FDA WARNING_LETTER - fogxvapor.com - October 01, 2025

On October 9, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to fogxvapor.com following a review of its website. The FDA determined that the company is offering electronic nicotine delivery system (ENDS) products, specifically Fog X Circuit – Aloe Lychee and Fog X Circuit – Strawberry Mango Dragonfruit, for sale in the United States without the required premarket marketing authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these are considered "new tobacco products" and must receive authorization to be legally marketed. Their unlawful sale without authorization makes them adulterated and misbranded under the Act.

Further, the FDA expressed significant concern regarding the youth appeal of the Fog X Circuit products. Their design and advertising, which mimic smartphones with features like "Customizable Wallpaper" and "Bluetooth Device Connectivity," are deemed to entice young individuals and potentially hide the product"s true nature as a tobacco product from adults.

Fogxvapor.com is required to take immediate action to address these violations, including ceasing the sale and distribution of the unauthorized products. The company must submit a written response to the FDA within 15 working days, detailing the corrective actions taken and outlining a plan for maintaining compliance with all applicable FD&C Act regulations. Failure to comply may result in further regulatory enforcement.