Extension Communications
Extension 4-H Youth Building
Ames, Iowa 50011-3630
(515) 294-9915
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Extension Communications |
2/11/04
For immediate release
Contacts:
Ruth Litchfield, Ph.D.,Food Science and Human Nutrition, (515) 294-9484,
litch@iastate.edu
Diane Nelson, Continuing Education and Communication Services, (515) 294-3178,
dinelson@iastate.edu
Ephedra Ban Final
AMES, Iowa---For the first time since the Dietary Supplement Health and Education Act (DSHEA) took effect in 1994, the Food and Drug Administration (FDA) will block the sale of a supplement. Ephedra is used by approximately 12 to 17 million Americans, according to industry information. The FDA issued the final rule banning the sale of dietary supplements containing ephedrine alkaloids (ephedra) on February 6.
"Dietary supplements can be banned when scientific evidence shows that the supplement presents an unreasonable risk of illness or injury," said Ruth Litchfield, Iowa State University Extension nutritionist.
FDA notified 62 firms known to market dietary supplements containing ephedra and ephedrine alkaloids in December. The FDA decision was based on a review of 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.
"Ephedra has been linked to about 16,000 adverse reactions, including strokes, heart attacks and irregular heartbeats," Litchfield said. "As many as 155 deaths also have been linked to ephedra, including deaths of professional athletes. Researchers have calculated that the use of ephedra poses a risk 200 times greater than the risks posed by all other herbal supplements combined."
Ephedra, also called Ma huang, is one of the plants that is a source of ephedrine alkaloids, including ephedrine and pseudoephedrine. It is an adrenaline-like stimulant that is marketed primarily as a weight-loss aid or to boost energy. Its principal active ingredient is ephedrin, which when chemically synthesized is regulated as a drug.
The rule states that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury and bans the sale of dietary supplements containing ephedrine alkaloids. The rule will become effective April 12, 2004.
"Current law makes it very difficult to remove dietary supplements that appears to be unsafe," said Litchfield. "Another dietary supplement that has raised concern is aristocholic acid. It is found in a variety of Chinese herbs and has been linked to cancer and kidney failure."
Although the FDA issued alerts about aristocholic acid, just as it did with ephedra, products are still widely available on the Internet. These supplements are commonly touted for weight loss, gastrointestinal symptoms, coughs and immune stimulation.
Additional information is available at these Web sites:
http://potency.berkeley.edu/aristolochicacid.html
http://www.fda.gov/bbs/topics/NEWS/2004/NEW01021.html
http://www.fda.gov/oc/initiatives/ephedra/december2003/
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