FDA WARNING_LETTER - Vape4usa.com - October 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Vape4usa.com on October 9, 2025, following a review of their website. The FDA determined that the company is offering for sale or distribution unapproved electronic nicotine delivery system (ENDS) products, specifically "Craftbox V-Touch 30K Puffs Smart Disposable Vape – Blueberry Watermelon" and "Craftbox V-Touch 30K Puffs Smart Disposable Vape -Strawberry Mango". These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed in the U.S. before February 15, 2007, and lack the required premarket authorization order. Consequently, these ENDS products are considered adulterated and misbranded under the FD&C Act. The FDA also expressed significant concern that the products" smartphone-like design and features, such as Bluetooth and a touch screen, may specifically entice youth and help conceal their nature as tobacco products. Vape4usa.com is required to immediately cease the unlawful sale and distribution of these violative tobacco products. The company must submit a written response to the FDA within 15 working days, detailing the actions taken to address these violations and ensure compliance with all applicable provisions of the FD&C Act and its implementing regulations.