Human Food Made with Cultured Animal Cells Inventory
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Cultured chicken cell material
Gallus gallus
UPSIDE Foods
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.: | 002 |
|---|---|
| Food: | Cultured Gallus gallus (chicken) myocytes (muscle) and fibroblast (connective tissue) cells, in the form of sheets of cells |
| Species of origin : | Gallus gallus |
| Sponsor: | UPSIDE Foods |
| Sponsor safety narrative: | Final submission with 4 amendments (disclosable information) (PDF, 1.4 MB) |
| Supplement with amendments (PDF, 4.6 MB) | |
| FDA response: | Nov 16, 2022 |
| FDA response letter (PDF, 123 kB) | |
| Apr 13, 2023 | |
| Additional FDA correspondence (PDF, 196 kB) | |
| Nov 14, 2024 | |
| Additional FDA correspondence (PDF, 211 kB) | |
| FDA scientific memo: | Nov 14, 2022 |
| Scientific memo (PDF, 831 kB) |
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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