CARE4U™ Human Milk Oligosaccharide is Generally Recognized as Safe (GRAS) for use in Infant and Toddler Formula; US Food and Drug Administration issues ‘no objection’ letter.
DuPont Nutrition & Health welcomes U.S. clearance of CARE4U™ 2´-fucosyllactose (2’-FL), a human milk oligosaccharide (HMO) that can help narrow the nutritional gap between breast milk and formula. The positive response by U.S. Food and Drug Administration to DuPont’s GRAS notice means infant formula manufacturers can confidently use CARE4U™ 2’-FL in infant and toddler formulas to mimic some of the health-promoting benefits of the HMOs naturally present in human milk. CARE4U™ 2´-FL HMO gained EU approval as a novel food from the beginning of 2018.
After lactose and lipids, HMOs are the third-most-abundant solid component of human milk. Today, there is considerable evidence that HMOs in human milk support digestive, immune and cognitive development by modifying the gut microbiota.
Research indicates that use of DuPont’s commercial ingredient CARE4U™ 2’FL HMO can bring some of the same health benefits to infant formula.
“Human milk remains the best option for nourishing infants, but not all mothers are able to breast-feed their babies. In such cases, it is essential that infant formula is a close second-best. CARE4U™ 2’FL HMO can help narrow the gap between human milk and infant formula,” said Steen Lyck, global business director for HMO, DuPont Nutrition & Health.
CARE4U™ 2’FL HMO contains more than 98 percent 2’-fucosyllactose, the most abundant of the more than 130 oligosaccharides in human milk making it the purest HMO product on the market today.
“We have developed CARE4U™ 2’-FL in collaboration with our partner Inbiose, who developed the ingredient by microbial fermentation, a process that DuPont has since improved and commercialized. Superior powder properties (high purity and density), make it easy to use in formulations,” Lyck adds.
Following decades of R&D experience in proteins, fibers and probiotics, DuPont is a recognized knowledge leader in infant nutrition ingredients. One of the recent developments by the DuPont scientific team is an infant gut simulator model for researching HMO fermentation.
DuPont scientists Johanna Hirvonen and Krista Salli presented their work at the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) in Geneva May 2018, where HMO science was in focus.
In addition to the infant gut simulator model, other HMO findings demonstrating the specificity of 2`-FL as an energy source were presented to an international audience of more than 250 scientists and practitioners.
The following week at Vitafoods Europe in Geneva, Steen Lyck explained the commercial relevance of HMO in infant nutrition and dietary supplements, describing the recent U.S. and EU regulatory clearance status to a packed audience at the Life Stages Theatre.
“HMOs are important bioactives that promote and maintain health from birth through early life. Both academic and industry conferences enabled DuPont to highlight the scientific research demonstrating that these health benefits may extend beyond infancy through nutrition in adult life. DuPont is now uncovering ways to use HMO health benefits in dietary supplements,” said Ratna Mukherjea, Ph.D., technical fellow, Technology & Innovation Leader - HMO, DuPont Nutrition & Health.
Find out more about DuPont™ CARE4U™ at hmo
Inbiose is a privately held, 50-person-strong company located in Belgium. Inbiose has made its mark as a leader in the development of human milk oligosaccharides, which are of paramount importance for the health of newborns and developing infants. The company develops cost-effective processes for the production of specialty carbohydrates using its proprietary GlycoActives® high-productivity biotechnological platform. Inbiose targets specialty carbohydrate ingredients that have differentiating functionalities addressing needs in global markets, areas such as human and animal nutrition, biomedical fields, agricultural applications and beyond. The company continues to seek partnerships to develop and commercialize such new ingredients.
DuPont Nutrition & Health, a business unit of DowDuPont Specialty Products Division, combines in-depth knowledge of food and nutrition with current research and expert science to deliver unmatched value to the food, beverage, pharmaceutical and dietary supplement industries. We are innovative solvers, drawing on deep consumer insights and a broad product portfolio to help our customers turn challenges into high-value business opportunities. More information is available at www.food.dupont.com
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