A Utah court ruling lifting an FDA ban on low-dose ephedra applies nationwide and cannot be interpreted by the agency as pertaining only to the district where the decision was issued, according to Jonathan Emord of the Washington, D.C. law firm Emord & Associates.

"The so-called 'non-acquiescence' doctrine does not apply here because this is not an adjudicatory case," Emord said during a May 6 call on the court decision. The law firm represented the plaintiff Nutraceutical Corp. in the case.

The Utah federal court decision April 13 overturned FDA's ban of ephedra products containing less than 10 mg of the ingredient and granted Nutraceutical Corp. the right to sell its ephedra-containing supplement (¹ Also see "Utah Court Overturns Ephedra Ban For Low-Dose Products" - Pink Sheet, 18 April, 2005., p. 5).

FDA could interpret the decision as applying only in the Utah district where the court is located (² Also see "Ephedra Ruling Does Not Preclude FDA Legal Action In New District – Lawyers" - Pink Sheet, 25 April, 2005., p. 15). The agency used the strategy in the early 1990s when it sought legal action in Boston against a company selling black currant oil supplements, even though a Chicago federal court ruled the company could sell the product.

However, because the current case is an appeal of FDA rulemaking, that option is not available to the agency, Emord maintained. The court's decision "applies to the rule itself, and thus, to its applicability in any context anywhere within the U.S."

The case was filed in Utah because of the location of Nutraceutical's headquarters - a detail that does not interfere with the ruling's nationwide applicability, he added.

The agency's options are to either appeal the case or provide dose-specific studies on ephedra, he said, adding that if FDA chooses to appeal, it has 60 days from the April 13 ruling to do so.

Although the ruling allows Nutraceutical to sell its product, Emord cautioned other firms against following suit. "The decision is not a green light for other companies to sell ephedrine alkaloids at any dose level," he said, because FDA may remove from the market any product that has been deemed unsafe.

"FDA does not lack the power to enforce - it just has to do it based on proof," he concluded.

FDA Must Recognize Ephedra Ruling’s Nationwide Implications – Emord

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