FDA WARNING_LETTER - BNC Distribution Inc. - December 08, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to BNC Distribution Inc. on December 11, 2025, following a review of their inspection records. The primary violation identified was the company"s sale and distribution of e-liquid products, specifically "Fruit Monster Strawberry Kiwi Pomegranate 3MG 100ML," without the required premarket authorization.Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are categorized as "new tobacco products" because they were not commercially marketed in the United States prior to February 15, 2007, and do not possess an FDA marketing order. Consequently, these products are considered adulterated and misbranded under the FD&C Act. The FDA"s jurisdiction over these products stems from the FD&C Act, notably its 2022 amendment that expanded the definition of "tobacco product" to include nicotine from any source.BNC Distribution Inc. is mandated to immediately cease the sale and distribution of these unauthorized products. The company must submit a comprehensive written response within 15 working days of receiving the letter. This response must detail the specific actions taken to address the violations, including the dates on which the non-compliant products were discontinued, and outline a robust plan for maintaining future compliance with all applicable provisions of the FD&C Act and its implementing regulations. Failure to comply may result in further regulatory actions.