Industry challenges the FDA’s 2020 graphic warning label rule on First Amendment grounds.

Why It Matters for Public Health

This case, along with R.J. Reynolds 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 illustrates the ongoing efforts by the Tobacco Industry to fight graphic warning labels 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

On May 6, 2020, Philip Morris filed a second challenge to the FDA’s updated graphic warning label rule in the U.S. District Court for the District of Columbia R.J. Reynolds filed earlier in the Eastern District of Texas).

Like the industry’s 2011 challenge to the previous iteration of the graphic warning rule, Philip Morris’ complaint alleges that the graphic warning label rule violates the First Amendment for several reasons. First, the complaint alleges that the labeling requirements place an impermissible burden on manufacturers by forcing them to display anti-smoking messages over 50% of cigarette packaging and 20% of advertising, thus “drowning out” their own messages about their product. Notably, the industry also argues that the provisions of the Tobacco Control Act mandating these specific percentage requirements violate the First Amendment--an issue that was decided earlier by the 6thCircuit Court of Appeals in Discount Tobacco City Lottery Inc. v. U.S. Second, the complaint alleges that FDA failed to meet the strict standards required for compelled speech. Specifically, the complaint states that “FDA’s marginal interest in more effectively educating consumers about less-known health risks of smoking is insufficient to justify a regime that forces manufacturers to carry messages aimed at pushing away their own customers.” The complaint also alleges that the warnings are in fact misleading in that they misrepresent the relative risks of smoking-related health consequences. Lastly, the industry argues that the new labeling requirements violate the First Amendment by forcing manufacturers to seek pre-approval of their labeling and advertising plans.

The industry also alleges numerous Administrative Procedure Act (APA) violations, including what it calls an effort to “thwart” meaningful notice-and-comment by withholding data and underlying reports and studies upon which the rule is based until it issued its final rule. In addition, the industry alleges the FDA acted arbitrarily and capriciously by ignoring the findings of the qualitative studies it did conduct and failing to adequately justify the rule. Finally, the complaint alleges that the FDA violated the Tobacco Control Act by mandating 11 total warnings while the Act itself specifies 9 warnings.

As a remedy, the industry requests both declaratory and injunctive relief to prevent implementation of the rule. However, they note that the parties in the R.J. Reynolds-led challenge to the same rule have requested that the implementation date be postponed 120 days—until October 16, 2021, due to COVID-19.

On August 5, 2020, the industry plaintiffs filed a combined motion for summary judgment and preliminary injunction.

On October 14, 2020, the Public Health Law Center filed an amicus brief in support of the government defendants’ cross-motion for summary judgment. View the Public Health Law Center’s brief here. The cross-motions for summary judgment have been put on hold until further developments in the parallel R.J. Reynolds v. FDA case, with the most recent order issued on November 24, 2021.

Litigation Status

The case is ongoing. The graphic warning rule’s effective date has already been postponed by the court in the parallel R.J. Reynolds v. FDA. Further briefing in this case has been suspended while the parallel litigation proceeds.

On December 7, 2022, the Court in the Eastern District of Texas granted partial summary judgment to R.J. Reynolds and ruled that the graphic warning labels violated the First Amendment. The Court declined to rule that the statutory provisions requiring such labels were prima facie unconstitutional.

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