13 Vapor Co LLC – FDA Warning Letter, Nov 9, 2021

The FDA issued a Warning Letter to 13 Vapor Co, LLC on November 9, 2021, 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 "13 Vapor Ripe Strawberry 3mg 20mL 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 adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

The FDA states that manufacturing, selling, or distributing such products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is a registered manufacturer with over 8,900 listed products, and all new tobacco products without premarket authorization are considered unlawfully marketed.

13 Vapor Co, LLC must submit a written response within 15 working days detailing corrective actions, including dates of discontinued sales/distribution and a plan for maintaining compliance