FDA Proposes New Nutrient Limits and Labeling Rules for Infant Formula

The Food and Drug Administration proposed new nutrient limits and related labeling changes for infant formula Thursday, beginning a three-phase review of the federal standards. The proposal is not a final rule and does not create an immediate requirement to change products.

The first phase covers eight of the 30 nutrients required in infant formula sold in the United States. It would revise requirements for iodine, manganese, vitamin A and vitamin D while keeping the existing specifications for chloride, potassium, selenium and sodium.

The proposed changes would raise the minimum iodine level while lowering its maximum, lower the minimum manganese level and add a maximum, and revise the permitted amounts of vitamins A and D. The FDA also proposes changing the units used to express vitamins A and D and updating labels to match the new specifications.

The agency is seeking public input on ingredients that manufacturers often add but are not currently required, including DHA, ARA and L-carnitine. Later phases will address the remaining required nutrients, possible new requirements and carbohydrate sources.

The FDA plans to combine the changes from all three phases into one final rule. Its proposal would give manufacturers three years after that final rule's effective date to reformulate and relabel products.

The FDA says formula currently sold in the United States remains safe for babies. It says the proposed nutrient changes are based on updated scientific understanding, not a newly identified safety concern. The public can review the proposal and comment through the federal rulemaking process.