FDA WARNING_LETTER - Artisan Vapor Company - August 01, 2025

The FDA issued a Warning Letter to Artisan Vapor Company, located at 2650 Conner Street, Noblesville, IN, on July 31, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that Artisan Vapor 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 company was found to distribute e-liquid products, such as UNO Mas X Blue Razz Breeze 5% Salt Nicotine, which are classified as "new tobacco products" because they were not marketed in the U.S. before February 15, 2007, and lack the required FDA marketing authorization.

The FD&C Act mandates that new tobacco products must have a premarket authorization order to be legally marketed. Without this, products are considered adulterated and misbranded. The FDA"s jurisdiction over such products was expanded by the Consolidated Appropriations Act, 2022, to include those containing nicotine from any source.

Artisan Vapor Company is required to respond in writing within 15 working days, detailing actions taken to address the violations and ensure compliance with the FD&C Act. Failure to comply may result in enforcement actions, including civil penalties or product seizure. The company must ensure all tobacco products and related advertising comply with FDA regulations. The letter serves as a formal notice and an opportunity for the company to rectify the issues.