After nearly a year of bureaucratic jockeying, FDA and USDA have agreed to work together to establish a regulatory framework in which the two agencies would jointly oversee the production and marketing of cell-based meat and poultry products.
“Both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry,” the agencies announced in mid-November. FDA will oversee cell collection, cell banks, and cell growth and differentiation. USDA oversight will begin from the cell harvest stage, and will continue during the production and labeling of food products. The agencies are “actively refining” the technical details of the framework, and believe they have sufficient statutory authority without the need for additional legislation.
Cell-based meat—also called “clean meat” by supporters and “lab-grown fake meat” by detractors—refers to animal tissue grown or cultured under controlled conditions using muscle or other cells from living animals, such as beef, pork, and poultry. While the process remains costly, supporters say cell-based meat can help fulfill the growing worldwide demand for high-quality protein and be produced in an environmentally friendly and sustainable manner, without the need to raise and slaughter animals.
The regulatory boundaries are somewhat vague. While FDA has purview over most food products, USDA has primary authority over meat, poultry, and most egg products. And FDA, not USDA, is typically involved in labeling disputes.
There are at least two issues of contention: regulatory oversight, namely which government agency or agencies would have jurisdiction over these products and how they should be regulated; and package labeling and claims, including what these products can be called.
The U.S. meat industry, including cattle growers, have objected to labeling any such products as “meat,” at least without extensive clarifiers, and maintain that USDA should have primary oversight.
Companies developing cell-based meat, on the other hand, insist there is no difference between muscle tissue obtained from a living animal and the same tissue that is grown in culture. They have favored oversight by FDA because that agency already regulates biotechnology products, which are manufactured in bioreactors using similar techniques, as well as beverages and foods produced by fermentation.
Until recently, FDA and USDA officials had also supported these delineations. In July 2018, FDA convened a public meeting at its headquarters to explore the potential safety hazards and regulatory challenges in cell-cultured products.
“Our past experience with novel food technologies and our extensive background in cell-culture technologies in the medical products space will help inform our approach to evaluating the safety of these cell-based food products,” said FDA Commissioner Scott Gottlieb, MD, in kicking off the two-day meeting.
It was evident that FDA had not invited anyone from USDA to participate. “I’m both surprised and disappointed,” commented Tiffany Lee, DVM, director of regulatory and scientific affairs at the North American Meat Institute (NAMI). “Primary jurisdiction over the regulation of cell-cultured meat products rests with the United States Department of Agriculture,” she told the gathering during the public comment portion.
But FDA hadn’t been alone in seeking to carve out its turf; Agriculture Secretary Sonny Perdue had been working Capitol Hill to cement USDA’s role as the sole regulator of cell-cultured meat products.
“Obviously there are some gray lines between FDA and USDA on many things,” Perdue told the House agricultural appropriations subcommittee in April 2018. “But meat and poultry has been the sole purview of USDA. We would expect any product that expects to be labeled as meat would come under that same inspection criteria.”
Lawmakers evidently agreed and, with the reported assistance of staffers from USDA’s Food Safety and Inspection Service, inserted language into the final appropriations bill authorizing USDA to be in charge of regulating “products made from cells of amenable species of livestock…or poultry.” The one-sentence directive charged USDA with issuing rules regarding inspections for manufacturing, processing, and preventing adulteration or misbranding of cell-based foods.
Industry Offers Compromise
Ironically, a solution to the agency oversight problem appears to have been spurred by industry. Memphis Meats, a developer of cultured meat, and NAMI suggested in a joint Aug. 23, 2018 letter to President Trump that FDA and USDA should both play important roles.
“To ensure the regulatory system protects consumers while fostering innovation, it is imperative that the agencies coordinate and collaborate in their efforts,” wrote Memphis Meats CEO Uma Valeti, MD, and NAMI CEO Barry Carpenter.
Under their proposed framework, FDA would have oversight over pre-market safety evaluations for cell-based meat and poultry products, with USDA providing input. “After pre-market safety has been established with FDA, USDA should regulate cell-based meat and poultry products, as it does with all other meat and poultry products, applying relevant findings from FDA’s safety evaluation to ensure products are safe, wholesome, and properly labeled,” they wrote.
“Such a regulatory framework is not new and plays into the strengths and experience of FDA and USDA,” they noted. They agreed that cell-based meat products “are an ‘and,’ and not an ‘or’ solution” to the world’s protein needs. “We support a fair and competitive marketplace that lets consumers decide what food products make sense for them and their families.”
They also agreed to stop the name-calling. “Moving forward we will use the term ‘cell-based meat and poultry’ to describe the products that are the result of animal cell culture,” they wrote. The meat industry took offense at the term “clean meat,” which suggested conventional meat was not. On the other hand, cattle growers and others in the meat industry had disparaged cultured meat, calling it “lab-grown fake meat,” “Frankenmeat,” and other colorful names.
Sharing the Sandbox
Subsequently, in October 2018, FDA and USDA convened a joint meeting at USDA headquarters to explore the regulatory framework, potential safety hazards, and labeling and claims issues surrounding animal cell culture technology. More than 600 people attended the two-day meeting, in person and remotely.
“We fully anticipate that both FDA and USDA will have active roles in the regulatory oversight of cell-cultured products,” Dr. Gottlieb said in his opening comments. Speaking with reporters afterwards, Perdue suggested a joint oversight framework might be drafted relatively quickly. “If we can get this done in 2019, I would think that would be probably pretty fast for federal purposes,” he said. “We will be moving posthaste after this meeting to more clearly define that.”
Despite conciliatory comments from the agency heads, many industry and consumer stakeholders held to their previous positions. For example, Kevin Kester, president of the National Cattlemen’s Beef Association, said “lab-grown, fake meat labels should be held to the same standards as other meat labels. Given that the goal of these products is to compete directly with real meat, only USDA oversight can adequately ensure this outcome.”
Jessica Almy, policy director at the Good Food Institute, a nonprofit that supports companies producing “clean and plant-based food products,” said no new regulations were needed. “FDA has a clear and strong precedent to address safety premarket. And FDA can provide a single point of entry for regulation.”
And while NAMI partnered with Memphis Meats in proposing joint FDA/USDA oversight, Mark Dopp, NAMI’s senior vice president, argued that “primary jurisdiction regarding the regulation of cell-based meat products rests with USDA.”
Regulatory clarity is essential, said Eric Schulze, vice president of Memphis Meats. “Without a clear, predictable, and timely framework, this industry cannot succeed. Any delays in moving forward would jeopardize the U.S.’s standing in the world as the leader in protein production and responsible, science-based food innovation.”
Until the federal regulatory landscape is clarified, states may be free to exercise their own oversight authority. In June 2018, Missouri enacted legislation that prohibits “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.” The law applies to existing plant-based meat substitutes and future cell-based meat and poultry products.
The Good Food Institute, Turtle Island Foods (Tofurky brand), and civil liberties and animal rights groups have filed a lawsuit challenging the law’s constitutionality and requested a motion for preliminary injunction. Just as the federal GMO labeling law has pre-empted state-enacted GMO laws, it is likely that federal regulatory decisions will impact state food labeling requirements.
Funding Moving Forward
Dozens of companies worldwide are developing alternative protein food products. In addition to Memphis Meats these include Beyond Meat, Amy’s Kitchen, JUST, Inc. (formerly Hampton Creek), Finless Foods, and Morningstar Farms in the U.S.; Cauldron Foods, Quorn Foods, and Vbites Food in the U.K.; Garden Protein International in Canada; Mosa Meat and Meatless B.V. in The Netherlands; SuperMeat and Future Meat Technologies in Israel; and Integriculture in Japan. Numerous small startups, such as San Francisco-based New Age Meats, are also hoping to gain a foothold in this burgeoning industry.
Memphis Meats has received $17 million in venture capital funding from a group of investors including Cargill, Virgin Group founder Richard Branson, and Microsoft founder Bill Gates. So far, the company has raised at least $22 million, including funding from Tyson New Ventures LLC, a $150-million venture capital fund.
Not surprisingly, given the overlap in cell-culture technology, biotech companies are showing an interest in cell-based food research and production. M Ventures, the corporate VC arm of pharmaceutical giant Merck, for example, has provided part of an initial €7.5 million ($8.5 million) investment into Mosa Meat. Merck has expertise in cell media, which currently comprises 80 percent of the cost of cultured meat. Mosa Meat plans to construct a pilot production plant by 2021, which is also when Memphis Meats expects to launch its first commercial products in the U.S.