‘The market opportunity is significant’: DuPont gets GRAS for HMO for infants

By Stephen Daniells

- Last updated on GMT

© Getty Images / Antonio_Diaz
© Getty Images / Antonio_Diaz
DuPont Nutrition & Health has received a ‘No Objection’ letter for its Care4U 2´-fucosyllactose (2’-FL), a human milk oligosaccharide (HMO), aimed at narrowing the nutritional gap between breast milk and formula.

“2’-fucosyllactose (2’-FL) is the HMO found in human milk in the greatest abundance,” ​explained Steen Lyck, global business director for HMO, DuPont Nutrition & Health. “Because it is the most abundant, it has naturally been a key initial focus for development and science studies into the potential health benefits supporting digestive, immune and cognitive development.”

The company’s Care4U 2´-FL HMO previously gained EU approval as a novel food at the start of 2018.

The ingredient, which contains over 98% 2’-FL, was developed in collaboration with Belgium-based Inbiose. Inbiose developed the ingredient by microbial fermentation, a process that DuPont has since improved and commercialized, said Lyck. High purity and density make it easy to use the powder in formulations.


Interest in HMOs is on the rise, specifically in the infant formula space. Human milk oligosaccharides, or HMOs, form a significant portion of human breast milk (about 12%) but they are not easily digested. Experts postulate that their purpose is to jump-start the infant’s microbiome.

Results of a study published in the Journal of Nutrition​ in 2016 by scientists at Abbott Nutrition found that infants fed a formula with 2’-FL had levels of inflammatory cytokines similar to those observed for breast feeding, and significantly lower than those observed for infants fed a control formula containing no 2’-FL.  

The purported health benefits of 2’-FL include digestive health, immune support, and cognitive development by modifying the gut microbiota.

“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 Lyck.

“Immune and gut health have been key innovation focuses in the infant formula category,” added Lyck. “In fact, digestive/gut health was the number one claim associated with infant formula launches in 2015, featured on 58% of all launches, according to Innova Market Insights.”​ 

From babies to adults

The GRAS affirmation limits the use of the ingredient to infant formula, but there is some early work exploring the potential benefits of HMO consumption in adults​. “Because of the expected selective interaction of HMOs with the human microbiome, investigating benefits of HMOs beyond infants should be an attractive area for future research,”​ added Lyck.

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