False Infant Formula Claims: FDA Concludes Whey-Protein Partially Hydrolyzed Baby Formulas Are Not Hypoallergenic

Despite claims by manufacturers that 100 percent whey-protein partially hydrolyzed infant formula is a hypoallergenic alternative for babies who are allergic to milk or babies with existing milk allergy symptoms, the Food and Drug Administration (FDA) concluded that such claims are not backed up by legitimate research, says a new article published in the August 2012 issue of the journal Pediatrics.

The article, which was written by the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland and published as “FDA’s Health Claim Review: Whey-protein Partially Hydrolyzed Infant Formula and Atopic Dermatitis,” evaluated the scientific evidence for a qualified health claim for 100 percent whey-protein partially hydrolyzed infant formula reduced the risk for atopic dermatitis.

Atopic dermatitis, or eczema, is a chronic skin condition characterized by scaly and itchy rashes. Eczema is most common among infants and is exacerbated by a number of factors including dietary influences such as infant formula feeding instead of breastfeeding and the early introduction of solid foods.

Claims have previously been made that whey-protein partially hydrolyzed infant formula may reduce the risk for atopic dermatitis by breaking down the cow milk protein into smaller peptides, thus reducing allergenicity.

As noted in the article, whey-protein partially hydrolyzed infant formulas have been marketed and sold in the United States safely and legally for decades. Unfortunately, this type of infant formula is not hypoallergenic and may cause allergic reactions in one-third to one-half of babies with milk allergies.

To evaluate the claims that whey-protein partially hydrolyzed infant formula might be hypoallergenic, the FDA looked at 20 studies addressing the relationship between the consumption of the infant formula and a reduced risk of atopic dermatitis. Unfortunately, legitimate conclusions could not be drawn from a majority (16 of 20) of those studies due to inherent problems with the designs of the studies.

After reviewing the remaining 4 studies, the FDA concluded that little to very little credible evidence exists for a qualified health claim about whey-protein partially hydrolyzed infant formula and a reduced risk of  eczema.

The FDA thus issued the following warning so that the qualified health claim would not mislead consumers:

“Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.”

Additionally, the following warning (including the bolded section) must accompany the previous qualified health claim:

“Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms. If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby’s care and feeding choices should be under a doctor’s supervision.”

The FDA will continue to evaluate claims that whey-protein partially hydrolyzed infant formula may reduce the risk of atopic dermatitis among infants.

Are you concerned about the lack of legitimate research backing up the health claims about infant formula?