# FDA WARNING_LETTER - HotHead Vapor - October 19, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/hothead-vapor/27b64ee4-f073-4746-a246-2dd84db6b72f

> FDA WARNING_LETTER for HotHead Vapor on October 19, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: HotHead Vapor
- Inspection Date: 2021-10-19
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to HotHead Vapor, identifying their e-liquid products, specifically "HOTHEAD VAPOR Brainz 3 Nic e-liquid," as tobacco products subject to FDA jurisdiction. The letter states 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 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, as no required notice or information was provided under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA emphasizes that all new tobacco products without statutory premarket authorization are unlawfully marketed and subject to enforcement, including civil money penalties, seizure, and/or injunction. HotHead Vapor, a registered manufacturer with over 10 listed products, must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance.

## Related Documents

- [WARNING_LETTER - 2022-01-27](https://www.globalkeysolutions.net/records/warning_letter/hothead-vapor/8af6dabe-0897-4fe2-84f3-690dff2e5cc5)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/hothead-vapor/fc5148c7-1d23-40e8-81f5-bde5ee020e2c

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