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Better Dairy has achieved Self-Affirmed Generally Recognized as Safe (GRAS) status for its precision-fermented lactopontin ingredient, paving the way for its commercial introduction in the US nutrition and supplements market.
The company said the regulatory milestone makes its ingredient the first commercially available supply of precision-fermented lactopontin, as well as the only commercially available source of lactopontin in the US.
Lactopontin is a protein naturally found in human and bovine milk. According to Better Dairy, the protein plays a role in biological signalling pathways linked to tissue growth, repair and renewal.
The company is positioning the ingredient as a functional nutrition solution that could support product development across areas including healthy ageing, gut health, immune health, joint health, skin health and sports recovery.
Unlike conventional nutritional ingredients that primarily provide nutrients to the body, Better Dairy said lactopontin could interact with existing biological processes, opening opportunities for a new category of functional nutrition products.
The company also sees potential for lactopontin to complement established functional ingredients, including collagen, lactoferrin and probiotics.
Rather than replacing these ingredients, Better Dairy said lactopontin could be incorporated alongside them to create products that combine multiple functionalities and build on ingredients already familiar to consumers.
Jevan Nagarajah, founder and CEO of Better Dairy, said: “For decades, nutrition has largely been about giving the body more of something – more protein, more vitamins, more minerals. 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.”
Nagarajah added that the company believes lactopontin could enable a new generation of functional products by bringing a naturally occurring signalling protein into nutrition and supplements.
Although lactopontin occurs naturally in milk, its use as a functional ingredient in nutrition and supplements has historically been limited.
Better Dairy has developed a precision-fermentation process to produce the protein, enabling it to establish a dedicated supply for potential commercial applications.
The Self-Affirmed GRAS determination follows the development of a safety dossier covering the ingredient’s composition, manufacturing process, purity, specifications and safety, according to the company.
An independent panel of qualified experts unanimously concluded that Better Dairy’s lactopontin is safe under its intended conditions of use based on the evidence presented by the company.
The GRAS status provides a safety basis for the ingredient’s intended use in the US and clears a pathway towards commercial launches.
Better Dairy said it is now working with customers on new products containing lactopontin, with launches expected in the coming months.
The company is continuing to pursue separate regulatory pathways for lactopontin in other markets, including Europe and Asia.
It is also seeking additional regulatory approvals for the ingredient, including its use in early life nutrition in the US.
