美国FDA拟议近30年首次更新婴儿配方奶粉营养标准：碘、维生素A、维生素D与锰四项限值调整
美国卫生与公众服务部（Department of Health and Human Services，HHS）10月29日宣布，食品药品监管局（Food and Drug Administration，FDA）发布拟议规则，拟更新在美国销售的婴儿配方奶粉营养素标准。这是 FDA 自 1998 年以来首次对婴儿配方奶粉全部营养素要求进行全面审查，卫生与公众服务部长 Robert F. Kennedy, Jr. 当天在 Des Moines, Iowa 的 Amanda the Panda Children Center 宣布这一消息。
此次行动是特朗普总统「Operation Stork Speed」行动与「让美国再次健康」（Make America Healthy Again）议程的一部分。FDA 此次共采取两项行动：一是发布营养标准拟议规则；二是公布新的化学污染物检测数据，显示多数受检婴儿配方奶粉样本的污染物含量为低水平或未检出，并上线新的婴儿配方奶粉检测网页与化学污染物数据面板。
拟议规则是 FDA 三阶段审查的第一阶段，涉及现行 30 种必需营养素中的 8 种。其中，碘、锰、维生素 A 与维生素 D 四项的限值拟作调整，氯、钾、硒、钠四项经评估后维持现行限值不变。
具体调整包括：碘的最低限由每 100 千卡 5 微克提高到 15 微克、最高限由 75 微克降到 50 微克；锰的最低限由每 100 千卡 5 微克降到 1 微克，并新设每 100 千卡 50 微克的最高限；维生素 A 的计量单位由国际单位改为微克视黄醇活性当量，最低限降至每 100 千卡 70 微克、最高限降至 120 微克，且只有预制维生素 A 计入限值；维生素 D 的计量单位由国际单位改为微克，最低限提高到每 100 千卡 2 微克、最高限提高到 3 微克。拟议规则同时拟更新婴儿配方奶粉标签要求，使其与新的营养标准一致。
FDA 还就三项目前并非必需、但生产商普遍添加的成分征求公众意见：花生四烯酸（ARA）、二十二碳六烯酸（DHA）与左旋肉碱。FDA 说，现有证据显示这三项成分有助于婴儿的神经发育健康。
Robert F. Kennedy, Jr. 说：「家长们应当对喂给宝宝的每一瓶奶都有信心。我们正在提出更严格的营养要求，检测配方奶粉中的污染物，并把结果直接交到家长手中。我们将以严格的科学标准要求婴儿配方奶粉生产商，把宝宝的健康放在首位。」
FDA 代理局长 Kyle Diamantas 说：「在特朗普总统的领导下，我们近三十年来首次更新婴儿配方奶粉的营养要求。我们正着手确保美国宝宝从第一天起就获得世界级的高标准营养。」
FDA 表示，现行市售婴儿配方奶粉仍然安全，此次调整不是出于安全担忧，而是为了让标准与最新科学认识保持一致。后续第二、三阶段将审查其余营养素、潜在新增营养素与碳水化合物来源，FDA 计划把全部变更合并为一项综合最终规则：最终规则在《联邦公报》刊登 60 天后生效，并拟给行业三年的合规期完成配方与标签调整。
公众可在 2027 年 2 月 26 日前就拟议规则提交意见，案卷号为 FDA-2026-56789，提交入口见 regulations.gov 公众评议提交页面。
FDA Proposes First Update to Infant Formula Nutrient Standards in Nearly 30 Years, Adjusting Iodine, Vitamin A, Vitamin D and Manganese
The U.S. Department of Health and Human Services (HHS) announced on October 29 that the Food and Drug Administration (FDA) has issued a proposed rule that would update nutrient requirements for infant formula marketed in the United States. It is the FDA's first comprehensive review of all infant formula nutrient requirements since 1998. HHS Secretary Robert F. Kennedy, Jr. made the announcement at Amanda the Panda Children Center in Des Moines, Iowa.
The actions are part of President Trump's Operation Stork Speed and the broader Make America Healthy Again initiative. The FDA took two actions: issuing the proposed nutrient rule, and releasing new chemical contaminant testing data showing that most infant formula samples tested had low or non-detectable levels of contaminants, alongside a new Infant Formula Testing Webpage and Chemical Contaminants Dashboard.
The proposed rule is the first phase of the FDA's three-phase review and covers eight of the 30 nutrients currently required in infant formula. Requirements for iodine, manganese, vitamin A, and vitamin D would be updated, while existing requirements for chloride, potassium, selenium, and sodium would be reaffirmed.
Under the proposal, the minimum level of iodine would rise from 5 micrograms per 100 kilocalories to 15, and the maximum would fall from 75 to 50. The minimum level of manganese would fall from 5 micrograms per 100 kilocalories to 1, with a new maximum of 50. Vitamin A would be measured in microgram retinol activity equivalents instead of International Units, with the minimum lowered to 70 micrograms per 100 kilocalories and the maximum to 120, and only preformed vitamin A counting toward the limits. Vitamin D would be measured in micrograms instead of International Units, with the minimum raised to 2 micrograms per 100 kilocalories and the maximum to 3. Labeling requirements would also be updated to match.
The FDA is also requesting public input on potential requirements for three ingredients that are not currently required but are commonly added by manufacturers: arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine. The agency said evidence supports that these nutrients contribute to neurodevelopmental health in infancy.
"Parents deserve confidence in every bottle they feed their baby," said HHS Secretary Robert F. Kennedy, Jr. "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."
"Under President Trump's leadership, we are modernizing our nutritional requirements for infant formula for the first time in nearly three decades," said FDA Acting Commissioner Kyle Diamantas. "We are stepping up to guarantee that American babies receive world class, gold-standard nourishment from day one."
The FDA said infant formulas currently on the market remain safe, and that the proposed changes are not driven by safety concerns but are meant to align standards with current science. Phases two and three will assess the remaining nutrients, potential new nutrient requirements, and carbohydrate sources. The FDA intends to consolidate all changes into a single comprehensive final rule, effective 60 days after publication in the Federal Register, with a proposed compliance date of three years from the effective date for industry to reformulate and relabel products.
Public comments on the proposed rule are due by February 26, 2027, under docket number FDA-2026-56789, and may be submitted through the regulations.gov public comment submission page.
来源：GSM·美国（原文链接）
图片来源：图：位于华盛顿的美国卫生与公众服务部总部 Hubert H. Humphrey 大楼入口。G. Edward Johnson 摄，经 Wikimedia Commons，授权 CC BY 4.0。 / Photo: Entrance to the U.S. Department of Health and Human Services headquarters, the Hubert H. Humphrey Building, in Washington. Photo by G. Edward Johnson, via Wikimedia Commons, CC BY 4.0.
