FrieslandCampina Ingredients, a supplier specializing in protein and prebiotics, announced that its Vivinal lactoferrin is Generally Recognized as Safe (GRAS) for use in cow’s milk-based non-exempt infant formula for term infants and in toddler infant formula.

The U.S. Food and Drug Administration (FDA) responded to FrieslandCampina’s GRAS declaration with a “decline to file” letter indicating that the ingredient’s identity, method of manufacturing, intended uses, and dietary exposure estimates are substantively similar to previously filed GRAS notices to which FDA had no objections.

The response supports FrieslandCampina Ingredients’ ability to provide lactoferrin to the U.S. infant formula market.

Over 8 million U.S. parents use powder and liquid infant milk formula, and the market is expected to grow annually at a CAGR of 3.38% between 2024 and 2029, FrieslandCampina Ingredients reported, citing Statista.

At the same time, immune health is a key priority for parents during the first year of a child’s life. The company noted that an estimated 59% of parents with children under one year want to support their child’s immunity, per Innova Market Insights. Relative to cow’s milk, breast milk contains high concentrations of immune-supporting proteins, including lactoferrin.

Lactoferrin is evidenced to help support a normal immune response, promote iron absorption, and help to maintain gut and respiratory health in infants and young children. Globally, 11% of new infant milk formula product launches in 2023 contained supplemental lactoferrin, reflecting a 22% year-on-year growth from 2019 to 2023, FrieslandCampina Ingredients reported, citing Innova Market Insights.

“Establishing GRAS status for our lactoferrin ingredients shows that we continue to put safety first, and cements us as a reliable and trusted leader in the early life nutrition sector in the U.S.,” said Jouke Veldman, marketing director of early life nutrition at FrieslandCampina Ingredients. “The response by the FDA reinforces our commitment to providing high-quality, safe ingredients that meet rigorous regulatory standards. As early pioneers of lactoferrin formulation in infant milk formula, we’ve been perfecting the production of this powerful ingredient for over 25 years. We’re therefore extremely proud to continue offering Vivinal Lactoferrin to our partners, helping to meet consumers’ growing demand for premium infant milk formula products hat support the immune system in early life.”