FDA WARNING_LETTER - chubbysmoke.com

The FDA Center for Tobacco Products issued a Warning Letter to chubbysmoke.com on September 18, 2025, following a review of their website. The company was found to be illegally offering for sale electronic nicotine delivery system (ENDS) products, specifically "Lost Vape Orion Bar 10K, Strawberry Summertime" and "Flum Mello 20K, Sour Apple Icy," to U.S. customers. 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 marketed before February 15, 2007, and lack the required premarket authorization from the FDA. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA emphasizes that all tobacco products, including those containing nicotine from any source, must comply with the FD&C Act and its regulations. chubbysmoke.com is required to promptly cease the sale and distribution of these unauthorized products and submit a written response within 15 working days. This response must detail the actions taken to address the violations, including the dates discontinued, and outline a plan for maintaining future compliance with FDA regulations. Failure to comply may result in further regulatory actions such as civil money penalties or seizure.