FDA WARNING_LETTER - Vape Royalty - June 25, 2024

The FDA Center for Tobacco Products issued a Warning Letter on June 20, 2024, to Vape Royalty (vaperoyalty.com) after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the U.S. These products, specifically Funky Republic Ti7000 Disposable Vape and Lost Mary OS5000 Disposable Vape, are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed before February 15, 2007. The letter highlights that these ENDS products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making their marketing unlawful. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices under section 905(j). The FDA emphasized the expanded definition of "tobacco product" to include nicotine from any source. Vape Royalty 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.