FDA Rejects Infant Formula Health Claim

Late last week, FDA rejected a proposed label claim submitted last year by Nestlé, Vevey, Switzerland. The company sought to make a label claim stating that feeding an infant formulas made with 100% partially hydrolyzed whey protein may reduce the risk of common food allergy symptoms, particularly skin rashes, compared to infant formulas made from whole-protein cow's milk. However, FDA said no credible evidence existed to support the company's claim.

The company's Good Start® Supreme infant formulas are made from 100% whey protein from cow's milk that is broken down into smaller proteins. Nestlé has suggested this process makes the proteins easier to digest, among other benefits.

Dr. José M. Saavedra, medical and scientific director, Nestlé USA, Glendale, CA--as well as associate professor of pediatrics, Johns Hopkins University, Baltimore--says the FDA decision came as a disappointment to the company. "There is generally accepted consensus among the scientific community that certain hydrolyzed protein formulas, including partially hydrolyzed whey protein formula, can reduce the risk of an infant developing atopic dermatitis, the most common type of infant allergy, when compared to standard cow's milk-based formulas," said Saavedra in a official statement. The company includes a list of supporting studies, drawn from published reports, at http://www.nestle-nutrition.com/product.aspx?objectID=CE568B54-A2DF-4282-A04F-1CDB5EFE7D32 (scroll to bottom of page).