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Smoke-Free Planet, LLC was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization as mandated under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing deemed tobacco products (electronic nicotine delivery systems), which have been subject to FDA jurisdiction since August 8, 2016. The e-liquid products were being offered for sale or distribution in the United States without the necessary premarket review that the FD&C Act requires for new tobacco products.