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

Summary

Juicemafia, Inc. d/b/a Ecig-Works manufactured and distributed e-liquid tobacco products containing nicotine without required FDA premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction requirements for tobacco products, which apply to all nicotine-containing products regardless of nicotine source following the March 2022 legislative expansion of FDA authority. The products were marketed for commercial distribution in the United States without the legally required premarket authorizations that the FD&C Act mandates for new tobacco products.