Warning Labels, Drawn and Then Litigated

The Statutory Mandate and the First Proposed Images

Section 201 of the Family Smoking Prevention and Tobacco Control Act, signed by President Obama on June 22, 2009, required the FDA to replace the Surgeon General's text-only warnings that had appeared on cigarette packaging since 1965 with graphic warning labels — colour images paired with text, covering the top fifty percent of each cigarette pack's principal display panels. Congress gave the FDA 24 months to issue a final rule.

The agency published its proposed rule in the Federal Register on November 12, 2010 (75 Fed. Reg. 69,524), presenting thirty-six candidate images. After public comment, FDA issued its final rule on June 22, 2011 (76 Fed. Reg. 36,628), selecting nine images. They depicted a corpse bearing chest-surgery scars, a tracheotomy site, smoke-damaged lungs, a mother and infant with a "Tobacco-Free Kids" caption, and related imagery. Each was paired with one of the nine rotating Surgeon General's text warnings Congress had specified. Compliance was required by September 2012.

R.J. Reynolds v. FDA and the First Amendment Ruling

Five tobacco companies — R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group, and Santa Fe Natural Tobacco — filed suit in the U.S. District Court for the District of Columbia in August 2011, arguing the labels compelled commercial speech in violation of the First Amendment. Judge Richard Leon ruled for the plaintiffs on February 29, 2012, finding the images were not purely factual and uncontroversial disclosures but rather emotionally evocative advocacy, and granted summary judgment to the plaintiffs and vacated the rule, blocking the September 2012 deadline.

The U.S. Court of Appeals for the D.C. Circuit affirmed on August 24, 2012, in R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012). Writing for a divided panel, Judge Janice Rogers Brown applied the standard from Zauderer v. Office of Disciplinary Counsel and concluded the chosen images went beyond factual disclosure and could not survive even intermediate scrutiny. The FDA withdrew the 2011 rule rather than seek further appeal on those images.

The Revised Rule and a New Round of Litigation

The FDA spent years developing replacement images supported by additional consumer-research evidence. It issued a new proposed rule on August 16, 2019 (84 Fed. Reg. 42,754), proposing thirteen new images drawn from an expanded pool. A final rule — the graphic warning labels ↗ rule — followed on March 18, 2020 (85 Fed. Reg. 15,638), with a compliance date originally set for June 18, 2021.

R.J. Reynolds and other manufacturers challenged the 2020 rule almost immediately in the U.S. District Court for the Eastern District of Texas. Judge J. Campbell Barker granted a preliminary injunction on March 15, 2021, finding the plaintiffs had shown a likelihood of First Amendment success. The Fifth Circuit affirmed the injunction in R.J. Reynolds Tobacco Co. v. FDA, 96 F.4th 863 (5th Cir. 2024), decided on March 13, 2024. The panel's analysis again centered on whether the labels amounted to government-compelled advocacy rather than factual disclosure, and whether FDA's consumer-research record was sufficient to justify the specific images chosen.

As of early 2025, the FDA had not announced a revised set of images or a new rulemaking timeline following the Fifth Circuit's 2024 ruling. The National Youth Tobacco Survey, administered by the CDC, has continued to track awareness of cigarette health risks among students, but no new federal graphic warning has appeared on a U.S. cigarette pack since the Surgeon General's text warnings took their present form in 1985.

The litigation has now consumed more than thirteen years without a single graphic image reaching a cigarette pack sold in the United States — a record that stands in contrast to the plain packaging regime Australia enacted in 2012 and that the World Trade Organization upheld in 2020.