The Department of Agriculture and Food and Drug Administration have completed an agreement to share regulatory jurisdiction over cell-based food products, but the language still needs to be implemented before the goods can be sold.
In an announcement on Thursday, FDA and USDA outlined an approach similar to their November declaration that led to this finalized agreement: FDA will oversee cell collection and growth, and USDA’s Food Safety and Inspection Service will take over when the process switches to harvesting and labeling.
The announcement closes one chapter of the debate over how to treat the cultured, or cell-based, products — meat grown from harvested animal cells rather than through the traditional harvesting process — but begins another as USDA and FDA must now iron out the details of the language.
In a statement, Frank Yiannis, FDA’s food safety deputy commissioner, said the joint approach “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.”
The release of a formal agreement now leaves the two entities to finalize the particulars. For instance, the agreement says USDA and FDA will mutually “develop joint principles for product labeling and claims to ensure that products are labeled consistently and transparently.” That leaves one of the biggest questions — what language the product labels will bear — yet to be answered.
A statement from Mindy Brashears, USDA’s deputy undersecretary for food safety, made it clear label integrity was a priority for USDA during the discussions.
“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products,” she said, adding a desire “to safely regulate these new products and ensure parity in labeling.”
FDA Commissioner Scott Gottlieb — who on Tuesday announced his plans to resign — told reporters last week the agreement will require a good deal of implementation.
“It’s not going to include all the details over exactly how the process will work, it will include the details about how the joint jurisdiction will work,” he said. “Both agencies will have to go back and define the processes. So we still have a lot of work to do in terms of issuing guidance and other principles of how we would inspect facilities, things like that.”
North American Meat Institute President and CEO Julie Anna Potts said the framework “will ensure cell-based meat and poultry products are wholesome, safe for consumption, and properly labeled.”
“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,” she added.
NAMI and cultured meat producer Memphis Meats sent a joint letter to the Trump administration last year suggesting an approach similar to what was announced Thursday. Memphis Meats CEO Uma Valeti commended the finished product.
“Demand for meat is projected to double by 2050, and every stakeholder we speak with, regardless of production method, shares the goal of feeding our growing planet in a safe and sustainable way,” he said. “As consumer interest for cell-based meat continues to grow, we will work with both FDA and USDA to bring safe and truthfully labeled products to market.”
Many producer groups were leery of the technology in early stages of discussion, showing signs of concern that a product grown in a lab could cut into the market share for meat raised in feedlots and pastures. But National Cattlemen’s Beef Association President Jennifer Houston signaled approval for the shared framework and the role of both agencies.
“The formal agreement announced today solidifies USDA’s lead oversight role in the production and labeling of lab-grown fake meat products,” Houston said. “This is what NCBA has been asking for, and it is what consumers deserve.”
A final regulatory framework would allow the sale of cultured meat products on American restaurant menus and in American stores. In February, Valeti said Memphis Meats is “ready to go to market tomorrow” once a regulatory pathway is established, but on a small scale that would equate to “consistently being able to supply a restaurant.”
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