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Talk to a SpecialistTalk to a Specialist9 South Vapes manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FD&C Act requirements applicable to newly deemed tobacco products, specifically electronic nicotine delivery systems that have been subject to FDA regulation since August 8, 2016. The products were determined to be unapproved "new tobacco products" requiring marketing authorization orders under section 910 of the FD&C Act before commercial distribution in the United States.