FDA Files Appeal of Judge Mehta’s Decision

February 1, 2024 By Matthew Tabacco
FDA Updates

On January 31, 2024, the U.S. Food and Drug Administration (FDA) filed its appealing Judge Amit Mehta’s orders holding the FDA’s decision to regulate premium cigars arbitrary and capricious and vacating it. The appeal is presented to the court of appeals in Washington, D.C., known as the United States Court of Appeals for the D.C. Circuit. 

In 2022, Judge Mehta issued a thorough opinion examining the rulemaking record and detailing the FDA’s failure to address evidence in the record showing that premium cigars have different usage patterns, with different resulting health effects, than other cigars. Judge Mehta later ruled that the FDA’s mishandling of significant questions the FDA itself asked in its proposed rule merited vacating it, as the FDA never made a non-arbitrary decision to regulate premium cigars.

Judge Mehta is not the only one to recognize that the FDA left serious questions unanswered regarding premium cigars. The FDA itself has recognized that premium cigars are its lowest priority for enforcement, given their different usage patterns, and that serious questions remain outstanding regarding whether or how the products should be regulated. 

In its appeal, the FDA attempts to defend its rulemaking against Judge Mehta’s detailed findings and urges the Court to elevate deference to the agency’s “scientific judgment” over its duty of explanation under the APA. The FDA also argues that Judge Mehta should have sent the flawed rule back to the agency to fix it, while allowing the FDA to continue regulating premium cigar retailers and manufacturers under the arbitrary rule in the meantime. 

The Premium Cigar Association (PCA) will be responding to these arguments and defending Judge Mehta’s thoughtful and well-reasoned opinion in a forthcoming filing with the D.C. Circuit Court. A hearing before three judges of the appellate court is likely to follow.

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