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Twisted Tongue Inc. was cited for manufacturing and distributing e-liquid tobacco products without the required premarket authorization order mandated by the Family Smoking Prevention and Tobacco Control Act. The company's products, identified through their website twistedtonguevapor.com, met the FDA's definition of newly deemed tobacco products subject to federal jurisdiction but lacked the necessary marketing authorization to legally sell them in the United States. The violation centered on the company's failure to obtain premarket approval before commercializing these electronic nicotine delivery system (ENDS) products.