FrieslandCampina Ingredients has achieved Generally Recognised as Safe (GRAS) status from the FDA for its lactoferrin ingredient, Vivnal Lactoferrin.
The nutraceutical is suitable for cow's milk-based infant formula, which can be given to term infants and toddlers.
This decision was presented through a decline to file letter, which means the ingredient's identity, manufacturing method, uses and dietary exposure estimates are similar to previously filed GRAS notices.
By achieving GRAS status, FrieslandCampina can now market and supply its lactoferrin ingredient to the US infant formula market.
Building immunity in the early years
Although breastfeeding is the best way to feed an infant, this is not always possible — which is reflected in the 8 million US parents who utilise milk formula alternatives.
In the early years of life, an infant's immunity has not yet been well established, potentially leaving them vulnerable to a plethora of diseases.
This means that many parents have begun actively looking for ways to support their baby's immune development, with 59% of parents with infants stating that this is a priority to them.
When comparing cow's milk with breast milk, there is a significantly higher proportion of immune-supporting proteins in breast milk — including lactoferrin.
Research suggests that lactoferrin plays a role in the immune response, as well as gut and respiratory health in young children; it also assists iron absorption.
Therefore, FrieslandCampina created its lactoferrin ingredient to allow infant formula products to better mimick the content of breast milk
Committing to infant safety
“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 U.S.,” 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 more than 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.”