FDA issues GRAS ‘no objection letter’ for alpha-lactalbumin in infant formula

September 5, 2019

Arla Foods Ingredients has obtained Generally Recognized as Safe (GRAS) approval relating to its use of alpha-lactalbumin in infant formula. The U.S. Food & Drug Administration (FDA) issued the company with a GRAS Notice known as a “no objection letter.” It states that it has no questions regarding the safety of fractionated whey protein concentrate containing 41% alpha-lactalbumin (Arla’s Lacprodan ALPHA-10) when used in infant formula.

The FDA’s decision means Lacprodan ALPHA-10 is permitted as an ingredient in cows’ milk-based non-exempt formula for term infants at levels of up to 8.3 g/L. It will also allow Arla Foods Ingredients to supply fractionated whey protein concentrate containing 41% alpha-lactalbumin to the U.S. infant formula market.

“This approval is a regulatory milestone in the United States,” said Kal Ramanujam, senior scientific advisor, pediatric, at Arla Foods Ingredients. “It will benefit millions of babies by allowing them to consume clinically documented levels of bovine alpha lactalbumin.”

Press release

FDA GRAS letter (pdf)