Cool Vape LLC – FDA Warning Letter, Oct 1, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Cool Vape LLC on October 2, 2025, following a review of their inspection records. The letter identifies that Cool Vape LLC is selling and distributing e-liquid products, specifically citing "Noms 100 Watermelon Blackberry Plum 100ML 3MG/ML," to customers in the United States.

The core violation is the marketing of new tobacco products without the required premarket authorization from the FDA. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), e-liquid products are classified as tobacco products and are subject to FDA jurisdiction. A "new tobacco product" is generally defined as one not commercially marketed in the U.S. before February 15, 2007, and requires specific premarket authorization, such as a marketing order or a finding of substantial equivalence. Because the identified e-liquid product lacks this essential authorization, it is deemed adulterated and misbranded under the FD&C Act.

The FDA requires Cool Vape LLC to take prompt action to address these violations. The company must submit a written response within 15 working days of receiving the letter. This response needs to describe the actions taken to correct the violations, including the dates on which the unauthorized sale and distribution of these tobacco products were discontinued. Additionally, Cool Vape LLC must provide a plan for maintaining future compliance with the FD&C Act and its implementing regulations. Failure to comply could result in further regulatory actions, including civil money penalties, product seizure, or injunctions.