South Florida Import & Export Corp Warning Letter Details

Summary

South Florida Import & Export Corp, a domestic importer of cigars and roll-your-own tobacco products, failed to remit user fee payments required under Section 919 of the Federal Food, Drug, and Cosmetic Act by the applicable quarterly deadlines. Due to this non-payment, FDA determined that all regulated tobacco products imported by the company were adulterated under Section 902(4) of the FD&C Act. The violation occurred after August 8, 2016, when the FDA's deeming rule extended regulatory authority to cigars and pipe tobacco products, which triggered the company's obligation to pay user fees to FDA's Office of Financial Management.