# FDA WARNING_LETTER - Ragin’ Vapors - October 25, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/ragin-vapors/6726e641-ea05-4926-b55a-15aef0c58309

> FDA WARNING_LETTER for Ragin’ Vapors on October 25, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ragin’ Vapors
- Inspection Date: 2022-10-25
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to Ragin’ Vapors on October 20, 2022, following a review of submissions and inspection records. The FDA determined that Ragin’ Vapors manufactures and distributes e-liquid products, specifically "Electric Lemon e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Electric Lemon e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order, a substantial equivalence order, or an exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act.

Ragin’ Vapors is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation dates for violative sales and distribution, and a plan for future 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/ragin-vapors/6faff7cd-3a79-4ae0-96fe-ee89c1a9127a

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