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ECigMafia LLC was warned for offering electronic nicotine delivery system (ENDS) products for sale through its website without the required premarket authorization from FDA, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's products, which contain nicotine from any source, were determined to be tobacco products subject to FDA jurisdiction and required to comply with applicable regulations, including obtaining a marketing authorization order before legal distribution in the United States. The FDA identified that ECigMafia LLC failed to meet the statutory requirement for "new tobacco products" to have premarket authorization in effect prior to commercial marketing.