In a decision on precedural issues, the Third Circuit Federal Court of Appeals has ruled on the scope of federal court review of FDA regulations imposed on dietary supplements regulated under DSHEA.
The statute refers to review on a de novo basis. On its face, this would appear to indicate that courts would have sweeping powers to review the propriety of FDA determinations. However, the Third Circuit has ruled that the review of FDA’s ephedra ban is limited and, as with other administrative determinations, entitled to deference.
The result strongly suggests that it is unlikely that the lower court will strike down the FDA’s ephedra ban. Law.com article – 3rd Circuit Limits Appeal of FDA Ban of Ephedrine.
Opinion: NVE Inc. v. Dept. of Health and Human Services, No. 04-4481 (Feb. 7, 2006).
About Joel Rothman
Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.
