MVRB2, LLC, d/b/a Kure CBD & Vape Warning Letter Details

Summary

MVRB2, LLC, d/b/a Kure CBD & Vape manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization orders from the FDA. The company's products fall under FDA jurisdiction as tobacco products because they contain nicotine from any source, subject to compliance requirements under the Federal Food, Drug, and Cosmetic Act following the March 2022 legislative expansion of tobacco product definitions. The Center for Tobacco Products determined that these e-liquid products were being sold to U.S. customers in violation of section 910 of the FD&C Act, which requires "new tobacco products" to have marketing authorization before legal distribution.