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Seacoi Investments, Inc. d/b/a Miura Cigars, a domestic cigar importer, was cited for failing to pay assessed user fees required under Section 919 of the Federal Food, Drug, and Cosmetic Act. Because the company did not remit its quarterly user fee payments by the required deadlines, all of its imported tobacco products were deemed adulterated under Section 902(4) of the FD&C Act. This violation stemmed from the company's obligations as a regulated tobacco product importer following the FDA's August 2016 deeming rule that extended tobacco product regulation to cigars and pipe tobacco.