FDA Completes Consultation on Food Made from Animal Cell Culture Technology

The U.S. Food and Drug Administration (FDA) reported Wednesday that it has 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," FDA reported. "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."

Upside Foods (formerly known as Memphis Meats) is a food technology company headquartered in Berkeley, Calif., aiming to grow sustainable cultured meat. The company was founded in 2015 by Uma Valeti, Nicholas Genovese, and Will Clem. Valeti was a cardiologist and a professor at the University of Minnesota.

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 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.