Arla Food Ingredient's whey protein hydrolysates approved by FDA for infant formulas

Published: 11-Jul-2024

Four protein hydrolysates designed to fortify infant formulas have been approved by the US FDA for cow's milk allergy management and gastrointestinal discomfort

Arla Foods Ingredients, a global supplier of functional food and beverages, has received approval from the US Food & Drug Administration (FDA) for the use of its whey protein hydrolysates in infant formulas.

These proteins are incorporated into infant formulas to support both allergy management and gut health.

Four ingredients in the Peptigen and Lacprodan ranges were considered to meet the definition of 'peptones' by the FDA, which stands in the Code of Federal Regulations — meaning they are suitable for use in early life nutritional products. These are:

  • Peptigen IF-3032: A hydrolysed whey protein for allergy management
  • Peptigen IF-3080: Allergy management and infant formula/follow-on milk
  • Peptigen IF-3085: Partially hydrolysed protein for infants at high risk of developing milk allergies
  • Lacprodan IF-3070: Formulated to support the reduction of gastrointestinal discomfort in infants

It's estimated that 2-3% of infants in the US now suffer from cow’s milk allergy.1 In most cases where breastfeeding is not possible, hydrolysed formulas are recommended to mothers as a suitable alternative. 
 

Anders Steen Jørgensen, Head of Arla Foods Ingredients’ Pediatric Business Unit, said: “US infant formula manufacturers can now use four of our hydrolysates in infant nutrition products targeting cow’s milk allergy management or reduction of gut discomfort.”

“We invest heavily in preclinical and clinical trials to provide scientific evidence for our ingredients’ benefits. Our whey protein hydrolysates have been shown to support the safe growth of formula-fed infants who are unable to tolerate traditional milk-based formulas.”

Arla Foods Ingredients has received approval for Lacprodan® IF-3070 and Lacprodan® DI-3072 for the Chinese formula market, and additional hydrolysate products are going through the country’s approval process. 
 

Reference

Ward C.E., Greenhawt M.J. Treatment of allergic reactions and quality of life among caregivers of food-allergic children. Ann Allergy Asthma Immunol Off Publ Am Coll Allergy Asthma Immunol (2015)
 

 

 

 

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