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Ferrum City Liquid manufactured and sold e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, identified as tobacco products under section 201(rr) of the Federal Food, Drug, and Cosmetic Act, were deemed tobacco products subject to FDA regulation effective August 8, 2016, and therefore required premarket approval as "new tobacco products" before being legally marketed in the United States. The FDA's review of the company's website determined that the products were being offered for sale or distribution to U.S. customers without the required marketing authorization order.