FrieslandCampina Ingredients announce GRAS status for Vivinal Lactoferrin product
FrieslandCampina Ingredients’ Vivinal Lactoferrin product receives GRAS status.
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A recent press release from FrieslandCampina Ingredients announced that the company's Vivinal Lactoferrin ingredient received Generally Recognized as Safe (GRAS) status for utilization in “cow’s milk-based non-exempt infant formula for term infants and in toddler infant formula.” In response to the GRAS notice the company submited to the U.S. Food and Drug Administration (FDA), the company received a "decline to file" letter. According to the company, with this letter, Vivinal Lactoferrins’, “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.”
Breastfeeding is one of the more common ways of providing nutrition for babies. Unfortunately, this is not something all parents can do. As reported in the press release, the market for powder and liquid formula is anticipated to increase annually at a compound annual growth rate (CAGR) of 3.38% from 2024 to 20291. Powder and liquid formulas are used by more than eight million parents in the United States (US). A 2020 Early Nutrition Survey by Innova Market Insights and RFC2 reported that more than 59% of parents with a child under the age of one wanted to support the child's immunity. Lactoferrin, found naturally in human and cow's milk – though in much higher concentration in the former – provides immune-supporting proteins. The press release cites studies indicating lactoferrin's immune health benefits3,4, its ability to promote the absorption of iron5, manage gut health, and support respiratory health in both infants and children6-9. According to a report from Innova Market Insights cited in the release,10, “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.”
“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.,” said Jouke Veldman, marketing director of early life nutrition at FrieslandCampina Ingredients, in the press release. “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.”
References
- Statista, 2020.
- Early Life Nutrition survey, Innova Market Insights & RFC, 2020.
- Donovan, S. M. The Role of Lactoferrin in Gastrointestinal and Immune Development and Function: A Preclinical Perspective. Journal of Pediatrics, 2016, 173, S16–S28. https://doi.org/10.1016/j.jpeds.2016.02.072
- Elzoghby, A. O., Abdelmoneem, M. A., Hassanin, I. A., Abd Elwakil, M. M., Elnaggar, M. A., Mokhtar, S., Fang, J. Y., & Elkhodairy, K. A. Lactoferrin, a multi-functional glycoprotein: Active therapeutic, drug nanocarrier & targeting ligand. Biomaterials, 2020, 263(August), 120355. https://doi.org/10.1016/j.biomaterials.2020.120355
- Kruzel, M. L., Zimecki, M., & Actor, J. K. Lactoferrin in a context of inflammation-induced pathology. In Frontiers in Immunology, 2017, (Vol. 8, Issue NOV). Frontiers Media S.A. https://doi.org/10.3389/fimmu.2017.01438
- Chen, K., Chai, L., Li, H., Zhang, Y., Xie, H. M., Shang, J., Tian, W., Yang, P., & Jiang, A. C. Effect of bovine lactoferrin from iron-fortified formulas on diarrhea and respiratory tract infections of weaned infants in a randomized controlled trial. Nutrition, 2016, 32(2), 222–227. https://doi.org/10.1016/j.nut.2015.08.010
- Gao, Y., Hou, L., Lu, C., Wang, Q., Pan, B., & Wang, Q. 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, 2020, 11, 1186. https://doi.org/10.3389/fphar.2020.01186
- King, J. C., Cummings, G. E., Guo, N., Trivedi, L., Readmond, B. X., Keane, V., Feigelman, S., & De Waard, R. A double-blind, placebo-controlled, pilot study of bovine lactoferrin supplementation in bottle-fed infants. Journal of Pediatric Gastroenterology and Nutrition, 2007, 44(2), 245–251. https://doi.org/10.1097/01.mpg.0000243435.54958.68
- 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. Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. Journal of Pediatrics. 2019. https://doi.org/10.1016/j.jpeds.2019.08.030
- Infant milk formula, 0-12 months, global, Innova Market Insights database.
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