119 



Mr. Synar. Adding ammonia in a way is really a way to adjust 

 the acidity or the pH level of the tobacco smoke; is that correct? 



Mr. Kessler. What, we have seen is ammonia as an impact — as 

 an impact booster and that impact is correlated with nicotine and 

 nicotine's effect. Yes, I believe that — the chairman asked me about 

 the biological mechanisms. 



From my basic chemistry understanding, putting one and one to- 

 gether, it has to do with ammonia as a base. It does affect pH 

 chemistry. Nicotine in the protonated and unprotonated forms, they 

 act differently. I am putting one and one together. 



Mr. Synar. So what we have learned today is that the tobacco 

 industry has been manipulating the nicotine by adjusting the pH 

 of the smoke; correct? 



Mr. Kessler. They have been adding ammonia and in their 

 words, that affects nicotine, the liberation of free nicotine to the 

 smoke. 



Mr. Waxman. Mr. Bilirakis, do you have questions? 



Mr. Bilirakis. Well, Mr. Chairman, if I may quickly read into 

 the record — when I asked the general question previously, I didn't 

 think I was going to start a small war in the process, and that 

 question still stands subject to the discussions that we have had 

 here, but these are more specific. 



Near the end of your March 25 testimony, you discussed the 

 legal question of whether nicotine as contained in cigarettes was a 

 drug for purposes of regulation under the FDA Act. It occurs to me, 

 how can it not be that this is the kind of question that you or your 

 predecessors would have put to your advisors? 



Will you please provide to the subcommittee for inclusion in the 

 hearing record any memoranda that have been written on the sub- 

 ject of the regulation of cigarettes under the FDA Act, specifically 

 the question of the possible regulation of cigarettes on the grounds 

 that they contain nicotine that may have been written by anyone 

 at the FDA over the years to the present? 



That is the question for the procedure. 



Next question, on page 27 — and I will furnish these to you. You 

 don't have to worry about writing them down. 



Mr. Kessler. Thank you very much. 



Mr. Bilirakis. On page 12 of your March 25 written statement, 

 you acknowledge that there is the possibility that, "regulation of 

 nicotine in cigarettes as drugs would result in the removal of nico- 

 tine-containing cigarettes from the market." Isn't it true that under 

 current law, if the FDA asserts jurisdiction over cigarettes on the 

 grounds that they contain nicotine as a drug, you would have no 

 alternative but to eliminate all nicotine-containing cigarettes from 

 the market because they would not be covered by any new ap- 

 proved drug application on file? 



[The information follows:] 



We are continuing our investigation and evaluation of public health and regu- 

 latory options under current law. While immediate removal of all tobacco products 

 with addictive levels of nicotine might be one regulatory alternative, I am not con- 

 vinced it is the only one. We are continuing our internal deliberations and consulta- 

 tion with other agencies on that issue. When we have completed those deliberations, 

 we will be pleased to share them with the Congress and the public. 



