FDA Enacts Infant Formula Safety Standards

June 10, 2014 — The U.S. Food and Drug Administration (FDA) has set new safety standards for manufacturers of infant formula. The final rule sets a date of September 8 for manufacturer compliance.

According to a Consumer Update, the new standards include:

• Current good manufacturing practices specifically designed for infant formula, including testing for Salmonella and Cronobacter.
• Manufacturers must demonstrate that the infant formulas they produce support normal physical growth.
• Infant formulas should be tested for nutrient content before entering the market and at the end of the product’s life.

In October 2012, a lawsuit was filed on behalf of a 10-day old Missouri baby who was sickened with Cronobacter sakazakii, a rare bacterial infection, after eating Enfamil Premium Newborn powdered infant formula in late 2011. Although several infections were linked to infant formula, federal health officials declined to recall the products after finding no evidence that the illnesses were related.

Lawsuits have also been filed by infants who were injured by SimplyThick, a thickening agent that was marketed to parents, caregivers, and health professionals as a way to thicken breast milk or infant formula to make it easier for babies to swallow. In 2011, the FDA warned that SimplyThick could cause life-threatening necrotizing enterocolitis (NEC) in premature babies. The FDA received reports of 15 cases of NEC, including two deaths, in which infants were fed SimplyThick. In 2012, the FDA updated the warning to say that infants of any age could develop NEC after being given SimplyThick.