After kids get sick from Applesauce with lead and Infant Formula with Cronobacter, FDA leaders step up

FDA Encourages Food Industry Leaders to Streamline, Enhance Product Recall Communications With Public and Agency

Stronger, More Transparent Notices Increase Public Safety

July 9, 2025

Dear Industry Leaders:

This letter is directed to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of infant formula, baby foods, and foods intended for children.

As we strive to ensure that food is recognized as a vehicle for wellness, recent incidents involving chemical contaminants in infant and toddler food products have raised public awareness and underscored our shared responsibility in safeguarding our most vulnerable consumers – our children.

At the FDA, we believe that radical transparency in food safety and nutrition actions is key to reducing foodborne illness and chronic disease, setting a strong foundation for lifelong health. It is imperative the food industry and FDA work together to ensure swift, transparent, and effective recall communication, especially for products vital to infant and child nutrition.

Today, we are seeking your assistance in creating a collaborative transformation in how we manage and communicate food recalls, particularly for infant formula, baby foods, and foods intended for children, to provide for greater public awareness of these recalls. We are encouraging our industry partners to enhance communication with the public and continue to work with the FDA when a product is recalled. And we are welcoming industry leaders’ input on how industry and the FDA can communicate recalls faster and in formats that leverage new digital tools.

Industry Call to Action

The FDA’s ability to make informed decisions and disseminate crucial updates to consumers hinges on industry providing prompt notification of recall information to the agency. Recognizing this interdependence, we kindly remind firms to inform the FDA immediately when a decision to initiate a recall is made, as outlined in 21 CFR 7.46(a) and 107.210(a).

Recognizing the public’s desire to have more information about recalled FDA-regulated foods, particularly foods for infants and children, the FDA appreciates the public may want firms to issue public notifications for a broader range of situations than previously experienced. For food safety issues in products for infants and children, firms should consider expanded use of public notification as appropriate to ensure that consumers have access to the most timely and comprehensive information.

FDA Actions to Improve Transparency

Industry and government recall systems must evolve to meet the public’s need for timely information. We are proposing a strategic overhaul, leveraging communications best practices as well as cutting-edge technologies to revolutionize how we work together to collect, analyze, and disseminate crucial recall information. Our vision includes:

Short term goals

• Enhancing public access to critical recall information by creating a centralized, consumer-focused webpage for streamlined access to recall information, with an emphasis on infant formula, baby foods, and foods intended for children.
• Evaluating internal and external recall communication protocols on public communications for certain recall situations, ensuring alignment with current best practices and public health priorities.
• Improving recall data granularity and accessibility by upgrading the FDA Enforcement Report system to allow for more refined and targeted filtering of recall information by the public, particularly for sensitive food categories.
• Improving the reach and clarity of our recall communications by leveraging focus group research and other stakeholder feedback on risk communication strategies.
• Further increasing the speed of recall classification through process improvements.

Long term goals

• Optimizing recall information collection by redesigning and digitizing key recall documentation to support automated data extraction and AI-assisted analysis, improving overall recall process efficiency.
• Modernizing data submission infrastructure through implementation of an advanced digital platform for industry partners to submit standardized data, enhancing efficiency in recall information processing, dissemination, and recall classification.

These enhancements, which require increased public-private partnerships, and sufficient resources and time, are aimed at achieving radical transparency, and empowering parents and caregivers to monitor the products they purchase or have in their home and safeguard their children’s immediate safety and long-term health outcomes.

This initiative reflects our commitment to increased collaboration with industry leaders, focused on placing the public’s needs first, empowering parents, protecting our children, and fostering a healthier future for generations to come.

Sincerely,

/S/

Marty

Martin A. Makary, M.D., M.P.H.

Commissioner of Food and Drugs

/S/

Kyle

Kyle A. Diamantas, J.D.

Deputy Commissioner for Human Foods

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/after-kids-get-sick-from-applesauce-withe-lead-and-infant-formula-with-cronobacter-fda-leaders-step-up/