FDA WARNING_LETTER - Best Vapes Store - August 23, 2023

On August 23, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to bestvapesstore.com after reviewing its website, which offered electronic nicotine delivery system (ENDS) products for sale in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, particularly noting the expanded definition to include nicotine from any source. The FDA determined that the firm was marketing "new tobacco products," including specific items like JODK Bottle Disposable and Elf Bar Disposable Vape BC 5000 Puffs, without the required premarket authorization order under section 910(a) of the FD&C Act. As a result, these unauthorized products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the lack of required notice under section 905(j). The FDA also highlighted significant concerns regarding product labeling and advertising for some ENDS products that imitate children's items, potentially promoting youth use and concealing their tobacco product nature. The letter mandates a written response within 15 working days detailing corrective actions, including discontinuing violative sales and outlining a compliance plan. Non-compliance could lead to severe enforcement actions, such as civil money penalties, seizure, or injunction.