The United States Food and Drug Administration recently obtained summary judgment on several cigar industry claims challenging the FDA’s Deeming Regulations.  The case was filed by industry plaintiffs Cigar Association of America, the International Premium Cigar and Pipe Retailers Association and Cigar Rights of America on July 15, 2016, shortly after the FDA issued the final regulations.  The plaintiffs have indicated that they will appeal the court’s decision, and have requested that the court enjoin enforcement of the FDA’s health warning requirements pending the resolution of the appeal. Continue Reading Deeming Regulations Litigation Update – Cigar Industry Plaintiffs Seek Stay of Health Warning Requirements Pending Appeal

There has been new activity in two of the three Deeming Regulations challenges filed by vapor-industry plaintiffs represented by the Pacific Legal Foundation (“PLF”): Moose Jooce, et al. v. Food & Drug Admin., et al., No. 1:18-cv-203 (D.D.C.), and Rave Salon, Inc. v. Gottlieb, et al., No. 3:18-cv-237 (N.D. Tex.). The cases involve challenges based on the Appointments Clause and the First Amendment of the U.S. Constitution. Continue Reading Deeming Regulations Litigation Update–Case Transferred, Appointments Clause Briefing Scheduled

U.S. Magistrate Judge Kimberly C. Priest Johnson has denied a motion to transfer the Deeming Regulations challenge in En Fuego Tobacco Shop LLC, et al. v. U.S. Food & Drug Administration, et al., No. 4:18-cv-00028 (E.D. Tex.). On June 5, the FDA appealed her decision to District Judge Amos L. Mazzant III. Continue Reading Deeming Regulations Litigation Update–Motion to Transfer Cigar Challenge Denied, Appealed by FDA

A federal court has dismissed a case challenging the FDA’s allowance of the word “natural” in Natural American Spirit’s (“NAS”) product packaging and labeling. The Plaintiff lacks standing to sue under Article III, § 2, of the U.S. Constitution, which limits federal courts to deciding actual “cases” or “controversies.” Continue Reading Plaintiff Lacks Standing to Force FDA Action Against Tobacco Company

On January 30, 2018, three separate challenges to the Deeming Regulations were filed by vapor-industry plaintiffs represented by the Pacific Legal Foundation (“PLF”), each raising issues under the Appointments Clause and the First Amendment of the U.S. Constitution:

  • Moose Jooce, et al. v. Food & Drug Admin., et al., No. 1:18-cv-203 (D.D.C.);
  • Rave Salon, Inc. v. Gottlieb, et al., No. 3:18-cv-237 (N.D. Tex.); and
  • Hoban, et al. v. Food & Drug Admin., et al., No. 0:18-cv-269 (D. Minn.).

When PLF announced the filings, it characterized “[t]hese three simultaneously filed lawsuits” as an “opening salvo.” Will the FDA be able to outmaneuver the three-pronged attack? Continue Reading Deeming Regulations Litigation Update–FDA Seeking to Consolidate PLF Legal Challenges in Single Court

Earlier this month, we reported on a lawsuit filed by U.S. Smokeless Tobacco Company (UST) challenging the FDA’s issuance of Not Substantially Equivalent Orders for a smokeless tobacco product.  The FDA has now moved to dismiss the lawsuit for lack of subject matter jurisdiction after rescinding the NSE orders at issue. Continue Reading FDA Moves to Dismiss Suit Regarding SE Standards

In connection with FDA Commissioner Scott Gottleib’s July 2017 announcement regarding a new comprehensive nicotine strategy, the FDA gave manufacturers an extension to comply with certain deadlines under the Deeming Regulations. The extension governed all premarket review submissions for newly-deemed products and “applie[d] only to compliance deadlines relating to . . . substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).” Continue Reading Deeming Regulations Litigation Update—Anti-Tobacco Groups Challenge the FDA’s Extension of Deadlines for Premarket Review Submissions

How many tobacco violations can a retailer be charged with for each transaction? On March 20, 2018, the U.S. Court of Appeals for the D.C. Circuit decided Orton Motor, Inc. v. U.S. Dep’t of Health & Human Servs., No. 16-1299 (D.C. Cir.), upholding the FDA Center for Tobacco Products’ (“CTP”) practice of counting multiple violations, even if all violations occurred within a single consumer transaction. Continue Reading Enhancement of FDA Tobacco Retailer Penalties Approved by D.C. Circuit Court of Appeals

In a pending vapor industry challenge to the FDA’s Deeming Regulations, on March 22, 2018, the Court permitted several anti-tobacco advocacy and public health groups to intervene in the litigation as Codefendants and, at the same time, stayed the case pending the decision of the U.S. Court of Appeals for the D.C. Circuit in Nicopure Labs, LLC, et al. v. FDA, et al., No. 17-5196 (D.C. Cir.). The case is Cyclops Vapor 2, LLC, et al. v. FDA, et al., No. 2:16-cv-00556 (M.D. Ala.). Continue Reading Deeming Regulations Litigation Update–Vapor Challenge Stayed Pending Nicopure Labs Decision, Intervention Permitted in Middle District of Alabama

With a merits decision anticipated in a cigar-industry challenge to the Deeming Regulations, will other Courts have the opportunity to decide similar challenges? The FDA has suggested “no,” in a motion to transfer filed on March 19, 2018. Continue Reading Deeming Regulations Litigation Update–FDA Attempts to Consolidate Cigar Challenges in U.S. District Court for the District of Columbia