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96 F.4th 863
5th Cir.
2024
Read the full case

Background

  • In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA), requiring new cigarette package warnings with color graphics depicting the negative health effects of smoking.
  • The FDA’s first attempt at implementing the graphics requirement was overturned by the D.C. Circuit in 2012 for violating the First Amendment; meanwhile, the Sixth Circuit upheld the constitutionality of the Act itself.
  • In 2020, FDA issued a revised rule with new text-and-image warnings, which tobacco companies challenged as unconstitutional compelled speech and a violation of the Administrative Procedure Act (APA).
  • The district court ruled for the tobacco companies, holding that the warnings were not purely factual or uncontroversial and thus failed the First Amendment under Zauderer scrutiny; it vacated the FDA rule.
  • FDA appealed; the Fifth Circuit reversed, finding the warnings both factual and uncontroversial, and held Zauderer was the correct standard, remanding for the district court to review the APA claims.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Zauderer Applicability Warnings not purely factual/uncontroversial; Zauderer inapplicable Warnings are factual, uncontroversial; Zauderer applies Zauderer applies because warnings are factual and uncontroversial
Sufficient Government Interest Only anti-deception interests suffice under Zauderer Legitimate informational interest suffices Government’s informational interest is sufficient
Unduly Burdensome Warnings burden more speech than necessary Warnings do not drown out other speech, are proportionate Warnings not unduly burdensome under Zauderer
APA Claim (not reached below) FDA issued rule in violation of APA Rule procedurally proper; followed appropriate study Remanded to district court for initial consideration

Key Cases Cited

  • Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985) (sets standard for compelled commercial disclosures: must be factual and uncontroversial, reasonably related to government interest)
  • Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980) (establishes intermediate scrutiny for commercial speech restrictions)
  • National Institute of Family & Life Advocates v. Becerra, 585 U.S. 755 (2018) (compelled disclosures must be factual, uncontroversial, and address real, not hypothetical, harm)
  • Milavetz, Gallop & Milavetz, P.A. v. United States, 559 U.S. 229 (2010) (Zauderer applies to factual commercial disclosures to prevent misleading speech)
  • Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012) (upheld constitutionality of TCA’s graphic warning requirement under Zauderer)
  • R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012) (struck down first FDA graphic warnings rule as not purely factual/uncontroversial)
  • Chamber of Commerce v. SEC, 85 F.4th 760 (5th Cir. 2023) (Zauderer applies to commercial disclosure requirements with legitimate informational interests)
  • NetChoice, LLC v. Paxton, 49 F.4th 439 (5th Cir. 2022) (Zauderer scrutiny applies to disclosure requirements intended to inform consumers)
Read the full case

Case Details

Case Name: R J Reynolds Tobacco v. FDA
Court Name: Court of Appeals for the Fifth Circuit
Date Published: Mar 21, 2024
Citations: 96 F.4th 863; 23-40076
Docket Number: 23-40076
Court Abbreviation: 5th Cir.
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    R J Reynolds Tobacco v. FDA, 96 F.4th 863