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This article was originally published in The Tan Sheet

Executive Summary

GERMAN HERBAL PRODUCT MONOGRAPHS: FIRST FIFTY-NINE TRANSLATIONS are expected to be completed by mid-August. The American Botanical Council expects to complete and publish translations of approximately 200 monographs from the German "Kommission E" on the regulation of German traditional medicines by the end of 1993. The first monographs being translated comprise all 59 of the food and spice grade herbs addressed by the Kommission. They will be submitted as comments responding to FDA's June 18 proposed rulemaking on herbals, amino acids and dietary supplements ("The Tan Sheet" June 21, p. 1). The council's translation is one of several self-regulatory steps being undertaken by the herbal products industry. The American Herbal Products Association finalized its Code of Ethics in spring 1993, and published its volume of standardized nomenclature, Herbs of Commerce, in 1992. Herbal product guidelines are also being developed as part of the Natural Product Quality Assurance Alliance initiative ("The Tan Sheet" July 26, p. 4). Funding for the monograph translation comes, in part, from the Boulder, Colo.-based Herb Research Foundation (HRF), which agreed to support the translation at its Herb Regulatory Summit June 5-6. During the summit, HRF also agreed to give "initial funding" of nearly $ 50,000 for the formation of a Botanical Ingredient Review (BIR), HRF said. The review was first conceived in 1991 as a response to the Nutrition Labeling & Education Act of 1990. The body, which is modeled on the Cosmetic Ingredient Review, will look exclusively at the validity of health claims. Although FDA has twice rejected the idea of conferring review powers to an outside expert panel, industry members have decided to launch the review. The BIR panel, according to HRF, ideally would consist of four scientists and three non-voting panelists from industry, FDA, and a consumer health group. HRF said the first ingredient reviewed by BIR would be garlic. In testimony before Rep. Henry Waxman's (D-Calif.) Energy and Commerce/health subcommittee on July 29, HRF President Robert McCaleb maintained that FDA "unfortunately, is not [a good model for safety review because] the FDA is clearly too biased" against herbs at present. He recommended that Congress look instead at foreign models, including the World Health Organization, and the approaches adopted by the governments of Japan, France and Germany. McCaleb testified that "many of the best-selling herbs have [already] been studied by the best universities and hospitals in Europe, Japan, and even in the U.S." He noted that "millions of people are taking these herbs -- in Europe, especially -- under clinical supervision. There's an excellent body of information about it." He claimed that "Europeans and Asians have access to government-approved preventive medicines against our top four killer diseases, and we have none." Herb regulation in the U.S., McCaleb suggested, should rely on the Ingredient Safety Review -- a protocol of literature and peer group review developed by HRF -- for safety analysis, and on the BIR for claims evaluation. He said that of the 400 major herbs for sale in the U.S., 279 have already been approved by FDA as safe food additives. The Ingredient Safety Review is currently looking at 25 of the remaining 121 herbs, he added.

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