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Kure CBD & Vape was cited for selling electronic nicotine delivery system (ENDS) products without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA jurisdiction requirements under section 901(b) of the FD&C Act, which mandates that all tobacco products and nicotine-containing products—regardless of nicotine source—obtain marketing authorization orders before legal distribution in the United States. The warning followed FDA's review of inspection records confirming the company was distributing these products to U.S. customers without the required premarket compliance documentation.