FDA approval for Arla Foods Ingredients’ infant formula ingredient

Arla Foods Ingredients has obtained ‘Generally Recognized as Safe’ (GRAS) approval from The US Food & Drug Administration (FDA) for the use of alpha-lactalbumin in infant formula.

This decision means that fractionated whey protein concentrate containing 41% alpha-lactalbumin (marketed by Arla Foods Ingredients as Lacprodan Alpha-10) is permitted as an ingredient in cows’ milk-based, non-exempt formula for term infants, at levels of up to 8.3g per litre. 

Alpha-lactalbumin is rich in essential amino acids and the most abundant protein in human milk, comprising about 25% of total protein content. Adding an alpha-lactalbumin ingredient such as Lacprodan Alpha-10 to an infant formula means it can emulate human milk more closely in terms of protein concentration and composition.

It also makes it possible to reduce overall protein levels in a formula. According to Arla, this is widely considered desirable; while more research is needed, reducing the protein concentration of formula has been suggested as a preventive strategy for cutting the risk of overweight and obesity in children. Other benefits associated with alpha-lactalbumin include a reduction in feeding-related gastrointestinal events, protection against intestinal infections and support for a healthy gut microbiota.

Kal Ramanujam, senior scientific advisor, pediatric, at Arla Foods Ingredients, said: “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 consume clinically documented levels of bovine alpha lactalbumin.” 

The FDA decision will allow Arla Foods Ingredients to supply fractionated whey protein concentrate containing 41% alpha-lactalbumin to the US infant formula market.