FDA WARNING_LETTER - Misthub, LLC - June 13, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Igor Petryuchenko after reviewing the website misthub.com, which offers electronic nicotine delivery system (ENDS) and e-liquid products for sale in the U.S. The FDA determined that specific products, including Bad Drip 60ML Vape Juice (Dont Care Bear, Cereal Trip) and Funky Republic Fi3000 Puffs Disposable Vape (Apple Watermelon), are "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed before February 15, 2007. These products lack the required premarket authorization order under section 910(c)(1)(A)(i), rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices under section 905(j). The FDA also raised concerns about some products' designs, such as Bad Drip Labs e-liquids imitating prescription pill bottles, which are likely to appeal to youth. The letter mandates prompt action to address these violations, including discontinuing violative sales and submitting a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may lead to regulatory actions like civil money penalties, seizure, or injunction.