FDA WARNING_LETTER - The National Tobacco Alliance, Inc. d/b/a KC Smoke & Vape - July 13, 2023

The FDA issued a Warning Letter to The National Tobacco Alliance, Inc. d/b/a KC Smoke & Vape on July 13, 2023, following a review of 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," specifically "KC Juice Creamy Vanilla Butterscotch 18MG 30ml," 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 adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification.

The FDA states that marketing new tobacco products without authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company 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 compliance. Failure to comply may lead to further regulatory action.