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Apvapeshop Inc was found offering electronic nicotine delivery system (ENDS) products for sale on its website without obtaining required premarket authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products, which contain nicotine from various sources, were classified as "new tobacco products" subject to FDA jurisdiction under expanded regulations that took effect in 2022, requiring marketing authorization orders prior to commercial distribution. The FDA determined that the products were being marketed illegally and were therefore both adulterated and misbranded under federal tobacco control requirements.