FDA WARNING_LETTER - My Vpro - February 01, 2024

On January 31, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to MyVpro.com after reviewing their website and determining they offer unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. These products, including "Elf Bar EBdesign BC5000 5% Disposable – Tropical Rainbow Blast" and "Lost Mary OS5000 Disposable – Forest Mint," are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

The FDA states these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The letter emphasizes that all new tobacco products without statutory premarket authorization are unlawfully marketed and subject to enforcement. MyVpro.com must submit a written response within 15 working days detailing corrective actions, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.