Resources for Food and Drug Administration (FDA)

Evidence On The Safety And Effectiveness Of Ephedra:

FDA

More than half of the population of the United States uses "dietary supplements," as the term is defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994. [Refs. 1, 2] Dietary supplements include vitamins, minerals, amino acids, enzymes, and herbs and other botanicals. Use of most dietary supplements does not appear to be associated with any serious adverse health effects, and there is evidence that supplements confer health benefits in certain cases. For example, it is well recognized that calcium helps to build strong bones and prevent osteoporosis and that folic acid helps to reduce the risk of neural tube defects. [Ref. 3]

Certain dietary supplements also include ephedra, a plant that contains six ephedrine alkaloids among which ephedrine is predominant. The dietary supplement industry estimates that approximately 12 million individuals were using ephedra in 1999. [Ref. 4] As the tragic death of Orioles' pitching prospect Steve Bechler has reminded Americans, ephedra has long posed difficult issues for clinical investigators, for regulators, and most importantly, for the health of the public, all of whom are concerned about the safety of ephedra relative to its potential benefits, if any. These concerns stem from both the sympathomimetic mechanism of action of ephedrine alkaloids, and accumulating evidence of potentially serious adverse events after use of ephedra-containing products.

FDA regulates ephedra under DSHEA, which places the burden of proof on the government if it wishes to take regulatory action against a supplement. The government must show that the supplement presents a "significant or unreasonable risk of illness or injury" under the conditions recommended or suggested in labeling (or under ordinary conditions of use if the labeling is silent). DSHEA's regulatory framework is primarily a "postmarket" program like the bulk of food regulation. Thus, there is no requirement for manufacturers to provide evidence of product safety prior to marketing ephedra-containing products. In contrast, drug regulation involves an extensive "premarket" evaluation of safety and effectiveness with explicit standards of evidence, providing opportunities for developing evidence to guide not only approval decisions but also conditions of use to manage benefits and risks. In addition, there are postmarket reporting requirements for drugs, to support product safety monitoring.

View the Resource

Share or bookmarklet this web page at: