The production of human food from cultured animal cells is jointly regulated by the FDA (Food and Drug Administration) and the USDA-FSIS (United States Department of Agriculture’s Food Safety and Inspection Service). This collaborative oversight stems from a formal agreement established in March 2019. This agreement delineates the responsibilities of each agency throughout the cell-cultured food production process.
The FDA’s purview encompasses cell collection, cell banking, and cell growth and differentiation. Oversight transitions to USDA-FSIS during the harvesting stage, where cells are extracted from the growth environment. USDA-FSIS then assumes responsibility for the subsequent production stages and the labeling of these innovative food products. Both agencies are actively collaborating to refine detailed procedures that ensure seamless coordination during the pivotal harvest phase of cultured livestock and poultry cells.
This structured agreement underscores that the regulation of cell-cultured food is inherently linked to the animal species serving as the original source of the cultured cells. The regulatory framework builds upon the existing jurisdiction of both agencies over traditionally produced products from the same species. The FDA traditionally regulates live animals intended for food until they are presented for slaughter. USDA-FSIS, on the other hand, regulates the slaughter and processing of animals intended for human consumption under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). This includes animals like cattle, sheep, swine, goats, chicken, turkeys, ducks, and geese.
For cell-cultured food falling under FMIA and PPIA jurisdiction, the FDA’s regulatory authority extends from cell collection, banking, growth, and differentiation. Regulatory oversight then transfers to USDA-FSIS at the point of harvest, continuing through processing and labeling.
It’s crucial to note that certain applications of cell-based food production technology fall exclusively under the FDA’s jurisdiction. These include the regulation of processing and the food itself when derived from the cultured cells of animals not covered by the FMIA or PPIA, such as seafood (excluding Siluriformes) and game meat. In these cases, the FDA applies requirements stipulated by the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Furthermore, the FDA regulates all food intended for animal consumption, regardless of the animal species from which the food or cells originate.
FDA’s Role in the Cultured Animal Cell Food Production Process
The FDA’s regulatory strategy for cultured animal cell products, as outlined in the formal agreement, hinges on a rigorous pre-market consultation process. This is coupled with inspections of records and facilities where applicable, which is designed to ensure safety and compliance.
Pre-Market Consultations: Ensuring Safe Food Production
The FDA’s voluntary pre-market consultation process plays a pivotal role in assessing the safety of cultured animal cell food before it reaches consumers. This process fosters collaboration between developers and the FDA, allowing for a product-by-product evaluation. It highlights potential issues that developers need to address to ensure their food is safe and compliant with the Federal Food, Drug, and Cosmetic Act.
During these consultations, the FDA meticulously evaluates the entire production process and the resultant cultured cell material. This includes the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs involved. The FDA’s paramount goal is to champion innovation in food technologies while maintaining an unwavering commitment to food safety.
The FDA actively encourages firms to engage in early and frequent discussions throughout the product and process development phases. It has already initiated discussions with numerous companies exploring diverse types of cultured animal cell food, encompassing seafood and animal feed applications. Information about completed consultations can be found in the FDA’s inventory of completed pre-market consultations for human food made with cultured animal cells.
On November 16, 2022, the FDA marked a significant milestone by completing its first pre-market consultation for human food produced from cultured animal cells. The agency thoroughly evaluated the submitted information and raised no further questions regarding the firm’s safety conclusion.
The FDA is dedicated to providing transparency regarding its oversight of cultured animal cell food.
Example of FDA Evaluation During Pre-Market Consultation
Alt Text: Flowchart detailing the FDA’s evaluation process for pre-market consultation of cultured animal cells, encompassing cell source, manufacturing process, and final product characterization to ensure food safety.
Firms seeking guidance on the pre-market consultation process for human food can contact the Center for Food Safety and Applied Nutrition, Office of Food Additive Safety at [email protected]. For firms interested in marketing cultured animal cell food products or byproducts for animal food, they should contact the Center for Veterinary Medicine, Division of Animal Food Ingredients, at [email protected].
The FDA plans to issue guidance on the pre-market consultation process, providing an opportunity for public comment.
Inspections and Oversight Activities
The FDA intends to conduct routine inspections at cell banks and facilities involved in cell culturing, differentiation, and harvesting. These inspections are crucial for ensuring that potential risks are effectively managed and that the biological material exiting the culture process meets safety standards and is not adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA will also verify compliance with facility registration requirements, Current Good Manufacturing Practices (CGMPs), and other relevant food safety regulations.
These inspections will be informed by the findings of pre-market consultations and thorough assessments of facility records. Should inspections reveal noncompliance, the FDA will take appropriate regulatory action. Furthermore, the FDA will ensure that the labeling of cultured cell products derived from animal species not under USDA jurisdiction is truthful and not misleading, aligning with the coordinated principles established by the FDA and USDA-FSIS for product labeling and claims.
USDA-FSIS’ Role in the Cultured Animal Cell Food Production Process
The USDA-FSIS collaborates closely with the FDA to transition regulatory oversight during the harvest stage. This is when the cells are removed from the active growth environment in preparation for conventional food processing. USDA-FSIS conducts inspections at facilities where livestock and poultry-derived cells are harvested. These facilities must obtain a USDA grant of inspection and adhere to USDA-FSIS regulatory requirements, including sanitation and Hazard Analysis and Critical Control Points (HACCP) systems.
USDA-FSIS ensures that all human food made from cultured animal cells is truthfully labeled, consistent with the coordinated principles for product labeling and claims established by the FDA and USDA-FSIS. The FMIA and PPIA mandate that all labeling for human food produced from cultured livestock or poultry cells must receive preapproval from USDA-FSIS.
More information on USDA-FSIS’ regulatory oversight and activities can be found on USDA’s Foods Made with Cultured Animal Cells page.
In conclusion, the production of food from cultured animal cells is a carefully regulated process involving collaborative oversight from both the FDA and USDA-FSIS. This framework prioritizes food safety, accurate labeling, and ongoing innovation in the field of cellular agriculture.
