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ivygang.com was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without the required premarket authorization from the FDA. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing these nicotine-containing products without obtaining a premarket authorization order, which is mandatorily required for "new tobacco products" under section 910 of the Federal Food, Drug, and Cosmetic Act. The violations covered both ENDS products made from tobacco-derived nicotine and those containing nicotine from non-tobacco sources, following the March 2022 legislative expansion of FDA's tobacco product jurisdiction.