The study recognized that such case studies are a weak form of scientific evidence. Other unmeasured factors may have contributed, and such serious adverse events are likely to happen (albeit at very low rates) among the millions of users of ephedra anyway. The study also identified other such events potentially associated with ephedra, in which other factors may have contributed to the adverse events or in which records were inadequate.

Two recent studies of ephedra's safety were published too late to be included in the RAND Corporation's review, and each raises further concerns about ephedra. One, published this month in the Annals of Internal Medicine, found that although ephedra-products make up less than one percent of all dietary supplement sales, these products account for 64 percent of adverse events associated with dietary supplements.

Another "case-control" study, published in the journal Neurology, concluded that the rate of hemorrhagic (bleeding) strokes among ephedra users was statistically significantly higher than among non-users, for people who take doses above 32 milligrams a day. Many ephedra dietary supplement labels recommend that users take up to approximately 100 mg of ephedra daily.

Additional relevant evidence on whether the current system of regulating ephedra's safety is adequate comes from results under FDA's more extensive regulation of synthetic ephedrine, which is identical to the main
active ingredient in ephedra. Ephedrine has long been available in some FDA-approved over-the-counter and prescription drugs. It appears that the more controlled availability of synthetic ephedrine products, which are available primarily for approved uses for respiratory symptoms and carry mandatory warning labels, has not been associated with the same kind of severe adverse events as have occurred with dietary supplements containing ephedra. This long experience with synthetic ephedrine (in over-the-counter drug products, not in dietary supplements) suggests that significant restrictions on labeling, marketing, and/or access to ephedrine might effectively address unreasonable risks associated with certain forms of ephedra today.

"Although the overall evidence suggests that serious adverse events from ephedra appear to be infrequent," said Dr. McClellan, "we know that such events can be very serious and possibly fatal. We believe that the current scientific evidence strongly suggests that at least some ephedra products present an unreasonable risk. We also believe that FDA's system for regulating synthetic versions of the chemicals in ephedra appears to have a much better track record of safety. To give us the strongest possible basis for further regulatory action, we are asking for quick comments on whether these dietary supplements present an unreasonable risk of harm, and whether it makes sense for FDA to seek new authority in this area."

Under the Dietary Supplement Health and Education Act of 1994, FDA does not review dietary supplements for safety and effectiveness before they are marketed. Rather, the law allows FDA to prohibit sale of a dietary supplement if it "presents a significant or unreasonable risk of injury." This legal standard of "significant or unreasonable risk" implies a risk-benefit calculation based on the best available scientific evidence. It strongly suggests that the agency must determine if a product's known or supposed risks outweigh any known or suspected benefits, based on the available scientific evidence, in light of the claims the product makes and in light of the product's being sold directly to consumers without medical supervision.

FDA Press Release

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