Black Note, Inc. Warning Letter Details

Summary

Black Note, Inc. was cited for importing, selling, and distributing electronic nicotine delivery system (ENDS) products without required premarket authorization orders, in violation of the Federal Food, Drug, and Cosmetic Act. The company's ENDS products, which contain nicotine from any source, fall under FDA's expanded tobacco product jurisdiction established by the Consolidated Appropriations Act of 2022 and must comply with FDA regulations requiring premarket authorization before legal U.S. marketing. The FDA determined that these products were being distributed without the legally mandated marketing authorization orders required for "new tobacco products" under section 910 of the FD&C Act.