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Sparky's Electronic Cigarettes was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing products containing nicotine (from any source) without obtaining a marketing authorization order, which is mandatory for new tobacco products under FDA regulations. The FDA determined that the company's e-liquid products fall under its jurisdiction as tobacco products and must meet all applicable requirements of the Federal Food, Drug, and Cosmetic Act.