California company Upside Foods has been given the green light from the U.S. Food and Drug Administration (FDA) for its lab-grown chicken, paving the way for its product to reach market shelves next year, and making the US the second country in the world to allow legal sales of lab-grown meat products.
In 2019 the FDA and the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) developed a formal regulatory process for future lab-grown meat products. The joint framework established the FDA as regulator of the cell culturing part of lab-grown meat manufacturing, and the USDA-FSIS as overseer of post-harvest cell processing and food labelling.
A recent announcement from the FDA has revealed Upside Foods is the first company to complete the initial pre-market consultation stage on the road to market approval. This means the FDA has completed its part of the regulatory process, giving the safety thumbs up to Upside Foods' lab-grown chicken manufacturing processes.
"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 FDA noted in a statement. "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."
The next steps before the product reaches American supermarkets is a "grant of inspection" for the manufacturing premises from the USDA-FSIS, and then finally, approval over the lab-grown chicken's final labeling. It is still unclear exactly what labeling will be necessary for these kinds of products.
Nevertheless, the FDA is enthusiastic about "supporting innovation in the food supply." An accompanying statement from Robert Califf, the FDA's Commissioner of Food and Drugs, and Susan Mayne, director of the Center for Food Safety and Applied Nutrition, indicated the regulatory agency is keen to work with food technology companies and get these novel products to market.
"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," said Califf and Mayne. "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."
If Upside Foods' lab-grown chicken product reaches US market shelves over the next year it will be only the second time a regulatory body has authorized commercial sales of what some are calling "cultivated meat." In late 2020 Singapore became the first nation in the world to approve a lab-grown meat product for commercial sale. That approval was also for a chicken product.
Lab-grown chicken will inevitably be just the first of many cultivated meat products to hit the market over the coming years. Upside Foods, one of several companies in the space, already has beef meatball, duck and seafood products in their pipeline.
"This is a watershed moment in the history of food," said Upside Foods CEO Dr. Uma Valeti. "This milestone marks a major step towards a new era in meat production, and I'm thrilled that U.S. consumers will soon have the chance to eat delicious meat that's grown directly from animal cells."
Source: FDA, Upside Foods
