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November 27, 2004

FDA Acts to Remove Ephedra-Containing Dietary Supplements From Market - What took so long?

Topics: Clinical Pharmacology

Medical News Today has this report of the FDA's intensified efforts to protect consumers against harmful products and their sometimes fatal side effects:

The Food and Drug Administration today intensified its efforts to protect consumers against harmful products and their sometimes fatal side effects by taking enforcement action against dietary supplements with ephedrine alkaloids marketed as a treatment for serious diseases and conditions.

"We are once again sending a message that HHS and the FDA will not tolerate the marketing of dietary supplements that are more likely to harm health than help it," said HHS Secretary Tommy G. Thompson.

The complaint, filed by the United States Attorney for the Southern District of Texas in U.S. District Court in Houston, charges that VITERA-XT, an ephedra-containing dietary supplement marketed by Houston-based Asia MedLabs, Inc., is an adulterated food as well as an unapproved and misbranded drug, which present an unreasonable risk of illness or injury.

At FDA's request, Asia MedLabs' supply of VITERA-XT was embargoed by the Texas Department of State Health Services prior to the filing of today's enforcement action. Read More...

These types of problems are not new. In Am J Health Syst Pharm. 2002 Feb 15;59(4):339-47 the authors reported on the fact that natural products can interact with drugs and with other natural products by the same mechanisms as drugs. Products containing substances such as ephedra have long been known to cause fatal side effects. The FDA should have acted sooner on this issue. Dietary supplements that are known to be safe can offer significant health benefits to those who need them. Ephedra is not in this category.

Posted by Hyscience at November 27, 2004 3:38 PM

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