Arla Gains Approval for Use of Fractionated Whey Protein Concentrate in Infant Formula

Arla Foods Ingredients has obtained Generally Recognized As Safe (GRAS) approval relating to its use of alpha-lactalbumin in infant formula.
 
The US Food & Drug Administration (FDA) issued a GRAS Notice known as a “no objection letter” to the company. It states that it has no questions regarding the safety of fractionated whey protein concentrate containing 41% alpha-lactalbumin—marketed by Arla Foods Ingredients as 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 up to 8.3 grams per liter. It will also allow Arla Foods Ingredients to supply fractionated whey protein concentrate containing 41% alpha-lactalbumin to the U.S. infant formula market.
 
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. This is widely considered desirable because, 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 U.S. It will benefit millions of babies by allowing them to consume clinically documented levels of bovine alpha lactalbumin.” 
 
Lacprodan ALPHA-10 is a whey protein fraction with 41% alpha-lactalbumin and a high content of tryptophan, cysteine and 88% protein concentrate in dry matter.
 
The GRAS notice (GRN No. 809) is available at:
 
https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices&id=809