FDA WARNING_LETTER - Seacoi Investments, Inc. d/b/a Miura Cigars - April 05, 2022

The FDA issued a Warning Letter to Seacoi Investments, Inc. d/b/a Miura Cigars on March 28, 2022, identifying them as a domestic importer of 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) of the FD&C Act.

This non-payment renders all regulated tobacco products imported by Seacoi Investments, Inc. adulterated under section 902(4) of the FD&C Act. The letter specifies that FDA has not received payment for assessed user fees, despite invoices being issued.

As a consequence, 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, FDA cannot issue substantial equivalence (SE) orders for new tobacco products until all assessed fees are paid in their entirety; entering a repayment plan does not negate the adulterated status.

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, and steps to prevent future occurrences. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction, and imported products may be