Better Dairy Self-Affirms GRAS for Lactopontin, Plans FDA Notification
Better Dairy has self-affirmed GRAS status for lactopontin, its yeast-made, human-identical osteopontin, and plans to notify the FDA next year.
London startup Better Dairy has self-affirmed generally recognized as safe (GRAS) status for lactopontin in the US. The yeast-made protein mirrors osteopontin in human milk and targets adult supplements first.
TLDR
- An independent expert panel concluded lactopontin is safe under its intended conditions of use.
- Self-affirmed GRAS is not a Food and Drug Administration (FDA) approval or an FDA “no questions” letter.
- The company told Green Queen it plans to notify the FDA next year.
- Better Dairy debuts the ingredient at SupplySide Global in Las Vegas, October 28 to 30.
What Better Dairy Announced
Better Dairy makes lactopontin through precision fermentation. A proprietary food-grade yeast produces the protein, which is purified and dried into a powder, per Green Queen. Vegconomist reports it uses the human osteopontin sequence.
Osteopontin occurs in cow’s milk at only about 18 milligrams per liter, per Green Queen. The initial scope covers adult nutrition, including gut health, immunity, joint health, skin and sports recovery. Founder and CEO Jevan Nagarajah said the milestone means “opening the door to real commercial applications,” according to FoodNavigator.
Self-Affirmed GRAS Versus FDA Review
The distinction matters. Self-affirmed GRAS rests on an independent expert panel, not FDA review. Vegconomist reports the panel was unanimous. Companies can also file a GRAS notice and seek an FDA “no questions” letter. Nagarajah told Green Queen the company will notify the FDA next year.
Timing is relevant. On August 10, 2026, the FDA proposed ending the self-affirmed pathway, per law firm Alston & Bird. Firms would have to report the basis for each GRAS conclusion. Comments close December 9, 2026. Nagarajah said the proposal does not change the company’s plan.
Scale and Next Markets
Better Dairy has secured 100,000-liter fermentation tanks via contract manufacturers in India and Europe, per Green Queen. Finished products are expected in the first quarter of 2027. The company has raised about £18 million ($24 million) and is in a new funding round. Infant formula requires a separate US pathway. The company is also pursuing approvals in Europe and Asia.
Why It Matters
For supplement teams, lactopontin is a new fermentation-derived protein option. Its status today is self-affirmed, with FDA notification planned. If the proposed rule is finalized, GRAS conclusions would have to be reported to the agency. Buyers may want to track that filing before building formulations or claims around it.
Sources: FoodNavigator; Green Queen; vegconomist; Food Business News; Alston & Bird.