Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor

Warning LetterOpen

Brendon Gunn Owner Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor 1055 W Red Cliffs Dr Ste B Washington , UT 84780-2541 United States brendongunn@gmail.comFEI 3010889080Issued Aug 25, 2021Center for Tobacco Products

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010889080.

Violations1

Issue DateAug 25, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor
Location: Brendon Gunn Owner Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor 1055 W Red Cliffs Dr Ste B Washington , UT 84780-2541 United States brendongunn@gmail.com
FEI Number: 3010889080
Country: United States
Issue Date: August 25, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as electronic nicotine delivery systems under FDA jurisdiction since the August 8, 2016 deeming rule, were offered for sale in the United States without the mandatory marketing authorization orders required for new tobacco products. The FDA determined these products were not commercially marketed prior to February 15, 2007, making them subject to premarket review requirements that the company failed to complete.

Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor FDA Warning Letter, August 25, 2021