FDA plans to update infant formula nutrition requirements for first time in nearly 30 years

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The US Food and Drug Administration is proposing changes to nutrient requirements for infant formula. The update marks the first nutrition review for formula in nearly 30 years, the agency’s acting director, Kyle Diamantas, said Thursday.

The review is part of the Trump administration’s Operation Stork Speed initiative, which was announced in March 2025.

The first phase of the review makes changes to four of the 30 required nutrients in formula: iodine, manganese, vitamin A and vitamin D.

Iodine is important for the production of thyroid hormone and brain development in infants. The proposed rule triples the amount of iodine required in infant formula, from 5 micrograms to 15, and sets a new upper limit of 50 micrograms.

Manganese is a trace mineral that supports enzyme function and bone development. The proposal reduces the minimum required amount from 5 micrograms to 1 microgram per 100 calories, and it establishes a new limit of 50 micrograms.

Vitamin A supports vision, immune function and cell growth. The proposal decreases the amount of vitamin A required in formula, from 250 international units per 100 calories to 233 IU. It would also change the units of measure for vitamin A from IU to retinol activity equivalents, or RAE.

Vitamin D helps with development of bones and teeth and helps prevent rickets, or soft bones. The proposed rule doubles the minimum required amount of vitamin D from 1 to 2 micrograms and increases the maximum amount allowed to 3 micrograms.

The proposed rule also reaffirms requirements for chloride, potassium, selenium and sodium.

Dr. Steven Abrams, a pediatrician and professor at the University of Texas’ Dell Medical School, said the nutrition update was overdue. He praised the first phase as “really well done” and “very well thought-out.”

The problem, Abrams said, is that the review is tackling the nutrient list piecemeal. This first group of nutrients will be followed by 12 in the next year or so and another batch of 10 after that. That means parents aren’t likely to see any changes to infant formula anytime soon, he said.

“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,” said Abrams, who is an expert on infant nutrition.

The nutrition review was conducted by the FDA’s staff scientists and will be submitted for peer review, as required by law.

“Parents deserve confidence in every bottle they feed their baby,” US Health and Human Services Secretary Robert F. Kennedy Jr. said in a news release.

“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. We will hold infant formula manufacturers to rigorous scientific standards and put babies’ health first.”

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The most consequential change in this first slate of recommendations is the proposal to increase vitamin D, Abrams said.

Right now, the amount of vitamin D in infant formula is a little below the recommended amount for babies. Many parents supplement formula with extra vitamin D.

Adding more vitamin D to formula could potentially save nearly $81 million each year in medical costs tied to a diagnosis of late-onset hypocalcemia, or low blood calcium, the proposed rule said. Vitamin D helps the body absorb calcium and phosphorus from food.

The FDA looked at several lines of evidence supporting the planned nutrition changes, including nutrient reference values, or what the minimum amount would be to support health growth and development, as well as what would be considered toxic for an infant. It also looked at the nutrient composition of human milk, nutrient standards used by other countries and new studies published since 1998.

Diamantas said the agency is seeking public input on nutrients that are not currently required to be added to infant formula but are commonly added by manufacturers, including long-chain fatty acids like ARA and DHA, as well as L-carnitine, which helps the body break down fats and use them in tissues.

“There’s evidence that these nutrients contribute to neurodevelopment and health in infancy. And we want to hear from the scientific community, from clinicians, from industry, and the public as we consider whether or not to make these nutrients mandatory in the U.S. infant formula supply,” Diamantas said.

The FDA said its nutrient review for infant formula is ongoing. Subsequent phases of this review will assess all of the remaining required nutrients, potential new nutrient requirements and carbohydrate sources, Diamantas said.

On Thursday , health officials also provided an update on ongoing testing for chemical contaminants in infant formula; the latest batch of results “continue to be reassuring,” Diamantas said.

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美国食品药品监督管理局（FDA）提议修改婴儿配方奶粉的营养成分要求。该机构代理局长凯尔·迪亚曼塔斯周四表示，此次更新是近30年来首次对配方奶粉的营养成分进行审查。

此次审查是特朗普政府“鹳鸟速度行动”计划的一部分，该计划于 2025 年 3 月宣布。

审查的第一阶段对配方奶粉中 30 种必需营养素中的 4 种进行了修改：碘、锰、维生素 A 和维生素 D。

碘对婴儿甲状腺激素的生成和大脑发育至关重要。拟议规则将婴儿配方奶粉中碘的含量要求从5微克提高到15微克，是之前的3倍，并将上限设定为50微克。

锰是一种微量元素，有助于酶的功能和骨骼发育。该提案将每100卡路里所需的最低锰含量从5微克降低到1微克，并设定了50微克的新上限。

维生素A有助于维持视力、免疫功能和细胞生长。该提案将配方奶粉中维生素A的含量从每100卡路里250国际单位（IU）降低至233国际单位（IU）。此外，维生素A的计量单位也将从国际单位（IU）改为视黄醇活性当量（RAE）。

维生素D有助于骨骼和牙齿发育，并有助于预防佝偻病（软骨病）。拟议规则将维生素D的最低需求量从1微克提高到2微克，并将最高允许摄入量提高到3微克。

拟议规则还重申了对氯化物、钾、硒和钠的要求。

德克萨斯大学戴尔医学院儿科医生兼教授史蒂文·艾布拉姆斯博士表示，营养学更新早就应该发布了。他称赞第一阶段“做得非常好”且“考虑得非常周全”。

艾布拉姆斯说，问题在于此次审查是分阶段进行的。第一批营养素之后，大约一年左右会审查12种，之后还会再审查10种。这意味着家长们短期内不太可能看到婴儿配方奶粉有任何变化。

“他们今天提出的这些改变，可能要过好几年才会体现在配方奶粉罐上，”婴儿营养专家艾布拉姆斯说。

营养成分审查由美国食品药品监督管理局 (FDA) 的科学家进行，并将按照法律规定提交同行评审。

美国卫生与公众服务部部长小罗伯特·F·肯尼迪在一份新闻稿中表示：“父母应该对他们喂给宝宝的每一瓶奶都充满信心。”

“在特朗普总统的‘鹳鸟速成行动’和‘让美国再次健康’计划的指导下，我们提议提高营养标准，检测配方奶粉中的污染物，并将检测结果直接告知家长。我们将要求婴儿配方奶粉生产商遵守严格的科学标准，并将婴儿的健康放在首位。”

小罗伯特·肯尼迪正在调查婴儿配方奶粉。这其中牵涉到很多问题。

艾布拉姆斯表示，第一批建议中最具影响力的变化是增加维生素 D 的提议。

目前，婴儿配方奶粉中的维生素D含量略低于婴儿的推荐摄入量。许多家长会额外给配方奶粉补充维生素D。

拟议规则指出，在配方奶粉中添加更多维生素D，每年可节省近8100万美元与迟发性低钙血症（即血液中钙含量低）相关的医疗费用。维生素D有助于人体从食物中吸收钙和磷。

美国食品药品监督管理局（FDA）审查了多项支持计划中的营养成分调整的证据，包括营养素参考值（即支持健康成长发育的最低摄入量）以及对婴儿有毒的摄入量。此外，FDA还研究了母乳的营养成分、其他国家使用的营养标准以及1998年以来发表的新研究。

迪亚曼塔斯表示，该机构正在征求公众意见，以了解目前婴儿配方奶粉中不需要添加但制造商通常会添加的营养成分，包括 ARA 和 DHA 等长链脂肪酸，以及 L-肉碱，L-肉碱有助于身体分解脂肪并将其用于组织中。

“有证据表明，这些营养素有助于婴儿的神经发育和健康。在考虑是否强制要求美国婴儿配方奶粉中添加这些营养素时，我们希望听取科学界、临床医生、行业人士和公众的意见，”迪亚曼塔斯说。

美国食品药品监督管理局（FDA）表示，对婴儿配方奶粉的营养成分审查仍在进行中。迪亚曼塔斯表示，后续阶段的审查将评估所有剩余的必需营养素、潜在的新营养素需求以及碳水化合物来源。

周四，卫生官员还提供了有关婴儿配方奶粉中化学污染物持续检测的最新情况；迪亚曼塔斯说，最新一批检测结果“继续令人放心”。