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giantvapes.com was cited for offering electronic nicotine delivery system (ENDS) products for sale without premarket authorization as required under the Federal Food, Drug, and Cosmetic Act. The FDA determined that these products constitute tobacco products subject to FDA jurisdiction because they contain nicotine from any source, including non-tobacco-derived nicotine covered under the 2022 legislative expansion of FDA's tobacco product definition. The company failed to comply with the requirement that "new tobacco products" must obtain a premarket authorization order before being legally marketed in the United States.