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NFV, LLC, operating as NFDVapes and Nic Fix Doctor, was warned that its electronic nicotine delivery system (ENDS) products offered for sale on its website were tobacco products subject to FDA jurisdiction but lacked required premarket authorization orders. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to "new tobacco products," which mandate premarket review and approval before legal marketing in the United States. The FDA's warning was issued following a review of the company's website demonstrating active distribution of these unapproved tobacco products to U.S. customers.