NEWARK, N.J. (AP) - The manufacturer of a popular diet supplement containing ephedra urged a judge to block a nationwide ban on the herbal stimulant that was taking effect Monday, arguing that there is no proof it is dangerous if used properly.
The herbal stimulant, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths and dozens more heart attacks and strokes.
In a lawsuit filed last month, lawyers for NVE Pharmaceuticals Inc. of Newton, manufacturer of the supplement Stacker 2, asked for a temporary restraining order blocking the ban on ephedra pending further scientific tests. U.S. District Judge Joel Pisano was to hold a hearing on the request Monday morning.
After years of fighting manufacturers over ephedra's risks, the Food and Drug Administration announced in December that it was banning sales of the amphetamine-like herb - the first such ban of a dietary supplement. The ban takes effect Monday.
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.
Unlike medications, which must be proven safe and effective before they're allowed to be sold, federal law allows dietary supplements to be marketed without any such proof. To curb a supplement, the law requires the FDA to show it poses a significant health threat.
NVE Pharmaceuticals maintains that the FDA lacks proof that ephedra is dangerous if used as directed, and its lawsuit argues that the agency simply reacted to the emotion of high-profile deaths like Baltimore Orioles pitcher Steve Bechler.
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.
Ephedra sales already had plummeted because of publicity about the risks, which peaked after Bechler's ephedra-related death a year ago. Three states - New York, Illinois and California - prohibited the stimulant on their own.
