Cell-cultured meat, also known as cultured meat, involves the production of meat from animal cells in a controlled environment. It has the potential to revolutionize the food industry by offering an alternative to traditional livestock farming, with potential benefits such as reduced environmental impact and improved animal welfare. Under the cooperative agreement between FDA and USDA, FDA will have jurisdiction over the preharvest production phase of the animal cell culture technology process, and jurisdiction will transfer to FSIS as the phase enters harvest, i.e., when the process halts the cell’s ability to further grow, multiply, or differentiate into other cell types.  FSIS jurisdiction will continue over the postharvest processing and labeling of cell-cultured meat.

As we have previously discussed, the successful FDA issuance of two “No Questions Letters” and USDA’s corresponding two labeling approvals for GOOD Meat and Upside Foods, has prompted FSIS to issue directives to its inspection program personnel (IPP) for future facility inspections.

All ingredients, including processing aids, used in products postharvest must be considered safe and suitable by FSIS and used in accordance with their intended use listed in 9 CFR 424.21(c) or FSIS Directive 7120.1. Approved ingredients are allowed to be added to cull-cultured meat food products, provided the intended use of those ingredients is consistent with its application, product type, and any other listed criteria. Any ingredient not listed in the above regulations must be submitted for review as described in FSIS Directive 5020.2.

Further, the issued directives inform IPP to refer to FSIS 5000.1 for comprehensive instructions on how to properly verify an establishment’s compliance with sanitation and the Hazard Analysis and Critical Control Point regulations. Additionally, IPP are directed to inspect the establishment’s harvesting and processing operations at least once per shift.

Finally, all cell-cultured meat product labels must be submitted to FSIS Labeling and Program Delivery staff for review and approval. FSIS Directive 7221.1 provides additional information for IPP to refer to on verification of the labeling requirements. Keller and Heckman will continue to monitor and report on developments impacting cell-cultivated meats