Study Calls For Major Reforms in Marketing of Ephedra

Newswise — In a study published in the August 2003 issue of Mayo Clinic Proceedings, researchers found that some Web sites that advertise dietary herbal supplements containing the popular weight-loss dietary supplement ephedra fail to disclose potential adverse effects and make misleading statements about the safety, use and efficacy of the supplements. Researchers suggest that by misleading consumers, the Web sites could be in violation of truth-in-advertising standards.

"In our study we clearly document the need to change the way ephedra products are advertised," says Bimal Ashar, M.D., assistant professor of medicine at The Johns Hopkins University School of Medicine and senior author of the study. "Since this article was written, there have been new steps taken by the Food and Drug Administration to investigate whether ephedra products should be more tightly regulated."

Ephedra is known to have some serious adverse effects, including hypertension, tachycardia (fast heart rate), palpitations, anxiety, stroke and psychosis. It has been linked to some well-publicized cases, including the death of 23-year-old Baltimore Orioles pitcher Steve Bechler who died earlier this year after taking an over-the-counter drug that contains ephedra as its primary ingredient.

Despite this and other well-publicized cases about the toxic effects of ephedra, sales have risen in the last five years. And, researchers estimate that approximately 1 percent of the general population in the United States has taken products that contain ephedra to lose weight.

Critics of ephedra's use as a dietary supplement point out that the active ingredient of this Asian herb is ephedrine, a stimulant that acts similarly to amphetamines.

The Federal Trade Commission (FTC), which is responsible for regulating product advertising, developed advertising guidelines that include substantiating marketing claims and disclosing potential safety issues. However, of the 32 Web sites evaluated in the study, the majority failed to meet the standards set forth by the FTC.

Using four popular Web site search engines - Excite, Google, HotBot and Lycos - the authors identified 32 Web sites that sold herbal dietary supplements containing ephedra. They found that 13 Web sites (41 percent) failed to disclose potential adverse effects or contraindications to supplement use; 17 sites (53 percent) did not reveal the dosage of ephedra alkaloids; and, 11 sites (34 percent) contained incorrect or misleading statements, some of which could result in serious harm to consumers.

Many of the Web sites in this study contained advertisements claiming no adverse side effects from the dietary supplement. Two Web sites claimed that the dietary supplement could be used to treat specific diseases, which is a promotion that is not allowed under the Dietary Supplement Health and Education Act of 1994. Also, some Web sites encouraged inappropriate use of supplements. For example, one site recommended its product for treatment of hypertension and coronary artery disease.

Even though FTC guidelines are not strictly enforced, the authors of the study suggest that the makers of dietary supplements containing ephedra should voluntarily disclose pertinent information about the supplements. "It's in the public's best interest that consumers be informed of any potential for pronounced toxicity," write the authors. "Given that most clinical studies to date examining ephedra (or ephedrine) for weight loss have documented adverse effects in 20 to 60 percent of patients, disclosure seems ethically warranted."

The authors identified a number of key concerns, including the need to educate consumers about the wide variations of ephedra content among herbal dietary supplements. Also, they expressed concern about the prevalence of incorrect and misleading statements in the advertisements. For example, many Web sites compared ephedra to pseudoephedrine, a compound in ephedrine found in sinus medications. The comparison, researchers say, is not medically valid.

Researchers also expressed concerns over the prevalence of embellished claims such as, "Burn up to 600 percent more fat" or, "Now you can enjoy increased vitality, enhanced mental clarity and effective weight loss all in one." Such statements are in violation of truth-in-advertising standards, lack medical support and pose a serious threat to public health.