The US Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have reached a formal agreement to regulate cell-cultured food products derived from the cells of livestock and poultry.
The FDA and Food Safety and Inspection Service (FSIS) have released a formal agreement addressing the regulatory oversight of human food produced using this new technology.
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.
This shared regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry are produced safely and are accurately labelled.
“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labelled products,” said USDA Deputy Under Secretary for Food Safety Mindy Brashears.
“We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labelling.”
Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, said: “We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labelling of these cell-cultured human food products while continuing to encourage innovation.
“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.”
Under the formal agreement, the agencies agree upon a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation.
A transition from FDA to FSIS oversight will occur during the cell harvest stage. FSIS will oversee the production and labelling of human food products derived from the cells of livestock and poultry.