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Electrik Smoke LLC, a manufacturer of e-liquid tobacco products, was cited for failing to obtain required premarket authorization before commercially distributing its products in the United States. The company's e-liquids, which contain nicotine from any source, are subject to FDA jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act and must comply with applicable regulations. The warning was issued following FDA review of the company's submissions and inspection records, with particular emphasis on the March 2022 legislative expansion extending FDA authority to all nicotine-containing products regardless of nicotine source.