September 16, 2025
On July 9, 2025, the U.S. Food and Drug Administration (FDA) sent a letter to businesses involved in the manufacturing and distribution of infant formula, baby foods, and foods intended for children. The communication urged businesses to streamline product recall communications with the agency and the public.
The FDA has been on high alert when it comes to infant formula since a recall in early 2022 resulted in a global shortage of the product and months of distribution disruption for the U.S. supply. It also prompted extensive internal and external reviews of the agency. Since then, the FDA has taken several additional steps to secure the infant formula supply chain and ensure the quality and safety of infant formula.
Most recently, in December 2024, the FDA issued a draft guidance outlining the steps infant formula manufacturers must follow to notify the agency in the event of a permanent discontinuance or manufacturing interruption that could significantly disrupt the U.S. supply of the product. Infant formula and other foods intended for young children remain a priority topic on the Human Foods Program’s (HFP’s) proposed guidance agenda.
In March, the FDA announced “Operation Stork Speed” to help the agency ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply. Under this plan, the FDA has committed to increasing testing for heavy metals and other contaminants in infant formula and other foods children consume, extending the personal importation policy for formula made outside the U.S., and encouraging collaboration between manufacturers and the FDA to proactively address questions about increased transparency and clearer labeling.
FDA plans to increase transparency
The July letter, signed by FDA Commissioner Dr. Marty Makary and Deputy Commissioner for Human Foods Kyle Diamantas, proposes a “strategic overhaul” of recall systems to meet the need for timely notifications. The FDA outlines several short-term and long-term goals to “revolutionize” how industry and government work together.
Short-term goals
- Enhance public access to critical recall information by creating a centralized, consumer-focused webpage with an emphasis on infant formula, baby foods, and foods intended for children.
- Evaluate internal and external recall communication protocols to ensure alignment with current best practices and public health priorities.
- Improve the reach and clarity of FDA recall communications by leveraging focus group research and other stakeholder feedback on risk communication strategies.
Long-term goals
- Optimize recall information collection by redesigning and digitizing key recall documentation to support automated data extraction and AI-assisted analysis.
- Modernize data submission infrastructure by implementing an advanced digital platform for industry partners to submit standardized data.
The FDA notes that achieving these goals will require increased public-private partnerships. It asks the industry to provide feedback on how the agency can transform how food recalls are managed and communicated to allow for greater public awareness of recalls.
The letter also suggests that manufacturers and retailers consider expanding their use of public notifications to a broader range of situations. This may include communicating about safety concerns that may not warrant a recall or the presence of contaminants in a product sample, even if the affected lot has not been distributed. The FDA has previously asked companies to voluntarily notify the agency when this scenario occurs.
Looking ahead
Legal experts with Hogan Lovells suggest that manufacturers, distributers, or retailers of infant formula, baby foods, and foods intended for children should review the FDA’s requests in the letter against their internal protocols for notifying FDA and the public about recalls. Even though the suggestions laid out by the agency are not legally binding, they will be best practices to follow. Businesses should evaluate whether to modify their recall approach in light of the agency’s requests to show both the regulators and the public that they are focused on keeping the public safe.
Companies should also take advantage of any opportunities to provide the FDA with input about how to improve recall communications and data management, including through the integration of new technologies. Any changes to recall communication for infant formula and other foods intended for children will likely be adopted throughout the FDA, so all companies that fall under its jurisdiction should closely monitor for new developments.
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