UPSIDE Foods is the First Company in the World to Receive U.S. FDA "Green Light" for Cultivated Meat as FDA Accepts UPSIDE's Conclusion That its Cultivated Chicken is Safe to Eat

• After a rigorous evaluation, UPSIDE Foods became the first company in the world to receive a "No Questions" letter from the U.S. Food and Drug Administration (FDA) for cultivated meat, poultry, or seafood
• This letter indicates that the FDA accepts UPSIDE's conclusion that its cultivated chicken is safe to eat
• This historic step paves the way for the company's path to market in the United States and brings cultivated chicken one step closer to consumers' plates

BERKELEY, Calif., Nov. 16, 2022 /PRNewswire/ -- Today, UPSIDE Foods, the leading cultivated meat, poultry and seafood company, became the first company in the world to receive a "No Questions" letter from the U.S. Food and Drug Administration (FDA) 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 today 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 (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).

"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 $400M 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

Based in Berkeley, CA, 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. Founded as the world's first cultivated meat company in 2015, UPSIDE Foods has achieved numerous industry-defining milestones, including being the first company to produce multiple species of meat (beef, chicken and duck). The company believes that people shouldn't have to choose between the foods they love and a thriving planet, and is working to build a better food system with access to delicious, humane, and sustainable meat, poultry, and seafood. UPSIDE Foods has won various industry awards, including New York Times' Good Tech Awards, FastCo's Next Big Thing in Tech, and the Best and Brightest Companies to Work For in the Nation by the National Association for Business Resources. UPSIDE Foods has raised a total of $608 million, including from the Abu Dhabi Growth Fund (ADG), Baillie Gifford, Bill Gates, Cargill, John Doerr, John Mackey, Kimbal and Christiana Musk, Norwest, Richard Branson, Softbank, Temasek, Threshold, Tyson Foods, and others. For more information, please visit www.upsidefoods.com.

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What others are saying:

Bruce Friedrich, President of The Good Food Institute: "We're thrilled that UPSIDE Foods, a pioneer in this space, has reached this critical and inspiring milestone toward the future of food. Cultivated meat will soon be available to consumers who desire their favorite foods made more sustainably, and cultivated meat is projected at scale to require a fraction of the land and water of conventionally produced protein. A shift towards cultivated meat has the potential to bring massive benefits for food security, public health, ecosystem recovery, and regional bio-economies that create new jobs and livelihoods. This is a history-making moment for our global food system."

Ann Veneman, former US Secretary of Agriculture, former executive director of UNICEF, UPSIDE Foods advisor: "The US continues to be a global leader in food safety and innovation, and it is great to see the FDA and the USDA applying this high regulatory standard to cultivated meat. As always, the agencies have been rigorous and thoughtful in establishing a regulatory process for cultivated meat. Today is a big step forward for food, innovation, and sustainability."

Barry Carpenter, former President and CEO of the North American Meat Institute, UPSIDE Foods advisor: "Demand for meat is skyrocketing, and we need every tool in our toolkit to feed the world. Cultivated meat, along with conventionally-produced meat, will play a crucial role in enabling our food system to get to this point. I congratulate UPSIDE Foods on this historic milestone."

The Alliance for Meat, Poultry and Seafood Innovation: "AMPS Innovation applauds the FDA's announcement that it accepts UPSIDE Foods' conclusion that UPSIDE Foods' chicken is safe to eat. The FDA's decision reflects a thoughtful, rigorous and science-based process that took place over the course of several years. During this time, UPSIDE Foods provided the agency with the safety and supporting information that UPSIDE used to determine its cultivated/cell-cultured chicken is safe and may proceed down the regulatory pathway. AMPS Innovation looks forward to continued progress by these and other companies to help expand safe and delicious food options for consumers and help support a more sustainable food supply."

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SOURCE UPSIDE Foods