Moore Cigarettes Warning Letter Details

Summary

Moore Cigarettes was cited for selling electronic nicotine delivery system (ENDS) products without obtaining required premarket authorization orders from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction over tobacco products containing nicotine from any source, a requirement that was expanded under legislation signed in March 2022. As "new tobacco products" not commercially marketed before February 15, 2007, these ENDS products were required to obtain marketing authorization orders under section 910 of the FD&C Act before being distributed in the United States.