On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP now oversees all FDA activities related to food safety and nutrition, organized in a single group working under the Deputy Commissioner of Human Foods.
On the same day, as part of the new HFP, FDA launched a new, streamlined approach for processing consumer and whistleblower complaints for foods and dietary supplements. This updated complaint process will improve FDA’s ability to detect and respond to problems related to FDA-regulated products in a timely manner, and better protect public health. Complaints may be submitted about an illness, injury, allergic reaction, or other health-related issue, or about quality or safety defects, for FDA regulated foods and dietary supplements through a new Safety Reporting Portal (SRP).
Food and dietary supplement manufacturers, processors, packers, distributors, and holders can submit complaints involving human or animal reportable foods, animal or human foods, human dietary supplements, or infant formula. Currently, the SRP accepts certain types of mandatory and voluntary reports. We recommend referring to the Frequently Asked Questions for information on how to use the SRP, what to include in safety reports and other important information.
In addition to submitting complaints through the SRP, consumers can now call a new dedicated number, 1-888-SAFEFOOD, to submit complaints about foods and dietary supplements. HFP will receive, triage, and evaluate complaints, and the new Office of Inspections and Investigations (OII), will follow up as needed. FDA expects that this will allow for expedited delivery of inquiries and complaints to FDA public health experts and allow for more consistent processing and earlier detection of potential public health problems.
Enhancements to the complaint and whistleblower system at HFP will create opportunities not only for consumers, but also for employees concerned about unaddressed food safety issues. Consequently, corporate attention to food safety compliance programs and opportunities for employees to report food safety issues early to company quality departments is critical. Similarly, the enhanced complaint system will attract attorneys hoping to create class action interest in food incidents and to cause FDA to initiate investigatory or enforcement action to support class action cases. Consequently, company monitoring of the database and quick investigation and action on complaints is prudent.
Establishment of the HFP and the new complaint process will also allow FDA to obtain from consumers valuable information about other FDA-regulated products such as cosmetics. Not only does FDA claim that the reorganization “extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products,” but the complaint process also directs industry to direct complaints about cosmetics through the MedWatch Voluntary Reporting Form. With more modernization and integration of these systems, industry can expect the agency to be better equipped to take quicker and possibly more enforcement action in connection with adulterated and misbranded food.