FDA proposes infant-formula nutrient changes and releases testing data
The first phase would revise four nutrient requirements, while a 312-sample survey reports mostly low or undetectable contaminant levels.
The nutrient proposal is the first of three planned phases
The Food and Drug Administration has proposed updating federal nutrient requirements for infant formula for the first time as part of a comprehensive review begun after the standards were last broadly examined in 1998. The October 29 proposal is not final. It opens a public-comment process before the agency decides whether and how to change the rules.
The first phase would revise required levels for iodine, manganese, vitamin A and vitamin D and reaffirm existing requirements for chloride, potassium, selenium and sodium. It would also change the units used for two nutrients and seek comment on ingredients often added voluntarily, including arachidonic acid, docosahexaenoic acid and L-carnitine.
FDA says later phases will examine the remaining nutrients, possible new requirements and carbohydrate sources. The agency intends to combine the completed work into one comprehensive final rule. Comments on docket FDA-2026-56789 are due February 26, 2027, giving clinicians, researchers, caregivers and manufacturers an opportunity to submit evidence.
A separate market-basket survey covers 312 samples
Alongside the proposal, FDA released results from testing 312 infant-formula samples covering 16 brands and multiple lots. The group included 278 powdered products, 11 concentrated liquids and 23 ready-to-feed formulas. The survey examined toxic elements, 30 PFAS compounds, 318 pesticides, 21 phthalates and one non-phthalate plasticizer.
FDA reports that most samples had undetectable or very low contaminant levels, while some values prompted additional follow-up. Mercury was not detected in 296 samples, and 309 samples had no detectable pesticides. Lead was not detected in 61 samples; among all samples, the reported range extended from non-detectable to 1.1 parts per billion.
Those figures should be interpreted within the survey’s limits. Market-basket testing is designed to identify signals and typical levels in products purchased at retail; it does not represent every product or every production lot. Detection also does not by itself establish that a product is unsafe. FDA says it is conducting more testing and developing risk-management approaches.
The proposal and testing results serve different purposes
Nutrient requirements address what formula must provide for growth and development, while contaminant monitoring addresses substances that can enter food through ingredients, the environment or manufacturing. FDA’s formula program also covers sanitation, pathogen testing, facility inspection, labeling and premarket notification. The agency does not approve individual formulas in the same manner that it approves drugs.
Caregivers should not infer from the rulemaking that current formula must be replaced, nor should they change an infant’s feeding plan solely because a contaminant was detectable in a survey. FDA maintains recall and safety-alert pages for product-specific action. Medical questions, allergies or feeding concerns should be discussed with a pediatric clinician.
The agency’s new testing page and dashboard make the underlying results available by contaminant and product characteristics. Future milestones include review of submitted comments, additional nutrient phases and continued contaminant surveillance. Until a final rule is issued with an effective date, the existing nutrient regulations remain in force.