FDA Seizes Ephedra Supplements

HOUSTON--At the behest of the Food and Drug Administration (FDA), the Texas Department of State Health Services embargoed more than 2.1 million tablets of an ephedra-containing dietary supplement from a company based here. A complaint filed by the U.S. Attorney for the Southern District of Texas in U.S. District Court charged Asia MedLabs Inc. with marketing VITERA-XT in violation of the federal ban on ephedra-containing dietary supplements, as well as making claims positioning the product as an unapproved or misbranded drug.

In a statement, Tommy G. Thompson, secretary of the U.S. Department of Health and Human Services, said the government would not tolerate marketing of such dietary supplements. Added Lester Crawford, Ph.D., FDA's acting commissioner, "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."

The complaint noted despite the product's labeling denoting it as a "traditional Asian herbal formulation," it is considered a dietary supplement because the labeling includes a "Supplement Facts" panel and the dietary supplement disclaimer. Also, claims on the Web site for VITERA-XT, including using the product to treat allergies, angina and flu, make the product an unapproved and misbranded drug.

On its Web site (www.asiamedlabs.com), Asia MedLabs posted information on FDA's ephedra ban, noting "FDA exempted Traditional Asian medicines containing ephedrine alkaloids. Comments also asserted that Ephedra in Traditional Asian formulae is usually combined with other botanicals that typically modify Ephedra's inherent stimulant effects. (So very true!) VITERA-XT contains Aimisu Grass, the best buffer available!" It also calls the product a "remarkable blend of natural herbs" that has been used by Chinese herbalists for "generations." At press time, Asia MedLabs had not responded to INSIDER's request for comment on the situation.

When the ephedra ban was implemented in April, 2004, FDA (www.fda.gov) did include language exempting preparations based on Traditional Chinese Medicines (TCMs), as the products are intended for episodic rather than chronic use. At the time, Michael McGuffin, president of the American Herbal Products Association (AHPA), noted this could represent a potential "loophole" in the regulatory system, provided marketers are selling products as TCMs and not dietary supplements. When contacted for comment on FDA's action against Asia MedLabs, he called the move both "timely and appropriate." "FDA made clear in its final rule on ephedrine alkaloids that 'traditional Asian medicines' containing ephedrine alkaloids would not be covered by the rule," he said. "In conversations with AHPA and its Chinese Herbal Products Committee, FDA has made clear to traditional practitioners and manufacturers of these traditional products that the rule would be enforced against anyone marketing such products for weight loss. Thus, FDA's action comes as no surprise to AHPA, and legitimate manufacturers of traditional Asian medicines have nothing to fear from this action. Indeed, FDA's action protects the integrity of those who manufacture and prescribe products that are truly traditional."