FDA WARNING_LETTER - Vaprwear Gear, LLC - April 27, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Vaprwear after reviewing its website, vaprwear.com, and identifying electronic nicotine delivery system (ENDS) products, specifically Vaprwear Weekender Pullover, Vape-Ready Hoodies, and Vaprwear HydroVape, Vape-Ready Backpacks, offered for sale. These products are classified as tobacco products under the FD&C Act and are subject to FDA regulation. The primary violation is that these are "new tobacco products" not commercially marketed before February 15, 2007, and are being sold without the required FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. As a result, the 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 notices or information under section 905(j). The failure to provide such reports also constitutes a prohibited act under section 301(p). FDA expressed significant concern that the products' design, featuring stealth pockets and discreet hosing, appeals to minors by enabling concealment of tobacco products, potentially encouraging youth use. Vaprwear is required to submit a written response within 15 working days outlining corrective actions, including discontinuing the sale and distribution of these products and a plan for maintaining compliance. Non-compliance could result in civil money penalties, product seizure, injunctions, and import detentions.