Arla Foods' FDA-approved hydrolysates simplify allergy, gut comfort integration in infant formulas

Arla Foods’ whey protein hydrolysates support allergy management and gut comfort in infant formula. Research​ suggests that an estimated 2-3% of infants experience cow’s milk allergy. In cases where breastfeeding is not possible, clinically proven hydrolyzed formulas are recommended, according to the company.

"Despite the inclusion of hydrolyzed protein for bottle-feeding infants, several infant formula manufacturers continue to use recipes that have remained unchanged for decades," Pedersen said. The company’s new hydrolysates offer a solution to "comfort formulas targeting colicky infants," backed by taste and clinical documentation, he added.

"The four hydrolysates are now available for use in both existing and new infant formula recipes produced by industry players in the United States," Pedersen said.

He added that once US infant formula manufacturers incorporate the hydrolysates into new products, Arla Foods Ingredients anticipates it will take one to two years to reach US consumers.

Four ingredients in the company's Peptigen and Lacprodan ranges permitted by FDA for use in early life nutrition in the US:

• Peptigen IF-3032, a hydrolyzed whey protein, which shows clinical efficacy​ for infants with cow's milk allergies.
• Peptigen IF-3080, which has been approved for safety and efficacy for allergy management nutrition in infant formula in the EU last year.
• Peptigen IF-3085, a partially hydrolyzed protein, which is ideal in products for infants who have a high risk of developing milk allergies.
• Lacprodan IF-3070, which supports the reduction of GI discomfort in infants. The ingredient, along with Lacprodan DI-3072, received approval for the Chinese formula market with additional hydrolysate products undergoing the country's approval process.

Highlighting the company’s global reach, Pedersen noted that its “whey-based CMA [cow’s milk allergy] hydrolysates, which differ from the predominantly casein-based CMA formulas in the USA, come with clinical documentation and are gaining traction globally, including in Europe and China.”

Arla Foods intends to provide global availability of its "scientifically backed ingredients" and that FDA's approval allows infant formula manufacturers to "now use four of our five hydrolysates in infant nutrition products targeting milk allergy management or reduction of gut discomfort," Pedersen said.

The company has invested significantly in preclinical and clinical trials "to ensure scientific credibility for its ingredients' benefits," Anders Steen Jørgensen, head of Arla Foods Ingredients’ pediatric business unit, said in a statement.

The cost impact of hydrolyzed whey protein are comparable to other efficacious ingredients​

Pedersen noted that pricing for hydrolyzed whey protein is comparable to other active ingredients like lactoferrin, HMOs and alpha-lactalbumin that target gut health and immune and allergy platforms. 

"This means that hydrolysates can be seamlessly integrated into existing or new infant formula recipes without affecting retail prices or the profit margins that formula manufacturers need to maintain for operational viability," he said.

While pricing may be similar between these ingredients, it is important to note that some, like lactoferrin, can be prohibitively expensive, with prices ranging from $300-$3,000 per kg, as reported previously by FoodNavigator​.

Preventing another infant formula shortage ​

The infant formula shortage in the US was caused by a variety of factors, including contamination risks, “reliance on a limited number of manufacturers, vulnerabilities in the supply chain exacerbated by COVID-19, new FDA quality handling requirements, and regulatory barriers hindering innovation and market entry," Pedersen explained.

He added that "decades of industry stagnation have compounded this crisis," and to address these challenges and prevent future shortages, "it is imperative to incentivize innovation, enhance regulatory clarity, and invest in expanding manufacturing capabilities to ensure a stable and diversified supply of infant formula."

Leveraging Arla Foods Ingredients’ manufacturing facility in Europe, which is "capable of supplying large quantities of high-quality whey protein hydrolysates," Pedersen said that the new four hydrolysates are "pivotal in driving innovation" for gut comfort, oral tolerance, allergy risk reduction and managing cow's milk allergy with Lacprodan and Peptigen hydrolysate ingredients.