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

Warning LetterOpen

Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia 1900 Vare Avenue Philadelphia , PA 19145 United StatesIssued May 7, 2024Center for Tobacco Products

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

Violations1

Issue DateMay 7, 2024

Product TypeTobacco

StatusOpen

Letter Details

Firm: Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia
Location: Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia 1900 Vare Avenue Philadelphia , PA 19145 United States
FEI Number: N/A
Country: United States
Issue Date: May 07, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing "new tobacco products" under section 901(b) of the Federal Food, Drug, and Cosmetic Act, which require premarket approval for any tobacco product not commercially marketed in the United States as of February 15, 2007.

Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia FDA Warning Letter, May 7, 2024