FDA WARNING_LETTER - Shenzhen Uptown-Tech Technology Co., Ltd. - May 26, 2020

The FDA issued a Warning Letter to Deming Dai of Uptown-Tech after reviewing their website, uptown-tech.com, which showed the sale and distribution of Electronic Nicotine Delivery System (ENDS) products to U.S. customers. These products, including various "Gem pods" (Blueberry, Grape, Pink Lemonade, Raspberry, Pineberry), are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation, including the deeming rule effective August 8, 2016, as per 21 C.F.R. § 1100.1. The primary violation is that these ENDS products are "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed in the U.S. before February 15, 2007. The firm has not obtained the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, rendering the products adulterated under section 902(6)(A) of the FD&C Act. Uptown-Tech must promptly correct these violations and ensure all tobacco products and related advertising comply with the FD&C Act. A written response detailing corrective actions, including discontinuation of violative sales and a compliance plan, is required within 15 working days. Failure to comply may lead to enforcement actions such as civil money penalties, product seizure, injunction, and refusal of admission for imported products.