FDA Moves to Ban Ephedra

Too Little, Too Late, Say Critics

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Dec. 30, 2003
The Food and Drug Administration (FDA) says it will ban dietary supplements containing ephedrine, commonly used in weight-loss and extra-energy preparations. Many manufacturers have already stopped using the substance because of a rash of product-liability cases.

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

"We're sending a strong and unambiguous signal about the safety of dietary supplement products containing ephedrine alkaloids," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "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."

Critics said the two waited too long.

"Today's announcement by the FDA to ban the dietary supplement ephedra, which comes more than two years after we petitioned the agency to do so, shows the dangerous cowardice of FDA Commissioner Mark McClellan and HHS Secretary Tommy Thompson, who waited to act until receiving reports of more than 155 deaths of ephedra users instead of acting much earlier," said Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group.

"When we filed our petition, there were reports of 81 ephedra-related deaths. Now, after that number has nearly doubled and very little ephedra is being manufactured, the FDA finally announces a ban. This is an inexcusable dereliction of responsibility by an agency that has acted more like an ephedra sales extension agency than the public health agency it is supposed to be," Wolf said.

The Feb. 16 death of Baltimore Orioles pitcher Steve Bechler, who keeled over from heatstroke after taking the herbal stimulant, reignited a long-simmering debate over the safety of the substance.

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.

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.

FDA's concerns about dietary supplements containing ephedra arise in part from ephedra's mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. FDA's evaluation also reflects the available studies of the health effects of ephedra. This includes many studies reviewed by the RAND Corporation, which found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting safety 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.

"We are going to issue a rule that clarifies and applies a legal standard that that has never been used before. Using the challenging standard provided under the law, we have done all we can to make sure our regulatory action will succeed," said Dr. McClellan. FDA's authority to regulate dietary supplements has been severely curbed by Congress, under heavy lobbying from the supplements industry.

FDA has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids alerting them of this future rule.

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