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Smoke Smart LLC was warned for offering electronic nicotine delivery system (ENDS) products for sale on its website without obtaining required FDA premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA's jurisdiction over tobacco products containing nicotine from any source, which expanded under legislation signed in March 2022. As a "new tobacco product" not commercially marketed before February 15, 2007, the ENDS products required a marketing authorization order before being legally distributed in the United States.