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Ohm Centric Coils LLC, which manufactures electronic nicotine delivery system (ENDS) products, was cited for failing to obtain required premarket authorization before commercially distributing tobacco products containing nicotine. The company did not comply with FDA jurisdiction requirements under the Federal Food, Drug, and Cosmetic Act, which mandate that "new tobacco products" marketed in the United States after February 15, 2007 must have premarket approval in effect. This violation occurred under expanded FDA authority that extended jurisdiction to products containing nicotine from any source, effective April 14, 2022.