FDA Releases Interim Rule for Infant Formula

The U.S. Food and Drug Administration has released an interim final rule and draft guidance documents regarding the manufacturing standards of infant formula.  Only 75 percent of infants in the U.S. start out being breastfed and by age three months, two-thirds rely on infant formula for some portion of their nutrition. The rule is meant to ensure that formulas for infants without unusual medical or dietary problems are safe and support healthy growth.  The draft guidance documents issued alongside the interim final rule address how manufacturers can demonstrate that their products meet the quality factor requirements of the interim final rule and information about manufacturing formulas made for infants with unusual medical or dietary problems  “Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being.”  The interim final rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of infant formulas. It also establishes current good manufacturing practices and requires testing for Cronobacter and Salmonella contamination.  FDA says that companies currently manufacturing infant formula in the U.S. already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the rule.  The agency will be accepting comments from the public on issues or information not previously considered in the interim final rule.