FDA WARNING_LETTER - Artisan Vapor Company - July 18, 2025

The FDA issued a Warning Letter to Artisan Vapor Company, located at 4835 North O Connor Road, Suite 114, Irving, TX, on July 17, 2025. The inspection revealed that the company sells electronic nicotine delivery system (ENDS) products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the product "UNO Mas X Tangy Twist 5% Salt Nicotine" was identified as lacking the required marketing authorization, making it both adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The regulatory framework stipulates that all new tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, must have a premarket authorization order. The FDA"s jurisdiction over products containing nicotine from any source was expanded by the Consolidated Appropriations Act, 2022.

Artisan Vapor Company is required to take immediate action to address these violations. This includes ceasing the sale and distribution of the non-compliant products and submitting a written response within 15 working days detailing corrective measures and compliance plans. Failure to comply may result in regulatory actions such as civil penalties, product seizure, or injunctions. The company is urged to ensure all products and related marketing comply with the FD&C Act and FDA regulations.