In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration (FDA) from requiring graphic warnings on cigarette packs. As we noted in prior coverage, the March 2020 FDA rule at issue would require new textual health warning statements alongside color, photorealistic images displayed on the top 50% of the front and rear panels of cigarette packs and the top 20% of cigarette advertisements.

If the Supreme Court agrees to review, the resulting opinion could have significant implications for the limits of the FDA’s authority to require these warnings and — more generally — agency authority to regulate commercial speech vis-à-vis the First Amendment.

Procedural History

District Court

In April 2020, a group of tobacco industry plaintiffs sued the FDA, alleging that its rule to establish new, graphic health warnings for cigarette packages and advertisements violates (i) the First Amendment, (ii) the Administrative Procedure Act (APA), and (iii) the requirements for health warnings set out in the Family Smoking Prevention and Tobacco Control Act (TCA). In December 2022, the U.S. District Court for the Eastern District of Texas ruled for the industry plaintiffs on summary judgment, vacating the FDA’s graphic warning rule.

The standard of review proved crucial to the outcome. The court evaluated the FDA rule’s restrictions on commercial speech using the standard articulated by the Supreme Court in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York. Under Central Hudson, a regulation on commercial speech must be, among other things, “no more extensive than is necessary to serve the [governmental]interest.” The FDA had urged the court to apply the more lenient standard of Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, under which a law passes muster if it is “reasonably related to the [government’s] interest in preventing deception of consumers.”

The court found Zauderer inapplicable and granted summary judgment to the plaintiffs on First Amendment grounds, without reaching the APA or TCA issues. In its view, applying Zauderer was not appropriate because the FDA’s required warnings were not inherently “accurate” or “purely factual and uncontroversial.” Instead, the required imagery is “provocative,” the court said, because “it is not beyond reasonable probability that consumers would take from it a value-laden message that smoking is a mistake.”

Court of Appeals

In March 2024, the U.S. Court of Appeals for the Fifth Circuit reversed. The Fifth Circuit held that the District Court erred in finding Zauderer inapplicable. The required warnings are “purely factual and uncontroversial” such that review under the Zauderer standard is appropriate, the court said. The panel further rebuffed the lower court’s notion that the warnings were “value-laden,” finding that a statement does not become controversial simply because it “drives a reaction” or because “the speaker does not like the message.”

Applying Zauderer, the Fifth Circuit found that the FDA’s required warnings are permissible under the First Amendment. Because the District Court granted summary judgment only on First Amendment grounds, the Fifth Circuit remanded the case for further consideration on the merits of plaintiffs’ APA challenge. In May, the Fifth Circuit declined to rehear the case en banc.

Petition for Supreme Court Review

Following the denial of its petition for en banc review in the Fifth Circuit, the District Court agreed to hold proceedings in abeyance, pending the result of plaintiffs’ petition for a writ of certiorari at the Supreme Court. The August 2024 petition asks the Supreme Court to resolve whether Zauderer provides the proper standard of review for the FDA warning rule. Specifically, the petition tees up: whether FDA’s mandated warnings are “purely factual and uncontroversial” and whether such warnings are “unjustified or unduly burdensome.”

Plaintiffs argue that the Fifth Circuit erred by holding that the required warnings are subject to Zauderer review because they are not “purely factual and uncontroversial.” The D.C. and Ninth Circuits’ interpretations of Zauderer are at odds with the Fifth Circuit’s holding, the petition says. Plaintiffs therefore urge the Supreme Court to resolve the circuit split. The parties must now wait for the Supreme Court to decide on the petition for certiorari. If the petition is granted, the proceedings at the District Court will remain stayed pending resolution of the First Amendment question. But, if the petition is denied, the District Court will proceed to resolve the plaintiff’s challenge to the FDA rule on APA and/or TCA grounds.

Why It Matters

From the tobacco/nicotine perspective, a Supreme Court ruling on the constitutionality of FDA-mandated graphic warnings would represent a significant regulatory development. In addition to the immediate context, the case bears on regulators’ authority to compel commercial speech generally. The Supreme Court’s consideration of this petition should be closely watched by industry members — both within the tobacco/nicotine space and in the consumer-packaged goods sector more broadly.

The case is R.J. Reynolds Tobacco Co., et al. v. Food & Drug Administration, No. 24-189.