FDA WARNING_LETTER - GSM Services, LLC - May 30, 2023

On May 17, 2023, the FDA issued Warning Letter 7533 to GSM Services, LLC., a domestic importer of pipe tobacco, cigars, and roll-your-own tobacco products. The FDA determined that GSM Services, LLC. failed to pay user fees assessed under section 919 of the FD&C Act (21 U.S.C. § 387s). Specifically, the company has outstanding user fee payments for multiple fiscal quarters from 2019 through 2022, with assessment invoice dates ranging from March 1, 2019, to December 1, 2022.

As a result of the failure to pay assessed user fees, all regulated tobacco products imported by GSM Services, LLC. are deemed adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)). The introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Furthermore, the FDA will be unable to issue substantial equivalence orders for new tobacco products until all assessed fees are paid in their entirety, even if a repayment plan is established.

GSM Services, LLC. is required to submit a written response within