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Elite Vapes was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without obtaining required premarket authorization orders from the FDA. The company's products, which contain nicotine and therefore qualify as tobacco products under FDA jurisdiction, failed to comply with the Federal Food, Drug, and Cosmetic Act's requirement that new tobacco products obtain marketing authorization before being legally distributed in the United States. The FDA's inspection of elitevapes.com determined that the listed products were being offered for sale to U.S. customers in violation of these premarket approval requirements.