FDA WARNING_LETTER - Walker Enterprises, LLC d/b/a MaddCatt Vapor - February 18, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to Walker Enterprises LLC, d/b/a MaddCatt Vapors, on February 14, 2025, following a review of inspection records. The letter states that MaddCatt Vapors 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 order. Specifically, the product "Maddcatt Vapors Madd Melons 120ml 18MG/ML" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information was not provided.

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement action, 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