I have some Ephedra (Ma Huang tincture actually) that I bought a while ago. I never figured out what the big hubbub was about, herbal remedies are so mild compared to drugs sold by Pfizer and other Big Pharma companies. But then, I don't really think any herbal medicine should be banned by governmental fiat, unless cane sugar, caffeine and alcohol are also made illegal.
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.TribThe 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.
Industry groups said supplements that included ephedra were once used by 12 million people. Last year's ban of ephedra was the first such ban of a dietary supplement.
Research shows ephedra -- an amphetamine-like herb -- can speed heart rate and constrict blood vessels even in seemingly healthy people, but it is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. ...
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.
The FDA was evaluating the ruling, but Health and Human Services spokesman William Pierce said the agency “made the right decision from the standpoint of science and our statutory authority. This is exactly when the dietary supplement law should apply.”
...
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 having the manufacturer prove it is safe, as is required with drugs.“The (FDA's) statement that a safe level cannot be determined is simply not sufficient to meet the government's burden,” Campbell wrote.
{Health}
