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Str8Vape, LLC manufactured and distributed e-liquid tobacco products containing nicotine without the required premarket authorization mandated by the FDA for new tobacco products. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products, particularly following the March 2022 legislation that extended FDA jurisdiction to products containing nicotine from any source, not just tobacco-derived nicotine. The Center for Tobacco Products determined the products were being offered for sale and distribution in the United States without proper regulatory authorization.