FrieslandCampina Ingredients secures US GRAS status for lactoferrin in infant and toddler formula

Protein and prebiotics specialist FrieslandCampina Ingredients has announced that its lactoferrin ingredient, 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 in the US. 

The Food and Drug Administration (FDA) issued a decline to file letter for Vivinal Lactoferrin, stating that the ingredient’s identity, method of manufacturing, intended uses and dietary exposure estimates are essentially the same as previously approved GRAS notices for the ingredient.

This response supports FrieslandCampina Ingredients’ ability to commercialize lactoferrin in the US infant formula market, with the backing of the FDA’s safety criteria.

“Establishing GRAS status for our lactoferrin ingredient 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 US,” says 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 that support the immune system in early life.”

Enriching powder formulas

Although breastfeeding remains the gold standard for feeding infants, it is not always an option, highlights FrieslandCampina Ingredients. Over eight million US parents use powder and liquid infant milk formula, with the market expected to grow annually at a CAGR of 3.38% between 2024 and 2029.

At the same time, immune health is a key priority for parents during the first year of a child’s life, details the brand. The company cites Innova Market Insights figures showing that over 59% of parents with children under one year want to support their child’s immunity.

“Relative to cow’s milk, breast milk contains high concentrations of immune-supporting proteins, including lactoferrin,” notes FrieslandCampina Ingredients.

Other cited studies indicate that lactoferrin can help to support a normal immune response, help to promote iron absorption and help to maintain gut and respiratory health in infants and young children.

“As more parents recognize the role of this protein in supporting immune function, its use in infant milk formula is on the rise. 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,” details FrieslandCampina Ingredients.

The company recently predicted that 2025 will be “a year of nutrition,” with consumers doubling down on health despite economic challenges. From AI-driven personalized plans to rising protein demand and gut health innovations, people’s wellness choices are refocusing on transparency and tailored solutions. 

Nutrition Insight recently spoke with company experts, alongside representatives from dsm-firmenich and Morinaga Milk, to explore key innovations and trends in infant nutrition, focusing on synbiotics and lactoferrin for immunity and Bifidobacteria for gut health.