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Wyo Witches Brew LLC was warned that its e-liquid products sold online were tobacco products subject to FDA regulation under the Family Smoking Prevention and Tobacco Control Act, specifically the August 8, 2016 deeming rule that extended FDA jurisdiction to electronic nicotine delivery systems (ENDS). The company failed to comply with premarket authorization requirements under section 910 of the FD&C Act, which requires "new tobacco products" to obtain marketing authorization orders before legal distribution in the United States. The violations were identified during FDA's review of the company's website at wyowitchesbrew.company, which advertised e-liquid products for sale to U.S. consumers without the required premarket approvals.