FDA WARNING_LETTER - Kure CBD & Vape dba Madvapes - August 01, 2025

The FDA issued a warning letter to Kure CBD & Vape, located at 10252 West Broad Street, Glen Allen, VA, following an inspection by the Center for Tobacco Products. The inspection revealed that Kure CBD & Vape manufactures, sells, and distributes e-liquid products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products in question, including "Melon Felon," are classified as new tobacco products because they contain nicotine and were not commercially marketed before February 15, 2007.

Under the FD&C Act, all new tobacco products must have a marketing authorization order unless they meet specific exemption criteria. The lack of such authorization means these products are considered adulterated and misbranded. The FDA"s jurisdiction over these products was expanded by the Consolidated Appropriations Act, 2022, to include nicotine from any source, not just tobacco-derived nicotine.

Kure CBD & Vape is required to take immediate corrective actions to comply with the FD&C Act. They must submit a written response within 15 working days detailing the steps taken to address the violations, including ceasing the sale and distribution of the non-compliant products. Failure to comply may result in enforcement actions such as civil penalties, product seizure, or injunctions. The company is advised to ensure all products and related marketing comply with FDA regulations to avoid further legal consequences.