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Bugatti Vape, LLC was warned for manufacturing and distributing electronic nicotine delivery system (ENDS) products without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company's ENDS products, which contain nicotine and fall under FDA jurisdiction as tobacco products, were being offered for sale on their website (vapebugatti.com) without compliance with FDA's regulatory requirements for new tobacco products. The FDA determined these products lacked the legally required premarket authorization order needed to be marketed in the United States, placing them in violation of section 901(b) of the FD&C Act and 21 C.F.R. § 1100.1.