FDA WARNING_LETTER - vapecityusa.com - October 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to vapecityusa.com on October 9, 2025, following a review of their website. The letter identifies that the company is offering electronic nicotine delivery system (ENDS) products, specifically "Humo Case 30000 Phone Case Vape" models, for sale to customers in the United States without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, these products are considered "new tobacco products" and must receive FDA authorization before being marketed. The FDA determined these products are unlawfully marketed because they lack the necessary clearance and were not commercially available before February 15, 2007, or subsequently approved. Furthermore, the FDA expressed significant concern regarding the product design, which mimics cell phone cases. This design feature is believed to entice youth and conceal the products" identity as tobacco products from adults, contributing to public health and safety concerns related to youth ENDS use. Vapecityusa.com is required to immediately cease the sale and distribution of all unauthorized tobacco products and ensure that all its products, labeling, and advertising comply with the FD&C Act and FDA"s implementing regulations. Failure to promptly correct these violations may result in further regulatory actions, including civil money penalties, product seizure, or legal injunctions.