Cigar retailers, manufacturers, and trade association challenged the deeming rule under the First Amendment and the Administrative Procedure Act (APA).
Why It Matter for Public Health
This case, like Cigar Association v. FDA, challenged the application of the deeming rule’s application to cigars. This case was consolidated with Cigar Association, which is ongoing and has resulted in some erosion of the deeming rule’s application to cigars. See that case for more detail and ongoing litigation updates.
On May 5, 2016, the FDA issued the final rule deeming all existing and future tobacco products to be subject to the agency’s jurisdiction, including cigars. Under the deeming rule, cigars were required to comply with warning label requirements.
District Court Proceedings
On January 11, 2018, En Fuego Tobacco Shop LLC, Cuba Libre Enterprises LLC, and the Texas Cigar Merchants Association, a cigar retailer, a manufacturer, and a trade association, filed suit in the Eastern District of Texas.
The lawsuit alleged that:
- the required warning labels impermissibly restrict speech, a violation the First Amendment;
- the required warning labels unconstitutionally compel speech, a violation of the First Amendment;
- the required submission of warning plans is an unconstitutional prior restraint and unconstitutionally restricts speech, a violation of the First Amendment;
- the FDA did not make findings required by the Tobacco Control Act before imposing required warning labels;
- the FDA did not make findings required by the Tobacco Control Act before imposing required warning labels, a violation of the APA.
The plaintiffs also requested that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeded.
The FDA’s filed its answer on March 19, 2018, along with a motion to transfer the case to the U.S. District Court for the District of Columbia. The motion to transfer highlighted the fact that the plaintiffs in this litigation are members of one of the organizations that is a plaintiff in Cigar Association of America, et al. v. FDA, the attorneys representing the plaintiffs in this lawsuit also represented the plaintiffs in that case, and that the claims made in this case were identical to the claims in that case. The FDA argued that the transfer of venue would allow this case to be consolidated with Cigar Association of America.
On March 27, 2018, the plaintiffs amended their complaint and filed a motion for summary judgment. On April 16, 2018, the FDA filed a motion to stay briefing on the plaintiff’s motion for summary judgment pending the outcome of the FDA’s motion to transfer. On April 20, 2018, the court stayed the briefing on the plaintiffs' motion for summary judgment until the court ruled on the FDA’s motion to stay. On May 22, 2018, the court denied the FDA’s motion to transfer and denied the FDA’s motion to stay briefing. On June 5, 2018, the FDA filed an appeal of the magistrate judge’s denial of the agency’s motion to transfer.
While the appeal of the denial of the motion to transfer was pending, briefing continued on the plaintiffs’ motion for summary judgment. A hearing on the motion was held on June 26, 2018.
On July 2, 2018, the court granted the FDA’s motion to transfer, overturning its previous decision to deny the motion. Even though the plaintiffs continued to resist the transfer, the case was eventually consolidated with Cigar Association of America, et al. v. FDA.
The case was consolidated with Cigar Association of America v. FDA and litigation in that case is ongoing.