FDA WARNING_LETTER - Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor - August 31, 2021

The FDA issued a Warning Letter to Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that Cloud 9 Vapor manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violation cited is the marketing of a "new tobacco product," specifically "Cloud 9 Vapor Ape Escape 3MG 30ml e-liquid product," without the required premarket authorization. This product 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 deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j).

The FDA states that the failure to provide the required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act, and any act resulting in an adulterated or misbranded product held for sale after interstate shipment is prohibited under section 301(k).

Cloud 9 Systems, a registered manufacturer with over 16,300 listed products, is required to ensure compliance. The FDA demands