61 



You can take the genetically derived bST and add it to a cow, or 

 you can breed a cow like Big Bertha that just has more bST in the 

 animal. Exogenous has to do with applied from without; endoge- 

 nous has to do with applied from within. 



Mr. Waxman. Will the gentleman yield? 



In other words, whether it is sprayed on and added to the to- 

 bacco or whether it is a mixture of a high-nicotine blend with a 

 low-nicotine blend; is that what we are talking about? 



Mr. Kessler. Absolutely. 



But biologically, Mr. Chairman, the nicotine— the nicotine that 

 ends up in the bloodstream is what we are concerned about. You 

 can raise nicotine levels either way, so its effect on structure and 

 function obviously can be affected either way. 



Mr. Synar. Second, Dr. Kessler, could you tell us how the FDA 

 regulates nicotine in other products, such as nicotine gum or nico- 

 tine patches or other things that it appears in? 



Mr. Kessler. Andrew, if I could have the chart on the products 

 that we have approved. 



Congressman Synar, I think this chart will show you the names 

 of the products that we have approved, the ingredient base, the 

 strength, the dosing intervals. We have approved those under the 

 drug provisions of the Act. 



Mr. Synar. That, I think, is an important point because, as you 

 know, one of the things that the industry would have us believe is 

 that the only option available to us is to ban the product. But we 

 are presently regulating nicotine in many products, which is some- 

 thing very short of the kind of ban which they claim is the only 

 alternative. 



Mr. Kessler. Congressman, those products have nicotine for a 

 therapeutic effect, obviously to prevent the withdrawal symptoms 

 that can occur from smoking cessation. I guess you can view the 

 cigarette as the same, having nicotine to prevent the withdrawal 

 symptoms, so there are similarities. But I should also make sure 

 that the subcommittee understands that there are differences. 



Certainly these products have the therapeutic claim that is at- 

 tached to them. 



Mr. Synar. I would like to go back to one chart that you used 

 in your presentation. I think it is this one right here where you 

 show examples of the highest, middle, and lowest lOO's and the 

 percentage of nicotine in each one of those products. 



Mr. Kessler. It is an example of three different varieties from 

 one brand family. Our lab ran those numbers. We actually had sev- 

 eral labs run those numbers; depending on how many hours of the 

 extraction, you can get somewhat different numbers, but they are 

 all in the same proportion. And all the numbers we have seen have 

 the lowest-yield product having the highest concentration of nico- 

 tine. And that surprised me. Congressman. 



Mr. Synar. That surprised me, too, because it flies in the face 

 of industry statements that they don't put in different levels of nic- 

 otine with respect to different levels of cigarettes within a chain. 



Mr. Kessler. This is concentration. 



Mr. Synar. I understand that. 



What disturbs me even more is if one takes that chart and cross- 

 tabs it with the type of advertising for those various products, one 



