FDA WARNING_LETTER - Reedhill Ventures LLC, d/b/a Vape On Wholesale - June 30, 2025

On June 26, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Reedhill Ventures LLC, d/b/a Vape On Wholesale, following a review of inspection records. The FDA determined that the company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Titanium Vapor 3MG 05pg/95vg Sour Heads of War" was found to be a new tobacco product, not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

The FDA requires Reedhill Ventures LLC to take prompt action to address these violations and bring all products into compliance with the FD&C Act and its implementing regulations. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The company must submit a