FDA completes pre-market consultation for human food made with cultured pork fat cells
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.
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.
FDA - US Food and Drug Administration
Inventory of Completed Pre-market Consultations for Human Food Made with Cultured Animal Cells