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BS Vapes LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as electronic nicotine delivery systems, fell under FDA jurisdiction as deemed tobacco products but lacked the necessary marketing authorization orders required for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act. The products were determined to be adulterated and/or misbranded due to the absence of proper premarket compliance documentation.