Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistBootstrap Runners LLC was warned for manufacturing and distributing e-liquid tobacco products without required premarket authorization as mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products, containing nicotine from any source, qualified as tobacco products subject to FDA jurisdiction and compliance requirements under the Federal Food, Drug, and Cosmetic Act. The warning was issued following the March 2022 legislative expansion that extended FDA tobacco product jurisdiction to include nicotine from non-tobacco sources, requiring all such products to obtain premarket authorization before legal U.S. distribution.