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Baby Formula Nutrition: US FDA Proposes Changes to Vitamins A, D, Iodine and Manganese – What Parents Must Know

For the first time in nearly three decades, the US Food and Drug Administration (<span>FDA</span>) is proposing changes to nutrient requirements for <span>infant formula</span>. The proposed changes cover vitamins A and D, iodine and manganese under the Trump administration's <span>Operation Stork Speed</span> initiative, announced in March 2025.

The FDA’s first phase of a three-phase review covers eight of the 30 nutrients required in infant formula. It proposes revising requirements for four nutrients and reaffirming existing limits for the other four. It is also seeking public input on nutrients commonly added by manufacturers but not currently required. The agency is accepting comments for 120 days.

“Parents deserve confidence in every bottle they feed their baby,” US Health and Human Services Secretary <span>Robert F. Kennedy Jr.</span> said in a statement.

<strong>Also read</strong>: <a href="https://www.healthandme.com/health-news/major-fda-study-confirms-baby-formula-in-us-safe-testing-to-continue-article-154204476" data-type="tilCustomLink">Major FDA Study Confirms Baby Formula In US Safe, Testing to Continue</a>

The FDA's first phase covers eight nutrients. It proposes changes to four and retaining existing limits for the other four.

<ul><li>Minimum: Increased from 5 to 15 µg/100 kcal.</li><li>Maximum: Reduced from 75 to 50 µg/100 kcal.</li></ul>

<ul><li>Minimum: Reduced from 5 to 1 µg/100 kcal.</li><li>Maximum: A new limit of 50 µg/100 kcal.</li></ul>

<ul><li>Measurement unit changed from IU to micrograms of retinol activity equivalents (µg RAE).</li><li>Minimum: Reduced from 250 IU (75 µg RAE) to 70 µg RAE/100 kcal.</li><li>Maximum: Reduced from 750 IU (225 µg RAE) to 120 µg RAE/100 kcal.</li><li>Only preformed vitamin A, not beta-carotene, will count towards the limits.</li></ul>

<ul><li>Measurement unit changed from IU to micrograms (µg).</li><li>Minimum: Increased from 40 IU (1 µg) to 2 µg (80 IU)/100 kcal.</li><li>Maximum: Increased from 100 IU (2.5 µg) to 3 µg (120 IU)/100 kcal.</li></ul>

The FDA also proposes updating formula labelling requirements to reflect the changes.

<h2>Which Nutrient Limits Will Remain Unchanged?</h2>

<strong>Read More: </strong><a href="https://www.healthandme.com/nutrition/new-international-food-pyramid-highlights-plant-foods-counters-trump-s-meat-heavy-diet-advice-article-156430994" data-type="tilCustomLink">New International Food Pyramid Highlights Plant Foods, Counters Trump’s Meat-Heavy Diet Advice</a>

The FDA proposes retaining existing levels for:

<ul><li>Chloride: 55–150 mg/100 kcal.</li><li>Potassium: 80–200 mg/100 kcal.</li><li>Selenium: 2–7 µg/100 kcal.</li><li>Sodium: 20–60 mg/100 kcal.</li></ul>

The FDA says formulas currently sold in the US remain safe for babies. The proposed changes are not prompted by safety concerns but aim to align standards with current scientific evidence.

Parents do not need to change the formula they currently use.

<h2>When Will The Changes Take Effect?</h2>

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The FDA is reviewing all 30 nutrients in three phases. The first covers eight, with the remaining 22 to follow.

The final rule will take effect 60 days after publication in the Federal Register. Manufacturers will have three years from that date to reformulate and relabel their products.

This means the proposed changes will not appear on formula packaging immediately.

Dr Steven Abrams, a paediatrician and professor at the University of Texas' Dell Medical School, called the update overdue. He described the first phase as “really well done” and “very well thought-out”, CNN reported.

However, he said the phased approach means manufacturers could take several years to implement the changes.

“These changes that they're recommending today are not going to be something that'll show up on the can of formula potentially for several years,” Abrams said.

He identified the proposed vitamin D increase as the most consequential change in this phase.

Meanwhile, the FDA is also seeking input on making commonly added nutrients such as DHA, ARA and L-carnitine mandatory. These are not currently required in infant formula.

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For the first time in nearly three decades, the US Food and Drug Administration (FDA) is proposing changes to nutrient requirements for infant formula. The proposed changes cover vitamins A and D, iodine and manganese under the Trump administration's Operation Stork Speed initiative, announced in March 2025. The FDA’s first phase of a three-phase review covers eight of the 30 nutrients required in infant formula. It proposes revising requirements for four nutrients and reaffirming existing limits for the other four. It is also seeking public input on nutrients commonly added by manufacturers but not currently required. The agency is accepting comments for 120 days.“Parents deserve confidence in every bottle they feed their baby,” US Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement.What Are The Proposed Changes?Also read: Major FDA Study Confirms Baby Formula In US Safe, Testing to ContinueThe FDA's first phase covers eight nutrients. It proposes changes to four and retaining existing limits for the other four.1. IodineMinimum: Increased from 5 to 15 µg/100 kcal.Maximum: Reduced from 75 to 50 µg/100 kcal.2. ManganeseMinimum: Reduced from 5 to 1 µg/100 kcal.Maximum: A new limit of 50 µg/100 kcal.3. Vitamin AMeasurement unit changed from IU to micrograms of retinol activity equivalents (µg RAE).Minimum: Reduced from 250 IU (75 µg RAE) to 70 µg RAE/100 kcal.Maximum: Reduced from 750 IU (225 µg RAE) to 120 µg RAE/100 kcal.Only preformed vitamin A, not beta-carotene, will count towards the limits.4. Vitamin DMeasurement unit changed from IU to micrograms (µg).Minimum: Increased from 40 IU (1 µg) to 2 µg (80 IU)/100 kcal.Maximum: Increased from 100 IU (2.5 µg) to 3 µg (120 IU)/100 kcal.The FDA also proposes updating formula labelling requirements to reflect the changes.Which Nutrient Limits Will Remain Unchanged?Read More: New International Food Pyramid Highlights Plant Foods, Counters Trump’s Meat-Heavy Diet AdviceThe FDA proposes retaining existing levels for:Chloride: 55–150 mg/100 kcal.Potassium: 80–200 mg/100 kcal.Selenium: 2–7 µg/100 kcal.Sodium: 20–60 mg/100 kcal.What Do Parents Need To Know?The FDA says formulas currently sold in the US remain safe for babies. The proposed changes are not prompted by safety concerns but aim to align standards with current scientific evidence.Parents do not need to change the formula they currently use.When Will The Changes Take Effect?   The FDA is reviewing all 30 nutrients in three phases. The first covers eight, with the remaining 22 to follow.The final rule will take effect 60 days after publication in the Federal Register. Manufacturers will have three years from that date to reformulate and relabel their products.This means the proposed changes will not appear on formula packaging immediately.Dr Steven Abrams, a paediatrician and professor at the University of Texas' Dell Medical School, called the update overdue. He described the first phase as “really well done” and “very well thought-out”, CNN reported.However, he said the phased approach means manufacturers could take several years to implement the changes.“These changes that they're recommending today are not going to be something that'll show up on the can of formula potentially for several years,” Abrams said.He identified the proposed vitamin D increase as the most consequential change in this phase.Meanwhile, the FDA is also seeking input on making commonly added nutrients such as DHA, ARA and L-carnitine mandatory. These are not currently required in infant formula.

baby formula nutrition us fda proposes changes to vitamins a d iodine and manganese what parents must know

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Baby Formula Nutrition: US FDA Proposes Changes to Vitamins A, D, Iodine and Manganese – What Parents Must Know

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Baby Formula Nutrition: US FDA Proposes Changes to Vitamins A, D, Iodine and Manganese – What Parents Must Know

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