FDA WARNING_LETTER - Transphere, Inc. - April 05, 2022

The FDA issued a Warning Letter to Transphere, Inc., a domestic importer of cigarettes, cigars, and roll-your-own tobacco, for failing to pay assessed user fees. As per section 919(b)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), importers must remit user fee payments by the last day of the applicable quarter. FDA records indicate Transphere, Inc. has not paid user fees assessed by the Office of Financial Management. This non-payment renders all regulated tobacco products imported by the firm adulterated under section 902(4) of the FD&C Act. Consequently, the introduction or delivery of these adulterated tobacco products into interstate commerce is a prohibited act under section 301(a) of the FD&C Act. Furthermore, FDA will be unable to issue substantial equivalence orders for new tobacco products until all assessed fees are paid. The FDA requires a written response within 15 working days detailing actions taken to pay outstanding fees, prevent future violations, and a timetable for implementation. Failure to comply may result in regulatory actions including civil money penalties, seizure, injunction, and detention or refusal of imported products.