claim that regulating tobacco will lead to bans on alcohol, caffeine 

 and fatty foods. 



The fact is that all those products are regulated now much more 

 than tobacco. The fact is, tobacco is the only product that kills peo- 

 ple when it is used as intended by the manufacturer. Intent is the 

 key issue in determining whether the FDA should regulate a prod- 

 uct as a drug. In this case, the intent is to use nicotine to addict 

 people to a deadly product. 



I look forward to hearing from Dr. Kessler about his progress 

 with his investigation. And again, Mr. Chairman, thank you for 

 holding these hearings. 



Mr. Waxman. Thank you, Mr. Kreidler. 



Mr. Greenwood. 



Mr. Greenwood. No statement. 



Mr. Waxman. Dr. Kessler, we want to welcome you back to our 

 subcommittee hearing today. I want to inform you that at the table 

 are the applicable rules of the House and the rules of this commit- 

 tee that apply. They indicate the limits and the power of the sub- 

 committee and the extent of your rights during your appearance 

 today. 



Do you desire to be represented by counsel or advised by counsel 

 during your appearance today? 



Mr. Kessler. We will have counsel from the Food and Drug Ad- 

 ministration join us. 



Mr. Waxman. There is a switch on the base of the mike, if you 

 would push it forward. 



Mr. Kessler. Counsel from the Food and Drug Administration is 

 with us. 



Mr. Waxman. Do you or those who you have asked to accompany 

 you object to appearing before this subcommittee under oath? 



Mr. Kessler. No, we do not. 



Mr. Waxman. If you have no objection to appearing under oath, 

 I would like you to rise and also have those that will be furnishing 

 testimony rise as well to take the oath. 



[Witnesses swom.l 



Mr. Waxman. Please consider yourselves to be under oath. Iden- 

 tify yourself for the record. And include those who are accompany- 

 ing you as witnesses. 



TESTIMONY OF DAVID A. KESSLER, COMMISSIONER OF FOOD 

 AND DRUGS, FOOD AND DRUG ADMINISTRATION, ACCOM- 

 PANIED BY ANN WITT, SPECIAL ASSISTANT TO THE DEPUTY 

 COMMISSIONER FOR OPERATIONS 



Mr. Kessler. Thank you very much, Mr. Chairman. My name is 

 David Kessler. I am commissioner of the Food and Drug Adminis- 

 tration. With me today will be Catherine Lorraine from the Office 

 of Policy; Margaret Porter, Chief Counsel; Mitch Zeller, Office of 

 Policy; and Ann Witt, in the Office of Operations. 



Mr. Chairman, in my last appearance before this subcommittee 

 on March 25, 1994, I raised the question of whether or not the 

 Food and Drug Administration should regulate nicotine containing 

 cigarettes as drugs under the Federal Food, Drug, and Cosmetic 

 Act. 



