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TXCel International, Inc. d/b/a Vaporider was cited for offering electronic nicotine delivery system (ENDS) products for sale through their website without required premarket authorization. The company's tobacco products, which contain nicotine from any source, failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to "new tobacco products." The FDA determined the products were subject to its jurisdiction under expanded tobacco product regulations that took effect in March 2022, which extended FDA oversight to all nicotine-containing products regardless of nicotine source.