Onego Bio receives “no questions” letter on GRAS status for egg protein ingredient

Onego Bio, a food ingredient company producing egg protein through precision fermentation, has revealed that the US Food and Drug Administration (FDA) has issued a “no questions” letter regarding the company’s conclusion that its flagship product, Bioalbumen, is Generally Recognized As Safe (GRAS) under its conditions of use in a range of F&B applications.

The FDA’s decision was communicated in response to a GRAS notice submitted in January, which confirms that Bioalbumen — a highly functional ovalbumin protein with an amino acid sequence identical to that found in chicken eggs — can be used as a source of dietary protein. Further, it can also be used as a foaming, gelling, and binding agent in baked goods, beverages, meat analogs, confections and sauces.

Harnessing fungus-derived ingredients 

Produced via precision fermentation with the filamentous fungus Trichoderma reesei, Bioalbumen delivers high-quality nutrition and matches the functionality of traditional egg protein. 

It has been designed to diversify egg protein sources for food manufacturers — representing a third of all eggs produced for industrial use — providing a secure supply while reducing price volatility and production disruptions. Additionally, supplementing the industrial egg supply offers a strong defense against the increasing threat of avian influenza on food security and public health across the US.

“This GRAS ‘no questions’ letter from the FDA is an important milestone for Onego Bio and the culmination of long-term scientific research,” says Maija Itkonen, CEO and co-founder of Onego Bio. 

“Bioalbumen provides the same high-quality nutrition and performance as conventional egg protein. Our US commercial and R&D team continues to sample and provide trial support to an array of food customers ranging from craft bakeries to large-scale food manufacturers.”

Scaling to meet demand

These conclusions from the FDA follow Onego Bio’s recent announcement of plans to construct its flagship production facility in Jefferson County, Wisconsin, US. 

The company will scale Bioalbumen manufacturing to meet sustained high demand, ensuring uninterrupted supply at every level. This increases Onego’s confidence in anchoring the facility for its US operations and supports its partnerships with leading F&B companies seeking more secure and sustainable commodity ingredients.

“At Onego, integrity and transparency are at the heart of our business, technology, intellectual property, and collaboration with customers and partners,” explains Itkonen. 

“That’s why we pursued the full FDA GRAS review process. The FDA’s conclusions confirm our right to commercialize and give customers full confidence in incorporating Bioalbumen as a reliable food solution.”