Federal agencies have settled on a framework for regulating lab-grown meats in the United States — putting the emerging industry one step closer to commercially selling cell-based animal protein.
The decision comes as companies around the world are racing to develop the technology to commercially grow meat in a lab. Multiple companies say they are close. A California-based business, Just, recently announced it plans to make its first commercial sale of a lab-grown chicken nugget product this year.
But before that can happen in the United States, federal regulators must determine that these product are safe to eat and then establish a method for regulating them.
They now have a plan to do that.
In a “formal agreement” released late last week, the Food and Drug Administration and the Department of Agriculture announced they will work together on regulations, with the FDA overseeing cell collection, cell banks and cell growth and differentiation, and the USDA handling day-to-day production and 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,” Frank Yiannas, deputy commissioner for the FDA’s food policy and response, said in a statement.
The agencies have yet to approve the commercial sale of any lab-grown meat — and it’s unclear if or when that will happen. Such approval would be sought on a case-by-case basis, with companies bringing their products to the FDA for review.
“This is how we approve drugs, this is how we approve food additives, including meat additives,” said Dale Woerner, an associate professor of sustainable meat science at Texas Tech University. “The FDA would have to approve both the process for making [the cell-based product] and the finished product itself. Once the FDA approves it, the USDA would oversee the production and the day-to-day operations.”
Earning such approval could take years, Woerner said.
Beyond the safety issues, there are other questions that would need to be answered before a lab-grown product could land in store meat counters. The biggest being: What is it? And next: What do we call it?
Companies developing the products say, unequivocally, it is meat. But many livestock producers argue that it is not.
Scientists have yet to weigh in — because they’ve not been allowed to study the lab-grown products, Woerner said. For now, companies are not releasing them because the production methods are considered proprietary intellectual property.
“We’re still dealing with an invisible product,” Woerner said. “We are theorizing what it is and what it could be. But without a tangible, measurable product, there is no way for us to say whether it is [meat] or not. The consensus from the scientific community is we cannot make a determination without actually having the product to evaluate.”
That information may become available after one of these businesses applies to the FDA for approval, Woerner said.
Cell-based meat companies — which have been calling for regulations to move forward with their products — celebrated the federal agencies’ decision.
“We commend the USDA and FDA for their commitment to creating a regulatory framework for cultured meat,” the company Just said in a statement. “Consumers must have confidence that cultured meat products are safe for consumption and appropriately labeled, and we look forward to working with the agencies on a clear and efficient path to market.”
Image: A chef cooks a lab-grown chicken nugget made by the company Just, which hopes to make its first commercial sale of the product this year. Photo courtesy of Just