Document Detail


The FDA may not regulate tobacco products as "drugs" or as "medical devices".
MedLine Citation:
PMID:  10557545     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Professor Richard Merrill contends that the Federal Food, Drug, and Cosmetic Act does not grant the FDA regulatory authority over cigarettes and smokeless tobacco products. The fact that Congress did not expressly deny the FDA regulatory authority over tobacco cannot, Professor Merrill argues, be used to infer such authority. This inference is particularly inappropriate in the case of tobacco regulation, he maintains, because there is compelling evidence that Congress had no intention of delegating this authority to the FDA. He is unpersuaded that presidential approval legally sanctions the FDA's claim of authority by granting it a superficial political legitimacy. Finally, he reminds us of the FDA's own repeated denials of jurisdiction over tobacco products, and he recalls the numerous times that Congress passed legislation directed at tobacco without granting the FDA any role in its regulation. Professor Merrill's Essay, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit.
Authors:
R A Merrill
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Duke law journal     Volume:  47     ISSN:  0012-7086     ISO Abbreviation:  Duke Law J     Publication Date:  1998 Apr 
Date Detail:
Created Date:  1999-09-30     Completed Date:  1999-09-30     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9877769     Medline TA:  Duke Law J     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1071-94     Citation Subset:  T    
Affiliation:
University of Virginia, USA.
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MeSH Terms
Descriptor/Qualifier:
Advertising as Topic* / legislation & jurisprudence
Drug and Narcotic Control* / legislation & jurisprudence
Humans
Plants, Toxic*
Tobacco*
United States
United States Food and Drug Administration* / legislation & jurisprudence

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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