The U.S. Food and Drug Administration (FDA) has completed its second premarket consultation for a food made from cultured animal cells intended for human consumption. FDA evaluated the information submitted by GOOD Meat Inc. and has no further questions at this time about the company’s safety conclusion.

GOOD Meat will use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make cultured meat (also known as “cell-based” or “lab-grown” meat). FDA’s present “no further questions” decision follows another premarket consultation that resulted in a “no further questions” determination in November 2022, regarding cultured meat products produced by company UPSIDE Foods.

The voluntary premarket consultation is not an approval process. Rather, it means that after FDA’s evaluation of the data and information shared by GOOD Meat, the agency has no further questions at this time about the company’s safety conclusion. FDA's premarket 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.

Human food produced by GOOD Meat from cultured animal cells must meet the same stringent FDA requirements, including facility registration and applicable safety requirements, as other foods. In addition, the firm will need a grant of inspection from the United States Department of Agriculture's Food Safety and Inspection Service (USDA’s FSIS) for the manufacturing establishment. The food itself also requires a mark of inspection from FSIS before it can enter the U.S. market. As GOOD Meat’s product comes closer to entering the U.S. market, FDA is coordinating with USDA-FSIS to ensure it is properly regulated and labeled.

FDA has also stated its intent to issue guidance to assist companies that intend to produce human food made from cultured animal cells prepare for premarket consultations, and the published draft of the guidance will represent a formal opportunity for public comment and discussion.