The tobacco industry challenges the FDA’s graphic warning label rule on First Amendment grounds.

Why It Matters for Public Health

This case, along with Philip Morris v. FDA, challenges the FDA’s recently issued graphic warning label rule that would require cigarette advertisements and packages to bear graphic warning labels. 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 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.

District Court Proceedings

Shortly after the FDA published its new graphic warning label rule, R.J. Reynolds Tobacco Company and several other manufacturers, distributers, and retailers filed suit against the FDA in U.S. 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 (APA).

The industry’s new challenge to the graphic warning label rule alleges that the new rule—like the earlier iteration of the graphic warning label rule 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 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 also revives the argument it made in the Discount Tobacco City and Lottery case, arguing that the graphic warning requirement itself, as set out in the Tobacco Control Act, is unconstitutional under the First Amendment in all circumstances. That argument was rejected by the Sixth Circuit Court of Appeals in Discount Tobacco City, but has not been considered by the 5th 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 COVIID-19 pandemic. The District Court granted this motion on May 8, 2020. The District Court also set a briefing schedule for the industry’s combined motions for preliminary injunction and summary judgment. The industry Plaintiffs’ combined Motion for Summary Judgment and Preliminary Injunction was filed 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 Public Health Law 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)

The case is ongoing and the court has issued multiple extensions. On November 12, 2021, the District Court issued another postponement for the effective date of the final rule, to January 9, 2023. On February 10, the District Court again postponed the effective date of the rule to April 9, 2023. On May 10, 2022, the District Court further postponed the effective date of the rule to July 8, 2023. On August 10, 2022, the District Court again postponed the effective date of the rule to October 6, 2023.


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