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7:16 a.m. April 11, 2004
WASHINGTON – A government ban on sales of ephedra kicks in Monday unless a federal judge issues the dwindling industry a late reprieve.
The herbal stimulant, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths – including that of Baltimore Orioles pitcher Steve Bechler a year ago – and dozens more heart attacks and strokes.
After years of fighting manufacturers over ephedra's risks, the Food and Drug Administration announced in December it would ban sales of the amphetamine-like herb – the first such ban of a dietary supplement – and urged consumers to quit using it immediately.
Research shows the herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it's particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise.
Ephedra sales already had plummeted because of publicity about the risks, which peaked after the ephedra-related death of Bechler. Three states – New York, Illinois and California – have prohibited the stimulant on their own.
The nationwide ban was set to go into effect Monday.
Last month, however, the maker of the Stacker 2 ephedra brand filed a lawsuit seeking to block the ban. NVE Pharmaceuticals of New Jersey contends the FDA lacks proof that ephedra is dangerous if used as directed. The suit argues that the agency simply reacted to the emotion of high-profile deaths like Bechler's.
Medications must be proven safe and effective before they're allowed to be sold, but federal law allows dietary supplements to be sold without any such proof. To curb a dangerous supplement, the law requires the FDA to show it poses a significant health threat, which is a high standard to meet.
The FDA argued that it amassed sufficient proof of ephedra's dangers from thousands of side-effect reports and scientific studies that proved the herb's stimulant-like effects inside the body.
A federal judge was scheduled to rule Monday on the ephedra maker's request for a temporary restraining order.
WASHINGTON – A government ban on sales of ephedra kicks in Monday unless a federal judge issues the dwindling industry a late reprieve.
The herbal stimulant, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths – including that of Baltimore Orioles pitcher Steve Bechler a year ago – and dozens more heart attacks and strokes.
After years of fighting manufacturers over ephedra's risks, the Food and Drug Administration announced in December it would ban sales of the amphetamine-like herb – the first such ban of a dietary supplement – and urged consumers to quit using it immediately.
Research shows the herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it's particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise.
Ephedra sales already had plummeted because of publicity about the risks, which peaked after the ephedra-related death of Bechler. Three states – New York, Illinois and California – have prohibited the stimulant on their own.
The nationwide ban was set to go into effect Monday.
Last month, however, the maker of the Stacker 2 ephedra brand filed a lawsuit seeking to block the ban. NVE Pharmaceuticals of New Jersey contends the FDA lacks proof that ephedra is dangerous if used as directed. The suit argues that the agency simply reacted to the emotion of high-profile deaths like Bechler's.
Medications must be proven safe and effective before they're allowed to be sold, but federal law allows dietary supplements to be sold without any such proof. To curb a dangerous supplement, the law requires the FDA to show it poses a significant health threat, which is a high standard to meet.
The FDA argued that it amassed sufficient proof of ephedra's dangers from thousands of side-effect reports and scientific studies that proved the herb's stimulant-like effects inside the body.
A federal judge was scheduled to rule Monday on the ephedra maker's request for a temporary restraining order.
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