FDA WARNING_LETTER - Prestige Tobacco Inc. - January 26, 2021

The FDA issued a Warning Letter to Prestige Tobacco Inc., identifying it as a domestic importer of cigars subject to user fees under section 919 of the FD&C Act. The core violation is the failure to pay assessed user fees by the last day of the applicable quarter, as required by section 919(b)(6) of the FD&C Act.

Due to this failure, all regulated tobacco products imported by Prestige Tobacco Inc. are deemed adulterated under section 902(4) of the FD&C Act. The letter specifies that FDA's Office of Financial Management (OFM) assessed user fees, but payment for enumerated invoices has not been received.

The introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act. Furthermore, FDA cannot issue substantial equivalence (SE) orders for new tobacco products (with specific exceptions) until all assessed user fees are paid. Entering a repayment plan does not negate the adulterated status of the products.

Prestige Tobacco Inc. must immediately correct these violations and submit a written response within 15 working days. The response must include documentation of user fee payment or contact with OFM for payment information/plan, steps taken to prevent future violations, and a timetable for planned corrections. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, seizure, and/or injunction.