Yesterday, August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016 rule that swept all tobacco products under the same set of regulations. In previous decisions, the District Court already had vacated the portions of the Deeming Rule that required premium cigars to display health warnings on packaging and advertising and to engage in the burdensome premarket authorization process.
Importantly, the court also found in July of 2022 that the Deeming Rule was issued with an arbitrary and capricious disregard for the data before the agency concerning the use of premium cigars and the health effects of such use. Yesterday’s District Court decision relieves the premium cigar category of the agency’s burdensome regulatory requirements, including the agency’s recently proposed tobacco product manufacturing practices rule. These effects are subject to the agency’s right to appeal and, assuming the appeal is unsuccessful, the agency’s option to “re-deem” premium cigars and propose new regulations in the future under properly and comprehensively considered data in a new rulemaking process.