FDA WARNING_LETTER - HQD Tech USA, LLC - July 20, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Abdelhamid Yousef after reviewing the website hqdtechusa.com, determining that the company manufactures and offers for sale electronic nicotine delivery system (ENDS) products to U.S. customers. These products are deemed tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation. The letter identifies two main categories of violations. First, the company is selling new tobacco products without the required premarket marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to a lack of required notices under section 905(j). Second, the ENDS products are considered modified risk tobacco products, adulterated under section 902(8) of the FD&C Act, as they are sold without an FDA order permitting such claims, violating section 911(a). The website makes explicit or implicit representations of lower risk or reduced substance exposure. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative activities and a plan for future compliance. Failure to comply may result in further regulatory action, and non-compliant products are subject to detention if imported.