FDA WARNING_LETTER - Global Tobacco LLC d/b/a X2O Vapes - March 10, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Munir M. Meghani after reviewing the website https://x2ovapes.com, which offered electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA determined that the "Mango Pod (4 Pack) Vape Juice" product is a "new tobacco product" that was not commercially marketed before February 15, 2007, and lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice under section 905(j). Furthermore, the failure to provide the required report is a prohibited act under section 301(p) of the FD&C Act. The company is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative activities and outlining a plan for future compliance. Failure to address these violations may lead to civil money penalties, seizure, injunction, and refusal of admission for imported products.