# FDA WARNING_LETTER - CVM 3, LLC d/b/a Carolina Vapor Mill - August 02, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/cvm-3-llc-dba-carolina-vapor-mill/81554004-b96e-4f33-8307-6713e8916554

> FDA WARNING_LETTER for CVM 3, LLC d/b/a Carolina Vapor Mill on August 02, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CVM 3, LLC d/b/a Carolina Vapor Mill
- Inspection Date: 2022-08-02
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to CVM 3, LLC d/b/a Carolina Vapor Mill, stating that their e-liquid products, specifically "V TFN Shine Love Shack 12mg 120ml," are considered tobacco products under the FD&C Act, including those containing nicotine from any source. The FDA determined that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that the company manufactures, sells, and/or distributes this e-liquid product without the required premarket marketing authorization order from the FDA. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). The failure to provide such a report is also a prohibited act under section 301(p).

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/cvm-3-llc-dba-carolina-vapor-mill/afff94b2-2c19-48e4-8440-615b6bdebde4

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