Arla Foods Ingredients obtains FDA approval for whey protein hydrolysates in infant formula

12 Jul 2024 --- The US FDA confirms that four whey protein hydrolysates of Arla Foods Ingredients are permitted for early-life nutrition. The company’s Peptigen and Lacprodan ingredients support allergy management and gut comfort. 

The ingredients — Peptigen IF-3032, Peptigen IF-3080, Peptigen IF-3085 and Lacprodan IF-3070 — meet the definition of peptones in the US Code of Federal Regulations. 

“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,” comments Anders Steen Jørgensen, head of Arla Foods Ingredients’ pediatric business unit. 

Cow’s milk allergies 
Hydrolyzed infant formulas are recommended for infants not fed through breastfeeding and have a cow’s milk allergy. An estimated 2–3% of infants in the US suffer from such an allergy. 

“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 cannot tolerate traditional milk-based formulas,” adds Steen Jørgensen. 

In the company’s Peptigen range, IF-3032 is an extensively hydrolyzed whey protein recommended for allergy management nutrition solutions. Arla Foods Ingredients notes that multiple clinical studies support its suitability for infants with cow’s milk allergies. 

In addition, IF-3080 has secured safety and suitability approval from EFSA in 2023 for use in infant formula and follow-on milk in the EU. IF-3085 is a partially hydrolyzed protein that can be used in products for infants at high risk of developing milk allergies. 

Meanwhile, Lacprodan IF-3070 aims to reduce gastrointestinal discomfort. 

This ingredient and Lacprodan DI-3072 have also been approved for the Chinese formula market. Arla Foods Ingredients notes that additional hydrolysate products are going through the country’s approval process. 

“We have over 30 years of experience developing and producing safe, high-quality whey protein hydrolysates for the infant formula market at our manufacturing facilities. Our strategy is to ensure these scientifically-backed ingredients are available worldwide,” highlights Steen Jørgensen. 

Infant formula innovations 
The infant nutrition industry sees substantial opportunities in premium market segments despite strict legislation, safety standards and a declining birth rate. For example, companies increasingly focus on ingredients that support gut health and immunity. 

Hypoallergenic and lactose-free formulas are also breaking ground, as the prevalence of allergic diseases is increasing globally. 

Industry players also highlight the growing need to create tailored nutrition solutions for infants and young children. Last year, Arla Foods Ingredients launched an alpha-lactalbumin-rich infant formula as a low-protein formulation.