The tobacco industry filed suit on First Amendment grounds to challenge the FDA’s graphic warning label rule.

Why It Matters for Public Health

This case, along with Philip Morris v. FDA (2022), challenges the FDA’s recently issued graphic warning label rule that would require cigarette advertisements and packages to bear graphic warnings. This case is yet another attempt by the tobacco industry to stave off graphic warning label requirements in the U.S.


The Tobacco Control Act TCA requires the FDA to issue regulations mandating graphic 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. 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 warning label rule, R.J. Reynolds and several other manufacturers, distributors, and retailers filed suit against the FDA in the District Court for the Eastern District of Texas. The complaint alleges 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% of packaging and 20% of advertising violates the First Amendment; and 3) the issuance of the warnings violated the Administrative Procedure Act.

The industry’s new challenge to the graphic warning label rule alleges that the new rule—like the earlier graphic warning label 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 effectives of smoking.” The complaint also criticizes the methodology and findings of the qualitative and quantitative studies that the FDA conducted to develop the warnings. The industry also argues that there are less intrusive means of conveying the messages that FDA failed to consider. The industry additionally revives the argument that it made in Discount Tobacco City & Lottery v. United States (2009) arguing 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 has not been considered by the Fifth Circuit.

On May 6, 2020, both the FDA and the industry plaintiffs filed a joint motion to postpone the rule’s effective date 120 days due to the pandemic. The district court granted this motion on May 8, 2020. The court also set a briefing schedule for the industry’s combined motions for preliminary injunction and summary judgment. The industry plaintiffs filed a combined Motion for Summary Judgment and Preliminary Injunction with the court on May 15, 2020.

The government responded with its own summary judgment motion and motion to dismiss on July 2, 2020. The Public Health Law Center, twenty states and the District of Columbia, and Public Citizen all filed amicus briefs with the court in support of the FDA (view the Center’s amicus brief here.) A hearing was held on the motion to dismiss on September 9, 2020. Oral argument on the summary judgment and preliminary injunction motions was held on December 11, 2020. The district court granted subsequent motions to postpone and issued further extensions on the final effective date for the rule.

Litigation Status (OPEN)

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 a second amicus brief in support of the FDA in this litigation. Our brief argues that the eleven pictorial warnings on cigarette packages and advertisements do not violate the First Amendment because they are factual and noncontroversial scientific depictions of typical health risks associated with smoking. 

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