FDA WARNING_LETTER - Shenzhen FreeMax Technology Co., Ltd. d/b/a FreeMaxVape - November 28, 2023

The FDA's Center for Tobacco Products issued a Warning Letter after reviewing the websites freemaxvape.com and friobarvape.com, determining that electronic nicotine delivery system (ENDS) products, specifically the Friobar RB5000 Disposable, are manufactured and offered for sale in the U.S. These products are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction. The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The Friobar RB5000 Disposable was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. Consequently, this product is 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 notice or information. The company must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and distribution, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or detention of imported products.