The US Food and Drug Administration (FDA) says it has “no further questions” for Upside Foods regarding the safety of its cultivated chicken, meaning it accepts Upside’s evidence the product is safe to eat. It is the first company to achieve this in the US.
The FDA said, “The FDA’s pre-market consultation with the firm included an evaluation of the firm’s production process and the cultured cell material made by the production process, including the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs.
“The voluntary pre-market consultation is not an approval process. Instead, it means that after our careful evaluation of the data and information shared by the firm, we have no further questions at this time about the firm’s safety conclusion,”.
Upside Foods founder and CEO Uma Valeti said it was a “watershed moment in the history of food”.
“We started Upside amid a world full of skeptics, and today, we’ve made history again… This milestone marks a major step towards a new era in meat production,” Valeti said.
Upside was founded in 2016 as Memphis Meats. Last year it opened a 5000 square metre factory that could make 181,437 kilograms of meat a year. Earlier this year, the company took in US$400 million in Series C funding, bringing its total raise to more than US$600 million. This latest round was co-led by Temasek and the Abu Dhabi Growth Fund, with Cargill, Givaudan, Tyson Foods, and Bill Gates just some of the investors.
FDA commissioner Robert Califf and director of the FDA’s Centre of Food Safety and Applied Nutrition, Susan Mayne, said the world was experiencing a food revolution and the FDA was committed to supporting innovation in the food supply.
While the FDA released a “no further questions” finding to Upside Foods’ pre-market consultation, it will still need to meet Department of Agriculture (USDA) and USDA Food Safety and Inspection Service (USDA-FSIS) requirements.
In 2019, the FDA and USDA-FSIS signed an agreement to develop a joint regulatory framework. The FDA oversees cell collection, cell banks, and cell growth and differentiation. The process transitions to USDA-FSIS during the cell harvest stage, to oversee the post-harvest processing and labelling of human food products derived from the cells of livestock and poultry.
“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 US 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 US consumers.
“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 said the FDA was ready to work with companies developing cultivated meat and production processes and would be issuing a guidance to help them prepare for pre-market consultations.
“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.”
