FDA WARNING_LETTER - Atomic Vapor - August 28, 2025

The FDA"s Center for Tobacco Products issued a warning letter to Atomic Vapor LLC on August 28, 2025, following an inspection of their operations. The inspection revealed that Atomic Vapor LLC manufactures, sells, and distributes e-liquid products in the U.S. without the necessary premarket authorization, specifically highlighting their product "Atomic Vapor Peach Fuzz." This is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates that new tobacco products, including those containing nicotine from any source, must have a marketing authorization order to be legally marketed in the U.S.

The regulatory framework under which these violations fall includes sections 201(rr), 901(b), and 910 of the FD&C Act, as well as the amendments made by the Consolidated Appropriations Act, 2022, which expanded the definition of tobacco products. The FDA determined that Atomic Vapor"s products are adulterated and misbranded due to the absence of required marketing authorization.

The FDA requires Atomic Vapor LLC to take immediate corrective actions to address these violations. The company must submit a written response within 15 working days detailing the steps taken to cease the sale and distribution of the non-compliant products and outline a plan to ensure future compliance with the FD&C Act. Failure to comply may result in enforcement actions, including civil penalties or product seizure. The company is advised to address all violations to avoid further regulatory actions.