FDA WARNING_LETTER - U Mart International, Inc. - June 13, 2023

On May 25, 2023, the FDA issued a Warning Letter to Mingzhe Pang regarding the sale of Electronic Nicotine Delivery System (ENDS) products on the website https://www.umartgo.com. The FDA's Center for Tobacco Products determined that the RELX Classic Replacement Pod – Dark Sparkle (Cola) ENDS product was sold to an individual under the age of 21, which constitutes a violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). Consequently, the product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

The letter emphasizes the responsibility to ensure compliance with all applicable provisions of the FD&C Act and FDA's implementing regulations for tobacco products, labeling, and advertising across all sales channels. Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, injunction, or refusal of import. The FDA also noted that "new tobacco products" require premarket authorization. A written response detailing corrective actions and a plan for maintaining compliance is required within 15 working days from the receipt of the letter.