AFI receives FDA approval for whey protein hydrolysates in infant formula

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

This approval allows four ingredients from the company’s Peptigen® and Lacprodan® ranges to be used in early-life nutrition, meeting the definition of peptones as per the US Code of Federal Regulations.

This includes Peptigen® IF-3032, an extensively hydrolyzed whey protein formulated for allergy management nutrition solutions. Supported by multiple clinical studies, Peptigen® IF-3032 offers a reliable option for infants with allergies.

 Also approved is Peptigen® IF-3080, suitable for allergy management and endorsed by the European Food Safety Authority (EFSA) for use across the EU, ensuring its safety and effectiveness.

Peptigen® IF-3085, a partially hydrolyzed protein, provides a tailored nutritional solution for infants at high risk of milk allergies.

Additionally, Lacprodan® IF-3070, designed to alleviate gastrointestinal discomfort, rounds out the approved ingredients, further enhancing the company’s offerings in early-life nutrition.

“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,” Anders Steen Jørgensen, Head of Arla Foods Ingredients’ Pediatric Business Unit, stated expressing satisfaction with the approval.

“Our strategy is to ensure these scientifically backed ingredients are available worldwide. 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.”

In addition, Jørgensen emphasized the company’s commitment to investing in preclinical and clinical trials to provide scientific evidence for their ingredients’ benefits.

“Our whey protein hydrolysates have been shown to support the safe growth of formula-fed infants who cannot tolerate traditional milk-based formulas.”

The approval of these hydrolysates is part of a broader strategy by Arla Foods Ingredients to expand their market presence globally, including in China, where Lacprodan IF-3070 and Lacprodan DI-3072 have also received approval.

Additional hydrolysate products are currently being approved in China.

Meanwhile, despite the challenges posed by strict legislation, safety standards, and a declining birth rate, the infant nutrition industry sees substantial opportunities in premium market segments.

Due to the increasing prevalence of allergic diseases globally, there is a growing focus on ingredients that support gut health and immunity, as well as hypoallergenic and lactose-free formulas.

Arla Foods Ingredients also caters to the need for tailored nutrition solutions for infants and young children.

Last year, the company launched an alpha-lactalbumin-rich infant formula as a low-protein formulation, further diversifying its product offerings in the competitive infant nutrition market.

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