FrieslandCampina Ingredients' Vivinal® Lactoferrin achieves GRAS status for US infant nutrition market

FrieslandCampina Ingredients, a leader in protein and prebiotics, announces 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. The U.S. Food and Drug Administration (FDA) has issued Vivinal^® Lactoferrin a decline to file letter, meaning that the ingredient’s identity, method of manufacturing, intended uses, and dietary exposure estimates are substantively similar to previously filed GRAS notices, to which the FDA had no objections. This response supports FrieslandCampina Ingredients’ ability to provide lactoferrin to the U.S. infant formula market, with the backing of the FDA's established safety criteria.

Supporting immune health in early life

Although breastfeeding remains the gold standard for feeding infants, it is not always an option. Over 8 million U.S. 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.ⁱ At the same time, immune health is a key priority for parents during the first year of a child’s life. Figures show that over 59% of parents with children under one year want to support their child’s immunity.ⁱⁱ Relative to cow’s milk, breast milk contains high concentrations of immune-supporting proteins, including lactoferrin.

(Photo courtesy: FrieslandCampina)

Studies indicate that lactoferrin can help to support a normal immune response,^{iii, iv} help to promote iron absorption^v and help to maintain gut and respiratory health in infants and young children.^{vi,vii,viii,ix} 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.^x

The FDA’s response to FrieslandCampina Ingredients’ GRAS determination supports the use of Vivinal^® Lactoferrin in infant milk formulas distributed in the U.S. market, tapping into the growing demand for immune-supporting formulations that are proven to be safe and supported by clinical research.

Unwavering commitment to safety standards

“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 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.”

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ⁱ Statista, 2020.

ⁱⁱ Innova Market Insights & RFC, Early Life Nutrition survey, 2020.

ⁱⁱⁱ Donovan, S. M. (2016). The Role of Lactoferrin in Gastrointestinal and Immune Development and Function: A Preclinical Perspective. Journal of Pediatrics, 173, S16–S28. https://doi.org/10.1016/j.jpeds.2016.02.072

^iv Elzoghby, A. O., Abdelmoneem, M. A., Hassanin, I. A., Abd Elwakil, M. M., Elnaggar, M. A., Mokhtar, S., Fang, J. Y., & Elkhodairy, K. A. (2020). Lactoferrin, a multi-functional glycoprotein: Active therapeutic, drug nanocarrier & targeting ligand. Biomaterials, 263(August), 120355. https://doi.org/10.1016/j.biomaterials.2020.120355

^v Kruzel, M. L., Zimecki, M., & Actor, J. K. (2017). Lactoferrin in a context of inflammation-induced pathology. In Frontiers in Immunology (Vol. 8, Issue NOV). Frontiers Media S.A. https://doi.org/10.3389/fimmu.2017.01438

^vi Chen, K., Chai, L., Li, H., Zhang, Y., Xie, H. M., Shang, J., Tian, W., Yang, P., & Jiang, A. C. (2016). Effect of bovine lactoferrin from iron-fortified formulas on diarrhea and respiratory tract infections of weaned infants in a randomized controlled trial. Nutrition, 32(2), 222–227. https://doi.org/10.1016/j.nut.2015.08.010

^vii Gao, Y., Hou, L., Lu, C., Wang, Q., Pan, B., & Wang, Q. (2020). Enteral Lactoferrin Supplementation for Preventing Sepsis and Necrotizing Enterocolitis in Preterm Infants : A Meta ‑ Analysis With Trial Sequential Analysis of Randomized Controlled Trials. Frontiers in Pharmacology, 11, 1186. https://doi.org/10.3389/fphar.2020.01186

^viii King, J. C., Cummings, G. E., Guo, N., Trivedi, L., Readmond, B. X., Keane, V., Feigelman, S., & De Waard, R. (2007). A double-blind, placebo-controlled, pilot study of bovine lactoferrin supplementation in bottle-fed infants. Journal of Pediatric Gastroenterology and Nutrition, 44(2), 245–251. https://doi.org/10.1097/01.mpg.0000243435.54958.68

^ix Li, F., Wu, S. S., Berseth, C. L., Harris, C. L., Richards, J. D., Wampler, J. L., Zhuang, W., Cleghorn, G., Rudolph, C. D., Liu, B., Shaddy, D. J., & Colombo, J. (2019). Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. Journal of Pediatrics. https://doi.org/10.1016/j.jpeds.2019.08.030

^x Innova Market Insights database, Infant milk formula, 0-12 months, global.

To learn more about FrieslandCampina Ingredient’s Vivinal^® Lactoferrin ingredient for the early life nutrition market, click here.