Herbal Stimulant Unreasonable Risk Of Illness. The Food and Drug Administration issued a consumer advisory last week warning that diet products containing ephedra pose “an unreasonable risk of illness or injury.”
The FDA plans to officially ban, and has given manufacturers 60 days to recall, ephedra-based dietary supplements linked to thousands of health complications, including the death of Baltimore Orioles pitcher Steve Belcher last February.
Once a popular supplement among serious dieters and athletes, ephedra can increase a person’s risk of heart attack, stroke and other ailments – even if taken in moderate doses, medical experts say.
FDA commissioner Mark McClellan made last week’s announcement alongside Health and Human Services Secretary Tommy Thompson, who reported more than 16,000 “adverse incidents” in a government study involving ephedra-related dietary products.
“Today’s actions tells consumers that the time to stop using these products is now,” said Thompson, who estimates there are about 62 companies making and selling dietary supplements with ephedra.
Sales already have plummeted because of publicity about the herb’s dangers. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.
The herbal remedy, which was originally extracted from a Chinese shrub called ma huang, is traditionally used to treat bronchial ailments. In recent years, companies have harnessed ephedra’s stimulative effects in dietary and performance-enhancing products.
drug’s efficacy and safety
Ephedra will be the first additive banned under 1994’s Dietary Supplement Health and Education Act, which forces federal regulators to clearly prove a public risk before triggering a product ban. The act differs greatly from the rules governing pharmaceutical makers, who must prove a drug’s efficacy and safety before winning FDA approval to sell it.
Local sellers of herbal remedies distanced themselves from the dietary products in question, saying ephedra’s risks have been known for years. At Debra’s Natural Gourmet in Concord, a ban on ephedra-based dietary and performance-enhancing products has been in effect since the store’s opening in 1989.
“We’re certainly familiar with it,” said Debra Stark, owner of the holistic shop. “We made the decision not to carry it in any dietary supplements anything to jazz you up.”
A spokesman at Whole Foods Market, which operates six stores in MetroWest, offered similar sentiments, adding that the grocery chain stopped selling ephedra-based dietary products well before yesterday’s news.
However, he said Whole Foods, like most pharmacies, carries some decongestants and bronchial dilators made with ephedra. The government’s ban does not include decongestants or bronchial medications.
“Is the problem with ma huang or ephedra? Not really. It’s the people marketing it and using it. They’re not reading the directions,” said Gary Kracoff, owner of Johnson Drug in Waltham. “Medicinally, it does have its place.”
Peguy Caddeus, manager of the Vitamin Shoppe in Framingham, stopped carrying ephedra-based dietary supplements last spring after Belcher’s collapse on the baseball diamond.
“Ever since that, we stopped. Everybody stopped,” he said.
With all of the negative publicity, Caddeus said shoppers would be hard pressed to find the products anywhere in MetroWest, let alone Massachusetts. Three states: Illinois, New York and California have already banned the sale of ephedra-based diet products.
Most retail chains have quit selling ephedra-containing products, and only a handful of major ephedra producers still are in business to supply Internet sellers. Even market leader Metabolife International suspended ephedra sales last month, citing ambiguities in state laws.
“It’s a dead product, and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before,” said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.
Ephedra makers insisted their products are safe if used correctly, but so far aren’t saying if they’ll sue to block the ban.
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