Ephedra marketers fail to improve image
meet standards set out by the Federal Trade Commission, report
scientists, with many making misleading statements about their
safety, use and efficacy.
Scientists are calling for major reforms in marketing of ephedra-containing supplements, after a study revealed several online advertisements for the weight-loss supplement failed to disclose potential adverse effects and made misleading statements about their safety, use and efficacy.
By misleading consumers, the websites could be in violation of truth-in-advertising standards, write the researchers in this month's Mayo Clinic Proceedings.
"In our study we clearly document the need to change the way ephedra products are advertised," said Dr Bimal Ashar, assistant professor of medicine at The Johns Hopkins University School of Medicine and senior author of the study. He added that since the article was written, the Food and Drug Administration has been investigating further whether ephedra products should be more tightly regulated.
Ephedra has been linked to some serious adverse effects, including hypertension, tachycardia (fast heart rate), palpitations, anxiety, stroke and psychosis. It is also thought to have been responsible for 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 highly-publicized cases concerning ephedra, sales have risen in the last five years. Researchers estimate that approximately 1 per cent of the general population in the US 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 websites evaluated in the study, the majority failed to meet the standards set forth by the FTC.
Using four popular website search engines - Excite, Google, HotBot and Lycos - the authors identified 32 websites that sold herbal dietary supplements containing ephedra. They found that 13 websites (41 per cent) failed to disclose potential adverse effects or contraindications to supplement use; 17 sites (53 per cent) did not reveal the dosage of ephedra alkaloids; and 11 sites (34 per cent) contained incorrect or misleading statements, some of which could result in serious harm to consumers.
Many of the websites in the study contained advertisements claiming no adverse side effects from the dietary supplement, added the researchers. And two websites claimed that the dietary supplement could be used to treat specific diseases, a promotion banned under the Dietary Supplement Health and Education Act of 1994. Some of the websites encouraged inappropriate use of supplements, they noted, such as one site which 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 per cent 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. They also expressed concern about the prevalence of incorrect and misleading statements in the advertisements. For example, many websites compared ephedra to pseudoephedrine, a compound in ephedrine found in sinus medications. The comparison, researchers say, is not medically valid.
And embellished claims such as, "Burn up to 600 per cent more fat" or, "Now you can enjoy increased vitality, enhanced mental clarity and effective weight loss all in one," continue to occur, despite being a violation of truth-in-advertising standards, lacking medical support and posing a serious threat to public health, they add.