Inventory of Completed Pre-market Consultations for Human Food Made with Cultured Animal Cells
The inventory of completed pre-market consultations for human food made with cultured animal cells provides the following information about any human food that has completed a pre-market consultation with the FDA:
- Description of the food and species of origin
- File number that the FDA has assigned to the pre-market consultation
- Sponsor’s final submission in the consultation explaining their basis for concluding that the cultured animal cell material is safe for use as human food
- Letter that the FDA sent in response to the sponsor at the completion of the pre-market consultation
- Scientific memo that documents the FDA’s evaluation of the sponsor’s final submission
Recently Published Consultations
The following is a list of recently published completed pre-market consultations for human food made with cultured cells. For a full list, please visit the inventory database.
| File No. | Food | Submission | FDA Response | Scientific Memo |
|---|---|---|---|---|
| 000039 | Cultured Gallus gallus domesticus (chicken) cell material | Part 1 - 5/21/2024 Disclosable Amendments of Supplement | 7/24/2025 9/24/2025 | 7/24/2025 |
| 000008 | Cultured Sus scrofa domesticus (pork) fat cell material | Part 1 - 5/25/2022 (PDF 19.5 MB) Part 2 - 5/25/2022 (PDF 17.6 MB) | 3/7/2025 (PDF 194 kB) | 3/7/2025 (PDF 564 kB) |
| 000005 | Cultured Oncorhynchus kisutch (salmon) cell material | Part 1 - 6/2022 | 5/28/2025 | 5/29/2025 |
| 000002 | Cultured Gallus gallus (chicken) cell material | 10/22/2022 Disclosable Amendments of Supplement | 11/16/2022 | 11/14/2022 (PDF 638 kB) |
| 000001 | Cultured Gallus gallus (chicken) cell material | 3/4/2022 (PDF 4.9 MB) | 3/20/2023 (PDF 128 kB) 6/9/2023 (PDF 170 kB) | 3/17/2023 (PDF 579 kB) |