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Government, health advocates, lawyers challenge safety of weight-loss supplement.

Article Excerpt
Once the darling of the "in" crowd, ephedra is now the product that no one wants to sit next to on the school bus. The government has taken up arms against the weight-loss supplement ingredient, also known as ma huang, which contains chemicals that have powerful stimulant effects on the nervous and cardiovascular systems.

The Department of Health and Human Services (HHS) launched a research effort in June to study ephedra's safety, followed shortly by a General Accounting Office (GAO) report that said the federal government has been more concerned with manufacturers' marketing claims than with monitoring the safety and efficacy of supplements containing ephedra. (Dietary Supplements for Weight Loss: Limited Federal Oversight Has Focused More on Marketing Than on Safety, No. GAO-02-985T, July 31,2002.)

While the Federal Trade Commission (FTC) has gone after manufacturers for unfair or deceptive advertising, the FDA cannot by law regulate the product as strictly as it can foods or drugs. It relies on consumer reports of adverse effects to track ephedra's safety.

In July, the FDA asked the Department of Justice (DOJ) to conduct a criminal investigation into the claims of ephedra-supplement manufacturer Metabolife International, Inc. Meanwhile, countless lawsuits have been filed across the country on behalf of plaintiffs who have been injured after taking ephedra supplements.

The dietary supplement industry estimates 3 billion doses of ephedra are sold annually in the United States; Metabolife says it has sold over 4.5 billion tablets in the last five years. Dietary supplements contain ephedrine alkaloids--the active chemicals found naturally in plants that closely mimic the actions of the synthetic norephedrine hydrochloride (ephedrine HCL), which the FDA approved as a drug in 1948.

The problem with ephedra-containing supplements, according to Janet Heinrich, director of public health issues for the GAO, is that they are not proven to aid weight loss, but they are potentially hazardous. The supplement may be contaminated with harmful ingredients or may not state the amount of active ingredients on its label. It can also interact...

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