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U.S. Department of Health and Human Services

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)
FDA response: Nov 16, 2022
FDA response letter (PDF, 123 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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