FDA WARNING_LETTER - Switch to Vapor - February 02, 2023

The FDA issued a Warning Letter to Switch to Vapor after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically KATY PEARY e-liquid, which are deemed tobacco products under section 201(rr) of the FD&C Act. The primary violation is the marketing of these "new tobacco products" without the required premarket authorization order under section 910(a) of the FD&C Act. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the necessary notice or information, as required by section 905(j), was not provided. The FDA also cited prohibited acts under sections 301(k) and 301(p) for marketing adulterated/misbranded products and failing to provide required reports. Switch to Vapor must submit a written response within 15 working days detailing actions taken to address these violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported non-compliant products may be detained.