Cigar Association of America et al. v. U.S. Food and Drug Administration

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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 American, 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 proceeds and asked the court to permanently strike down the rule. The FDA filed its answer on October 26, 2016.12 The plaintiffs filed a motion for summary judgment on February 13, 2017.

The lawsuit alleges that:

  1. the enforcement of premarket review will be costly, rendering the FDA’s action “arbitrary and capricious” in violation of the APA;
  2. 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;
  3. 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;
  4. 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;
  5. 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;
  6. 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;
  7. the required warning labels impermissibly restrict speech, a violation the First Amendment;
  8. 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;
  9. the FDA’s decision to regulate pipes as components or parts of a tobacco product is “arbitrary and capricious” in violation of the APA.

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 is adequately defended, after the government had filed several requests to delay motions in this and other cases, as well as delaying some of the enforcement dates implementing the deeming rule. 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. The court has asked for supplemental briefs from the parties and potential intervenors to be filed on September 20, 2017. On October 14, 2017, the court denied the 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 by October 24, 2017 and public health groups filed a supporting amicus curiae brief on October 31, 2017. The plaintiffs filed their reply on November 14, 2017. The FDA filed its reply on December 4, 2017 and oral arguments 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 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 to the Court of Appeals for the D.C. Circuit.

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 and on June 29, 2018, the plaintiffs filed their reply regarding the motion to for an injunction. 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 on March 5, 2019. The FDA filed its brief on April 22, 2019. Amicus curiae briefs in support of the FDA were filed on May 6, 2019. The appellants filed their reply on June 10, 2019. The FDA filed its final brief on June 25, 2019 and the appellants filed their final brief on July 1. Oral arguments were held on October 29, 2019.

As the appeal is proceeding, the district court has also allowed the En Fuego plaintiffs to proceed with their own complaint at the same time. 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 from the Moose Jooce plaintiffs. On March 15, 2019, the En Fuego plaintiffs filed a motion for summary judgment and 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. On June 4, 2019, the En Fuego plaintiffs filed a memorandum in opposition to the FDA’s cross-motion for summary judgment. The FDA filed a reply on June 26, 2019. Oral arguments on these motions were heard on September 10, 2019.

The district court has also allowed the Cigar Association plaintiffs to amend their original complaint as well. On August 8, 2019, the Cigar Association plaintiffs amended their complaint to include a request for declaratory relief. This claim asks the court to declare that the FDA’s 2017 guidance document changing its premarket review enforcement for products subject to the deeming rule is valid. This is the guidance document at issue in AAP v. FDA, that was declared invalid by the District Court for the District of Maryland. The amended complaint and 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. The plaintiffs filed their reply on September 25, 2019. On September 26, 2019, public health groups that had filed an amicus brief, 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 motion for partial summary judgment.  On October 23, 2019, the plaintiffs amended their complaint a second time, adding five new causes of action. The court has established the following briefing schedule: December 6, 2019, the FDA will file its opposition and cross-motion by January 14, 2020, the Cigar Association plaintiffs will file their reply by February 4, 2020, and the FDA will file its reply by February 25, 2020. Oral Arguments have not yet been scheduled.

Public Health Law Center Amicus Brief