Dietary Supplements: Ephedra

Publication Date: February 2004

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

Type:

Abstract:

Ephedrine is a natural constituent of the herb ephedra and a synthetic compound present in certain over-the-counter drug products. The herbal form, known as Ma Huang in China, has been used as a remedy for asthma. In western cultures, ephedrine, the active drug product ingredient, has been used as a bronchodilator and decongestant for various respiratory problems. More recently, dietary supplements containing ephedra have been promoted for weight reduction and as a performance enhancer in body building and other sports.

Under the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the Food and Drug Administration (FDA) must show that a supplement is unsafe and causes harm before it can be removed from the market. In 1997, following several hundred reports of adverse effects alleged to be caused by ephedra use, FDA proposed rules to restrict the dosage, require specific warnings on ephedra-containing supplements, prohibit supplements containing ephedrine combined with other known stimulants, and require warnings against excessive intakes. This proposal was criticized for the lack of scientific evidence to support FDA's dosage limitations and the labeling requirements. In 2000, FDA withdrew part of the proposed rule, but subsequent high profile deaths attributed to ephedra led FDA to re-propose the original regulation in 2003. On December 30, 2003, the Department of Health and Human Services (HHS) and FDA announced plans to prohibit sale of ephedra, using the safety provisions of DSHEA for the first time.

Several congressional hearings have focused on the limitations of FDA's current adverse events reporting system, which was used by the agency to conclude that dosage restrictions and mandatory labeling were needed, and specific cases of death attributable to ephedra. A General Accounting Office report examined the scientific basis for FDA's ephedra proposal and concluded that the number of adverse events reports related to ephedra warranted agency attention to safety concerns but failed to provide adequate evidence to support the dosing levels and duration of use limits. In June 2002, HHS announced it would plan expanded research on ephedra's safety, following completion of a RAND Corporation report it had commissioned for review of the existing science. The RAND report indicated that the literature showed that although ephedra can promote a modest short-term weight loss in clinical trials, there is insufficient data on long-term benefits for weight-loss and body building. Combined with other stimulants, it was associated with increased health risks.

In the 108th Congress, H.Con.Res. 52 expresses the sense of the Congress that all major sports organizations should ban the use of ephedra. H.R. 725 would establish labeling and advertising rules for supplements containing ephedra and prohibit sales to minors. H.R. 1025, the Ephedra Public Protection Act, would require pre-market approval for supplements containing ephedra alkaloids and postmarket reporting of serious adverse effects. S.Res. 260 expresses the sense of the Senate that the Secretary of HHS should take action to remove ephedra from the market. These bills were referred to the appropriate committees, but no additional action has yet been taken on any bill or resolution.