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Bootstrap Runners LLC d/b/a Sinister Liquids manufactured and distributed e-liquid tobacco products without the required premarket authorization mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products, which contain nicotine derived from tobacco and are intended for human consumption, fall under FDA jurisdiction as deemed tobacco products but were being sold in violation of premarket approval requirements that took effect August 8, 2016. The warning was issued after FDA review of the company's submissions and inspection records confirmed the unauthorized commercial distribution of these tobacco products in the United States.