347 



4- 



respect to the use of reconstituted tobacco in the cigarette manufacturing process. The 

 manufacturers confirmed that there is less nicotine in cigarettes than is contained in 

 the unprocessed tobacco used in their manufacture. 



Dr. Kessler recognizes that subjecting cigarettes to FDA regulation as "drugs" 

 would require his agency to ban the product. He said as much in his February 25 

 letter and in his March 16 testimony before the FDA Appropriations Subcommittee. 

 But Dr. Kessler made clear that he has no intention of moving in this direction unless 

 directed to do so by Congress. In short, Dr. Kessler has raised a "problem" that is not 

 a problem at all, and he has left it to Congress to consider an appropriate "solution." 



Before turning to Dr. Spears, I would like to touch on a number, though by no 

 means all, of the objectionable features of Rep. Synar's bill, H.R. 2147. 



H.R. 2147 is an omnibus antitobacco bill that would subject tobacco products 

 to ongoing FDA regulation. Although Rep. Synar has portrayed his bill as being 

 designed to treat tobacco products like other products, H.R. 2147 would single out 

 tobacco products, which already are highly regulated, for inapposite and uniquely 

 punitive treatment. Indeed, despite Rep. Synar's insistence that he does not mean to 

 ban tobacco products, H.R. 2147 in fact could produce an instant ban on all tobacco 

 products currently on the market. 



The regulatory scheme that H.R. 2147 would establish regarding additives is one 

 that HHS Secretary Louis Sullivan in 1990 told Congress is "unnecessary." It also 

 would interfere, directly and indirectly, with FDA's performance of its core functions. 

 The tobacco companies themselves would be forced to pay the cost of their regulation 



