FDA WARNING_LETTER - Reedhill Ventures LLC, d/b/a Vape On Wholesale - June 26, 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, for manufacturing, selling, and/or distributing e-liquid products without required marketing authorization. The FDA determined that the company's e-liquid products, specifically "Titanium Vapor 3MG 05pg/95vg Sour Heads of War," are "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007.

Under sections 201(rr), 901(b), and 910(a) of the FD&C Act (21 U.S.C. §§ 321(rr), 387a(b), 387j(a)), and 21 C.F.R. § 1100.1, these products require premarket authorization. The identified product lacks an FDA marketing authorization order, making it adulterated under section 902(6)(A) (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) (21 U.S.C. § 387c(a)(6)) due to the absence of required notice or information under