NXNW Vapor Inc. – FDA Warning Letter, Mar 8, 2022

On March 8, 2022, the FDA issued a Warning Letter to NXNW Vapor Inc. after reviewing submissions and inspection records. The FDA determined that NXNW Vapor Inc. manufactures and distributes e-liquid products, specifically "NXNW VAPOR Black Tea 1MG," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the "NXNW VAPOR Black Tea 1MG" e-liquid product is a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The letter states that marketing new tobacco products without authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. NXNW Vapor Inc. is a registered manufacturer with over 100 products listed with the FDA.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing