Juicemafia, Inc. d/b/a Ecig-Works Warning Letter Details

Summary

Juicemafia, Inc. d/b/a Ecig-Works manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products qualified as tobacco products under FDA jurisdiction and were required to comply with premarket review requirements under the Federal Food, Drug, and Cosmetic Act. The warning was issued following FDA review of the company's submissions and inspection records, with particular attention to the March 2022 legislative expansion of FDA tobacco product jurisdiction to include all nicotine-containing products, regardless of nicotine source.