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Judge Strikes Down FDA Ban on Ephedra
- Thread starter redspy
- Start date
Here's an editorial on this topic from the NY Times
EDITORIAL
Time to Ban Ephedra
The recent disappointing federal court decision that the Food and Drug Administration lacks the authority to issue a blanket ban on ephedra, a dangerous herbal supplement, is a clarion call to the Bush administration and Congress to change the 1994 law on dietary supplements. The law should be amended to give health regulators clear and unambiguous power to take harmful products off the market, and to require supplement makers to report any adverse reactions.
Ephedra, an adrenalinelike stimulant promoted as a weight-loss aid and energy booster, excites the central nervous system and speeds metabolism, increasing the rate at which a person burns calories. But it can also drive up blood pressure and stress the circulatory system. It has been linked to heart attacks and strokes and dozens of deaths.
A year ago, the F.D.A. imposed a ban on all products containing ephedra on the grounds that it poses "an unreasonable risk of illness or injury." Overturning that decision, Judge Tena Campbell of the Federal District Court in Utah said the agency had erred in using a cost-benefit analysis, weighing the supplement's substantial risks against its dubious benefits. The judge also said that the 1994 law required dose-specific findings to justify a ban. The judge concluded that the agency's assertion that it was impossible to establish a level of safe use failed to meet the burden of proving that the supplement poses an unreasonable risk when taken in the 10-milligram doses contained in the product at issue.
The ruling leaves the ephedra ban intact for products containing doses above 10 milligrams. But by dismissing the F.D.A.'s voluminous evidence of potential danger, the court set an unrealistically high threshold for agency action, and that could undermine the ban even for higher-dose ephedra products.
Under current law, supplement manufacturers may sell products without first having to establish their safety or efficacy. But after the F.D.A. found a significant hazard, it was only reasonable for the agency to weigh ephedra's lack of any real health benefits in deciding on a regulatory response.
The agency should appeal, but the White House and Congress should not let the F.D.A. do all the heavy lifting. The decision is their cue to move promptly to enact overdue legal revisions that will significantly strengthen the agency's power to monitor and police the supplement industry.
EDITORIAL
Time to Ban Ephedra
The recent disappointing federal court decision that the Food and Drug Administration lacks the authority to issue a blanket ban on ephedra, a dangerous herbal supplement, is a clarion call to the Bush administration and Congress to change the 1994 law on dietary supplements. The law should be amended to give health regulators clear and unambiguous power to take harmful products off the market, and to require supplement makers to report any adverse reactions.
Ephedra, an adrenalinelike stimulant promoted as a weight-loss aid and energy booster, excites the central nervous system and speeds metabolism, increasing the rate at which a person burns calories. But it can also drive up blood pressure and stress the circulatory system. It has been linked to heart attacks and strokes and dozens of deaths.
A year ago, the F.D.A. imposed a ban on all products containing ephedra on the grounds that it poses "an unreasonable risk of illness or injury." Overturning that decision, Judge Tena Campbell of the Federal District Court in Utah said the agency had erred in using a cost-benefit analysis, weighing the supplement's substantial risks against its dubious benefits. The judge also said that the 1994 law required dose-specific findings to justify a ban. The judge concluded that the agency's assertion that it was impossible to establish a level of safe use failed to meet the burden of proving that the supplement poses an unreasonable risk when taken in the 10-milligram doses contained in the product at issue.
The ruling leaves the ephedra ban intact for products containing doses above 10 milligrams. But by dismissing the F.D.A.'s voluminous evidence of potential danger, the court set an unrealistically high threshold for agency action, and that could undermine the ban even for higher-dose ephedra products.
Under current law, supplement manufacturers may sell products without first having to establish their safety or efficacy. But after the F.D.A. found a significant hazard, it was only reasonable for the agency to weigh ephedra's lack of any real health benefits in deciding on a regulatory response.
The agency should appeal, but the White House and Congress should not let the F.D.A. do all the heavy lifting. The decision is their cue to move promptly to enact overdue legal revisions that will significantly strengthen the agency's power to monitor and police the supplement industry.
I can't believe a liberal paper like the NYT would be so anti-Ephedra.
NYT is probably being paid by Weight Watchers and Jenny Craig to speak out against ephedra - more money for them.
