DuPont attains US green light on HMO infant nutrition solution

636621480246236689baby formula (2).jpg

17 May 2018 --- DuPont Nutrition & Health’s CARE4U human milk oligosaccharide (HMO) is now Generally Recognized as Safe (GRAS) for use in infant and toddler formula following a “No Objection” letter from the US Food and Drug Administration.

The ingredient, which was developed in partnership with Inbiose, can help narrow the nutritional gap between breast milk and formula, according to DuPont.

The positive response by US Food and Drug Administration to DuPont’s GRAS notice means infant formula manufacturers can confidently use CARE4U 2´-fucosyllactose (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.

Steen Lyck, Global Business Director for HMO, DuPont Nutrition & Health, tells NutritionInsight that the company is working on introducing the ingredient in other areas, such as China, in collaboration with the relevant authorities.

After lactose and lipids, HMOs are the third-most-abundant solid component of human milk. 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,” says Lyck.

CARE4U 2’-FL HMO contains more than 98 percent 2’-fucosyllactose, which the company notes is 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.

At Vitafoods Europe in Geneva, Steen Lyck explained the commercial relevance of HMO in infant nutrition and dietary supplements, describing the recent US 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,” says Ratna Mukherjea, Ph.D., technical fellow, Technology & Innovation Leader - HMO, DuPont Nutrition & Health.

To contact our editorial team please email us at