FDA WARNING_LETTER - MVRB2, LLC, d/b/a Kure CBD & Vape - November 03, 2025

On November 6, 2025, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products issued a Warning Letter to Kure CBD & Vape concerning the unlawful marketing of certain electronic nicotine delivery system (ENDS) products. The FDA"s review of inspection records determined that Kure CBD & Vape sells and distributes ENDS products, specifically citing "NEXA PIX 35000 PUFFS Fcuking FAB 50mg/ml," without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including amendments extending jurisdiction to all nicotine sources, new tobacco products introduced after February 15, 2007, must obtain FDA marketing authorization. Kure CBD & Vape"s product is deemed a "new tobacco product" lacking this essential authorization, rendering it both adulterated and misbranded under the FD&C Act. Kure CBD & Vape is required to take prompt action to address these violations and ensure all tobacco products comply with federal regulations. The company must submit a written response within 15 working days, detailing actions taken, including the discontinuation of violative sales and distribution, and outlining a plan for future compliance. Failure to comply may result in further regulatory actions.