FDA WARNING_LETTER - Morevaping - October 30, 2024

The FDA Center for Tobacco Products issued a Warning Letter on October 29, 2024, to Morevaping.com for offering electronic nicotine delivery system (ENDS) products for sale in the U.S. without required premarket authorization. The FDA determined that products like South Connect 35K, V-Touch 30000, and V-Play 20K Disposable Vapes are 'new tobacco products' under section 910(a) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and lack the necessary marketing authorization orders. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. A significant concern highlighted by the FDA is the youth appeal of these products, with designs imitating smartphones and gaming devices, potentially encouraging unlawful sales and increasing youth use. The firm is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.