Human Food Made with Cultured Animal Cells Inventory
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Cultured chicken cell material
Gallus gallus domesticus
Believer Meats
Our use of a term to refer to the subject of a consultation should not be understood as our recommendation of that term as an appropriate common or usual name for declaring the substance.
Publicly disclosable information only.
| CCC (Cell Culture Consultation) No.: | 039 |
|---|---|
| Food: | Cultured Gallus gallus domesticus (chicken) cells, with characteristics of fibroblasts (connective tissue), in the form of cell biomass |
| Species of origin : | Gallus gallus domesticus |
| Sponsor: | Believer Meats |
| Sponsor safety narrative: | Final submission with 8 amendments (Part 1) (disclosable information) (PDF, 8.1 MB) |
| Final submission with 8 amendments (Part 2) (disclosable information) (PDF, 13.4 MB) | |
| Final submission with 8 amendments (Part 3) (disclosable information) (PDF, 11.4 MB) | |
| Final submission with 8 amendments (Part 4) (disclosable information) (PDF, 17.4 MB) | |
| Final submission with 8 amendments (Part 5) (disclosable information) (PDF, 2.5 MB) | |
| Disclosable Amendments of Supplement (PDF, 992 kB) | |
| FDA response: | Jul 24, 2025 |
| FDA response letter (PDF, 169 kB) | |
| Sep 24, 2025 | |
| Additional FDA correspondence (PDF, 156 kB) | |
| FDA scientific memo: | Jul 24, 2025 |
| Scientific memo (PDF, 1.0 MB) |
Notes:
- CCC No.: Cell Culture Consultation (CCC) file number that the FDA has assigned to the pre-market consultation
- Food: Description of the food resulting from the process defined in the final submission
- Sponsor safety narrative: Sponsor’s final submission in the consultation explaining their basis for concluding that the cultured cell material is safe for use as human food
- FDA response: Letter that the FDA sent in response to the firm at the completion of the pre-market consultation
- FDA scientific memo: Scientific memo that documents the FDA’s evaluation of the sponsor’s final submission
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