FDA WARNING_LETTER - CloudT3n, LLC d/b/a The Cloud - September 07, 2021

The FDA issued a Warning Letter to CloudT3n, LLC d/b/a The Cloud, identifying that their e-liquid products, specifically "The Cloud DRAGON’S BREATH 3% 120ml," 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 the manufacturing, sale, and/or distribution of 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. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

CloudT3n, a registered manufacturer with over 16,900 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil