FDA WARNING_LETTER - Apex Vape, Inc - August 23, 2023

The FDA issued a Warning Letter to Apex Vape Wholesale after reviewing their website, apexvapewholesale.com, and finding electronic nicotine delivery system (ENDS) products offered for sale or distribution in the United States. These products, including examples like Pod Mesh Flo Single Disposable and Elf Bar BC5000 Ultra Disposable, are considered "new tobacco products" under the FD&C Act, as they were not commercially marketed before February 15, 2007, and contain nicotine from any source. The primary violation is the marketing of these new tobacco 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) due to the failure to provide required notice under section 905(j). The FDA expressed particular concern regarding the products' labeling, advertising, and design, which appear to imitate beverage containers and children’s toys, potentially promoting youth use and concealing their nature as tobacco products. The letter emphasizes that all unauthorized new tobacco products are marketed unlawfully and are subject to enforcement actions, including civil money penalties, seizure, or injunction. Apex Vape Wholesale is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance.