FDA WARNING_LETTER - AMV Holdings, d/b/a Kure CBD and Vape - July 18, 2025

The FDA issued a Warning Letter to AMV Holdings, operating as Kure CBD and Vape, on July 17, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that the company sells and distributes e-liquid products in the U.S. without the required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the product "Innevape HEISENBERG MENTHOL ORIGINAL BLUE SLUSHIE 6mg 100ml" lacks the necessary marketing authorization and is thus considered adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The regulatory framework mandates that all new tobacco products, defined as those not marketed in the U.S. before February 15, 2007, must have a premarket authorization order. The FD&C Act, amended by the Consolidated Appropriations Act, 2022, extends FDA jurisdiction to products containing nicotine from any source.

The FDA requires AMV Holdings to take immediate corrective actions, including ceasing the sale and distribution of non-compliant products and submitting a written response within 15 working days. This response should outline the steps taken to address the violations and ensure future compliance. Failure to comply may result in enforcement actions such as civil penalties or product seizure. The company is advised to ensure all products and related marketing comply with the FD&C Act and FDA regulations.