Arla Foods Ingredients has secured US Food & Drug Administration approval for the use of whey protein hydrolysates that support allergy management and gut comfort in infant formula.
The FDA agreed that four ingredients in the company’s Peptigen and Lacprodan ranges meet the definition of peptones in the US Code of Federal Regulations. As such, they are permitted for use in early life nutrition.
Anders Steen Jørgensen, head of Arla Foods Ingredients’ pediatric business unit, said, “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.”
It is estimated that 2-3% of infants in US now suffer from cow’s milk allergy. In most cases where breastfeeding is not possible, hydrolysed formulas backed by clinical proof of efficacy are recommended for them.
The four ingredients now permitted by the FDA for use in early life nutrition products are:
Peptigen IF-3032, an extensively hydrolysed whey protein recommended for use in allergy management nutrition solutions. Multiple clinical studies support its suitability for infants with cow’s milk allergies.
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 hydrolysed 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.
Jørgensen said, “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.”
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