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Jay Shree Hanuman, Inc., a domestic importer of cigarettes and cigars located in Havana, Florida, failed to pay user fees assessed by the FDA as required under Section 919 of the Federal Food, Drug, and Cosmetic Act. Because the company did not remit payment of its quarterly user fee assessments, all regulated tobacco products imported by the company were deemed adulterated under Section 902(4) of the FD&C Act. The Center for Tobacco Products determined that the company was subject to user fee obligations following the FDA's 2016 deeming rule that expanded the definition of regulated tobacco products to include cigars and pipe tobacco.