FDA WARNING_LETTER - Thayer Distribution, Inc. - October 01, 2025

GT Hyper Distribution, Inc. received a Warning Letter from the U.S. Food and Drug Administration (FDA) on October 16, 2025, for unlawfully marketing and distributing electronic nicotine delivery system (ENDS) products. Specifically, the FDA identified the "FOGER SWITCH PRO KIT 5% NICOTINE STRAWBERRY B-POP" as a new tobacco product sold without the required premarket authorization. This determination followed a review of inspection records.Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including a 2022 amendment that expanded the definition of "tobacco product" to include nicotine from any source, new tobacco products must obtain FDA marketing authorization to be legally sold in the U.S. As this product was not commercially marketed before February 15, 2007, and lacks authorization, it is deemed adulterated and misbranded under the FD&C Act.GT Hyper Distribution, Inc. is required to immediately address these violations by discontinuing the sale and distribution of all unauthorized tobacco products. The company must submit a written response within 15 working days, detailing the corrective actions taken, including the dates of discontinuation, and outlining a plan for maintaining full compliance with the FD&C Act. Non-compliance could lead to further regulatory enforcement.