FDA WARNING_LETTER - Stella Blues Vapors Inc - July 27, 2023

The FDA issued a Warning Letter to Stella Blues Vapors Inc. after reviewing inspection records, determining the company manufactures and distributes e-liquid products, including "Admiral Crunch," which are considered "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products, containing nicotine from any source, require premarket authorization to be legally marketed in the U.S. The FDA found that Stella Blues Vapors Inc. is marketing these products without the necessary marketing authorization orders, as they were not commercially marketed as of February 15, 2007, and are not otherwise exempt. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). The letter also cites prohibited acts under sections 301(k) for holding adulterated/misbranded products for sale after interstate shipment, and 301(p) for failing to provide required reports. The firm's existing Premarket Tobacco Product Application (PMTA) does not cover the identified violative products. Stella Blues Vapors Inc. must take prompt action to address these violations, discontinue the sale and distribution of non-compliant products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.