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Maduro Distributors d/b/a The Loon was cited for manufacturing and distributing electronic nicotine delivery system (ENDS) products through their website without required FDA premarket authorization. The company failed to comply with the Federal Food, Drug, and Cosmetic Act by offering "new tobacco products" for sale without obtaining the legally required marketing authorization orders under section 910 of the FD&C Act. As deemed tobacco products subject to FDA jurisdiction since August 8, 2016, the ENDS products were in violation of applicable tobacco product regulations and restrictions on sale and distribution.