Synopsis

Swisher, International (Swisher) is a manufacturer of flavored cigars and little cigars. In 2016 the U.S. Food and Drug Administration (FDA) issued the Deeming Rule, which among other products deemed cigars and little cigars to be under FDA regulatory oversight. FDA stated that the newly-deemed products could remain on shelves while manufacturers submitted their premarket tobacco product applications (PMTA). Since 2016, FDA has extended the deadline for submission of PMTAs, but has not issued any final decision with respect to Swisher’s 171 product applications. On August 4th, 2021, Swisher filed a complaint in the U.S. District Court for the Middle District of Florida seeking a preliminary injunction against FDA enforcement. The District Court denied the motion and granted FDA’s motion to transfer the case to the District of Columbia, and Swisher filed an interlocutory appeal to the 11th Circuit Court of Appeals. The Court of Appeals affirmed the lower court’s decision on February 3rd, 2022, and the case transferred from Florida to the District of Columbia on April 8th, 2022.

Why it matters for Public Health

Flavored tobacco products are particularly appealing to youth and contribute significantly to youth initiation. In addition, flavored tobacco products can stymie cessation efforts by maintaining current-user interest and enjoyment in consuming these products. Flavorings can mask the abrasive qualities of tobacco smoke and other tobacco product consumption. Cigar and little cigar use is particularly prevalent among key populations historically targeted by tobacco industry marketing, including the African American/Black community and Latinx community in the United States. Beginning in 2019, cigars surpassed cigarettes as the most commonly reported combustible tobacco product used by youth. Among youth who have ever tried a cigar, 68% of cigarillo users and 56% of filtered cigar users report that their first cigar was a flavored product. Certain cigars can closely resemble cigarettes and cigars pose many of the same harms as cigarettes.

Background

The Tobacco Control Act requires “new tobacco products,” defined as those that were commercially marketed after February 15th, 2007, to go through a premarket review process and receive affirmative marketing orders before being sold in the U.S. In 2016, FDA deemed that cigars and little cigars (also known as cigarillos) were within its regulatory jurisdiction under the Tobacco Control Act, which amended the Food, Drug, and Cosmetic Act. Flavored cigars and little cigars had been on-market for several years already, and in light of enforcement difficulties resulting therefrom FDA granted a grace period for on-market products before manufacturers would need to submit PMTAs. Following some parallel administrative and court action the deadline for PMTA submissions of this type was set for September 9th, 2020 – with final decisions issued by September 9th, 2021 for the majority of products (with the one-year between continuing the grace period). Relatedly, FDA signaled its intention to promulgate new product standards for cigars and little cigars in 2022, including to prohibit the sale of flavored cigars and little cigars.

District Court Proceedings

On August 4th, 2021, Swisher filed its complaint against the FDA in the District Court. Swisher alleges 4 claims against FDA warranting a preliminary injunction against enforcement:

  1. The Deeming Rule is unconstitutional.
  2. The Deeming Rule, if not unconstitutional, violates the Administrative Procedures Act and goes beyond the authority provided by Congress to regulate tobacco products.
  3. FDA is unlawfully and unreasonably withholding action on Swisher’s PMTAs, the failure of which to act in a timely fashion on violates due process.
  4. FDA enforcement against Swisher would constitute a violation of due process and fair notice.

On August 5th, Swisher’s motion for preliminary injunction was taken under advisement as the Court solicited responses and other information from the parties. On August 16th FDA issued a response in opposition to the motion, denying the claims generally that it acted without proper authority and further that Swisher’s claims of harm are not ripe. FDA also filed a motion to transfer the case from Florida to the District Court for the District of Columbia. On September 7th, 2021, the Court denied Swisher’s motion for preliminary injunction and granted the motion to transfer. Swisher filed an interlocutory appeal for this decision on the same day to the 11th Circuit Court of Appeals, seeking a stay of the motion to transfer and to hold the proceedings in abeyance pending a decision from that court. The District Court granted the stay of the motion to transfer on September 9th and held the proceedings in abeyance pending the higher court’s decision.

On February 3rd, 2022, the 11th Circuit Court of Appeals affirmed the District Court’s decision to deny Swisher’s motion for preliminary injunction, concluding that the lower court did not abuse its discretion in determining FDA was unlikely to enforce against products which were pending marketing decisions. On April 5th, 2022, the District Court in Florida ordered the case transferred to the District Court in the District of Columbia, which occurred in April 8th, 2022.

Litigation Status

This dispute is ongoing and no final decision has yet been reached.

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