The Food and Drug Administration last week pulled from the market VITERA-XT, an ephedra-containing dietary supplement, which was was marketed as a treatment for serious diseases and conditions.

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, 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.

“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.

U.S. Marshalls armed with a warrant seized more than 2.1 million VITERA-XT capsules in the possession of Asia MedLabs, Inc., at the FDA’s request.

“We’ve issued a rule banning ephedra-containing products and we’re sparing no effort to stop their manufacture and distribution. If any of these dietary supplements are still on the store shelves, I urge the retailers to stop selling them immediately,” Acting Commissioner of the FDA, Dr. Lester M. Crawford said.

In December 2003, the FDA informed manufacturers of dietary supplements containing ephedra, including MaxLabs, Inc., which is under the same ownership as Asia MedLabs, that products would be considered adulterated under a forthcoming rule banning ephedra-containing dietary supplements. FDA’s ephedra ban was published in February and took effect in April 2004.

Although the product, VITERA-XT, is labeled as a “traditional Asian herbal formulation,” the product is still considered a dietary supplement, based on FDA regulations, because its label included a panel with “Supplement Facts” and the dietary supplement disclaimer.

Ephedra, also called Ma Huang, is a source of ephedrine alkaloids that, when chemically synthesized, are regulated as drugs. FDA has warned consumers against the use of dietary supplements containing ephedra since June, 1997, and banned these products after research confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system.

(via U.S. Food and Drug Administration)