FDA Rejects Nestle Bid on Health Claim

12/05/06 WASHINGTON - Health officials on Friday rejected an attempt by Nestle USA to add labeling language to a line of its infant formulas that would have implied they reduced the risk of some food allergy symptoms.

The Food and Drug Administration, in a letter denying the petition posted to its Web site, said there was no credible evidence to support the company's claim.

Nestle, in the 2005 petition filed with the FDA, sought permission to claim that feeding an infant 100 percent whey-protein partially hydrolyzed formulas may reduce the risk of common food allergy symptoms, particularly skin rashes, when substituted for formulas made from whole-protein cow's milk.

Nestle formulas like Good Start Supreme are made from 100 percent whey proteins from cow's milk that are broken down into smaller proteins that are easier to digest, according to the company's Web site.

Abbott Laboratories and Mead Johnson & Co., two competing infant formula manufacturers, sharply criticized the petition in comments filed with the FDA. Both called it misleading, alleging that parents and doctors could interpret the claim as meaning the formula was safe to feed children with allergies to cow's milk.

The "inadvertent use of such formula by a cow's milk allergic infant has the potential for causing a severe allergic reaction," Dr. Jon Vanderhoof, vice president of global medical affairs for Mead Johnson, wrote the FDA in a Sept. 30 letter asking that the regulatory agency deny the Nestle petition.

Dr. Jose M. Saavedra, medical and scientific director of Nestle Nutrition North America, said the FDA decision "disappointed and surprised" 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," Saavedra said in a statement.

Nestle's formula business is no stranger to controversy. Beginning in the 1970s, Nestle was boycotted over allegations that aggressive marketing of its infant formulas in poor countries led to increases in malnutrition.

Nestle says that breast feeding is best for babies.

Nestle USA is part of Vevey, Switzerland-based Nestle SA, the world's biggest food and beverage company.