120 



Mr. BlLlRAKlS. You also state that there might be other possibiH- 

 ties such as limiting the amount of nicotine in a cigarette. You did 

 that today, too, I believe, to such so-called non-addictive levels, 

 surely given the monumental societal consequences of your pro- 

 posal, someone at the FDA must have made some type of analysis 

 or proposal as to what those levels might be and would you provide 

 those to the subcommittee for inclusion in the hearing record if 

 they exist. 



[The information follows:] 



We have evaluated published research on the subject of addictive levels of nico- 

 tine. We believe strongly that this subject requires full scientific exploration. As a 

 next step, we are presenting this issue to a panel of experts, the Drug Abuse Advi- 

 son^ Committee, scheduled for August 1. A copy of the notice of that meeting is at- 

 tached. We will have a number of scientific presentations and will ask the commit- 

 tee members a series of questions designed to elicit scientific opinion on the issue 

 of addictive levels of nicotine. Afler that meeting, we will determine what additional 

 scientific development, if any, of this issue will be necessary. 



Mr. BiLlRAKlS. You have acknowledged the dramatic effects on 

 society that FDA regulation of cigarettes as drugs would have. 

 Surely you have outlined the precise steps that you would take if 

 you asserted such jurisdiction. 



Would you give the subcommittee all memoranda from your staff 

 or anyone at FDA concerning these steps. 



[The information follows:] 



Clearly, when a product used by 45 million Americans is at issue, assertion of 

 FDA jurisdiction could have dramatic effects. As I have stated repeatedly, that is 

 why I have asked Congress for guidance. The precise steps that we would take 

 would be based on the results of our investigations into manufacturers' activities, 

 which are ongoing, as well as our continuing scientific exploration of the precise ad- 

 dictive effects of nicotine. We are also exploring with other agencies which regu- 

 latory requirements and other government action, both within our jurisdiction and 

 which might require additional legislation, would be best designed to produce desir- 

 able public health outcomes. Some alternatives we are exploring are additional ad- 

 vertising and promotional restrictions, more restricted access to minors, and reduc- 

 tion of nicotine in tobacco products to nonaddictive levels. To the extent possible, 

 we want to be sure that the regulatory scheme we arrive at serves valid public 

 health objectives and has public and Congressional support. 



Mr. BiLlRAKlS. The next question, you state in your March 25 

 testimony that FDA might otherwise restrict access — ^your words, 

 "otherwise restrict access" — ^to cigarettes unless the industry could 

 show that nicotine-containing cigarettes were "safe and effective" — 

 your words. Do you expect this subcommittee to believe that there 

 is any possibility that you could be convinced that any nicotine-con- 

 taining cigarettes are safe and effective for some therapeutic pur- 

 pose? 



I am sure you could take probably the rest of my time to answer 

 that and therefore I would ask your response be in the record. 



[The information follows:] 



At this point in our consideration of this issue, I would not predict what any ciga- 

 rette manufacturer might produce in response to a request to submit a new drug 

 application for cigarettes. They have never had to do the detailed assessment of 

 risks and benefits that such an application would require, and I would not want to 

 prejudge that effort. I want to stress, however, that we have not in any way con- 

 cluded that new drug applications would be required if we determined that tobacco 

 products containing addictive levels of nicotine are drugs. 



Mr, BiLlRAKls. Next, Dr. Kessler, I assume you have considered 

 the manner in which FDA might restrict the sale of cigarettes. For 



