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Mr. Kessler, Congressman, I tried very hard not to deal with 

 specific companies today, but to respond to this comment 



Mr. Wyden. Let's set aside then Philip Morris, even though they 

 said it in The Washington Post. 



If a drug company admits that they are adding nicotine to ciga- 

 rettes — this is what I am asking, in a hypothetical case — isn't that 

 an admission that they are in the drug business and therefore sub- 

 ject to regulation under the 1938 Act? 



Mr. Kessler. I am sorry, if you can ask the question again. 



Mr. Wyden. If a drug company admits that they are adding nico- 

 tine to cigarettes is that an admission that they are in the drug 

 business and therefore subject to regulation? 



Mr. Kessler. Andrew, if I could get the definition of drug, this 

 is what it comes down to. There are three parts of the definition 

 of drug. One has to do the formularies; that is not at issue here. 

 The relevant two sections — something is a drug either of two ways, 

 for all practical purposes: an article intended for use in the diag- 

 nosis, cure, mitigation, treatment, or prevention of disease. Does 

 that apply to nicotine in cigarettes? 



It certainly is possible to argue addiction is a disease. And then 

 the question is, is the article intended for the mitigation of a dis- 

 ease? 



But I think the harder question for the Agency to deal with is 

 the third definition. And that is — something can be a drug if it is 

 an article other than food intended to affect the structure or func- 

 tion of the body. 



So is a psychoactive effect affecting the structure and function of 

 the body? Is an addictive effect from the psychoactive effect affect- 

 ing the structure and function the body? Again, it is that word "in- 

 tended" that the Agency pays a lot of attention to. 



Mr. Wyden. If it looks like a drug and acts like a drug, it sounds 

 to me like a drug. And I think that is essentially what you have 

 spelled out for us today. 



Now Philip Morris is quoted in the papers this morning as saying 

 that no powerful extract containing nicotine is added in its manu- 

 facturing process. Can you tell us again in a generic way, apart 

 from any company, what kinds of powerful tobacco extracts are 

 added in the manufacturing process? 



Mr. Kessler. Congressman, I had an option and I declined that 

 option; I had an option to sign a confidentiality agreement and to 

 see what substances are actually in cigarettes, to see the list. I de- 

 clined to exercise that option. I did not want to be bound by infor- 

 mation that I could not share with the American public. 



Mr. Wyden. Well, you know, this industry says that it has got 

 nothing to hide. Why don't we just change the law and make that 

 ingredient list that I held up public? Wouldn't that be in the public 

 interest? 



Mr. Kessler. Congressman, I think that is for the Congress obvi- 

 ously to decide. 



Mr. Wyden. What would be your personal opinion? 



Mr. Kessler. I worked very hard. I spent 3 years of my life try- 

 ing to let people know what is in food, to give them the whole 

 story. I think we have to be careful, though. Nothing is more dan- 



