Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistBe Smokeless LLC d/b/a Southwest Smokeless manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization from the FDA, which is mandatory for "new tobacco products" under the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products fell under FDA jurisdiction as tobacco products because they contained nicotine from any source, including non-tobacco sources, following the March 2022 expansion of FDA authority under the Consolidated Appropriations Act. The products were found to be in violation of FD&C Act requirements for legal marketing in the United States.