FDA approves Arla Foods’ whey protein hydrolysates for infant formula

Posted: 11 July 2024 | | No comments yet

Arla Foods has secured FDA approval for whey protein hydrolysates in infant formula, aiding allergy management and gut comfort for US infants.

FDA offices Washington

Arla Foods Ingredients has obtained approval from the US Food & Drug Administration (FDA) to use whey protein hydrolysates in infant formula, enhancing allergy management and gut comfort.

The regulatory body has confirmed that four ingredients in the company’s Peptigen® and Lacprodan® ranges “meet the definition of peptones in the US Code of Federal Regulations”. Consequently they have now been authorised for use in early life nutrition.

 Commenting on the landmark approval, Anders Steen Jørgensen, Head of Arla Foods Ingredients’ Pediatric Business Unit, shared: “We have over 30 years’ experience of developing and producing safe, high-quality whey protein hydrolysates for the infant formula market at our state-of-the-art manufacturing facilities.

“Our strategy is to ensure these scientifically backed ingredients are available all over the world. We are delighted that 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.”

 Currently, an estimated 2-3 percent of infants in the US now live with a cow’s milk allergy. In situations where breastfeeding is not an option, hydrolysed formulas with clinical evidence supporting their efficacy are typically recommended for infants.

Looking at the four ingredients that the FDA have approved for use in early life nutrition products, the regulator has confirmed usage of the following:


  • Peptigen® IF-3032, an extensively hydrolyzed whey protein recommended for use in allergy management nutrition solutions. Multiple clinical studies support its suitability for infants with cow’s milk allergies.[2]
  • Peptigen® IF-3080, which is also suitable for allergy management nutrition solutions, and secured safety and suitability approval from EFSA for use in infant formula and follow-on milk in the EU in 2023.
  • Peptigen® IF-3085, a partially hydrolyzed protein, which can be suitable in products for infants at high risk of developing milk allergies.
  • Lacprodan® IF-3070, which is designed to support the reduction of gastrointestinal 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,” continued Anders Steen Jørgensen.

Previously, Arla Foods Ingredients has obtained approval for Lacprodan® IF-3070 and Lacprodan® DI-3072 in the Chinese formula market, and currently there are more hydrolysate products currently undergoing the approval process.

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