Court Green-Lights Ephedra Ban

Ephedra banned. AP

A federal judge allowed a nationwide ban on dietary supplements containing ephedra to take effect Monday.

U.S. District Judge Joel Pisano refused to grant a temporary restraining order sought by two ephedra manufacturers that would have prevented the U.S. Food and Drug Administration from banning the products.

Pisano's decision does not effect medicines containing ephedra, such as prescription or over-the-coutner cold remedies.

The New Jersey manufacturer of a popular diet supplement had hoped to head off the nationwide ban on the herbal stimulant, arguing the main ingredient in its product is safe if used as directed.

NVE Pharmaceuticals Inc. of Newton, which makes the supplement Stacker 2, had asked for the temporary restraining order pending further scientific tests.

Ephedra, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths and dozens more heart attacks and strokes.

On Monday, a second company had been allowed to join the motion for the restraining order. The National Institute for Clinical Weight Loss is an Atlanta manufacturer of a product called Thermalean.

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 Baltimore Orioles pitcher Steve Bechler during spring training last year. Three states — New York, Illinois and California — have prohibited the stimulant on their own.

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.
  • Dan Collins

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