DSM gets FDA approval for infant formula ingredient

The US Food and Drug Administration has approved Royal DSM’s recently produced ingredient for newborn nourishment.DSM can provide the same bacterial and immunological benefits that naturally occur in breast milk to nutritious formulas by using a component called human milk oligosaccharides (HMO).

“HMOs are a powerful emerging ingredient capturing increasing attention across the health and nutrition space — especially in the infant nutrition market,” said Christoph Röhrig, head of HMO regulatory at DSM. “The discoveries have been incredibly positive so far, but there is still a lot to be uncovered regarding the potential health benefits and applications of HMOs — which is extremely exciting. Consequently, it’s anticipated that HMO solutions will continue to breakthrough onto the market as the industry learns more about the role these ingredients play in human health.”

Now Generally Recognized as Safe (GRAS) for several early life nutritional applications, the company’s 3-fucosyllactose (FL) HMO, marketed as Glycare 3FL 9000, will be able to provide formula-fed infants with nutrients that are more comparable to the natural alternative.

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In addition to the FDA approval, Glycare 3FL received approval for use in dietary supplements in Australia.

“3-FL is a highly abundant HMO in human breast milk and was therefore an important ingredient for us to develop and add to our growing portfolio,” said Marta Mikš, senior regulatory and scientific affairs manager at DSM. “The approval of 3-FL in these two important markets is another positive step toward delivering the benefits of HMOs to the global population.”