Chinese Herbal Medicines Coalition Calls For Lifting Of Aristolochia Ban
This article was originally published in The Tan Sheet
Executive Summary
The Chinese Herbal Medicines Coalition intends to demand FDA end its standing import alert against products containing aristolochic acid, the group said.
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The Chinese Herbal Medicines Coalition intends to demand FDA end its standing import alert against products containing aristolochic acid, the group said. The coalition is in the process of arranging a meeting with the agency to discuss Aristolochia and other issues related to the decreasing availability of some traditional Chinese medicines. CHMC contends FDA's ban is not based on conclusive science and is too broad, encompassing herbs not related to Aristolochia. The group maintains Aristolochia is safe when used properly and noted FDA has not received any adverse event reports connected to aristolochic acid use. However, the coalition stressed its members have complied with FDA's decision and have withdrawn aristolochic acid-containing products from commercial distribution. FDA issued the import alert in July, ordering the detention of any product containing aristolochic acids or derivatives or plants that could be confused with the Aristolochia family; the list effectively banned over 60 botanicals (1 (Also see "Aristolochic acids" - Pink Sheet, 17 Jul, 2000.)). The agency took action based on evidence connecting the herb with kidney failure (2 (Also see "Aristolochic Acids Kidney AEs Subject Of Pending FDA Import Alert" - Pink Sheet, 29 May, 2000.)). Health Canada has issued a public health warning similar to FDA's, and the U.K. Medicines Control Agency recently proposed making permanent a similar ban that was issued in 1999 (3 (Also see "MCA Permanent Order Banning Aristolochia Use Proposed" - Pink Sheet, 29 Jan, 2001.)). A New England Journal of Medicine report published last summer linked aristolochic acid with urothelial cancer and end-stage renal failure, similar to the results of a 1999 Lancet study and other recent findings. CHMC criticized the various studies' conclusions, contending the herb was misused in each of the interventions. The group's stance counters that taken by the American Herbal Products Association and the Council for Responsible Nutrition, both of which have publicly expressed conditional support for FDA's actions. AHPA adopted a policy in 1998 against the use of aristolochic acids, which the group noted can be substituted with other botanical ingredients that have not been linked to toxic effects. CHMC was founded at a Jan. 20 "emergency meeting" in Los Angeles hosted by the American Association of Oriental Medicine. Representatives of more than 25 Chinese medicine manufacturers, distributors, vendors, professional organizations and practitioners attended, as did an AHPA representative. The coalition noted although FDA was invited to the meeting, it did not send a delegate; the California Department of Health Services Food & Drug Branch was represented. The group said its primary mission will be to protect its pharmacopeia from being regulated out of existence. CHMC contended FDA's scrutiny of Chinese herbal products has made industry fear it will lose access to traditional ingredients. CHMC also hopes to be an intermediary between FDA and industry by acting as the unified voice of the Chinese herbal medicine community through lobbying efforts, legal support and other services. The coalition additionally plans to take measures to ensure quality control among its members by enforcing manufacturing standards such as raw ingredient identification and sanitary manufacturing facilities. CHMC said the standards are based on dietary supplement good manufacturing practices developed by the Australian government that already are in force in China and other Asian countries. Keeping Chinese herbal products uncontaminated is another of the coalition's priorities. Within the past year, several Chinese herbal medicine manufacturers have been forced to recall products adulterated with prescription drugs (4 (Also see "Five Chinese Herbals Contain Drug Ingredients, Calif. Health Dept. Warns" - Pink Sheet, 21 Feb, 2000.) and 5 (Also see "Chinese herbals recall" - Pink Sheet, 19 Feb, 2001.)). The group also plans to research and establish safe and therapeutic dosage levels for Chinese herbal medicines, including Aristolochia. A risk analysis currently is being performed on the botanical family to determine areas of future study; a report is due by the summer, CHMC said. |