ABC Files Public Comment to USP in Response to Proposed Caution
(Austin, TX, October 31, 2007). The nonprofit American Botanical Council (ABC), an Austin, Texas-based research and education organization, filed comments today 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, available here, 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.
The USP announced in June that its Dietary Supplements Information Expert Committee had decided to add a caution to the labels of black cohosh products. The USP recommendation was published as an Interim Revision Announcement in USP’s Pharmacopeial Forum 33 (5) (Sept-Oct 2007), with a 60-day comment period. USP announced that its proposed caution would be open to comments from the public.
ABC’s comment included the following points:
Many of the case reports indicating an association between hepatotoxicity and black cohosh use lack adequate documentation. For instance, most fail to provide the actual identity of the black cohosh used or fail to address possible confounding factors. A total of 42 case reports have been compiled based on international reporting, yet only 18 of those cases have been deemed sufficiently documented to qualify for assessment according to a standard rating scale. Of the 18 assessable cases, 3 were considered “possible” and only 2 were considered “probable.” ABC pointed out that in one of the cases deemed “probable,” there were significant problems with this case, which was the subject of a lawsuit that was dismissed by the presiding judge due to the lack of scientific foundation on the part of the plaintiff.
In recent workshops on black cohosh safety sponsored by the National Institutes of Health (NIH), international experts have noted that no scientific evidence has been reported implicating any chemical, pharmacological or clinically-verifiable mechanism to support concerns related to the poorly documented cases where there has been alleged black cohosh-associated hepatotoxicity.
Analysts who have compared black cohosh’s estimated frequency of use with case reports and statistics of hepatotoxicity have determined that the risk of black cohosh negatively impacting the liver seems to be practically negligible and probably less than the incidence of liver toxicity occurring in the general population due to unexplained causes.
ABC’s comment to USP was co-written by ABC Founder and Executive Director Mark Blumenthal; Professor Norman R. Farnsworth, PhD, of the University of Illinois at Chicago, director of the UIC Center for Botanical Dietary Supplement Research and an ABC Board of Trustee member; Professor Richard Kingston, PharmD, of the University of Minnesota, president and senior toxicologist of SafetyCall International Poison Center and an ABC Advisory Board member; and Professor Tom Kurt, MD, of the University of Texas Southwestern Medical Center, an ABC Advisory Board member.
About Black Cohosh
Black cohosh, also known by its scientific names Actaea racemosa and Cimicifuga racemosa, is a member of the buttercup family (Ranunculaceae) and is native to the Eastern United States. The roots and rhizomes (lateral roots) of the herb have a long history of traditional use by native American tribes to deal with genitourinary complaints in women. Black cohosh preparations have been approved by the German government as safe and effective nonprescription medications for treatment of menopausal symptoms.
In the past few years black cohosh has become increasingly popular as the most widely-used natural alternative to hormone replacement therapy (HRT). The herb’s popularity with middle-aged women and gynecologists grew significantly after the summer of 2002 when a large-scale government-sponsored clinical trial on HRT was halted prematurely after suspicions that HRT may have been responsible for an increase in cancer and cardiovascular disease in menopausal women.
About the American Botanical Council
Established in 1988, the American Botanical Council (ABC) is the leading nonprofit, member-based international organization working to educate consumers, healthcare professionals, researchers, educators, industry, and the media on the safe and effective use of herbs and medicinal plants products. ABC is located on a 2.5 acre site in Austin, Texas where it publishes HerbalGram, a peer-reviewed quarterly journal; HerbClip, a twice-monthly scientific literature review service; and HerbalEGram, a monthly electronic newsletter. ABC is also the publisher of The ABC Clinical Guide to Herbs, a continuing education and reference book, which contains extensive monographs on the safety and efficacy of 29 popular herbs, including black cohosh, and the recent The Identification of Medicinal Plants: A Handbook of Morphology of Botanicals in Commerce, a guide to the macroscopic identification of botanical materials for industry quality control laboratories that ABC published in cooperation with the Missouri Botanical Garden. More information is available at http://www.herbalgram.org/.