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R.J. Reynolds Tobacco Co. v. FDA (2020)

The Family Smoking Prevention and Tobacco Control Act authorized 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.

The tobacco industry, acting through tobacco manufacturers and retailers, brought this action seeking to invalidate the FDA’s regulations. Among other things, the industry argues that the graphic health warnings violate the industry’s First Amendment rights.

Public Citizen filed an amicus brief supporting the FDA’s defense of its tobacco health warnings. The amicus brief addressed the issue of the appropriate level of First Amendment scrutiny that the court should apply. Traditionally, a commercial disclosure requirement is subject to deferential review, and will be upheld if it is not unduly burdensome and is rationally related to the government’s interest. The industry argued, however, that heightened review – either intermediate scrutiny or strict scrutiny – should be the First Amendment standard. Public Citizen’s amicus brief refuted that argument. In particular, our brief addressed the industry’s arguments that the FDA could not require warnings simply to inform consumers of the health risks of tobacco, as well as the industry’s argument that the FDA could require disclosures only if it were the least restrictive alternative available for achieving the government’s objectives.

In December 2020, the court ruled against the FDA, holding that the rule violated the First Amendment and vacating the rule. The FDA appealed to the Fifth Circuit, and Public Citizen filed an amicus brief supporting FDA. Our brief argued that the district court applied the wrong standard to consideration of the health warnings and that the warnings, including the images, presented factual information to consumers about the health risks of smoking.

In March 2024, the Fifth Circuit reversed the district court. The court held that the warnings address a legitimate state interest, are justified, and are not unduly burdensome, and therefore that they comply with the First Amendment.