The Vape Giant – FDA Warning Letter, Sep 14, 2023

The FDA Center for Tobacco Products issued a Warning Letter to thevapegiant.com after reviewing its website and identifying electronic nicotine delivery system (ENDS) products offered for sale or distribution in the United States. These products, including Cali Bars V2 Dispo Blueberry 6000 Puffs, Elf Bar Disposable Lemon Mint BC5000 Puff, Lava Plus Disposable Banana 2000 Puffs, and Lava Plus Disposable Peach Ice 2000 Puffs, are considered "new tobacco products" as they were not commercially marketed before February 15, 2007. The letter highlights that the definition of "tobacco product" was expanded on March 15, 2022, to include products containing nicotine from any source. The primary violation is the marketing of these ENDS products without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided per section 905(j). The FDA mandates a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a compliance plan. Failure to comply may result in civil money penalties, seizure, injunction, or detention of imported products.