FDA WARNING_LETTER - Vape123 - August 23, 2023

The FDA issued a Warning Letter to vape123.com after reviewing its website and identifying electronic nicotine delivery system (ENDS) products offered for sale in the United States. These products are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the recent amendment extending jurisdiction to products with nicotine from any source. Generally, "new tobacco products" require premarket authorization to be legally marketed. The FDA found that vape123.com offers specific ENDS products, including Oly Frozen, Vapin’ Donuts, Elfbar Pi9000, and Esco Bar, without the required marketing authorization. These products are considered new tobacco products as they were not commercially marketed before February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, these 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 notice or information under section 905(j). The FDA expressed particular concern regarding the youth appeal of some products, which imitate beverage containers and conceal their nature, potentially encouraging youth use. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.