The American Botanical Council (ABC), Austin, TX, has filed comments with the U.S. Pharmacopeia (USP) regarding its proposal to require a cautionary statement for black cohosh products. In its comments to USP, ABC stated that the available data concerning the possible association between hepatotoxicity and black cohosh ingestion provide insufficient evidence to warrant the proposed caution by USP. ABC further commented that the widespread and historical use of black cohosh products, coupled with the lack of scientific evidence of toxicity, strongly suggest that there is no attributable risk associated with the use of properly manufactured black cohosh preparations. ABC added that case reports suggesting potential hepatotoxicity of black cohosh are not adequately substantiated and the process by which the USP has evaluated black cohosh’s safety may not meet some of the standards proposed to perform an adequate safety evaluation.