FDA WARNING_LETTER - Vapes and Such - October 30, 2024

The FDA Center for Tobacco Products issued a Warning Letter to VapesandSuch.com after reviewing its website and identifying electronic nicotine delivery system (ENDS) products offered for sale in the U.S. These products, including Swype 30K, Posh Xtron 30000, V-Play 20000, and Posh Pro Max 30000, are considered "new tobacco products" under the FD&C Act, especially following the 2022 amendment extending jurisdiction to nicotine from any source. The FDA determined that these ENDS products lack the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required notices or information under section 905(j). The FDA expressed particular concern regarding the products' labeling and advertising, which imitate smartphones, smart technology, or gaming products, making them attractive to youth and potentially aiding concealment from adults. The firm is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and outlining a compliance plan. Failure to comply may result in civil money penalties, seizure, or injunction.