Califa Imports, Inc. – FDA Warning Letter, May 16, 2023

On May 4, 2023, the FDA issued a Warning Letter to Califa Imports, Inc., identifying the company as a domestic importer of cigars and roll-your-own tobacco, subject to user fees under section 919 of the FD&C Act. The letter states that all regulated tobacco products imported by Califa Imports, Inc. are adulterated under section 902(4) of the FD&C Act because the company failed to pay assessed user fees. Specifically, the FDA's Office of Financial Management (OFM) assessed user fees that remain unpaid, violating section 919(b)(6) which requires payment by the last day of the applicable quarter.

The introduction or delivery of adulterated tobacco products into interstate commerce is a prohibited act under section 301(a) of the FD&C Act. Failure to pay user fees also prevents the FDA from issuing substantial equivalence orders for new tobacco products, except for specific grandfathered products. Even a repayment plan does not render products compliant if fees remain unpaid.

Califa Imports, Inc. must submit a written response within 15 working days detailing actions to address violations and ensure future compliance. The response must include documentation of fee payment or contact with OFM to arrange payment, steps taken 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.