On Friday, September 29, 2023, the Food and Drug Administration (FDA) held a hybrid public meeting on modernizing FDA recalls to provide stakeholders with an opportunity to share information and feedback about topics related to recall modernization for FDA-regulated products. Participants were encouraged to address topics including creating successful recall strategies and strategies for reducing recurrence of similar situations, among others. FDA explained that although the agency has been working to update recall strategies, inefficiencies and delays in the recall process can still result in FDA-regulated products remaining on the market for long periods before problems are recognized.
Erik Mettler, an Assistant Commissioner for Partnerships and Policy in FDA’s Office of Regulatory Affairs, opened the meeting by stating FDA’s interest in improving the effectiveness of recalls across all FDA regulated commodities following recent foodborne illness outbreaks and associated recalls. He was followed by over forty participants who delivered oral presentations offering critiques of current FDA recall policies and recommendations for improvements. The discussion broadly applied to all FDA regulated product, but this discussion focuses on food and consumer products.
Speakers at the meeting included representatives of industry trade groups, advocacy groups, and patient advocacy groups, and urged FDA to consider, among other things:
- Coordinating recall processes within FDA by producing templates, clear workflows, and standardized forms to reduce confusing and inconsistent recall processes;
- Centralizing recall processes within FDA;
- Clarifying the metrics FDA uses to classify a product recall, so that recalls for similar issues are classified consistently or distinctions among recall classifications are made clearer;
- Speeding up processes for classifying a recall to allow affected parties to take swift and effective action;
- Improving public communication strategies through new technologies, such as social media, QR Codes, and text alerts;
- Creating the opportunity for manufacturers and distributors to participate in recall simulations with FDA, rather than mock recalls that some commenters found to be insufficient; and
- Publishing more informative, accessible, and specific recall documents, including those that address when a recall has been initiated, the status of a recall, the extent of the risk, and when a recall is considered closed, to better inform the public as well as industry of a recall’s status.
In this listening session, FDA did not comment on whether the agency currently has the authority to implement all of the suggestions made by participants.
Interested stakeholders have until October 27, 2023 to submit comments to FDA.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device practice.
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