The Food and Drug Administration (FDA) today issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements present an unreasonable risk of illness or injury. The rule will become effective 60 days from the date of publication.
“This FDA rule reflects what the scientific evidence shows – that ephedra poses an unreasonable risk to those who use it,” Health and Human Services Tommy G. Thompson said. “The regulations prohibit the sale of dietary supplements containing ephedra, and we intend to take swift action against anyone who puts consumers at risk by continuing to sell such products after the prohibition takes effect.”
“In December, we advised consumers to stop using ephedra products, and we asked responsible companies to stop selling them,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “We intend to use this regulation to make sure consumers are protected by removing these risky products from the market.”
Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use. FDA’s final regulation presents a framework for applying this unique statutory standard.
To meet the standard required by the dietary supplement law, the FDA gathered and thoroughly reviewed evidence about ephedra’s pharmacology; peer-reviewed scientific literature on ephedra’s safety and effectiveness; adverse event reports; and a seminal report by the RAND Corporation, an independent scientific institute. The FDA also reviewed tens of thousands of public comments on the agency’s request in March 2003 for information about ephedra-associated health risks.
In recent years, dietary supplements containing ephedrine alkaloids have been extensively promoted for aiding weight control and boosting sports performance and energy. The totality of the available data showed little evidence of ephedra’s effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These effects are linked to significant adverse health outcomes, including heart attack and stroke. “Until the final rule prohibiting the sale of ephedra-containing dietary supplements takes effect, FDA reiterates its warning to consumers: ‘Do not take these products. They are simply too risky,’” said Dr. McClellan.
Ephedra, also called Ma huang, is one of the plants that are a source of ephedrine alkaloids, including ephedrine and pseudoephedrine. When chemically synthesized, ephedrine and pseudoephedrine are regulated under the Federal Food, Drug, and Cosmetic Act as drugs. In contrast to the DSHEA-regulated dietary supplements that contain ephedrine alkaloids, the safety and effectiveness of drug products containing ephedrine alkaloids in drug products have to be proven by the manufacturer.
The issuance of this final rule continues a process that started in June, 1997 when FDA first issued a proposal that required a statement on dietary supplements containing ephedrine alkaloids warning that they are hazardous and should not be used for more than seven days. FDA also proposed to restrict the amount of ephedrine alkaloids in dietary supplements and to prevent combining ephedra with other ingredients that have a known stimulant effect.
FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included taking enforcement actions against firms making unsubstantiated claims regarding enhanced athletic performance for their ephedra-containing products. FDA also issued warning letters to firms promoting these products as alternatives to illicit street drugs. Many firms have complied with FDA’s warning against making such claims. FDA has also followed up with seizures and injunctions and joint enforcement actions with the Federal Trade Commission and the Department of Justice.