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317 F. Supp. 3d 555
D.C. Cir.
2018
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Background

  • In 2016 the FDA promulgated the Deeming Rule, extending cigarette-like statutory and regulatory requirements to cigars and pipe tobacco, including mandatory health warnings on packaging and advertisements effective August 10, 2018 (21 C.F.R. §§ 1143.3, 1143.5).
  • Plaintiffs (cigar industry parties) sued challenging the warnings under the Tobacco Control Act, the APA, and the First Amendment (Counts VI–VII among others); the court issued a May 15, 2018 memorandum resolving several claims.
  • The court previously rejected Plaintiffs’ TCA and APA arguments and applied Zauderer to uphold the warnings as compelled disclosures of factual, uncontroversial information, but Plaintiffs appealed the First Amendment rulings.
  • Plaintiffs moved for an injunction pending appeal under Fed. R. Civ. P. 62(c) (and alternatively under 5 U.S.C. § 705), seeking to block enforcement of the cigar and pipe-tobacco warning requirements while their appeal proceeds and for 60 days after final disposition.
  • The court found Plaintiffs raised "serious legal questions" (especially in light of the Supreme Court’s recent decision in NIFLA v. Becerra), and that Plaintiffs would suffer irreparable First Amendment and unrecoverable financial harm absent a stay; the court therefore enjoined enforcement of the warnings until 60 days after final disposition of the appeal.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether an injunction pending appeal is warranted Mehta (Plaintiffs) argued the warnings present serious First Amendment issues and compliance would cause irreparable speech and financial harm FDA argued the district court already decided the merits against Plaintiffs and that Plaintiffs cannot show likelihood of success Court granted injunction pending appeal under Rule 62(c), finding serious legal questions and other factors favored stay
Whether Zauderer permits the compelled warnings Plaintiffs argued FDA must meet a stricter standard and warnings are unjustified/unduly burdensome FDA argued warnings are purely factual, uncontroversial, and permissible under Zauderer Court recognized this as a serious legal question that could be decided differently on appeal
Whether plaintiffs will suffer irreparable harm without relief Plaintiffs argued compelled government speech, diminution of commercial speech, and millions in unrecoverable compliance costs FDA did not meaningfully dispute imminent constitutional and financial harms Court found irreparable First Amendment injury and unrecoverable financial harm established
Public interest and balance of equities for a stay Plaintiffs argued free-speech interests and ongoing FDA rulemaking on premium cigars support a stay FDA argued public health interests favor immediate enforcement Court concluded equities and public interest favor preserving constitutional review and granted stay

Key Cases Cited

  • Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) (establishes relaxed First Amendment test for compelled factual, uncontroversial disclosures)
  • Winter v. Natural Res. Def. Council, 555 U.S. 7 (2008) (standard for preliminary injunctions requires likelihood of success, irreparable harm, balance of equities, public interest)
  • Washington Metro. Area Transit Comm’n v. Holiday Tours, Inc., 559 F.2d 841 (D.C. Cir. 1977) (articulates sliding-scale approach for injunctions pending appeal)
  • National Inst. of Family & Life Advocates v. Becerra, 138 S. Ct. 2361 (2018) (recent Supreme Court decision narrowing permissible compelled disclosures under Zauderer)
  • Population Inst. v. McPherson, 797 F.2d 1062 (D.C. Cir. 1986) (describes "serious legal question" standard for stays)
  • Chaplaincy of Full Gospel Churches v. England, 454 F.3d 290 (D.C. Cir. 2006) (explains irreparable-injury standard for preliminary relief)
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Case Details

Case Name: Cigar Ass'n of Am. v. U.S. Food & Drug Admin.
Court Name: Court of Appeals for the D.C. Circuit
Date Published: Jul 5, 2018
Citations: 317 F. Supp. 3d 555; Case No. 1:16–cv–01460 (APM)
Docket Number: Case No. 1:16–cv–01460 (APM)
Court Abbreviation: D.C. Cir.
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