10 August, 2023
dsm-firmenich, innovator in health, nutrition and beauty, today announced that it has received ‘no questions’ response letters from the US Food and Drug Administration (FDA) to its Generally Recognized as Safe (GRAS) notices submitted by Glycom A/S* for three new human milk oligosaccharide (HMO) ingredients.
For the first time globally, lacto-N-fucopentaose I with 2′-fucosyllactose (LNFP-I/2’-FL) can be commercialised in formula for infants 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), rather than a trisaccharide [e.g., 2’-FL, 3-fucosyllactose (3-FL), 3’-sialyllactose (3’-SL) or 6’-sialyllactose (6’-SL)] or tetrasaccharide (e.g., difucosyllactose (DFL), lacto-N-tetraose (LNT) or lacto-N-neotetraose (LNnT)], is commercially available.
dsm-firmenich’s 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).
These latest regulatory approvals will support greater accessibility to high-quality HMO products in the US and further strengthen the company’s end-to-end offering for early life nutrition innovation.
Specifically, 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.1 Approvals at these maximum use levels were made possible thanks to dsm-firmenich’s recent review on the mean concentration of HMOs in global pooled human milk, which included updated summary statistics of LNFP-1.2
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.3 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. While dsm-firmenich 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.
Christoph Röhrig, Head of HMO Regulatory at dsm-firmenich, commented: “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. 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.4”
HMOs are a unique component of human breast milk with important benefits for immunity, gut health and potentially cognitive development. dsm-firmenich’s science-backed GlyCare™ HMO portfolio is available for use in more than 160 countries worldwide.
To learn more about dsm-firmenich’s portfolio of next generation HMOs and the research behind these unique ingredients, visit: https://www.dsm.com/human-nutrition/en/products/hmos/hmos-for-early-life.html
*Glycom A/S is ultimately controlled by DSM-Fimenich AG, registered in Kaiseraugst, Switzerland.
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.
This press release may contain forward-looking statements with respect to dsm-firmenich’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of dsm-firmenich and information currently available to the company. dsm-firmenich cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. dsm-firmenich has no obligation to update the statements contained in this press release, unless required by law. The English language version of this press release prevails over other language versions.
1. GRAS notice 1035
2. Soyyilmaz et al. The Mean of Milk: a review of human milk oligosaccharide concentrations throughout lactation. Nutrients, 2021.
3. GRAS notices 1059 and 1034
4. Šuligoj T, Vigsnæs LK, Abbeele PVD, Apostolou A, Karalis K, Savva GM, McConnell B, Juge N. Effects of Human Milk Oligosaccharides on the Adult Gut Microbiota and Barrier Function. Nutrients. 2020 Sep 13;12(9):2808.