Natural Foods Merchandiser

Ephedra ban not truly lifted

When it comes to ephedra, what happens in Utah stays in Utah. In fact, what happens for Nutraceutical is only for Nutraceutical.

On April 13, a district court in Utah ruled for Nutraceutical Corp. and Solaray Inc. in a case challenging the validity of the U.S. Food and Drug Administration's ban on ephedra. Tena Campbell, the district judge in the case, sent the ban back to FDA for further rulemaking consistent with her order, and blocked all action by FDA against Nutraceutical and Solaray for the sale of "a dietary supplement containing 10 mg or less of ephedrine alkaloids per daily dose."

Justin Prochnow, an attorney with Greenberg Traurig LLP, said the specific effect of the ruling pertains only to Nutraceutical. "This was a U.S. District Court in Utah case. The reality is that district court cases really only have precedent on that particular case. They're not dispositive on even other judges in that same district. ? If the 10th Circuit Court of Appeals affirmed the decision then it would have precedence over all the cases in the 10th Circuit, but when an individual district court judge makes a ruling you can look at it as influential in what the court might decide but it doesn't control the other cases."

However, the case may still have implications for the industry. "With respect to the ruling itself, we view it as a good ruling for the supplement community as a whole," Prochnow said. "It says FDA basically tried to shift the burden and instead of FDA having to prove that a product was unreasonably dangerous or harmful, they made the manufacturers prove that it was safe, and that was an unfair shifting of the burden. Manufacturers don't have to prove the safety, the FDA has to prove the harmful nature of it." The Dietary Supplement Health and Education Act makes that so by classifying supplements as foods.

As for FDA's "further rulemaking," Prochnow said the agency might still have the necessary evidence to reinstate the full ban. "All the judge said was that the way they went about it is wrong and she sent it back. All the FDA really has to do is go back and do it the right way and provide evidence that it is harmful and they can still ban it. And my guess is that's probably going to happen in the long run."

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