Embattled ephedra status uncertain

The FDA is under increasing pressure from consumers, politicians and doctors to ban ephedra from the market while some manufacturers are already voluntarily withdrawing the ingredient. American Medical Association Trustee Ron Davis, MD, told Congress last October: "The risk/benefit ratio for these products is unacceptable."

New York-based Twinlab Corp is voluntarily pulling out of the market, citing escalating insurance costs and regulatory uncertainty as principal reasons. It was recently granted a US patent for an ephedra-free weight-loss formulation.

In Suffolk County, New York, in late December, legislators considering an outright ban on sales of ephedra instead passed a resolution preventing retailers from selling the weight-loss supplement to anyone under the age of 18.

General Nutrition Centers has stopped selling ephedra products to minors. GNC, a division of Dutch company Royal Numico NV, will comply with the decision even though it is not legally required to do this in most US states. One exception is California, where ephedra and other 'steroid hormone precursors' can be purchased only by those over the age of 18.

The Washington, DC-based Council for Responsible Nutrition has also come out against ephedra, giving it a 'red light' in its 'Guidelines for Young Athletes.'

Last year San Diego-based Metabolife International was ordered to pay $4.1 million to four people who sued the company over claims they suffered heart attacks or strokes after taking Metabolife 356, a weight-loss product that contains ephedra. Metabolife, facing additional personal injury lawsuits in other jurisdictions, is appealing the decision on the grounds the plaintiffs did not use the product as directed.

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