FDA Calls on Infant Formula Industry to Better Safeguard Against Contaminants Introduced through their Supply Chain (FDA 呼吁婴儿配方奶粉行业加强防范供应链引入的污染物)

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FDA Calls on Infant Formula Industry to Better Safeguard Against Contaminants Introduced through their Supply Chain

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On July 13, 2026, the U.S. Food and Drug Administration sent a letter to the infant formula industry and their supply chain partners highlighting multiple recent public health events where risks were introduced through the supply chain and to call for increased vigilance by industry to ensure the safety of ingredients and finished infant formula products.

Recent public health events have underscored the critical importance of robust supplier oversight. FDA has investigated two multistate outbreaks of infant botulism associated with two separate brands of powdered infant formula — ByHeart, Inc., and Nara Organics, Inc. — resulting in voluntary recalls and an ongoing FDA investigation into the shared ingredient suppliers. Likewise, a global contamination event occurring in late 2025 through early 2026 resulted in nearly 150 suspected and confirmed cases of cereulide intoxication across 10 countries, traced to contaminated arachidonic acid (ARA) oil used as an ingredient in infant formula. This prompted multiple global downstream recalls, and a supplier of ARA oil being added to multiple import alerts.

Manufacturer Responsibility: Know Your Suppliers

The FDA expects manufacturers to exercise substantive oversight of their suppliers, including understanding where their ingredients come from, how they are produced, what risks they may carry, and whether those risks are effectively controlled. When a contaminated ingredient or supplier concern is identified, whether by FDA or through industry’s own monitoring, manufacturers are expected to act swiftly to assess and address the risk.

The FDA also recommends that infant formula manufacturers and their supply chain partners stay abreast of applicable recall notifications, outbreak investigations and import alerts, which may serve as important safety signals. Experience has shown that ignoring or downplaying these safety signals can lead to increased risks to infants and preventable public health events.

FDA Actions

The FDA acknowledges the challenges in managing the risks related to spore-forming microbes in infant formula ingredients and recognizes there might not be a single approach for addressing them. The Agency is prepared to work with industry to identify best practices and will continue to solicit advice from experts in academia and international scientific bodies, such as the Codex Committee on Food Hygiene and the International Commission on Microbiological Specifications for Foods.

The FDA also is continuing to investigate the root causes of the 2025 and 2026 infant botulism outbreaks associated with powdered infant formula and has completed initial surveillance to better understand the prevalence of Clostridium botulinum in powdered milk, the results of which are available on FDA’s Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.

Infants are a uniquely vulnerable population. Infant formula, whether used exclusively or in combination with breastfeeding, is an important source of nutrition for many infants, and its safety is paramount. The FDA calls on all members of the infant formula industry to use the information in this letter to take prompt action to strengthen supplier oversight programs and safeguard the integrity of the infant formula supply chain. The Agency appreciates the industry’s continued commitment to ensuring the safety of infant formula products marketed in the United States and looks forward to continued collaboration in protecting the health of infants and their families.

Additional Information

An unofficial translation of this announcement is provided below.

翻译参考：

FDA 呼吁婴儿配方奶粉行业加强防范供应链引入的污染物

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2026 年 7 月 13 日，美国食品药品管理局（FDA）向婴儿配方奶粉行业及其供应链合作伙伴发出一封信函，重点指出近期多起通过供应链引入风险的公共卫生事件，并呼吁行业提高警惕，确保原料及成品婴儿配方奶粉的安全。

近期发生的多起公共卫生事件再次凸显了强化供应商监管的极端重要性。FDA 已就两个独立品牌的婴儿配方奶粉——ByHeart, Inc. 和 Nara Organics, Inc.——引发的两起多州婴儿肉毒中毒暴发展开调查，相关产品已自愿召回，FDA 对共同原料供应商的调查仍在进行中。此外，2025年底至2026年初发生的一起全球性污染事件，导致10个国家近150例疑似及确诊的蜡样芽孢杆菌毒素（cereulide）中毒病例，溯源至婴儿配方奶粉中作为原料使用的受污染花生四烯酸（ARA）油。此事件引发全球多起下游产品召回，相关ARA油供应商亦被纳入多项进口警告。

制造商责任：了解您的供应商

FDA 要求制造商对其供应商实施实质性监管，包括了解原料的来源、生产方式、潜在风险及风险控制是否有效。一旦发现受污染原料或供应商问题——无论是由FDA发现还是通过行业自身监测发现——制造商均应迅速采取行动，评估并应对相关风险。

FDA 还建议婴儿配方奶粉制造商及其供应链合作伙伴密切关注适用的召回通知、暴发调查及进口警告，这些信息可作为重要的安全预警信号。经验表明，忽视或淡化上述安全信号可能导致婴儿面临更大风险，并引发本可预防的公共卫生事件。

FDA 的行动

FDA 认识到管控婴儿配方奶粉原料中产芽孢微生物相关风险所面临的挑战，并承认可能不存在单一的解决方案。FDA 愿与行业合作，共同识别最佳实践，并将继续向学术界及国际科学机构的专家征询意见，包括食品法典食品卫生委员会和国际食品微生物规格委员会。

FDA 还在持续调查2025年和2026年与婴儿配方奶粉相关的婴儿肉毒中毒暴发的根本原因，并已完成初步监测工作，以更好地了解肉毒梭菌（Clostridium botulinum）在奶粉中的流行情况。相关结果已发布于FDA"暴发后应对活动：与婴儿配方奶粉消费相关的肉毒梭菌致病"网页。

婴儿是极为脆弱的特殊群体。婴儿配方奶粉——无论是单独使用还是与母乳喂养结合使用——是许多婴儿的重要营养来源，其安全性至关重要。FDA 呼吁婴儿配方奶粉行业全体成员参照本信函所提供的信息，迅速采取行动，强化供应商监管体系，保障婴儿配方奶粉供应链的完整性。FDA 感谢行业持续致力于确保在美国市场销售的婴儿配方奶粉产品的安全，并期待继续携手合作，共同保护婴儿及其家庭的健康。