FDA WARNING_LETTER - Hongkong Iplayvape Techlonogy Co. Ltd - August 26, 2025

The FDA"s Center for Tobacco Products issued a warning letter on August 15, 2025, to the company operating the website https://store.iplayvape.com. The inspection revealed that the company offers electronic nicotine delivery system (ENDS) products for sale in the United States without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products in question include IPLAY Pirate 10000/20000, IPLAY ELITE 12000, IPLAY ENGINE 40K, and IPLAY CLOUD PRO 12000, which are considered "new tobacco products" as they were not marketed in the U.S. before February 15, 2007.

Under the FD&C Act, these products are deemed adulterated and misbranded because they lack FDA marketing authorization and the required notice or information submission. The regulatory framework mandates that all new tobacco products must have a premarket authorization order unless they qualify for specific exemptions, which these products do not.

The FDA requires the company to take immediate corrective actions, including ceasing the sale and distribution of the unauthorized products and ensuring compliance with all applicable regulations. A written response detailing the actions taken to address these violations must be submitted within 15 working days. Failure to comply may result in enforcement actions such as civil penalties, seizure, or injunction. The company is advised to reference the FD&C Act and FDA regulations to ensure ongoing compliance.