FDA WARNING_LETTER - Quan 5 Inc. d/b/a District F5VE - July 21, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Lan Nguyen and Ton Phi Nguyen (District F5VE) on April 22, 2020, after reviewing their website, https://www.districtf5ve.com. The review determined that the firm manufactures and offers for sale electronic nicotine delivery system (ENDS) products, specifically "QWIN-NIC Capsules – Shortcake," which are deemed tobacco products subject to FDA regulation. The primary violation identified is the sale of a "new tobacco product" without the required premarket authorization, as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, this product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to the failure to provide required information under section 905(j). Furthermore, the failure to provide the necessary report under section 905(j) constitutes a prohibited act under section 301(p) of the FD&C Act. 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 address these violations may result in civil money penalties, product seizure, injunctions, and refusal of admission for imported products.