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Judge Strikes Down FDA Ban on Ephedra
By MARK THIESSEN, AP
AP
Nutraceutical said it is too soon to say whether it will put the product back on shelves.
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SALT LAKE CITY (April 15) - A federal judge has struck down the FDA ban on supplements containing ephedra, a weight-loss aid linked to dozens of deaths, but it's too early to tell whether the product will be back in stores anytime soon.
The judge Thursday ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's year-old ban. Nutraceutical claimed that ephedra has been safely consumed for hundreds of years.
Research shows that the amphetamine-like herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. Among the deaths linked to the substance was that of Baltimore Orioles pitching prospect Steve Bechler, who collapsed and died during spring training two years ago.
The judge's decision was seen by some anti-ephedra advocates as falling short of an outright reversal of the ban, though a Nutraceutical lawyer declared flatly, "the ban is gone.'' The company said it is too soon to say whether it will put the product back on shelves.
Industry groups said supplements that included ephedra were once used by 12 million people.
Judge Tena Campbell's order prevents the FDA from stopping Nutraceutical from selling its product and sent the case back to the FDA for a determination of what are safe and dangerous levels of ephedrine.
The FDA was evaluating the ruling, but Health and Human Services spokesman William Pierce said the agency "made the right decision from the standpoint of science and our statutory authority. This is exactly when the dietary supplement law should apply.''
Health officials and Justice Department lawyers are looking at the ruling to determine the next step, Pierce said.
Campbell agreed with Nutraceutical that ephedra was wrongly being regulated by the FDA as a drug and not a food. She said a 1994 federal dietary supplement law places more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs. The judge said the law requires the FDA to prove that a dietary supplement is harmful, rather than having the manufacturer prove it is safe, as is required with drugs.
"The (FDA's) statement that a safe level cannot be determined is simply not sufficient to meet the government's burden,'' Campbell wrote.
Nutraceutical President Bruce Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it.
"This is a great affirmation for the system, that the court goes back and says, 'This is Congress' intent,' and follow it,'' he said.
Ephedra opponents said the language in the order applies only to a very specific, lower-dosage segment of the market. The ruling's final page prohibits the FDA from enforcing the ban on Nutraceutical's supplements containing 10 milligrams or less of ephedra.
Ten milligrams per day was the dosage of Nutraceutical's products.
"No one - not the FDA, the supplement industry, nor the public - has been satisfied by how ephedra has been regulated,'' said Sen. Orrin Hatch, R-Utah, who helped write the 1994 law that also deregulated the supplement industry. "Millions of people have used the product with satisfaction, but there is no doubt the product has had some serious problems,'' he said.
Illinois Democratic U.S. Sen. Dick Durbin, a frequent ephedra critic who worked for the ban, said the ruling underlined the need for "a mandatory and uniform system of reporting adverse health events that result from use of certain dietary supplements.''
By MARK THIESSEN, AP
AP
Nutraceutical said it is too soon to say whether it will put the product back on shelves.
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Talk About It: Post | Chat
SALT LAKE CITY (April 15) - A federal judge has struck down the FDA ban on supplements containing ephedra, a weight-loss aid linked to dozens of deaths, but it's too early to tell whether the product will be back in stores anytime soon.
The judge Thursday ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's year-old ban. Nutraceutical claimed that ephedra has been safely consumed for hundreds of years.
Research shows that the amphetamine-like herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. Among the deaths linked to the substance was that of Baltimore Orioles pitching prospect Steve Bechler, who collapsed and died during spring training two years ago.
The judge's decision was seen by some anti-ephedra advocates as falling short of an outright reversal of the ban, though a Nutraceutical lawyer declared flatly, "the ban is gone.'' The company said it is too soon to say whether it will put the product back on shelves.
Industry groups said supplements that included ephedra were once used by 12 million people.
Judge Tena Campbell's order prevents the FDA from stopping Nutraceutical from selling its product and sent the case back to the FDA for a determination of what are safe and dangerous levels of ephedrine.
The FDA was evaluating the ruling, but Health and Human Services spokesman William Pierce said the agency "made the right decision from the standpoint of science and our statutory authority. This is exactly when the dietary supplement law should apply.''
Health officials and Justice Department lawyers are looking at the ruling to determine the next step, Pierce said.
Campbell agreed with Nutraceutical that ephedra was wrongly being regulated by the FDA as a drug and not a food. She said a 1994 federal dietary supplement law places more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs. The judge said the law requires the FDA to prove that a dietary supplement is harmful, rather than having the manufacturer prove it is safe, as is required with drugs.
"The (FDA's) statement that a safe level cannot be determined is simply not sufficient to meet the government's burden,'' Campbell wrote.
Nutraceutical President Bruce Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it.
"This is a great affirmation for the system, that the court goes back and says, 'This is Congress' intent,' and follow it,'' he said.
Ephedra opponents said the language in the order applies only to a very specific, lower-dosage segment of the market. The ruling's final page prohibits the FDA from enforcing the ban on Nutraceutical's supplements containing 10 milligrams or less of ephedra.
Ten milligrams per day was the dosage of Nutraceutical's products.
"No one - not the FDA, the supplement industry, nor the public - has been satisfied by how ephedra has been regulated,'' said Sen. Orrin Hatch, R-Utah, who helped write the 1994 law that also deregulated the supplement industry. "Millions of people have used the product with satisfaction, but there is no doubt the product has had some serious problems,'' he said.
Illinois Democratic U.S. Sen. Dick Durbin, a frequent ephedra critic who worked for the ban, said the ruling underlined the need for "a mandatory and uniform system of reporting adverse health events that result from use of certain dietary supplements.''
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