Synopsis

Swisher International is a manufacturer of flavored cigars and little cigars. In 2016, the U.S. Food and Drug Administration (FDA) issued the Deeming Rule, which extended the agency’s authority to regulate tobacco products to cigars and little cigars, among other products. Newly deemed products that fell under the agency’s authority were allowed to remain on shelves while manufacturers submitted their premarket tobacco product applications (PMTAs). The FDA subsequently extended the deadline for submission of PMTAs, but it still has not issued any final decisions regarding Swisher’s 171 tobacco product applications.

On August 4, 2021, Swisher filed a complaint in the District Court for the Middle District of Florida, seeking a preliminary injunction against enforcement of the FDA’s Deeming Rule. The district court denied the motion and granted the FDA’s motion to transfer the case to the District of Columbia, and Swisher filed an interlocutory appeal to the Eleventh Circuit. On February 3, 2022, the Eleventh Circuit affirmed the lower court’s decision and on April 8, 2022, the case was transferred from Florida to the District of Columbia.

Why it matters for Public Health

Flavored tobacco products mask the hard taste of tobacco and contribute significantly to initiation, particularly among youth who are attracted to sweet and fruity flavors. Beginning in 2019, cigars surpassed cigarettes as the most common combustible tobacco product used by youth. Among youth who have ever tried a cigar, 68 percent of cigarillo users and 56 percent of filtered cigar users reported that their first cigar was a flavored product. Cigars closely resemble cigarettes and pose similar health harms, both to users and to bystanders exposed to secondhand smoke.

Background

Under the Family Smoking Prevention and Tobacco Control Act, “new tobacco products”—defined as those commercially marketed after February 15, 2007—must receive FDA’s premarket review and approval before they can be sold in the U.S. The pre-market review requirements were deferred for a time for products that were already on the market at the time of the 2016 decision that deemed cigars and little cigars subject to FDA regulatory authority, but enforcement is now at the discretion of the FDA. Following some parallel administrative and court action, the deadline for PMTA submissions of this type was set for September 9, 2020, with final decisions for most products to be issued by September 9, 2021. In June 2021, the FDA announced that new tobacco products potentially would be subject to FDA enforcement if they were not authorized by the September 2021 deadline.

Swisher asked the FDA to use its discretion and not begin enforcement proceedings while the company’s applications were pending. The FDA responded that it was not planning any imminent enforcement action, but if it was, Swisher would first be informed in writing and would have 60 days to respond.

Proceedings

On August 4, 2021, Swisher sued the FDA, requesting a preliminary injunction to the agency’s enforcement activities and seeking to overturn the Deeming Rule due to alleged violations of the Administrative Procedure Act and other deficiencies. On August 16, the FDA opposed the motion, denying claims that it acted without proper authority and stating that Swisher’s claims of harm failed for lack of ripeness. The FDA also moved to transfer the case from Florida to the District Court for the District of Columbia. On September 7, the court denied Swisher’s motion for a preliminary injunction and granted the FDA’s motion to transfer. Swisher appealed this decision. On February 3, 2022, the Eleventh Circuit affirmed the district court’s decision to deny Swisher’s motion for preliminary injunction, ruling that the lower court did not abuse its discretion in determining that the FDA was unlikely to enforce against products that were pending marketing decisions. On April 5, the district court in Florida ordered the case transferred to the District Court for the District of Columbia.

In related news, on August 9, 2023, the U.S. District Court for the District of Columbia struck down the FDA’s authority to regulate premium cigars.

Litigation Status (OPEN)

The litigation is ongoing.