The Trump administration is proposing new limits for essential vitamins and minerals in infant formula, including higher vitamin D requirements and tighter controls on manganese, as part of a federal initiative to improve infant nutrition and strengthen product safety.
By yourNEWS Media Newsroom
The Food and Drug Administration announced Thursday, Oct. 29, a proposed overhaul of federal infant formula nutrition standards, introducing updated requirements for eight essential nutrients in what officials describe as the first comprehensive review of baby formula composition since 1998.
The proposal, developed under the Trump administration’s Operation Stork Speed initiative, would revise the permitted levels of iodine, manganese, vitamin A and vitamin D while retaining existing standards for sodium, potassium, selenium and chloride. The agency is also considering additional nutritional requirements and changes to ingredient labeling.
Health and Human Services Secretary Robert F. Kennedy Jr., who launched the initiative in March 2025, has made reforming infant formula standards a central component of the administration’s Make America Healthy Again agenda.
“We’re going to make American infant formula the gold standard for the world,” Kennedy said when announcing the initiative.
The FDA’s proposed rule represents the first of three planned regulatory phases examining all 30 nutrients currently required in infant formula sold in the United States. The agency intends to combine the findings into a single comprehensive final regulation after reviewing scientific evidence and public comments.
Among the most significant proposed changes is a doubling of the minimum vitamin D content, from 40 international units to 80 international units per 100 calories. The maximum permitted level would increase from 100 to 120 international units per 100 calories.
Vitamin D is essential for calcium absorption, bone development and healthy growth during infancy. The FDA says the proposed increase reflects updated research into nutritional requirements during early childhood.
The agency also proposes increasing the minimum iodine content from 5 to 15 micrograms per 100 calories while reducing the maximum from 75 to 50 micrograms. Iodine supports thyroid function and neurological development, making appropriate intake particularly important during infancy.
Manganese requirements would undergo substantial revisions. The minimum permitted amount would decrease from 5 micrograms to 1 microgram per 100 calories, while a new maximum of 50 micrograms would be established.
Manganese is necessary for normal growth and metabolism, but excessive exposure during early development can raise neurological concerns. Establishing a maximum concentration would place new limits on how much manufacturers may include in formula products.
Vitamin A requirements would also change, with the FDA proposing lower minimum and maximum concentrations and a revised measurement system based on micrograms of retinol activity equivalents rather than international units.
Under the proposal, only preformed vitamin A would count toward meeting the required levels. The agency would no longer allow beta-carotene to contribute toward those minimum and maximum calculations.
The FDA determined that existing requirements for chloride, selenium, potassium and sodium remain appropriate based on the available scientific evidence and would leave those limits unchanged.
According to a Reuters report published by SRN News, the proposed regulations would also update labeling requirements to reflect the revised nutritional standards and measurement units.
The agency is requesting public input on whether additional substances frequently included in commercial infant formula should become mandatory ingredients. These include docosahexaenoic acid, or DHA; arachidonic acid, known as ARA; and L-carnitine.
DHA and ARA are fatty acids associated with brain and visual development, while L-carnitine plays a role in energy metabolism. Although some manufacturers already include these ingredients, they are not universally required under current federal regulations.
The FDA says additional research will determine whether new requirements are justified.
The broader review follows heightened federal attention to infant formula safety after the nationwide shortage in 2022 exposed vulnerabilities in manufacturing and distribution. The disruption followed contamination concerns and a major production shutdown at an Abbott Nutrition facility in Michigan, leaving parents struggling to obtain formula for their children.
Operation Stork Speed was introduced to strengthen the domestic formula market, expand product options and improve regulatory oversight. The initiative includes updated nutrient standards, increased testing for heavy metals and other contaminants, and efforts to encourage additional manufacturers to enter the U.S. market.
As part of Thursday’s announcement, the FDA also released new chemical contaminant testing results and expanded public access to information about substances detected in infant formula.
The agency said most tested products had low or nondetectable levels of the contaminants examined.
“Parents deserve confidence in every bottle they feed their baby,” Kennedy said in the Department of Health and Human Services’ announcement.
“Under President Trump’s Operation Stork Speed and Make America Healthy Again agenda, we are proposing stronger nutrient requirements, testing formula for contaminants, and putting the results directly in parents’ hands.”
Kennedy said the phased review would allow federal regulators to assess scientific findings while considering public feedback before adopting comprehensive changes.
The three-part review process will next examine 11 additional required nutrients, including several B vitamins, vitamin C, vitamin E, choline and inositol.
The final phase will address more complex nutritional components, including protein, fat, iron, calcium, zinc, copper, phosphorus, magnesium and vitamin K. Regulators will also examine carbohydrate sources and additional ingredients associated with infant development.
The FDA plans to submit the scientific evidence supporting its final decisions for independent peer review.
Under the proposed implementation schedule, a comprehensive final rule would become effective 60 days after publication in the Federal Register. Manufacturers would then have three years to reformulate and relabel affected products, allowing time to adjust manufacturing processes and maintain formula supplies.
Federal regulators estimate that the proposed changes would cost manufacturers approximately $8.4 million to $31.7 million annually, with a central estimate of $17.6 million.
The agency is accepting public comments for 120 days following publication of the proposed rule in the Federal Register. Parents, healthcare professionals, researchers, manufacturers and other interested parties may submit feedback before the FDA determines which requirements to finalize.
The proposed changes do not take effect immediately, and the agency emphasized that infant formulas currently sold in the United States remain safe for babies. Officials said the nutritional review is intended to incorporate updated scientific findings rather than respond to evidence that existing products are broadly unsafe.
The FDA also said the rule would not immediately affect the Special Supplemental Nutrition Program for Women, Infants, and Children, commonly known as WIC, which provides nutrition assistance to eligible families. The agency plans to coordinate with the Agriculture Department to minimize disruptions as manufacturers adapt to any new standards.
The earlier NBC News examination of infant formula regulation highlighted the limited changes to federal nutrient requirements over several decades, despite advances in scientific understanding of infant growth, development and human milk composition.
The latest proposal begins a regulatory process that could substantially change the nutritional composition of commercially available infant formula. Final requirements will depend on the remaining scientific reviews, public comments and the FDA’s evaluation of potential benefits, manufacturing costs and effects on product availability.
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