FDA Reorganizes to Create Human Foods Program; Introduces Updated Complaint Portal

The FDA announced the reorganization creating the Human Foods Program, "a new model for field operations and other modernization efforts is now in effect."  According to the release, this "is is the single largest reorganization in the agency’s modern history, as it impacts more than 8,000 employees and touches almost every facet of the FDA."

The goal is to better "zero in on those issues where intervention has the greatest opportunity for the prevention of disease and for the promotion of wellness."  FDA states that "An important part of this reorganization also includes restructuring and renaming our field operations unit to focus on inspections, investigations and imports as its core mission. Restructuring the Office of Inspections and Investigations, formerly known as the Office of Regulatory Affairs, extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products. We have created an enterprise-wide structure that will enhance collaboration between our field investigators and other subject matter experts throughout the agency and modernize and strengthen the entire agency to work more cohesively and collaboratively in accomplishing our collective public health mission."

FDA also announced "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."

https://www.fda.gov/news-events/press-announcements/fdas-unified-human-foods-program-new-model-field-operations-and-other-modernization-efforts-go
FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
The following is attributed to Robert M. Califf, M.D., FDA Commissioner, and Jim Jones, Deputy Commissioner for Human Foods and Michael Rogers, Associate Commissioner for Inspections and Investigations

For Immediate Release:
October 01, 2024

Statement From:

The U.S. Food and Drug Administration, the oldest comprehensive consumer protection agency in the country, is marking a new chapter. For more than a century the FDA has, among other things, had the responsibility to help ensure the safety of food products consumed by hundreds of millions of U.S. consumers while also promoting healthy diet and improved nutrition.

We are pleased to announce that today, the unified Human Foods Program, a new model for field operations and other modernization efforts is now in effect. This is the single largest reorganization in the agency’s modern history, as it impacts more than 8,000 employees and touches almost every facet of the FDA. We appreciate the dedication and enthusiasm of the FDA staff who are on this reorganization journey with us, as well as the helpful feedback we received from external parties over the last year and a half.

In particular, the establishment of the Human Foods Program allows us to most effectively deliver on our 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 our food. This will enable us to zero in on those issues where intervention has the greatest opportunity for the prevention of disease and for the promotion of wellness. We are confident that the new, world-class Human Foods Program will better protect and support consumers and improve our employees’ ability to carry out the FDA’s public mission.

An important part of this reorganization also includes restructuring and renaming our field operations unit to focus on inspections, investigations and imports as its core mission. Restructuring the Office of Inspections and Investigations, formerly known as the Office of Regulatory Affairs, extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products. We have created an enterprise-wide structure that will enhance collaboration between our field investigators and other subject matter experts throughout the agency and modernize and strengthen the entire agency to work more cohesively and collaboratively in accomplishing our collective public health mission.

We will also pilot a new online consumer complaint form to both improve the consumer experience when submitting complaints as well as internally handle complaints more efficiently and effectively, helping the FDA to better detect and respond to emerging public health risks.

We are committed to building a stronger, more integrated and modernized agency. This is the goal across the agency and includes our laboratories, food safety and nutrition, medical products, tobacco products and cosmetics.

The work has really only begun. We are hopeful this modernization and reorganization will enhance transparency and trust in the agency as we work together both inside and outside the FDA to better meet our country’s shared public health goals.


https://www.fda.gov/food/hfp-constituent-updates/fda-introduces-streamlined-complaint-process-new-human-foods-program

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. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.