MedWatch Safety Summaries

This is the retyped text of a press release from the FDA

April 10, 1996

Contact: Arthur Whitmore
202-205-4144

FDA Statement on Street Drugs Containing Botanical Ephedrine

The Food and Drug Administration is warning consumers not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as "ecstacy," because these products pose significant health risks to consumers. These products contain botanical, or so-called "natural," sources of ephedrine. Ephedrine is an amphetamine-like stimulant that can have potentially dangerous effects on the nervous system and heart.

These types of products are marketed under a variety of brand names with labels that claim or imply that they produce such effects as euphoria, increased sexual sensations, heightened awareness, increased energy, and other effects.

Possible adverse effects of ephedrine range from clinically significant effects such as heart attack, stroke, seizures, psychosis and death, to clinically less significant effects that may indicate the potential for more serious effects (for example, dizziness, headache, gastrointestinal distress, irregular heartbeat, and heart palpitations). "Ecstacy" is the street name for MDMA (4-methyl-2, dimethoxyamphetamine), which produces euphoria.

Ingredient panels on these products may list ma huang, Chinese ephedra, ma huang extract, ephedra, Ephedra sinica, ephedra extract, ephedra herb powder, epitonin or ephedrine. Any one of these ingredients listed on the label indicate the presence of ephedrine in the product.

Many of these ephedrine-containing products bear labels that appear to be targeted at adolescents and young adults and that imply the products can produce a "high." The agency considers this type of promotion and these claims to violate the Federal Food, Drug and Cosmetic Act, even as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which governs the U.S. marketing of dietary supplement products.

The FDA takes seriously the health risks inherent in these products and is currently investigating the production and marketing of ephedrine-containing products marketed as alternatives to illicit street drugs. The agency is committed to taking whatever action is necessary to remove dangerous products from the market. However, under recent amendments to the Federal Food, Drug and Cosmetic Act, the agency has to act product-by-product and the legal burden is now on the FDA to show that a marketed product is unsafe, rather than on the company to gain FDA approval by showing that the product is safe before it is marketed.

Consumers who have been injured or suffered an adverse effect after taking a dietary supplement or any product containing an ephedrine alkaloid should call 1-800-FDA-4010. Health professionals who have treated patients suffering from an adverse event to these products are urged to report the event to the FDA's MEDWATCH adverse event and product problem hot line at 1-800-FDA-1088.

Return to Summary