Pearson v. Shalala

Argued December 1, 1998 Consolidated with 98-5084 Opinion for the Court filed by Circuit Judge Silberman. Marketers of dietary supplements must, before including on their labels a claim characterizing the relationship of the supplement to a disease or health-related condition, submit the claim to the Food and Drug Administration for preapproval. The FDA authorizes a claim only if it finds ""significant scientific agreement"" among experts that the claim is supported by the available evidence. Appellants failed to persuade the FDA to authorize four such claims and sought relief in the district court, where their various constitutional and statutory challenges were rejected. We reverse.