FDA, USDA to Jointly Regulate Animal Cell-Cultured Foods

Last month, the USDA and FDA held a public meeting to discuss the use of livestock and poultry cell lines to develop cell-cultured food products. At the 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 to remain open through December 26, 2018.

After several discussions between the two agencies that incorporated the stakeholder feedback, it was decided that both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.

The USDA and FDA agreement provides a joint regulatory framework through which:

• FDA will oversee cell collection, cell banks, and cell growth and differentiation, then transition oversight to USDA during the cell harvest stage.
• USDA will 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, the agency statement said, adding, USDA and FDA are confident that this regulatory framework can be successfully implemented and assure the safety of these products. 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.