FDA WARNING_LETTER - Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia - May 07, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia on May 7, 2024, following a review of inspection records. The company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "PINA COLADA" e-liquid, a new tobacco product, without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because no notice or information was provided as required by section 905(j).

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation dates for the violative product sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. Imported products appearing adulterated or misbranded may be detained or refused admission.