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Int. J. Mol. Sci. 2016, 17(3), 331; doi:10.3390/ijms17030331

Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

1
Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
2
Office of Dietary Supplement Products, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, USA
3
6403 Hillmead Rd, Bethesda, MD 20817, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Rolf Teschke
Received: 8 January 2016 / Revised: 16 February 2016 / Accepted: 16 February 2016 / Published: 3 March 2016
(This article belongs to the Special Issue Drug, Herb, and Dietary Supplement Hepatotoxicity)
View Full-Text   |   Download PDF [317 KB, uploaded 3 March 2016]   |  

Abstract

In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA) as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized. View Full-Text
Keywords: US Food and Drug Administration; regulation; Dietary Supplement Health and Education Act (DSHEA); herbal supplement epidemiology; drug induced liver injury; herbal supplement contamination; herbal supplement adulteration; challenges in assessing herbal hepatotoxicity US Food and Drug Administration; regulation; Dietary Supplement Health and Education Act (DSHEA); herbal supplement epidemiology; drug induced liver injury; herbal supplement contamination; herbal supplement adulteration; challenges in assessing herbal hepatotoxicity
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Avigan, M.I.; Mozersky, R.P.; Seeff, L.B. Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States. Int. J. Mol. Sci. 2016, 17, 331.

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