BERKELEY, Calif. — Upside Foods, a leading cultivated meat, poultry and seafood company, on Wednesday became the first company in the world to receive a "No Questions" letter from the U.S. Food and Drug Administration for cultivated meat, poultry, or seafood.
The letter signals that the FDA has accepted Upside's conclusion that its cultivated chicken is safe to eat. The agency issued this letter following a rigorous evaluation.
"This is a watershed moment in the history of food," said Dr. Uma Valeti, CEO and founder of Upside Foods. "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. 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."
The FDA released a memo detailing the agency's review of the data and information provided by Upside Foods to establish the safety of its cultivated chicken filet. In addition, FDA released a comprehensive 104-page document, prepared by Upside Foods, that provides detailed information regarding the safety of and production process for Upside's cultivated chicken filet.
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 the U.S. Department of Agriculture. 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).
"Since our earliest days, our top priority has been to ensure the safety and quality of our products," said Eric Schulze, PhD, VP 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."
In the U.S., cultivated meat is regulated by both the FDA and the USDA. Having received a "No Questions" letter from the FDA, Upside Foods will now work with the USDA's Food Safety and Inspection Service (FSIS) to secure the remaining approvals that are required before Upside Foods' cultivated chicken can be sold to consumers. More details on the timing of the launch will follow.
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. In addition, it's projected that cultivated meat production at scale will use less water and land than conventionally-produced meat. And because it's 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.
This announcement comes after a series of milestones as Upside Foods approaches commercialization, including a $400 million Series C placing their valuation at over $1 billion, the acquisition of cultivated seafood company Cultured Decadence, a partnership with three-Michelin starred chef Dominique Crenn, and the opening of its Engineering, Production, and Innovation Center (EPIC), one of the world's most advanced cultivated meat production facilities.