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FDA Commissioner Recommends Major League Baseball Ban of Ephedra

Jul 25, 2003 | www.HeartCenterOnline.com

Major League Baseball should place a ban on ephedra, an herbal stimulant. The recommendation came from Dr. Mark B. McClellan, commissioner of the U.S. Food and Drug Administration (FDA), in remarks to U.S. House of Representatives subcommittees on July 24.

The active component of the herb ephedra (ma huang) is a central nervous system stimulant, ephedrine, which can relax smooth muscle. Ephedra has a long history in Chinese medicine as a remedy for colds and asthma. Ephedrine also has what is known as thermogenic properties that cause an increase in body metabolism. This led to its marketing as an energy/endurance enhancer and "fat burner."

But, ephedrine has been linked to such side effects as increased blood pressure, abnormally rapid heart rate (tachycardia), breathing problems, convulsions, stroke and sudden cardiac death. As reported in the January 2002 issue of Mayo Clinic Proceedings, toxic effects have been documented with both short-term and long-term use of ephedrine. Also cited is a comparison study of 20 dietary supplements containing ma huang that showed inconsistencies between the actual ephedrine content and what was printed on the label.

Since manufacturers made no explicit health claims about the product (which would then require the corroboration of scientific evidence), ephedrine had not been regulated by the FDA. Under the Dietary Supplement Health and Education Act of 1994, the FDA does not review dietary supplements for safety and effectiveness before they are marketed. The FDA can, however, prohibit their sale if they present "a significant or unreasonable risk of injury." On February 28, 2003, the FDA and U.S. Department of Health and Human Services announced an initial series of actions toward protecting individuals from the potential hazards of ephedrine containing supplements. These include an analysis of available research and proposed warning label on the risks of injury and illness.

The FDA's actions coincided with the death of 23-year old Baltimore Orioles pitcher Steve Bechler on February 17th, which was linked to his use of ephedrine. In Dr. McClellan's remarks yesterday, he said "professional sports leagues like baseball teams should take action to protect their players." "There is a medical basis for action on this important issue, he added.

Currently, ephedrine is banned by the National Football League (NFL), National Collegiate Athletic Association (NCAA), International Olympic Committee (IOC) and minor league baseball.


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