Pearson v. Shalala : The Beginning of the End for FDA Speech Suppression

Abstract

On January 15, 1999, the Food and Drug Administration (FDA) regulations for evaluating health claims for dietary supplements were declared invalid under the First Amendment to the U.S. Constitution and under the Administrative Procedure Act. The Court of Appeals for the District of Columbia Circuit held the FDA's refusal to authorize four nutrient–disease relationship claims with disclaimers a violation of the First Amendment commercial speech doctrine. That court also held the FDA's refusal to define a standard for review of health claims arbitrary and capricious. The decision is final and binding on the FDA. It is destined to have a profound impact on the way the FDA regulates claims for dietary supplements and potentially all other products.