In a recent development, the U.S. Food and Drug Administration (FDA) has filed an appeal against Judge Amit Mehta’s decision to deem the regulation of premium cigars as arbitrary and capricious, leading to its vacating. The appeal is set to be heard by the United States Court of Appeals for the D.C. Circuit in Washington, D.C.
Back in 2022, Judge Mehta conducted a comprehensive analysis, highlighting the FDA’s failure to address evidence indicating distinct usage patterns and health effects of premium cigars compared to other varieties. Notably, the judge found the FDA’s mishandling of critical questions posed in its proposed rule as grounds for vacating the decision, emphasizing the agency’s lack of a non-arbitrary rationale for regulating premium cigars. We talked about this with Rocky Patel on The Cigar Authority podcast last summer.
Judge Mehta echoed concerns shared by the FDA itself, acknowledging that premium cigars are of the lowest enforcement priority due to their unique usage patterns. The agency itself admits lingering uncertainties about how these products should be regulated, raising questions that remain unanswered.
In its appeal, the FDA defends its rule-making against Judge Mehta’s findings, emphasizing deference to its “scientific judgment.” The agency argues that the flawed rule should have been sent back for correction while allowing continued regulation under the existing arbitrary rule. The Premium Cigar Association (PCA) is gearing up to respond to these arguments, supporting Judge Mehta’s well-reasoned opinion in an upcoming filing with the D.C. Circuit Court. A hearing before a panel of three appellate court judges is expected to follow.
Stay tuned for updates on this crucial issue as the case unfolds before the D.C. Circuit Court.