The tobacco industry sued the FDA in the Eastern District of Texas on First Amendment grounds to challenge the agency’s graphic health warning label rule. On December 7, 2022, the district court granted the industry partial summary judgment, finding that the FDA’s graphic health warnings requirement for cigarette packages and advertising violated the industry’s First Amendment rights. On February 1, 2023, the FDA appealed this decision to the Fifth Circuit, and on March 21, 2024, the Fifth Circuit reversed and remanded, finding that the FDA’s graphic warning rule did not violate the First Amendment.

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 the health risks of smoking to consumers.


The 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.


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 violated 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. 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. Though it remanded on the question of whether the agency violated the Administrative Procedure Act, it held 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.’” Since the Fifth Circuit already found the FDA’s interest to be legitimate, it seems unlikely that the district court on remand will find the agency to have violated the Administrative Procedure Act by acting arbitrarily and capriciously.

Litigation Status (OPEN)

The Fifth Circuit reversed and remanded the district court’s decision on March 21, 2024. The court reversed with respect to the First Amendment claims and remanded on the issue of whether the FDA violated the Administrative Procedure Act.

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