There is a possibility US FDA’s deeming rules on premium cigars may be reenacted during the appeals process by DOJ.
The US Department of Justice (DOJ) is appealing the decision in Cigar Association of America et al. v. United States Food and Drug Administration et al that had vacated the Food and Drug Administration’s (FDA) deeming regulations for premium cigars.
In August, Judge Amit P. Mehta of the US District Court for the District of Columbia vacated FDA’s 2016 rules classifying premium cigars as tobacco products that were subject to the same federal law as cigarettes. Last year Judge Mehta found the rule “arbitrary and capricious.” In his recent ruling, Judge Mehta rejected FDA’s argument that the deeming rule could be sent back to the agency for further consideration without vacating it, saying that a rule found to be arbitrary and capricious under the federal Administrative Procedure Act must be vacated unless there are exceptional circumstances.
Following Judge Mehta’s decision, FDA told cigar companies that deeming regulations do not apply to cigars that meet the criteria of being premium cigars, and that user fees cigar companies and importers paid to FDA to fund the Center for Tobacco Products would no longer be applied to premium cigars. FDA said it does not intend to assess user fees for premium cigars for FY23 Q4.
DOJ, which represents FDA on legal matters, had 60 days to appeal. It is unclear if DOJ will ask for a stay, which may reenact the premium cigars deeming laws while the appeals process is resolved.