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Freedom Smoke USA International was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization from the FDA. The company's products, which contain nicotine and are subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, failed to comply with federal requirements for new tobacco products to obtain premarket authorization orders before being legally marketed in the United States. The FDA's inspection of the company's website identified e-liquid products being offered for sale or distribution to U.S. customers in violation of these regulations.