Judge Removes Ban on Sale of Ephedra
A federal judge has struck down the FDA ban on dietary supplements containing ephedra. FDA had pulled the weight-loss aid from the market more than a year ago after it was linked to dozens of deaths.
The judge ruled in favor of Nutraceutical Corp., a Utah supplement company that challenged the FDA’s ban. Nutraceutical claimed that ephedra “has been safely consumed” for hundreds of years, and that FDA was wrongly regulating ephedra as a drug and not as a food, according to the Associated Press.
Judge Tena Campbell agreed, saying federal law places more restrictive rules on FDA in determining whether to ban foods as opposed to drugs. The judge said the law requires 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 says the lawsuit had little to do with ephedra and more to do with forcing 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.
FDA spokeswoman Kimberly Rawlings says the agency is “evaluating the decision.” Campbell’s ruling sends the matter back to FDA “for further rulemaking consistent with the court’s opinion” and keeps the agency from enforcement action against the companies.