FDA Issues Letter Regarding Safeguarding Against Contaminants Introduced through the Infant Formula Supply Chain

On July 13, 2026, the Food and Drug Administration (“FDA” or “the Agency”) sent a letter to members of the infant formula industry and their partners in response to recent public health events involving risks introduced through the infant formula supply chain. FDA’s letter urges infant formula manufacturers to appropriately oversee their suppliers and encourages manufacturers and their supply chain partners to monitor for potential safety signals including applicable recall notifications, outbreak investigations, and import alerts. The letter is the most recent action as part of the Agency’s continued focus in this Administration on issues related to infant formula, including through Operation Stork Speed.

Key Points in FDA’s Letter

FDA states that its letter is intended for manufacturers, packagers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of infant formula and ingredients used in infant formula, focusing on supplier oversight and ingredient safety. Specifically:

• FDA explains that the letter was prompted by three recent public health events involving infant formula: two multistate outbreaks of infant botulism and a set of global recalls of infant formula related to cereulide contamination. The letter notes that the infant botulism outbreaks may have been linked to a particular dairy ingredient supplier, and that FDA’s investigation of these matters, which is focused on ingredients and their production environments, remains ongoing. The cereulide-related recalls, according to the letter, were traced to contaminated arachidonic acid (ARA) oil from a supplier based in China. FDA describes these incidents to highlight that the relevant risks derived from issues in the infant formula supply chain, rather than in the finished product manufacturing environment.
• FDA urges infant formula manufacturers to “know your suppliers,” reminding industry of FDA’s expectations and requirements regarding supplier monitoring and related topics. The Agency:
  • Reiterates its position outlined in its March 2023 Letter to the Powdered Infant Formula Industry that suppliers of ingredients that do not receive a lethal treatment at the infant formula facility are considered an extension of the infant formula manufacturing process;
  • Points to its regulations at 21 CFR Part 106 requiring that infant formula manufacturers maintain production and in-process controls, including “developing and enforcing ingredient specifications, quarantining and dispositioning ingredients that fail to meet those specifications, and conducting regularly scheduled audits to verify compliance with current good manufacturing practices (CGMPs) and quality control procedures;”
  • References FDA’s CGMP regulations at 21 CFR Part 117, which require that manufacturers and suppliers maintain food safety plans including a hazard analysis, preventive controls, and a risk-based supply chain program (as applicable);
  • Reminds infant formula manufacturers that they must develop a redundancy risk management plan identifying and evaluating risks to the supply of infant formula; and
  • Generally highlights that FDA will hold manufacturers responsible for overseeing suppliers, including understanding the source of ingredients, their production method, potential risks, and whether those risks are being controlled by the supplier.
• Additionally, FDA’s letter counsels members of the infant formula industry, including manufacturers and their supply chain partners, to “stay abreast” of events that may serve as signals that an ingredient or supplier presents a risk, including recall notifications, outbreak investigations, and import alerts. FDA states that the Agency expects manufacturers to act quickly when an ingredient contamination or supplier concern is identified.
• Finally, FDA acknowledges that there may not be a single approach to managing risks related to spore forming microbes in infant formula ingredients, and describes some of its ongoing activities working with experts and key international scientific bodies, such as Codex and the International Commission on Microbiological Specifications for Foods, to help identify best practices to mitigate risk.

If you have any questions concerning the material discussed in this client alert, or any other aspects of infant formula regulation or Operation Stork Speed, please contact the following members of our Food, Beverage, and Dietary Supplements practice.