FDA WARNING_LETTER - vapeologyma.com - October 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated October 31, 2025, to vapeologyma.com, along with affiliated entities World Traders USA LLC and Vapeology, Inc. The letter followed a review of the company"s website, which identified the unlawful sale and distribution of Electronic Nicotine Delivery System (ENDS) products. Specifically, "EB Design TE6000 6000 Puff Disposable – Lemon Drop" and "Key West" were cited for lacking 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 marketing authorization before they can be legally sold in the United States. The absence of such authorization renders the products adulterated and misbranded, as per sections 902(6)(A) and 903(a)(6) of the FD&C Act. The regulatory scope, broadened by the Consolidated Appropriations Act, 2022, now includes nicotine from any source.The FDA requires the company to immediately cease the sale and distribution of all unauthorized tobacco products. A written response is mandated within 15 working days, detailing the actions taken to address these violations, including the discontinuation of the violative products and a comprehensive plan to maintain future compliance with the FD&C Act and its implementing regulations.