...um...make that health.
Quote of note:
U.S. District Judge Tena Campbell agreed with Nutraceutical that ephedra was wrongly being regulated by the FDA as a drug and not a food. She said a 1994 federal dietary supplement 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 requiring the manufacturer to prove it is safe, as is required with drugs.
Damn. I was right the first time.
Oh, I am so confused...
Judge Rules Against FDA Ban on Ephedra
Product More Food Than Drug, She Says
By Mark Thiessen
Associated Press
Friday, April 15, 2005; Page E05
SALT LAKE CITY, April 14 -- 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 one year ago 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 International Corp. claimed that ephedra has been safely consumed for hundreds of years.
Industry groups said supplements that included ephedra were once used by 12 million people. Last year's ban of ephedra was the first such outlawing of a dietary supplement.
Research shows that ephedra -- an amphetamine-like herb -- can speed heart rate and constrict blood vessels even in seemingly healthy people but that it is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. Among the deaths linked to the substance was that of Baltimore Orioles pitching prospect Steve Bechler, who collapsed and died during spring training two years ago.
The judge's decision was seen by some anti-ephedra advocates as falling short of an outright reversal of the ban, though a Nutraceutical lawyer declared flatly, "The ban is gone." The company said it is too soon to say whether it will put the product back on shelves.