The Food and Drug Administration said at a public meeting today that it has the expertise to address the regulatory challenges posed by the young but fast-growing industry of cell-cultured animal products.
“This is still early days,” Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, told a packed auditorium at CFSAN’s offices in College Park, Md. “But make no mistake, FDA has been preparing for this for quite some time.”
“This is not our first rodeo, so to speak, in this area,” she said.
The meeting was billed as an opportunity for FDA officials to listen and learn as they contemplate how to go about regulating the new products – known as “clean meat” by many of their supporters and manufacturers, and as “fake meat” by detractors such as conventional beef producers. The new products are not yet on the market, but they "are likely to reach retail shelves in the near future," FDA Commissioner Scott Gottlieb (pictured above) said at the meeting.
But the question of whether FDA or USDA will regulate the industry remains. USDA officials did not take part in the meeting, and afterwards, FDA officials weren’t eager to discuss what role USDA might play in the regulation of the cell-based products.
After the meeting, an FDA spokesperson sent Agri-Pulse a statement saying, “We work closely with our USDA colleagues on many food-related matters as part of fulfilling our respective food safety missions. The purpose of today’s meeting (was) to focus on the scientific and technical considerations with respect to emerging cell cultured food products. This is important for ensuring an appropriate regulatory framework that advances safe innovations for consumers.”
Gottlieb kicked off the proceedings, telling attendees, “Our past experience with novel food technologies and our extensive background in cell-culture technologies in the medical products space will help to inform our approach to evaluating the safety of these cell-based food products.”
Gottlieb did not mention USDA, but told a POLITICO reporter after his remarks, “We’ve been in dialogue with them. We continue to be in dialogue with them.”
USDA Secretary Sonny Perdue told House appropriators at a hearing in April that although there are “some gray lines between FDA and USDA on many things,” meat has been USDA’s responsibility for many years. “We would expect any product that expects to be labeled as meat would come under that same inspection criteria,” he said.
Today's meeting featured public comments from representatives of the nascent cell-cultured meat industry, the traditional beef industry, and food safety groups, among others.
“FDA has both a robust food regulatory system and the expertise that is capable of ensuring the safety of clean meat,” Peter Licari, chief technology officer for JUST, a food company in San Francisco, said.
“A clean meat facility will be similar to what FDA sees every day in both biologic and food processing plants,” he said. “It will not look like a slaughterhouse, but much more like, for example, a clean fermentation-based food processing plant.”
Memphis Meats, another San Francisco-based company doing cell-based meat, also endorsed FDA’s “risk- and product-based approach.” And Eric Schulze, senior scientist at the company, said at the meeting that his company’s products are “real meat.”
“Our products are not plant-based,” he said. “Instead, they are comprised of muscle and other tissues derived from cows, chicken, or other animals. In short, our beef is beef, and our chicken is chicken.”
The traditional beef industry, however, pushed back against both the notion that the cell-based products should be called meat, and that FDA should have regulatory oversight.
Said Danielle Beck, director of government affairs for the National Cattlemen’s Beef Association, “While there may be some ongoing debate internally among FDA and USDA, NCBA believes that the law governing oversight of meat food products is clear, and that any fair reading of the law places lab-grown meat food products within the primary jurisdiction of the USDA’s Food Safety and Inspection Service.”
“The only difference between cultured and traditional meat food products is the process by which the animal parts are grown and harvested,” she said.
Tiffany Lee, director of scientific and regulatory affairs for the North American Meat Institute, said she was “surprised and disappointed that no one from USDA is on any of the panels. This should have been a joint meeting.”
The American Meat Science Association’s Dustin Boler, a meat scientist at the University of Illinois, said it’s too early to decide on regulatory jurisdiction because AMSA “has determined there is not enough scientific information available to conclude that cultured animal tissues should be called meat.”
“To the knowledge of the American Meat Science Association, there is no publicly available information or actual product available for independent scientific evaluation to determine if food produced from cultured animal tissue is similar to meat obtained naturally from animals in terms of composition and functionality,” Boler said.
Michael Hansen, senior scientist at Consumers Union, struck a cautionary note about potential FDA oversight. He warned against the agency using its food additive authority because of the possibility that companies could use the “Generally Recognized as Safe” notification process, which does not require companies to notify FDA that they have deemed a product safe.
More discussion will take place in the months ahead. FDA said its science board will hold a meeting this fall on the subject. And FDA officials at the meeting repeatedly urged attendees – both those present and those tuning in over the Internet – to submit comments to FDA’s docket.
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