FDA WARNING_LETTER - A & S Tacna, Inc. d/b/a Vape Mobs - December 12, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to Ali Hasan Ali and Stewart J. Namao after reviewing their website, https://vapemobs.com, which offers electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA determined that several ENDS products, specifically Breeze Plus 800 Pineapple Lemon, Elf Bar BC5000 Miami Mint, Funky Republic TI7000 Frozen Edition Watermelon Nana Duo Ice, and Lost Mary OS5000 Blueberry P&B Cloudd, are being marketed without the required premarket authorization order. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed before February 15, 2007, and lack the necessary marketing authorization. Consequently, these products are deemed 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 under section 905(j). The firm is required to submit a written response within 15 working days detailing actions taken to cease violative sales and ensure future compliance, or provide justification if they believe no violation occurred. Failure to comply could result in regulatory actions, including civil money penalties, seizure, or injunction.