At the forefront of current food innovation and technology is the “cell-cultured protein” sector (also described as “cultured,” “cell-based,” “cultivated,” “lab-grown,” and “in vitro”).
Manufacturers across the globe are rushing to culture proteins that have a taste, texture and nutrition profile that is indistinguishable from their animal-based counterpart. With products ranging from beef to yellowtail to foie gras to lobster, the cell-cultured protein industry has the potential to revolutionize the food and agriculture industries.
While Singapore became the first nation to approve a cell-based protein, the U.S. is poised to be fertile ground for the growth of the cell-cultured protein industry. Both FDA and USDA have asserted regulatory authority over cell-cultured meats.
Following public comment periods, the agencies decided FDA will oversee the cell culturing process for meat and poultry products until the harvest stage, and FDA will retain sole jurisdiction over seafood. Facilities will need to comply with FDA food safety requirements, including food facility registration, hazard analysis and risk-based preventative controls (HARPC), and current Good Manufacturing Practices (GMPs).
Following harvest of cells from bioreactors, USDA assumes regulatory authority and is responsible for inspection of the meat cells and finished products derived from livestock and poultry under its authority from the Federal Meat Inspection Act and Poultry Products Inspection Act.
FDA and USDA have agreed to collaborate to develop a more detailed joint framework on standard operating procedures, product labeling, and other issues. However, aside from FDA’s issuance of a Request for Information regarding the labeling of foods containing cell-cultured seafood products, as of the date of this publication, neither agency has published further details on these initiatives.
Industry is concerned by the lack of action. In October 2020, the Alliance for Meat, Poultry, and Seafood Innovation joined the North American Meat Institute in urging FSIS to issue an Advance Notice of Proposed Rulemaking to initiate an information collection process. The agencies have expressed a great deal of interest in collaborating with cell-cultured meat producers, but companies appear to be reluctant to participate, perhaps given the highly-confidential processes and proprietary information at stake.
Cell-cultured meat products could pose safety concerns unique from those in traditional meat production. In fact, the technology is so new that it remains unclear just how FDA and USDA will approach the specifics of approving cell-cultured foods.
The concerns highlighted in an April 2020 report by the Government Accountability Office (GAO) included the potential use of antibiotics at the cell growth stage and potentially new safety issues unique to this new technology (e.g., residues or constituents not seen in conventional meat or other foods).
While industry’s hesitation is understandable, stakeholders should also recognize that there is an opportunity to be among the first to drive the dialogue, to focus regulators on specific issues, and to be the first entrants into the U.S. market. The more the agencies know about the process, the better they can create a regulatory framework that will most accurately capture the way the industry operates.
Another murky legal and regulatory area facing the cell-cultured protein industry is the marketing and naming of such products. Some current contenders for naming cell-cultured products include terms like “clean,” which critics argue reflects a bias for or against other products and affect how they are perceived in the market.
While both USDA and FDA are aware of this labeling question, neither entity has proposed a regulatory solution. Various pieces of legislation have been introduced (but have not passed) in Congress that seek to clarify when a “meat,” “milk” or other traditional term can be used.
Perhaps because of the lack of action by Congress or federal agencies, several states—including Arkansas, Arizona, Louisiana, Mississippi, Missouri, Oklahoma, Nebraska, North Dakota, South Dakota, Texas, and Wyoming—have passed laws restricting use of the term “meat” on cell-cultured meat or plant-based meat alternative products. Many of these laws have been challenged in court by companies in the meat-alternative space.
Cell-cultured products will be ready to enter the market soon, and USDA and FDA will need to act quickly to create a framework that manufacturers can work with if they want to assert leadership in this space.
Even if cell-cultured meat products can overcome regulatory hurdles and enter the market, recent studies show consumers may not yet be willing to embrace cell-cultured meat because of concerns over taste, food safety, and lack of knowledge about the process. Manufacturers will need to focus on consumer outreach and launch education initiatives to garner an understanding of their products to be successful.