DrugBuyers.Com: Last Appeals for Ephedra Denied

The FDA has been advocating such a total ban, two companies appealed, and the two last appeals were denied.
This article underscores the regulation that "supplements" don't have to be tested for safety before they can be sold in supplement/health food stores.
Supplements are not held to the same standards of alleged safety that prescription meds are through testing and clinical trials.

Judge Allows Nationwide Ephedra Ban

Updated 2:41 PM ET April 12, 2004

By WAYNE PARRY

NEWARK, N.J. (AP) - A federal judge allowed a nationwide ban on dietary supplements containing ephedra to take effect Monday, turning aside a request by two supplement makers.

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

NVE Pharmaceuticals Inc. of Newton, the manufacturer of the popular diet supplement Stacker 2, 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.

The company had asked for the temporary restraining order pending further scientific tests. On Monday, a second company had been allowed to join the motion _ the National Institute for Clinical Weight Loss, manufacturer of a product called Thermalean.

Ephedra, once hugely 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 FDA 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 correctly. Its lawsuit argued that the agency simply reacted to the emotion of high-profile deaths like that of 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.

Reuters 4/12/2004