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

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

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Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Office of Dietary Supplement Products, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, USA.
6403 Hillmead Rd, Bethesda, MD 20817, USA.


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.


Dietary Supplement Health and Education Act (DSHEA); US Food and Drug Administration; challenges in assessing herbal hepatotoxicity; drug induced liver injury; herbal supplement adulteration; herbal supplement contamination; herbal supplement epidemiology; regulation

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