# FDA WARNING_LETTER - Blackbeard Vapor LLC - January 31, 2022

Source: https://www.keypedia.com/records/warning_letter/blackbeard-vapor-llc/ebe94ac7-eed1-4f64-aca1-f6acbc263775

> FDA WARNING_LETTER for Blackbeard Vapor LLC on January 31, 2022. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Blackbeard Vapor LLC
- Inspection Date: 2022-01-31
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On January 31, 2022, the FDA issued a Warning Letter to Blackbeard Vapor LLC, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that Blackbeard Vapor LLC manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product," specifically "Icy Extreme 3mg e-liquid," without the required premarket authorization. Under section 910(a) of the FD&C Act, a new tobacco product is one not commercially marketed in the U.S. as of February 15, 2007, or a modified product marketed after this date. The "Icy Extreme 3mg e-liquid" was found to be a new tobacco product lacking an FDA marketing authorization order, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter states that the failure to provide a required report under section 905(j) of the FD&C Act is a prohibited act under section 301(p). Blackbeard Vapor LLC is a registered manufacturer with over 1,600 products listed with FDA. The FDA emphasizes that all new tobacco products

## Related Officers

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

Company: https://www.keypedia.com/companies/blackbeard-vapor-llc/926a197f-a163-49ba-9777-ea3d10ac44e0

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