FDA WARNING_LETTER - Freaz LLC d/b/a Vapor Wize - September 13, 2022

The FDA issued a Warning Letter to Freaz LLC d/b/a Vapor Wize on September 13, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically identified as "Vapor Kicks Ash Jolly Dragon 24mg 100ml e-liquid," which are deemed tobacco products under the FD&C Act.

The primary violation is the marketing of a "new tobacco product" without the required premarket authorization. The "Vapor Kicks Ash Jolly Dragon 24mg 100ml e-liquid" 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 no required notice or information was provided under section 905(j).

Prohibited acts include holding for sale after interstate shipment resulting in adulteration or misbranding (section 301(k)) and failing to provide a required report (section 301(p)). The FDA prioritizes enforcement against products lacking premarket authorization.

Vapor Wize must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative