Arla Foods Ingredients’ alpha-lactalbumin ingredient for infant formula now GRAS

September 3, 2019

Arla Foods Ingredients received a “no objection” GRAS (generally recognized as safe) notice from FDA for the use of alpha-lactalbumin in infant formula. 

Arla Foods Ingredients (Viby, Denmark) received a “no objection” GRAS (generally recognized as safe) notice from FDA for the use of alpha-lactalbumin in infant formula. Marketed by Arla as Lacprodan Alpha-10, a fractionated whey protein concentrate containing 41% alpha-lactalbumin, FDA’s decision means that it is permitted as an ingredient in cows’ milk-based non-exempt formula for term infants at levels of to 8.3 g per liter.

Alpha-lactalbumin is rich in amino acids, and the most abundant protein in human milk, comprising about 25% of total protein content. Using alpha-lactalbumin in an infant formula allows the product to better emulate human milk, says Arla. Additionally, because the whey protein hydrolysates in Lacprodan Alpha-10 are pre-digested, having been broken down by enzymes, there is a reduced risk of gastrointestinal discomfort for infants consuming it.

“Lacprodan Alpha-10 delivers safe and documented benefits when used in infant formula. This approval is a regulatory milestone in the U.S. It will benefit millions of babies by allowing them to consume clinically documented levels of bovine alpha-lactalbumin,” said Kal Ramanujam, senior scientific advisor, pediatric, at Arla Foods Ingredients, in a press release.