DuPont’s 3-FL safety test brings HMO closer to market launch

26 Feb 2020 --- A safety assessment of 3-Fucolsyllactose (3-FL) human milk oligosaccharide (HMO) brings DuPont Nutrition & Biosciences one step closer to the launch of CARE4U 3-FL. The study supports prior research indicating that commercially produced HMOs can mimic some of the health-promoting effects of the HMOs present in human milk. The weight of evidence from these studies supports the safe use of 3-FL produced using biotechnology as a nutritional ingredient in infant formula, as well as in foods and dietary supplements.

Ratna Mukherjea, Technical Fellow and Technology & Innovation Leader of HMOs at DuPont, tells NutritionInsight that 3-FL could be used in adults as a prebiotic to support microbiotic changes, as well as benefits in digestive and immune health. Additionally, as with 2’-fucosyllactose (2-FL) – which DuPont launched last year under the CARE4U umbrella – 3-FL is appropriate for infant formula. 

“While the preclinical testing for safety and tolerance of 3-FL has been successfully completed, regulatory approvals are still pending. The initial markets are expected to be the US and Europe this year, with other countries set to be added later,” Mukherjea explains. 

As part of the research, 3-FL was produced by fermentation and then measured for acute oral toxicity, as well as using in vitro and in vivo methods to assess genetic toxicity. Additionally, there was a subchronic rodent feeding study. The results showed that subchronic dietary exposure of rats to 3-FL did not produce any statistical or biologically relevant differences in growth, food intake or efficiency, clinical observations, or clinical or anatomic pathology changes 

Additionally, 3-FL was found to be not acutely toxic at a rate of 5,000 mg per kg of body weight, and no evidence was found for genetic toxicity in the bacterial reverse mutation test and chromosomal aberration assay.

There are over 130 HMOs that have been identified in human milk. The complex carbohydrates are indigestible and therefore function as a prebiotic by promoting early microbial colonization of the gut. This, in turn, provides benefits related to immunity, digestion and potentially cognitive health – benefits that begin in infancy but have a lifelong impact on human health.

“Clinical studies support that formula supplemented with commercially produced HMOs are safe and well-tolerated. Studies with such HMOs added to infant formula demonstrate benefits in the digestive and immune system. We need to continue to identify and commercialize the key HMOs present in human milk,” says Mukherjea.

This latest breakthrough in the HMO space follows a spate of action surrounding the carbohydrate. Last week, DSM agreed to acquire Glycom, a major HMO supplier, for US$826 million. Also in the last few days, EU regulation set stricter marketing requirements to assure that HMO advertising does not overexaggerate nutrient claims or mislead consumers. 

Nonetheless, a slew of studies points to the supplements of various HMOs. It was recently found that 2-FL has the potential to improve the cognitive development of babies. Separate research uncovered some of the prebiotic mechanisms behind Care4U 2-FL, which beneficially changes microbiota composition and the production of microbial metabolites compared to galacto-oligosaccharides (GOS) and lactose. 

By Katherine Durrell