FDA reorganization gets approval to advance food safety focus

06 Jun 2024 --- The US Food and Drug Administration (FDA) has received the nod from the Department of Health and Human Services to create a unified Human Foods Program (HFP) after more than a year of scrutiny. The agency will also undergo reorganization through the adoption of a new model for its field operations and other modernization efforts.

The approval will enhance the agency’s ability to oversee and protect the human food supply and other products the FDA regulates.

Reorganization implementation is planned for October 1, 2024, allowing the FDA to more effectively realize the “preventive vision” laid out in the FDA Food Safety Modernization Act, elevate the importance of nutrition and strengthen local, state and international partnerships. 

Additionally, the move will position the FDA to regulate innovative food and agricultural products more effectively amid the emergence of new food technologies, the impacts of globalization and climate change.

“This is a distinctive moment for the FDA. I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall,” says Robert M. Califf, FDA Commissioner. 

The HFP will combine the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response and key functions of the ORA.“This reorganization has been a major undertaking for the FDA.”

The HFP will support the agency in upholding the “safety of the nation’s food supply” and respond to food-related emergencies, such as the 2022 infant formula shortages.

Renaming and realignment
The reorganization will bring the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response and key functions from the Office of Regulatory Affairs (ORA) under one program.

“The restructuring of ORA will enable our field operations unit to focus on inspections, investigations and imports as its core mission,” notes the FDA.

Meanwhile, ORA is being renamed to Office of Inspections and Investigations (OII) to “better convey the organization’s role as the frontline of the FDA.” The OII will give real-time insights and science-based evidence to ensure the safety and quality of products.

The reorganization will allow FDA to regulate innovative food more effectively amid the emergence of new food technologies.Moreover, a “modernized FDA” is looking to optimize resources to help meet the agency’s public health mission. It aims to give employees clearer priorities and career opportunities and comply with the recently enacted Food and Drug Omnibus Reform Act of 2022, which mandates the establishment of the Office of Critical Foods (infant formula or medical food).

Some of the other changes listed in the Federal Register include retitling the Office of Clinical Policy and Programs and realigning functions to form the Office of the Chief Medical Officer and renaming the Office of External Affairs’ Stakeholder Engagement Staff to Public Engagement Staff.

Road to reorganization
The FDA’s reorganization plan comes after a 2022 scrutiny of the HFP, when an independent expert panel criticized the agency’s management of the infant formula crisis. In response, the FDA underlined supply chain disruptions and rapid food science advancements as pressure points. 

Later, the FDA came under fire from former FDA and USDA officials who advocated for consolidation measures to boost food safety, security and nutrition in the US. The FDA responded by saying that the HFP was its number one priority.

This led to the agency proposing a redesign of HFP and searching for a new Deputy Commissioner for Human Foods who would report directly to the FDA Commissioner and lead the FDA’s nutrition and food safety programs.

In 2022, the FDA’s internal review of infant formula shortage management revealed a need for improvement.The FDA’s recent efforts to enhance food safety and nutrition in the country include requesting US$7.2 billion as part of the President’s fiscal year 2025 proposed budget to support supply chain resiliency, strengthen the agency’s public health capacity and modernize its infrastructure and facilities.

Transition and industry reaction
The FDA highlights that the Centers and Offices impacted by the reorganization are creating “new processes and procedures” for a seamless transition to the new structure. 

“The agency will continue formal union negotiations and finalize agreements prior to implementation,” notes the FDA.

The FDA’s approval of the reorganization of its HFP has garnered positive feedback from Consumer Reports.

“Consumers depend on the FDA to be effectively organized and governed to ensure our food is safe,” says Brian Ronholm, director of food policy at Consumer Reports.

“We recognize that a significant amount of work remains to be done because a meaningful change in culture does not happen overnight. We look forward to working with the FDA to ensure this plan is effectively implemented so that it can carry out its critical mission to protect the public from food safety risks,” Ronholm concludes.

By Insha Naureen