FDA WARNING_LETTER - ecmvape.com - November 03, 2025

The FDA issued a Warning Letter to ecmvape.com on November 7, 2025, after reviewing its website and identifying the unlawful sale of certain electronic nicotine delivery system (ENDS) products to customers in the United States. The main violation stems from offering "new tobacco products" – specifically "FUME Pro Disposable 30K Puffs - Dubai Chocolate" and "SMOK SpaceMan Prism Disposable 20K Puffs - Dark Grapefruit" – without the required premarket authorization orders. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products introduced after February 15, 2007, must secure FDA authorization. Lacking this, the products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The company is required to promptly cease the sale and distribution of these violative products and submit a written response to the FDA within 15 working days. This response must detail the actions taken to address the violations and outline a plan for maintaining full compliance with the FD&C Act, or face potential regulatory actions like civil money penalties.