chillzoneusa.com – FDA Warning Letter, Sep 2, 2025

The FDA issued a warning letter to Chill Zone USA, located at 1603 Florence Road, Killeen, TX, following an inspection of their website, https://chillzoneusa.com. The inspection, conducted by the Center for Tobacco Products, identified that the company was offering electronic nicotine delivery system (ENDS) products for sale in the U.S. without the necessary premarket authorization. This action violates the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates that new tobacco products, including those containing nicotine from any source, must have FDA authorization to be legally marketed.

The specific products cited include Funky Republic TI7000 – Pink Bomb and Funky Republic TI7000 – Pomelo Pearl Grape. These products are considered "new tobacco products" as they were not commercially available in the U.S. before February 15, 2007, and lack the required marketing authorization. Consequently, they are deemed adulterated and misbranded under the FD&C Act.

The FDA requires Chill Zone USA to take immediate corrective actions, including ceasing the sale and distribution of these unauthorized products and submitting a written response within 15 working days detailing their compliance plan. Failure to address these violations could lead to enforcement actions such as civil penalties or product seizure. The company is advised to ensure all products and marketing materials comply with the FD&C Act and FDA regulations.