FDA Addresses Cultured Meat in Crucial First Step for New Industry

“There are no great mysteries when it comes to cell culture. This technology has been around for a long time,” said Jeremiah Fasano, a consumer safety officer focused on biotech and food additive safety at the US Food and Drug Administration (FDA).

Fasano was speaking at a July 12 public meeting in Maryland where scientists, lobbyists, and entrepreneurs gathered to discuss a crucial hurdle between much-hyped cultured meat products and consumers: regulation.

The purpose of the meeting was to “give interested parties and the public an opportunity to comment on these emerging food technologies.” The technologies in question are the processes often referred to as cellular agriculture, which scientists and entrepreneurs are working to use to create slaughter-free meat products at scale – often called cultured meat or lab-grown meat. 

Though the handful of startups in this space have begun to raise sizable rounds, the most recent one less than a month ago, we’re definitely months and likely years away from the first product hitting the market.

And while it was a positive first step that the FDA addressing the space, how it will play out is still a mystery as participants debated who should regulate the products, what it should be called, and how its safety will be determined.

The Need for Regulation

The group of stakeholders in attendance were tasked with answering the following questions about cellular agriculture processes and products in order to give the FDA an informed baseline on which to develop proposed standards for the industry:

• What considerations specific to animal cell culture technology would be appropriate to include in an evaluation of food produced by this method of manufacture?
• What kinds of variations in manufacturing methods would be relevant to safety for foods produced by animal cell culture technology?
• What kinds of substances would be used in the manufacture of foods produced using animal cell culture technology and what considerations would be appropriate in evaluating the safety of these uses?
• Are the potential hazards associated with production of foods using animal cell culture technology different from those associated with traditional food production/processing? Is there a need for unique control measures to address potential hazards associated with production of foods using animal cell culture technology?

And the industry is on board with this pursuit.

“We can’t just throw our food on the market and assume that people will trust us,” said Mike Selden, CEO of Finless Foods, a startup culturing seafood.

Several speakers offered the example of genetically modified foods as a cautionary tale of how a lack of government review can lead to mistrust of technology; GMO foods bypassed thorough safety verification by the FDA when they received a “generally recognized as safe” designation (GRAS).

Gregory Jaffe, director of biotechnology at the Center for Science in the Public Interest said that this preliminary work and the possible resultant regulations could avoid a situation where “the products are safe but consumers don’t think they are safe or don’t believe the developers’ determination that they are safe.”

Though many startups claim that the products they eventually sell will look and taste like their traditional counterparts, a few speakers suggested that cultured meat may lead to entirely new products, which could complicate the regulatory development process even more.

“This technology is a toolbox, not an outcome. In creating a new toolbox for producing foods we can open up a whole suite of products we cannot fathom today,” said Isha Datar, executive director at New Harvest,  a non-profit cellular agriculture research institute.

She likened the potential size of the culinary earthquake to that of the introduction of fermentation, which led us to yogurt and cheese and myriad other flavors and textures that previously didn’t exist.

Jurisdiction Drama

Since the technology behind culturing animal proteins is borrowed from the medical sciences, many speakers expressed that regulation by the FDA was a natural fit since the administration also regulates medical products and technologies, in addition to many elements of food safety.

But jurisdiction turned out to be one of the more contentious issues brought up both by invited speakers and public commenters – with some in favor of the FDA overseeing cultured meat with others insisting the USDA be responsible.

At least among those who spoke at this meeting, there appears to be a divide forming on this issue between those that seek to benefit from cultured meat propagation and those that may not. Several supportive nonprofits and industry entrepreneurs expressed that the FDA should have jurisdiction. They argue that the FDA is best-suited to understand the technology and create and enforce necessary safety controls.

Meat and dairy industry representatives argued for the USDA to take on oversight with Tiffany Lee of the North American Meat Institute even remarking on the lack of USDA representatives speaking at the meeting as a problem.

“I’m both surprised and disappointed that no one from the USDA is on any of these panels. This meeting should have been held jointly by the USDA and FDA,” she said. The USDA oversees traditional meat production and slaughterhouses and so the argument is that jurisdiction should be determined by the product and not the process.

What’s in a Name?

Often closely linked to jurisdiction is what these new products will be called, since the words can suggest which agency should oversee them. Making headlines for months has been the controversy over what to call these new products.

Many industry players and proponents have promoted the term “clean meat.” But several speakers took issue with that term.

Jaffey, for example expressed concern that the idea that this meat is cleaner than traditional meat could lead consumers to treat it differently, perhaps eating it raw or not refrigerating it because of a perception that it is risk-free.

Memphis Meats VP of product and regulation Eric Schulze said that his company has begun using the term “cell-based meat.”

“We believe this term to be clear, factual, and inclusive,” said Schulze.

A ranching and meat industry representative took issue with any terminology using the word “meat” in the public commentary portion of the meeting.

“There’s not enough scientific information available to conclude that cell cultured animal protein should be called meat,” said Dustin Boler of the Meat Science Association.

Maggie Nutter, director of the US Cattleman’s Association doubled down on that sentiment.

“We believe that the term meat pertains exclusively to the proteins that are harvested from the flesh of an animal in the traditional manner. Cultured cell protein would not be included in this definition,” said Nutter. 

But Finless Food’s Selden finds fault in the industry argument.

“If you’re going to use it in your legal argument that this should fall under the jurisdiction of the USDA because it is meat, then we definitely get to call it meat,” he told AgFunderNews.

Onward

While cultured meat startups continue to amass funding, other stakeholders are calling for more research on the opportunities and risks involved with the introduction of cellular agriculture into the food system.

“Samples of cultured tissue have not been available for evaluation of the safety, composition, nutritional bioavailability, functionality, and properties to understand how it compares to conventional animal production,” said Rhonda Miller of the American Meat Science Association. 

Nutter also called for publicly-available research on whether or not cultured meat is truly more sustainable than tradition meat, as many companies and proponents claim.

Safety, the topic of the day, is also still theoretical at this moment. Though JUST’s (another startup working on a culture meat product) chief technology officer Peter Licari proclaimed, “We believe clean meat products will be inherently safer than rationally-processed meat due to the well-controlled environment,” several other stakeholders expressed much less certainty.

Even industry supporters posed questions about how a cultured meat product will respond in packaging. Will it have different water content than traditional meat? Will it require a different refrigeration temperature or have a different shelf life?

All of these and many more questions remain unanswered, but both cellular agriculture critics and boosters were eager to move the conversation away from theory and into reality.