FDA WARNING_LETTER - Game Trader - November 03, 2025
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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.
ID · 8f3ccfe3-5d92-4460-b6a5-e5871c2bc3fa
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