FDA WARNING_LETTER - discountvapeoutlet.com - September 26, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to discountvapeoutlet.com on September 26, 2025, following a review of their website. The FDA determined that the company is illegally offering for sale electronic nicotine delivery system (ENDS) products to U.S. customers.

The main violation identified is the marketing of "new tobacco products" without the necessary premarket authorization orders from the FDA. Specifically, the products "HQD Everest 25K Disposable Vape, Cherry Lemon" and "HQD Everest 25K Disposable Vape, Grape" were cited as new tobacco products that were not commercially available before February 15, 2007, and lack the required FDA marketing authorization. Consequently, these products are deemed adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The FDA emphasizes that all tobacco products, including those containing nicotine from any source, must comply with the FD&C Act.

discountvapeoutlet.com is required to take prompt action to address these violations, including immediately discontinuing the sale and distribution of the unauthorized ENDS products. The company must submit a written response to the FDA within 15 working days from the letter"s receipt, outlining the corrective actions taken, including the dates violative sales ceased, and their plan for ensuring ongoing compliance with the FD&C Act. Failure to comply may result in further regulatory actions such as civil money penalties, seizure, or injunction.