USDA, FDA plan to jointly regulate cell-cultured food products
In October, the U.S. Dept. of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the use of livestock and poultry cell lines to develop cell-cultured food products.
In October, the U.S. Dept. of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) 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 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 Dec. 26, 2018.
The USDA and FDA have concluded that both agencies should jointly oversee the production of cell-cultured food products derived from livestock and poultry. The agencies will develop a joint regulatory framework wherein the FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from the FDA to the USDA oversight will occur during the cell harvest stage. The USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry. 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. Because the 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.