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Sabor Vapors LLC manufactured and distributed e-liquid products (electronic nicotine delivery systems) that are subject to FDA tobacco product regulation but lacked required premarket authorization as "new tobacco products" under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FD&C Act requirements applicable to tobacco products deemed subject to FDA jurisdiction effective August 8, 2016, specifically the mandate that new tobacco products obtain marketing authorization before commercial distribution. The inspection and submission review identified these products as lacking the legally required premarket approval to remain on the market.