REGULATION OF TOBACCO PRODUCTS 



TUESDAY, JUNE 21, 1994 



House of Representatives, 

 Committee on Energy and Commerce, 

 Subcommittee on Health and the Environment, 



Washington, DC. 



The subcommittee met, pursuant to notice, at 9:47 a.m., in room 

 2123, Raybum House Office Building, Hon. Henry A. Waxman 

 (chairman) presiding. 



Mr. Waxman. The meeting of the subcommittee will come to 

 order. 



It is hard to believe that it was less than 2 months that Dr. 

 David Kessler, Commissioner of the Food and Drug Administration 

 presented his testimony to this subcommittee about the investiga- 

 tion as to whether nicotine and tobacco are drugs subject to regula- 

 tion under the Federal Food, Drug and Cosmetic Act. Since that 

 time, this subcommittee has engaged in the wide-ranging investiga- 

 tion which has included the critical issue of whether cigarette com- 

 panies intend that tobacco have drug-like effects. 



This morning, we will hear testimony from Dr. Kessler on the 

 current status of his investigation. On Thursday, we will have 

 Thomas Sandefur, a CEO, back before the subcommittee. Before 

 calling on Dr. Kessler, I want to see if any members have opening 

 statements and recognize Mr. Bliley first. 



Mr. Bliley. Thank you Mr. Chairman. Gk)od morning Dr. 

 Kessler. I must say, as I review this room, that there seems to be 

 a good bit of media interest in this subject. Brings to mind a ver- 

 sion of that old question concerning the tree falling in the forest. 

 If the media was not here, would we be holding this hearing today. 



Four months ago. Dr. Kessler dropped a bombshell that made all 

 the papers. For decades, the Food and Drug Administration had de- 

 clined to assert jurisdiction over cigarettes as drugs as long as the 

 manufacturers promoted their products on the basis of smoking en- 

 joyment and not for some effect cigarettes might be thought to have 

 on bodily structures or functions. 



In his famous letter of February 25, however, Dr. Kessler sug- 

 gested that FDA would now be considering regulating cigarettes as 

 drugs if the Agency found that the manufacturers intended that 

 people buy their products to satisfy a "nicotine addiction." 



With the stage properly set. Dr. Kessler then appeared before the 

 subcommittee on television cameras to describe the mounting evi- 

 dence that nicotine is addictive and that cigarette manufacturers 

 deliberately manipulate the amount of nicotine in cigarettes in 

 order to "produce a sustained addiction." 



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