Arla Foods Ingredients, a branch of the multinational dairy cooperative Arla Foods, has secured approval from the US Food & Drug Administration (FDA) to use its whey protein hydrolysates in infant formula.
The company states that an estimated 2-3 per cent of infants in the US suffer from a cow’s milk allergy. In cases where breastfeeding is not possible, clinically backed hydrolysed formulas can be an effective alternative.
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.
The FDA verdict stated that the four ingredients in the company’s Peptigen and Lacprodan ranges meet the definition of peptones, or soluble digestion proteins, in the US Code of Federal Regulations.
Arla Foods Ingredients Pediatric Business Unit head, Anders Steen Jørgensen, said that the company wanted to ensure that its scientifically backed ingredients were available all over the world.
“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,” he said.
“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.”
Arla Foods Ingredients has also 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.
