Calling it a “watershed moment in the history of food,” Uma Valeti, CEO and founder of UPSIDE Foods, praised the first-ever “no questions” letter from the Food and Drug Administration on the safety of UPSIDE's cultivated chicken fillet.

FDA Commissioner Robert Califf and Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, said FDA evaluated the information submitted by UPSIDE Foods as part of a pre-market consultation and “has no further questions at this time about the firm's safety conclusion.” 

In the U.S., cultivated meat is regulated by both the FDA and the USDA, and remaining approvals from USDA’s Food Safety and Inspection Service are needed before cultivated chicken can be sold to consumers. More details on the timing of the consumer launch will follow, UPSIDE said.

"We started UPSIDE amid a world full of skeptics, and today, we've made history again as the first company to receive a 'No Questions' letter from the FDA for cultivated meat,” Valeti said. “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."

UPSIDE Foods grows meat, poultry and seafood directly from animal cells. The cell lines are originally isolated from either adult chickens or mid-stage fertilized chicken eggs. The harvested material, following washing, is described as a coherent tissue of chicken cells, similar in composition and nutritional characteristics to conventional poultry products.

UPSIDE said these products are not vegan or vegetarian, but are still considered meat, made without the need to raise and slaughter animals. In addition, it's projected that cultivated meat production at scale will use less water and land than conventionally produced meat, the company said.

Because the cultivated meat is made in a controlled environment subject to high standards of testing for safety and quality control, it has the potential to help reduce the risk of harmful bacterial contamination, UPSIDE added. 

The regulation of cell culture technology is being done collaboratively and in close partnership with FSIS for food made from cultured livestock or poultry cells. In March 2019, FDA and USDA 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, FDA said it concludes when all questions relevant to the consultation are resolved.

Since its founding in 2015, UPSIDE Foods has supported the development of a regulatory framework for cultivated meat that ensures safety and transparency. In 2018, it partnered with the North American Meat Institute to advocate for joint regulatory oversight of cultivated meat by the FDA and USDA. The following year, UPSIDE Foods co-founded the world's first trade coalition for cultivated meat, the Alliance of Meat, Poultry and Seafood Innovation (AMPS Innovation).

A transition from the FDA to FSIS oversight will take place during the cell harvest stage. 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 is designed to 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 make sure the products meet all applicable FDA and FSIS requirements, FDA said. 

"Since our earliest days, our top priority has been to ensure the safety and quality of our products," said Eric Schulze, vice president of regulatory and public policy at UPSIDE Foods. "FDA sets the standard for global acceptance of new food innovations, and we are incredibly grateful for the agency's rigorous and thoughtful process to ensure the safety of our food supply. We're also extremely proud to have played a leading role in helping to champion the framework for how cultivated meat, poultry and seafood are regulated in the U.S."

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