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Shake Hemp was warned for offering electronic nicotine delivery system (ENDS) products containing nicotine on its website without obtaining required premarket authorization orders, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products fall under FDA's tobacco product jurisdiction as they contain nicotine from any source and are intended for human consumption, yet lack the mandatory premarket approval needed for new tobacco products to be legally marketed in the United States. The Center for Tobacco Products determined these unapproved ENDS products were being offered for sale or distribution to U.S. customers, placing the company in violation of applicable FDA regulations.