69 



Mr. Waxman. Thank you, Mr. Synar. 



Mr. Greenwood. 



Mr. Greenwood. Thank you, Mr. Chairman. 



Dr. Kessler, your testimony has been fascinating and interesting 

 in that it has helped us to better understand a fine point in the 

 debate about the ability of tobacco companies to affect the amount 

 of nicotine in their product and whether or not they can somehow 

 inject it into the process or whether they actually manipulate the 

 tobacco leaf itself. 



But it doesn't really go at all to the central question which you 

 raised in the first sentence of your testimony which is whether the 

 Food and Drug Administration should regulate nicotine containing 

 cigarettes as drugs under the Food, Drug, and Cosmetic Act. That's 

 really the issue. This is interesting, but the issue is whether we 

 ought to change the law in some way to give you the responsibility 

 to do that. 



Let me make it very clear that I don't have any interest in de- 

 fending the tobacco industry. I think the world would be a lot bet- 

 ter if no one smoked another cigarette and tobacco companies went 

 out of business. We would all be healthier, and that would be fine. 

 The question is what is the government's role and specifically what 

 would the FDA's role be in controlling and regulating tobacco prod- 

 ucts if we gave it to you? 



Would tobacco companies be in the business of advertising that 

 their cigarette is guaranteed by the FDA to have the highest nico- 

 tine levels possible? Do we want to see the tobacco company saying 

 that Dr. Kessler has certified that the tobacco in this cigarette is 

 the safest cigarette on the market or that this has been approved 

 by the FDA to contain no higher levels of tar and nicotine? I don't 

 see that this would be progress on public policy with regard to 

 smoking. 



What would be the Fed's role? Would it be to limit nicotine in 

 cigarettes, to set some sort of level and say, "All right manufactur- 

 ers, you can't have more than this amount of nicotine in your prod- 

 uct and tar and so forth." If that is the role that the FDA should 

 play, where in Grod's earth would you set that level? Who wants the 

 assignment to decide what is the lethality or the habituating quali- 

 ties of cigarettes? 



So I guess my question for you is, flat out, do you want the re- 

 sponsibility to regulate tobacco products and, B, if we gave it to 

 you, what would you do with it? 



Mr. Kessler. Congressman, I think those are all excellent ques- 

 tions. Please understand that the current Federal Food, Drug, and 

 Cosmetic Act has a definition of drug, and without any other con- 

 gressional intervention, then we as an agency are left with the 

 question of deciding whether nicotine-containing cigarettes, and it 

 is a nuance here, but we are focusing on nicotine in the cigarettes, 

 nicotine containing cigarettes rather than just the cigarettes, 

 whether the nicotine containing cigarettes are drugs for the pur- 

 pose of the Federal Food, Drug, and Cosmetic Act. 



If Congress does nothing, if Congress is not in a position to be 

 able to give us guidance, then we have a responsibility to answer 

 that question under the law as it is presently written. 



