Vapor Proz USA LLC – FDA Warning Letter, Feb 24, 2022

The FDA issued a Warning Letter to Vapor Proz USA LLC on February 24, 2022, following a review of submissions and inspection records. The FDA determined that Vapor Proz USA LLC manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of a "new tobacco product," specifically "Vapor Proz USA Blue Raspberry 6mg 100ml 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 due to the failure to provide required notice or information.

The letter states that manufacturing or holding for sale adulterated or misbranded tobacco products, or failing to provide required reports, are prohibited acts under sections 301(k) and 301(p) of the FD&C Act. Vapor Proz USA LLC is a registered manufacturer with over 11,700 listed products, and all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement.

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