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WARNING LETTER
•Game Trader•November 3, 2025

Game Trader – FDA Warning Letter, Nov 3, 2025

Record Details

The U.S. Food and Drug Administration (FDA) Center for Tobacco Products issued a Warning Letter to The Game Trader Inc on November 6, 2025, concerning the unlawful marketing and distribution of e-liquid tobacco products. The FDA identified that The Game Trader Inc is selling "new tobacco products," specifically citing "Yogi E-liquid Original Granola Bar 6mg 60ml," without the required premarket authorization.Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), e-liquid products, including those containing nicotine from any source, are considered tobacco products subject to FDA jurisdiction. For new tobacco products—defined as those not commercially marketed in the U.S. as of February 15, 2007—a premarket authorization order is mandatory. The absence of such authorization renders the listed e-liquid product adulterated and misbranded according to FDA regulations.The FDA requires The Game Trader Inc to immediately cease the sale and distribution of all violative tobacco products. The company must submit a comprehensive written response within 15 working days from the letter"s receipt. This response needs to detail specific actions taken to correct the violations, including discontinuing sales, and outline a plan to maintain compliance with the FD&C Act. Failure to comply may result in further regulatory actions such as civil money penalties, seizure, or injunction.

Company
Game Trader
Inspection date
November 3, 2025
Product type
Tobacco
Office
Office of Compliance and Enforcement
Person
  • John E. Verbeten (Director)
View Company Profile

ID · 8f3ccfe3-5d92-4460-b6a5-e5871c2bc3fa

Violation Codes10
FD&C Act 201(rr)21 U.S.C. 321(rr)FD&C Act 901(b)21 U.S.C. 387a(b)21 CFR 1100.1FD&C Act 910(a21 U.S.C. 387j(a)FD&C Act 910(c}(1)(A)(i)21 U.S.C. 387j(c)(1)(A)(i)FD&C Act 905(j)

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Other documents for Game Trader
  • WARNING_LETTER - 2023-08-10August 10, 2023

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