TABLE 2.

Summary of key revisions for the Infant Formula Act and subsequent FDA regulations on infant formula composition

➢Creation of an independent review panel to assess requirements for all formula components

➢Modernize the definition of IF to reflect manufacturing realities and emphasize infant outcomes

➢Evaluate the need to adjust iron content to align with current evidence

➢Consider adding the fatty acids (DHA and AA) to the required nutrients

➢Create a framework for the addition of bioactive components as evidence emerges

➢Update regulations on quantity and quality of protein

➢Incorporate energy density requirements

➢Include specific regulations for formulas intended for preterm infants

➢Reconsider labeling regulations to align more closely with international standards

➢Evaluate concurrently the processes by which infant formulas are evaluated by the FDA before registration

AA, arachidonic acid; FFs, fatty acids; IF, infant formula.