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Matter goes back to FDA 'for further rulemaking'

SALT LAKE CITY -- A federal judge Thursday struck down the FDA ban on ephedra, the once-popular weight-loss aid that was yanked from the market after it was linked to dozens of deaths -- including that of Baltimore Orioles pitching prospect Steve Bechler.

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."

Bechler was 23 when he died after a spring training workout on
Feb. 17, 2003, sent his body temperature to 108 degrees.

The medical examiner who performed the autopsy said the pitcher
had a history of borderline high blood pressure and an abnormal
liver. The medical examiner also said that ephedrine -- the active
substance in the plant ephedra -- played a major role in the pitcher's death.

In an effort to quickly shed the weight he gained during the
offseason, Bechler took over-the-counter diet pills containing
ephedra. The drug had been banned by the NCAA, NFL and
International Olympic Committee, but not by Major League Baseball.

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. The federal government banned it one year ago.

Campbell's ruling 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.