FDA Completes Pre-Market Consultation for Human Food Made with Cultured Pork Fat Cells
Constituent Update
March 7, 2025
The U.S. Food and Drug Administration (FDA) completed a pre-market consultation for a human food made with cultured pork fat cells. The FDA has no questions at this time about Mission Barn’s conclusion that food made with cultured pork fat cells resulting from the production process defined in the pre-market consultation are as safe as comparable foods produced by other methods. The firm uses belly fat cells from domestic Yorkshire pigs and grows the cells in a controlled environment to make cultured pork fat. Before this cultured pork fat product can be marketed for use in food, it must also meet USDA’s regulations. As the FDA continues to support innovation in food technologies, resulting in more choices for consumers in the marketplace, the agency’s priority is the safety of food produced through both innovative and traditional methods.
Through the pre-market consultation process, the FDA evaluates the safety of food made with cultured animal cells before it enters the market. The pre-market consultation allows developers to work with the FDA on a product-by-product basis and informs them of issues they must consider to produce safe food that does not violate the Federal Food, Drug and Cosmetic Act’s (FD&C Act) requirements. As part of the pre-market consultation process, the FDA evaluates the firm’s production process and the resulting cultured cell material, including the establishment of cell lines and cell banks, manufacturing controls, and reviews all components and inputs.
Under the FD&C Act and implementing regulations, food products made with cultured pork fat cells that are under the FDA’s jurisdiction must meet the same FDA requirements as similar food products made with conventional pork fat. The FDA’s requirements include facility registration, applicable safety requirements, and accurate labeling.
In addition to the pre-market consultation, the FDA has been on site at the firm’s facility where pork fat cells are cultured and grown. The FDA currently plans on conducting another inspection after commercial production begins and will continue to exercise oversight of the facility as needed on an ongoing basis. This will help ensure that potential risks are being managed and that the food is safe and not adulterated. The USDA and the FDA established a joint formal agreement that outlines the agencies’ shared oversight of food made with cultured animal cells.
The FDA is committed to transparency on our approach to regulating human food made with 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).
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 plans to issue guidance on pre-market consultations for food made with cultured animal cells, which will open a formal opportunity for public comment and discussion.