# FDA WARNING_LETTER - Ecig Charleston LLC - April 12, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/ecig-charleston-llc/6807e64e-b223-4207-b5e3-394b3f8701db

> FDA WARNING_LETTER for Ecig Charleston LLC on April 12, 2024. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ecig Charleston LLC
- Inspection Date: 2024-04-12
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Ecig Charleston LLC on April 4, 2024, based on a review of inspection records. The company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source.

The primary violation identified is the marketing of "Blue Razz Chiller" e-liquid without the required premarket authorization. This product is deemed a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor is it exempt. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

Ecig Charleston LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation dates for the violative sales/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 Documents

- [WARNING_LETTER - 2024-04-09](https://www.globalkeysolutions.net/records/warning_letter/ecig-charleston-llc/d1d562f3-f6c5-4b47-8d1f-ed725a349460)
- [WARNING_LETTER - 2024-07-03](https://www.globalkeysolutions.net/records/warning_letter/ecig-charleston-llc/bf0b904e-af06-493b-96f6-ca852e90d7a1)
- [WARNING_LETTER - 2025-01-08](https://www.globalkeysolutions.net/records/warning_letter/ecig-charleston-llc/d7f6468d-2ec1-487c-98b4-653583134659)
- [WARNING_LETTER - 2025-04-28](https://www.globalkeysolutions.net/records/warning_letter/ecig-charleston-llc/bb391ff2-2e77-4663-93de-c3760fecef57)
- [WARNING_LETTER - 2025-05-09](https://www.globalkeysolutions.net/records/warning_letter/ecig-charleston-llc/f61a2daa-fba7-4ce9-8354-9fbd4ff489e9)

## Related Officers

- [Acting Director](https://www.globalkeysolutions.net/people/ele-ibarra-pratt/c1e13bd6-9779-4877-a361-7b4bac089697)

Company: https://www.globalkeysolutions.net/companies/ecig-charleston-llc/77ffeae0-3f8b-4dd4-8d0c-50046b9e2a93

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