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JSMT LLC d/b/a VaporFI manufactured and distributed e-liquid tobacco products without the required premarket authorization orders mandated by the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which contain nicotine from any source, are subject to FDA jurisdiction as tobacco products and must comply with Federal Food, Drug, and Cosmetic Act requirements, including obtaining marketing authorization for any new or modified tobacco products. The FDA determined that VaporFi's products were being legally marketed without the necessary premarket authorization under section 910 of the FD&C Act.