USDA, FDA Announce Agreement to Regulate Cell-Cultured Food Products
March 8, 2019
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) on Thursday announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.
In public meetings and in comments, NCC has emphasized the importance of coordinating regulatory efforts between FDA and FSIS to leverage each agency’s knowledge and expertise.
“While cell-cultured food products are still in their infancy, this announcement is a positive first step for their future regulation and NCC supports the joint FSIS and FDA regulatory oversight role,” said NCC President Mike Brown. “FSIS has the statutory authority, relevant experience, and robust regulatory frameworks to regulate the labeling and safety of these products, and FDA has experience with similar food production technologies and has long played a role in ensuring that ingredients used in meat and poultry products are safe for use in food.”
The formal agreement describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce. FDA will oversee collection of initial cell lines, maintenance of a cell bank, and oversee proliferation and differentiation of cells through the time of harvest. At harvest, USDA will determine whether harvested cells are eligible to be processed into meat or poultry products that bear the USDA mark of inspection. Establishments that are harvesting cells cultured from livestock or poultry are subject to the Federal Meat Inspection Act or the Poultry Products Inspection Act. USDA will conduct inspections of establishments where cells cultured from livestock and poultry are harvested, processed, packaged, or labeled in accordance with applicable regulations.
“The same framework through which the federal government has ensured that traditionally-derived meat and poultry products are safe, wholesome, and accurately labeled can readily ensure that cell-cultured food products are safe and truthfully labeled,” Brown continued.
In addition to the joint regulatory oversight, NCC believes that the following tenants are also essential for ensuring that cell-cultured food products are marketed in a safe, orderly, and truthful manner for consumers:
- It is not appropriate to refer to these products using terms such as “clean meat,” nor should these products be named or described in a way that disparages conventional animal proteins;
- These products should be named or labeled in a manner that clearly discloses the process by which they are made; and
- Claims that these products are superior to conventional animal proteins should be prohibited unless such a claim is substantiated by scientific evidence.
On Oct. 23-24, 2018, NCC participated in a joint FSIS/FDA public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The public meeting focused on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.