FDA WARNING_LETTER - The Vape Shop - December 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to The Vape Shop on December 4, 2025, following a review of their inspection records. The company, which manufactures and distributes e-liquid products, was cited for marketing "new tobacco products" without the legally required premarket authorization. Specifically, their product "The Vape Shop Turkish Blend" was identified as a new tobacco product, meaning it was not commercially marketed in the U.S. before February 15, 2007, and lacked necessary FDA marketing authorization orders. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these unauthorized products are considered adulterated and misbranded. The regulatory framework, including sections 201(rr), 901(b), 910(a), 902(6)(A), and 903(a)(6) of the FD&C Act, mandates premarket authorization for all new tobacco products, including those containing nicotine from any source. The FDA requires The Vape Shop to promptly address these violations by discontinuing the sale and distribution of the non-compliant e-liquid products. The company must submit a written response within 15 working days detailing their corrective actions, the dates on which violative sales ceased, and their plan for maintaining full compliance with the FD&C Act. Failure to comply could lead to further regulatory actions, such as civil money penalties or product seizure.