FDA WARNING_LETTER - South Florida Vape, LLC and Flovape - June 22, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to Michael Diaz regarding ENDS products sold on https://flovape.com. The FDA determined that products like EBDesign BC5000 Disposable Devices (Gumi, Sakura Grape) and Esco Bars Disposable Device (Salted Caramel) are new tobacco products under section 201(rr) of the FD&C Act, including nicotine from any source as per recent legislation. These products are offered for sale or distribution in the U.S. without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, as they were not commercially marketed before February 15, 2007. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice under section 905(j). The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing the sale and distribution of violative products and outlining a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction, and imported non-compliant products may be detained.