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that Mr. Waxman and I, and Mr. Wyden and Mr. Durbin have 

 been involved in. 



Could I get your opinion on that legislation and whether or not 

 you favor the basic principles that are behind it? Do you favor list- 

 ing ingredients and chemical additives on the product of tobacco? 



Mr. Kessler. Congressman, I apologize for this, but as you 

 know, the Food and Drug Administration, our job is to deal with 

 the questions within our jurisdiction. Commenting on legislation is 

 not something that I do as an Agency head. That is left, obviously, 

 to the Secretary. So I apologize; I am not trying to not be as forth- 

 coming. I am just not able to comment on any specific legislation. 



Mr. Synar. Let me ask you this, then. Clearly if you do find nico- 

 tine to be a drug, it is probably, based upon the evidence that you 

 presented today and other evidence that is available, going to be 

 impossible to prove that it can be consumed safely. We know that 

 the mere consumption of two cigarettes a day increases the chance 

 of heart disease and cancer by 50 percent. 



We have favored an approach for the FDA that would not define 

 it as a drug or food product, but create a new, unique status. Is 

 that a way to accomplish the goal of avoiding a ban, but getting 

 the type of regulatory authority that we need in order to protect 

 the public? 



Mr. Kessler. We understand the enormous social consequences 

 that could attach to a decision to exert jurisdiction. And it is be- 

 cause of those enormous social consequences that we are seeking 

 guidance. 



There are those at the Agency, I must tell you. Congressman, 

 that have a hard time believing that an Agency that is charged 

 with making sure that there are safe and effective products on the 

 market would ever find nicotine-containing cigarettes for anyone to 

 establish that they are safe and effective. Maybe that could hap- 

 pen. Maybe there are levels below which the nicotine is not addict- 

 ive and there can be an argument made. 



But you are right. There are enormous social consequences. And 

 that is why we are here today to seek your guidance. 



Mr. Synar. Thank you, Mr. Chairman. 



Mr. Waxman. Thank you, Mr. Synar. 



Mr. Wyden. 



Mr. Wyden. Thank you, Mr. Chairman. 



Dr. Kessler, just one other area I am interested in, and that is 

 this matter of clear direction from the Congress. You have said, for 

 example, and I quote, "Should the Agency make this finding based 

 on an appropriate record or be able to prove these facts in court, 

 it would have a legal basis to regulate these products." 



Now, is that something you are going to go ahead with anyway? 

 Or does Congress have to pass a law and say, Dr. Kessler, this is 

 a drug, have at it? 



Mr. Kessler. Congressman, my job is to enforce the statute and 

 the statute has the FDA making the decision of whether to exert 

 jurisdiction. Let me be clear though that I think there are a lot of 

 questions. I have shown you some data. 



There are many issues that we don't fully understand. Philip 

 Morris was very kind to allow us in for a day and a half, but there 

 are many companies and there are still a lot of questions that need 



