Announcing it has completed the first pre-market consultation of a human food made from cultured animal cells, the U.S. Food and Drug Administration (FDA) said today that it is committed to supporting innovation in the food supply.
According to a statement from FDA Commissioner Robert M. Califf, M.D., and Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, the agency evaluated information submitted by Upside Foods, a leading cultivated meat, poultry and seafood company, 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.
Upside Founder and CEO Uma Valeti, MD, called the development “a truly historic milestone,” one that the company has been working towards since it was founded in 2015.
Essentially, the FDA’s completion gives Upside the greenlight and paves the way for commercialization of the product in the U.S. “It marks a major step towards a new era in meat production and brings us closer towards our ultimate goal of making meat a force for good,” Valeti added.
Before 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. As such, the next step for Upside is to work with USDA to obtain the additional approvals needed to sell products in the U.S.
A transition from the FDA to USDA-FSIS oversight takes 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.
The FDA’s goal is to support innovation in food technologies while always maintaining food safety as its first priority. 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.
Califf and Mayne said they are 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. Guidance will also be issued 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,” they said. “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.”