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Nexus Smoke was warned for offering electronic nicotine delivery system (ENDS) products for sale on its website without obtaining required premarket authorization from the FDA. The products violated the Federal Food, Drug, and Cosmetic Act because they contain nicotine and lack the legally required marketing authorization orders as "new tobacco products." Under expanded FDA jurisdiction that took effect in 2022, all nicotine-containing products—regardless of nicotine source—must comply with tobacco product regulations, a requirement the company had failed to meet.