In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance document. Although a federal district court previously found the rule unconstitutional, an appeals court reversed that decision and the final rule is now in effect. In its guidance, FDA says that it will not begin enforcing until December 2025 at the earliest, but we believe it likely that the rule might yet again be postponed or vacated, as it remains the subject of ongoing litigation.
Enforcement Policy for Graphic Cigarette Warning Rule
FDA’s recent guidance states that the agency intends to exercise enforcement discretion and “generally not enforce requirements of the final rule for 15 months after the issuance of [the] guidance, until December 12, 2025.” With respect to products manufactured before December 12, 2025, FDA also intends to exercise enforcement discretion such that it will “generally not enforce the requirements of the final rule for an additional 30 days, until January 12, 2026.”
Status of Final Rule
Today, the rule is in effect, albeit not presently enforced. The rule initially had an effective date of June 18, 2021—15 months after its publication in accordance with Section 201(b) of the Family Smoking Prevention and Tobacco Control Act (TCA). However, this effective date was postponed several times over the course of the ensuing litigation in the U.S. District Court for the Eastern District of Texas. The District Court issued multiple orders during this litigation to postpone the rule’s effective date, the most recent of which pushed the date to November 6, 2023. Although the litigation continues, no further court orders have postponed the effective date of the graphic warning rule.
Ongoing Litigation
As we noted in our prior coverage, the District Court ultimately vacated the rule on First Amendment grounds in December 2022—but the U.S. Court of Appeals for the Fifth Circuit reversed this vacatur in March 2024. Rather than reinstate the rule, the Fifth Circuit remanded the case for further proceedings in the District Court on the tobacco companies’ other claims, including under the Administrative Procedure Act (APA).
In June 2024, the District Court stayed the case pending the tobacco companies’ petition for a writ of certiorari from the U.S. Supreme Court. Specifically, the companies ask the Supreme Court to review the Fifth Circuit’s finding that the graphic warning rule passes constitutional muster under the First Amendment. The Fifth Circuit, in reaching its decision in favor of FDA, applied a lower standard of review under Zauderer v. Office of Disciplinary Counsel because it found the required warnings to be “purely factual and uncontroversial.” The main issue on review at the Supreme Court would be whether it was appropriate for the Fifth Circuit to apply the lower Zauderer standard rather than strict scrutiny—a more exacting standard under which the graphic warning rule would likely be deemed unconstitutional. The tobacco company plaintiffs have not sought further relief postponing the effective date of the graphic warning rule since the District Court’s last postponement to November 6, 2023.
What to Look for Next
There are additional opportunities for the graphic warning rule to be delayed or vacated as the litigation proceeds. If the Supreme Court agrees to review the case, it could reverse the Fifth Circuit and find that the rule is unconstitutional under the First Amendment. In that scenario, vacatur is the likely remedy.
Alternatively, if the Supreme Court either (i) declines to review the case, or (ii) agrees to review the case and affirms the Fifth Circuit’s ruling, the matter should be remanded to the District Court to consider the plaintiffs’ APA and TCA challenges. In this scenario, the plaintiffs would likely request that the District Court again postpone the effective date of the rule pending the resolution of their remaining claims. Given the District Court’s previous postponements of the rule’s effective date, further postponement seems likely to us under these circumstances.
Members of the public may provide comments on the guidance in the docket of the Federal Register.
