Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements

Abstract

The author examines the recent decision of the U.S. Court of Appeals in Pearson v. Shalala, which struck down on First Amendment grounds the Food and Drug Administration's (FDA's) regulatory scheme for approving health claims for dietary supplements. In its recent ruling, the Pearson court rejected the FDA's view that health claims that cannot be proved as either true or false pose a serious risk to consumers. Although the court recognized that some health claims will mislead consumers, it reasoned that the FDA's regulations are nonetheless impermissibly restrictive because they do not allow manufacturers to make health claims accompanied by clarifying disclosures when significant scientific agreement is lacking. The court suggested that disclaimers referring to the absence of FDA approval, or the inconclusive nature of the scientific evidence, might be sufficient to guard against consumer deception. The author explains why the reasoning of Pearson misconceives basic First Amendment commercial speech principles and places the public at risk. Congress enacted the Nutrition Labeling and Education Act to ensure that consumers would no longer be subjected to unreliable and unverifiable health claims for dietary supplements. Pearson thwarts that purpose. The disclaimers envisioned by the court will simply underscore the uncertainty about the product's utility. Accordingly, Pearson relegates consumers to a marketplace that will be rife with unproven and unreliable health claims and thus poses a real threat to the health of consumers.