FDA WARNING_LETTER - elfbarvapesusa.com - November 03, 2025

The FDA Center for Tobacco Products issued a Warning Letter to elfbarvapesusa.com on November 26, 2025, following a review of their website. The letter identifies electronic nicotine delivery system (ENDS) products, specifically Elf Bar BC5000 - Blue Razz Ice and Elf Bar TE6000 Disposable Vape - Hawaii Punch, as being offered for sale and distribution in the United States without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these ENDS products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing orders. Recent legislation also expanded the definition of "tobacco product" to include nicotine from any source, subjecting these products to FDA jurisdiction. The absence of premarket authorization renders these products adulterated and misbranded under the FD&C Act. Elfbarvapesusa.com is required to cease the unlawful marketing of these unauthorized products. The company must submit a written response within 15 working days, detailing the actions taken to address these violations, including the discontinuation of sales and distribution of the violative products, and outlining a plan for future compliance with the FD&C Act and its implementing regulations. Failure to comply may result in further regulatory actions such as civil money penalties, seizure, or injunction.