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The Honorable John Joseph Moakley 

 Pace 2 



responsible approach co an excremely controversial and difficult 

 matter, as did the Chairnan of the Health and the Environment 

 SubcommittGG, in public comments following FDA's statements. 



It is clear -■ and FDA emphasized this point -- thaL if FDA 

 were simply to consider nicotine in tobacco aa a drug and 

 regulate it as it regulates prescription drug products, lu would 

 be banned from sale. This is because, once defined as a drug, 

 nicotine in tobacco would not meet the fundamental test lux FDA 

 approval -- that it has been shown to be "safe and effective for 

 its intended use." PDA's only option relative tu the marketing 

 and sale of an unapproved drug is to take legal action to remove 

 the product Troni the niaiKet. Thus, under this scenario, FDA 

 would be required by law to remove from the market cigarettes, 

 smukeless tobacco products, and cigars, while many in congress 

 might agree that this action would be beneficial to our health, I 

 am certain they also would acknowledge the enormous social 

 consequences of such an action -- consequences reminiscent of 

 alcohol prohibition. 



hor many weeks, the Health and the Environment Subcommittee 

 has held hearings on matters associated with nicotine and its 

 potential addict]. ve properties, the health effects of using 

 tobacco products, and various activities of the tobacco industry. 

 The hearings have been detailed and exhaustive, and have laid 

 groundwork for consideration by the Subcommittee and the 

 Committee of whether additional legislation to regulate nicotine 

 would be appropriate. This is the proper way to deal with this 

 matter -- not by a legislative amendment to an appropriations 

 bill that, in an area as complex as this, lacks thorough 

 consideration. 



With respect to use of FDA appropriations for the purpose 

 intended by the proposed amendment, let me make two points. 

 First, because of the enormity of its public health mission and 

 the increasing responsibilities assigned to it by Congiress, FDA 

 is sorely and sadly underfunded. This is a fact acknowledged and 

 lamented by Chairman Durbin. Though he works mightily to alr.^r 

 the situation, he, like all of us, is constrained by spending 

 caps and deficit reduction goals. "Vhmrmfnrti, we annually faes a 

 situation where w« know full well that Congress cannot provide 

 FHA with the full resources it nssds to lcs«p up with its work. 

 Because of this, we must be vigilant not to assign the agency 

 highly resourcs-intenniva obligations that it will find 

 enormously difficult, if not impossible, to fulfill. 



Second, if it were feasible to increase FDA's resources, the 

 Congress should sxamine closely to what purposs thooe reoourccs 

 should be put. Should those fiinds go, for example, to improving 

 the agency's •xieting seafood regulation program, controlling the 

 entry into the U.S. of contaminated and misbranded foreign 



