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Rev Products LLC was warned that its ENDS (electronic nicotine delivery systems) products sold through revecig.com were tobacco products subject to FDA jurisdiction and lacked required premarket authorization orders for legal U.S. marketing. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to new tobacco products, which mandate premarket review and approval before commercial distribution. This enforcement action came after the March 2022 legislative expansion of FDA's tobacco jurisdiction to include products containing nicotine from any source, broadening the regulatory scope beyond traditional tobacco-derived nicotine.