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Rip It Vapors, LLC manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act's requirements for "new tobacco products," which mandate FDA approval before commercial distribution in the United States. This violation occurred under the FDA's Center for Tobacco Products jurisdiction, which expanded in March 2022 to cover products containing nicotine from any source, not just tobacco-derived nicotine.