FDA WARNING_LETTER - Buy Pods Now - June 25, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Ryan Doka and Kristen Vanorski Doka after reviewing buypodsnow.com, where electronic nicotine delivery system (ENDS) products were offered for sale in the United States. The FDA determined that products, specifically "Lava Bar Disposable Vape 2000 Puffs – Lemon Smooth 5%" and "Lost Mary OS5000 Disposable 5000 Puffs – Forest Mint," are tobacco products under section 201(rr) of the FD&C Act, including those with nicotine from any source. These are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are 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 must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction, and potential detention or refusal of import.