USP Proposes Green Tea, Black Cohosh Label Cautions

ROCKVILLE, Md.The U.S. Pharmacopeia (www.USP.org) Dietary Supplements Information Expert Committee (DSI-EC) voted to require cautionary label statements for green tea extract (Camellia sinensis) and black cohosh (Actaea racemosasyn. Cimicifuga racemosa) dietary supplements. The committee reviewed case reports suggesting a potential link between ingestion of the extracts and liver damage; it is currently preparing case details, evaluation criteria and discussion on the safety reviews to be published in peer review journals. The cautionary statements will require verbiage stating the botanicals have been noted, in rare cases, to affect the liver, and urge consumers to consult a health care practitioner if they develop symptoms of liver trouble. The cautionary statement for green tea extracts will appear in Pharmacopeial Forum for public comment as a revision to the initial USP proposal of the monograph Powdered Decaffeinated Green Tea Extract.

The cautionary statement for black cohosh is scheduled to appear in September 2007 as a proposed Interim Revision Announcement in Pharmacopeial Forum for 60-day public comment. Steven Dentali, Ph.D., vice president of scientific and technical affairs, American Herbal Products Association (www.AHPA.org), noted: It would be helpful if the safety reviews that led to the committees decisions were available to the public so that comments on the proposed cautionary statements could be better informed.