The Honorable Henry A. Wuman 



Page 2 



March 23, 1994 



There has been a dramatic drop in the avenge nicotine content of cigarettes since the 

 1950's. Aooording to Thf NtW f^lmnAlotiroal of Medicine, the average nicotine 

 delivery dropped from 2 milligtams to 0.9 millitrams between 1955 and 1987. 

 [Editorial, p. 1619, July 15. 1989.] 



FDA JurbJietton Over Nicotic 



In responding to recent petitions submitted by the Coalition on Smoldng OR Health 

 aeeldng FDA r^ulation of low "tar* and low nicotine cigarettei and de-nicotized 

 oigaretteSf ^ FDA CommiisiOQer has expressly deferred jurisdiction over dgarettes 

 to Congfus. The Illative histny of the Federal Food, Drug and Cosmetic Act as 

 amexvdfid, and csms interpreting that Act, clearly stand for the proposition that 

 tobacco and oicotiAe are not "drugs' and are, therefore, not lubject to FDA 

 regulation. W« are pleased the Commissioner recognizes ^ffhal the law is and 

 acknowledges flie need for Coogress to provide direction to hl« agency. 



Congress should Instruct FDA not to escpend further time, energy and financial 

 resources aeeldng authority to regulate tobacco or nicotine. We abo o^ote any 

 effort by Congress to extend the FDA's Jurisdiction to tobacco or nicotine. Cigarettes 

 are alnady highly regxilated. Tbere ii no need or justification for FDA to regulate 

 dgaitttes. Whatever policy decdiioni need to be made relating to tobaooo and 

 nicotine can best be nude by Conffreti. 



We would ^)predate your including this letter in the hearing record. 



Sinocfdy yours, . 



TESfdIb 



