## Facts

- Congress enacted the Family Smoking Prevention and Tobacco Control Act, directing FDA to require new textual warnings paired with “graphic images” covering 50% of the front and back of cigarette packages and 20% of cigarette advertisements.
- FDA issued a 2011 final rule selecting nine color photographic images (e.g., diseased lungs, tracheotomy imagery, a cadaver) and requiring inclusion of the “1-800-QUIT-NOW” quitline, rotated across packaging and ads.
- Cigarette manufacturers and a distributor challenged the rule, arguing it compelled them to display emotionally charged, advocacy-oriented content on their own packaging and advertising.
- FDA defended the rule as a permissible compelled disclosure of factual health-risk information, arguing for application of a deferential standard for commercial disclosures.
- The district court granted summary judgment to the challengers and permanently enjoined enforcement; FDA appealed.

## Issues

1. What First Amendment standard governs FDA’s compelled graphic warning requirement for cigarette packaging and advertising: a deferential disclosure standard or heightened commercial-speech scrutiny?
2. Under the applicable standard, did FDA’s 2011 rule unconstitutionally compel manufacturers to disseminate non-factual, advocacy-oriented messages?
3. If intermediate scrutiny applies, did FDA show the rule materially and directly advances a substantial governmental interest and is not more extensive than necessary?

## Decision

- The D.C. Circuit affirmed the permanent injunction and summary judgment against FDA.
- The court held the compelled images and quitline were not limited to “purely factual and uncontroversial” disclosures, so the deferential disclosure standard did not apply.
- Applying at least Central Hudson–type intermediate scrutiny, the court concluded FDA failed to justify the rule with evidence that the specific warnings would materially and directly advance the asserted interests.
- The court also treated the mandated size and placement as highly intrusive and found FDA had not shown the scheme was appropriately tailored.
- A concurring judge characterized the requirement as viewpoint-based compelled speech warranting even stricter review.
- A dissenting judge would have upheld the rule under the deferential disclosure standard as accurate depictions of smoking’s health consequences.

## Legal Principles

- Compelled commercial disclosures receive more deferential review only when they require “purely factual and uncontroversial” information; that doctrine does not authorize compelled government advocacy on private speakers’ property.
- When a compelled commercial-speech regime goes beyond factual disclosure and functions as persuasion, heightened scrutiny applies.
- Under Central Hudson–type review, the government must show (1) a substantial interest, (2) that the regulation materially and directly advances that interest, and (3) that the means are not more extensive than necessary.
- Agency reliance on speculation, generalized legislative findings, or post hoc rationales is insufficient to satisfy the evidentiary burden for the specific compelled-speech rule adopted.

## Conclusion

The D.C. Circuit held that FDA’s 2011 cigarette graphic-warning rule compelled advocacy-oriented speech rather than neutral factual disclosure and, under intermediate scrutiny, was not adequately supported by evidence or tailoring; the court therefore affirmed a permanent injunction barring enforcement of the rule.


R.J. Reynolds Tobacco Co. v. Food & Drug Admin., 696 F.3d 1205 (D.C. Cir. 2012)