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Staccato Ventures LLC d/b/a Carolina Vape Kings, a North Carolina e-liquid manufacturer and distributor, was warned that their nicotine-containing products are tobacco products subject to FDA jurisdiction and premarket authorization requirements under the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing tobacco products, including the requirement to obtain premarket authorization before legally marketing new tobacco products in the United States. The warning was issued following FDA review of the company's submissions and inspection records, and notably referenced the March 2022 legislation expanding FDA's tobacco jurisdiction to include products containing nicotine from any source, not just tobacco-derived nicotine.