Correction on byline: This opinion piece originally posted with the wrong byline. The error has been corrected.
By Brian P. Sylvester, Jessica P. O’Connell and John C. Balzano
In a global first, in recent days, Singapore greenlighted the marketing of a cell-based meat product for human consumption. The approval represents an inflection point in the rapid rise of alternative proteins around the world.
In contrast to plant-based meat, which mimics the organoleptic characteristics of real meat but uses proteins from plants, cell-based meat is actually meat tissue produced without animal slaughter. Also known as cultivated meat or cell cultured meat, cell-based meat is intended to replicate the organoleptic, nutritional, and compositional characteristics of meat tissue harvested from food-producing animals.
Until last week, cell-based meat remained fully entrenched in the universe of research and development. To facilitate commercialization, investments have been pouring in from the likes of Cargill, Tyson Ventures, and PHW Group, alongside high net worth investors like Bill Gates and Richard Branson. Regulators around the world have concurrently sought to keep pace with rapid advancements in cellular agriculture technology with an eye towards developing appropriately tailored regulatory frameworks. And the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have moved at a record speed considering the novelty of the production process and the need to ensure that labeling claims are accurate and provide consumers with sufficient information about the nature of the products.
The question on everyone’s mind is whether and to what extent the news from Singapore will translate to cell-based meat products making their way to Americans’ plates. The answer will turn on conversations currently underway at USDA, FDA, and Capitol Hill, and will be influenced by the direction of the incoming White House administration.
Evolving U.S. regulatory developments
In March 2019, following a congressional briefing, a regulatory turf battle, and public meetings over the course of the prior year, FDA and USDA released a Memorandum of Understanding (MOU) outlining how the U.S will regulate cell-based meat, poultry, and seafood products within the bounds of the existing statutory framework for foods. The MOU clarifies how existing law will apply, providing that FDA will oversee cell collection and propagation up to the point of harvest of meat or poultry from the bioreactor, after which jurisdiction for meat or poultry products would shift to USDA’s Food Safety and Inspection Service (FSIS). The agreement also clarifies that cell-based seafood and game meat will be overseen solely by the FDA.
FDA will execute its oversight pursuant to the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321 et seq.), and USDA will execute its oversight pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), and the Poultry Products Inspection Act (21 U.S.C. 453 et seq.), and the applicable implementing regulations. To determine the details of how FDA and USDA will execute their oversight responsibilities, three Interagency working groups have been formed.
Interagency working groups
The first working group, led by FDA, focuses on pre-market safety and aims to develop details for a pre-market consultation process. This working group is actively meeting with cell-based meat producers to better understand various production methodologies that, in turn, will inform the details of oversight. Industry expects FDA to release a draft guidance to clarify pre-market regulatory oversight.
The second working group covers the transfer of jurisdiction from FDA to USDA at the cell harvest stage. This working group, co-led by FDA and USDA, is developing specific procedures for transferring inspection oversight.
The third and final working group, led by USDA-FSIS, covers labeling and has been tasked with developing coordinated principles across USDA and FDA for product labeling and claims to ensure consistency and transparency.
The U.S. labeling debate
Labeling has proven to be a contentious issue. In February 2018, the U.S. Cattlemen’s Association (USCA) petitioned USDA-FSIS, asking the agency to limit the term “meat” to mean the “tissue of flesh of animals that have been harvested in the traditional manner.” As of this writing, USDA has not formally responded. In the meantime, states have taken labeling oversight into their own hands. Several states, like Louisiana and Missouri, have passed laws prohibiting cell-based — and plant-based — foods from bearing conventional meaty terms, like “meat,” “burger”, and “sausage,” if those terms misrepresent the products as being derived from harvested production livestock or poultry. Legal challenges to these laws are ongoing in Louisiana, Missouri, and other states in which such laws have been passed.
Against this backdrop, the USDA announced this summer that it will be considering new regulatory requirements for cell-based meat and poultry, and FDA recently issued a Request for Information (RFI) concerning how cell-based seafood should be labeled.
Singapore’s potential influence on U.S. and global frameworks
In contrast to the U.S., where the regulatory and policy framework governing conventional agriculture must be balanced against agricultural innovation goals and where two distinct regulators must align, Singapore offers an easily navigable regulatory landscape, recently revamped to facilitate alternative protein production. Singapore currently imports over 90 precent of its food, and plans to boost local food production to 30 percent by 2030 — with a focus on alternative proteins. Earlier this year, in March 2020, the Singapore Food Agency (SFA) formed a Novel Food Safety Expert Working Group, and ostensibly offers a measured, painstaking review of new food technologies to rival highly regarded regulators around the world.
Singapore’s approval likely sets the stage for other Asian jurisdictions to follow suit, particularly southeastern Asian countries who may look to the Singapore Food Agency as a leader. China is also exploring research and development for cell-based meat, although its laws and regulations around this issue are still developing and new foods can often take time to obtain approval. The Japanese government embarked on a project in 2020 to develop standards to directly permit the sale of cell-based meat, among other alternative sources of protein.
To be sure, we expect the SFA nod to further foment regulatory conversations around the world, including in the US.
The FDA and USDA are to be commended for the record pace at which they have moved to clarify the regulatory framework for cell-based meat. But the considerations outlined above mean we will have a few more steps to go before cell-based meat enters the U.S. market.
Agricultural innovation is a bipartisan effort, and we anticipate that the Biden Administration will continue working toward establishing a clear regulatory pathway for cell-based meat. Doing so would align well with the incoming administration’s overarching sustainability goals, including the promotion of climate-smart agriculture. In the short term, we’re likely to begin seeing tangible direction from the key regulators on issues like premarket safety and labeling.
About the authors:
John C. Balzano, partner in Covington’s Food, Drug, and Device Practice, represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.
Jessica P. O’Connell, former Associate Chief Counsel at FDA and partner in Covington’s Food, Drug, and Device Practice, provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress.
Brian P. Sylvester, former USDA regulatory lawyer and special counsel in Covington’s Food, Drug, and, Device Practice, advises food, dietary supplement, cosmetic, OTC drug, veterinary pharmaceutical, and animal feed clients on a broad range of regulatory, legislative, and compliance issues before FDA, USDA, and analogous food and drug regulatory bodies.
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