Clinical Scorecard: FDA proposes major infant formula update after nearly 30 years

At a Glance

Key Highlights

• The proposal is the first major update to infant formula nutrient requirements since 1998 and is the first phase of a review of 30 currently required nutrients.
• The FDA proposed updates for iodine, manganese, vitamin A, and vitamin D, and reaffirmed existing requirements for chloride, potassium, selenium, and sodium.
• The FDA is seeking public input on whether arachidonic acid, docosahexaenoic acid, and L-carnitine should become required ingredients.
• Later review phases will address remaining required nutrients, potential new nutrient requirements, and carbohydrate sources; the FDA intends to consolidate changes into one comprehensive final rule.
• The FDA reported that most tested formula samples had low or nondetectable chemical contaminant levels and launched a testing webpage and dashboard.

Guideline-Based Recommendations

Diagnosis

Management

• The proposed nutrient requirements are not final; the FDA is accepting comments through February 26, 2027.

Monitoring & Follow-up

• The FDA released chemical contaminant testing data and launched an Infant Formula Testing Webpage and Infant Formula Chemical Contaminants Dashboard.
• Through its Closer to Zero initiative, the FDA is working toward establishing action levels for certain chemical contaminants in infant formula.

Risks

• The source reports that most tested infant formula samples contained low or nondetectable contaminant levels; it does not provide specific contaminant concentrations or individual risk estimates.

Patient & Prescribing Data

Infants receiving infant formula marketed in the United States.

The source describes proposed regulatory nutrient requirements and does not provide individual prescribing or dosing guidance.

Clinical Best Practices

Related Resources & Content

• US Department of Health and Human Services