The “cell-cultured proteins” sector is at the forefront of food innovation and technology. Also known as “cultured”, “cell-based,” or “cultivated,” or “lab-grown,” it is the most current in food innovation and technology.
Globally, manufacturers are racing to create proteins with a unique taste, texture, and nutrition profile. Cell-cultured proteins can be used to produce a variety of products, including lobster, yellowtail, foie gras and beef.
Singapore was the first country to approve a cell based protein. The U.S. is poised for growth in the cell-cultured proteins industry. Both USDA and FDA have a regulatory authority on cell-cultured meats.
After public comment periods, both agencies determined that FDA would oversee cell culturing for poultry and meat products up to the harvest stage. However, FDA will have sole jurisdiction over seafood. FDA will require that all facilities comply with food safety regulations, such as food facility registration, hazard analysis, risk-based preventive controls (HARPC), current Good Manufacturing Practices and (GMPs).
After harvesting cells from bioreactors the USDA assumes regulatory power and inspects the meat cells and finished products derived form livestock and poultry. It is subject to the Federal Meat Inspection Act (Federal Poultry Products Inspection Act) and other regulations.
FDA and USDA have agreed that they will collaborate in developing a more detailed joint framework for standard operating procedures and product labeling. As of the date this publication, FDA has not published any further information on the labeling of cell-cultured seafood foods.
The lack of action is causing concern in the industry. The Alliance for Meat, Poultry, and Seafood Innovation joined forces with the North American Meat Institute to urge FSIS to issue an advance notice of proposed rulemaking in October 2020 to begin a process of information collection. The agencies expressed great interest in working with cell-cultured meat producers. However, companies seem to be reluctant to take part, possibly because of the highly confidential processes involved.
Safety concerns could be unique to cell-cultured meat products. The technology is still so new that it’s not clear how FDA or USDA will handle cell-cultured food approvals.
In an April 2020 report, the Government Accountability Office (GAO), highlighted concerns about antibiotics in cell growth and new safety issues that could arise from this new technology.
Although industry is understandable in its hesitation, stakeholders need to recognize that there is an opportunity for them to lead the dialogue, focus regulators on specific issues and be the first to enter the U.S. marketplace. The better agencies understand the process, they can create a regulatory structure that best captures the way the industry works.
The marketing and naming aspects of cell-cultured proteins are another area that is a bit murky in legal and regulatory terms. Names like “clean” are a few of the current contenders to be marketed as cell-cultured protein products. Critics argue that this reflects a bias against or for other products and can affect how they are perceived on the market.
Both FDA and USDA are aware of the labeling issue, but neither has offered a regulatory solution. A variety of pieces legislation were introduced in Congress, but have yet to be passed. They seek to clarify whether a “meat”, “milk”, or any other traditional term is allowed.
Possibly due to the inaction of Congress or federal agencies, many states, including Arkansas, Arizona, Louisiana Mississippi, Missouri and Oklahoma have passed laws that restrict the use of the word “meat” for cell-cultured meats or plant-based alternatives. Companies in the meat-alternative sector have challenged many of these laws in court.
Cell-cultured products are expected to be available on the market within the next few days. FDA and USDA must quickly create a framework for manufacturers to work with, if they wish to take over this sector.
Recent studies have shown that consumers are not willing to eat cell-cultured meat, even if they can pass regulatory hurdles. To be successful, manufacturers will need to reach consumers and offer education programs to help them understand their products.
