In a statement issued Friday, the FDA and USDA proposed “a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation," with USDA to oversee the production and labeling of food products from the harvested cells.
The statement - issued by FDA commissioner Dr Scott Gottlieb and USDA secretary Sonny Perdue - added: "A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry.” [Seafood, which is currently under the purview of the FDA, was not mentioned.]
In concluding remarks that will be a huge source of relief for start-ups in the space keen to get their products to market, the pair added that the government does not believe new legislation is required to regulate cell-cultured meat (also known as cell-based meat).
“Because our agencies have the statutory authority necessary to appropriately regulate cell-cultured food products derived from livestock and poultry the Administration does not believe that legislation on this topic is necessary."
Attorney: ‘This outcome should not surprise anyone’
Stuart Pape, chair of the FDA practice group at law firm Polsinelli, who told delegates at the IFT show this summer that cell cultured meat “will not see the market in the lifetime of anyone in this room” were it left solely under USDA’s jurisdiction, told FoodNavigator-USA that, “This outcome should not surprise anyone.”
He added: “The agencies have only announced the broad framework so everyone will need to standby as the details get filled in, including how a company will initiate the review process at FDA and what the parameters of that review process will be.
“The conclusion that new legislation is not needed seems correct, although that conclusion does not mean that there will be no Congressional involvement. Seafood will remain solely the responsibility of FDA.”
Ryan Fournier, associate at Morgan, Lewis & Bockius LLP, added: “It is promising to see the agencies work together to develop a functioning regulatory review process for cell-cultured meat and poultry. However, we will need more details as to what these processes will look like to determine both their effectiveness and their credibility. In many ways this is where the tougher questions of science and public policy will begin to come into focus. It is also encouraging to hear that the agencies believe they can address this issue under their current statutory authorities.”
"Now that the agencies have made clear that they will work together within the existing regulatory framework, a number of critical questions core to developing a functioning regulatory review process need to be addressed.
"For example, how will the FDA and USDA initiate their respective application processes, how long will it take to obtain premarket approval, and what will inspection of the production facilities look like? Further, how should the food products be labeled?"
Brian P. Sylvester, special counsel, Wiley Rein LLP
BlueNalu: ‘Extremely pleased at the speed and efficiency of this announcement’
Cell-based meat companies also welcomed the statement, with Lou Cooperhouse, president and CEO at ‘cellular aquaculture’ start-up BlueNalu, told FoodNavigator-USA that he was “Extremely pleased at the speed and efficiency of this announcement,” and that the “level of collaboration between the agencies was extremely impressive,” during the joint USDA/FDA meeting on cell-based meat last month.
He added: “This dual oversight of meat and poultry products is extremely appropriate, and is best for the public and is also best for industry as well. This will ensure that the initial phase of the cell-based manufacturing process will be under the regulatory oversight of the FDA, which has tremendous expertise and infrastructure already in place regarding product safety, cell culture technology and living biosystems, including cell collection, cell banks, and cell growth and differentiation.
“The final phase of the cell-based meat and poultry manufacturing process will be under USDA oversight, which will ensure that Preventive Controls and HACCP systems are in place, similar to those that are in place already for traditionally-produced meat and poultry products. As real-world examples, the USDA already regulates meat-based prepared foods, based upon definitions that have been in place for several decades, for items like meat lasagna, meatballs, beef chili, beef fajitas, beef burritos and meat ravioli.
“As the USDA will continue to have regulatory oversight at the finished product level for cell-based meat and poultry products, this will ensure that cell-based meat items are labeled consistently to items that today originate only from a living animal, resulting in consumer confidence and trust.”
"We're happy the agencies feel they can move forward without needing new legislation. We welcome seeing a clear roadmap develop for regulation of these products. We think working with regulators is the best way to engender public trust and so are excited to continue on this path."
Mike Selden, co-founder, Finless Foods
What does this mean for seafood?
While it only refers to livestock and poultry, the announcement also seems to provide clarity that the FDA will be the sole agency regulating cell-based seafood products, he argued: “FDA currently oversees all food products, except for those containing meat and/or poultry (except for catfish).”
“We’re pleased the agencies have initiated the steps to work together on regulating cell-based meat products and appreciate the work that USDA Secretary Perdue has put in to ensure USDA’s role in regulating these new products. We look forward to seeing more details on how these plans will be implemented and participating in that process.”
Mark Dopp, senior VP, regulatory and scientific affairs, North American Meat Institute
Memphis Meats: ‘This provides a clear path to market for cell-based products’
Uma Valeti, MD, CEO and co-founder at cell-based meat start up Memphis Meats noted that the statement “provides a clear path to market for cell-based products,” while the joint framework “plays to the respective strengths of both USDA and FDA, while continuing to foster innovation and assure a safe and reliable food system.”
Andrew Noyes, head of communications at JUST, which is also developing cell-based meat products, added: “We commend FDA Commissioner Gottlieb and USDA Secretary Perdue for their commitment to creating a regulatory framework for cultured meat and we look forward to working with both agencies.”
Didier Toubia, co-founder and CEO at Israeli cell-based meat start-up, Aleph Farms, welcomed the news, adding: "We encourage other jurisdictions in the world to follow the US leadership and take action," while Brian Spears, co-founder and CEO at US-based start-up new Age Meats, said the move "reduces uncertainty and allows us to move forward developing innovative technology here in the United States to make meat tastier, healthier, and more sustainable.
"The joint framework allows us to more quickly create safe, high paying jobs in both R&D and manufacturing."
"SuperMeat believes that if the agencies succeed in bringing their resources jointly to the table and fully collaborating, they will provide producers and consumers alike the security of professional, experienced, food-appropriate regulation at all stages of cell cultured meat production."
Shir Friedman, co-founder, CCO, Supermeat
Good Food Institute: Gov’t has recognized that clarity was needed, quickly
Jessica Almy, director of policy at the Good Food Institute, which works with cell-based and plant-based meat companies, said the announcement was “an exciting indication that FDA and USDA are clearing the way for a transparent and predictable regulatory path forward."
And time is of the essence, she added: “The governments of Israel, Japan, and Singapore have already signaled significant interest in this important food technology, and so we share FDA’s and USDA’s commitment to ensuring a clear regulatory path forward for cell-based meat as quickly as possible.
“We agree with Secretary Perdue and Commissioner Gottlieb that no new laws or regulations are necessary, and we look forward to working with the agencies on their guidance to the cell-based meat industry under the current regulatory framework.”
Labeling and cell-cultured meat
The labeling of cell-cultured meat was not referenced in the statement, and remains a bone of contention within the food industry, with clear divisions between stakeholders emerging at the recent joint USDA/FDA meeting, with the National Cattlemen’s Beef Association repeatedly referring to “lab grown fake meat,” while advocates of the technology deployed more neutral terms such as “cell-based meat” or “cell-cultured meat.”
The US Cattlemen's Association said: "“Now that we have settled on the jurisdiction of these products, it’s time to move on to ensuring a truthful and transparent label for consumers. Our petition for rulemaking to the USDA’s Food Safety and Inspection Service on the definitions of ‘beef’ and ‘meat’ must be addressed.”
Read the statement in full HERE.
What should we call cell-cultured meat? Click HERE.
Who’s who in the global clean meat market?
While no cultured meat products are on the market yet, a handful of players from Mosameat and Meatable in the Netherlands, Higher Steaks in the UK, Future Meat Technologies, Aleph Farms, and SuperMeat in Israel, Memphis Meats, Finless Foods, Wild Type, BlueNalu and JUST Inc in the US, and Integriculture in Japan are looking to introduce them over the next five years