July 2006

UK’s MHRA requires label warning on black cohosh

The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. issued a press release that stated it “is concerned about links between black cohosh (Actaea racemosa; syn: Cimicifuga racemosa) and the risk of liver disorders.”

The agency stated that the basis for its concern is that the Commission on Human Medicines and the Herbal Medicines Advisory Committee have both “reviewed all available data and concluded that the data underlines an association between black cohosh and risk of liver disorders.”

MHRA has therefore determined that warnings will be required on labeling of black cohosh products and it “is working with the herbal sector to ensure the public is fully informed about this potential risk.”

The U.K. is now the second country to state its intention to require liver-related label information on black cohosh products. The American Herbal Products Association (AHPA) reported on February 14, 2006, that the Australian Therapeutic Goods Administration has decided that medicines containing black cohosh should be labeled with the following statement: “Warning: Black cohosh may harm the liver in some individuals. Use under the supervision of a healthcare professional.”

The Australian policy was effective immediately for new products, while existing products have until February 2007 to allow adequate time to comply with the new labeling requirements.

Source: American Herbal Products Association, www.ahpa.org

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