Midwest Goods Inc., d/b/a Midwest Distribution and Midwest Distribution Illinois Warning Letter Details

Summary

Midwest Goods Inc. was warned for selling and distributing e-liquid products containing nicotine without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act and FDA's tobacco product regulations. The company failed to comply with FDA jurisdiction over tobacco products containing nicotine from any source, which expanded under the Consolidated Appropriations Act of 2022 to include non-tobacco-derived nicotine. As a "new tobacco product," their e-liquid products were required to obtain premarket authorization orders before being legally marketed in the United States.