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Talk to a SpecialistTalk to a SpecialistPrestige Worldwide LLC d/b/a Vape 911 manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization orders, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA's tobacco product regulations under 21 C.F.R. § 1100.1, which mandate that "new tobacco products" obtain premarket approval before commercial distribution in the United States. This violation was particularly significant given the March 2022 legislative expansion of FDA's tobacco jurisdiction to include all nicotine-containing products, regardless of nicotine source.