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11. Ik. i^ousc 9( Ec|»uftcuia(iticf 

 Committee on Cnergp anb Comm 



ftoom 2125. JUffeurn kdifr 0fUu loflbui 

 llJftinBton, BC 20515-61 13 



June 13, 1994 



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V" 



The Honorable John Joseph Moakley 



Chairman 



Committee on Rule* 



U.S. HouBC of Representatives 



Washington, D.C. 20515 



Dear Mr. Chairman: 



I understand that there is pending before the Committee on 

 Rules a request to maXe in order an amendment to the Agriculture, 

 Rural Development, Food and Drug Administration, and Related 

 Agencies hiscal ifear l»94 Appropriations bill that would instruct 

 the Food and Drug Administration (FDA) on how to regulate 

 nicotine in tobacco products as a drug. The amendment, as I 

 understand it, would also allocate a portion of the agency's 

 appropriation tor this purpose. Such an amendment would 

 constitute legislation on an appropriations bill, in violation of 

 House Rule XXI, clause 2, on a matter in this Committee's 

 jurisdiction. For that reason and the others set forth below, 1 

 urge that such an amendment not be made in order when this bill 

 comes before the House. 



Under current provisions of the Federal Food, Drug, and 

 Cosmetic Act, the authorizing legislation for the FDA, the agency 

 is not sc>ecif ically prohibited from regulating any product which, 

 in its judgment, meets the definition of "drug." The question of 

 whether nicotine in tobacco products meets that definition is one 

 with which FDA's legal counsel -- and legal counsel to both the 

 tobacco industry and consumer groups -- have grappled for a 

 number of years. Just within the last several months, the agency 

 responded to a petition from the American Heart Association and 

 others, indicating that while It believed a legal case could be 

 made for defining nicotine in tobacco products as a drug, it. 

 preferred to work with the Congress to achieve legislation 

 specifically authorizing r.h* rugrulat 1 on of such nicotine and 

 defining the parameters of the regulation. I supported this 



