142 



During all this time Mr. Chairman, FDA has never suggested, 

 and this has been here again with nothing new, has never sug- 

 gested that cigarettes ought to be regulated by FDA. Now, he sug- 

 gests that evidence now available — I listened carefully, as you did, 

 Mr. Chairman, and other members of the panel to the new evi- 

 dence that, to see what new evidence Dr. Kessler had. 



About the only thing I heard was a long lengthy description of 

 patents. There was not a single allegation that any of these patents 

 were in use, that even the technology to put them into use had 

 been developed. 



You made a statement, Mr. Chairman, that we don't take the 

 words of the companies for what they do. Neither did Dr. Kessler. 

 He sent 10 men this week to Philip Morris — I mention that one 

 company because that is the only one he made the request to to 

 send people at that time — and they responded positively. 



He sent a whole team including scientists, lawyers and others. 

 They were received, all their questions were answered, they were 

 taken through the plant, they were told that anj^hing they wanted 

 to see, they could see, nothing was withheld from them. There are 

 not any secrets. 



The companies are doing what they say they are doing and all 

 six have either appeared here in person or filed statements describ- 

 ing their manufacturing process and verifying that nobody is add- 

 ing nicotine, manipulating nicotine, that the cigarette manufactur- 

 ing process is what it has been all the time and there is nothing 

 new or startling that should provide a basis for Dr. Kessler and the 

 FDA suddenly to decide to classify cigarettes as a drug and for the 

 FDA to assume jurisdiction. 



The cigarette manufacturers address the issues raised in Dr. 

 Kessler's letter in a recent exchange of correspondence with HHS' 

 office on smoking and health. As Mr. Synar knows pursuant to a 

 law that he helped to author in 1984, we have provided to HHS 

 for the last 9 years a complete list of all ingredients. We have re- 

 sponded to any and all questions and concerns that they raised. 



We got a letter from Dr. Louis Sullivan in 1990 asking for some 

 quantitative information about ingredients. We responded prompt- 

 ly, we provided that information, we assured him that we would 

 give him additional information that he might need, and we prom- 

 ised cooperation with him, and that remains our position, that we 

 are ready, willing and able to cooperate with him and to provide 

 him with any further information in that regard. 



So we are not hiding anything. It was written into that law, and 

 again I think Mr. Synar had a good deal to do with the drafting 

 of that law that brand specific ingredients and quantities would not 

 be revealed to protect confidentiality; but the ingredients are there 

 and the manner in which they are used is available. 



If the Office of Smoking and Health and HHS thinks there are 

 problems with those ingredients, they are free to raise those ques- 

 tions, and we stand ready to provide them with information and 

 with the benefit of detailed research that we have done in connec- 

 tion with those ingredients. 



Dr. Sullivan testified in the Senate in 1990 regarding additives 

 that further regulation regarding additives is "unnecessary". He, as 

 you know, Mr. Chairman, certainly was no friend of tobacco. 



