Herbal Science Group Clarifies Herbal Regulation Issues
Austin TX (Dec. 18). An expert panel of appropriately qualified experts should evaluate the quality, safety and efficacy of herbal products, according to the nonprofit American Botanical Council (ABC).
The regulation of herbal preparations in the United States is a complex issue and is requires thoughtful analysis, said ABC. The organization has issued some perspectives on herb regulation in response to an article in this week’s issue of the New England Journal of Medicine by physicians Donald M. Marcus and Arthur P. Grollman, one of three herb articles that appeared in the journal.
“It is understandable that leading physicians would propose changes in the way herbs are currently regulated,” said Mark Blumenthal, founder and executive director of ABC, referring to one of the articles published by the journal this week. “However, many of the issues raised in the article and the proposals are not really new, and, in some cases, may not be feasible.”
“ABC welcomes the opportunity for a national dialog on improving the regulatory environment for herbal products,” Blumenthal said. “For many years, ABC has proposed that a special expert committee be established to evaluate the literature on herbs sold in the U.S. to determine their safety and benefits. The primary reasons ABC translated and published The Complete German Commission E Monographs in 1998 were to offer the public reliable guidelines for the responsible use of many of the herbs officially recognized as medicines in Germany, and also to propose a Commission E-like model for the U.S.”
Based in part on testimony provided by ABC, two White House Commissions have recommended that an independent expert advisory panel be established to evaluate herbs and related products.
In Germany from 1978 to 1995 the Commission E evaluated all the available scientific literature on over 300 herbs to help determine their safety and efficacy. The Commission’s findings were published as monographs intended to be used as package inserts for herbal drugs sold in pharmacies. The Commission, composed of experts in various fields of herbal science, acts in an advisory capacity to the German counterpart of the Food and Drug Administration.
Under federal Dietary Supplement Health and Education Act of 1994 (DSHEA), herbs are classed as dietary supplements, along with vitamins, minerals, amino acids and other similar substances. In many other countries around the world, herbs are regulated as either over-the-counter drugs or as traditional medicines, where the traditionally used benefits are officially recognized without the herbs having to meet stringent standards required for pharmaceutical drugs. In 1991 the World Health Organization proposed that herbs be evaluated for their quality, safety, and efficacy according to standards appropriate for either OTC drugs or traditional medicines.
Numerous health professional groups have expressed dissatisfaction with the current regulatory system for herbs, partly because herbs are extremely different from conventional pharmaceutical drugs. Herbs are chemically complex and are not as amenable to “standardization” as single-chemical drugs, although many herbal products are standardized to specific compounds, either as quality assurance measures or to help maintain a consistent level of activity.
The safety of herbs is one of the primary concerns of health professionals, who claim that the FDA cannot protect the public from unsafe supplements, citing the DSHEA provision that puts the “burden of proof’ on the FDA to prove a supplement unsafe before it is removed from the market. However, said Blumenthal, many experts believe that FDA has adequate authority to protect the public. He cited former FDA Commissioner Jane Henney, MD, testifying before Congress in 1999, who stated that “FDA has tools at its disposal to take enforcement actions against dietary supplements found to have safety, labeling, or other violations of [federal laws]…. I also believe DSHEA provides FDA with the necessary legal authority to protect the public health.”
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.