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(CBS/AP) Finding they pose an "unreasonable risk to the public health," the federal government on Tuesday said it will ban dietary supplements containing ephedra.
"Based on the best possible scientific evidence," Health and Human Services Secretary Tommy Thompson said government scientists had concluded ephedra-based supplements "are simply too risky to be used."
The government will soon publish a regulation stating "dietary supplements containing ephedra present an unreasonable risk to the public health," Thompson added.
Under the rule, which will become effective 60 days after its publication, it will be illegal to sell ephedra in the United States. The measure will also bar the importation of ephedra — often sold over the Internet — from abroad
FDA was issuing a consumer alert on ephedra products and was sending letters to 62 manufacturers, "telling them as soon as our rule takes effect they must stop selling these products," Thompson said, noting that the announcement of the ban was well-timed to caution Americans who were looking for ways to shed unwanted pounds gained over the holidays.
Food and Drug Administration commissioner Dr. Mark McClellan said Tuesday's decision was "the result of a long, hard road of seeking out all possible evidence on the benefits and risks of ephedra."
There are reports of more than 100 deaths and more than 16,000 other health problems being linked to the herb, also sometimes called epitonin, ma huang, sida cordifolia, pseudoephedrine and sinica.
California, Illinois and New York have banned the supplement, as the National Collegiate Athletic Association, the National Football League and the International Olympic Committee.
Health concerns about ephedra include the effect of the herb, which works like adrenaline, on the heart and nervous system. A RAND corporation study found risks include psychiatric and digestive problems. The General Accounting Office reported this summer that many of the health complaints liked to ephedra came from users under 30.
McClellan says ephedra raises the blood pressure and "stresses your system," potentially leading to a stroke, and possibly death.
Ephedra was thrust into the spotlight in February following the death of Baltimore Orioles minor league pitcher Steve Bechler, 23, who had taken a dietary supplement containing ephedra. The medical examiner said toxicology tests confirmed "significant amounts" of an over-the-counter supplement containing ephedra led to Bechler's heatstroke, along with other factors.
The ban is likely to be met with litigation from manufacturers. Executives of several companies that make ephedra-based products have said that studies have proven that they are safe when used properly.
"Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products," said Russell Schreck, chief executive officer of San Diego-based nutritional supplement-maker Metabolife International. "We make it quite clear on our label that the ephedra products are not to be sold or used by minors and that customers with certain pre-existing medical conditions should 'consult a physician before product use'."
But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems — the people most likely to be hurt by the product.
The supplement industry's Council for Responsible Nutrition said it didn't oppose a ban, noting that very few companies still make the stimulant.
"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.
Thompson said the ban will set a "new, significant legal precedent" by establishing a framework for evaluating the safety of other dietary supplements.
Compared to its work on medications, regulating supplements is nearly uncharted territory for the FDA. Companies making drugs have to demonstrate to the FDA that they are safe before selling them.
But the burden of proof is on federal regulators when it comes to supplements. Under a 1994 law under, the FDA can only prohibit the sale of a supplement if it "presents a significant or unreasonable risk of injury."
The FDA had proposed warning labels and dosage limits for dietary supplements with ephedra back in 1997, but then withdrew the proposal after complaints from the industry and members of Congress.
The government ban, one of the first involving a dietary supplement, comes after Thompson this summer urged Congress to rewrite the 1994 law, and to require manufacturers to acknowledge potential side effects.
To meet the narrow requirements of the 1994 law, the legal standard used to ban ephedra applies to an "adulterated" product that causes health problems even when ephedra is used as labeled, McClellan said. The finding will be based on research and reports of adverse effects.
CBS News legal analyst Andrew Cohen said the ban will likely help plaintiffs who are suing firms over deaths linked to ephedra, but "ultimately, it is going to be the science that drives these lawsuits and not necessarily when the government decided to ban Ephedra."
(CBS/AP) Finding they pose an "unreasonable risk to the public health," the federal government on Tuesday said it will ban dietary supplements containing ephedra.
"Based on the best possible scientific evidence," Health and Human Services Secretary Tommy Thompson said government scientists had concluded ephedra-based supplements "are simply too risky to be used."
The government will soon publish a regulation stating "dietary supplements containing ephedra present an unreasonable risk to the public health," Thompson added.
Under the rule, which will become effective 60 days after its publication, it will be illegal to sell ephedra in the United States. The measure will also bar the importation of ephedra — often sold over the Internet — from abroad
FDA was issuing a consumer alert on ephedra products and was sending letters to 62 manufacturers, "telling them as soon as our rule takes effect they must stop selling these products," Thompson said, noting that the announcement of the ban was well-timed to caution Americans who were looking for ways to shed unwanted pounds gained over the holidays.
Food and Drug Administration commissioner Dr. Mark McClellan said Tuesday's decision was "the result of a long, hard road of seeking out all possible evidence on the benefits and risks of ephedra."
There are reports of more than 100 deaths and more than 16,000 other health problems being linked to the herb, also sometimes called epitonin, ma huang, sida cordifolia, pseudoephedrine and sinica.
California, Illinois and New York have banned the supplement, as the National Collegiate Athletic Association, the National Football League and the International Olympic Committee.
Health concerns about ephedra include the effect of the herb, which works like adrenaline, on the heart and nervous system. A RAND corporation study found risks include psychiatric and digestive problems. The General Accounting Office reported this summer that many of the health complaints liked to ephedra came from users under 30.
McClellan says ephedra raises the blood pressure and "stresses your system," potentially leading to a stroke, and possibly death.
Ephedra was thrust into the spotlight in February following the death of Baltimore Orioles minor league pitcher Steve Bechler, 23, who had taken a dietary supplement containing ephedra. The medical examiner said toxicology tests confirmed "significant amounts" of an over-the-counter supplement containing ephedra led to Bechler's heatstroke, along with other factors.
The ban is likely to be met with litigation from manufacturers. Executives of several companies that make ephedra-based products have said that studies have proven that they are safe when used properly.
"Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products," said Russell Schreck, chief executive officer of San Diego-based nutritional supplement-maker Metabolife International. "We make it quite clear on our label that the ephedra products are not to be sold or used by minors and that customers with certain pre-existing medical conditions should 'consult a physician before product use'."
But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems — the people most likely to be hurt by the product.
The supplement industry's Council for Responsible Nutrition said it didn't oppose a ban, noting that very few companies still make the stimulant.
"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.
Thompson said the ban will set a "new, significant legal precedent" by establishing a framework for evaluating the safety of other dietary supplements.
Compared to its work on medications, regulating supplements is nearly uncharted territory for the FDA. Companies making drugs have to demonstrate to the FDA that they are safe before selling them.
But the burden of proof is on federal regulators when it comes to supplements. Under a 1994 law under, the FDA can only prohibit the sale of a supplement if it "presents a significant or unreasonable risk of injury."
The FDA had proposed warning labels and dosage limits for dietary supplements with ephedra back in 1997, but then withdrew the proposal after complaints from the industry and members of Congress.
The government ban, one of the first involving a dietary supplement, comes after Thompson this summer urged Congress to rewrite the 1994 law, and to require manufacturers to acknowledge potential side effects.
To meet the narrow requirements of the 1994 law, the legal standard used to ban ephedra applies to an "adulterated" product that causes health problems even when ephedra is used as labeled, McClellan said. The finding will be based on research and reports of adverse effects.
CBS News legal analyst Andrew Cohen said the ban will likely help plaintiffs who are suing firms over deaths linked to ephedra, but "ultimately, it is going to be the science that drives these lawsuits and not necessarily when the government decided to ban Ephedra."
