Loading…
DK Global Enterprises LLC, operating as I Love Vape LLC and Matrix Wholesaler LLC, was warned for offering electronic nicotine delivery system (ENDS) products for sale through their websites without required premarket authorization. The FDA determined these products are tobacco products under federal law because they contain nicotine from any source and are intended for human consumption, making them subject to FDA jurisdiction and compliance requirements under the Federal Food, Drug, and Cosmetic Act. The company failed to obtain premarket authorization orders, which are required for new tobacco products to be legally marketed in the United States.