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Edward T. Ned Brethitt, former Governor of Kentucky (1964), in a recent interview with a 

 Kentucky Newspaper, indicated that the strategy of Senator Earle Clements back in the 

 1960s was to make tobacco regulation the province of Congress, where the industry had 

 influence and could keep the issue out of the hands of unelected regulators. 



And Mr. Chairman, the strategies were brilliantly conceived and brilliantly executed. What 

 other industry could, in spite of 23 Surgeon General's Rqx>its and over 60,000 scientific 

 studies, continue to sell an addictive killer virtually unfettered from government oversight 

 and regulation? What other industry could so flagrantly target our children with seductive 

 advertising of an addictive product that kills? 



In 1988, the Coalition on Smoking OR Health, after taking a careful look at the history of 

 how tobacco products have been regulated (or should I say unregulated), realized that the 

 Federal Food, Drug and Cosmetic Act could be applied against tobacco products under 

 certain circumstances. It became clear to us that if and when the tobacco industry sold its 

 products with the intent of "mitigating or preventing disease" or with an intent to "affect the 

 structure and/or function of the body of man," the industry was no longer merely selling 

 tobacco products for smoking pleasure only, it was selling "drugs" under section 201 of the 

 FDC Act. Based on this analysis, the Coalition filed a petition in April of 1988 asking the 

 FDA to classify low tar and low nicotine cigarettes as "drugs" under the FDC Act. That 

 petition is attached to your copy of this testimony for inclusion in the record. 



The legislative history of these two sections of the Act, added in 1938, makes their purpose 

 clear - to ensure that products that did not appear on the U.S. Pharmacopoeia list, and 

 which had drug like effects and/or were intended to mitigate and or prevent disease, were 

 to be treated as "drugs" under the Act. E>o today's tobacco products meet these 

 definitions? The answer must be a resounding yes. 



