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Getsmoke was warned for offering electronic nicotine delivery system (ENDS) products for sale on its website without 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, which qualify as tobacco products under FDA jurisdiction, without obtaining a premarket authorization order as mandated for new tobacco products. The FDA's enforcement action was based on the company's website sales activity and the products' classification as tobacco products containing nicotine from any source, regardless of origin.