AMV Holdings, d/b/a Kure CBD and Vape Warning Letter Details

Summary

AMV Holdings, operating as Kure CBD and Vape, was cited for selling and distributing e-liquid products containing nicotine without required premarket authorization. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing these products as "new tobacco products" without obtaining FDA premarket authorization orders, as mandated under section 910 of the FD&C Act. The warning was issued because the e-liquids fell under FDA jurisdiction as tobacco products containing nicotine from any source, following the March 2022 legislative expansion that extended FDA tobacco authority beyond tobacco-derived nicotine to include nicotine from all sources.