FDA Completes First Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology
Before Entering the U.S. Market, the Food Must Meet Other Federal Requirements
November 16, 2022
The U.S. Food and Drug Administration (FDA) completed its first pre-market consultation for a human food made from cultured animal cells. We evaluated the information UPSIDE Foods submitted to the agency and have no further questions at this time about the firm’s safety conclusion. The firm will use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make the cultured animal cell food.
The FDA's pre-market consultation with the firm included an evaluation of the firm’s production process and the cultured cell material made by the production process, including the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs. The voluntary pre-market consultation is not an approval process. Instead, it means that after our careful evaluation of the data and information shared by the firm, we have no further questions at this time about the firm’s safety conclusion.
The FDA is committed to sharing information about our oversight of human food made from cultured animal cells and today released:
- The FDA's response letter to the firm
- The FDA's scientific memo that describes our evaluation of the data and information provided by the firm
- The firm's own assessment that their food is safe
In addition to meeting the FDA’s requirements, including facility registration for the cell culture portion of the process, the firm will need a grant of inspection from the United States Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) for the manufacturing establishment. Additionally, the food itself requires a mark of inspection from USDA-FSIS before it can enter the U.S. market. As this product comes closer to entering the U.S. market, we are closely coordinating with USDA-FSIS to ensure it is properly regulated and labeled.
The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their food is safe and lawful under the Federal Food, Drug, and Cosmetic Act. We encourage firms to have these conversations with us often and early in their product and process development phase, well ahead of making any submission to us. We are already engaged in discussions with multiple firms about various types of food made from cultured animal cells, including food made from seafood cells that will be overseen solely by the FDA. Our goal is to support innovation in food technologies while always maintaining as our priority the production of safe food. Human food made with cultured animal cells must meet the same stringent requirements, including safety requirements, as all other food.
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