FDA WARNING_LETTER - NLC Products, Inc.

On October 2, 2025, the U.S. Food and Drug Administration"s (FDA) Center for Tobacco Products issued a Warning Letter to LBC Products Inc., following a review of inspection records. The company was found to be unlawfully selling and distributing e-liquid products, specifically "HUSTLER PREMIUM E-LIQUID STRAWBERRY BLONDE 60 ML 3MG/ML," to customers in the United States. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), e-liquid products are categorized as tobacco products, regardless of whether their nicotine is tobacco-derived or from other sources, making them subject to FDA jurisdiction. The primary violation involves the marketing of a "new tobacco product" without the mandatory premarket authorization order. According to section 910(a) of the FD&C Act, any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed thereafter, requires such authorization. LBC Products Inc."s aforementioned product lacked this crucial approval, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA requires LBC Products Inc. to take prompt action to address these violations. This includes immediately discontinuing the sale and distribution of all non-compliant tobacco products. Furthermore, the company must submit a written response to the FDA within 15 working days, detailing the specific corrective actions taken, including the dates of discontinuation, and outlining a comprehensive plan to ensure sustained compliance with all applicable provisions of the FD&C Act and its implementing regulations.