Synopsis

The tobacco industry sued the U.S. Food and Drug Administration on First Amendment grounds, challenging the agency’s graphic health warning label rule.

Why It Matters for Public Health

This case, along with Philip Morris v. FDA (2022), challenged the FDA’s requirement that cigarette packages contain images that accurately depict the hazards of tobacco use, along with textual warnings related to the images. This case is yet another attempt by the tobacco industry to stave off graphic health warning requirements in the U.S. Graphic warnings are an important way to convey to consumers the health risks of smoking.

Background

The Family Smoking Prevention and Tobacco Control Act requires the FDA to issue regulations mandating graphic health warnings on cigarette packages and advertisements. In 2011, the FDA issued its first set of warnings, which were challenged by the industry and eventually struck down in court (see R.J. Reynolds v. FDA (2011)). After a lawsuit by public health groups, the FDA issued its new rule on March 18, 2020.

Proceedings

District Court

Shortly after the FDA published its new graphic warnings label rule, R.J. Reynolds and several other manufacturers, distributors, and retailers sued the FDA in the District Court for the Eastern District of Texas. The complaint alleged that 1) the graphic warnings violate the First Amendment; 2) the Tobacco Control Act’s requirement that graphic warning labels be issued and occupy 50 percent of cigarette packaging and 20 percent of advertising violates the First Amendment; and 3) the issuance of the warnings violate the Administrative Procedure Act. The Public Health Law Center submitted an amicus brief to the district court in support of the FDA.

The industry’s challenge to the graphic warning label rule alleged that the new rule—like the earlier rule that the industry challenged in 2011—similarly uses “gruesome images” that are “designed to evoke negative emotions, such as fear and shock” and that “misrepresent or exaggerate the potential effects of smoking.” The industry also revived the argument it made in Discount Tobacco City & Lottery v. United States (2009), an argument that the graphic warning requirement itself, as set out in the TCA, is unconstitutional under the First Amendment in all circumstances. That argument was rejected by the Sixth Circuit in Discount Tobacco but had not been considered by the Fifth Circuit.

On December 7, 2022, the district court granted partial summary judgment to R.J. Reynolds and ruled that the FDA’s graphic warning requirement violated the First Amendment. The court declined to hold that the TCA’s provisions requiring such labels were prima facie unconstitutional, but it vacated the FDA’s graphic warning rule.

Fifth Circuit

On February 1, 2023, the FDA appealed the district court’s decision to the Fifth Circuit. On May 17, 2023, the Public Health Law Center filed another amicus brief in support of the FDA.

On March 21, 2024, the Fifth Circuit reversed the district court’s vacatur of the FDA’s rule, holding that the FDA’s new graphic warning rule did not violate the First Amendment because the mandated warnings were “purely factual and uncontroversial” and served a legitimate government interest. Citing the Public Health Law Center’s amicus brief, the court found that, “[a]s one of the amici explained it, each of the images provides ‘a straightforward, science-based, objectively truthful depiction of the accompanying text.’” However, the Fifth Circuit remanded the case back to the district court to address R.J. Reynolds’ separate and unresolved claim that the rule violated the Administrative Procedure Act.

The plaintiffs petitioned the U.S. Supreme Court for a writ of certiorari, and on November 25, 2024, the Court denied the motion, returning the case to the district court for further litigation.

Additional District Court Proceedings

On January 13, 2025, the district court entered a preliminary injunction, finding a substantial likelihood the FDA went beyond its statutory authority by requiring packaging and advertising to contain one of eleven warnings with wording that the FDA chose, rather than the nine specific warnings authorized by Congress in the Tobacco Control Act. The judge’s decision also reflected the impact of the fall of Chevron deference. Citing to Loper Bright Enterprises v. Raimondo (2024), the court emphasized that “its analysis proceeds without any deference to the agency’s view.” The judge delayed the rule pending further litigation on the statutory authority claim.

Additional Fifth Circuit Proceedings

On March 14, 2025, the FDA appealed the district court decision to the Fifth Circuit. On August 18, 2026, the Fifth Circuit found that the delay of the rule pending further litigation involved no abuse of discretion and affirmed the district court's ruling. The court agreed that the plaintiffs were likely to succeed on their claim that the FDA exceeded its statutory authority by selecting eleven particular warnings instead of the nine warnings provided by Congress.

Litigation Status (OPEN)

The Fifth Circuit affirmed the district court’s delay of the FDA’s graphic warnings rule pending further litigation on August 18, 2026. The case is ongoing.