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

The FDA issued a Warning Letter to Kure CBD & Vape, located at 4119 Arendell Street, Suite D, Morehead City, NC, on September 18, 2025. The letter follows an inspection by the FDA"s Center for Tobacco Products, which determined that Kure CBD & Vape sells e-liquid products containing nicotine, classifying them as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The inspection revealed that these products, specifically "The Milk Berry Crunch 3MG 100ML," lack the required premarket authorization, rendering them adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

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

Kure CBD & Vape is required to submit a written response within 15 working days, detailing corrective actions taken to address the violations and ensure compliance with the FD&C Act. This includes ceasing the sale and distribution of non-compliant products and outlining plans to maintain adherence to FDA regulations. Failure to comply may result in enforcement actions, such as civil penalties or product seizure. The company is advised to reference ER2501264 in their response to the FDA"s Office of Compliance and Enforcement.