Cultured chicken cell material

Gallus gallus

GOOD Meat, 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.: 001
• Food: Cultured Gallus gallus (chicken) cells, with characteristics of fibroblasts (connective tissue), in the form of cell biomass
• Species of origin : Gallus gallus
• Sponsor: GOOD Meat, Inc.
• Sponsor safety narrative: Final submission with 4 amendments (disclosable information) (PDF, 5.0 MB)
• FDA response: Mar 20, 2023 ; FDA response letter (PDF, 129 kB) ; Jun 9, 2023 ; Additional FDA correspondence (PDF, 170 kB)
• FDA scientific memo: Mar 20, 2023 ; Scientific memo (PDF, 580 kB)

 

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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