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Route 66 Vapor, an electronic nicotine delivery system (ENDS) retailer, was found to be selling tobacco products without required premarket authorization orders as mandated by the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction requirements for ENDS products containing nicotine from any source, which became subject to FDA oversight following legislation signed in March 2022 that expanded the definition of "tobacco product" to include all nicotine-containing products regardless of source. The products were deemed adulterated and misbranded under the Family Smoking Prevention and Tobacco Control Act due to the absence of required premarket authorization for these "new tobacco products."