(2003; 14 pages)
EPHEDRA - Moves to reduce risks of ephedra-containing products
USA. In the US, the Department of Health and Human Services (HHS) has announced plans to take action regarding the potentially serious risks associated with ephedra-containing dietary products. Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. It is an adrenaline-like stimulant that can have potentially dangerous effects on the nervous system and heart. On the basis of new evidence in the medical literature and in adverse event reports, there are reasons for the heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury.
Under the Dietary Supplement Health and Education Act of 1994, FDA does not review dietary supplements for safety and efficacy before they are marketed but the law allows the FDA to prohibit the sale of a dietary supplement if it ‘presents a significant or unreasonable risk’. In order to assess these risks, the HHS and FDA will
• seek rapid pubic comment on the new evidence on health risks associated with ephedra
• seek rapid public comment on whether the currently available evidence presents a ‘significant or unreasonable risk of illness or injury’
• seek rapid public comment on a strong new warning label for ephedra products
• immediately execute a series of actions against ephedra products making unsubstantiated claims.
The American Heart Association has also called for a ban on ephedra-containing products in comments submitted to the US FDA. The Association supports the FDA's proposal to limit the manufacturing and marketing of ephedra-based supplements, but believes these products should be completely banned. The president of the American Heart Association, Dr Robert O. Bonow, says that there is growing evidence that the risks of ephedra-containing supplements, which are primarily cardiovascular, far outweigh any potential benefit, and because patients have a tendency to ignore warning labels and dosage information, a complete ban is necessary to eliminate the risks
1. Department of Health and Human Services Media Release: 28 Feb 2003. Available from URL: http://www.fda.gov
2. American Heart Association Media Release, 3 Apr 2003. Available from URL http://www.americanheart.org