FDA Introduces Streamlined Complaint Process in New Human Foods Program

Constituent Update

October 1, 2024

Today FDA’s Human Foods Program (HFP) is announcing a new, streamlined approach for processing complaints, including whistleblower complaints, that will improve the Agency’s ability to detect and respond to problems related to FDA-regulated products and better protect public health. A complaint may be about an illness, injury, allergic reaction, or other health-related issue or about defects in the quality or safety of an FDA-regulated food, dietary supplement, or cosmetic product. Now, the public will be able to direct complaints about foods and dietary supplements to HFP by using our online reporting forms for:

• Foods and Dietary Supplements: Safety Reporting Portal
• Cosmetics: MedWatch Voluntary Reporting Form

The links to these forms and more information about how to submit questions or complaints about FDA-regulated products can be found on the Industry and Consumer Assistance from HFP webpage. 

Until today, consumer complaints were directed to Consumer Complaint Coordinators (CCCs) in the FDA’s Office of Regulatory Affairs (ORA). As of October 1, 2024, the phone numbers associated with the CCCs will no longer be in service. Instead, consumers now will be able to call 1-888-SAFEFOOD to submit complaints by phone about foods and dietary supplements. HFP will receive, triage, and evaluate complaints, and the new Office of Inspections and Investigations (OII), formerly ORA, will follow up with firms as needed. This streamlined process will expedite delivery of inquiries and complaints to the appropriate public health experts at the FDA and allow for more consistent processing and earlier detection of potential public health problems. 

The FDA first announced this change was underway in an October 2023 joint statement by Commissioner Robert M. Califf and Deputy Commissioner for Human Foods Jim Jones confirming the reorganization and modernization efforts of the foods program had begun. The reorganization, which took effect today, is the single largest reorganization in the agency’s modern history, impacting more than 8,000 employees and touching every facet of the FDA. Establishment of the Human Foods Program with a new streamlined process for consumer complaints and inquiries will allow the FDA to more effectively interface with consumers to learn new and valuable information about FDA-regulated products. It will also help the FDA deliver on its mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in food.  

For more information, please visit Industry and Consumer Assistance from HFP.