| FDA regulation of dietary supplements and requirements regarding adverse event reporting. | |
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MedLine Citation:
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PMID: 20032973 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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V H Frankos; D A Street; R K O'Neill |
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Publication Detail:
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Type: Journal Article Date: 2009-12-23 |
Journal Detail:
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Title: Clinical pharmacology and therapeutics Volume: 87 ISSN: 1532-6535 ISO Abbreviation: Clin. Pharmacol. Ther. Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-01-28 Completed Date: 2010-02-18 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372741 Medline TA: Clin Pharmacol Ther Country: United States |
Other Details:
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Languages: eng Pagination: 239-44 Citation Subset: AIM; IM |
Affiliation:
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Division of Dietary Supplement Programs, US Food and Drug Administration, College Park, Maryland, USA. vasilios.frankos@fda.hhs.gov |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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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