FDA WARNING_LETTER - Smoke N Vape Inc. - November 16, 2022

The FDA issued a Warning Letter to Smoke N Vape Inc. on November 16, 2022, after reviewing submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product," BLUE OX VAPOR BANANA SPLIT 11mg 30ml 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, as no required notice or information was provided.

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act for holding for sale an adulterated/misbranded product and failing to provide a required report, respectively. The letter emphasizes that all new tobacco products without premarket authorization are unlawfully marketed and subject to enforcement, including civil money penalties, seizure, and injunction.

Smoke N Vape Inc. must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future