| U.S. Food and Drug Administration |
FDA Statement, Apr 12, 2004
FDA Announces Rule Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids Effective April 12
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.
This advisory was prepared by the FDA Office of Public Affairs.