ZiipStock – FDA Warning Letter, Sep 14, 2023

The FDA's Center for Tobacco Products reviewed ziipstock.com and determined that electronic nicotine delivery system (ENDS) products, specifically Cali Bars 4500 Disposable Vape – Watermelon, Cali Bars 6000 Disposable Vape – Gummy, and Elf Tank BX6000 Disposable Vape – Banana Ice, are offered for sale or distribution in the United States without the required premarket authorization. These products are considered "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and lack an FDA marketing authorization order. Consequently, these ENDS 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 notices under section 905(j). The FDA mandates that the firm promptly address these violations by discontinuing the unlawful sale and distribution of these products. A written response detailing corrective actions, discontinuation dates, and a compliance plan must be submitted within 15 working days. Failure to comply may result in regulatory actions, including civil money penalties, seizure, injunction, and import detention.