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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 consisted of both textual warnings and medically accurate, photorealistic images that depict some of the health consequences of tobacco use. In this case, two tobacco manufacturers challenged the health warnings, arguing, among other things, that the 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 explained that a commercial disclosure requirement should be upheld if it is not unduly burdensome and is rationally related to the government’s interest. The brief also explained why the companies’ arguments that the FDA cannot require warnings to inform consumers about 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 incorrect under the case law.

In March 2023, after another district court invalidated the FDA’s disclosure requirements on First Amendment grounds, the plaintiffs voluntarily dismissed this lawsuit.