FDA WARNING_LETTER - South Florida Import & Export Corp - July 27, 2021

On June 8, 2021, the FDA issued a Warning Letter to South Florida Import & Export Corp, identifying it as a domestic importer of cigars and roll-your-own tobacco products subject to user fees under section 919 of the FD&C Act. The core 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 the company adulterated under section 902(4) of the FD&C Act. The letter specifies that the FDA's Office of Financial Management (OFM) assessed user fees, but payment has not been received for enumerated invoices.

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, the FDA will be unable to 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 corrective actions, including documentation of fee payment or contact with OFM to arrange payment, steps to prevent future violations, and a timetable for implementation if corrections are ongoing. Failure to address this may result in regulatory actions such as civil money penalties, seizure,