FDA WARNING_LETTER - vapesatl.com - October 01, 2025

On October 17, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to vapesatl.com after reviewing their website and identifying the unlawful sale of electronic nicotine delivery system (ENDS) products. The FDA determined that specific products, including Kangvape ONEE Stick 3000, Aloe Grape, and Juicy Bar JB5000, Red Mojito, are being marketed without the required premarket authorization.Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these ENDS products are classified as "new tobacco products" because they were not commercially available in the U.S. prior to February 15, 2007, and lack the necessary FDA marketing authorization orders. The FDA recently expanded the definition of "tobacco product" to include nicotine from any source. As a result, the FDA deems these products adulterated and misbranded due to their non-compliance with the premarket review requirements.Vapesatl.com is mandated to submit a written response within 15 working days from receipt of the letter. This response must detail the specific actions taken to address the identified violations, including the dates when the sale and distribution of the unauthorized products were discontinued, and present a comprehensive plan to ensure future compliance with the FD&C Act. Failure to rectify these violations may lead to further regulatory actions, such as civil money penalties, product seizure, or injunctions.