dsm-firmenich gets FDA GRAS for novel HMOs

By Stephen Daniells

- Last updated on GMT

© Tom Merton / Getty Images
© Tom Merton / Getty Images

Related tags HMO HMOs Infant formula Infant nutrition Gras DSM-Firmenich

The US FDA has issued ‘Good Day Letters’ to dsm-firmenich for three Generally Recognized as Safe (GRAS) notices submitted for the human milk oligosaccharides (HMOs) LNFP-l/2’-FL and hypoallergenic grade LNnT and 2’-FL.

HMOs are unique carbohydrates that make up about 10% of the dry weight of mother’s milk. HMOs are not easily digested, so experts postulate that their purpose is to jump-start the infant’s microbiome.

There are over 150 different HMOs. 2’FL is the most abundant and is therefore the most studied. It is already commercially available from a number of different suppliers. Other HMOs have also been released onto the market, such as 3-fucosyllactose (3-FL), 3’-sialyllactose (3’-SL), 6’-sialyllactose (6’-SL), and lacto-N-neotetraose (LNnT).

Supported by its GRAS affirmation, dsm- firmenich will now commercialize lacto-N-fucopentaose I with 2′-fucosyllactose (LNFP-I/2’-FL) for infant formula and young children, as well as other food applications.

The US is also the first market in which an HMO that is a pentasaccharide (LNFP-I) is commercially available, rather than a trisaccharide (for example, 2’-FL, 3-FL, 3’-SL or 6’-SL) or tetrasaccharide (for example, difucosyllactose (DFL), lacto-N-tetraose (LNT) or LNnT).

dsm-firmenich’s also confirmed that its hypoallergenic grade 2’-FL and LNnT ingredients are also GRAS for use in exempt hypoallergenic infant formula for term infants with cow milk protein allergy (CMPA).

The successful GRAS notifications were initially submitted by Glycom A/S, which was acquired by DSM in 2020​, prior to the merger with Firmenich.


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

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

Marta Miks, Senior Regulatory & Scientific Affairs Manager at dsm-firmenich, added: “We are always looking for ways to enhance our HMO offering to help create brighter lives for babies around the world. 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, which will enable these HMOs to be commercialized in exempt infant formula in the US.

“Moreover, approval for the use of LNFP-I/2’-FL in conventional foods in the US means we 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.”


According to dsm-firmenich, LNFP-I/2’-FL is GRAS for use as an ingredient under the following intended conditions of use: up to 0.8 g/L in non-exempt term infant formula and formulas for young children, up to 1.2 g/L in other drinks for young children, up to 8.33g/kg in other foods for infants and young children; and up to a maximum range of 1.0 to 20 g/kg or g/L in a variety of conventional foods (GRAS notification 1035​).

dsm-firmenich‘s hypoallergenic grade HMOs 2’-FL and LNnT – 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 term infants with CMPA (GRAS notifications 1034​ and 1059​). The maximum use levels approved for 2’-FL and LNnT under this intended condition of use are 2.4 g/L and 0.6 g/L, respectively.

dsm-firmenich stated in a press release that while it has previously achieved approval for use of these HMOs in several markets, as they are derived from lactose obtained from cow’s milk, stricter processes to control potential residual milk protein are applied for use in exempt hypoallergenic infant formula in the US.

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