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ToxSci Advance Access published online on February 19, 2004
Toxicological Sciences, doi:10.1093/toxsci/kfh075
Toxicological Sciences © Society of Toxicology 2004; all rights reserved
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Received December 6, 2003; accepted January 6, 2003
© 2004 Society of Toxicology

Forum

Workshop Overview: Hepatotoxicity Assessment for Botanical Dietary Supplements

Kristine L. Willett 1*, Robert A. Roth 2, and Larry Walker 3

1 Department of Pharmacology and Environmental Toxicology, School of Pharmacy, University of Mississippi, University, MS 38677
2 National Center for Food Safety and Toxicology, Michigan State University, East Lansing, MI 48824
3 National Center for Natural Products Research, Research Institute of Pharmaceutical Sciences, University of Mississippi, University, MS 38677

* To whom correspondence should be addressed. E-mail: kwillett{at}olemiss.edu.


  Abstract

Botanical dietary supplements (herbal products) have flooded the market in the US over the past decade, and studies show a significant percentage of Americans use them. With increasing frequency and duration of exposure, some serious adverse effects, though relatively uncommon overall, have been reported. Among the most troublesome is the association of some botanicals with serious hepatotoxicity. These effects in some cases have been linked to consumption of botanicals with recognized hepatotoxic components (e.g., pyrrolizidine alkaloids). However, in other cases the causative agent(s) is less clear, and in any case the mechanisms poorly understood. In recognition of the need for a better scientific base for understanding botanical-induced hepatotoxicity, and for better tools for assessment and prediction, the National Center for Natural Product Research (NCNPR) hosted a workshop on September 8-9, 2003, under a cooperative agreement with the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA). The workshop featured presentations by 22 experts and was attended by 65 individuals. The agenda can be found in the supplementary data at __________.

The purpose of the workshop was to review and discuss methods of assessing the hepatotoxicity of botanical dietary supplements with an emphasis on in vitro techniques that might be applied in screening for assessment and eventually, prediction of hepatotoxic potential. Although application of existing and emerging methodologies can well characterize and even predict some hepatic insults, the workshop identified important gaps in understanding that should be addressed by researchers.


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