Another challenge from the cigar industry has been filed against the FDA’s Deeming Regulations. Among the plaintiffs are a premium cigar retailer/lounge, a premium cigar manufacturer, and a non-profit association comprised of premium cigar manufacturers and retailers. The case is En Fuego Tobacco Shop LLC, et al. v. U.S. Food & Drug Administration, et al., No. 4:18-cv-00028 (E.D. Tex.).

According to the plaintiffs, “[t]he FDA’s new cigar and pipe tobacco warnings regime violates the First Amendment, the Administrative Procedure Act . . . , and the Family Smoking Prevention and Tobacco Control Act . . . . The underlying regulations must be enjoined, vacated in full, and remanded to the agency.”

Specifically, the plaintiffs’ claims are as follows:

  • Count I: “The Final Rule Unconstitutionally Restricts the Speech of Plaintiff Cigar and Pipe Tobacco Manufacturers and Retailers;”
  • Count II: “The Final Rule Unconstitutionally Compels the Speech of Plaintiff Cigar and Pipe Tobacco Manufacturers and Retailers;”
  • Count III: “The Final Rule’s Cigar Warning Plan Requirement Is an Unconstitutional Prior Restraint and Otherwise Unconstitutionally Restricts Speech;”
  • Count IV: “The FDA Imposed the New Warning Requirements Without First Making the Findings Required by the Act;” and
  • Count V: “The FDA’s Warning Label Requirements Are Arbitrary, Capricious, an Abuse of Discretion, and Not in Accordance with Law, and Exceed the FDA’s Regulatory Authority;”

Meanwhile, a separate cigar-industry challenge is still pending in Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.), where the parties’ cross-motions for summary judgment are awaiting decision.