Better Dairy Secures Self-Affirmed GRAS for Precision-Fermented Lactopontin, an Animal-Free Osteopontin for Adult Nutrition

London-based precision fermentation company Better Dairy has completed a self-affirmed GRAS (Generally Recognized as Safe) determination in the United States for lactopontin, its animal-free version of the milk protein osteopontin. The determination gives the company a safety basis to sell the ingredient into food and supplement products, and it says customer launches are planned for the coming months.

Better Dairy describes itself as the first supplier of precision-fermented lactopontin and currently the only commercially available source of the protein in the U.S.

What self-affirmed GRAS does and doesn’t cover

A self-affirmed GRAS determination rests on a review by an independent panel of qualified experts. It does not involve a review or approval by the U.S. Food and Drug Administration. Under U.S. rules, companies can establish GRAS status on the basis of scientific evidence and expert review without filing a notification with the agency.

Better Dairy’s panel examined a safety dossier covering the ingredient’s composition, manufacturing process, purity, specifications and safety. The panel concluded unanimously that lactopontin is safe under its intended conditions of use.

The initial clearance covers adult nutrition. It does not extend to early-life nutrition. Better Dairy says a separate U.S. regulatory process for that category is under way, along with separate regulatory pathways in Europe and Asia.

A signalling protein, not a bulk protein

Osteopontin occurs naturally in human and bovine milk, as well as in bone and other tissue. Unlike dietary proteins consumed mainly for their amino acids, it is involved in biological signalling linked to growth, repair and immune processes. Better Dairy uses the name “lactopontin,” a term found in scientific literature for the milk-derived form. According to vegconomist, the company’s recombinant protein is produced in yeast and built from the human osteopontin sequence.

Because its use as a standalone ingredient has been limited by the lack of supply, precision fermentation gives Better Dairy a route to the protein without extracting it from milk. Dairy News Today notes that the announcement identifies potential application areas but provides no clinical data on the effectiveness of finished products.

“For decades, nutrition has largely been about giving the body more of something – more protein, more vitamins, more minerals,” said founder and CEO Jevan Nagarajah. “We believe the next big opportunity is different – it’s about understanding how nutrition can help the body make better use of its own biology.”

Target categories and go-to-market

Better Dairy is aiming lactopontin at healthy ageing, gut health, immunity, joint health, skin health and sports recovery. It positions the protein as a complement to ingredients already common in those formulations, such as collagen, lactoferrin and probiotics.

The company will present lactopontin to manufacturers and brand owners at SupplySide Global in Las Vegas from 28 to 30 October. “We’re now ready to work with customers who are equally excited to bring this new functionality and next generation of products to consumers,” Nagarajah said.

From casein to high-value bioactives

The milestone marks a clear strategic turn. Better Dairy raised a $22 million Series A in 2022 to develop animal-free casein for aged cheeses. Last year it shifted focus to osteopontin, citing, as FoodNavigator reported, the protein’s higher value and the small quantities needed in finished products.

The move fits a wider pattern in precision fermentation, where several developers have been moving from bulk dairy proteins, where cost parity with conventional milk is hard to reach, towards low-dose, high-value bioactives such as lactoferrin, where small volumes can support a viable business. Lactopontin’s commercial test will come with the first customer launches. Brands will need to substantiate any health or function claims on their own products, and any move into early-life nutrition will depend on further regulatory clearances.