22 



To provide one illustration of FDA's tendency to speak first and 

 think later I note, as Mr. Bliley already has, that Philip R. Lee an- 

 nounced last week at a recent House appropriation subcommittee 

 hearing the FDA had asked the Justice Department to investigate 

 allegations that tobacco manufacturers manipulate nicotine levels 

 of their products. 



In fact, no such referral has taken place and shortly thereafter, 

 it was necessary for HHS to retract Dr. Lee's statements. 



I also question the startling suggestion that FDA should perhaps 

 regulate cigarettes as drugs. One would think, to hear the talk of 

 nicotine "spiking," that cigarette manufacturers are increasing the 

 nicotine levels in their cigarettes. But the only alteration over the 

 years in the nicotine content of cigarettes of which I am aware has 

 been to lower nicotine levels in response to changing consumer 

 taste preferences. 



I wonder if this subcommittee has considered where this line of 

 reasoning takes us. If the FDA should regulate or even ban ciga- 

 rettes based on nicotine, because nicotine has been deemed "addict- 

 ive," why shouldn't the FDA regulate wine, beer, distilled spirits on 

 the same basis — that is because alcohol is deemed addictive too. 



Certainly there is evidence that alcohol has "addictive" properties 

 for some individuals. Assistant Secretary Lee himself acknowledged 

 as much at the FDA-Appropriations Subcommittee hearing on 

 March 16. Based on the logic of Commissioner Kessler's letter, it 

 is difficult to see why the FDA is not also taking immediate steps 

 to regulate the alcohol content of the excellent wines produced by 

 West Coast wineries. And what about the fortified wines which are 

 indisputably "spiked"? 



Mr. Chairman, it would be foolish for the FDA to assume, or for 

 Congress to give this Agency, any significant new responsibilities, 

 whether they relate to tobacco or not. FDA is seriously under- 

 funded and understaffed. The Agency is hard pressed as it is to get 

 new drugs and food additives approved in a timely fashion and to 

 enforce the laws that apply to millions of food, drug and cosmetic 

 products currently on the market. 



FDA's existing mandate is extraordinarily broad. It encompasses 

 the regulation of foods, prescription and over-the-counter pharma- 

 ceuticals, animal drugs, cosmetics, medical devices, radiological 

 products, and Congress imposes more every year. FDA staff al- 

 ready is stretched beyond endurance, a fact that has prevented the 

 Agency from completing in a timely manner many of its existing, 

 central responsibilities. 



Let's insist that the Agency meet its current mandates before we 

 give it additional assignments. And let's hope our regulators pro- 

 ceed more thoughtfully in the future on the issue of nicotine in 

 cigarettes than they have to date. 



Mr. Chairman, may I request that a "dear colleague" letter I cir- 

 culated early this year be included in the record at this point. 



Mr. Waxman. Without objection, we will receive the letter for in- 

 clusion in the record. 



[The letter follows:] 



