Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

FDA Statement

• For Immediate Release: November 16, 2018
• Statement From: Scott Gottlieb, M.D.

Last month, the U.S. Department of Agriculture and the U.S. Food and Drug Administration held a public meeting to discuss the use of livestock and poultry cell lines to develop cell-cultured food products. At this meeting, stakeholders shared valuable perspectives on the regulation needed to both foster these innovative food products and maintain the highest standards of public health. The public comment period will be extended and will remain open through December 26, 2018.

After several thoughtful discussions between our two Agencies that incorporated this stakeholder feedback, we have concluded that both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry. Drawing on the expertise of both USDA and FDA, the Agencies are today announcing agreement on a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry. And, the Agencies are actively refining the technical details of the framework, including robust collaboration and information sharing between the agencies to allow each to carry out our respective roles.

This regulatory framework will leverage both the FDA’s experience regulating cell-culture technology and living biosystems and the USDA’s expertise in regulating livestock and poultry products for human consumption. USDA and FDA are confident that this regulatory framework can be successfully implemented and assure the safety of these products. Because our agencies have the statutory authority necessary to appropriately regulate cell-cultured food products derived from livestock and poultry the Administration does not believe that legislation on this topic is necessary.