U.S. Bans Ephedra, Drug Linked to DeathsDec 30, 2003 | AP
The Bush administration is banning the sale of ephedra early next year, and urged consumers Tuesday to immediately stop using the herbal stimulant that has been linked to 155 deaths and dozens of heart attacks and strokes.
It was the government's first-ever ban on a dietary supplement, one that comes eight years after the Food and Drug Administration first began receiving reports that ephedra could be dangerous.
"The time to stop taking these products is now," Health and Human Services Secretary Tommy Thompson said. "They are simply too risky to be used."
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 use the recommended doses, because the amphetamine-like stimulant 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.
The ban isn't immediate because federal rules require paperwork steps that mean the earliest it could take effect would be March. But the FDA wrote 62 current and former makers and sellers on Tuesday that, "we intend to shut you down," said Commissioner Mark McClellan.
"There are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk," McClellan said. "Any responsible manufacturer and retailer should stop selling these products as soon as possible."
Thompson said he was announcing the upcoming ban now so that people making New Year's resolutions to lose weight won't be tempted to try ephedra.
"Ephedra raises your blood pressure and stresses your system," McClellan added. "There are far better, safer ways to get in shape."
The FDA put manufacturers on notice that it will be watching what ingredients replace ephedra in weight-loss products. But while the ban sets an important legal precedent for supplement regulation, no other crackdowns are imminent, McClellan said.
Critics called the ephedra ban long overdue.
Sales already have plummeted because of publicity about the herb's dangers, which peaked after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler last February. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.
Three states: New York, Illinois and California have passed their own bans. 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.
Wolfe petitioned the government for a ban in 2001, when the agency had reports of 81 deaths. That number now is 155; also, FDA has reports of more than 16,000 health complaints from ephedra users.
"It was unfortunately only with the tragic death of a high-profile athlete that this started to get the attention that was due," added Dr. Mark Estes of the New England Medical Center in Boston, who called FDA unresponsive to years of physician complaints.
Others welcomed FDA's crackdown.
"It won't bring Steve back, but it will help and protect other people," said Pat Bechler, the baseball player's mother. Her husband Ernie recently urged Congress to pass a ban, saying, "Please don't let my son die in vain."
Added the American Heart Association "Being thin is not worth risking your life by using questionable products."
The FDA said it couldn't act any sooner because of a controversial federal law that lets dietary supplements sell over the counter without any requirements that they prove safe first. To curb supplement sales, FDA must prove a clear danger to public health something Thompson called "a tremendous burden of proof" that Congress should rethink.
In March, the FDA proposed putting tough new warning labels on ephedra and said it was building a case for a ban. In the ensuing months, FDA scoured all the available science and more than 10,000 public comments about ephedra to carefully build a case that could withstand court challenge.
"We are laying the strongest possible foundation to not only take the product off the market, but to keep it off," McClellan said.
Ephedra makers insisted their products are safe if used correctly, but so far aren't saying if they'll sue to block the ban.
"Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive and effective means by which to support weight loss," San Diego-based Metabolife said.
"Cold medicine kills more people a year than ephedra does," charged Robert MacKenzie, owner of MaxOutBody.com, an Internet supplement seller that has sold $300,000 worth of ephedra since July. He said he is looking for ephedra-free alternatives to sell once the ban begins.
But ephedra, also called ma huang, has divided the supplement industry, and the leading Council for Responsible Nutrition had no plans to oppose the ban.
"We think the reputable players have found so much controversy and difficulty in this marketplace that they've decided to get out of it," said CRN's John Hathcock. "We recognize the controversy is a cloud over our whole industry."
The final regulation outlining the ephedra ban will be formally released in a few weeks, and take effect 60 days later.