# FDA WARNING_LETTER - CloudT3n, LLC d/b/a The Cloud - September 07, 2021

Source: https://www.keypedia.com/records/warning_letter/cloudt3n-llc-dba-the-cloud/00a3c231-6ba2-4bb9-bf4a-3f35feaed054

> FDA WARNING_LETTER for CloudT3n, LLC d/b/a The Cloud on September 07, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CloudT3n, LLC d/b/a The Cloud
- Inspection Date: 2021-09-07
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to CloudT3n, LLC d/b/a The Cloud, identifying that their e-liquid products, specifically "The Cloud DRAGON’S BREATH 3% 120ml," are tobacco products subject to FDA jurisdiction. The letter states that this product is a "new tobacco product" as it was not commercially marketed in the U.S. before February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

CloudT3n, a registered manufacturer with over 16,900 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/cloudt3n-llc-dba-the-cloud/f8e2ad92-a648-49d3-bb07-4633788eee01

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374