FDA signals it is way ahead on cell-based meat regulation
July 12, 2018
COLLEGE PARK, Md. — Food and Drug Administration officials and executives from companies that plan to make meat and seafood from animal cells made a clear case on July 12 for FDA to be the regulator of that industry.
The lab-grown meat industry has made many statements favoring FDA as the regulator while the conventional meat industry has been campaigning for the Agriculture Department, which inspects meat and poultry, to play a major role.
In a series of morning presentations related to issues that emerge if these lab-grown products become available to consumers, FDA officials explained the work their agency, a division of the Health and Human Services Department, has already done on the development of cell-based meat and seafood, and tied that to the work FDA has done for years in the use of cells to develop medicines.
"Past experience with novel technologies and our extensive background in cell culture technology in the medical product space will help inform our approach to evaluate the safety of these cell-based food products," FDA Commissioner Scott Gottlieb said as he opened the conference.
“We have both premarket and post-market programs for evaluating the safety of substances used in the production and manufacture of foods. So we are ready to face the challenges and to support the promise of this and other emerging technologies,”
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Gottlieb also emphasized that FDA wants to assure food safety, promote innovation and inform consumers about their changing food choices.
Susan Mayne, director of the FDA's Center for Food Safety in whose auditorium the event was held, said she wanted to emphasize Gottlieb's combined commitment to food safety and innovation.
"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."
Mayne pointed out that FDA has evaluated a variety of foods produced by cell culture, including microbial products such as probiotics and fungal products.
"We have both premarket and post-market programs for evaluating the safety of substances used in the production and manufacture of foods. So we are ready to face the challenges and to support the promise of this and other emerging technologies," Mayne said.
She also noted she has been attending food tech conferences "to help prepare the center for the technological advances that we know are in the early stages of development but will soon be coming to us here at the FDA."
Mayne also said FDA's science board will hold a meeting on the subject of cell-based foods this fall which will be organized by the office of FDA's chief scientist.
The meeting took place in the midst of intense conflict between the conventional and cell-based meat industries over the regulatory structure.
NOT MEAT OR BEEF
The U.S. Cattlemen's Association, for example, has petitioned the Agriculture Department to exclude products not derived from animals from labels reading "meat" and "beef."
Lia Bondo, who lobbies for the USCA, told The Hagstrom Report that Douglas Stearn, the director of FDA's Office of Enforcement and Import Operations in the Office of Regulatory Affairs, had said at a recent meeting that FDA had received a ruling from the Justice Department that it has jurisdiction over food produced using animal cell culture technology.
Asked to confirm that statement, Stearn, who was attending the meeting today, said he was not authorized to speak to news media. When told that The Hagstrom Report would publish what Bondo said, Stearn did not object.
FDA's press office would not authorize Stearn to speak to reporters, but Jennifer Corbett Dooran, 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.
In addition, The Hagstrom Report 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.
In the letter, House Agriculture Appropriations Subcommittee Chairman Robert Aderholt, R-Ala., and ranking member Sanford Bishop, R-Ga., and House Agriculture Committee Chairman Michael Conaway, R-Texas, and ranking member Collin Peterson, D-Minn., said that they understood the role that FDA should have in "overseeing the regulation of these innovative products," but said USDA has "an obvious role in ensuring their safety and accurate labeling."
The four House agriculture leaders sent the letter on July 11, only a day before the conference was to be held.
There were no USDA officials scheduled to speak. A USDA spokesman said today, "As the new products begin to emerge in the marketplace, we look forward to working with the FDA and the public to tackle these issues."
On a stakeholder panel, the comfort level of executives with cell-based food companies was obvious.
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.
Schulze also made the only mention of the Agriculture Department when he noted that Memphis Meat gets its cells from "healthy animals" after they have been inspected by USDA's Food Safety and Inspection Service.
Memphis Meats uses the cells to grow meat in a lab without animals.
Rhonda Miller, a Texas A&M meat scientist who is also former president of the American Meat Scientist Association, said there are still many questions about food safety as the cell-based meat is harvested and becomes available for human consumption.
Peter Licari, the chief technology officer for JUST, which is already well known for making eggless mayonnaise, emphasized he had spent 20 years in the biologics and drug industry, and said, "With plants providing nutrients for animal cells to grow, we believe we can produce meat that is infinitely more efficient than conventional approaches with a fraction of the greenhouse gas emissions and water use."
Michael Selden, the founder and CEO of Finless Foods, a company that takes fish cells and grows them into fish meat, particularly blue fin tuna, said in an interview that the farm-raised fish industry has embraced cell-based fish in contrast to the beef and pork industries, which have been hostile to it.
Selden also noted that there is no jurisdictional conflict about the regulation of cell-based fish meat because FDA is clearly in charge of all fish except catfish, and the cell-based industry is not working on that species.
The question of conflicts between USDA and FDA did not come up during the morning session, but lawyers and lobbyists for both the cell-based industry and the conventional meat industry were present and willing to provide reporters with their interpretations of what U.S. laws say about which agency should be in charge.
The National Cattlemen's Beef Association said in a news release today that it "applauds the pointed questions FDA has posed regarding risks, hazards and manufacturing methods of lab-grown meat food products," but "despite existing federal laws which designate USDA as the primary oversight body of lab-grown fake meat, USDA was not afforded a role in the public meeting."
The meeting continued in the afternoon. ❖