/>i- On July 9, 2025, FDA Commissioner Marty Makary published a letter encouraging manufacturers of infant formula, baby food, and foods intended for children to improve their product recall communications. The letter urges industry leaders to adopt FDA’s “radical transparency” efforts to help protect what Commissioner Makary calls “our most vulnerable consumers—our children.” Specifically, Commissioner Makary calls on industry leaders to “consider expanded use of public notification as appropriate to ensure that consumers have access to the most timely and comprehensive information.”
- FDA outlines both short-term and long-term goals within the letter. In the short term, FDA plans to create a “centralized, consumer-focused webpage for streamlined access to recall information” for infant formula, baby food, and foods intended for children. FDA also mentions that the Agency hopes to improve its own communications about recalls “by leveraging focus group research and other stakeholder feedback on risk communication strategies.” In the long term, FDA aims to improve recall process efficiency “by redesigning and digitizing key recall documentation to support automated data extraction and AI-assisted analysis,” as well as modernize the digital platform where manufacturers submit recall information.
- The letter is an extension of a March 18, 2025, FDA announcement of its new initiative known as “Operation Stork Speed.” This initiative seeks to improve product recall communications with consumers, and encourage companies to work alongside FDA to “[increase] transparency” and create “clearer labeling” on their products. Before transitioning to the current administration, FDA had also released a strategy in January 2025 outlining goals to improve safety requirements and “resiliency” in the infant formula market by addressing vulnerabilities in production and regulatory oversight.
- Keller and Heckman will continue to report on FDA announcements and updates that impact the infant formula and children’s food space.
FDA Calls on Infant and Children’s Food Brands to Improve Recall Communications
Saturday, July 19, 2025
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