SILVER SPRING, Md. — The world is experiencing a food revolution and the U.S. Food and Drug Administration is committed to supporting innovation in the food supply. As an example of that commitment, today we are announcing that we have completed our first pre-market consultation of a human food made from cultured animal cells.
The agency evaluated the information submitted by UPSIDE Foods as part of a pre-market consultation for their food made from cultured chicken cells and has no further questions at this time about the firm’s safety conclusion.
Before this food can enter the market, the facility in which it is made also needs to meet applicable U.S. Department of Agriculture (USDA) and FDA requirements. In addition to the FDA’s requirements, including facility registration for the cell culture portion, the manufacturing establishment needs a grant of inspection from USDA-Food Safety and Inspection Service (FSIS) for the harvest and post-harvest portions and the product itself requires a USDA mark of inspection.
The regulation of cell culture technology is being done collaboratively and in close partnership with USDA-FSIS for food made from cultured livestock or poultry cells. Under the March 2019 formal agreement, both agencies agreed to a joint regulatory framework wherein the FDA oversees cell collection, cell banks, and cell growth and differentiation. The FDA’s approach to regulating products derived from cultured animal cells involves a thorough pre-market consultation process. While this is not considered an approval process, it concludes when all questions relevant to the consultation are resolved. A transition from the FDA to USDA-FSIS oversight will take place during the cell harvest stage. USDA-FSIS will oversee the post-harvest processing and labeling of human food products derived from the cells of livestock and poultry. This closely coordinated regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry meet federal regulations and are accurately labeled. Both agencies are working with manufacturers to ensure these products meet all applicable FDA and USDA-FSIS requirements.
Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock, poultry, and seafood in the production of food, with these products expected to be ready for the U.S. market in the near future. The FDA’s goal is to support innovation in food technologies while always maintaining as our first priority the safety of the foods available to U.S. consumers. The FDA has extensive experience in food safety assessment across a wide range of food production technologies, including the use of biological systems and biotechnology. The agency is evaluating new substances all the time as industry practices evolve to meet consumer demands and preferences. Food made with cultured animal cells must meet the same stringent requirements, including safety requirements, as all other food regulated by the FDA.
The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their products are safe and lawful under the Federal Food, Drug, and Cosmetic Act. We also plan to issue guidance to assist firms that intend to produce human foods from cultured animal cells to prepare for pre-market consultations. The published draft of this guidance will provide a formal opportunity to the public for comment. We are already engaged in discussion with multiple firms about various types of products made from cultured animal cells, including those made from seafood cells, which will be overseen solely by the FDA. We continue to encourage firms to enter into dialogue with us often and early in their product development phase, well ahead of making any submission to us.
- Constituent Update: FDA Completes First Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology
- Human Food Made with Cultured Animal Cells
- Overview of FDA and USDA Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products Webinar
- FDA response letter to the firm
- FDA’s scientific review memo of the firm’s product
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
–U.S. Food and Drug Administration