Believer Meats secures FDA green light and completes world’s first large-scale cultivated meat facility

Believer Meats has reached a pivotal point in its journey to scale cultivated meat, securing a regulatory green light from the US Food and Drug Administration and completing construction of what it says is the world’s first large-scale cultivated meat production facility.

The FDA has issued Believer Meats a 'No Questions' letter, formally concluding that the agency accepts the company’s determination that its cultivated chicken is safe for consumption. It marks one of the final hurdles in the FDA’s pre-market consultation process and puts Believer Meats one step closer to commercial launch in the USA.

CEO Gustavo Burger called the milestone “a transformative moment for Believer Meats and the cultivated meat industry as a whole”, adding that “this is more than just progress – it’s a defining moment, a bold leap forward in our vision to lead food innovation that cares for the planet”.

The FDA's acceptance of Believer's safety conclusion follows a comprehensive review of the company's data on its cultivated chicken product. While the 'No Questions' letter clears the way on the FDA side, Believer Meats is now working with the US Department of Agriculture on the remaining steps to gain full regulatory approval for commercial sale.

In tandem with the FDA announcement, Believer confirmed it has completed construction of its production facility in Wilson, North Carolina. The company says it is the only large-scale site of its kind in the world, designed from the ground up to produce cultivated meat at commercial volumes. The site is currently undergoing commissioning and awaiting a USDA grant of inspection.

Located on a 200,000-square-foot footprint, the North Carolina facility will serve as Believer Meats’ production hub, innovation center, and consumer showcase. Once fully operational, it will have capacity to produce up to 12,000 metric tons (approximately 26 million pounds) of cultivated chicken annually. The company says this will allow it to demonstrate real scalability while maintaining high standards of safety, quality, and sustainability.

“With our regulatory progress on track, production facility complete, and clear path to market, we are closer than ever to delivering cultivated meat at scale, strengthening global food security, and helping shape a more sustainable food system,” Believer Meats said in its announcement.

The completion of both milestones underscores the company’s drive to translate promise into product. “As we move forward, our focus remains on execution,” said Burger. “Advancing cultivated meat from promise to product, and contributing to a more resilient, sustainable food system.”

These achievements build on the groundwork laid in 2024, when Believer Meats announced a strategic partnership with German engineering giant GEA to co-develop next-generation production technologies. That collaboration, unveiled in September last year, is focused on improving the efficiency, performance, and environmental sustainability of cultivated meat production – starting with chicken and later expanding to other species.

Under the partnership, GEA is helping Believer design and commission custom bioreactors capable of achieving high cell density and yields. A core area of focus is Believer’s proprietary perfusion process, which uses a centrifuge-based system to rejuvenate cell culture media, remove waste byproducts, and conserve water and nutrients. This closed-loop approach helps minimize production costs while improving consistency and resource efficiency.

“Believer is making significant strides in overcoming the challenges of scaling cultivated meat production,” Burger said at the time of the announcement. “Partnering with GEA – a world-class leader in engineering and biotech equipment – allows us to innovate cutting-edge technologies and process engineering capabilities that are essential for producing cultivated meat at a commercially viable cost.”

Stefan Klebert, CEO of GEA, added, “With the global population projected to reach 10 billion by 2050, it’s crucial to find ways to feed more people using fewer resources. We share Believer’s belief that cell cultivation is key to providing safe, healthy, and affordable meat on a large scale.”

Together, the companies are also exploring joint commercial ventures to help accelerate adoption of cultivated meat globally, with a shared goal of reducing costs, scaling operations, and promoting circular economy principles through waste stream reuse and energy optimization.

With FDA clearance secured and its production facility nearing full operation, Believer Meats appears in a prime position to become one of the first companies to bring cultivated chicken to American consumers.