All G secures FDA ‘no questions’ letter under GRAS for precision-fermented lactoferrin in US

All G has secured a ‘no questions’ letter from the US Food and Drug Administration (FDA) under the Generally Recognized as Safe (GRAS) process for its precision-fermented bovine lactoferrin, clearing a key regulatory hurdle and enabling commercialization of the ingredient in the USA.

• All G has received an FDA ‘no questions’ letter under the GRAS process for its precision-fermented bovine lactoferrin, confirming the agency has no safety concerns regarding its conclusion
• The decision has enabled commercial use of the ingredient in the US across food, beverage and supplement applications
• The company has developed the protein using precision fermentation, achieving purity levels above 99.5%

The FDA’s response confirmed that it had no questions regarding All G’s determination that its recombinant lactoferrin is Generally Recognized as Safe for use in food. The outcome has allowed the Australian biotechnology company to move forward with commercial activity in one of the world’s largest markets for functional ingredients and dietary supplements.

All G has developed its precision-fermented lactoferrin, marketed as LFX, using precision fermentation to produce the protein without relying on traditional dairy supply chains. The company reported that the ingredient is manufactured through a controlled fermentation process and purified to defined specifications, with analytical testing showing purity levels exceeding 99.5%.

Lactoferrin is a high-value functional protein naturally found in milk and widely used in applications including infant formula, dietary supplements and functional foods. Demand for the ingredient has continued to grow globally, driven by its association with immune support and nutritional benefits, while supply from conventional sources has remained limited and subject to variability.

The FDA’s ‘no questions’ letter represents a critical step in bringing alternative production methods to market, particularly for proteins such as lactoferrin that are difficult to source at scale through traditional means. By enabling commercial use in the USA, the decision provides a regulatory foundation for All G’s near-term market entry and expansion across multiple product categories.

Jim Mellon, Executive Chair of Agronomics, said: “FDA clearance for All G’s precision fermented lactoferrin is an important milestone for the company and for the broader precision fermentation sector. Regulatory validation of this kind reduces uncertainty around commercial deployment and supports the transition from technical development to revenue generation. All G operates in a category characterised by strong demand, constrained traditional supply and attractive pricing dynamics. We believe this outcome positions the company to establish itself as a supplier of high-value functional proteins to global nutrition markets.”

“You can expect the first products to begin entering the US market within months as supply ramps up – we already have many customers waiting,” CEO & Founder Jan Pacas told Green Queen in an exclusive interview. “Our GRAS conclusion supports the use of LFX across a broad range of food and beverage applications, including functional foods, beverages, nutritional products, and dietary supplements.”

All G has indicated that the GRAS determination is expected to support its broader regulatory strategy, including potential applications in early life nutrition and expansion into additional jurisdictions. The company is developing a wider portfolio of recombinant human and bovine milk proteins using precision fermentation, with the aim of enabling more consistent, scalable and functional ingredient supply for nutrition products.

The approval also adds to a growing body of regulatory progress for precision fermentation-derived proteins in the USA, as companies seek to bring novel ingredients to market through established safety pathways. The GRAS notification process has become a key route for commercialization, particularly for ingredients intended for use across multiple food and supplement categories.

While lactoferrin has long been used in the USA, the ability to produce it through fermentation rather than extraction from dairy sources offers potential advantages in terms of supply stability, scalability and production control. Companies developing these technologies have increasingly focused on high-value, low-volume proteins where traditional sourcing constraints create clear commercial opportunities.

All G’s progress reflects this broader shift within the precision fermentation sector toward targeting functional ingredients with defined market demand and established use cases. By focusing on proteins such as lactoferrin, companies are moving closer to bridging the gap between technical development and commercial viability, using regulatory milestones to unlock access to key markets.

The FDA clearance follows a series of recent developments for All G as it moves toward commercialization. In January 2026, the company secured additional backing from existing investor Agronomics, which committed AU$3 million (US$2.0 million) through a convertible note as part of a broader funding round aimed at supporting scale-up, regulatory activity and market expansion.

That investment built on earlier regulatory and commercial progress. All G had already achieved self-affirmed GRAS status in the USA in January 2025 and became the first company to receive regulatory clearance in China for recombinant bovine lactoferrin in November 2024, establishing initial pathways into two of the world’s largest nutrition markets.

Alongside its regulatory efforts, the company has also moved to strengthen its production and go-to-market capabilities. In December 2025, All G announced a joint venture with French dairy group Armor Protéines to scale animal-free lactoferrin production, combining its fermentation technology with established manufacturing expertise and global distribution networks.

Earlier in 2025, the company also worked with the University of Queensland and the Food and Beverage Accelerator to transfer its fermentation process from lab scale to industrial systems, supporting the transition toward commercial production.

Taken together, these developments reflect a shift from technical validation toward market execution, with regulatory clearance in the United States marking a further step in bringing precision-fermented lactoferrin into mainstream food, beverage and nutrition applications.