No. 1:16-cv-1460 (D.D.C.)
No. 18-05195 (D.C. Cir. 2018)
On July 15, 2016, the Cigar Association of America, the International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America, non-profit trade associations for retailers and manufacturers, filed suit in the District Court of the District of Columbia. The plaintiffs requested that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeded and asked the court to permanently strike down the rule.
The lawsuit alleged that:
- the enforcement of premarket review would be costly, rendering the FDA’s action “arbitrary and capricious” in violation of the APA;
- the imposition of user fees is an illegal tax, an action that is in excess of statutory authority and therefore a violation of the APA;
- the imposition of user fees on cigar manufacturers but not e-cigarette manufacturers is “contrary to [the] constitutional right” to due process protected by the Fifth Amendment, a violation of the APA;
- the FDA’s Final Regulatory Flexibility Analysis did not properly quantify the costs of the rule or identify significantly less costly alternatives to the rule, a violation of the RFA;
- the FDA’s decision to regulate all cigars rather than exempting premium cigars is an action that is “arbitrary and capricious” in violation of the APA;
- the FDA’s imposition of particularly sized warning labels without adequately explaining why it decided on the size and format is “arbitrary and capricious” in violation of the APA;
- the required warning labels impermissibly restrict speech, a violation the First Amendment;
- the FDA’s decision to treat retailers who blend or repackage pipe tobacco or cigars as manufacturers is “arbitrary and capricious” in violation of the APA;
- the FDA’s decision to regulate pipes as components or parts of a tobacco product is “arbitrary and capricious” in violation of the APA.
The FDA filed its answer on October 26, 2016. The plaintiffs filed a motion for summary judgment on February 13, 2017. On July 24, 2017, the American Academy of Pediatrics, the American Lung Association, the American Heart Association, the American Cancer Society Cancer Action Network, the Campaign for Tobacco-Free Kids, and the Truth Initiative filed a motion to intervene as defendants to ensure that the deeming rule was adequately defended, after the government had filed several requests to delay motions (in this and other cases).The plaintiffs and the defendant filed responses to this motion on August 7, 2017, and the potential intervenors filed their reply on August 14, 2017. On October 14, 2017, the court denied the public health groups’ motion to intervene.
Following the FDA’s July announcement of a new regulatory plan, the plaintiffs agreed to narrow the scope of their lawsuit and the court established a new briefing schedule. The plaintiffs filed a motion for summary judgment on October 3, 2017. The FDA filed its opposition to the plaintiffs’ motion and its own motion for summary judgment, and public health groups filed a supporting amicus curiae brief on October 31, 2017. Oral arguments on the cross-motions were heard on December 14, 2017.
On May 15, 2018, the court partially granted and partially denied the plaintiffs’ motion for summary judgment. The court found that the required warning labels did not violate the First Amendment, that the FDA’s user fee rule was legal, and that the FDA’s decision to regulate pipes did not violate the APA. The court did find, however, that the FDA’s regulation of tobacco retailers who blend pipe tobacco as manufacturers was a violation of the APA and remanded the issue to the FDA. The plaintiffs filed an appeal of the rulings on the First Amendment, user fee, and pipe tobacco regulation claims to the Court of Appeals for the D.C. Circuit.
Meanwhile, several issues remained unresolved at the district court level. On June 8, 2018, the plaintiffs filed a motion for an injunction of the enforcement of the warning label requirement for cigars and pipe tobacco pending the resolution of the plaintiffs’ appeal. On June 22, 2018, the FDA filed its memorandum in opposition to the plaintiffs’ motion. On July 5, 2018, the court granted the injunction, staying enforcement of the warning label requirement for cigars and pipe tobacco until sixty days after the resolution of the plaintiffs’ appeal.
At the Court of Appeals for the D.C. Circuit, the appellants filed their opening brief on February 19, 2019. Amicus curiae briefs in support of the appellants were filed in early March, 2019. The FDA filed its brief on April 22, 2019 followed by supporting amicus curiae briefs shortly thereafter. Oral arguments were held on October 29, 2019.
As the appeal was proceeding, the district court allowed plaintiffs in En Fuego Tobacco Shop et al. v. FDA (which had been consolidated with the Cigar Association case) to proceed with their own complaint. The court also allowed the En Fuego plaintiffs to amend their complaint and add three additional causes of action: another claim focused on the warning labels and the First Amendment and two claims borrowing the Appointments Clause claims brought by the plaintiffs in Moose Jooce et al. v. FDA. On March 15, 2019, the En Fuego plaintiffs filed a motion for summary judgment and a request for a permanent injunction. On April 26, 2019, the FDA filed a memorandum in opposition to the plaintiffs’ motion for summary judgment and a cross-motion for summary judgment. Oral arguments on these motions were held on September 10, 2019.
During the briefing on the summary judgment cross-motions, the district court also allowed the Cigar Association plaintiffs to amend their original complaint. On August 8, 2019, the Cigar Association plaintiffs amended their complaint to include a request for declaratory relief. This claim asked the court to declare the FDA’s 2017 guidance document effectively suspending premarket review enforcement for products subject to the deeming rule invalid. This 2017 guidance document was declared invalid by the District Court for the District of Maryland and upheld by the Fourth Circuit Court of Appeals in AAP v. FDA. Motions for leave to file the amended complaint, along with a motion for partial summary judgment were filed on July 2, 2019. The FDA filed its answer on August 8, 2019 and an opposition to the motion for partial summary judgment on September 18, 2019. On September 26, 2019, the public health groups that had previously participated as amicus filed a motion requesting to participate in oral arguments. The court granted the motion and oral arguments were held on October 1, 2019. On October 18, 2019, the court denied the plaintiffs’ motion for partial summary judgment.
On October 23, 2019, the plaintiffs amended their complaint again, adding five new causes of action. After several motions to delay the briefing schedule, the plaintiffs filed motions for summary judgment and a preliminary injunction on December 24, 2019. On January 8, 2020, the FDA filed a notice of its revised guidance document setting its enforcement priorities for electronic nicotine delivery (ENDS) and other deemed products. On February 2, 2020, the government filed its own cross-motion for summary judgment and opposition to the plaintiffs’ motion for summary judgment. On February 3, 2020, the court granted the plaintiffs’ motion for summary judgment and denied the defendant’s cross-motion for partial summary judgment, vacating the warning requirement for premium cigars and finding that the FDA had failed to “explain…why health warnings for premium cigar packaging and advertising are appropriate” in light of the “demographic differences and usage patterns” specific to premium cigars. This partially impacted the argument pertaining to warning labels still at issue on appeal (as to the premium cigar product subset), prompting FDA to file a notice of the En Fuego ruling with the D.C. Circuit on February 11, 2020.
Public health groups filed a motion to file an amicus brief in the distrcit court on February 10, 2020, and on February 24, 2020, plaintiffs filed their third amended complaint along with continued briefing on the ongoing summary judgment motions filed by the government.
Meanwhile, the evolving COVID-19 pandemic resulted in industry requests to extend the deadline for filing premarket tobacco product applications. When the petitions were denied by FDA, the plaintiffs filed a motion for a preliminary injunction with the court against enforcement of premarket and substantial equivalence application. Once the extension for the submission of premarket tobacco product applications was granted in AAP v. FDA and the deadline extended to September 9th, the motion was withdrawn.