Containing Ephedrine Alkaloids


by: 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/



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