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Mr. Wyden. Thank you, Mr. Chairman, and thank you very 

 much for an important presentation. Dr. Kessler. I think the people 

 of this country should not be mistaken at this point. It seems to 

 me that the Food and Drug Administration is now building an ad- 

 ministrative record that would require that tobacco be regulated as 

 a drug in our country. For example, look at what you have said. 

 Tobacco companies have patented the technology to manipulate 

 nicotine content. 



The tobacco companies have bioengineered tobacco plants specifi- 

 cally for higher nicotine content. Tobacco companies have added 

 chemicals to enhance the nicotine effect of cigarettes. It seems to 

 me that you have already built what amounts to an undeniable 

 proposition with respect to requiring that tobacco be regulated as 

 a drug. My first question to you is: Do you have evidence that the 

 nicotine content of cigarettes tested in your laboratories meets the 

 drug content uniformity specifications that are set out in the U.S. 

 pharmacopoeia? 



Mr. Kessler. Andrew, could we have the USP chart? My staff 

 always jumps on me when I refer to this chart because it is very 

 complicated. So just indulge me for a second. Congressman. 



Our St. Louis drug laboratory tested over the years more than 

 11,000 drug samples and tested many different tablets within each 

 of those drug samples, and we also tested 10 different cigarette 

 brands and tested a lot of different cigarettes within those 10 

 brands. The bottom line is that if you fall, as you see all cigarettes 

 fall, within either the yellow or blue areas of that chart, you meet 

 USP, United States Pharmacopoeia standards for drug uniformity 

 and drug delivery. You even see that some drugs don t meet that 

 standard but all cigarettes meet it. 



Now, this, again, shows very fine control, very precise uniformity. 

 It is a measure of Quality control. It may iust be, hey, we just want 

 every cigarette to be exactly the same, out when you get to this 

 level of uniformity, it is striking to us that the uniformity is — does 

 meet USP drug delivery standards. 



Mr. Wyden. I have heard reports that there is evidence that Eu- 

 ropean manufacturers are using other means of manipulating nico- 

 tine levels in cigarettes. My question to you is: Have you all picked 

 up this evidence? If so, can you share with the subcommittee what 

 information you may have about other approaches being used in 

 Europe to manipulate nicotine levels and whether or not those ap- 

 proaches are used in our country? 



Mr. Kessler. I have seen certain other additive, certain 

 humectants. For example, I have seen a patent for the use of cer- 

 tain percentages of chemicals, other chemicals that are called 

 humectants, that are used in an attempt, according to the patent, 

 to alter nicotine and t£ir ratios. 



We would be happy to submit that, Mr. Wyden, for the record. 



[The information follows:] 



