The Food and Drug Administration (FDA) on Wednesday confirmed the next step toward regulating the development and sale of cell-cultured chicken products.

The agency this week confirmed that it had completed a premarket review of a cell-cultured chicken product created by the California-based company Upside Foods. FDA stated they had no unresolved questions about its safety for humans to eat.

“Before this food can enter the market, the facility in which it is made also needs to meet applicable U.S. Department of Agriculture (USDA) and FDA requirements,” FDA Commissioner Robert M. Califf and Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said in a statement. “In addition to the FDA’s requirements, including facility registration for the cell culture portion, the manufacturing establishment needs a grant of inspection from USDA-Food Safety and Inspection Service (FSIS) for the harvest and post-harvest portions and the product itself requires a USDA mark of inspection.”

This approval only applies to a product in development from Upside Foods. FDA has not given further industry guidance, nor has it indicated it has made any other premarket approvals. However, the agency has stated it is ready to work with other firms developing cultured animal cell foods.

“Although still in its infant stages, it is imperative that cell-cultured products like these be properly regulated, inspected and labeled by both USDA and FDA,” said NCC President Mike Brown in response to the news. “Americans are set to eat a record amount of chicken this year, and we don’t see that demand waning. I think most people want their chicken raised on a farm, not in a laboratory.”

The premarket approval follows a 2019 interagency agreement between the USDA and FDA. That agreement, known as a Memorandum of Understanding (MOU), laid out oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce.

Under the MOU, USDA and FDA agreed upon a joint regulatory framework where FDA would oversee cell collection, cell banks, and cell growth and differentiation. A transition from FDA to FSIS would occur during the cell harvest stage. FSIS would oversee the production and labeling of human food products derived from the cells of livestock and poultry.

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said of the MOU. “Collaboration between USDA and FDA will allow us to draw upon the unique expertise of each agency in addressing the many important technical and regulatory considerations that can arise with the development of animal cell-cultured food products for human consumption.”

 

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