FDA WARNING_LETTER - CT Vapors - March 01, 2022

The FDA issued a Warning Letter to CT Vapors after reviewing submissions and inspection records, determining the firm manufactures and distributes e-liquid products, including CT Vapors Strawberry 3 mg e-liquid, which are deemed tobacco products subject to FDA regulation. The primary violation identified is the marketing of this specific e-liquid as a "new tobacco product" without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide necessary information as required by section 905(j). The letter also highlights prohibited acts under section 301(k) for holding an adulterated or misbranded product for sale, and section 301(p) for failing to submit a required report. CT Vapors, a registered manufacturer with numerous products, is reminded of its responsibility to ensure all tobacco products comply with the FD&C Act and relevant regulations. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a compliance plan. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction.