In August 2021, Swisher International Inc. filed a lawsuit against the Food and Drug Administration (FDA) seeking to have the FDA’s Deeming Rule declared invalid. Swisher followed its lawsuit with a petition for injunction to prevent FDA from taking enforcement action against Swisher while Swisher’s lawsuit against the FDA’s implementation of the Deeming Rule is under consideration and while the FDA processes Swisher’s pending 173 premarket applications. On February 3, 2022, the Eleventh Circuit Court of Appeals upheld a lower court’s denial of a motion for a preliminary injunction finding that Swisher was not likely to suffer “irreparable harm.”
Background. As part of the agency’s efforts to implement the Tobacco Control Act, the FDA implemented the “Deeming Rule” in 2016 and ruled that all products that meet the statutory definition of a “tobacco product” were subject to the Tobacco Control Act. This included a requirement from the FDA that all tobacco products that were not on the market as of February 2007 would require FDA authorization before they could be marketed. The FDA also created a pathway where a manufacturer could obtain premarket authorization for a product that was “substantially equivalent” “to a tobacco product commercially marketed” in February 2007. See 21 U.S.C. § 387e(j)(1).
Initially, the FDA said it would not begin enforcement of this rule for 18 months while manufacturers submitted their applications and then for another 18 months while the FDA took action on the applications. These deadlines were later extended until August 2021 for many products, including Swisher’s cigars, but in an unrelated court case in 2019, a federal court in Maryland ordered the FDA to only permit these products to “remain on the market without being subject to FDA enforcement actions” until September 9, 2021. See Am. Acad. of Pediatrics v. Food & Drug Admin., 379 F.Supp.3d 461 (D. Maryland 2019).
In response to the Maryland court’s order, the FDA announced in a public webinar in June 2021 that new tobacco products potentially would be subject to FDA enforcement if they were not authorized by the September 2021 deadline. Swisher wrote to the FDA asking the FDA to use its discretion and not begin enforcement proceedings while the company’s applications were pending. The FDA replied in a letter 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. Swisher filed its lawsuit in August 2021 seeking an injunction to the FDA’s enforcement activities and to overturn the Deeming Rule due to violations of the Administrative Procedure Act and other deficiencies.
This Week’s Ruling. Put simply, it is generally very difficult to get a court to issue a preliminary injunction. In the Eleventh Circuit, there is a four-part test that is used when an injunction is requested. An injunction is granted when the requesting party shows that: “(1) it has a substantial likelihood of success on the merits; (2) irreparable injury will be suffered unless the in-junction issues; (3) the threatened injury to the movant outweighs whatever damage the proposed injunction may cause the opposing party; and (4) if issued, the injunction would not be adverse to the public interest.” Siegel v. Le-Pore, 234 F.3d 1163, 1176 (11th Cir. 2000) (en banc). In the Swisher ruling, the Eleventh Circuit focused mainly on the issue of irreparable harm and found that the possibility of enforcement action was not sufficient to warrant granting the injunction. As the FDA has not warned Swisher that it intends to begin enforcement proceedings and not triggered the 60-day response period discussed above, the court found there was no reason to believe Swisher would be harmed imminently and stated that, if Swisher did receive a warning letter, the court could reconsider the issue at that time.
Our Take. The FDA has now put its credibility on the line with the court, should the agency now try to take enforcement action against Swisher prior to completing its review of Swisher’s premarket applications, the FDA runs the risk of appearing to be less than forthright about its intentions. In the short term, this should provide some comfort to manufacturers and importers filing that filed substantial equivalence report by the September 2020 deadline that enforcement action prior to completion of the agency’s review of those reports is unlikely.