Rao Tobacco Imports – FDA Warning Letter, Jul 30, 2019

The FDA issued a Warning Letter to Rao Tobacco Imports for failing to pay assessed user fees for cigar tobacco products, as required by section 919 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company, identified as a domestic importer, has outstanding user fee assessments for the 1st, 2nd, 3rd, and 4th quarters of 2018, and the 1st and 2nd quarters of 2019. This failure to remit payments by the specified due dates renders all regulated tobacco products imported by Rao Tobacco Imports adulterated under section 902(4) of the FD&C Act. The letter emphasizes that introducing adulterated tobacco products into interstate commerce is a prohibited act under section 301(a) of the FD&C Act. Furthermore, FDA will be unable to issue substantial equivalence orders for new tobacco products until all assessed fees are paid in full, and repayment plans do not negate the adulterated status of products. Rao Tobacco Imports is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions and a compliance plan, noting that failure to comply could lead to further enforcement actions including civil money penalties, criminal prosecution, seizure, and injunction.