Sønderhøj, Denmark—Arla Foods Ingredients has obtained GRAS approval for its use of alpha-lactalbumin in infant formula, according to a press release.

FDA issued a ‘no objection letter’ with regards to the safety of fractionated whey protein concentrate containing 41% alpha-lactalbumin, marketed by Arla as Lacprodan ALPHA-10, when used in infant formula.

Alpha-lactalbumin is the most abundant protein in human milk, comprising about 25% of total protein content. Lacprodan can therefore be used to make an infant formula that more clowely emulates human milk. Alpha-lactalbumin has also been associated with a reduction is gastrointestinal events, a healthy gut microbiota, and protection against intestinal infections.
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Kal Ramanujam, senior scientific advisor of pediatrics at Arla, said in the release: “Lacprodan ALPHA-10 delivers safe and documented benefits when used in infant formula. This approval is a regulatory milestone in the US. It will benefit millions of babies by allowing them to consumer clinically documented levels of bovine alpha-lactalbumin.”

The GRAS notice is availablehere.