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CSVAPE.COM LLC 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's products, which contain nicotine from any source, fall under FDA jurisdiction as tobacco products under the Family Smoking Prevention and Tobacco Control Act and must comply with all applicable regulations, including obtaining premarket approval for new tobacco products. The FDA determined that these ENDS products were not commercially marketed in the United States as of February 15, 2007, and therefore require an approved premarket authorization order before legal distribution in the U.S. market.