FDA WARNING_LETTER - onlinevapeshop.us - October 01, 2025

On October 31, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to onlinevapeshop.us, following a review of their website. The FDA determined that the company is offering electronic nicotine delivery system (ENDS) products for sale in the United States that lack the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), ENDS products not commercially marketed before February 15, 2007, are considered "new tobacco products" and require prior FDA authorization to be legally sold. The letter specifically cited "White Gummy (Sour Control) AirFuze Addon 40K (W/ Art Patch)" and "Frozen Fcuking Fab (Ice Control) AirFuze Addon 40K (W/ Art Patch)" as examples of unauthorized products. Because these products do not have FDA marketing orders, they are considered adulterated and misbranded. onlinevapeshop.us is required to promptly address these violations, discontinue the sale and distribution of all unauthorized tobacco products, and submit a written response to the FDA within 15 working days. The response must detail the actions taken to achieve compliance and outline a plan for maintaining adherence to the FD&C Act.