A decision by the Food and Drug Administration to advise consumers to stop buying and using dietary supplements containing ephedrine alkaloids has been lauded by NCAA officials as sending a "strong and clear message" to student-athletes about the dangers of ephedra products.

The FDA issued the consumer alert December 30 and also notified 62 manufacturers of its intent to publish a rule stating that dietary supplements containing ephedrine alkaloids present an unreasonable risk of injury or illness. That rule, which would become effective 60 days after publication, would have the effect of banning the sale of those dietary supplements.

"FDA will publish a final rule as soon as possible that will formalize its conclusions that dietary supplements containing ephedrine alkaloids present unreasonable risks to those who take them for any reason," said Tommy G. Thompson, U.S. Secretary of Health and Human Services. "This action puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now."

The NCAA is one of several organizations that has sought a ban on over-the-counter ephedra products, by offering testimony to Congress, supporting legislative efforts and providing comment to the FDA.

"We are pleased that these efforts have resulted in the FDA's decision to safeguard the health of collegiate athletes and the general public from these dangerous products," said Abe Frank, NCAA director of government relations. "The announcement by Secretary Thompson has sent a strong and clear message to student-athletes and the general public about the safety of dietary supplements containing ephedrine alkaloids."

The NCAA banned the use of ephedrine by student-athletes in 1997 and began year-round drug testing for it in 2002 on recommendations from its Committee on Competitive Safeguards and Medical Aspects of Sports. Ephedrine is a central nervous system stimulant that causes increased heart rate and blood pressure and carries a significant risk of heat illness, arrhythmias, heart attacks, strokes, seizures and sudden death, and the federal government regulates it as a drug when it is chemically created.

Ephedrine is the principal active ingredient of ephedra, a naturally occurring chemical found in the herb ma huang. Ephedra typically is marketed as an ingredient of over-the-counter dietary supplements aimed at aiding weight loss, enhancing athletic performance and increasing energy.

Dietary supplements including ephedra alkaloids have been regulated under terms of the 1994 Dietary Supplement Health and Education Act, which treats the substance as a food, rather than a drug. Under the act, the FDA must prove a supplement dangerous before it can prevent the sale of such products to consumers.

"Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law," said FDA Commissioner Mark B. McClellan. "We worked hard to obtain and review all the available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra's safety and effectiveness, adverse-event reports, and reviews by independent experts."

The FDA solicited comment in February 2003 regarding ephedra, and reported that it received "tens of thousands" of responses. The agency also reviewed various studies and reports, including a RAND Corporation report presenting ephedra data.

With publication of the rule, ephedra-based products would become the first dietary supplements banned for safety reasons under the 1994 law.

"We are going to issue a rule that clarifies and applies a legal standard that has never been used before," McClellan said. "Using the challenging standard provided under the law, we have done all we can to make sure our regulatory action will succeed."