Cigar Ass'n of Am. v. U.S. Food & Drug Admin.

317 F. Supp. 3d 555
Court of Appeals for the D.C. Circuit·Decided July 5, 2018·No. Case No. 1:16–cv–01460 (APM)·Published·Cited by 17 cases

Opinion

Amit P. Mehta, United States District Judge

Pursuant to Federal Rule of Civil Procedure 62(c) and 5 U.S.C. § 705, Plaintiffs ask for an injunction or stay pending their appeal of a portion of the court's May 15, 2018 Memorandum Opinion and Order, which granted in part and denied in part Plaintiffs' Motion for Partial Summary Judgment and denied as moot Plaintiffs' Motion for Preliminary Injunction. Specifically, Plaintiffs seek "an injunction against the enforcement of the [Food and Drug Administration's ("FDA") ] cigar and pipe tobacco warnings requirements set forth at 21 C.F.R. §§ 1143.3 and 1143.5" or "a postponement of the August 10, 2018 effective date of those requirements," while their appeal is pending and for 60 days after the resolution of that appeal. See Pls.'

*558Mot. for Stay or Inj. Pending Appeal, ECF No. 95 [hereinafter Pls.' Mot.], at 1. Alternatively, Plaintiffs move to postpone the effective date of the cigar warnings requirements, see 21 C.F.R. § 1143.5, until 60 days after the court resolves Count V of the Complaint, which challenges the FDA's decision to subject premium cigars to the same regulatory regime as other cigar products, id. ; see Compl., ECF No. 1, ¶¶ 125-33.

The court grants Plaintiffs' Motion for an Injunction Pending Appeal. The issues appealed by Plaintiffs present "serious legal questions" as to the constitutionality of FDA's warnings regime, a conclusion only reinforced by the Supreme Court's recent decision in National Institute of Family and Life Advocates v. Becerra , --- U.S. ----, 138 S.Ct. 2361, --- L.Ed.2d ----, 2018 WL 3116336 (2018). Additionally, Plaintiffs likely will suffer irreparable harm absent injunctive relief: they will have to communicate purely factual government speech in a form and size to which they object; will have their own commercial speech diminished; and will have to incur millions of dollars in compliance costs, which they will not be able to recover if the warnings regime is determined to be unconstitutional. Finally, both the balance of equities and the public interest favor an injunction pending appeal.

In the end, this court believes that Plaintiffs are entitled to a full hearing before an appellate court without the specter of a warnings regime going into effect that might ultimately be found to run afoul of the First Amendment. Accordingly, the court enjoins Defendants from enforcing the new warnings requirements for cigars and pipe tobacco set forth in 21 C.F.R. §§ 1143.3 and 1143.5 until final disposition of Plaintiffs' appeal.1

I.

The court starts with a brief overview of the relevant history of this case.2 On May 10, 2016, the FDA published a final rule-the "Deeming Rule"-subjecting cigars, pipe tobacco, and other products to statutory and regulatory requirements comparable to those already imposed on cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. See 81 Fed. Reg. 28,974 (May 10, 2016). As relevant here, the Deeming Rule imposed comprehensive warning statement requirements for pipe tobacco and cigar products. Effective August 10, 2018, cigar product packaging and advertisements must display one of six health warning statements regarding the health risks associated with cigar and nicotine use. See 21 C.F.R. § 1143.5(a)(1) ; see also id. § 1143.13. On cigar product packages, each warning statement must occupy "at least 30 percent of each of the principal display panels." Id. § 1143.5(a)(2). On cigar product advertisements, each warning statement must occupy "at least 20 percent of the area of the advertisement." Id. § 1143.5(b). The Deeming Rule imposed similar warnings requirements on pipe tobacco products.3

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Cigar Ass'n of Am. v. U.S. Food & Drug Admin., 317 F. Supp. 3d 555 (D.C. Cir. 2018).

317 F. Supp. 3d 555 (Cigar Ass'n of Am. v. U.S. Food & Drug Admin.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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