On October 1, 2024, the Food and Drug Administration (FDA) began implementing the largest reorganization in the Agency’s recent history, including launching a unified Human Foods Program (HFP) to oversee all activities related to food safety and nutrition and transforming the Office of Regulatory Affairs (ORA) into the Office of Inspections and Investigations (OII), amongst other modernizations. This reorganization is intended to enhance the FDA’s ability to protect the human food supply and make the Agency more efficient and prepared to respond to changes in industries, food and medical product technologies, and the impacts of globalization and climate change.

HFP: Priorities for 2025

The FDA regulates 80% of the U.S. food supply. The HFP was designed to help ensure that the FDA-regulated food supply is safe by taking a systematic, risk management approach to implementing the preventive measures outlined in the Food Safety Modernization Act (FSMA) and responding to food-related emergencies. Specifically, the HFP’s mission is to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe.

To support this mission, FDA is implementing several operational changes, including developing enhanced risk modeling, advancing inspectorate training, establishing a Human Foods Advisory Committee, developing a performance management framework, improving recall communications, and integrating food laboratories to advance science.

The HFP has also prioritized key deliverables for FY2025 to strengthen regulatory oversight, advance science, and better leverage partnerships in the following risk management areas:

Microbiological Food Safety

Advancing strategies to prevent foodborne illness. Specific deliverables include:

• Finalizing an implementation plan for the FSMA Final Rule on Pre-harvest Agricultural Water.
• Advancing traceability tools and resources to remove contaminated products from the marketplace more quickly.
• Issuing final guidance for the Produce Safety Rule and developing associated compliance resources.
• Initiating a study to better understand Salmonella outbreaks linked to melons.
• Enhancing the use of GenomeTrakr to help identify and respond to outbreaks.
• Working with various stakeholder groups to develop strategies to prevent and mitigate microbiological foodborne risks.
• Enhancing communication and transparency, including publishing a new public outbreak report and facilitating information sharing related to fresh produce and seafood.
• Implementing regulatory partnerships with Ecuador, India, and Indonesia for imported seafood.

Food Chemical Safety

Ensuring exposure to chemicals in food is safe. Planned actions include:

• Reviewing inefficiencies in the current premarket review process for food or color additives to help prevent unsafe uses of chemicals.
• Updating the framework for post-market assessments of chemicals in food and publishing an updated list of substances prioritized for re-assessment.
• Establishing action levels and associated guidance for environmental contaminants in food intended for infants and young children.
• Releasing additional guidance on submitting new dietary ingredient notifications (NDINs).
• Issuing draft guidance for Preventive Controls for Human Food specific to chemical hazards.
• Completing external review and validation of the Expanded Decision Tree, which sorts chemicals into classes of toxic potential.
• Developing AI approaches to help monitor new data and trends.
• Evaluating and characterizing potential effects of PFAS exposure from selected foods.
• Partnering with international organizations on food chemicals and innovation to strengthen the global food safety system.

Nutrition

Elevating nutrition to improve health equity. Deliverables include:

• Issuing a final rule to update the definition of the claim “healthy” and educating the public.
• Proposing a rule to establish mandatory front-of-package nutrition labeling.
• Publishing a long-term national strategy to help facilitate the entry of new infant formula manufacturers and continuing education on safe handling of powdered infant formula.
• Advancing nutrition research to better inform food-related policy and regulatory decision making.

OII’s Focus on Inspections

Restructuring the ORA into the new OII is intended to allow the Agency’s field operations unit to focus on inspections, investigations, and imports to support its core mission to conduct rigorous, transparent, and science-based inspections and investigations, providing real-time evidence and insight essential in empowering fact-based regulatory decisions to protect public health. OII is charged with inspecting regulated products and manufacturers, as well as reviewing imported products.

This restructuring will enable the FDA to put more focus directly on inspections and investigations and, subsequently, create a more efficient compliance and enforcement process, clearer communication, and faster decision-making. As a result of this transformation, inspections have the potential to become more efficient—and more frequent. In addition, increased inspection resources may allow inspectors to specialize in specific product areas, which could lead to more thorough and knowledgeable inspections.

Keeping Up

As with any regulatory change, FDA-regulated companies need to get up to speed on FDA’s recent restructuring and its potential impacts:

• Educate staff on FDA’s reorganization and potential implications for your organization.
• Identify any new points of contact for your organization within the FDA (i.e., HFP, OII), anticipate how your interactions may change, and start building new relationships, where necessary.
• Review the HBP priorities and compliance expectations for FY2025 compared to internal programs, protocols, etc. and make any required updates to ensure alignment.
• Prepare for potential changes when it comes to inspections, including more frequent and more specialized inspections. This may include educating staff to get a deeper understanding of products/operations and the associated regulatory requirements and/or stepping up compliance efforts, where necessary.