123 



Mr. BILIRAXIS. Finally — and I appreciate the Chair's indul- 

 gence — on pages 27 and 28 of your March 25 written testimony, 

 you stated that a black market could develop if the FDA asserted 

 jurisdiction over cigarettes and either removed them or restricted 

 their sale. Has anyone at FDA made any type of analysis of the 

 likelihood and the problems with such a black market; and if so, 

 will you agree to provide any memos relating to such analysis? 



Dr. Kessler, those are the specific questions which obviously, if 

 you respond adequately to the first general question, they would 

 probably all be covered therein. 



Dr. Kessler, as I read Chapter 2 definitions, the term drug 

 means an article recognized in the official United States pharma- 

 copoeia, et cetera; and then B, articles intended for use in the diag- 

 nosis, cure, mitigation, treatment, or prevention of disease in man 

 or other animals; and then Article C — ^Article (c) goes on, "Articles 

 other than food intended to affect the structure of any function." 



I guess my question is, have you received any testimony that 

 would show intent consistent with the definitions of the term drug 

 in the FDA regulations? 



Mr. Kessler. Testimony? 



Mr. BILIRAKIS. Testimony, evidence, et cetera. 



Mr. Kessler. There are certainly statements that are appearing 

 in — ^that have been reported, a statement that says, for example, 

 we are then in the business of selling an addictive drug. A state- 

 ment that says, and I can't quote it exactly, that we are in the nico- 

 tine business, not the tobacco business. With nicotine's physio- 

 logical effects, those statements. Congressman, may be relevant to 

 the question of intent. But, we need to see all those documents, see 

 them in full context, the full analysis, before we can reach any de- 

 cision. 



Mr. BiLlRAKis. All right. So what you are saying, you have not 

 reached any decision as yet? 



Mr. Kessler. On the question of intent, that is correct. 



Mr. Bilirakis. Well, that is the key question. 



Mr. Kessler. Absolutely. 



Mr. Bilirakis. It seems to me as I read the 



Mr. Kessler. Absolutely. I don't want to leave any misunder- 

 standing. 



Mr. Bilirakis. You will share all your investigative reports and 

 all your information to us to the extent that you 



Mr. Kessler. We will go through questions and, again, I appre- 

 ciate all the questions and we will respond. 



Mr. Bilirakis. But even in those circumstances where you do not 

 deem it fit, you are going to get together with majority and minor- 

 ity, so we might help you determine whether or not you are in- 

 deed 



Mr. Kessler. Congressman, as you know, we have very good 

 working relationships with this committee and personally, and we 

 will make sure that you can do your job and that we can do our 

 job. 



Mr. Bilirakis. Thank you. Thank you, Mr. Chairman. 



Mr. Waxman. Thank you, Mr. Bilirakis. 



Mr. Wyden. 



Mr. Wyden. Thank you, Mr. Chairman. 



