A United States District Court ruled yesterday that the Food and Drug Administration failed to prove that a dosage of 10 milligrams or less of ephedrine alkaloids presents an unreasonable risk of illness of injury when the agency banned all ephedrine-containing dietary supplements last year.
Court Overturns FDA Ban on Low-dose Ephedra Products
A United States District Court ruled yesterday that the Food and Drug Administration failed to prove that a dosage of 10 milligrams or less of ephedrine alkaloids presents an unreasonable risk of illness of injury when the agency banned all ephedrine-containing dietary supplements last year. The ruling has no effect on FDA's ban on higher dose products, such as products that were formerly sold to promote weight loss.
"This court has provided a rational opinion that the amount of an ingredient must be considered when evaluating the safety of that ingredient," commented Michael McGuffin, AHPA president. "This is not a new idea. This has been the way we evaluate the ingredients we add to foods, the way we evaluate drug safety, and now it will be the way we evaluate the safety of dietary supplements. And what the court has said is that FDA needs to pay better attention to this detail."
Judge Tena Campbell ruled on a case brought by Nutraceutical Corporation and Solaray, Inc., who had filed suit against FDA last May to allege that FDA's final rule on ephedrine alkaloids in dietary supplements was unlawful as applied to the company's whole herb low ephedrine level product. In its lawsuit Nutraceutical Corporation stated that in order for FDA to completely ban an ingredient it bears the burden of proving that an ingredient presents an unreasonable or significant risk at every dose level and as labeled. The complaint also argued that when Congress passed the Dietary Supplement Health and Education Act it did not intend for FDA's new authority to remove unsafe ingredients to be used to ban ingredients at every dosage level with no consideration of the use of warning labels.
Yesterday's District Court decision also concluded that FDA's use of a risk-benefit analysis in determining an unreasonable risk of ephedrine-containing dietary supplements was "improper." The Court explained that it is "contrary to the clear intent of Congress" to require marketers to demonstrate a benefit for their ephedra dietary supplements, as is implied by FDA's use of a risk-benefit analysis. In addition, FDA was instructed by the court to consider further rulemaking "consistent with this Order" and to refrain from taking any enforcement action against Nutraceutical Corporation for their sale of products containing less than 10 mg of ephedrine alkaloids. FDA was not, however, specifically instructed to refrain from acting against other brands that contain less than 10 mg of ephedrine while it reviews its current regulation.
This case is Nutraceutical Corporation and Solaray, Inc., Plaintiffs, vs. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Defendants, and can be downloaded at