Austin, TX (Dec. 18, 2002). 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."