FDA WARNING_LETTER - Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. - April 27, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. after reviewing submissions and inspection records, determining the firm imports and distributes electronic nicotine delivery system (ENDS) products in the U.S. These ENDS products are classified as 'new tobacco products' because they were not commercially marketed in the U.S. as of February 15, 2007. The firm is in violation for importing, selling, and distributing these products without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are 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 or information under section 905(j). The failure to provide such a report is also a prohibited act under section 301(p). The FDA expressed particular concern regarding the Uwell Amulet Watch Pod System's design, which resembles smartwatches and is likely to appeal to children, potentially concealing tobacco product use. The firm must respond within 15 working days, detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may lead to civil money penalties, seizure, injunction, and refusal of admission for imported products.