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U.S. FDA Issues Final Rule Setting Manufacturing Standards for Infant Formula

June 25, 2014

The U.S. Food and Drug Administration (FDA) announced a final rule, setting standards for manufacturers of infant formula to help ensure that product formulations made for the U.S. market continue to be safe and support healthy growth for infants.

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, and requirements for notifying FDA about new formulas, including major changes to formulas and requirements concerning recordkeeping.