FDA WARNING_LETTER - Za Imports Inc - October 26, 2021

The FDA issued a Warning Letter to Za Imports Inc., a domestic importer of cigars, for failing to pay assessed user fees as required by section 919 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA determined that all regulated tobacco products imported by Za Imports Inc. are adulterated under section 902(4) of the FD&C Act due to this failure.

The letter specifies that Za Imports Inc. imports tobacco products subject to user fees and was assessed fees by FDA’s Office of Financial Management (OFM), but payment for enumerated invoices has not been received. Section 919(b)(6) of the FD&C Act mandates payment by the last day of the applicable quarter or within 30 days of final agency action on any fee dispute.

As a consequence of this violation, the introduction or delivery into interstate commerce of these 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 new tobacco products described in pending or future Substantial Equivalence (SE) Reports to be substantially equivalent until all assessed fees are paid. Even entering a repayment plan does not render products compliant.

Za Imports Inc. is required to submit a written response within 15 working days, detailing actions taken to address the violations, including documentation of fee payment or contact with OFM to arrange payment,