FDA Makes Its Case by Highlighting Agency’s History With Cell Cultures in Various Industries
COLLEGE PARK, Md. (DTN) — In the debate over which agency should take the lead in regulating cell-cultured proteins — or meats — the Food and Drug Administration on Thursday laid out its long history overseeing cell cultures for products ranging from pharmaceuticals to yogurt.
FDA and USDA share duties on food inspection with FDA overseeing as much as 80% of food products, but USDA’s Food Safety and Inspection Service is taking charge of traditional meat products such as beef, pork and poultry. The advent of cell-cultured meat has created a regulatory turf battle as cell-cultured companies want FDA in charge while traditional livestock groups want USDA in charge.
Opening up Thursday’s hearing, FDA Commissioner Scott Gottlieb alluded to the notion that agricultural technology has outpaced regulators’ understanding of the science.
“Innovation in American agricultural production dwarfs the technology progress in almost any industry,” Gottlieb said. He added that cell-cultured food will be making its way to retail shelves in the near future.
Gottlieb also noted that the risks of cell-cultured meat products differ from traditionally harvested meat products.
Susan Mayne, director of food safety and applied nutrition at FDA, said FDA already has been working with the cell-cultured meat industry for several years as these startup firms start prepping for regulatory approval and market access.
“These are still early days, but make no mistake, FDA has been preparing for this for quite some time,” Mayne said. “This is not our first rodeo, so to speak. We have multiple authorities and programs that can support efforts to bring products with new ingredients in the market.”
These start-up meat companies, working primarily right now on beef and chicken products, made it clear in the hearing that they see FDA as the appropriate agency for this work.
Meanwhile, traditional livestock groups have a different take. Just before Thursday’s hearing, the National Pork Producers Council characterized the FDA’s move as “regulatory land grab.” NPPC called on USDA “to assert its proper oversight on two emerging issues critical to the future of animal agriculture: laboratory-produced cultured protein and gene editing in livestock production.”
Livestock groups are concerned about the emerging cell-cultured industry, which is already receiving venture capital money from traditional meatpackers, taking market share away from livestock producers over time as the price of cell-cultured meat eventually comes down to a competitive price level with meats from animal-raised livestock.
While FDA hosted the daylong event offering various players in the meat industry as panelists or for public comment, USDA officials did not publicly participate.
DTN Political Correspondent Jerry Hagstrom also obtained a letter from House agriculture leaders to White House Director of Management and Budget Mick Mulvaney, complaining that FDA was moving forward with the meeting with no USDA involvement, even though the White House Domestic Policy Council held a meeting with the two agencies to discuss the regulation of cell-based foods.
A USDA spokesman replied to DTN, “As these new products begin to emerge in the marketplace, we look forward to working with the FDA and the public to tackle these issues.” The USDA spokesman added, “We have nothing further to add.”
At the hearing, Paul Mozdziak, a poultry science professor at North Carolina State University, pointed out that animal enzymes are already used to make vaccines, noting this is a “very routine cell culture.” Still, Mozdziak said the issues with converting cells to marketable meat products come downstream after the actual lab meat is produced.
“Once you get cells down, how are they going to be able to treat downstream and how are they going to treat the final integrity of the product?” the professor said. “In the post-harvest, there is the opportunity to contaminate all the way through to packaging.”
Eric Schulze, the vice president of product for Memphis Meats, said that his company had designed its production to conform with FDA’s approach, including identifying and managing potential differences between its products and existing meat products. Memphis Meats uses the cells to grow meat in a lab without animals, yet at the moment, Memphis Meats has not begun to market its products.
Rhonda Miller, a Texas A&M meat scientist who is also a former president of the American Meat Scientist Association, stressed there are still many questions about food safety as the cell-based meat is harvested and becomes available for human consumption.
DTN was unable to remain for the entire hearing, but interviews this week with representatives from livestock groups highlighted the FDA-USDA turf battle.
“This is building up to be a turf battle between USDA and FDA over who has regulatory authority over cell-cultured meats,” said Danielle Beck, director of government affairs at the National Cattlemen’s Beef Association. “It is starting to be a little bit concerning, I think, from our perspective, or a lot bit concerning,” Beck said.
NCBA supports USDA’s Food Safety and Inspection Service (FSIS) taking the lead on regulating cell-cultured meats and sees USDA as having authority over such products based on law.
“At the end of the day, regardless of the production method, any product that is compositionally meat, or a meat food product or a meat byproduct as designed through the CFR (Code of Federal Regulations) under the Meat Inspection Act, all fall under the same jurisdiction which is USDA FSIS,” Beck said.
NCBA’s take, representing cattle producers, is that FDA is considering some of the right risk-based issues, “but, ultimately, they are putting the cart before the horse because the question that first needs to be addressed is jurisdiction,” Beck said.
Lobbyists told DTN that FDA had gotten approval from the Department of Justice citing that FDA had oversight on the issue of cell-cultured meats.
However, Jennifer Corbett Dooren, a senior adviser in FDA’s press office, said in an email, “Our response is that it is mischaracterization of what was discussed at a stakeholder meeting earlier this year.” She did not respond to a request to relay what was said at the meeting.
FDA sees the broad definition of food giving them the authority to claim the primary position of regulation and moving forward on this.
“Legally, we don’t believe your justification is there,” Beck said. “We believe USDA FSIS is the best agency out there equipped to regulate these products from a safety perspective, but also from the labeling perspective because of the mandatory labeling pre-approval process. That is a powerful regulatory tool that FDA just doesn’t have. At the end of the day there needs to be fair, accurate product labels for any product out there regardless of the enforcement method.”
Beck said FDA has not responded to labeling demands, pointing to a push in the dairy industry going back 18 years to get FDA to enforce accurate labeling for imitation milk products, such as almond and soy products.
By and large, even the sellers of cell-cultured meat said they believe USDA is the best venue to regulate their products.
Still, lobbyists who had worked with USDA on the oversight of cell-cultured meats said USDA staff “were just as surprised as we were about the FDA hearing.” There’s a notion that FDA staff “literally stole” USDA’s plans for a public comment period and guidance moving forward.
Then there is the prospect that farm bill conferees could also add a provision in the farm bill conference report to provide a clear statement on who should have oversight.
Lia Biondo, a spokesperson for the U.S. Cattlemen’s Association, said USCA “is working the congressional angle pretty hard, but, yeah, there is definitely an opportunity in the farm bill to provide some clarification over who has jurisdiction.”
USCA also filed a petition earlier this year seeking clear labeling that would require sellers of cell-cultured proteins not to use the words “meat” or “beef” on their products. The state of Missouri also has approved a law that makes similar requirements. Right now, USCA is waiting for USDA to respond to the petition.
“We have got to find a way to get out ahead of this and provide some clear rules for how they will management these products,” Biondo said.