FDA pledges to root out ephedra supplements
its efforts to ensure that any manufacturers still selling dietary
supplements containing the banned substance ephedra would be
stopped.
The FDA said in a statement that it was taking enforcement action against dietary supplements containing ephedrine alkaloids that were being 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 Tommy Thompson, secretary of the HHS.
The action was initiated, according to the FDA, by a complaint filed by the attorney for the southern district of Texas, charging that VITERA-XT, a dietary supplement containing ephedra that is marketed by Houston-based Asia MedLabs, is: "an adulterated food as well as an unapproved and misbranded drug, which present an unreasonable risk of illness or injury".
The FDA had earlier requested that Asia MedLabs' supply of VITERA-XT be embargoed by the Texas Department of State Health Services. Yesterday morning, more than 2.1 million VITERA-XT capsules were found in the company's possession.
"Of the total, one million were yet unpackaged capsules; the remainder were contained in more than 14,000 labeled bottles," said the FDA in a statement.
"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 Dr. Lester Crawford, acting commissioner of the FDA.
The government body had, in December 2003, informed manufacturers of dietary supplements containing ephedra that products would be considered "adulterated" under a forthcoming rule banning ephedra-containing dietary supplements. The ephedra ban was published in February and took effect in April of this year.
The FDA said it had 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.
Several supplement companies have suffered since the ban on ephedra, not least San Diego-based supplement maker Metabolife whose reputation as one of the largest retailers of dietary supplements in the US, until the interdiction of ephedra, was based largely on sales of its ephedra-based product Metabolife 356.
In June, for example, a Crosby woman who suffered brain damage in a stroke after taking ephedra received a $7.4 million jury award. A Southeast Texas jury awarded Rhea McAllister $2.4 million for damage caused by Metabolife's supplement and $5 million in punitive damages.
The FDA noted that two firms have destroyed more than a quarter of a million dollars worth of ephedra-containing dietary supplements and several others have removed ephedra products from the market.
