FDA WARNING_LETTER - Walker Enterprises, LLC d/b/a MaddCatt Vapor - March 20, 2025

On March 20, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Walker Enterprises LLC, d/b/a MaddCatt Vapors, following a review of inspection records. The FDA determined that the company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Bussin Blue" was cited as a new tobacco product that was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. Walker Enterprises LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and