Upside Foods has become the first company in the world to receive a “No Questions” letter from the US Food and Drug Administration (FDA) for cultivated meat, poultry or seafood, which means the government food agency accepts Upside’s conclusion that its cultivated chicken is safe to eat.
This is a truly groundbreaking moment for food and is seen as a step closer to commercialization.
“After a rigorous evaluation, FDA accepts our safety conclusion. Upside Foods is ushering in a new era in meat production with this “No Questions” letter, and this historic step paves the way for our path to market in the US. Cultivated meat has never been closer to the US market than it is today,” an Upside spokesperson tells FoodIngredientsFirst.
“It’s a hugely legitimizing moment for the cultivated meat industry, and will set the stage for the industry in the US and around the world. Our technology platform is capable of producing full cuts of meat, not just a ground or minced product. This enables our products to have amazing texture, and allows for greater versatility of culinary applications. Our first product to market will be our delicious cultivated chicken filet,” they explain further.
Although much R&D continues to gather pace in the burgeoning cultivated meat industry, Singapore has been the only country to allow the commercialization of products, proving to be a hub for the cell-based movement.
Approval in a major market has been absent, including the EU, where it is expected in 2025/2026.
Meanwhile, South Korea is set to globally dominate cultivated meat patent filings, according to an analysis of the developing market of future protein sources.
Cultivated chicken on US horizon
To have an official “greenlight” in the US regulatory process is a huge step forward for this major market.
The evaluation by the FDA as part of a pre-market consultation which concludes the agency has “no further questions at this time” about UPSIDE Foods’ conclusion that its cell-based chicken is safe to eat.
“This is a watershed moment in the history of food,” says Dr. Uma Valeti, CEO and Upside Foods founder.
“We started Upside amid a world full of skeptics, and 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 toward a new era in meat production, and I’m thrilled that US consumers will soon have the chance to eat delicious meat that’s grown directly from animal cells.”
In the US, cultivated meat is regulated by the FDA and the USDA. Having received the FDA letter, Upside Foods will now work with the USDA’s Food Safety and Inspection Service (FSIS) to secure the remaining approvals so the cultivated chicken can go on sale.
“We’ve found that the more people learn about cultivated meat and the potential benefits it can provide to the world, the more excited they become about it. Those who have tasted our products have been blown away by how good and familiar they taste, so ultimately it will come down to consumer education and having people taste cultivated meat for themselves,” the spokesperson continues.
“The real magical moment happens when someone sees the meat, hears it sizzling, and tastes it. The more these moments happen, the greater consumer enthusiasm will be.”
The approval is being welcomed by other players in the emerging cell-based industry.
“This is fantastic news and means that the cultivated meat revolution is changing gear,” says Mathilde Alexandre, senior project manager for cellular agriculture at ProVeg.
“This paves the way for cultivated meat to enter the US, a major market, bringing a method of meat production to America that emits less greenhouse gas and does not involve the suffering of animals,” she continues. “It really is a ground-breaking development.”
Alexandre points out that research from the UK Food Standards Agency has shown that assurance around the food safety of cultivated meat is one of the top factors for consumers to eat the product. Upside Foods’ blessing from the FDA on its production method is a milestone in showing consumers that cultivated meat is safe to eat.
ProVeg supports companies that develop cultivated products through its ProVeg Incubator scheme. The Incubator offers start-ups a 12-week accelerator program with an intensive, tailor-made curriculum, expert mentoring, funding and exclusive networking opportunities to help get products to market.
What does the FDA say?
The US government agency says this nod for Upside Foods cultivated chicken demonstrates the country’s commitment to supporting innovation in the food supply.
Before this food can enter the market, the next evaluation stage includes examining the company’s facility to ensure it meets USDA and FDA requirements.
In addition to the FDA’s requirements, including facility registration for the cell culture portion, the manufacturing establishment needs a grant of inspection from the USDA-Food Safety and Inspection Service (FSIS) for the harvest and post-harvest portions and the product itself requires a USDA mark of inspection.
“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, it concludes when all questions relevant to the consultation are resolved. A transition from the FDA to USDA-FSIS oversight will take place during the cell harvest stage,” explains the FDA.
Advancements in cell culture technology
USDA-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 will 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 ensure these products meet all applicable FDA and USDA-FSIS requirements,” it says.
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, notes the FDA.
“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 FDA has extensive experience in food safety assessment across a wide range of food production technologies, including the use of biological systems and biotechnology.
The FDA says it’s constantly evaluating new substances 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,” it concludes.
Slaughter-free, leveraging cells
Upside Foods grows meat, poultry and seafood directly from animal cells. These products are not considered vegan or vegetarian but meat, made without the need to raise and slaughter animals.
Cultivated meat has been gathering pace for several years, with many developments globally. Seen as the solution to the world’s ballooning population, alternative proteins without the need for animals and as a way to mitigate increasing climate pressures, companies are attracting billions in investments and the R&D race is well and truly on.
Cell-based meat is made in a controlled environment subject to high testing standards for safety and quality control. It has the potential to help reduce the risk of harmful bacterial contamination.
This latest announcement comes after a series of milestones as UPSIDE Foods approaches commercialization, including a US$400 million series C placing the company’s valuation at over US$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), a cultivated meat production facility.
Other moves in cell-based meat
Earlier this month, Mosa Meat launched in the Asian market through Singapore while partnering with local manufacturing organization Esco Aster. The company plans to bring its cultured beef to the city-state market in less than a year.
SuperMeat is working toward setting up what it hails as the largest open high-throughput screening system for cultivated meat media ingredients, supplements and cell scaffolds for cultivated meat production. The system – partially funded with a grant from the Israeli Innovation Authority – will allow SuperMeat to screen “hundreds of thousands of materials every month,” helping identify the highest quality ingredients with the lowest costs, according to the company.
In May, Good Meat began scaling what is hailed as industry’s largest known bioreactors for producing avian and mammalian cell-based meat to be integrated into US and Singapore-based facilities. When fully operational, the company can produce up to 30 million pounds of meat without the need to slaughter a single animal.
While in the cultivated seafood space, Bluu Seafood’s cell-based sashimi and cultured fish products are poised to make a splash in Singapore.
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