FDA WARNING_LETTER - Absolute Vapor Lounge, LLC - September 12, 2025

The FDA issued a Warning Letter to Absolute Vapor LLC, located at 1801 North Summit Street, Suite C, Arkansas City, KS, on September 11, 2025. The inspection revealed that Absolute Vapor LLC manufactures and distributes e-liquid products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products are classified as tobacco products under section 201(rr) of the FD&C Act because they contain nicotine derived from any source, including non-tobacco sources, as per the Consolidated Appropriations Act, 2022.

The FDA identified that Absolute Vapor LLC"s product, "ABSOLUTE FLAVORS PREMIUM FLAVORINGS Tribute 1.5mg 120mL," is a new tobacco product that lacks the required marketing authorization order. Consequently, it is considered adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA mandates Absolute Vapor LLC to cease the sale and distribution of these non-compliant products and to ensure all products meet the FD&C Act"s requirements. The company must submit a written response within 15 working days detailing corrective actions and compliance plans. Failure to comply may result in enforcement actions, including penalties, seizure, or injunction. The FDA emphasizes that this letter does not serve as a formal notice under section 303(f)(9)(B)(i)(II) of the FD&C Act.