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Top Shelf Vaping LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's nicotine-containing e-liquid products were deemed new tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, but lacked the legally required premarket authorization to be marketed in the United States. The warning was issued following an FDA inspection that confirmed the company was manufacturing and offering these products for commercial distribution without compliance with federal tobacco product regulations.