Arla Foods Ingredients has received FDA approval for its whey protein hydrolysates, Peptigen® and Lacprodan®, to be used in infant formulas. This approval marks a significant advancement in managing cow’s milk allergies and improving gut comfort in infants, providing scientifically proven options for parents and healthcare providers. The ingredients are designed to reduce allergic reactions and gastrointestinal issues, ensuring adequate nutrition for infants who cannot tolerate standard cow’s milk-based formulas. This development highlights Arla’s commitment to enhancing early-life nutrition worldwide.
The landscape of infant nutrition is evolving with a new breakthrough. Arla Foods Ingredients has secured approval from the US Food & Drug Administration (FDA) for its whey protein hydrolysates to be used in early-life nutrition products. This approval signifies a promising advancement, offering new possibilities for addressing cow’s milk allergies and enhancing gut comfort in infants. The integration of these scientifically backed ingredients into infant formulas marks a significant step forward in providing safe and effective nutrition solutions for the youngest and most vulnerable population.
What are Whey Protein Hydrolysates?
Whey protein hydrolysates are proteins that have been broken down into smaller fragments through a process called hydrolysis. This makes them easier to digest and less likely to cause allergic reactions, making them ideal for use in infant formulas.
FDA Approval Details
The FDA has confirmed that four ingredients from Arla Foods Ingredients’ Peptigen® and Lacprodan® ranges meet the definition of peptones in the US Code of Federal Regulations. This permits their use in infant formulas aimed at managing cow’s milk allergies and reducing gastrointestinal discomfort.
Key Ingredients Approved
- Peptigen® IF-3032: Peptigen® IF-3032 is an extensively hydrolyzed whey protein designed specifically for allergy management. Clinical studies have demonstrated its effectiveness in managing cow’s milk allergies, making it suitable for infants who are unable to tolerate traditional cow’s milk-based formulas. The extensive hydrolysis process breaks down the whey protein into very small peptides, reducing the allergenic potential and making it easier for infants to digest. This ingredient has shown promise in significantly reducing symptoms such as eczema, colic, and respiratory issues associated with cow’s milk allergies.
- Peptigen® IF-3080: Peptigen® IF-3080 is another extensively hydrolyzed whey protein that has received safety and suitability approval from the European Food Safety Authority (EFSA) for use in infant formula and follow-on milk. This ingredient is also designed for allergy management, providing a reliable option for infants with cow’s milk protein allergies. The hydrolysis process in Peptigen® IF-3080 ensures that the protein is broken down into smaller fragments, reducing the likelihood of allergic reactions and improving digestibility. Its approval by EFSA underscores its safety and efficacy in infant nutrition.
- Peptigen® IF-3085: Peptigen® IF-3085 is a partially hydrolyzed whey protein, suitable for infants at high risk of developing milk allergies. While it is not as extensively hydrolyzed as Peptigen® IF-3032 or IF-3080, it still offers a reduced allergenic potential compared to intact whey proteins. This makes it a valuable option for infants who may not yet exhibit full-blown allergies but are at increased risk. By partially hydrolyzing the protein, Peptigen® IF-3085 balances providing allergenic protection and maintaining the protein’s nutritional quality.
- Lacprodan® IF-3070: Lacprodan® IF-3070 is designed to address gastrointestinal discomfort in infants. It aims to improve gut health by promoting a more favourable gut microbiota composition, which can help alleviate symptoms such as constipation, diarrhoea, and colic. The ingredient supports the intestinal barrier function, reducing inflammation and enhancing overall digestive health. By targeting gut discomfort, Lacprodan® IF-3070 provides relief to infants who struggle with common gastrointestinal issues, ensuring they receive the necessary nutrients for growth and development without the added distress of digestive discomfort.
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Expert Insights
Anders Steen Jørgensen, Head of Arla Foods Ingredients’ Pediatric Business Unit, emphasized the company’s dedication to developing safe, high-quality whey protein hydrolysates. “We have over 30 years’ experience in producing these ingredients. Our strategy is to ensure they are scientifically backed and available globally. We are delighted that US infant formula manufacturers can now use four of our hydrolysates to address cow’s milk allergy management or gut discomfort.”
Impact on Infant Nutrition
- Managing Cow’s Milk Allergies
Cow’s milk allergy affects 2-3% of infants in the US, and for those who cannot be breastfed, hydrolyzed formulas are recommended. These newly approved ingredients provide clinically proven options for parents and healthcare providers to manage these allergies effectively.
- First Line of Defense
Hydrolyzed formulas, such as those incorporating Peptigen® and Lacprodan®, are often prescribed as a first line of defense against milk protein allergies. They can significantly reduce allergic reactions, which include symptoms such as eczema, colic, vomiting, and respiratory issues. Clinical studies have shown that extensively hydrolyzed whey proteins, like Peptigen® IF-3032 and IF-3080, can reduce these allergic reactions due to their smaller peptide size and lower allergenic potential.
- Improving Gut Health
Additionally, these formulas can improve gut health by promoting a more favorable gut microbiota composition. They are associated with lower incidences of gastrointestinal issues such as constipation and diarrhoea. For infants suffering from gut discomfort, formulas containing Lacprodan® IF-3070 can provide relief by improving intestinal barrier function and reducing inflammation.
- Ensuring Adequate Nutrition
Furthermore, the availability of these hydrolyzed whey protein formulas ensures that infants receive adequate nutrition even if they cannot tolerate standard cow’s milk-based formulas. This can be crucial for their growth and development, providing essential amino acids and nutrients necessary for their early development stages.
Global Reach
Arla Foods Ingredients is also making strides in other markets. Lacprodan IF-3070 and Lacprodan® DI-3072 have received approval for the Chinese formula market, with additional products in the approval pipeline.
The FDA’s approval of Arla Foods Ingredients’ whey protein hydrolysates marks a significant advancement in infant nutrition, offering new solutions for managing cow’s milk allergies and gastrointestinal discomfort. This approval reflects Arla’s commitment to providing scientifically backed, high-quality nutrition products for infants worldwide.
