FDA rejects Nestlé infant formula health claim
claim submitted by Nestlé, which would have implied that its whey
protein infant formulas reduced the risk of food allergy symptoms.
The Food and Drug Administration (FDA) said in a letter to Nestlé that there was "no credible evidence" to support this claim.
The Swiss-based food giant last year filed the petition, which proposed a health claim stating that "clinical research in healthy infants with family history of allergy shows that feeding a 100 percent whey-protein partially hydrolyzed formula may reduce the risk of common food allergy symptoms, particularly allergic skin rash, when used instead of whole-protein cow's milk formula from the initiation of formula feeding."
However, according to the FDA, this conclusion could not be drawn from the 36 studies submitted for review, as the majority of these did not properly control for the removal of casein as a confounding variable.
Casein and whey proteins are the two major allergens found in cow's milk. A reduction in allergy symptoms may therefore be attributable to the elimination of casein proteins in the infant formulas, and not just to the partially hydrolyzed whey proteins, said the FDA.
In addition, most of the studies did not definitively diagnose food allergy incidence, which is the appropriate endpoint for measuring allergy risk reduction, said the agency.
Some of the studies also provided no information of the nutritional status of the infants that would indicate that they had experienced normal physical growth during the study period, said the FDA. This could potentially have altered immune mediated responses, thereby affecting allergic reactions.
Nestlé said it was "disappointed and surprised" with the FDA's decision.
"In part this may reflect an incomplete understanding of the scientific support of thepetition, or differences in interpretation of the language of the proposed claim," said the company's medical and scientific director Jose Saavedra.
"This claim would help to inform an even greater number of mothers about a very important and currently available allergy prevention option for infants who are not exclusively breastfed," he added.
The company said it plans to formally ask the FDA to reconsider its decision.
"We are confident that in working with FDA, we can find the best way to communicate the scientific evidence to benefit the greatest number of infants," said Saavedra.
The FDA said it intends to evaluate new information that becomes available, and would consider changing its decision if sufficient scientific evidence supporting the health claim was released.
