FDA WARNING_LETTER - First Choice Pipe Tobacco - April 15, 2025

The FDA issued a Warning Letter to Eritrean Corporation d/b/a First Choice Pipe Tobacco, identifying it as a domestic importer and manufacturer of pipe tobacco subject to user fees under section 919 of the FD&C Act. The firm's products are deemed adulterated under section 902(4) of the FD&C Act because it failed to pay assessed user fees for multiple fiscal quarters from 2019 to 2023, despite invoices being issued and due dates passing.

The failure to pay user fees means the introduction into interstate commerce of the firm's tobacco products is a prohibited act under section 301(a) of the FD&C Act. Consequently, FDA cannot issue substantial equivalence (SE) orders for new tobacco products until all assessed fees are paid. Even entering a repayment plan does not render products compliant. The FDA requires a written response within 15 working days detailing actions to address violations, including proof of payment or contact with OFM for a payment plan, steps to prevent recurrence, and a timetable for corrections. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction, and imported products may be detained or refused admission.