Jash International, Inc – FDA Warning Letter, Apr 13, 2021

The FDA issued a Warning Letter to Jash International, Inc., a domestic importer of cigarettes, cigars, and pipe tobacco, for failing to pay assessed user fees. As a domestic importer, Jash International, Inc. is subject to user fees under section 919 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA determined that all regulated tobacco products imported by Jash International, Inc. are adulterated under section 902(4) of the FD&C Act because the company failed to remit payment for assessed user fees by the last day of the applicable quarter, as required by section 919(b)(6).

The introduction or delivery into interstate commerce of any adulterated tobacco product is a prohibited act under section 301(a) of the FD&C Act. Furthermore, the FDA will not issue substantial equivalence (SE) orders for new tobacco products from firms that have not paid their assessed fees in their entirety. Even entering a repayment plan for assessed user fees does not render a product compliant.

Jash International, Inc. must submit a written response within 15 working days detailing corrective actions, including documentation of user fee payment or contact with the Office of Financial Management (OFM) to arrange payment, and steps taken to prevent future violations. Failure to address this matter may result in regulatory actions such as civil money penalties, seizure, and/or injunction.