Electric Clouds, LLC Warning Letter Details

Summary

Electric Clouds, LLC manufactured and distributed e-liquid products containing nicotine, which the FDA determined are tobacco products subject to federal jurisdiction under the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket authorization orders for these "new tobacco products" before marketing them in the United States, in violation of section 910(a) of the FD&C Act. This enforcement action followed the 2022 legislative expansion of FDA's tobacco authority to include products containing nicotine from any source, not solely tobacco-derived nicotine.