January 2004

Herbal industry responds to FDA-ephedra ban

In a move which many dietary supplement manufacturers anticipated, the U.S. Food and Drug Administration (FDA) issued on December 30 a consumer advisory indicating it will ban dietary supplements containing ephedra. The agency has notified 62 firms that manufacture and market these products of the rule, which will take effect 60 days after publication.

The rule will state that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury.

The American Medical Association applauds the FDA move; herbal associations accept it; and some manufacturers promoting the use of herbal supplements challenge the FDA move.

Ephedra, also called Ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been promoted as aids to weight-loss.

Manufacturers disagree with FDA

Some manufacturers of dietary supplements are at odds with the FDA’s action. Galen Ballard, president of Titan Laboratories, a manufacturer of nutritional alternatives to drugs, told Chiropractic Economics, “Ephedra is the most effective product for weight loss that has been found. What we’re seeing in [the FDA’s action on] ephedra is the tip of the iceberg. The government is making a concerted effort to ban and discredit whatever works in alternative medicine.”

Ballard considers the FDA at odds with its own mission, as he wrote in “Is the clock ticking on alternative healthcare?” in Vol. 49, Issue 13, of Chiropractic Economics. In that article he addressed the controversy concerning ephedra.

Ballard’s company no longer manufactures weight-loss products containing ephedra. He said the company anticipated the FDA’s action some time ago.

Metabolife International, a manufacturer of drugstore-available weight-loss products, said in a press release, “Metabolife respectfully disagrees with the decision of the Food and Drug Administration to ban ephedra-based dietary supplements. [We] strongly believe in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed. Metabolife has long supported reasonable, science-based regulations for all dietary supplements. We have supported bans on sales to minors and on marketing for athletic performance enhancement. Following the publication of the final rule by the FDA, Metabolife will carefully consider its options.”

Associations accept ban

Associations that support the use of herbal supplements accept the FDA decision. Michael McGuffin, industry representative to the FDA Dietary Supplement Subcommittee and president of the American Herbal Products Association (AHPA), a trade organization whose mission is to promote the responsible commerce of herbal products, acknowledged to Chiropractic Economics an ongoing disagreement between experts concerning the safety of ephedra.

He commented on the FDA action. “The FDA has the responsibility and the authority to serve as the arbiter in this controversy and has now made its decision. This decision is evidence that the agency has acknowledged its authority under the current law. AHPA will attentively evaluate the data on which this decision to ban ephedrine-containing supplements was based as soon as that information is available.”

Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), a nonprofit education and research organization that disseminates science-based information for the safe and effective use of medicinal plants and phytomedicines, told Chiropractic Economics that ABC does not believe herbs should be banned because of perceptions of health concerns.

“In principle, they should be allowed to be marketed so long as they are made according to proper GMP (general manufacturing principles), do not contain any synthetic additives or adulterants (such as synthetic ephedrine), are marketed for appropriate purposes and are properly labeled with warnings and risk disclosures and there are industry and government education campaigns regarding the potential risks and potential benefits,” said Blumenthal.

He added, “Nevertheless, while not agreeing with the ban in principle, ABC would not challenge the ban and would accept the FDA’s determination regarding safety. ABC would also hope that members of the herb industry will not challenge the ban. We believe that the majority of the industry will support it.”

For chiropractors who provide herbal supplements to their patients, Blumenthal had reassuring words. “ABC does not believe that this [FDA ban] bodes ill for the herb industry, as it will not become a precedent or gateway for the banning of other herbs. In fact, we believe that this may have a benefit for the industry as a whole, as it will remove the shadow that ephedra has cast over the rest of the herbs and possibly lower some of the demands by some in Congress for more stringent yet unreasonable regulation of the entire herb and supplement industry.”

The AMA came out in strong favor of the ban. In a press statement, AMA trustee Ron Davis, MD, said, “Dietary supplements containing ephedra are a serious health threat … Seizure, stroke, psychiatric problems, heart attack and death are all recognized risks of ephedra use. The American Medical Association strongly supports the ban.”

The FDA has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids, alerting them of future rule.

Sources: Food and Drug Administration, www.fda.gov; Michael McGuffin, American Herbal Products Association, www.ahpa.org; Galen Ballard, Titan Laboratories, www.titanlabs.com, Mark Blumenthal, American Botanical Council, www.herbalgram.org

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