The U.S. Food a
nd Drug Administration has published its final rule regarding infant formula standards.
While breastfeeding is strongly recommended and many mothers hope to breastfeed their infants, most newborns in the U.S. 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 final rule contains some modifications, clarifications and technical revisions that differ from the interim final rule issued on Feb. 10, 2014. Manufacturers must comply with the final rule by Sept. 8, 2014.
It establishes Current Good Manufacturing Practices specifically for infant formula, which include required testing for the pathogens Salmonella and Cronobacter. It 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 record keeping.
Manufacturers must demonstrated that their infant formulas support normal physical growth and test them for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.
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.
nd Drug Administration has published its final rule regarding infant formula standards.While breastfeeding is strongly recommended and many mothers hope to breastfeed their infants, most newborns in the U.S. 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 final rule contains some modifications, clarifications and technical revisions that differ from the interim final rule issued on Feb. 10, 2014. Manufacturers must comply with the final rule by Sept. 8, 2014.
It establishes Current Good Manufacturing Practices specifically for infant formula, which include required testing for the pathogens Salmonella and Cronobacter. It 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 record keeping.
Manufacturers must demonstrated that their infant formulas support normal physical growth and test them for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.
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.
