FDA WARNING_LETTER - Nestle Infant Nutrition U.S. dba Gerber Products Company - October 31, 2014

The FDA issued a Warning Letter to Nestle Infant Nutrition regarding its Gerber Good Start Gentle Infant Formula (23.2 ounce milk based powder). The FDA reviewed the product label in August 2014 and the company's website (www.gerber.com) in October 2014.

The product is deemed misbranded under section 403(r)(1)(B) of the Federal Food, Drug, and Cosmetic Act because its labeling bears unauthorized health claims. Specifically, the product label states it is the "1st and ONLY Routine Formula TO REDUCE RISK OF DEVELOPING ALLERGIES" and refers to "100% whey partially hydrolyzed" potentially reducing the risk of atopic dermatitis. The FDA previously denied a petition for a qualified health claim linking 100% partially hydrolyzed whey protein infant formula to reduced food allergy risk due to lack of credible evidence.

The product is also misbranded under section 403(a)(1) of the Act because its labeling is misleading. While the claims regarding atopic dermatitis are generally consistent with claims for which FDA would consider enforcement discretion, the label and website fail to include the crucial statement: "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." This omission is considered material information necessary for consumer safety. Furthermore, the