FDA WARNING_LETTER - Paramount Imports LLC - January 26, 2021

On September 1, 2020, the FDA issued a Warning Letter to Paramount Imports LLC, identifying them as a domestic importer of cigars subject to user fees under section 919 of the FD&C Act. The letter states that Paramount Imports LLC failed 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.

This failure to pay user fees renders all regulated tobacco products imported by Paramount Imports LLC adulterated under section 902(4) of the FD&C Act. 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, the FDA will be unable to issue an order finding a new tobacco product described in a pending or future Substantial Equivalence (SE) Report to be substantially equivalent until all assessed fees are paid. Entering a repayment plan does not negate the adulterated status of the products.

Paramount Imports LLC is required to 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 to set up a payment plan, and steps taken to prevent future violations, including a timetable for implementation if corrections are ongoing. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, seizure, and/or injunction.