MVRB2, LLC, d/b/a Kure CBD & Vape – FDA Warning Letter, Jul 18, 2025

The FDA issued a warning letter to MVRB2, LLC, operating as Kure CBD & Vape, following an inspection of their operations. The inspection revealed that the company sells and distributes e-liquid products in the United States without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The inspection, conducted by the FDA"s Center for Tobacco Products, identified that the e-liquid product "Cloud Nurdz Strawberry Lemon 3MG 100ML" is marketed unlawfully as it lacks the required FDA marketing authorization order. This product is classified as a "new tobacco product" because it was not commercially available in the U.S. before February 15, 2007, and does not meet the criteria for exemption from marketing authorization.

The regulatory framework under which these violations fall includes sections 201(rr), 901(b), and 910 of the FD&C Act, as well as recent amendments expanding the definition of tobacco products to include those containing nicotine from any source. The FDA requires that all new tobacco products have a premarket authorization order to be legally marketed in the U.S.

The FDA has requested that MVRB2, LLC take immediate action to address these violations. The company must submit a written response within 15 working days detailing their corrective actions, including ceasing the sale and distribution of the non-compliant products and outlining plans to ensure future compliance with the FD&C Act. Failure to comply may result in enforcement actions, including penalties or product seizures.