# FDA WARNING_LETTER - MVRB2, LLC, d/b/a Kure CBD & Vape - December 09, 2024

Source: https://www.keypedia.com/records/warning_letter/mvrb2-llc-dba-kure-cbd-vape/bd5440f6-f888-4f89-8a89-ad7979aba530

> FDA WARNING_LETTER for MVRB2, LLC, d/b/a Kure CBD & Vape on December 09, 2024. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MVRB2, LLC, d/b/a Kure CBD & Vape
- Inspection Date: 2024-12-09
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On December 9, 2024, the FDA issued a Warning Letter to MVRB2, LLC, d/b/a Kure CBD & Vape, for manufacturing, selling, and/or distributing e-liquid products without required marketing authorization. The FDA determined that "The Brew" e-liquid product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization.

This product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization or exemption. The letter emphasizes that e-liquid products, including those containing nicotine from any source, are subject to FDA jurisdiction and must comply with the FD&C Act.

MVRB2, LLC must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales/distribution of violative products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.

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## Related Officers

- [Director](https://www.keypedia.com/people/john-e-verbeten/80be3640-a657-41ff-92c0-f6178bd12378)

Company: https://www.keypedia.com/companies/mvrb2-llc-dba-kure-cbd-vape/123d78b8-feb0-4bce-a6bc-830f90c028b6

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