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Talk to a SpecialistTalk to a SpecialistWalker Enterprises, LLC d/b/a MaddCatt Vapor manufactures and distributes e-liquid tobacco products containing nicotine, which fall under FDA jurisdiction as tobacco products requiring premarket authorization. The company failed to obtain required premarket authorization orders for its "new tobacco products" as mandated under the Federal Food, Drug, and Cosmetic Act, making the products adulterated and misbranded. The FDA's inspection records indicated that the company was manufacturing, selling, and distributing these unauthorized e-liquid products to U.S. customers without compliance with applicable regulatory requirements.