FDA Introduces Streamlined Complaint Process on First Day of New Human Foods Program
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On October 1, 2024, the U.S. Food and Drug Administration (FDA) began implementing its long-awaited reorganization, involving the creation of a unified Human Foods Program (HFP). The first official announcement from the newly effective HFP introduced a streamlined approach for processing consumer and whistleblower complaints about foods and dietary supplements.
The updated complaint process under HFP aims to improve FDA’s ability to detect and respond to problems related to regulated products and better protect public health. Now, the public can submit complaints about an illness, injury, allergic reaction, or other health-related issue, or about quality or safety defects, of FDA-regulated food or dietary supplements through a new Safety Reporting Portal. Additionally, the number 1-888-SAFEFOOD is now active to receive complaints by phone.
Prior to October 1, consumer complaints were directed to Consumer Complaint Coordinators (CCCs) in FDA’s Office of Regulatory Affairs (ORA). Phone numbers associated with CCCs are no longer in service.
HFP will receive, triage, and evaluate complaints, and the new Office of Inspections and Investigations (OII)—formerly ORA prior to FDA’s reorganization—will follow up with firms as needed. This streamlined process is designed to expedite delivery of inquiries and complaints to the appropriate public health experts at FDA, and to allow for more consistent processing and earlier detection of potential public health problems.
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