Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). As we have previously discussed here and here, FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium cigars to the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act (TCA). On January 24, the U.S. Court of Appeals for the District of Columbia Circuit (the D.C. Circuit) issued an opinion agreeing[1] with (i) the district court’s ruling that FDA acted arbitrarily and capriciously when it sought to include premium cigars in its Deeming Rule and (ii) the district court’s vacatur of the Deeming Rule as applied to premium cigars, but it remanded the case to the district court to determine the appropriate definition of “premium cigar.” Now, the district court will reconsider the appropriate definition of “premium cigar,” which will ultimately determine the types of cigars that are not subject to the TCA and FDA’s Deeming Rule. In one potential setback for industry, the D.C. Circuit also stated that it understood the district court’s order as granting relief from user fees prospectively but that it does not read it as permitting the refunding of past user fee payments.
