FDA WARNING_LETTER - CSVAPE.COM LLC - October 30, 2024

The FDA issued a Warning Letter to Nader Tawil, operating https://csvape.com, for offering electronic nicotine delivery system (ENDS) products for sale in the U.S. without required marketing authorization. The products, including Craftbox V-Touch and CraftBox V-Play disposable vapes, are classified as tobacco products under section 201(rr) of the FD&C Act, encompassing nicotine from any source. These are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack the necessary FDA marketing authorization orders under section 910(a) and 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) for failing to provide required information under section 905(j). FDA expressed significant concern regarding the youth appeal of these products, noting their design imitates smartphones and gaming devices, potentially concealing their nature as tobacco products. The firm must respond within 15 working days, detailing corrective actions, including discontinuing violative sales and outlining a compliance plan. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, injunction, or import detention.