FDA WARNING_LETTER - Smoke Euphoria Inc d/b/a Euphoria Vapor Outlet - January 12, 2022

The FDA issued a Warning Letter to Smoke Euphoria Inc d/b/a Euphoria Vapor Outlet after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically "Euphoria Custom Gourmet 12mg 20ml e-liquid product," without the required premarket authorization. Under the FD&C Act, these e-liquid products are deemed tobacco products subject to FDA regulation. The identified product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. Consequently, the product is 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. Furthermore, the act of holding for sale an adulterated or misbranded tobacco product after interstate shipment, and the failure to provide a required report under section 905(j), constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act, respectively. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. The firm, a registered manufacturer with over 800 listed products, must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for future compliance.