Ephedra Use, Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

HHS Announces New Actions

In February 2003, researchers at the RAND Corporation released results of a federally sponsored study that examined available information on products containing the herb ephedra and the drug ephedrine. The study included a review of more than 1,500 adverse event reports related to ephedra that were voluntarily reported to the FDA, and 125 such reports related to products containing synthetic ephedrine.

The researchers concluded that ephedra is associated with risks of side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of hyperactivity such as tremor and insomnia, especially when taken with other stimulants.

RAND's review of some 15,000 additional reports submitted by Metabolife International in the summer of 2002 revealed two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases involving ephedra, in which no other contributing factors were identified. RAND called such cases "sentinel events" because they may indicate a safety problem, but don't prove that ephedra caused the adverse event. The review also found some evidence of ephedra's modest effect on short-term weight loss and scant evidence of its effect on performance enhancement in certain physical activities.

In February 2003, the Department of Health and Human Services and the FDA announced a series of actions designed to protect Americans from potentially serious risks of dietary supplements containing ephedra. These include:

Seeking rapid public comment on the new information on health risks associated with dietary supplements containing ephedrine alkaloids. This will establish an up-to-date public record to support new restrictions on products containing ephedrine alkaloids.

Seeking rapid public comment on whether currently available information and medical literature present a "significant or unreasonable risk of illness or injury" from dietary supplements containing ephedra. In seeking comment, the FDA reopened a 1997 proposed rule titled "Dietary Supplements Containing Ephedrine Alkaloids." That rule would have required a warning statement for these products, as well as restrictions on dosage. The FDA withdrew parts of this 1997 proposed rule because of concerns expressed by the General Accounting Office about the information used to establish dose limits.

Seeking public comment on a mandatory warning label on any ephedra products that continue to be marketed. The proposed warning label warns about the risks of serious adverse events, including heart attack, seizure, stroke, and death, and further cautions that the risk can increase with dose, with strenuous exercise, and when used with other stimulants, such as caffeine. The proposed label specifies those who should never use these products, such as women who are pregnant or breast-feeding. It also lists other conditions, such as diabetes and the use of certain medications, that rule out the use of products containing ephedra.

Taking actions against ephedra products making unsubstantiated claims about sports performance enhancement. The FDA has sent more than two dozen warning letters to firms marketing dietary supplements that contain ephedrine alkaloids. The letters explain that any claims products make on the structure and function of the human body must be truthful and not misleading. The agency letters also warn companies that they must not make claims about their products' ability to treat or cure a disease or condition, such as obesity. Under the Federal Food, Drug, and Cosmetic Act, dietary supplements with disease claims are considered unapproved new drugs and therefore subject to prompt regulatory actions, including injunctions against firms and seizures of their products.

The FDA continues to work closely with the Federal Trade Commission to ensure that makers of dietary supplements containing ma huang or ephedra don't make false and misleading claims.

Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., says the steps announced show the FDA's commitment to taking the most effective actions possible under current law. "The standard for regulating the safety of dietary supplements is largely untested," McClellan says, "but we are committed to finding the right public health solution."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.