# FDA WARNING_LETTER - IOC Marketing, LLC d/b/a eCig Source - October 13, 2023

Source: https://www.keypedia.com/records/warning_letter/ioc-marketing-llc-dba-ecig-source/544bdd8b-82fc-42ee-824a-07ba756957c1

> FDA WARNING_LETTER for IOC Marketing, LLC d/b/a eCig Source on October 13, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: IOC Marketing, LLC d/b/a eCig Source
- Inspection Date: 2023-10-13
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to IOC Marketing, LLC d/b/a eCig Source on October 12, 2023, following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "KRAKEN eCig Source Signature Series 1.8% 30mL" and "KRAKEN eCig Source Signature Series 0.6% 30mL," which are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j).

The FDA states that marketing these products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is required to submit a written response within

## Related Officers

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

Company: https://www.keypedia.com/companies/ioc-marketing-llc-dba-ecig-source/916f698a-5932-4272-bc71-f5dea90fb7e0

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