Federal officials on Tuesday announced plans to ban dietary supplements containing ephedra because of continued health concerns about the product, and warned consumers not to take products containing the stimulant.
“The time to stop using these products is now,” Health and Human Services Secretary Tommy Thompson told reporters.
The government has determined that products containing ephedra “present an unreasonable risk of illness or injury,” said Food and Drug Administration Commissioner Mark McClellan.
Tuesday’s announcement marks the first time U.S. officials have blocked the sale of an over-the-counter nutritional supplement. Unlike drugs, dietary supplements do not have to be proven safe before going on the market, but federal authorities can act to take them off the shelves if they are shown to be unsafe.
The FDA notified 62 companies that market products containing ephedra of the planned ban, and Thompson said he expects manufacturers will file suit to try to block the move.
The FDA also issued a consumer alert warning the public to stop buying and using ephedra immediately. The government will issue a regulation “in a matter of a few weeks” that would make it illegal to sell products containing ephedra within 60 days of that notice, McClellan said.
“Any responsible manufacturer and retailer should stop selling these products as soon as possible,” he said.
Ephedra is an herbal supplement that is found in various over-the-counter products designed to help people lose weight or increase their energy, and has long been the subject of criticism.
In February, a medical examiner said an ephedra supplement was linked to the death of Baltimore Orioles pitcher Steve Bechler.
A study commissioned by the National Institutes of Health also called into safety the use of ephedra, saying it was associated with higher risks of heart palpitations, tremors and insomnia.
Industry groups say ephedra is safe when used as directed, and between 12 and 17 million Americans use it each year. The Ephedra Education Council, which is funded by manufacturers and distributors, has supported tougher labeling requirements but opposes a federal ban.
Earlier this year, the EEC told the FDA in a statement that under the FDA’s current definition, “There is no question that ephedra supplements that meet current industry standards are safe and provide significant public health benefits for consumers who need to lose weight.”
Other studies over the past year have also suggested links to health problems.
The Annals of Internal Medicine reported that, although products with ephedra make up less than 1 percent of dietary supplement sales, it has accounted for 64 percent of the serious side effects that have been reported to the Centers for Disease Control and Prevention in association with dietary supplements.
A second study published in the journal Neurology found that the rate of strokes among ephedra users was higher than in nonusers. The supplement users in the study took more than 32 milligrams a day; some ephedra labels recommend almost 100 milligrams daily.
Illinois and New York already have banned the sale of products containing ephedra, and Florida banned ephedra sales to minors in May.