Jay Shree Hanuman, Inc. – FDA Warning Letter, Feb 15, 2022

The FDA issued a Warning Letter to Jay Shree Hanuman, Inc. on February 1, 2022, identifying them as a domestic importer of cigarettes and cigars subject to user fees under section 919 of the FD&C Act. The primary violation is the failure to pay assessed user fees by the last day of the applicable quarter, as required by section 919(b)(6). This non-payment renders all regulated tobacco products imported by the company adulterated under section 902(4) of the FD&C Act.

The letter states that the introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a). Consequently, the FDA cannot issue substantial equivalence (SE) orders for new tobacco products until all assessed fees are paid in their entirety, even if a repayment plan is in place. The FDA requires a written response within 15 working days detailing actions taken to address the violations, including documentation of user fee payment or contact with OFM to arrange payment, steps to prevent future violations, and a timetable for corrections. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.