The U.S. Food and Drug Administration has issued a final rule setting standards for manufacturers of infant formula to help ensure that the formulas made for the U.S. market continue to be safe and support healthy growth for infants who consume formula. The final rule contains some modifications, clarifications and technical revisions that differ from the interim final rule issued Feb. 10, 2014.

While breastfeeding is strongly recommended and many mothers hope to breastfeed their infants, most infants in the U.S. rely on infant formula for some portion of their nutrition. The final rule applies only to infant formulas intended for use by healthy infants without any unusual medical or dietary problems.

The final rule establishes current Good Manufacturing Practices (cGMPs) specifically for infant formula, which include required testing for the pathogens Salmonella and Cronobacter. The rule also establishes quality control procedures, requirements about how and when manufacturers must notify FDA about new formulas, including major changes to formulas, and requirements concerning recordkeeping.

Companies currently manufacturing infant formula for the U.S. market already voluntarily conduct many of the cGMPs and quality control procedures included in this final rule.

FDA also is publishing a final guidance document explaining how certain “eligible” infant formula manufacturers can demonstrate that their products meet the quality factor requirements of the final rule. This document applies to infant formulas that are the subject of a premarket notification submitted prior to the Sep. 8, 2014 compliance date of the final rule. The guidance document answers questions about what evidence is needed to show that these products fulfill the quality factor requirements (i.e., sufficient biological quality of protein contained in the product and normal physical growth of infants consuming the formula), related record requirements, and the process for the voluntary submission of a citizen petition to demonstrate that the eligible infant formula products meet the quality factor requirements.

The final rule and final guidance are on display at the Federal Register and will be published officially in the Federal Register June 10. 

Additional Information: 

• Federal Register Notice: Final Rule – Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
• Federal Register Notice: Guidance for Industry – Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas
• Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas
• Consumer Update: FDA 101 – Infant Formula

FDA noteed the sudden passing of Dr. Benson Silverman, a neonatologist who led the FDA’s infant formula initiative and who worked on this effort for 11 years. He died on Saturday, June 7, 2014, the weekend before the issuance of the final rule.