Health, nutrition, and beauty company Dsm-firmenich recently received ‘no questions’ response letters from the U.S. Food and Drug Administration (FDA) in response to three GRAS (Generally Recognized as Safe) notifications it submitted for three new human milk oligosaccharide (HMO) ingredients.
 
HMOs are a unique component of human breast milk linked to immune support, gut health, and cognitive development benefits. Dsm-firmenich’s HMO portfolio is available for use in more than 160 countries worldwide.
 
While a ‘no questions’ response from the FDA is not considered an express approval for new dietary ingredients, FDA uses these letters to express that the agency doesn’t question the basis for the self-affirmed GRAS declaration submitted to it.
 
For the first time globally, lacto-N-fucopentaose I with 2′-fucosyllactose (LNFP-I/2’-FL) can be commercialized in formula for infants and young children, as well as other food applications.
 
The U.S. is also the first market in which a HMO that is a pentasaccharide (LNFP-I), rather than a trisaccharide (2’-FL, 3-fucosyllactose (3-FL), 3’-sialyllactose (3’-SL) or 6’-sialyllactose (6’-SL), or tetrasaccharide (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).
 
The ‘no-questions’ letters, the company reports, will strengthen the company’s end-to-end offering for early life nutrition products.
 
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. The maximum use levels for 2’FL and LNnT are 2.4 g/L and 0.6 g/L respectively. While the company has achieved market access for HMOs in several other markets, stricter processes to control potential residual milk protein are applied for exempt hypoallergenic formula in the U.S., Dsm-firmenich noted.
 
“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.”
 
“We are always looking for ways to enhance our HMO offering to help create brighter lives for babies around the world,” said Marta Miks, senior regulatory and scientific affairs manager. “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.”