FDA WARNING_LETTER - Artisan Vapor & CBD - November 03, 2025

On November 6, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Artisan Vapor & CBD for marketing unauthorized electronic nicotine delivery system (ENDS) products. The FDA"s Center for Tobacco Products identified that the company was selling the RAZ RYL SPRING Wild Berry Dew 35K 50 MG/ML product, which is classified as a "new tobacco product" under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Under the FD&C Act, new tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, require premarket authorization from the FDA. Artisan Vapor & CBD"s product lacked this essential authorization, rendering it unlawfully marketed as both adulterated and misbranded. The FDA emphasizes that these products fall under their jurisdiction due to containing nicotine, regardless of its source, following recent amendments to the FD&C Act.

Artisan Vapor & CBD is required to take immediate action to address these violations. Specifically, the company must cease the sale and distribution of all unauthorized tobacco products. Furthermore, they must submit a written response to the FDA within 15 working days, detailing the steps taken to discontinue the violative sales and outlining a comprehensive plan to ensure future compliance with all applicable provisions of the FD&C Act and its implementing regulations.