US FDA Proposes New Infant Formula Rules

The US Food and Drug Administration proposed new nutrient limits and labeling rules for infant formula. The rule amends limits for four required nutrients and establishes a maximum level for manganese. Manufacturers face annualized compliance costs estimated at $17.6 million.

FILE PHOTO: Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020.

The United States Food and Drug Administration proposed new nutrient limits and labeling rules for infant formula on Thursday afternoon, targeting shifts in iodine, vitamin A, vitamin D, and manganese requirements. The regulatory updates follow a series of product recalls and infant botulism cases that triggered tighter federal oversight of baby food supply chains. The revisions will impose annualized compliance costs ranging from $8.4 million to $31.7 million for formula manufacturers.