Hi-Tech Pharmaceuticals, Inc. v. Crawford

We consider in this appeal whether 21 U.S.C. § 342(f)(l)’s de novo provision impacts the evidentiary weight to be given to Food and Drug Administration (FDA) regulations. Section 342(f)(l)’s de novo provision provides that a reviewing court shall decide any issue in an adulterated dietary supplement proceeding de novo. The issue is whether a FDA regulation which declares that dietary supplements containing ephedrine alkaloids are adulterated is sufficient proof of adulteration, or is more evidence needed under § 342(f)(l)’s de novo provision? Because FDA regulations have the force and effect…