FDA issues letter to industry on recall communications for infant and baby foods

FDA’s request of industry

In the letter, Commissioner Makary and Deputy Commissioner Diamantas remind industry to report recalls to FDA immediately following the decision to recall, highlighting that prompt notification allows FDA to disseminate updates to consumers more effectively. The letter also urges companies to expand the use of public notifications specifically for food safety issues in products for infants and children. The letter states this is needed because consumers want more information regarding the safety of these products.

FDA’s transparency goals

The letter also outlines FDA’s short- and long-term goals for improving recall communications for foods for infants and children. In framing its goals, FDA proposes using technology to lower costs and collect, analyze, and communicate recall information. In the short term, FDA is working to implement initiatives that will work with the existing data structures and frameworks to improve information access for consumers, including:

• Developing a centralized webpage on FDA.gov for consumers to access recall information related to infant formula, baby foods, and foods intended for children;
• Aligning recall communication protocols with best practices and public health priorities;
• Upgrading the current FDA Enforcement Report system to allow for more search and filtering options;
• Conducting research on recall communication effectiveness through focus groups and stakeholder feedback; and
• Identifying process improvements to speed up the recall classification process.

In the longer term, FDA is suggesting more sweeping changes to its systems to facilitate recall communications. These include identifying ways to use AI in recall communications and developing a new system for industry data submission that would allow for increased data standardization. FDA notes that these short and long-term initiatives will require public-private partnerships and additional resources, but the hope is that they will provide consumers with the ability to more easily monitor the safety of products. FDA also said that the agency is welcoming industry leaders’ input on how industry and FDA can communicate recalls faster and in formats that leverage new digital tools.

Although the letter discusses these goals in the context of foods for infants and children, they should be considered in conjunction with the agency’s broader focus on recall modernization. The agency started this initiative in 2023 with a public meeting and comment period and it was included in the Human Foods Program’s list of fiscal year 2025 priority deliverables, which was issued during the Biden Administration.³

The issuance of this letter suggests that recall modernization will continue to be an agency priority under Commissioner Makary and is another area where the agency is looking at how it can use digital tools and AI to improve existing systems.

Next steps

Companies involved in the manufacture and distribution of products for infants and children should review the requests in the letter against their internal protocols for notifying FDA and the public about recalls and evaluate whether to modify their approach going forward in light of the agency’s requests. More broadly, food companies and their trade associations should consider engaging with FDA about recall communications and execution to help inform the agency’s broader evaluation on this issue.

Authored by Maile Gradison and Erin Pannek.