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Smooth Vapes, Inc. was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization orders as mandated under the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquids, sold through their website, constitute "new tobacco products" under federal law and therefore require marketing authorization before legal sale in the United States. The company failed to comply with Section 910 of the Federal Food, Drug, and Cosmetic Act, which has required premarket approval for new tobacco products since the FDA's deeming rule took effect on August 8, 2016.