Document Detail


FDA regulation of dietary supplements and requirements regarding adverse event reporting.
MedLine Citation:
PMID:  20032973     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to set up a distinct regulatory framework for what we now call dietary supplements. The DSHEA was passed with the intent of striking a balance between providing consumers access to safe dietary supplements to help maintain or improve their health and giving the US Food and Drug Administration (FDA) authority to regulate and take action against manufacturers of supplements or supplement ingredients that present safety problems, are presented with false or misleading claims, or are adulterated or misbranded. This article will present FDA's recent experience in collecting and evaluating dietary supplement adverse event data for the purpose of assuring the public that the dietary supplements they purchase are safe.
Authors:
V H Frankos; D A Street; R K O'Neill
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Publication Detail:
Type:  Journal Article     Date:  2009-12-23
Journal Detail:
Title:  Clinical pharmacology and therapeutics     Volume:  87     ISSN:  1532-6535     ISO Abbreviation:  Clin. Pharmacol. Ther.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-01-28     Completed Date:  2010-02-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372741     Medline TA:  Clin Pharmacol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  239-44     Citation Subset:  AIM; IM    
Affiliation:
Division of Dietary Supplement Programs, US Food and Drug Administration, College Park, Maryland, USA. vasilios.frankos@fda.hhs.gov
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems*
Dietary Supplements / adverse effects*
Food Industry / legislation & jurisprudence
Food Labeling / legislation & jurisprudence
Humans
Legislation, Food*
United States
United States Food and Drug Administration

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


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