District Judge Orders FDA to Reopen Ephedra Rulemaking

SALT LAKE CITY--A U.S. District Court judge declared the Food and Drug Administration's (FDA) ephedra ban unlawful and ordered the agency to reopen its ephedra rulemaking. The April 13 decision from Judge Tena Campbell, U.S. District Court, District of Utah, Central Division, stems from a lawsuit filed in May 2004 by Nutraceutical Corp. against the agency.

Nutraceutical Corp. is the parent company of Solaray, which manufactures an ephedra dietary supplement (EDS) with no more than 10 mg of naturally occurring ephedrine alkaloids per serving. In its original complaint, Nutraceutical alleged FDA failed to prove ephedra presented a significant or unreasonable risk of illness or injury at every dose level, and that the agency's use of a risk-benefit ratio in determining whether ephedra posed an unreasonable risk was in violation of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

In her decision, Campbell examined the process FDA took in releasing the final April 2004 ban on EDS, which dates back to the early 1990s. In making the final rule, FDA considered evidence on the pharmacology of ephedrine alkaloids, peer reviewed scientific literature, adverse event reports (AERs) and expert reviews of the scientific evidence. In issuing its ban, FDA concluded the benefits did not outweigh the risks of EDS and could not determine a safe intake level; therefore, all EDS were found to pose an unreasonable risk.

However, Campbell found the agency erred in using a risk-benefit analysis, noting "dietary supplements are not classified on the basis of a risk-benefit analysis … [and] FDA's requirement that EDS demonstrate a benefit is contrary to the clear intent of Congress." In addition, after a review of the scientific evidence, Campbell concluded it did not support the conclusion that a dose of 10 mg per day of EDS presented a significant or unreasonable risk. "A negative inference is different from the affirmative proof required," she wrote. "The statue requires an affirmative demonstration of 'significant or unreasonable' risk at a particular dose level to support a finding of adulteration."

Campbell ordered FDA to reopen its ephedra rulemaking and adopt a dose-dependent toxicity analysis, and enjoined FDA from taking any enforcement action against Solaray's sale of its EDS containing 10 mg or less of ephedrine alkaloids.

Jonathan Emord, the lead attorney for Nutraceutical, said the company was "delighted" with the judge's decision and believes it was the correct legal analysis. Emord noted the judge's ruling that FDA cannot take enforcement action against the Solaray EDS is company-specific, but other companies supplying EDS with similar or lower levels of ephedrine alkaloids could argue that their products are equivalent.

The National Nutritional Foods Association (NNFA) issued a member alert, noting that while the decision appears to permit sales of low-dose EDS, the issue is far from over. "It is important to remember this decision does not undo state laws, nor does it alter the ban established by FDA in the federal rule against dosages in excess of 10 milligrams," said David Seckman, NNFA's executive director and chief executive officer. "However, an important effect of this decision is that it does challenge FDA's risk/benefit safety analysis test, which most industry members agreed was inappropriate under DSHEA."

Kim Rawlings, a spokeswoman for FDA, told INSIDER the agency is currently evaluating the court's decision. FDA does have the option to appeal to the 10th Circuit Court of Appeals.

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