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Mr-Joy Group Holding B.V. was warned for manufacturing and distributing electronic nicotine delivery system (ENDS) products via their website to U.S. customers without obtaining required premarket authorization orders. The company's ENDS products, which contain nicotine and fall under FDA jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act, were found to be in violation of premarket review requirements applicable to "new tobacco products" not commercially marketed in the United States as of February 15, 2007. The warning specifically noted that following March 2022 legislation expanding FDA tobacco jurisdiction to products containing nicotine from any source (not just tobacco-derived nicotine), the company's products remained non-compliant with applicable regulations.