FDA WARNING_LETTER - giantvapes.com - December 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to giantvapes.com on December 5, 2025, following a recent review of their website. The letter identifies significant violations regarding the marketing and sale of certain electronic nicotine delivery system (ENDS) products. Specifically, giantvapes.com was found to be offering "Lost Vape Orion Bar 7500 Disposable - Apple Cotton Candy" and "Lost Vape Orion Bar 7500 Disposable - Chicago Cocktail" for sale in the United States. These products are classified as "new tobacco products" under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed before February 15, 2007, and contain nicotine. The primary violation is that these ENDS products lack the required premarket authorization order from the FDA, making them unlawfully marketed. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Giantvapes.com is required to take prompt action to address these violations, including immediately discontinuing 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, the dates these actions were completed, and their plan for ensuring ongoing compliance with federal regulations. Failure to comply may result in further regulatory actions.