Ephedra ban lifted?

[Guest guest]

This just in on the wires (I don't have a link, it was forwarded to me,

but it is on all news sites at this point):

 

Judge Strikes Down FDA Ban on Ephedra

 

Thursday, April 14, 2005

SALT LAKE CITY - A federal judge Thursday struck down

the FDA ban on supplements containing ephedra, the

once-popular weight-loss aid that was yanked from the

market after it was linked to dozens of deaths.

 

The judge ruled in favor of a Utah supplement company

that challenged the Food and Drug Administration's

ban. Nutraceutical claimed that ephedra " has been

safely consumed " for hundreds of years, and that

ephedra was wrongly being regulated by the FDA as a

drug and not a food.

 

Judge Tena Campbell agreed, saying federal law places

more restrictive rules on the FDA in determining

whether to ban foods as opposed to drugs. The judge

said the law requires the FDA to prove that a dietary

supplement is harmful, rather than having the

manufacturer prove it is safe, as is required with

drugs.

 

Nutraceutical President Bruce Hough said the lawsuit

had little to do with ephedra and more to do with

forcing the FDA to follow the rules Congress set down

for it.

 

He said Nutraceutical interprets the ruling to mean

that the company is allowed to start selling ephedra

supplements again, but added that it is too soon to

say whether it will put the products back on the

market.

 

" This is a great affirmation for the system, that the

court goes back and says, 'This is Congress' intent,'

and follow it, " he said.

 

FDA spokeswoman Kimberly Rawlings said the agency is

" evaluating the decision. "

 

Supplements that included ephedra were once widely

used for weight loss and bodybuilding, with industry

groups claiming at least 12 million users. The

amphetamine-like stimulant, which speeds the heart

rate and constricts blood vessels, has been linked to

155 deaths, including that of Baltimore Orioles

pitching prospect Steve Bechler. The federal

government banned it one year ago.

 

Campbell's sends the matter back to the FDA " for

further rulemaking consistent with the court's

opinion " and keeps the agency from enforcement action

against the companies.