FDA WARNING_LETTER - Wisemen Wholesale, Inc. - November 03, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Wisemen Wholesale, Inc. on November 20, 2025, following a review of inspection records. The letter identifies the company"s sale and distribution of unapproved electronic nicotine delivery system (ENDS) products, specifically citing "RAZ TN9000 BLACK CHERRY PEACH 5% NIC 12ml," to customers in the United States. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including amendments extending jurisdiction to products with nicotine from any source, these ENDS products are considered "new tobacco products." They lack the mandatory premarket authorization required by section 910(a) of the FD&C Act, rendering them unlawfully marketed, adulterated, and misbranded.

The FDA requires Wisemen Wholesale, Inc. to promptly cease the sale and distribution of all violative products and to take immediate steps to ensure full compliance with the FD&C Act. The company must submit a written response within 15 working days of receiving the letter. This response needs to detail the specific actions taken to address the violations, including the discontinuation dates for the illicit products, and outline a plan for maintaining future compliance. Failure to comply may result in further regulatory actions, such as civil money penalties, seizure, or injunction.