FDA WARNING_LETTER - Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Forest - October 12, 2023

The FDA issued a Warning Letter to Caribbean Cloud Dot Com d/b/a Gorilla Vapes for manufacturing and distributing unapproved e-liquid products. The inspection records indicated the company sells e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the March 15, 2022 amendment.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, the product "GORILLA VAPES Fire & Ice 30ml 3% nicotine" was identified as a new tobacco product not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information.

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 money penalties, seizure, and/or injunction.