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.