FDA WARNING_LETTER - Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Beachwood - January 04, 2024

On January 4, 2024, the FDA issued a Warning Letter to Caribbean Cloud Dot Com d/b/a Gorilla Vapes for manufacturing and distributing unapproved new tobacco products. The FDA determined that the company's e-liquid product, "Bad Santa," is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization.

This product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because no notice or information was provided as required by section 905(j). The failure to provide such a report is a prohibited act under section 301(p). The FDA emphasizes that all new tobacco products require premarket authorization, either through a marketing order, substantial equivalence finding, or exemption.

The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of the violative products, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.