Caribbean Cloud Dot Com d/b/a Gorilla Vapes

Warning LetterOpen

Russ Jurczyk Owner Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell 2954 Highway 9 South Howell , NJ 07731 United States russ@caribbeancloudcompany.comIssued Sep 21, 2023Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateSep 21, 2023

Product TypeTobacco

StatusOpen

Letter Details

Firm: Caribbean Cloud Dot Com d/b/a Gorilla Vapes
Location: Russ Jurczyk Owner Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell 2954 Highway 9 South Howell , NJ 07731 United States russ@caribbeancloudcompany.com
FEI Number: N/A
Country: United States
Issue Date: September 21, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Caribbean Cloud Dot Com d/b/a Gorilla Vapes manufactured and distributed e-liquid products containing nicotine, which fall under FDA jurisdiction as tobacco products under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with federal requirements governing tobacco products, including the requirement that new tobacco products obtain premarket authorization before being legally marketed in the United States. The FDA's jurisdiction over these products was expanded in March 2022 to include all nicotine-containing products regardless of nicotine source, establishing that the company's e-liquid offerings required regulatory compliance.

Caribbean Cloud Dot Com d/b/a Gorilla Vapes FDA Warning Letter, September 21, 2023