FDA Proposes First Substantial Revision of Infant Formula Standards in Nearly Three Decades

Category	Detail
Condition	Clinical topic addressed by the source article: FDA Proposes First Substantial Revision of Infant Formula Standards in Nearly Three Decades
Key Mechanisms	The FDA proposes revisions to requirements for iodine, manganese, vitamin A, and vitamin D; reaffirms requirements for chloride, potassium, selenium, and sodium; and reports chemical contaminant testing. The FDA is working to establish action levels for selected contaminants.
Target Population	Patients or participants described in the source article.
Care Setting	Care setting described in the source article.

The FDA proposed the first phase of a planned three-phase review of the 30 nutrients currently required in U.S.-marketed infant formula.
The proposal would revise requirements for iodine, manganese, vitamin A, and vitamin D and reaffirm existing requirements for chloride, potassium, selenium, and sodium.
The FDA is seeking public comment on possible requirements for ingredients not currently mandated but frequently added by manufacturers, including ARA, DHA, and L-carnitine.
Most tested infant formula samples contained chemical contaminants at low or non-detectable levels, according to the FDA.
The FDA published testing information through an Infant Formula Testing Webpage and an Infant Formula Chemical Contaminants Dashboard.

The FDA reported that most tested infant formula samples contained chemical contaminants at low or non-detectable concentrations, consistent with results issued earlier this year.

Infants receiving formula; the article provides no patient-level prescribing or treatment data.

No formula selection or prescribing recommendations are provided. The nutrient changes described are proposed and would apply if finalized.

For information on FDA contaminant testing, consult the agency's Infant Formula Testing Webpage and Chemical Contaminants Dashboard.
Written comments on the proposed rule should identify docket FDA-2026-56789; electronic submissions may be made through regulations.gov.

Clinical Scorecard: FDA Proposes Revisions to Infant Formula Nutrient Requirements and Reports Contaminant Testing Results