I think they may have a chance. See the last paragraph.
http://1010wins.com/topstories/winstopstories_story_103075308.html
Apr 12, 2004 11:12 am US/Eastern
(1010 WINS) (NEWARK) The New Jersey manufacturer of a popular diet supplement hoped to head off a nationwide ban on the herbal stimulant ephedra Monday, heading to federal court to argue the main ingredient in its product is safe if used as directed.
Ephedra, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths and dozens more heart attacks and strokes. It was to be banned Monday under a dictate from the U.S. Food and Drug Administration.
NVE Pharmaceuticals Inc. of Newton, the manufacturer of the supplement Stacker 2, was expected to ask U.S. District Judge Joel Pisano for a temporary restraining order that would stay the ban pending further scientific tests.
NVE's lawsuit, filed last month, argues the FDA lacks proof ephedra is dangerous and that agency simply reacted to the emotion of high-profile deaths like that of Baltimore Orioles pitcher Steve Bechler a year ago.
The FDA announced in December it would ban sales of the amphetamine-like herb -- the first such ban of a dietary supplement -- and urged consumers to stop 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 Bechler's death. Three states -- New York, Illinois and California -- have prohibited the stimulant on their own.
Medications must be proved 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.