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Dotmod, Inc. was warned for manufacturing and selling electronic nicotine delivery system (ENDS) products through its website without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products contained nicotine from unspecified sources and were offered for sale to U.S. customers without compliance with FDA's tobacco product regulations, including the requirement that "new tobacco products" obtain premarket authorization orders before legal marketing. The FDA's enforcement action reflected the expanded regulatory authority over nicotine-containing products that took effect on March 15, 2022, under the Consolidated Appropriations Act, which extended FDA jurisdiction beyond tobacco-derived nicotine to products containing nicotine from any source.