Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell – FDA Warning Letter, Sep 21, 2023

The FDA issued a Warning Letter to Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell on September 21, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Beetlejuice" was cited as a new tobacco product not commercially marketed in the U.S. as of 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, as no notice or information was provided as required by 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 adulterated or misbranded products held for sale after interstate shipment is prohibited under section 301(k).

The company is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/