FDA WARNING_LETTER - Artisan Vapor Company - June 03, 2025

On May 29, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Artisan Vapor Company, identifying that the company sells and/or distributes e-liquid products in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source and being intended for human consumption.

The FDA determined that Artisan Vapor Company offers for sale or distribution the e-liquid product "NOMS 100 BLACK CHERRY SOUR APPLE 6MG/ML" without the required premarket authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing 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) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter states that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement action, including civil money penalties, seizure, and/or injunction. Artisan