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  1. Human Food Made with Cultured Animal Cells

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

Launch the Inventory Database

 

   

 


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
(PDF 4.73MB)

11/16/2022
(PDF 180KB)

4/13/2023
(PDF 191KB)

11/14/2022
(PDF 638KB)

 
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