87 



Mr. McMillan. They said in here that they work at nicotine con- 

 tent to try to hit a standard target and in no case did it exceed the 

 natural percentage of the constituent product. 



Mr. Waxman. I guess the point is they do control and the ques- 

 tion is for what reason do they control. 



Mr. Kessler. Mr. Chairman, could I just add one statement. The 

 reason, Congressman McMillan, that control and manipulation, 

 that we raise that issue is, again, when you look at the definition 

 of a drug and that is: an article except for food intended to affect 

 the structure and function of the body. I never thought that there 

 would be direct evidence, direct information, that the tobacco in- 

 dustry intended to affect the structure or function of the body. 



We have used the issue of control and manipulation as a surro- 

 gate as one of the elements perhaps of intent. I think the docu- 

 ments that I have referred to in my testimony that this committee 

 has worked very hard to make sure that the American public have 

 as part of the investigation, those documents may be relevant, di- 

 rectly to the question of intent. 



When I see a statement that is reported from a general counsel 

 of a major American tobacco company that says we are then in the 

 business of selling an addictive drug, that statement may go di- 

 rectly to the issue of intent. We may need not be focused on control 

 and manipulation. 



I would ask. Congressman McMillan, Mr. Chairman, that those 

 documents as well as any other documents regarding nicotine, its 

 physiological properties, its pharmacological properties, control ma- 

 nipulation or drug-like effects or research on nicotine be made 

 available to this Agency so that we can thoughtfully and analyt- 

 ically determine whether when, in fact, nicotine is an article in- 

 tended to affect the structure and function of the body. 



Mr. McMillan. Would you also recommend that the committee 

 have access to all documents of your Agency with respect to this 

 issue? 



Mr. Kessler. Congressman, I have 



Mr. Waxman. Mr. McMillan, I really don't think it is important 

 what Dr. Kessler recommends for the committee. It is up to this 

 committee. 



Mr. McMillan. I think that's why he was here. 



Mr. Waxman. What documents we think are appropriate are the 

 documents we are going to pursue further. It is Mr. Bilirakis' turn 

 and I want to recognize him. 



Mr. McMillan. With the privilege of the Chair, I ask unanimous 

 consent that the documents of the Agency be made available to this 

 committee. 



Mr. Waxman. We will give the unanimous consent agreement to 

 documents that are furnished to us by the FDA and we will make 

 them part of the record. 



Mr. McMillan. I thank the Chair. 



Mr. Waxman. Mr. Bilirakis. 



Mr. Bilirakis. Thank you, Mr. Chairman. That was going to 

 really be my first request. You have talked about your investiga- 

 tion. Dr. Kessler. I wonder if you wouldn't please provide this com- 

 mittee for the record all of the memoranda prepared by your inves- 

 tigators on their interviews and any memoranda or draft memo- 



