Sales of ephedra must stop by early April, the Food and Drug Administration said Friday in finalizing its ban of the herbal stimulant.
In the meantime, “do not take these products. They are simply too risky,” warned FDA Commissioner Mark McClellan.
Ephedra has been linked to 155 deaths and dozens of heart attacks and strokes.
The FDA first announced in December that the ban was coming, but on Friday issued a regulation formally setting it in motion. The law requires a phase-in period, and the FDA says sale of ephedra will become illegal on April 12.
It is the government’s first-ever ban of a dietary supplement.
Ephedra once was hugely popular for weight loss and body building. But it can cause life-threatening side effects even in seemingly healthy people who take the recommended doses, because it speeds heart rate and constricts blood vessels. It is particularly risky for anyone with heart disease or high blood pressure or people engaging in strenuous exercise.
Critics say the ban was too long in coming. Sales already have plummeted because of publicity about the risks, which peaked after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler a year ago. Three states — New York, Illinois and California — have passed their own bans.
The FDA says it couldn’t have acted faster because, unlike with pharmaceuticals, federal law allows dietary supplements to sell without first providing proof of safety. That law requires the FDA to prove a clear danger to public health to curb sales. Manufacturers blocked a 1997 FDA attempt to restrict sales of certain dosages and put warning on the herb by arguing the agency lacked enough proof that it harmed.
'Shameful track record'
The delay marks a “shameful track record” that “points to the need for fundamental reform,” said Bruce Silverglade of the Center for Science in the Public Interest, a consumer advocacy group. He called on Congress to change the law so the FDA could more easily protect consumers.
Ephedra divided the dietary supplement industry. Some manufacturers welcomed the upcoming ban as a way to lift a cloud of controversy over their industry.
Even though the market leader, Metabolife International, suspended ephedra sales last year, it continues to defend the herb. But Metabolife isn’t saying whether it will sue to try to block the ban.
“Metabolife believes their products are safe and effective when used as directed,” said spokeswoman Jan Strode. “We are currently reviewing the rule and are assessing our options.”
The FDA cautions that it is monitoring the new ingredients that are replacing ephedra in supplements touted for energy and weight loss. Top of that list is bitter orange, an ephedra mimic that some studies show can interact dangerously with certain medications.