Title: First Amendment Scrutiny of FDA'S Fight Against Misbranding: Placing Labeling on the Spectrum of Speech (1995 Third Year Paper)
Author(s): Kenneth I. Weissman
Subject & Subject keywords: Food and Drug Law "mislabeling" "misbranding" "Food Drug and Cosmetic Act" "FD&C Act"
Abstract:In order to further the Food and Drug Administration's (FDA) mission of "assur[ing] that the products it regulates are safe and truthfully labeled," the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the power to enforce prohibitions on labeling that causes a food, drug, cosmetic, or medical device to be misbranded. The FD&C Act defines labeling as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." Because of the expansive nature of this definition, independently written pamphlets, newspapers, and books that accompany products covered by the FD&C Act constitute labeling in certain circumstances. This exacerbates the tension between the First Amendment's free speech guarantee and FDA's mandate, and raises the question of how courts should scrutinize FDA's ability to seize or enjoin the sale of misleading labeling. The importance of both the Free Speech Clause and the protection of consumers makes this a difficult issue to resolve, and as of yet, "no case has squarely confronted the issue."

The analysis of constitutional limitations on FDA's anti-misbranding powers turns on how the Supreme Court would classify labeling: is it a distinct category of regulated speech, commercial speech, or ordinary speech? FDA has advocated the classification of labeling as a distinct category of regulated speech, but there is little authority or logic to support this position, and the First Amendment tradeoff of such a classification would be too great. The evidence suggests that the Court would almost definitely deal with labeling as commercial speech, but should instead treat it as ordinary speech. By treating labeling as ordinary speech, the Court can circumvent the myriad infirmities of the commercial speech doctrine, while providing an acceptable balance between the First Amendment and consumer protection.