# FDA WARNING_LETTER - Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes - November 03, 2022

Source: https://www.keypedia.com/records/warning_letter/cloud-x-vapes-forest-lake-llc-dba-cloudxvapes/3c625ad3-2155-48fa-bd9a-04e2dd52205e

> FDA WARNING_LETTER for Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes on November 03, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes
- Inspection Date: 2022-11-03
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes on November 3, 2022, based on a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically an "Apple e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation is that the "Apple e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires Cloud X Vapes to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/

## Related Officers

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

Company: https://www.keypedia.com/companies/cloud-x-vapes-forest-lake-llc-dba-cloudxvapes/b5c8d3a3-cc84-4056-9cb8-e1ec18f943ce

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