From The October 2000 Issue of Nutrition Science News

FDA Lurches Toward Ephedra Ruling

Washington, D.C.—The U.S. Food and Drug Administration (FDA) is taking a slow approach to an herb revered and reviled for its weight-loss and speedlike effects. A multidisciplinary panel was first convened in 1997 to help FDA assess the safety of ephedra (Ephedra sinica), also known as ma huang. In August, FDA conducted another set of public meetings under the auspices of the U.S. Department of Health and Human Services Office of Women's Health. The agency then extended the public comment period to September 30.

Citing a failure by FDA to conduct an objective and comprehensive assessment of the scientific data on the safety of ephedra, the Washington, D.C.-based American Herbal Products Association (AHPA) assembled a panel of scientific and medical experts to release findings on the herb's safety for the August public hearing. Critics say FDA relied too heavily on adverse events reports in their preliminary plan to ban ephedra products.

"Adverse events reports are simply anecdotal reports and do not demonstrate a cause-and-effect relationship between a product and a reported condition," says R. William Soller, Ph.D., senior vice president of the Consumer Healthcare Products Association, based in Washington, D.C.

Adverse events associated with ephedrine alkaloid dietary supplements include stroke, seizure and myocardial infarct. The seven-member AHPA panel concluded that the estimated incidence of seizure is no greater in the nonephedrine-using population than among ephedrine supplement users "when used according to AHPA trade recommendations," says Stephen E. Kimmel, M.D., AHPA panel chairman.

AHPA recommends FDA rule that serving limits should be not more than 25 mg of total ephedrine alkaloids, a daily consumption limit of 100 mg total ephedrine alkaloids, and that appropriate warnings consistent with other available over-the-counter (OTC) ephedrine alkaloid products.

Today, more than 3 billion servings of dietary supplements containing ephedra are safely consumed annually, according to AHPA. (See also "Ephedra's Alkaloids Provide Its Kick," NSN 1999;4(10):456-69.)

— Todd Runestad