CloudT3n, LLC d/b/a The Cloud

Warning LetterOpen

Karn Elofson Owner CloudT3n, LLC d/b/a The Cloud 929 S Marion Rd Sioux Falls , SD 57106-0238 United States elofsoninc@gmail.comIssued Sep 7, 2021Center for Tobacco Products

View Letter

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

Violations1

Issue DateSep 7, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: CloudT3n, LLC d/b/a The Cloud
Location: Karn Elofson Owner CloudT3n, LLC d/b/a The Cloud 929 S Marion Rd Sioux Falls , SD 57106-0238 United States elofsoninc@gmail.com
FEI Number: N/A
Country: United States
Issue Date: September 07, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

CloudT3n, LLC d/b/a The Cloud manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which were deemed tobacco products effective August 8, 2016, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements for new tobacco products that require premarket review before commercial distribution. The FDA determined that these products were marketed in the United States without the mandatory premarket authorization needed for tobacco products not commercially available as of February 15, 2007.

CloudT3n, LLC d/b/a The Cloud FDA Warning Letter, September 7, 2021