# FDA WARNING_LETTER - Vapor Rage LLC - November 17, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/vapor-rage-llc/6a481ae7-b521-460d-a9b7-e111f39dd88e

> FDA WARNING_LETTER for Vapor Rage LLC on November 17, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vapor Rage LLC
- Inspection Date: 2023-11-17
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Vapor Rage LLC on November 16, 2023, following a review of inspection records. The FDA determined that Vapor Rage LLC manufactures and distributes e-liquid products, specifically "Sour Apple," which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is that the "Sour Apple" e-liquid product is a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed 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).

Vapor Rage LLC is required to submit 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 outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure

## Related Documents

- [WARNING_LETTER - 2021-10-26](https://www.globalkeysolutions.net/records/warning_letter/vapor-rage-llc/a4587b85-e39e-4825-9ed3-d890ca88cc44)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/vapor-rage-llc/7fef2468-40db-47ab-b0b5-912a01a6020d

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