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Mountain Vaporz LLC was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization, as e-liquids containing nicotine from any source fall under FDA jurisdiction as tobacco products. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act and regulations governing new tobacco products under 21 C.F.R. § 1100.1, which mandate premarket approval before commercial distribution in the United States. The violation was identified through FDA review of the company's submissions and inspection records, with the letter emphasizing that products containing nicotine from any source—not just tobacco-derived nicotine—became subject to these requirements following legislation signed in March 2022.