FDA WARNING_LETTER - The Vapor Vendor - April 21, 2020

The FDA issued a Warning Letter to The Vapor Vendor on April 9, 2020, following a review of submissions and inspection records. The FDA determined that The Vapor Vendor manufactures and distributes e-liquid products, specifically "Lucky Number 13 STYX e-liquid," which are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Lucky Number 13 STYX e-liquid" product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided.

The letter cites prohibited acts under sections 301(k) and 301(p) of the FD&C Act for misbranding and failure to provide required reports. The FDA requires The Vapor Vendor to submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales and distribution, and a plan for ongoing compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/