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Wizman Limited d/b/a Wizvapor was warned for manufacturing and distributing electronic nicotine delivery systems (ENDS) products through their website to U.S. customers without obtaining required premarket authorization orders. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act and FDA regulations governing newly deemed tobacco products, which have been subject to FDA jurisdiction since August 8, 2016. Under the FD&C Act, new tobacco products not commercially marketed in the United States before February 15, 2007 must obtain marketing authorization orders before legal distribution, a requirement Wizvapor did not meet for their ENDS products.