Botanical dietary supplements (herbal products) have flooded the market in the United States 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, have been reported. Among the most troublesome is the association of some botanicals with serious hepatotoxicity. In some cases, hepatotoxicity has been linked to the consumption of botanicals with recognized hepatotoxic components (e.g., pyrrolizidine alkaloids). However, in other cases, the causative agent(s) is less clear and, overall, the mechanisms of hepatotoxicity are poorly understood. To help create a scientific basis for understanding botanical-induced hepatotoxicity and better tools for hepatotoxicity assessment and prediction, the National Center for Natural Product Research (NCNPR) hosted a workshop (September 8 and 9, 2003) in cooperation 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 www.toxsci.oupjournals.org.