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United Zone Store was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring that "new tobacco products"—including ENDS products and those containing nicotine from any source—obtain premarket authorization orders before being legally marketed in the United States. The FDA determined that products listed on unitedzonestore.com were tobacco products subject to FDA jurisdiction and enforcement action under the Federal Food, Drug, and Cosmetic Act.