Ephedra ban puts supplement industry on notice
Wednesday, December 31, 2003
WASHINGTON (AP) -- The pending ban on the herb ephedra sends a signal to a large and loosely regulated industry that the government is willing to crack down on risky dietary supplements.
But unless current law is changed, such bans may not occur very often.
Federal law makes it very difficult for health officials to curb sales of dietary supplements that seem dangerous, far harder than it is to curb risky drugs, says Health and Human Services Secretary Tommy Thompson, who wants Congress to change that.
"We have a tremendous burden of proof in order to take supplements off of the market," Thompson said Tuesday in announcing the ban on a supplement that has been linked to 155 deaths and dozens of heart attacks and strokes. But he stressed that "we crossed the t's and dotted the i's" so that the ephedra ban should stand up in court if challenged.
The ban, which could take effect by March, comes eight years after the Food and Drug Administration first began receiving reports that the herb used for weight loss and bodybuilding could be dangerous.
While federal paperwork requirements will leave the amphetamine-like stimulant on the market for a few more months, Thompson and the FDA urged consumers to stop taking ephedra-containing supplements immediately.
"Ephedra raises your blood pressure and stresses your system," leading to heart attacks, strokes and death, FDA Commissioner Mark McClellan said. "There are far better, safer ways to get in shape."
Even seemingly healthy people who use the recommended doses are at risk, although ephedra is particularly dangerous for anyone with heart disease or high blood pressure or who engages in strenuous exercise, he said.
While the ban isn't immediate, the FDA on Tuesday informed 62 companies that make or sell ephedra that "we intend to shut you down," McClellan said. "Any responsible manufacturer and retailer should stop selling these products as soon as possible."
Ephedra makers insisted their products were safe when used correctly, but didn't say whether they would 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 International, a major ephedra marketer, said.
"Cold medicine kills more people a year than ephedra does," asserted Robert MacKenzie, owner of MaxOutBody.com, an Internet supplement seller that has sold $300,000 worth of ephedra since July. MacKenzie said he was looking for ephedra-free alternatives to sell once the ban begins.
Ephedra, also called ma huang, has divided the supplement industry, and an industry trade association, the Washington-based Council for Responsible Nutrition, said it had no plans to oppose the ephedra ban.
The final regulation outlining the ban will be released formally in a few weeks, and take effect 60 days later.
Wednesday, December 31, 2003
WASHINGTON (AP) -- The pending ban on the herb ephedra sends a signal to a large and loosely regulated industry that the government is willing to crack down on risky dietary supplements.
But unless current law is changed, such bans may not occur very often.
Federal law makes it very difficult for health officials to curb sales of dietary supplements that seem dangerous, far harder than it is to curb risky drugs, says Health and Human Services Secretary Tommy Thompson, who wants Congress to change that.
"We have a tremendous burden of proof in order to take supplements off of the market," Thompson said Tuesday in announcing the ban on a supplement that has been linked to 155 deaths and dozens of heart attacks and strokes. But he stressed that "we crossed the t's and dotted the i's" so that the ephedra ban should stand up in court if challenged.
The ban, which could take effect by March, comes eight years after the Food and Drug Administration first began receiving reports that the herb used for weight loss and bodybuilding could be dangerous.
While federal paperwork requirements will leave the amphetamine-like stimulant on the market for a few more months, Thompson and the FDA urged consumers to stop taking ephedra-containing supplements immediately.
"Ephedra raises your blood pressure and stresses your system," leading to heart attacks, strokes and death, FDA Commissioner Mark McClellan said. "There are far better, safer ways to get in shape."
Even seemingly healthy people who use the recommended doses are at risk, although ephedra is particularly dangerous for anyone with heart disease or high blood pressure or who engages in strenuous exercise, he said.
While the ban isn't immediate, the FDA on Tuesday informed 62 companies that make or sell ephedra that "we intend to shut you down," McClellan said. "Any responsible manufacturer and retailer should stop selling these products as soon as possible."
Ephedra makers insisted their products were safe when used correctly, but didn't say whether they would 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 International, a major ephedra marketer, said.
"Cold medicine kills more people a year than ephedra does," asserted Robert MacKenzie, owner of MaxOutBody.com, an Internet supplement seller that has sold $300,000 worth of ephedra since July. MacKenzie said he was looking for ephedra-free alternatives to sell once the ban begins.
Ephedra, also called ma huang, has divided the supplement industry, and an industry trade association, the Washington-based Council for Responsible Nutrition, said it had no plans to oppose the ephedra ban.
The final regulation outlining the ban will be released formally in a few weeks, and take effect 60 days later.
