Cool Vapes Cranberry – FDA Warning Letter, Aug 26, 2021

The FDA issued a Warning Letter to Cool Vapes, LLC, following a review of submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically Cool Vapes Irish Cream 30ml 0.3% e-liquid. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of the Cool Vapes Irish Cream 30ml 0.3% e-liquid product without the required premarket marketing authorization. This product is deemed a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). Prohibited acts under sections 301(k) and 301(p) are cited.

Cool Vapes, LLC, a registered manufacturer with over 19,500 listed products, is responsible for ensuring compliance with the FD&C Act. The FDA requires a written response within 15 working days detailing actions taken to address