FDA WARNING_LETTER - Florida Import Export Services - October 01, 2019

This FDA Warning Letter, dated September 24, 2019, addresses Florida Import Export Services, a domestic importer of cigar tobacco products. The letter states that the company is subject to user fees under section 919 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation identified is the failure to pay assessed user fees. FDA records indicate that Florida Import Export Services imports tobacco products subject to these fees and has not remitted payment for six assessment invoices spanning from the 2nd Quarter 2018 to the 3rd Quarter 2019. Specific assessment and due dates are provided for each quarter.

According to section 902(4) of the FD&C Act, all regulated tobacco products imported by Florida Import Export Services are deemed adulterated due to the failure to pay user fees as required by section 919. The introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act.

Furthermore, compliance with the FD&C Act, including user fee payment, is required for FDA to issue orders for new tobacco products described in Substantial Equivalence (SE) Reports, with limited exceptions. Entering a repayment plan does not render products compliant; products remain adulterated if fees are not paid by the specified dates.

Florida Import Export Services is required to immediately correct these violations and submit a