Diet Supplement Ephedra Banned (cont.)


HHS Secretary Tommy G. Thompson today announced that the Food and Drug Administration (FDA) has issued a consumer alert on the safety of dietary supplements containing ephedra and has notified manufacturers of its intent to publish a final rule on dietary supplements containing ephedrine alkaloids. The rule will state that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of dietary supplements containing ephedrine alkaloids when it becomes effective, 60 days following publication.

"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," Secretary Thompson said. "Today's action puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now."

"We are taking action today to notify Americans about the unreasonable risk of ephedra as currently marketed in dietary supplements," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law. 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."

"By issuing these letters today, we're sending a strong and unambiguous signal about the safety of dietary supplement products containing ephedrine alkaloids. Consumers should stop buying and using ephedra products right away, and FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective."

According to the Federal Food, Drug, and Cosmetic Act, a dietary supplement product is adulterated if it or a dietary ingredient within it presents a significant or unreasonable risk of illness or injury under conditions of use suggested in the labeling or under ordinary conditions of use. Under the Dietary Supplement Health and Education Act of 1994, the FDA bears the burden of proof to show that a dietary supplement presents a significant or unreasonable risk to prevent it from being marketed; in contrast, for drugs that have similar pharmacologic properties to ephedra, manufacturers bear the burden of proof of showing that the drug is safe and effective before it can be marketed.

Ephedra, also called Ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted for use to aid weight loss, enhance sports performance, and increase energy.

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