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F & N Trading 1 Inc. d/b/a/ Puffholic was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products contained nicotine and fell under FDA jurisdiction as tobacco products subject to compliance requirements, including obtaining a premarket authorization order before marketing. The FDA identified the violation following a review of the company's website that documented the unlawful sale and distribution of these tobacco products to U.S. customers.