USDA, FDA to Oversee Production of Cell-Cultured Food or "Fake Meat"

The U.S. Department of Agriculture’s (USDA) and Food and Drug Administration (FDA) will both be involved in regulatory oversight of cell-culture food originating from livestock and poultry, also known as “fake meat.”

In a statement, the USDA’s Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) FDA announced the agencies will jointly oversee the production of human food products derived from the cells of livestock and poultry. The announcement by FDA and USDA was made on March 7 after months of speculation on which agency would handle regulatory authority on the emerging food technology.

The formal agreement outlines the roles and responsibilities for both agencies to regulate cell-cultured or lab grown proteins as they enter the marketplace. The agencies believe that a shared approach will ensure safety and labeling of cell-cultured products derived from the cell lines of livestock and poultry.

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

“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,” says 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.”

FDA would oversees the initial stages of the production starting at cell collection, cell banks, and cell growth and differentiation.

USDA’s FSIS will take on oversight during the transition to cell harvesting. From there, FSIS would handle regulations on production and labeling of human food products derived from the cells of livestock and poultry.

Livestock and Meat Groups Pleased

From the onset of discussions there were concerns amongst groups representing livestock producers and meat processors that regulatory oversight would fall to FDA. Many of these concerns were regarding labeling enforcement which FDA had proven to have a poor track with in after the emergence of plant based “milks.”  

Prior to this announcement by FDA and USDA, the North American Meat Institute (NAMI) had sent a letter to President Trump with Memphis Meats, Inc., a company focused on cell-based meats. In the letter both NAMI and Memphis Meats supported having joint oversight from FDA and USDA.

NAMI is pleased to see that FDA and USDA will move forward together because it will “ensure cell-based meat and poultry products are wholesome, safe for consumption, and properly labeled” says NAMI President and CEO Julie Anna Potts.

“We support a fair and competitive marketplace that lets consumers decide what food products make sense for them and their families, and this agreement will help achieve these goals by establishing the level playing field necessary to ensure consumer confidence,” Potts adds.

Debates early on in the process between the National Cattlemen's Beef Association (NCBA) and the U.S. Cattlemen’s Association (USCA) on what to call cell-cultured, lab-grown “meat” have also simmered. Prior to the announcement of the joint oversight by FDA and USDA there were concerns. Under existing rules and regulations, if the product was called “meat” it would then be regulated by USDA. However, if the product isn’t called “meat” it would move to FDA.

NCBA believes that with this joint regulation announcement that USDA will have the strongest position for oversight.

“Under the terms of the agreement, USDA will be responsible for inspecting all facilities that harvest, process, package, or label cell-cultured products derived from livestock or poultry. All product labels will also be subject to USDA’s pre-approval and verification process,” says NCBA President Jennifer Houston. “Ensuring that all lab-grown fake meat products are safe and accurately labeled remains NCBA’s top priority.”

In previous statements, USCA had also expressed interest in having both USDA and FDA regulate cell-cultured products. However, any use of verbiage like “meat,” “beef,” or language associated with meat were concerns for USCA.

Those concerns about labeling were reaffirmed by USCA President Kenny Graner in a statement where he pointed to a petition submitted by USCA as helping jump start the conversation on cell-cultured technology.

“USCA is strongly opposed to the utilization of any of the three purple-inked USDA meat inspection stamps for cell-cultured product. A new stamp should be created for cell-cultured products that is inspected by USDA and by state inspection agencies, using a different format and color ink on the stamp. Neither the Federal or State meat inspection stamps should appear on the cell-cultured protein products, retail packaging or wholesale containers,” Graner says.

Despite those possible issues with labeling, Graner and USCA were happy to see USDA having authority regarding labels.

The National Pork Producers Council (NPPC) was also pleased to see that the two agencies will have oversight and Jim Monroe, NPPC senior director of public relations says it will offer a “level playing field” for livestock producers.

NAMI, NCBA, NPPC and USCA all expressed interest in working with USDA and FDA regarding regulatory framework cell-cultured food derived

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