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Self-Regulation by the Herb Industry
Self-Regulation by the Herb Industry

This issue contains a Guest Editorial dealing with the relative safety of dietary supplements containing bitter orange. Michael McGuffin, president of American Herbal Products Association (AHPA), the national trade association of the herb industry, expresses his concerns about the FDA's releasing of raw data from its adverse event report (AER) database to members of the media, who, in turn, have published what has turned out to be erroneous and misleading information on the safety of these supplements. Articles in the New York Times and later the Los Angeles Times misreported that bitter orange has been associated with numerous adverse events, even some deaths. McGuffin's analysis shows that the FDA's data included many duplicate reports, plus many AERs related to supplements containing the now-banned and controversial herb ephedra. We invited officials at the FDA to review the editorial and provide us any corrections and/or comments, including a possible rebuttal for publication. After at least six communications with FDA, we have received no response at press time.

There has been considerable interest in the level of regulation of herbs and related dietary supplements. We support the implementation of rational regulations as well as self-regulation by the industry. Self-regulatory initiatives are usually the optimal way to regulate any product category and industry, but this requires a wide degree of voluntary compliance, often difficult to affect. AHPA has taken leadership in numerous areas of self-regulation, including three "trade recommendations" that it has recently enacted and/or revised regarding the presence of heavy metals in some herbal materials, prohibitions against drug-masking claims, and pesticide/fungicide analysis for cultivated ginseng, as we report. We also include a story on FDA's recognition of AHPA's self-regulatory guidelines for establishing common names for herbs used in commerce, as published in AHPA's book Herbs of Commerce, 2nd edition, which has become federal law as of January 1, 2006.

If it appears that there is a lot of coverage of AHPA and its work in this issue, with three articles about AHPA initiatives, you're correct. AHPA has done some laudable self-regulatory work and deserves recognition. In addition, we were also planning to run an extensive article on new guidelines by the US Fish and Wildlife Service (FWS) regarding the harvest of wild American ginseng, issued in August 2005 in accordance with FWS's responsibilities to monitor threatened and endangered species for CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora); however, we did not have adequate space for all the regulatory articles initially slated for this issue.

One of our features profiles some of the historical and modern literature on jimsonweed (Datura), a plant with a long but somewhat speckled tradition in folklore, shamanism, and medicine. Kofi Busia and Fiona Heckels write that this interesting medicinal plant and its documented psychoactive effects may have some yet unrealized value for psychiatric medicine, under properly controlled conditionsÑa proposal that we find interesting and worthy of future research.