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TRADITIONAL HERBAL MEDICINE SEPARATE REGULATORY CATEGORY RECOMMENDED

This article was originally published in The Tan Sheet

Executive Summary

TRADITIONAL HERBAL MEDICINE SEPARATE REGULATORY CATEGORY RECOMMENDED as a way of providing suitable patient labeling for phytomedicines by Herb Research Foundation President Robert McCaleb at a May 23 meeting of the Alternative Medicine, Wellness and Health Care Reform conference in Washington, D.C. McCaleb called for legislation to create a regulatory category for traditional medicines that would be distinct from prescription and OTC drugs. Such a category already exists "in many countries," he asserted, including Germany and Japan. "Many of the herbs that are used not for prevention, but for the treatment of an acute condition, would fall appropriately into that category," he explained. "They're not economically viable for the new drug application process, and yet [they have been] used traditionally for the treatment of simple conditions," he told the audience. These phytomedicines, McCaleb declared, "have to be acknowledged and/or a legitimate regulatory place given to them so that they have the clearance and proper labeling that they need for people to use them right." He added: "Right now, people are trying to buy and use these substances without the package information they need to use them safely and appropriately." However, McCaleb asserted, phytomedicines "are not causing problems demanding the kind of attention that FDA is giving to them." He noted that an HRF survey "could not find evidence" to support FDA's view that these substances are a major health risk." "We need an abbreviated safety approval mechanism that acknowledges historical information as a valid form of safety documentation and acknowledges historical and cultural use of these substances as valid documentation of their efficacy," McCaleb said. "We have to take a few steps beyond that in order to assure that there isn't any product toxicity that could have been missed, but we need to compare apples and apples." Echoing a concern often expressed by phytomedicines advocates, American Botanical Council Executive Director Mark Blumenthal told the Wellness conference that "there's no way to get a drug approval for these herbs" given the estimated cost of bringing a new drug to market, which was projected at a pretax cost of $ 359 mil. by the Office of Technology Assessment. Like McCaleb, Blumenthal suggested establishing a system of criteria for allowing historical support of phytomedicine approvals in a format similar to the OTC monograph. Blumenthal cited the World Health Organization's "Guidelines for the Assessment of Herbal Medicines," which was first presented at a symposium of the European Scientific Cooperative for Phytotherapy (ESCOP) in March 1992, as a format for the regulation of phytomedicines. Referring to WHO, Blumenthal maintained that "these people believe that historical use should play an important role [as] criteria in establishing the labeling of herbal products, as long as no modern scientific information comes to bear to show that this particular plant product is either unsafe or ineffective. That kind of modern scientific information that the WHO is talking about should then be considered to possibly override historical use." Several European countries have already adopted monograph systems for the marketing of these herbal products along the WHO guidelines, Blumenthal said. "ESCOP is designing monographs on herbal medicines that are proposed for inclusion in the new European Pharmacopeia," he said, adding that 15 monographs have already been published by the group. Blumenthal reported that the German government has monographed approximately 200 herbal medicines, and that his organization is currently translating those monographs into English so that American groups can understand how the system functions. France has also monographed a similar number of medicines in 13 distinct OTC categories, according to Blumenthal. He said that the French government allows the sale of those products, provided that the product label carries a disclaimer stating that its claims are based on historical and cultural use.
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