Black Note, Inc. – FDA Warning Letter, May 27, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Black Note, Inc. after determining the company imports and distributes electronic nicotine delivery system (ENDS) products in the U.S. These products are classified as tobacco products under the FD&C Act, with jurisdiction expanded in March 2022 to include nicotine from any source. The primary violation identified is the marketing of a "new tobacco product," specifically the BLACK NOTE CHANGE Pod System Translucent Black, without the required premarket authorization order under section 910(a) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide required notice under section 905(j). The FDA emphasizes that all new tobacco products require premarket authorization to be legally marketed. Black Note, Inc. is required to take prompt action to address these violations, discontinue the sale and distribution of the non-compliant products, and submit a written response within 15 working days. The response must detail corrective actions, discontinuation dates, and a plan for future compliance. Failure to comply may result in regulatory actions including civil money penalties, seizure, injunction, and import detention.