FDA WARNING_LETTER - Artisan Vapor Company - August 07, 2025

The FDA"s Center for Tobacco Products issued a warning letter to Artisan Vapor Company on August 7, 2025, following an inspection of their operations. The inspection revealed that Artisan Vapor Company sells and distributes electronic nicotine delivery systems (ENDS) in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products in question, such as UNO Mas X Strawberry Pina Colada 5% Salt Nicotine, are considered "new tobacco products" as they were not marketed in the U.S. before February 15, 2007, and lack the required FDA marketing authorization.

The regulatory framework under the FD&C Act mandates that all tobacco products, including those containing nicotine from any source, must comply with FDA regulations. The company’s failure to secure a marketing authorization order renders these products adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA has requested that Artisan Vapor Company take immediate corrective actions to address these violations. The company must submit a written response within 15 working days detailing the steps taken to comply with the FD&C Act, including ceasing the sale and distribution of the non-compliant products. Failure to comply may result in enforcement actions, including civil penalties or product seizures. The FDA has provided contact information for further inquiries and emphasized the importance of adhering to regulatory requirements to avoid potential legal consequences.