FDA makes final ruling on dietary supplements containing ephedrine alkaloids

Apr 12 2004

The Food and Drug Administration (FDA) announced today that the final rule on dietary supplements containing ephedrine alkaloids is effective immediately. The rule, which was published on February 11, 2004 in the Federal Register, declares dietary supplements containing ephedrine alkaloids (ephedra) adulterated because such supplements present an unreasonable risk of illness or injury.

Two manufacturers had asked the United States District Court in New Jersey to enter a temporary injunction to prohibit FDA from enforcing the rule. However, the court ruled today that it would not immediately stay the rule. The court ordered the parties to submit additional briefs so that it may decide whether to permanently stay the rule.

"We will take appropriate enforcement actions if needed to stop manufacturers from illegally selling and distributing dietary supplements containing ephedra alkaloids," Health and Human Services Secretary Tommy G. Thompson said. "These products pose unacceptable health risks, and any consumers who are still using them should stop immediately."

On December 30, 2003, FDA issued over 60 letters to manufacturers notifying them of our intent to publish the rule as well as a consumer alert warning the public of the dangers of ephedra and asking that they stop taking these products immediately.

“Dietary supplements containing ephedrine alkaloids have been shown to pose a real risk to health,” said Dr. Lester M. Crawford, Acting FDA Commissioner. “The court's decision today makes clear that these dietary supplements may not be lawfully marketed while the matter remains under review by the Court.”

FDA plans to step up Internet surveillance to determine whether anyone, including the original 60 + targeted firms, is continuing to actively promote and sell these products.

FDA has already seen progress in its regulatory efforts, as a majority of the manufacturers to whom letters were sent have ceased selling dietary supplements containing ephedrine alkaloids.

For more information go to: http://www.fda.gov/oc/initiatives/ephedra/february2004/