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Australian TGA Requires Liver Warning on Black Cohosh

(February 14, 2006, Silver Spring, MD) -- The Australian Therapeutic Goods Administration (TGA) has decided that medicines containing black cohosh (Actaea racemosa syn. Cimicifuga racemosa) 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." New Australian products must comply with the requirement from the time of manufacture. Existing products have a 12-month phase-in period to allow adequate time to comply with the new labeling requirements. This decision was published February 9 on the TGA website:

TGA reportedly reviewed 47 cases of liver reactions worldwide, including nine Australian cases, but did not reference their sources or explain what their review consisted of, and stated, “Considering the widespread use of black cohosh, the incidence of liver reaction appears to be very low.” They also advise, “Although some reports are confounded by multiple ingredients, by multiple medications, or by other medical conditions, there is sufficient evidence of a causal association between black cohosh and serious hepatitis.” TGA offers no explanation of how they reached this conclusion against this background of confounding information.

A U.S. National Institutes of Health workshop on black cohosh safety in clinical trials, held in November 2004 — Steven Dentali, vice president of scientific and technical affairs at the American Herbal Products Association, participated in this workshop as an invited expert — concluded that the evidence for liver toxicity risks from black cohosh “remains equivocal but certainly warrants continued monitoring.” The NIH also noted, “At this time, there is no known mechanism with biological plausibility that explains any hepatotoxic activity of black cohosh.” The NIH reviewed information on 51 adverse events. The complete NIH workshop review is available at


The American Herbal Products Association (AHPA) is the only national trade association devoted solely to herbal issues. Representing the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website:

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