Human Food Made with Cultured Animal Cells Inventory
-
Cultured salmon cell material
Oncorhynchus kisutch
Wildtype Inc.
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.: | 005 |
|---|---|
| Food: | Cultured salmon cell material |
| Species of origin : | Oncorhynchus kisutch |
| Sponsor: | Wildtype Inc. |
| Sponsor safety narrative: | Final submission with 8 amendments (Part 1) (disclosable information) (PDF, 14.0 MB) |
| Final submission with 8 amendments (Part 2) (disclosable information) (PDF, 15.2 MB) | |
| Final submission with 8 amendments (Part 3) (disclosable information) (PDF, 14.2 MB) | |
| Final submission with 8 amendments (Part 4) (disclosable information) (PDF, 5.6 MB) | |
| FDA response: | May 28, 2025 |
| FDA response letter (PDF, 194 kB) | |
| FDA scientific memo: | May 29, 2025 |
| Scientific memo (PDF, 630 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
-
