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

• Main Authors: Mark I. Avigan, Robert P. Mozersky, Leonard B. Seeff
• Format: Article
• Language: English
• Published: MDPI AG 2016-03-01
• Series: International Journal of Molecular Sciences
• Subjects: 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
• Online Access: http://www.mdpi.com/1422-0067/17/3/331

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.