The Food and Drug Administration issued a Consumer Alert on the safety of dietary supplements containing ephedra today. Manufacturers of products containing the ingredient have been notified of the FDA's intent to publish a final rule on dietary supplements containing ephedrine alkaloids.
The rule will state that ephedrine alkaloids present an unreasonable risk of illness or injury to its users. The sale of dietary supplements containing ephedrine alkaloids will be banned 60 days following publication of the rule.
"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," HHS Secretary Tommy G. Thompson stated via press release.
"Today's action puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now."
FDA commissioner, Mark B. McClellan, M.D., Ph.D., stated that the action has been taken in order to notify the American public of the unreasonable risk of ephedra's use in dietary supplements:
"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."
Ephedra, also called Ma huang, is a naturally-occurring botanical substance; its principle active ingredient is ephedrine. When ephedrine is chemically synthesized, it is regulated as a drug. Ephedra-containing products have been extensively promoted in the last few years, particularly for use as a weight loss aid and to enhance athletic performance.
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.
The FDA's concerns about dietary supplements containing ephedra have been attributed in part to ephedra's mechanism of action in the body. Ephedra is a stimulant with an adrenaline-like effect on the body, which puts the heart at risk for adverse effects.
The evaluation also reflects findings from studies by the RAND Corporation, which found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting additional safety and health risks.
Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.
This story contains content adapted from a news release provided by the FDA.
