All G Receives an FDA ‘No Questions’ Letter for Precision Fermentation Bovine Lactoferrin
Australian biotech company All G has received a “No Questions” letter from the U.S. Food and Drug Administration for its recombinant bovine lactoferrin produced by Komagataella phaffii. This outcome confirms that the agency has no further questions regarding All G’s conclusion that the ingredient is Generally Recognized as Safe (GRAS) for its intended use.
This milestone highlights the growing maturity of precision fermentation pathways. Conventionally, isolating just 1kg of lactoferrin requires approximately 10,000 litres of cow milk, underscoring the efficiency and scalability advantages of fermentation derived, animal-free production systems. The resulting high-purity protein is suitable for a wide range of applications, including dairy and plant-based products, sports drinks, nutritional bars and beverages, and non-alcoholic beverages.
This achievement builds on a series of regulatory milestones for the company. In 2024, All G became the first company to secure approval for cow-free lactoferrin in China, establishing an early regulatory precedent in a key market. The company also completed a self-affirmed GRAS determination for use of its lactoferrin in the US.
In May 2025, Vireo Advisors supported All G in submitting its GRAS notification dossier to the FDA and guiding interactions throughout the agency's review process.
The FDA’s March 2026 ‘no questions’ letter represents a notable achievement for precision-fermented functional proteins and further validates the regulatory pathway for bioidentical ingredients entering the food system.
We are pleased to have supported All G through this regulatory process and to contribute our expertise toward the successful commercialization of innovative food ingredients.