Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Howell

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 of Howell
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 of Howell manufactured and distributed e-liquid tobacco products containing nicotine without required premarket authorization as mandated by the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products fell under FDA jurisdiction as tobacco products under the expanded definition that includes all products containing nicotine from any source, following the March 2022 legislative amendment. The FDA determined that the company failed to comply with applicable tobacco product regulations and requirements necessary for legal marketing in the United States.

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