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 Herbal Medicine: Herbal Science Group Clarifies Herbal Regulation Issues 
 

Although the NEJM article calls for herb manufactures to submit products for "premarketing approval from FDA" to demonstrate their safety, Blumenthal noted that under current federal law, all new dietary ingredients (i.e., herbs and other supplements that are introduced into the U.S. after October 1994) do require that FDA approve safety data supplied by the company before a product can be sold.

"Under the current situation, premarket approval on safety and claims for herbal products is untenable," said Blumenthal. He cited two cases where an industry group composed of research-based European and American herb manufacturers petitioned the FDA to approve as over-the-counter (OTC) drugs the popular herb valerian for night-time sleep aid (in 1994) and ginger for motion sickness and nausea (1995). FDA has not responded to these petitions.

"Despite the potential benefits for a scientific review of the safety and efficacy of popular herbs, it is clearly not in the interests of the American consumer for the FDA to take seven to eight years to review and approve the OTC drug status of herbs when other Western industrialized nations have already done so," he said. FDA has stated that it could not respond to such petitions until publicly available standards were available for herbs that might be approved as drugs, although the United States Pharmacopeia published such standards for ginger and valerian several years ago.

The NEJM article calls for good manufacturing practices (GMPs) for herbs, something that many reputable manufacturers and trade organizations have been wanting from FDA for years, since the passage of DSHEA. In fact, the proposed GMPs that were published by FDA in 1997 for public comment were developed with the assistance of industry experts familiar with the technical aspects of GMPs. For the past several years FDA has been promising publication of new GMPs specifically suited for the manufacture of dietary supplements, but they have yet to be released.

In some cases, some of the most popular herbs are also conventional foods or spices (e.g., garlic, ginger, cayenne pepper, bilberry or blueberry extract) and some consumer and industry groups may not want to see these products treated like drugs, especially if they were to be removed from the market until FDA has approved them, said Blumenthal.

"We need rational herb regulation that fits this category," Blumenthal said, "but we also need the FDA to fully enforce the existing laws and regulations." He also noted that in the new Canadian regulatory model herb products are treated under a new regulatory category as "natural health products" where they will be regulated in a way that will help ensure their quality, safety and appropriate claims. "We may want to look North for some possible answers to these issues," he said.

About the American Botanical Council
The American Botanical Council is the nation's leading nonprofit organization addressing research and educational issues regarding herbs and medicinal plants. The 14-year-old organization occupies a 2.5 acre campus in Austin, Texas where it publishes HerbalGram, a peer-reviewed journal on herbal medicine, and will publish in 2003 a book and continuing education course for healthcare professionals, The ABC Clinical Guide to Herbs. In 1998 ABC published The Complete German Commission E Monographs, a 715-page reference book that was ranked second of all medical books published that year. Information contact: ABC at P.O. Box 144345, Austin, TX 78714-4345, ph: 512-926-4900, fax: 512-926-2345. Website: www.herbalgram.org.

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