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Artisan Vapor Company was cited for selling and distributing e-liquid products without required premarket authorization orders, as these products are classified as tobacco products subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act. The company failed to comply with regulations requiring "new tobacco products" to obtain marketing authorization orders before being legally sold in the United States, particularly given that the FDA's tobacco product definition was expanded in March 2022 to include all products containing nicotine from any source. The warning letter emphasized that the company's e-liquid products, whether derived from tobacco or containing synthetic nicotine, must meet all applicable FD&C Act requirements and obtain proper premarket authorization to remain in compliance.