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

Warning LetterOpen

Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Beachwood 649 Atlantic City Boulevard Beachwood , NJ 08722 United StatesIssued Jan 4, 2024Center for Tobacco Products

View Letter

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

Violations1

Issue DateJan 4, 2024

Product TypeTobacco

StatusOpen

Letter Details

Firm: Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Beachwood
Location: Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Beachwood 649 Atlantic City Boulevard Beachwood , NJ 08722 United States
FEI Number: N/A
Country: United States
Issue Date: January 04, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Beachwood manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company's e-liquid products fell under FDA jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act, as they contained nicotine from any source and were intended for human consumption. The products were found to be adulterated and/or misbranded for lacking the legally mandated premarket review and approval required for new tobacco products marketed in the United States.

Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Beachwood FDA Warning Letter, January 4, 2024