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 |
---|---|---|---|---|
000001 | Cultured Gallus gallus (chicken) cell material | 3/4/2022 (PDF 4.88MB) |
3/20/2023 (PDF 128KB) 6/9/2023 (PDF 170KB) |
3/17/2023 (PDF 579KB) |
000002 |
Cultured Gallus gallus (chicken) cell material |
10/22/2022 |
11/16/2022 4/13/2023 |
11/14/2022 |