FDA WARNING_LETTER - DK Global Enterprises LLC d/b/a I Love Vape LLC / Matrix Wholesaler LLC - December 19, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Damaris Pantoja after reviewing the websites https://i-lovevape.com and https://matrix-wholesale.com, which offer electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA determined that several listed ENDS products, including "Hulkamania Disposable Vape" and "Ozuna Insta 15000 Puffs Disposable Device," are new tobacco products under section 201(rr) of the FD&C Act, which now encompasses nicotine from any source. These products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the FDA found these products to be adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). The letter mandates a written response within 15 working days detailing actions to address these violations, including discontinuing sales and a plan for sustained compliance. Non-compliance may lead to regulatory actions such as civil money penalties, product seizure, injunction, or import detention.