Several tobacco manufacturers, distributors, and retailers challenged the U.S. Food and Drug Administration's (FDA) March 2020 graphic health warning rule on First Amendment grounds. Under the challenged rule, cigarette packaging and advertisements would be required to display graphic health warnings covering 50% and 20%, respectively. A lower court granted partial summary judgment in favor of the plaintiffs, holding that the rule is invalid under the First Amendment. On appeal, the court reversed the lower court ruling, finding that the district court applied the incorrect standard and that the graphic health warnings are, in fact, "factual and uncontroversial" and do not violate the First Amendment. The case was then remanded to the lower court for consideration of plaintiffs' procedural objections.

Tobacco-Free Kids filed an amicus brief, joined by other public health organizations, defending the warnings and arguing that the graphic warnings advance the governmental interest in enhancing public knowledge of the health hazards of smoking.

After this ruling from the U.S. Court of Appeals for the Fifth Circuit, the tobacco companies petitioned for a writ of certiorari to have the U.S. Supreme Court review the case.  On November 25, 2024, the Supreme Court denied the request to hear the challenge to the graphic health warning requirements, leaving the Fifth Circuit ruling in place.