April 12, 2004 | 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.

yep, they actually ruled on it 60 days ago, but had to hear the motions today.

Another knee jerk reaction to a "problem" that never really existed. 155 deaths over the past 10-15 years - those numbers pale in comparison to tobacco, alcohol, aspirin, and obesity.

I wonder how many of these deaths were due to usage that was done as directed on the label? How many of these individuals consulted their doctor first? How many parents talked with their kids to see what they were doing/taking? The ignorant masses are once again "protected" from themselves since they can't read a label

Oh well. What's done is done. The idiots are just doing this to make it seem that the government is doing something and so the pharmaceutical companies can make more money. How do they make more money? Well, Vasopro sales are skyrocketing. Ephedrine HCl is still on the market and available OTC. Homemade ECA stacks will still be available and now you have those same people that can't read a label mixing this stuff on their own.

Idiot: Hmmm......was that 20 mg of Ephedrine HCl or 200 mg? Well, 20 doesn't make sense. It must be 200. More is always better right?

<Takes 200 mg of Ephedrine and waits for heart attack to happen>

Homemade ECA stacks will still be available and now you have those same people that can't read a label mixing this stuff on their own.

Idiot: Hmmm......was that 20 mg of Ephedrine HCl or 200 mg? Well, 20 doesn't make sense. It must be 200. More is always better right?

<Takes 200 mg of Ephedrine and waits for heart attack to happen>
what's so bad about that? if all the idiots kill themselves off it might help out in the long run.

So is this ban just in America?.

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.
Kinda like Thalidomide. It is now making a comeback for use with AIDS. Always on the watch for the people..... http://www.sciencedaily.com/releases/1998/06/980630081514.htm

F*ck the FDA.

what's so bad about that? if all the idiots kill themselves off it might help out in the long run.

Hmmmm.........in that light, I guess it won't be too bad ;)

I have a real problem with the Ephedra ban. It is funny that in the article they mention Steve Belcher. I was reading an article on bodybuilding.com about him. They quoted the coronor's report as saying "Ephedra did not cause or contribute to the death of Steve Belcher" (Looking for the link as we speak).

What really bugs me is that "In 2001, over 15,000 people died from taking aspirin... In any given year, there has been no more than 10 possible deaths from Ephedra in a year."

Yet Aspirin is still available. This is because the benefits far outweigh the risk associated with it. The same is true with Ephedra. It is projected that obesity kills 300,000 people a year. Yet no more than 10 people have died a year because of Ephedra. Go Figure (Shrugs)

Yet Aspirin is still available. This is because the benefits far outweigh the risk associated with it. The same is true with Ephedra. It is projected that obesity kills 300,000 people a year. Yet no more than 10 people have died a year because of Ephedra. Go Figure (Shrugs)

Tell me what Aspirin is and who makes it. Tell me what ephedra(the source) is and who makes it....The answer to this mess is who makes it.


Edit:// I wonder how many people die from a head ache every year? Good point with the obesity figure :nod: .