FDA WARNING_LETTER - TXCel International, Inc. d/b/a Vaporider - June 22, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Gan Chen and Rong Yu regarding the sale of unauthorized electronic nicotine delivery system (ENDS) products on their website, https://vaporider.deals. The FDA determined that products like "EBDesign BC5000 Disposable Device – Sakura Grape" and "Esco Bars X Kilo Edition Disposable Device – Rainburst" are "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.

These ENDS products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as they lack the required premarket authorization order or exemption. The letter emphasizes that the definition of "tobacco product" now includes products with nicotine from any source, as per the Consolidated Appropriations Act, 2022.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.