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Alien Vape LLC was warned that its e-liquid products sold on alienvape.com are tobacco products subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act because they contain nicotine from any source. The company failed to comply with premarket authorization requirements, which mandate that "new tobacco products" obtain an FDA premarket authorization order before being legally marketed in the United States. The warning referenced the March 2022 legislation that expanded FDA's tobacco product definition to include all nicotine-containing products, regardless of whether the nicotine derives from tobacco or other sources.