Onego Bio Receives FDA “No Questions” Letter on GRAS Status of Bioalbumen®

Onego Bio, a food ingredient company producing egg protein through precision fermentation, announced today that the U.S. Food and Drug Administration (FDA) has issued a “no questions” letter regarding the company’s conclusion that its flagship product, marketed as Bioalbumen®, is Generally Recognized As Safe (GRAS) under its conditions of use in a wide range of food and beverage applications.

The FDA’s decision, communicated in response to GRAS Notice No. GRN 1249, 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 and, for example, as a foaming, gelling, and binding agent in baked goods, beverages, meat analogs, confections, sauces, and more.

Produced via precision fermentation with the filamentous fungus Trichoderma reesei, Bioalbumen® delivers high-quality nutrition and matches the functionality of traditional egg protein. It is designed to diversify egg protein sources for food manufacturers—which represents 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 U.S.

“This GRAS ‘no questions’ letter from the FDA is an important milestone for Onego Bio and the culmination of long-term scientific research,” said Maija Itkonen, CEO and Co-Founder of Onego Bio. “Bioalbumen® provides the same high-quality nutrition and performance as conventional egg protein. Our U.S. 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.”

These conclusions from the FDA follows Onego Bio’s recent announcement of plans to construct its flagship production facility in Jefferson County, Wisconsin, where the company will scale Bioalbumen® manufacturing to meet sustained high demand, ensuring uninterrupted supply at every level. This milestone increases Onego’s confidence in anchoring the facility for their U.S. operations and supports its partnerships with leading food and beverage companies seeking more secure and sustainable commodity ingredients.

“At Onego, integrity and transparency are at the heart of everything we do—our business, our technology, our intellectual property, and our collaboration with customers and partners,” added Itkonen. “That’s why we pursued the full FDA GRAS review process. Based on that commitment, the FDA’s conclusions now confirm our right to commercialize and gives customers full confidence in incorporating Bioalbumen ® as a reliable food solution.”

About Onego Bio

Onego Bio is a food ingredient company on a mission to create a more resilient food system through its product Bioalbumen^®—the first non-animal egg protein with an amino acid sequence identical to the natural protein. Made through precision fermentation, Bioalbumen^® matches the taste, nutrition, and functionality of the main protein from traditional eggs with an environmental impact around 90% smaller. Its unmatched versatility makes it ideal across a wide range of applications, while providing greater cost and supply stability for food manufacturers. Learn more at www.onego.bio.

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