FDA WARNING_LETTER - Elite Vapor LLC

The FDA issued a Warning Letter to ELITE VAPOR LLC, located at 2115 Fashion Outlet Boulevard, Suite 100, Niagara Falls, NY, on September 25, 2025. The letter follows an inspection by the FDA"s Center for Tobacco Products, which revealed that ELITE VAPOR LLC manufactures, sells, and distributes e-liquid products in the United States without the necessary premarket authorization. These products fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Consolidated Appropriations Act, 2022, which extends FDA jurisdiction to all nicotine-containing products, regardless of the nicotine source.

The main violation identified is the marketing of new tobacco products, such as PRIMUS VAPE CO NIGHT CRAWLER 3MG/ML 120ML, without an FDA marketing authorization order. This lack of authorization renders the products adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA requires ELITE VAPOR LLC to take immediate corrective actions to address these violations. The company must submit a written response within 15 working days outlining the steps taken to comply with the FD&C Act, including cessation of violative sales and a compliance maintenance plan. Failure to comply may result in enforcement actions, including civil penalties, seizure, or injunction. ELITE VAPOR LLC is advised to ensure all products and related advertising comply with FDA regulations to avoid further regulatory actions.