Arla Foods Ingredients obtains GRAS approval

Date 09.02.2019 | Category: News
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AFI_GRAS IDM Sept19

The US 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 – 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 of to 8.3g per liter. It will also allow Arla Foods Ingredients to supply fractionated whey protein concentrate containing 41% alpha-lactalbumin to the US 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.

 

Said Kal Ramanujam, Senior Scientific Advisor, Pediatric, at Arla Foods Ingredients: “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: accessdata.fda.gov/scripts/fdcc/?set=GRASNotices&id=809

 



Source: Arla Foods Ingredients
Author: COX
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