Philip Morris USA v. FDA

The Family Smoking Prevention and Tobacco Control Act directed the Food and Drug Administration (FDA) to update the health warnings on cigarette packaging and advertising, including authorizing the use of graphic images to illustrate the dangers of tobacco use. In 2019, the FDA exercised that authority by adopting rules that require tobacco products to include new warnings about the lesser known health risks of smoking. The warnings consist of both textual warnings and medically accurate, photorealistic images that depict some of the health consequences of tobacco use.

Two tobacco manufacturers brought this action seeking to invalidate the FDA’s regulations. Among other things, the companies argue that the graphic health warnings violate the industry’s First Amendment rights. Public Citizen filed an amicus brief supporting the warnings. Addressing the appropriate level of First Amendment scrutiny that the court should apply, the brief explains that a commercial disclosure requirement is subject to deferential review, and should be upheld if it is not unduly burdensome and is rationally related to the government’s interest. The brief also explains why the companies’ arguments that the FDA cannot require warnings to inform consumers of the health risks of tobacco and that the FDA can require disclosures only if they are the least restrictive alternative available for achieving the government’s objectives are both incorrect under the case law.