DSM-Firmenich’s immunity and gut health-boosting HMO portfolio cleared by US FDA approval

16 Aug 2023 --- DSM-Firmenich has received “no-questions” response letters from the US FDA on its Generally Recognized as Safe (GRAS) notices for three new human milk oligosaccharide (HMO) ingredients, indicating that the ingredients are permitted for use on the US market.

HMOs are a component of human breast milk with benefits for immunity, gut health and potentially cognitive development. 

The company’s latest approval covers the HMO ingredients lacto-N-fucopentaose I with 2’-fucosyllactose (LNFP-I/2’-FL) and hypoallergenic grade LNnT and 2’FL, which are also approved for use in hypoallergenic infant formula for infants with a cow milk protein allergy. 

“The GRAS status of LNFP-I/2’-FL for use in formula products for infants and young children, as well as other food applications in the US, is a milestone for the use of this ingredient globally,” says Christoph Röhrig, head of HMO Regulatory at DSM-Firmenich. 

“What’s more, infants with cow’s milk protein allergies now can benefit from exempt formula supplemented with HMOs. Thanks to the approval for using hypoallergenic grade 2’-FL and LNnT in the US, more infants can now enjoy the unique health benefits of HMOs.”

The GRAS notices were submitted by Glycom, a biotechnology company acquired by DSM-Firmenich.  

Expanding HMO offer
DSM-Firmenich notes that the latest regulatory approvals will support greater access to HMO products in the US. 

“We are always looking for ways to enhance our HMO offering to help create brighter lives for babies around the world,” adds Marta Miks, senior regulatory and scientific affairs manager at DSM-Firmenich. 

GRAS notices for three new HMO ingredients indicate that the ingredients are permitted for use on the US market.“Currently, we are petitioning for exemption of our hypoallergenic grade 2’-FL and LNnT from food allergen labeling requirements of the Food, Drug and Cosmetic Act, as amended by Food Allergen Labeling and Consumer Protection Act (FALCPA). 

“With the FDA’s ‘no questions’ response letter to the GRAS notifications, evaluation of the associated FALCPA exemption can now be completed, enabling these HMOs to be commercialized in exempt infant formula in the US.” 

She adds that approval for using LNFP-I/2’-FL in conventional foods in the US means the company can also offer the unique benefits of HMOs to an adult audience. “This is especially exciting, as emerging evidence indicates that HMOs may support the gut microbiota and immunity across the lifespan.”

In related news, DSM-Firmenich recently confirmed plans into the stringent Chinese infant formula market with HMO ingredients. 

Generally recognized as safe 
The HMO LNFP-I/2’-FL is considered safe for use as an ingredient at up to 0.8 g/L in a non-exempt term infant formula and formula for young children. It can also be added to other drinks for young children at up to 1.2 g/L, to other foods for infants and young children at up to 8.33 g/kg and to a variety of conventional foods up to a maximum range of 1-20 g/kg or g/L. 

DSM-Firmenich’s hypoallergenic grade HMOs, marketed as GlyCare 2FL 9000 HA and Glycare LNnT 9000 HA, are GRAS for use in extensively hydrolyzed- or amino acid-based exempt infant formula for infants with cow milk protein allergy. 

The maximum levels for these ingredients are 2.4 g/l for GlyCare 2FL 9000 HA and 0.6 g/l for Glycare LNnT 9000 HA. 

Though DSM-Firmenich has previously achieved approval for the use of these HMOs in several markets, stricter processes are in place to control potential residual milk protein for use in exempt hypoallergenic infant formula in the US, since the ingredients are derived from lactose obtained from cow’s milk. 

Exempt formula products are intended for infants with inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.

Edited by Jolanda van Hal