The US Food and Drug Administration has completed its first pre-market consultation for human food made from animal cell cultures with UPSIDE Foods. According to FDA, the pre-market consultation includes an evaluation of the firm’s production process and the cultured material made by the production process. The pre-market consultation is voluntary and not an approval process, says FDA, but the agency has no further questions about UPSIDE Food’s safety conclusions after evaluating the data and information shared by the firm. After meeting FDA requirements, including facility registration for the cell culture portion of the process, the firm will need their manufacturing establishment as well as the food itself inspected by the US Department of Agriculture Food Safety and Inspection Service (USDA-FSIS).
Under a March 2019 formal agreement, the two agencies have agreed to a joint regulatory framework, “wherein the FDA oversees cell collection, cell banks, and cell growth and differentiation [and]…USDA-FSIS will oversee the post-harvest processing and labeling of human food products derived from the cells of livestock and poultry.”
UPSIDE Foods makes products from what the FDA refers to as “cultured chicken cell material.” However, in its letter to the company, FDA states that this terminology is “not our recommendation of that term as an appropriate common or usual name for declaring the substance in accordance with the United States Department of Agriculture (USDA), Food Safety and Inspection Service’s (FSIS) labeling requirements.” Based on their joint agreement, USDA-FSIS will oversee labeling requirements. According to that agreement USDA-FSIS will:
“Require that the labeling of human food products derived from the cultured cells of livestock and poultry be preapproved and then verified through inspection, as required by FSIS regulations…As needed, develop additional requirements to ensure the safety and accurate labeling of human food products derived from the cultured cells of livestock and poultry subject to the FMIA and PPIA.”
Following the completion of this first pre-market consultation, the FDA is inviting other cultured meat companies to participate in the process. “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,” states the FDA. “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.”