Reprieve for ephedra hinges on judge

ASSOCIATED PRESS

A government ban on sales of ephedra kicks in today unless a federal judge issues the dwindling industry a late reprieve.

The herbal stimulant, once popular for weight loss and bodybuilding, has been linked to 155 deaths 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 amphetaminelike 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 is 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 a year ago. Three states — New York, Illinois and California — have prohibited the stimulant.

The nationwide ban was set to go into effect today.

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 lawsuit argues that the agency simply reacted to the emotion of high-profile deaths such as Mr. Bechler’s.

Medications must be proved safe and effective before they are 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 stimulantlike effects inside the body.

A federal judge was scheduled to rule today on the ephedra maker’s request for a temporary restraining order.