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 healthy people at risk
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.
Ephedra, the herbal form of the stimulant ephedrine, was used as a weight-loss supplement by millions of Americans. Reports of links to illness and sudden death resulted in a heated debate over its safety and led to the government ban on products containing ephedra.
Ephedra, which is also known by its Chinese name, ma huang, has been used as a medicinal herb for thousands of years in India and China to treat asthma, bronchitis and coughs.
In recent years, it was widely promoted in the United States as an appetite suppressant and weight-loss aid in over-the-counter products, such as Xenadrine. An estimated 12 million Americans used the supplement in 1999, according to researchers.
The two main chemicals in ephedra, ephedrine and pseudoephedrine, are stimulants that lead to the constriction of blood vessels.
In low doses, they act as decongestants, but in higher doses, they can raise blood pressure. The stimulant effect contributes to the herb’s effectiveness as an appetite suppressant but can lead to severe cardiovascular reactions. Consumption of ephedra can also result in a false-positive for amphetamines in urine tests.
A variety of studies have linked ephedra to cardiovascular problems, including high blood pressure, palpitations and heart attacks. Strokes, seizures, psychosis, insomnia and heatstroke have also been reported.
The supplement has been conclusively linked to cases of healthy adults suddenly falling ill or even dying after taking it. People with high blood pressure, heart disease, anxiety, glaucoma, enlarged prostate or hyperthyroidism are particularly at risk.
Researchers studying ephedra at the University of California, San Francisco, reported that people who take ephedra products are 200 times more likely to suffer a complication than are users of other herbal supplements.
Ephedra is responsible for 64 percent of all adverse reactions from the use of herbal supplements, although ephedra products make up less than 1 percent of all herbal supplements sold in the United States, researchers say. Public Citizen, a consumer advocacy group, says more than 150 deaths since 1995 have been linked to ephedra.
“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.
Ban called long overdue
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.
Critics called the ban long overdue.
Ephedra 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 in February. The Nutrition Business Journal estimates $500 million worth of ephedra was sold this year, down from $1.3 billion in 2002.
Overall, the dietary supplement industry is a $19 billion-a-year business with more than 1,000 companies producing products ranging from mainstream vitamins to herbs to controversial hormones and stimulants
Associated Press article, 12/03
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