November 23, 2004 -- The U.S. 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.
This morning the U.S. Marshalls armed with a warrant seized more than 2.1 million VITERA-XT capsules in the possession of Asia MedLabs, Inc. located on the 9100 block of Winkler Drive in Houston, Texas. Of the total, one million were yet unpackaged capsules; the remainder were contained in more than 14,000 labeled bottles.
"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," said Acting Commissioner of the Food and Drug Administration, Dr. Lester M. Crawford.
In December 2003, the FDA informed manufacturers of dietary supplements containing ephedra, including MaxLabs, Inc., located at the same address and 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 of this year.
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. In addition, the civil complaint alleges, that VITERA-XT, contains ephedrine alkaloids, thereby making it an adulterated food. Moreover, Asia MedLabs's Internet website has made medical claims, including "treat[s]... persistent flu, fevers, and [may be used] for poison release ..., treat[s] allergies, especially, allergic rhinitis ..., treat[s] heart muscle ailments ..., [and] expands cardiac vessels to prevent the ischemic injury of myocardium and relieves the symptoms of angina pectoris." In making these medical claims the civil complaint alleges VITERA-XT is considered an unapproved new and misbranded drug.
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.
FDA's enforcement efforts have focused on manufacturers and major distributors of ephedra-containing dietary supplements. As a result, two firms have voluntarily destroyed more than a quarter of a million dollars worth of these dietary supplements and several others have removed ephedra products from the market.
FDA continues to warn consumers to avoid consumption of products containing ephedra as they pose an unreasonable risk to health.
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