the cigarette industry that 

 resemble those of pharmaceutical manufacturers. I presented 

 information that raised the question of whether tobaccos were 

 blended to manipulate and control nicotine levels. And I 

 provided data showing that over the last decade, nicotine levels 

 have not dropped in parallel with tar levels -- in fact, they 

 have risen. 



Since March 25th we have continued to focus our analysis and 

 investigation on the physiological and pharmacological effects of 

 nicotine and on the degree to which cigarette companies 



manipulate and control the level of nicotine in their products. 



The information that I presented about industry control and 

 manipulation of nicotine the last time I testified before you was 

 suggestive. Today I am going to provide you with actual 



