Game Trader – FDA Warning Letter, Aug 10, 2023

The FDA issued a Warning Letter to Game Trader on August 10, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of a "new tobacco product," specifically "GOAT Strawberry Watermelon Iced 3mg" e-liquid, without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information. Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

Game Trader is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation dates for violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.