Onego Bio secures FDA “no questions” letter on GRAS status for Bioalbumen
It can be used as a dietary protein or a foaming, gelling, and binding agent in baked goods, beverages, confections, sauces, and meat analogs.
USA – Onego Bio, a Finnish-American food technology company, has received a “no questions” letter from the U.S. Food and Drug Administration (FDA) in response to the company’s Generally Recognized As Safe (GRAS) notice for its precision-fermented egg protein, Bioalbumen.
The decision confirms that Bioalbumen is considered safe for use under its intended conditions across a broad range of food and beverage applications.
Onego Bio first submitted its GRAS notification in January, providing extensive evidence to support the safety and functionality of Bioalbumen.
The product is a highly functional ovalbumin protein with an amino acid sequence identical to the egg white protein found in chicken eggs.
It can be used not only as a source of dietary protein but also as a foaming, gelling, and binding agent in products such as baked goods, beverages, confections, sauces, and meat analogs.
Produced through precision fermentation using the filamentous fungus Trichoderma reesei, Bioalbumen delivers the same nutritional quality and performance as conventional egg protein, while offering food manufacturers a new, secure, and sustainable supply.
Eggs are among the most widely used ingredients in the global food industry, with roughly one-third of all eggs produced going into industrial applications.
Bioalbumen is designed to help meet this demand while protecting the food supply from risks such as avian influenza, which has posed growing challenges to food security and price stability.
“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 manufacturers.”
The FDA’s conclusion comes as Onego Bio prepares to scale its operations in the U.S., specifically in Wisconsin, where the company announced plans to establish a flagship production facility.
The plant will serve as the cornerstone of its U.S. operations, enabling large-scale Bioalbumen manufacturing to meet growing demand and strengthen supply security for food and beverage partners nationwide.
“It was important for us to pursue the full FDA GRAS review process to give customers complete confidence,” added Itkonen. “The FDA’s conclusions affirm our commitment to transparency and strengthen our ability to commercialize Bioalbumen as a reliable and sustainable food solution.”
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