IGMPI India



New FDA regulations for baby formula manufacturers

The U.S. Food and Drug Administration (FDA) recently finalized new stricter regulations for the safe manufacture of infant formula. Until now, FDA regulations have not been stringent enough to guarantee quality in infant formula.

The new ruling for infant formula manufacturers will be effective from Sept. 8 will require companies to have good manufacturing practices that will include a test that will detect harmful pathogens, including Salmonella and Cronobacter. The manufacturers will have to show the formulas support normal physical growth in infants, and during the final product stage, formulas need to be tested for nutrient content before entering the market and at the end of the formula’s shelf life.

These rules will not apply to infant formulas specially designed for infants with unusual dietary issues.Before these new sets of standards were put into place, the FDA was still providing safe formula for babies by requiring companies to give the notification before marketing a new formula, ensuring that all formulas meet federal nutrition requirements, conducting yearly inspections of all the plants that manufacture infant formula and determining if a safety recall would be needed. FDA also acknowledgedthat many of the manufacturers were already in compliance with the new regulations.