What is ephedra?
Ephedra is a naturally occurring substance that comes from botanicals. The principal active ingredient ephedrine is an amphetamine-like compound that can powerfully stimulate the nervous system and heart. Ephedrine alkaloids are found naturally in a number of plants, including the ephedra species (also known by the traditional Chinese medicine name – ma huang or Chinese Ephedra, or epitonin). In recent years, ephedra products have been marketed as dietary supplements to promote weight loss, increase energy, and enhance athletic performance.

What evidence was collected to determine the safety and effectiveness of ephedra products?
The FDA reviewed information about ephedra's pharmacology, studies of its safety and effectiveness, newly available adverse event reports, and the RAND Corporation report – a review of the published scientific literature on ephedra efficacy and safety, sponsored by NCCAM and the NIH Office of Dietary Supplements. In addition, FDA considered additional recent studies confirming that ephedra use raises blood pressure and otherwise stresses the circulatory system. In February 2003, the agency solicited public comments regarding ephedra's side effects and whether ephedra-containing dietary supplements pose a “significant or unreasonable risk of illness or injury.”

After a careful review of the available evidence about the risks and benefits of ephedra in supplements, the FDA found that these supplements present an unreasonable risk of illness or injury to consumers. The data showed little evidence of ephedra's effectiveness, except for short-term weight loss, while confirming that the substance raises blood pressure and stresses the heart. The increased risk of heart problems and strokes negates any benefits of weight loss.

What is covered by these actions?
Essentially all currently marketed dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, ma huang, Sida cordifolia, and pinellia will be affected by this rule. The rule does not pertain to traditional Chinese herbal remedies. It generally doesn't apply to products like herbal teas that are regulated as conventional foods. In addition, products regulated as drugs that contain chemically-synthesized ephedrine are not dietary supplements and not covered by this rule. These include drugs used for the short-term treatment of asthma, bronchitis, and allergic reactions.

The Annals of Internal Medicine reported that, although products with ephedra make up less than 1% of dietary supplement sales, it has accounted for 64% of the serious side effects that have been reported to the Centers for Disease Control and Prevention in association with dietary supplements.

A second study published in the journal Neurology found that the rate of strokes among ephedra users was higher than in nonusers. The supplement users in the study took more than 32 milligrams a day; some ephedra labels recommend almost 100 milligrams daily.

Products Containing Ephedra

• Ripped Fuel (TwinLab Laboratories) • Diet Fuel (Twin Laboratories) • GH Fuel (TwinLab Laboratories) • Herba Fuel (TwinLab Laboratories) • MetaboLift (TwinLab Laboratories) • ThermiCare® (Met-Rx USA) • ETA Stack® (Nutra Sport) • Xenadrine RFA-1® (Cytodyne Technologies) • Metabolife 356® (Metabolife International) • Ultimate Orange (Next Nutrition, Inc.) • UltraCuts (BioPlex) • Vasopro (Mega Pro International) • Adipokinex (Syntrax Innovations, Inc)

• ThermoPlex (Bioplex) • Thermogenic Power (Nature's Herbs) • Chinese Ephedra (Frontiers, Inc.) • MetaCuts (Metaform) • Chinese Ma Huang (Gaia Herbs, Inc) • Lipokinetix (Syntrax Innovations, Inc) • Clenbutrx (Vital Pharm, Inc) • BetaLean HP (EAS) • Diet Pep (Natural Balance, Inc) • Diurlean (ISS Research) • Dyma-Burn Xtreme (Dymatize Nutrition) • Extreme Ripped Force (American Bodybuilding)

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