FDA WARNING_LETTER - Elk River Vapor Shop - February 28, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Elk River Vapor Shop after reviewing inspection records, determining the firm manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the March 2022 legislative amendment. The letter states that the firm is marketing "new tobacco products," specifically "White Chocolate" e-liquid, without the required premarket authorization order. This constitutes a violation of section 910(a) of the FD&C Act. Consequently, the 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 marketed without authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, or injunction. Elk River Vapor Shop is required to submit a written response within 15 working days detailing actions taken to address these violations, including dates of discontinued sales and a plan for future compliance. The firm is responsible for ensuring all tobacco products and related advertising comply with the FD&C Act and its implementing regulations.