New Questions Raised Over Hypoallergenic Infant Formula

Share this

New evidence raises serious doubts about the claims made by hypoallergenic infant formula makers saying the products prevent allergies in children.

EMAX Health   Robyn Nazar 2011-07-14

In the largest clinical trial ever on hypoallergenic infant formula Australian researchers found that babies who consumed these products were just as likely as other infants drinking cow's milk or soy formulas to develop allergies later in life.


This is a stark contrast to claims made by product manufacturers, such as Nestle, that were researched and approved by the FDA.


"Our findings do not support the role of hypoallergenic formula for the prevention of allergic disease. Families at high risk of allergy should continue to be encouraged to breast feed for the many known benefits associated with breastfeeding," said David Hill, PhD., senior Consultant Allergist at the Murdoch Children's Research Institute.


The hypoallergenic formula in question are those made with 100% whey protein, also known as partially hydrolyzed whey formula (pHWF).The researchers studied over 600 infants who had a strong family history of allergies. Once weened from breastfeeding the infants were given either standard cow's milk formula, soy formula or the pHWF. At 6, 12, and 24 months of age the children were tested for common allergies including milk, egg, peanut, dust mite, rye grass and cat dander. Some children were tested again at 6 or 7 years of age.


The results were surprising. The researchers found that the children who consumed the pWHF developed the same amount of allergies as those who drank cow or soy milk.


"In our study of high risk children, this 'hypoallergenic' formula did not show any beneficial effect, when compared with a normal cows' milk based formula, for the prevention childhood eczema, asthma or hay fever up to seven years of age," concluded the researchers.


According a report on the FDA's website Nestle recently sought approval to post a health claim on their pWHF infant product label which would read:


“Emerging clinical research shows that, in healthy infants with family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula instead of a formula containing intact cow's milk proteins may reduce the risk of developing the most common allergic disease of infancy — atopic dermatitis — throughout the 1st year of life and up to 3 years of age.”


In the detailed report of the investigation the FDA points out that several studies have shown that these types of formulas are not hypoallergenic and may not be safe for all infants. Furthermore, only two studies exist showing a reduced risk for this allergy up to 1 year of age, one study demonstrated this up to 3 years and an additional study showed no affect at all.


However, despite the lack of evidence the FDA submitted formal response in May of 2011 saying, “FDA concludes that that the current scientific evidence is appropriate for consideration of a qualified health claim regarding the relationship between the consumption of 100 percent whey-protein partially hydrolyzed infant formula and a reduced risk of atopic dermatitis," and subsequently approved a modified version of the request label.


Nestle, who sponsored the study, is defending their claims of a hypoallergenic formula. A spokesperson for the study commented, "There have been at least eight different meta-analyses conducted and all conclude that [hypoallergenic formula] is recommended for reducing the allergy risk in high-risk infants.”


"Having said that, while partially hydrolysed whey-based infant formula may benefit children who are not breastfed compared to cows milk formula, Nestle firmly believes that breast feeding is always best for babies," she concluded.



FDA Qualified Health Claims Response


Lowe, et. al. Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high-risk children: A randomized controlled trial. Journal of Allergy and Clinical Immunology.