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Breeze Smoke Official was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without the required FDA premarket authorization. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing these nicotine-containing products, which fall under FDA jurisdiction regardless of whether the nicotine derives from tobacco or other sources. The violation centered on the distribution of unapproved "new tobacco products" that lacked the legally mandated premarket authorization order required for legal U.S. marketing.