FDA WARNING_LETTER - Cool Vapes Allison Park - August 26, 2021

The FDA issued a Warning Letter to Cool Vapes, LLC, identifying that their e-liquid products, specifically "Cool Vapes Looper 30ml 0.3% e-liquid," are tobacco products subject to FDA jurisdiction. The letter states that this product is a "new tobacco product" as it was not commercially marketed in the U.S. before February 15, 2007.

The primary violation is that Cool Vapes, LLC manufactures, sells, and/or distributes this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided. Prohibited acts under sections 301(k) and 301(p) of the FD&C Act are cited.

Cool Vapes, LLC, a registered manufacturer with over 19,400 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product, and a plan for maintaining compliance. Failure to address these issues may result in regulatory actions such as civil