KL Labs, LLC, d/b/a Known Distro Warning Letter Details

Summary

KL Labs, LLC, operating as Known Distro, manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization as mandated by the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA tobacco product regulations under section 901(b) of the FD&C Act and 21 C.F.R. § 1100.1, which require all new tobacco products—including those containing nicotine from any source following the March 2022 legislative expansion of FDA jurisdiction—to have premarket authorization before commercial marketing in the United States.