USDA and FDA announce formal agreement to jointly regulate cell-cultured food products

USA – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and Food and Drug Administration (FDA) have announced a formal agreement to jointly regulate cell-cultured food products derived from livestock and poultry.

The two agencies said they will jointly oversee the production of human food products developed using the cell-cultured technology.

According to them, the 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.

The formal agreement describes the oversight roles and responsibilities for both agencies in collaboration to ensure production, regulation and commercialization of the products.

Under the agreement, FDA oversees cell collection, cell banks, and cell growth and differentiation while FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry.

A transition from FDA to FSIS oversight will occur during the cell harvest stage.

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

“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.”

In October last year, FDA and FSIS jointly held a public meeting focused on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.

The two agreed to joint regulation of the livestock and poultry cells derived products to ensure their safety and commercialization.

The regulatory framework leverages on FDA’s experience regulating cell-culture technology and living biosystems and the USDA’s expertise in regulating livestock and poultry products for human consumption.

“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled 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 labeling.”

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