FDA WARNING_LETTER - Caribbean Cloud Dot Com d/b/a Gorilla Vapes LLC - September 28, 2023

The FDA issued a Warning Letter to Caribbean Cloud Dot Com d/b/a Gorilla Vapes LLC on September 28, 2023, following a review of submissions and inspection records. The FDA determined the company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "GV Tobacco E-Liquid TFN Ex-mint 8MG 30ML" was found to be a new tobacco product not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order or exemption. 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 a required notice or information under section 905(j).

The FDA states that marketing such products is unlawful and subject to enforcement actions including civil money penalties, seizure, and/or injunction. The company is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of non-compliant products, and outlining a plan for maintaining compliance with the FD&C Act.