Onego Bio receives FDA ‘no questions’ letter confirming GRAS status of Bioalbumen

Onego Bio has received a 'no questions' letter from the US Food and Drug Administration (FDA) regarding the Generally Recognized As Safe (GRAS) status of its Bioalbumen ingredient, a precision fermentation-derived alternative to egg protein. The decision confirms that Bioalbumen can be used in a wide variety of food and beverage applications, providing food manufacturers with a secure, scalable, and animal-free protein source.

The FDA response, tied to GRAS Notice No. GRN 1249, affirms Onego Bio’s scientific conclusion that Bioalbumen is safe under its intended conditions of use. The product is a highly functional ovalbumin protein with an amino acid sequence identical to that found in chicken eggs. Its properties allow it to act as a source of dietary protein and as a foaming, gelling, and binding agent in baked goods, beverages, meat analogs, confectionery, sauces, and other foods.

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

Bioalbumen is produced with the help of Trichoderma reesei, a filamentous fungus widely used in industrial biotechnology. By using precision fermentation, Onego Bio has created a protein ingredient that mirrors the nutritional profile and functionality of egg protein but without the reliance on animal agriculture.

Eggs represent a major commodity for the food industry, with roughly one-third of global production going into processed foods. Bioalbumen offers manufacturers a way to diversify protein supply, reduce dependence on volatile egg markets, and strengthen resilience against disease outbreaks such as Avian Influenza.

According to Onego Bio, the ingredient not only ensures consistency in price and supply but also delivers sustainability advantages by reducing reliance on animal farming.

The FDA milestone follows Onego Bio’s recent announcement of plans to build a flagship production facility in Jefferson County, Wisconsin. The plant will serve as the company’s anchor for US operations and will enable Bioalbumen production at commercial scale.

The decision also provides greater confidence for food and beverage companies exploring the use of non-animal egg protein in their portfolios. Onego Bio said demand is already strong, with partnerships spanning from small bakeries to multinational food groups.

“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,” Itkonen said. “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.”

The FDA’s “no questions” letter does not constitute an approval but signals that the agency has reviewed Onego Bio’s GRAS submission and has no objections to the company’s conclusion of safety. For customers and partners, the confirmation provides regulatory clarity and enhances market readiness.

By pursuing the FDA-reviewed route rather than relying solely on self-affirmed GRAS status, Onego Bio has sought to demonstrate transparency and accountability to both regulators and customers. The move aligns with the company’s strategy of positioning Bioalbumen as a mainstream, dependable commodity ingredient.

With FDA recognition now in place and a US production hub on the horizon, Onego Bio is poised to expand Bioalbumen’s footprint across multiple categories. The ingredient offers manufacturers the opportunity to reduce exposure to egg price volatility, simplify supply chains, and meet growing consumer demand for sustainable protein solutions.

For Onego Bio, the achievement marks both a scientific validation and a commercial catalyst. As Itkonen emphasized, the milestone represents more than regulatory clearance – it is a foundation for scaling partnerships and accelerating the transition to resilient, animal-free protein supply chains.