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Smoke and Vape LLC was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without required premarket authorization from the FDA. The company's tobacco products, which contain nicotine from any source, were found to be in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations, as they lacked the necessary marketing authorization orders required for "new tobacco products" under FDA jurisdiction. The FDA's enforcement action was issued following a review of the company's website operations in June 2023.