FDA tries to take the reins on regulating cultured meat

COLLEGE PARK, MARYLAND—There may be a turf war on between two U.S. federal agencies over who will regulate the emerging industry of cultured meat, but you wouldn’t know it from the presentations by the Food and Drug Administration (FDA) at a meeting here yesterday.

In a daylong discussion of safety considerations, the agency asserted its jurisdiction over products made of chicken, beef, pork, and seafood cells grown in a culture medium, despite recent calls—including a proposal from lawmakers in the House of Representatives—to leave that responsibility to the U.S. Department of Agriculture (USDA).

Cultured meat, also sometimes called clean meat or lab-grown meat, is made by extracting cells from an animal and prompting them to mature into muscle fibers and grow in a bioreactor. No products have yet hit the market, though several companies have suggested that their first generation of cultured meat will be available in the next 5 years.

“These are early days, but make no mistake that FDA has been preparing for this for quite some time,” said Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition here. “This is not our first rodeo, so to speak, in this area.”

It’s true that FDA has expertise in judging the safety of foods that involve cultured cells. It already has oversight over food products that include extracts of the algae spirulina and a fermented fungus used in a line of meat substitutes known as Quorn. But in the tangle of federal food safety regulations, a few categories of products are regulated by USDA’s Food Safety Inspection Service: meat, poultry, processed egg products such as cartons of pourable eggs, and catfish. And although cultured meat production facilities may look very different from livestock feedlots and slaughterhouses, some argue that their status as meat producing facilities puts them firmly under USDA’s control.

At yesterday’s meeting, experts walked through the basic manufacturing process for cultured meat products—and the steps that will require particular attention to safety. “There are no great mysteries when it comes to cell cultures,” said Paul Mozdziak, an expert in animal cell culture at North Carolina State University in Raleigh. “This technology has been around for a very long time.”

Though production methods will vary by company, Mozdziak expects many will isolate cells from a tissue biopsy of a living animal to establish cell banks—vials of starting material that can be thawed and multiplied in batches. Bacteria or viruses could sneak into the initial tissue sample, or into the cultured cells as they’re transferred to successively larger quantities of culture medium, or when medium is added to prompt them to grow, he noted. And large-scale bioreactors must also be carefully sanitized. The materials used in cellular scaffolds—structures that support the muscle cells as they grow—must also be evaluated for safety.

Some attendees were confident that FDA already has the expertise to oversee that process. “A clean meat facility will be similar to what the FDA sees every day in both biologics and food processing plants. It will not look like a slaughterhouse,” said Peter Licari, chief technology officer at JUST, a San Francisco, California–based company that makes plant-based egg and dairy replacements, and is preparing to launch a lab-grown meat product.

But others pointed out that use of the term “meat” comes with a particular set of scientific considerations. “Meat scientists do not have enough information about cultured tissue to determine whether it should be called meat, or how it should be regulated,” said Rhonda Miller, a meat scientist at Texas A&M University in College Station, speaking on behalf of the American Meat Science Association, based in Champaign, Illinois. She pointed to several unanswered questions: Does cultured meat spoil at the same rate as conventional meat? Does it allow the same growth of potentially harmful microbes? Is its shelf life the same? Does it have the same nutritional qualities?

Some representatives of the meat industry argued that the new products should be held to the same safety and labeling standards applied to conventional meat—standards enforced by USDA. “If these companies wish their products to be marketed as meat … production of these items should be regulated by the agency Congress chose when it enacted the Federal Meat Inspection Act,” said Tiffany Lee, director of regulatory and scientific affairs at the North American Meat Institute in Washington, D.C.

Other groups, such as the U.S. Cattlemen’s Association, also based in Washington, D.C., have challenged the cultured meat industry’s claim to using the term “meat” in the first place. “They’re hijacking our branding for benefit of their own marketing,” said association director Maggie Nutter.

Some expect that either Congress or the White House Office of Management and Budget will ultimately have to clarify which agency should step back as cultured meat products near the market—or whether the responsibility for different stages of its production could somehow be split between the two agencies. In the meantime, FDA is pressing ahead with its plans to regulate. Mayne said the agency’s science board will hold a meeting on the issue later this year.