FDA Completes Second Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology
Before Entering the U.S. Market, the Food Must Meet Federal Requirements
March 21, 2023
The U.S. Food and Drug Administration (FDA) completed its second pre-market consultation for a human food made from cultured animal cells. We evaluated the information GOOD Meat, Inc 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 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'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 FDA is committed to sharing information about our approach to regulating human food made from cultured animal cells. Information about this pre-market consultation is available on the FDA’s Human Food Made with Cultured Animal Cells Inventory (fda.gov).
Human food produced by this firm from cultured animal cells must meet the same stringent FDA requirements, including facility registration and applicable safety requirements, as other food. In addition, the firm will need a grant of inspection from the United States Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS) for the manufacturing establishment. The food itself also 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 that are developing cultured animal cell food and production processes to ensure their food is considered safe and lawful under the Federal Food, Drug, and Cosmetic Act. We encourage firms to engage with us often and early in their product and process development phase, well ahead of making any submissions to the agency. The FDA will issue guidance to assist firms that intend to produce human food made from cultured animal cells prepare for pre-market consultations, and the published draft of this guidance will represent a formal opportunity for public comment and discussion. As we continue to support innovation in food technologies, resulting in more choices for consumers in the marketplace, our priority is the safety of food produced through both new and traditional methods.
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