FDA WARNING_LETTER - Route 66 Vapor - February 18, 2025

The FDA issued a Warning Letter to Route 66 Vapor on February 14, 2025, after reviewing inspection records, determining the company sells and distributes unauthorized electronic nicotine delivery system (ENDS) products in the U.S. These products, including "Raz Razzle Dazzle DC25000 5% NIC," are classified as tobacco products under the FD&C Act, particularly following the 2022 amendment extending FDA's jurisdiction to nicotine from any source. The core violation is marketing new tobacco products without the required premarket authorization order, as stipulated by section 910(a) of the FD&C Act. As a result, the product is considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice under section 905(j). Route 66 Vapor must submit a written response within 15 working days, outlining actions taken to discontinue violative sales and detailing a plan for maintaining compliance. Failure to address these deficiencies could lead to regulatory actions such as civil money penalties, product seizure, or injunction, and imported products may face detention or refusal of admission. The letter underscores the firm's responsibility to ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations.