Reducing Ephedra-Related Risks
U.S. Department of Health and Human Services
February 28, 2003
The U.S. Department of Health and Human Services (DHHS) is cautioning all Americans—particularly athletes and those who engage in strenuous activities—about using dietary supplements that contain ephedra. There continue to be serious questions about the risks surrounding this particular dietary supplement.
Today's Actions
DHHS announced a series of actions designed to protect Americans from potentially serious risks of dietary supplement products containing ephedra and cautioned about the use of such products, especially under conditions of strenuous exercise and in combination with other stimulants, including caffeine.
What action is DHHS taking?
- Seeking rapid public comment on the new evidence on health risks associated with ephedra to establish an up-to-date record as quickly as possible to support new restrictions on ephedra-containing products.
- Seeking rapid public comment on whether the currently available evidence and medical literature present a "significant or unreasonable risk of illness or injury" from dietary supplements containing ephedra.
- Seeking rapid comment on a strong new warning label on any ephedra products that continue to be marketed.
- Immediately executing a series of actions against ephedra products making unsubstantiated claims about sports performance enhancement.
- In seeking the 30-day public comment period, FDA is reopening a proposed rule entitled "Dietary Supplements Containing Ephedrine Alkaloids," which would have required a warning statement for these products, as well as restrictions on their potency and composition. FDA later withdrew parts of this proposed rule because of concerns about the specific scientific evidence, expressed by the General Accounting Office.
Why are we taking these steps?
- There continue to be serious questions about the risks surrounding ephedra, and we therefore caution all Americans about using dietary supplements containing ephedra.
- Although the overall evidence suggests that serious adverse events from ephedra appear to be infrequent, 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 may present an unreasonable risk.
- We are particularly concerned about the risks of using products containing ephedra during heavy workouts, with caffeine and other stimulants, in a diet program that stresses the cardiovascular system, or by people under the age of 18.
What evidence is there that ephedra may be harmful?
- A RAND Corporation study commissioned by NIH concluded ephedra is associated with higher risks of mild to moderate side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when taken with other stimulants.
- The RAND review of 16,000 adverse event reports revealed two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases involving ephedra in which the records appeared thorough and no other contributing factors were identified. RAND called such cases "sentinel events," because they may indicate a safety problem but do not prove that ephedra caused the adverse event.
- A study published this month in the Annals of Internal Medicine found that although ephedra products make up less than 1 percent of all dietary supplement sales, these products account for 64 percent of adverse events associated with dietary supplements.
- A 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.
Background on ephedra
- Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. While products containing natural ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years they been extensively promoted and used with the goals of aiding weight loss, enhancing sports performance, and increasing energy.
Background on the law
- FDA does not review dietary supplements for safety and effectiveness before they are marketed under the Dietary Supplement Health and Education Act of 1994.
- 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 FDA 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.
What is next?
- Once the comment 30-day period has ended, FDA will analyze the comments and publish its conclusions about the most appropriate approach to reducing the risk of using dietary supplement products containing ephedrine alkaloids.
