On February 6, 2004, the Food and Drug Administration (FDA) issued a Final Rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (also known as ephedra) because such supplements present an unreasonable risk of illness or injury.1 The rule will become effective on April 12, 2004, 60 days from the date of publication in the Federal Register. Ephedra, also called Ma huang, is a naturally occurring substance derived from plants that is a source of ephedrine alkaloids including, ephedrine and pseudoephedrine. In recent years, products containing ephedrine alkaloids have been promoted to aid weight loss, enhance sports performance, and increase energy.

In issuing this rule, FDA exercised its authority pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the Federal Food, Drug and Cosmetic Act. DSHEA grants FDA the authority to take action against a dietary supplement under certain circumstances, including when the product presents a significant or unreasonable risk of illness or injury. To meet this standard, FDA conducted pharmacological evaluations of ephedra, reviewed scientific literature on ephedra’s safety and effectiveness, and analyzed adverse event reports associated with dietary supplements containing ephedrine alkaloids. FDA found that such products raise blood pressure and increase heart rate, the consequence of which could result in stroke and heart attack and, possibly, lead to death. Indeed, according to the FDA, several deaths have been associated with the use of dietary supplements containing ephedrine alkaloids. Based on this analysis, FDA found that the risks of illness or injury associated with dietary supplements containing ephedrine alkaloids far outweigh the benefits of such products.

Not all products containing ephedra will be affected by the new rule. The scope of the rule does not pertain to traditional Chinese herbal remedies and does not apply to products such as herbal teas that are regulated as conventional foods. Further, the rule does not pertain to over-the-counter and prescription drug products that contain ephedrine alkaloids, such as allergy relief and decongestant products. Finally, the rule does not affect the marketing and distribution of dietary supplements that contain ephedra substitutes. FDA stated that it will evaluate such ephedra substitutes in the same manner as all other dietary ingredients.