Extension Communications
3614 Administrative Services Building
Ames, Iowa 50011-3614
(515) 294-9915
3/13/03
For immediate release
Contacts:
Ruth Litchfield, Human Nutrition and Food Science, (515) 294-9484, litch@iastate.edu
Diane Nelson, Continuing Education and Communication Services, (515) 294-3178,
dinelson@iastate.edu
Ephedra Example Reminds Consumers to Speak Up
AMES, IOWA--- Nearly 100 deaths have been attributed to the dietary supplement ephedra. The International Olympic Committee, National Football League and National Collegiate Athletic Association have banned its use and the American Medical Association has advised people not to use it. Ephedra-containing products made up less than 1 percent of herbal supplement sales in the United States in 2001, but accounted for 62 percent of all herbal-related reports of adverse effects reported to poison control centers nationwide. Researchers have calculated that the use of ephedra poses a risk 200 times greater than the risks posed by all other herbal supplements combined.
"But you can probably still find an ephedra-containing 'weight-loss' or 'performance-enhancing' product in local drugstores or supermarkets," says Ruth Litchfield, Iowa State University Extension nutritionist. "By law, the Food and Drug Administration (FDA) does not authorize or test dietary supplements. Unlike pharmaceutical drugs and food additives, dietary supplements are not required to get pre-market approval from the FDA."
Pharmaceutical drugs and food additives must conduct safety studies and submit the results to the FDA for review before they can be placed on the market. In the case of dietary supplements, the burden of proof is on the FDA after the product is already on the market to demonstrate that the supplement is unsafe before it can restrict the product's use or remove it from the market.
On February 28, federal officials proposed tough new labels on ephedra-containing products to warn consumers that it could cause heart attack, stroke and death. They also ordered 24 companies to stop advertising ephedra as a way to build muscles or enhance athletic performance. However, they have stopped short of an outright ban of ephedra.
On March 7, FDA proposed new regulation to require current good manufacturing practices (CGMPs).
"The proposed rule would establish standards to ensure that dietary supplements and dietary ingredients do not contain contaminants or impurities, and are labeled to accurately reflect the active and other ingredients in the product," Litchfield says. "Unfortunately, these changes will not tell consumers whether supplements like creatine, ephedra, St John's wort and ginkgo biloba are dangerous, nor whether they work. The only benefit to consumers will be that FDA will check if the manufacturing process is safe and the product is correctly labeled."
Some consumers want more action. Suffolk County, New York, for example, banned all sales of dietary supplements containing ephedra under a law signed earlier this month. Bans and/or regulation of ephedra also exist in Ohio and Florida.
"Consumers have three options," says Litchfield. "They should report any adverse reactions that they suspect are related to any supplement use. Plus, they can send comments to FDA about whether ephedra should be banned, as well as whether dietary supplements should be required to obtain the same premarket approval as pharmaceutical drugs and food additives."
To report adverse reactions to dietary supplements
Individuals who have experienced any adverse reactions that they suspect are related to supplement use should call the toll free MedWatch number (1-800-FDA-1088) or go to http://www.fda.gov/medwatch/report/consumer/consumer.htm.
To file a report, consumers will be asked to provide:
* Name, address and telephone number of the person who became ill
* Name and address of the doctor or hospital providing medical treatment
* Description of the problem
* Name of the product and store where it was purchased
To share opinions regarding FDA's role in monitoring dietary supplements
The Food and Drug Administration has asked for public responses to the following issues. Consumers can respond by mail or via the Internet to
The Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
http://www.fda.gov/dockets/ecomments
To comment on whether ephedra-containing products should be removed from the market, include a reference to Docket No. 95N-0304 and send comments by April 4.
To comment on whether the same premarket approval process required of pharmaceutical drugs and food additives should be applied to the dietary supplement market, include a reference to Docket No. 96N-0417. No deadline has been set for receiving these comments.
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OPTIONAL SIDE BAR: Ephedra and You
What is ephedra?
"Ephedra, is an extract of the Ephedra vulgaris plant also known
as Ma Huang, epitonin or ephedrine," says Ruth Litchfield, Iowa State
University Extension nutritionist. "It is marketed as a weight control
or energy-boosting formula, usually combined with caffeine, which can
enhance its adverse effects."
How many consumers use ephedra?
Industry estimates say 12 to 17 million Americans consume more than 3
billion doses, or 'servings,' of ephedra products each year for weight
loss, increased strength/energy and enhanced physical performance. Ephedra-containing
products made up less than 1% of herbal supplement sales in the U.S. in
2001, but accounted for 62% of all herbal-related reports of adverse effects
reported to poison control centers nationwide.
What is the problem with ephedra?
Several negative effects have been linked to ephedra, including elevated
blood pressure and heart rate, nerve damage, muscle injury, psychosis,
stroke, memory loss, anxiety and insomnia. Heart attacks, stroke and death
also have been reported. According to the American Association of Poison
Control Centers, 1,178 adverse reactions to ephedra were reported in 2001.
Researchers have calculated that the use of ephedra poses a risk 200 times
greater than the risks posed by all other herbal supplements combined.
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ml: imajor
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