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FDA regulation of dietary supplements and requirements regarding adverse event reporting.
Clin Pharmacol Ther. 2010 Feb; 87(2):239-44.CP

Abstract

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+Show Affiliations

Division of Dietary Supplement Programs, US Food and Drug Administration, College Park, Maryland, USA. vasilios.frankos@fda.hhs.govNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

20032973

Citation

Frankos, V H., et al. "FDA Regulation of Dietary Supplements and Requirements Regarding Adverse Event Reporting." Clinical Pharmacology and Therapeutics, vol. 87, no. 2, 2010, pp. 239-44.
Frankos VH, Street DA, O'Neill RK. FDA regulation of dietary supplements and requirements regarding adverse event reporting. Clin Pharmacol Ther. 2010;87(2):239-44.
Frankos, V. H., Street, D. A., & O'Neill, R. K. (2010). FDA regulation of dietary supplements and requirements regarding adverse event reporting. Clinical Pharmacology and Therapeutics, 87(2), 239-44. https://doi.org/10.1038/clpt.2009.263
Frankos VH, Street DA, O'Neill RK. FDA Regulation of Dietary Supplements and Requirements Regarding Adverse Event Reporting. Clin Pharmacol Ther. 2010;87(2):239-44. PubMed PMID: 20032973.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - FDA regulation of dietary supplements and requirements regarding adverse event reporting. AU - Frankos,V H, AU - Street,D A, AU - O'Neill,R K, Y1 - 2009/12/23/ PY - 2009/12/25/entrez PY - 2009/12/25/pubmed PY - 2010/2/19/medline SP - 239 EP - 44 JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. VL - 87 IS - 2 N2 - 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. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/20032973/FDA_regulation_of_dietary_supplements_and_requirements_regarding_adverse_event_reporting_ L2 - https://doi.org/10.1038/clpt.2009.263 DB - PRIME DP - Unbound Medicine ER -