FDA Faces $10M Lawsuit from Cigar Companies Over User Fees

Nine premium cigar manufacturers filed a lawsuit in the U.S. Court of Federal Claims seeking at least $10 million plus interest in refunds of FDA user fees paid between 2016 and 2023. The lawsuit follows the cigar industry’s victory in a separate legal challenge that resulted in premium cigars being exempted from FDA regulation, with the companies arguing they should not have been required to pay user fees on products the agency ultimately lacked authority to regulate.

Arturo Fuente, Ashton, CLE Cigar, J.C. Newman, Oliva, La Flor Dominicana, My Father Cigars, Padrón, and Rocky Patel contend they paid the fees despite premium cigars being excluded from most FDA requirements and are now seeking reimbursement after the FDA stopped collecting user fees on premium cigars following a key 2023 court ruling. Court filings in the earlier litigation suggested the government could face more than $100 million in past user fee refunds. The case has been assigned to Judge Edward H. Meyers, with the plaintiffs represented by Morgan Lewis, including attorney Michael Edney, who led much of the industry’s successful challenge to the FDA’s premium cigar regulations.