Silver Spring / MD. (fda) The world is experiencing a food revolution and the U.S. Food and Drug Administration (FDA) is committed to supporting innovation in the food supply. As an example of that commitment, FDA is announcing that it has completed the first pre-market consultation of a human food made from cultured animal cells in the U.S. The agency evaluated the information submitted by Upside Foods in Berkeley, California, 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 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, 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.
Addendum: Based in Berkeley, CA, Upside Foods grows meat, poultry and seafood directly from animal cells. These products are not vegan or vegetarian—they are delicious meat, made without the need to raise and slaughter billions of animals. Founded as the world’s first cultivated meat company in 2015, Upside Foods has achieved numerous industry-defining milestones, including being the first company to produce multiple species of meat (beef, chicken and duck). The company believes that people shouldn’t have to choose between the foods they love and a thriving planet, and is working to build a better food system with access to delicious, humane, and sustainable meat, poultry, and seafood. Upside Foods has won various industry awards, including New York Times’ Good Tech Awards, FastCo’s Next Big Thing in Tech, and the Best and Brightest Companies to Work For in the Nation by the National Association for Business Resources. Upside Foods has raised a total of $608 million, including from the Abu Dhabi Growth Fund (ADG), Baillie Gifford, Bill Gates, Cargill, John Doerr, John Mackey, Kimbal and Christiana Musk, Norwest, Richard Branson, Softbank, Temasek, Threshold, Tyson Foods, and others.