No Longer Business as Usual: FDA Exceptionalism, Commercial Speech, and the First Amendment

Carl Wiersum


FDA’s crucial mission of protecting the safety and integrity of our nation’s food and drug supply has led to several areas of “FDA exceptionalism”—a tendency to apply available exceptions to general legal norms. Until the late 1990s, the First Amendment seemed another of these areas, and FDA was free to regulate the labeling and advertisement of products within its jurisdiction. But in the last two decades, FDA has lost case after case with respect to challenges under the First Amendment. Its response has been to strategically avoid appealing these decisions, to construe these decisions as narrowly as possible, and to attempt to continue on business as usual. This article covers the evolution of the Supreme Court’s First Amendment jurisprudence as relates to FDA. It argues that commercial speech restrictions are currently subject to a de facto strict scrutiny applied under the Central Hudson name. It also covers the areas of compelled speech, compelled access, compelled subsidies, government speech, and compelled commercial disclosure, all of which will prove relevant to FDA in designing future regulatory approaches. It discusses three areas of current FDA First Amendment difficulty—health claims for dietary supplements, off-label pharmaceutical promotion, and graphic cigarette warning labels—and argues that FDA’s current approach to addressing First Amendment concerns is unsustainable. It uses First Amendment case law to offer guidance on possible future approaches that would proactively address these issues and balance the First Amendment rights of regulated entities with FDA’s crucial public health goals.