In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, which revised the required warnings each cigarette manufacturer must place on its packages and advertisements. Modernizing the ubiquitous text of the Surgeon General’s current warnings, the Act requires cigarette packages to include color graphics depicting the negative health consequences of smoking to accompany the updated label statements. Those graphics and statements “shall comprise the top 50 percent of the front and rear panels of the package” of cigarettes and “at least 20 percent of the area of any advertisement.” Tobacco companies quickly brought a facial challenge to the Act’s constitutionality, but the Sixth Circuit upheld it in 2012. The FDA’s first attempt at a rule interpreting and applying the Act fared less well, as the FDA failed to rebut an as-applied First Amendment challenge before the D.C. Circuit in 2014. Now, ten years later, the FDA has tried again. Upholding the Act on First Amendment grounds, the U.S. Fifth Circuit remanded for further consideration under the APA.

As to the First Amendment challenge, the Court ruled as follows: “The Warnings are government-compelled speech — not speech restrictions. Because of that, the many cases plaintiffs and their amici cite regarding prohibitions or restrictions on speech provide, at best, merely persuasive authority. That said, government-compelled speech inherently regulates speech on the basis of its content. And, as plaintiffs point out, we generally review content-based regulations of speech under strict scrutiny unless they come within an exception such as the commercial speech exceptions of Zauderer or Central Hudson…. Distilling that precedent, Zauderer applies where the compelled speech is (1) purely factual and (2) uncontroversial. To survive Zauderer scrutiny, the warnings must (3) be justified by a legitimate state interest and (4) not unduly burdensome.” The Fifth Circuit found that the FDA’s Warnings met all four requirements.

With respect to the APA challenge: “The district court never reached the issue, granting summary judgment for plaintiffs solely on its finding that the Rule violated the First Amendment. Plaintiffs are right that this Court may affirm on any ground supported by the record and presented to the district court. But we generally will not reach the merits of an issue not considered by the district court and we see no reason to stretch for them here.”


R.J. Reynolds v. FDA, 96 F.4th 863 (5th Cir. 2024).