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Talk to a SpecialistTalk to a SpecialistBorn Blessed Enterprises, LLC d/b/a One Stop Vape Shop manufactured and distributed e-liquid tobacco products containing nicotine without complying with FDA requirements under the Family Smoking Prevention and Tobacco Control Act. The company failed to obtain premarket authorization for these "new tobacco products" as required by the Federal Food, Drug, and Cosmetic Act, despite FDA's expanded jurisdiction over all nicotine-containing products regardless of source (effective March 15, 2022). The inspection determined that the e-liquids were being offered for sale or distribution in the United States without the legally mandated premarket approval.