November 2007

ABC: Warning label for black cohosh not warranted

The American Botanical Council (ABC) recently filed comments with the United States Pharmacopeia (USP) regarding the USP’s proposal to require a cautionary statement for black cohosh products.

In its comments to the USP, ABC stated 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.

In June, the USP announced that its dietary supplements information expert committee had decided to add a caution to the labels of black cohosh products. The USP’s recommendation was published as an interim revision announcement in the September-October edition of USP’s Pharmacopeial Forum. USP announced that its proposed caution would be open to comments from the public for a 60-day period.

Source: American Botanical Council, www.herbalgram.org

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