Friday, April 15, 2005
A Park City, Utah, nutritional supplement manufacturer won its appeal against the FDA on Wednesday as a Federal Judge lifted a ban and sent the case back to the agency for revised rulemaking in accordance with the court’s decision.
Judge Tena Campbell ruled that no further enforcement of the FDA action can take place until the FDA reviews its current regulation.
Neutraceutical claimed in its lawsuit that the product “has been safely consumed” for hundreds of years and is not harmful at low ephedrine product levels. The FDA had decided to ban the supplement based on a reverse logic that the product had to be proven safe. The lawsuit effectively argued that it is the FDA’s task to prove that all dosage levels of ephedrine were unsafe. The court agreed with the manufacturer that this assumption could not be proven and, when taken in low doses, less than 10 mg, that agree with the product labeling, ephedrine was not shown to be an “unreasonable or significant risk.”
A group of private researchers claimed that ephedra was the most dangerous herbal product on the market. They collected data from poison control centers. It was not considered to be a drug and could not be controlled the way pharmaceuticals were, and was sold over the counter.
The death in 2003 of 23-year old Baltimore Orioles pitcher Steve Bechler brought a slew of negative reports on the product that foreshadowed a sharp drop in sales.