FDA Overhauls Infant Formula Rules for First Time in Nearly 30 Years

The baby formula on American store shelves is governed by nutrition rules written in 1998. Now, for the first time in nearly three decades, the Food and Drug Administration has proposed rewriting them.

Announced on October 29, 2026, the proposed rule is the opening phase of a three-part review of all 30 nutrients required in infant formula sold in the United States. It would raise the minimum amounts of iodine and vitamin D, tighten vitamin A limits, and set a first-ever maximum for manganese. The agency stresses that the changes are not yet in force — and that formula currently on sale remains safe.

The proposal sits inside Operation Stork Speed, the Trump administration initiative launched in March 2025 to review infant formula safety and nutrition.

What would change: four nutrients, new limits

The first phase covers eight nutrients. Four would see their required levels revised, all measured per 100 calories of prepared formula:

• Iodine: the minimum would triple, from 5 to 15 micrograms, while the maximum would fall from 75 to 50 micrograms. Iodine supports thyroid hormone production and brain development in infants.
• Manganese: the minimum would drop from 5 to 1 microgram, and a new upper limit of 50 micrograms would be set — the first cap ever for the mineral, which supports enzyme function and bone development but can harm the developing brain in excess.
• Vitamin A: the range would narrow from 75–225 to 70–120 micrograms of retinol activity equivalents (RAE), and only preformed vitamin A — not beta-carotene — would count toward the limit. The agency would also switch the unit of measurement from international units (IU) to micrograms RAE. Vitamin A supports vision, immune function and cell growth.
• Vitamin D: the minimum would double, from 1 to 2 micrograms, and the maximum would rise from 2.5 to 3 micrograms. Units would switch from IU to micrograms. Vitamin D helps build bones and teeth and prevents rickets, a softening of the bones.

What would stay the same

Four nutrients reviewed in this phase would keep their current levels, after the FDA concluded the existing specifications remain appropriate: sodium (20–60 milligrams), potassium (80–200 milligrams), chloride (55–150 milligrams) and selenium (2–7 micrograms), all per 100 calories.

The proposal would not add or remove any required nutrient. It would, however, ask for public input on whether nutrients that manufacturers commonly add already — such as DHA and ARA fatty acids and L-carnitine, which evidence links to infant brain development — should become required in the future.

Why the FDA is acting now

Infant formula is, for many babies, their only source of nutrition, and its nutrient requirements have not had a comprehensive review since 1998. Since then, the science on infant nutrition — including how much iodine and vitamin D babies need, and how much manganese is too much — has moved on, and so has the composition of breast milk research the standards are benchmarked against.

“Under President Trump’s leadership, we are modernizing our nutritional requirements for infant formula for the first time in nearly three decades,” FDA Acting Commissioner Kyle Diamantas said in the announcement.

Alongside the rule, the FDA released new chemical contaminant testing data showing most infant formula samples had low or non-detectable levels of contaminants, and launched a public testing webpage and chemical contaminants dashboard. The agency said it is working toward action levels for certain contaminants under its Closer to Zero initiative.

What it means for parents right now: nothing changes yet

The most important message for families is timing. This is a proposed rule, not a final one. Nothing on store shelves changes today, and parents do not need to switch formulas or stockpile products.

The FDA said explicitly that the proposal is a modernization effort, not a response to a finding that existing formulas are unsafe. Pediatric health authorities continue to say breast milk is optimal for the first six months when possible, and that commercially prepared formula is the validated alternative when breast milk is unavailable, insufficient or not advised.

Families with questions about a specific baby’s feeding — including premature infants, babies with allergies or medical conditions, or anyone considering a formula change — should speak with their pediatrician rather than making changes based on a regulatory announcement.

The criticism: a piecemeal review, and a testing gap

Not everyone is satisfied with the pace. Because the review is split into three phases, with 12 more nutrients due in the next phase and the remaining 10 after that, critics note that parents are unlikely to see any changed formula on shelves for years. The FDA plans to fold all three phases into a single final rule, which would take effect 60 days after publication, with manufacturers then given a proposed three years to reformulate and relabel.

Others have pointed to what the rule does not cover: it does not change bacterial testing requirements for powdered formula, and commentators have noted recent infant botulism outbreaks involved an organism not currently on the mandatory finished-product testing list.

What happens next

The public comment period is open, with comments due by February 26, 2027, through regulations.gov. The FDA will also put the science behind the proposal through external peer review, as required by law. Phases two and three will then assess the remaining required nutrients, potential new requirements and carbohydrate sources, before one comprehensive final rule.

For now, the message from regulators is reassurance mixed with a long horizon: the standards are finally being updated, but the formula parents buy today is the same formula they bought last week — and, by the agency’s own account, it remains safe.

Frequently asked questions

Is current baby formula still safe?
Yes, according to the FDA. The agency says the proposal modernizes standards based on current science; it is not driven by a finding that formulas now on sale are unsafe.

Do I need to change my baby’s formula?
No. The rule is only proposed, and no product changes are required until a final rule is issued and a compliance period runs. Talk to your pediatrician before changing a baby’s formula for any reason.

Which nutrients would change?
Iodine, manganese, vitamin A and vitamin D would have revised limits. Sodium, potassium, chloride and selenium would stay the same.

When could the new formula reach shelves?
Not soon. The FDA plans a single final rule covering all three phases, effective 60 days after publication, with a proposed three-year compliance window for manufacturers after that.

How can the public weigh in?
Comments are open until February 26, 2027, via regulations.gov. The FDA invited input from parents, caregivers, clinicians, scientists and industry.

Sources: FDA: Infant Formula Notice of Proposed Rulemaking | HHS: First Major Update to Infant Formula Standards in Nearly 30 Years | CNN: FDA plans to update infant formula nutrition requirements for first time in nearly 30 years | Contemporary Pediatrics: FDA proposes new iodine, vitamin A and D limits for infant formula