Introduction
The FDA is responsible for regulating 80% of the U.S. food supply, with the Human Foods Program (HFP) overseeing all activities related to food safety and nutrition. The FDA launched the HFP as part of a broader agency reorganization on October 1, 2024. The HFP’s design streamlines operations and unifies all FDA food functions, personnel, and resources that are programmatic in nature under the leadership of the Deputy Commissioner for Human Foods.
The HFP’s vision is to ensure that food serves as a vehicle for wellness, and our day-to-day activities support our mission 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.
In FY 2025, we will develop a multi-year strategic plan to advance the HFP’s vision and mission. While that work is underway, we have developed this document to highlight the key deliverables that we will accomplish in FY 2025 within the context of our program’s design and responsibilities. It is also intended to demonstrate the HFP’s commitment to transparency and accountability as we continuously evolve to meet the demands of constantly changing public health and regulatory challenges.
We will provide updates on our FY 2025 priority deliverables as we make progress throughout the year.
Human Foods Program: Designed with Public Health and Organizational Effectiveness in Mind
The HFP is designed to facilitate a consistent, systematic, and intentional risk management approach to our regulatory responsibilities. To meet our public health mission and vision more effectively and efficiently, we centralized our risk management activities into three main areas:
- Microbiological Food Safety: Advancing strategies to prevent pathogen-related foodborne illness in close collaboration with other regulatory agencies, states, industry, and other stakeholders.
- Food Chemical Safety: Ensuring that exposure to chemicals, including both additives and contaminants, that occur in foods is safe, advancing dietary supplement safety, and supporting and effectively regulating food ingredient innovation.
- Nutrition: Elevating and empowering action on nutrition science, policy, and initiatives to help reduce the burden of diet-related chronic diseases, improve health equity, and ensure the nutritional adequacy and safety of infant formula.
Organizing our work in these areas will help us ensure a consistent approach across similar areas of focus, enabling the FDA to better leverage limited resources and more efficiently and effectively deliver risk management actions by the HFP and the Office of Inspections & Investigations (OII).
FY 2025 Priority Deliverables
While long-term strategic planning to advance our risk management approach is underway, the work to ensure that food is and continues to be a vehicle for wellness is ongoing. Outlined below are the key deliverables that the HFP will prioritize in FY 2025 within each risk management area to strengthen our regulatory oversight and promote priority policy initiatives, advance the science needed to inform our decision-making, and better leverage partnerships and engagement to help us better achieve our public health mission. We will also continue to prioritize efforts to continue the overall transformation of the organization.
Microbiological Safety: The FDA’s Role in Preventing Foodborne Illness
Using a risk management approach, we focus our efforts in FY 2025 on a regulatory framework based on prevention, scientific rigor, and strong partnerships to prevent or significantly reduce the incidence of foodborne illnesses from foods regulated by the FDA.
Strengthening Regulatory Oversight
- Pre-harvest Agricultural Water: We will finalize an implementation plan and continue to execute key actions, to include educating industry and other partners on the new requirements in the FSMA Final rule on Pre-harvest Agricultural Water. The rule is intended to reduce the likelihood of produce becoming contaminated with foodborne pathogens from the water used during produce cultivation.
- Food Traceability: We will advance traceability tools and other resources to work toward implementation of the final rule using a multi-pronged approach to educate and engage with industry members. Implementation of the FDA Food Traceability final rule will enable the FDA and industry to identify and remove contaminated products from the marketplace more quickly, reducing incidences of foodborne illness.
- FSMA Guidance for Industry: We will target issuance of the final guidance for the Produce Safety Rule and continue to prioritize development of key resources to support the requirements of the FDA Food Safety Modernization Act (FSMA). These guidance documents and resources provide industry with important information to help them comply with the FSMA rules.
Advancing Science
- Impacts of Environmental Conditions on Produce Safety: We will initiate a new study in Southwest Indiana to better understand the ecology of human pathogens in the environment following multiple Salmonella outbreaks linked to melons grown in this region. This study is intended to help the FDA and the local growing community better understand the source of pathogens, their persistence, and how they transfer through the region’s growing environment to help inform food safety practices.
- Using Genomics to Better Identify Foodborne Pathogens: We will integrate GenomeTrakr data from food and facility inspections and sampling by FDA and state partners into the CDC’s new outbreak surveillance platform, PN 2.0, which collects whole-genome sequencing data from the PulseNet clinical laboratory network. These investments will enable HFP and regulatory partners to use genomics data to better identify and respond to outbreaks, including identifying illnesses caused by reoccurring, emerging, and persistent bacterial strains.
Leveraging Partnerships and Engagement
- Focused Engagement on Risk Management Strategies: We will meet with stakeholders to help inform, develop, and implement strategies for the prevention and mitigation of microbiological foodborne risks. We will learn from those who grow, produce, manufacture, and sell foods to appreciate the challenges on the ground and listen to industry coalitions, consumer advocacy groups, government co-regulators, and academia to understand the potential impact of our decisions, particularly as we continue to tackle complex issues, such as approaches to the control of Listeria monocytogenes in facilities and bacterial and viral contamination in fresh produce and other commodities.
- Post-Outbreak Report: We will publish a new public outbreak report summarizing the data and findings from past outbreak investigations on a pathogen/commodity pair that has caused repeated outbreaks of foodborne illness. This report will increase transparency of outbreak investigations for specific pathogen/commodity pairs, help facilitate improved collaboration on investigation activities, and in conjunction with other information, help inform priorities for risk management strategies to reduce foodborne illness.
- Data-Sharing: We will establish formal agreements with industry to facilitate food safety data and information sharing related to the growth, harvest, transportation, manufacturing, and distribution of fresh produce and seafood. Increased sharing and analysis of data, including the application of new tools such as artificial intelligence, can help industry and regulators maximize resources as both work to identify, analyze, and address trends contributing to contamination in these commodities.
- Imported Seafood Safety: We will implement our regulatory partnership agreement with Ecuador for shrimp and work towards establishing additional agreements with India and Indonesia for seafood by assessing their regulatory frameworks. These efforts ensure that imported seafood meets US safety requirements and assists in risk-informed allocation of our inspection and import review resources.
- Expanding Surveillance of Foodborne Pathogens: We will onboard new labs, both in the U.S. and internationally, to the GenomeTrakr program and launch a public training resource site covering the entire genomic surveillance workflow, from data collection to analysis. The GenomeTrakr program coordinates genomic surveillance of foodborne bacterial pathogens in collaboration with FDA labs, state public health and agricultural labs, and international partners.
- Combatting HPAI: We will advance the Highly Pathogenic Avian Influenza (HPAI) silo study in collaboration with the U.S. Department of Agriculture (USDA), the Centers for Disease Control and Prevention (CDC), the National Conference on Interstate Milk Shipments (NCIMS), and state partners to monitor the safety of dairy and milk products. This collaboration supports the federal government’s on-going response to HPAI.
Food Chemical Safety: The FDA’s Role in Ensuring Exposure to Chemicals in Food is Safe
Using a risk management approach, we will focus our efforts in FY 2025 on enhancing our regulatory approach to food chemical safety and dietary supplement policy and coordinating on regulatory and scientific issues for foods made through innovative technologies.
Strengthening Regulatory Oversight
- Pre-market Review: We will complete a review to identify efficiencies in our current premarket-review processes for manufacturer submissions for food and color additives, food contact substances, and GRAS substances and ensure operational alignment under the new HFP organizational structure. The HFP’s pre-market programs are critical to helping prevent unsafe uses of chemicals and help ensure that innovative approaches in manufacturing food ingredients and packaging result in safe food products.
- Post-Market Assessment of Chemicals in Food: We will update the assessment framework based on feedback from the public meeting on a systematic approach for post-market assessments of chemicals in food and publish an updated list of substances prioritized for re-assessment with projected timelines. This process will help to ensure that FDA is taking a risk-informed approach in reviewing new science and information about the safety of chemicals in the food supply.
- Closer to Zero Action Levels: We will advance our work under Closer to Zero by targeting issuance of a guidance to establish action levels for environmental contaminants in foods intended for infants and young children, including a final guidance on action levels for lead. These actions levels will help to ensure infants and young children continue to have access to nutritious foods while reducing dietary exposure to unavoidable harmful contaminants.
- New Dietary Ingredient Notification (NDIN) Guidance: We will continue working to release additional sections of final guidance to better inform industry on how and when to submit new dietary ingredient notifications. Manufacturers or distributors of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to the FDA before introducing the product into the market.
- FSMA Guidance for Industry: We will target issuance of the draft guidance for Preventive Controls for Human Food specific to Chemical Hazards. The guidance is intended to help industry meet their responsibility to minimize or prevent hazards from contaminants and ensure the safety of chemicals they use.
Advancing Science
- Use and Development of New Methods: We will complete the external review and validation of the Expanded Decision Tree, a scientific tool that sorts chemicals into classes of toxic potential using a series of structure-based questions, and engage with stakeholders on its use. The EDT is one example of New Approach Methods that leverage large data sets to achieve faster, less expensive, and informative new approaches into chemical assessments that can inform risk management decisions and actions.
- Post-market Signal Detection and Prioritization: We will continue to develop AI approaches to enhance our oversight such as implementation of the Warp Intelligent Learning Engine (WILEE), a horizon-scanning monitoring tool for signal detection and surveillance of the food supply. The use of WILEE will better support the HFP’s post-market assessment activities by helping to monitor for new data, information, and trends across the food supply and inform prioritization.
- Better Understanding PFAS Exposure: We will expand the use of new methods to better understand exposure to Per- and Polyfluoroalkyl Substances (PFAS), a diverse group of human-made chemicals used in a variety of consumer and industry products that can enter the food supply through the uptake of crops and animals grown, raised, or processed in contaminated areas. This work will help the FDA to more accurately evaluate and characterize potential effects of PFAS exposure from selected foods and inform on-going collaboration with our federal partners and state departments of agriculture and health.
Leveraging Partnerships and Engagement
- Consumer Education and Outreach: We will develop and disseminate plain language educational materials (fact sheets, short videos, infographics) to increase awareness about foods for infants and young children that are nutritious while minimizing dietary exposure to unavoidable contaminants. It is crucial to inform parents and caregivers of infants and young children about the importance and significant nutritional benefits of these foods (vegetables, fruits, whole grains, seafood) compared to the risks from certain environmental contaminants.
- International Collaboration: We will pursue formal agreements with international regulatory counterparts to facilitate partnering on food chemical and innovation issues and encourage the harmonization of science-based food chemical safety standards. The FDA collaborates with foreign partners to strengthen the global food safety system and ensure safe and fair trade in food.
Nutrition: FDA’s Role in Empowering Consumers to Build Nutritious Diets that Support Health and Wellness
Using a risk management approach, we focus our efforts in FY 2025 on labeling and other initiatives to help consumers make more informed choices about the food they eat, and, for those who rely on certain critical foods, such as infant formula, as their sole source of nutrition, we work to make sure those products are safe, properly labeled, and nutritionally sound.
Promoting Priority Policy Initiatives
- Updating FDA’s Nutrient Content Claim “Healthy”: We will target issuance of the final rule to establish an updated definition of the claim “healthy” and continue work on a proposed design for a symbol, which food manufacturers could voluntarily use on products that meet the definition. “Healthy” claims on food labels can act as quick signals for consumers to help them identify foods that are the foundation of healthy eating.
- Proposing Front-of-Package Nutrition Labeling: We will target issuance of a proposed rule to establish a mandatory front-of-package (FOP) nutrition labeling scheme and will consider public input on the proposal. FOP nutrition labeling is another tool that can provide simplified, at-a-glance nutrition information to help consumers quickly understand how foods fit into their overall diet.
- Supporting Reductions in Sodium in the Food Supply: We will continue to assess progress on sodium reduction across the food supply using information from packaged food labels, sales, and restaurant menu data to inform a formal evaluation of the Phase I voluntary sodium reduction targets, review public comments as we work to finalize the draft Phase II targets, and continue work to finalize the draft rule on the use of salt substitutes to help reduce sodium content in standardized foods. We will also collaborate with our federal partners and engage with key stakeholders to enhance sodium-related data sharing and learnings, as part of these efforts to help reduce diet-related chronic diseases and deaths associated with high sodium intake, such as hypertension and stroke.
- Increasing the Resiliency of the U.S Infant Formula Market: We will publish a long-term national strategy to help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages and to recommend necessary authorities to gain insight into the supply chain and risks for shortages. Many infants in the U.S. rely on infant formula for some or all of their nutrition.
Advancing Science
- Collaborating on a Nutrition Research Agenda: We will continue to collaborate with other federal agencies on developing and advancing a nutrition research agenda, including accelerating high-quality research to better understand the mechanisms between ultra-processed foods and poor health outcomes. For example, the FDA will work with NIH to host a joint workshop to highlight how nutrition science can generate evidence and data to inform food-related policy and regulatory decision making and to foster additional collaboration between NIH and FDA in supporting research that addresses priority nutrition research gaps.
Leveraging Partnerships and Engagement
- Focused Engagement on Nutrition Initiatives: We will engage with manufacturers, retailers, consumer and public health groups, health care groups, and community members to raise awareness about the updated “healthy” claim once the final rule publishes as well as support greater use of the claim to help consumers quickly find foods that are the foundation of healthy eating patterns. The HFP will also gather input on a “healthy” symbol and consider public feedback on the HFP’s FOP labeling work.
- Safe Handling Practices for Infant Formula: We will develop and widely share a continuing medical education program for pediatricians on safe handling of powdered infant formula in partnership with USDA-WIC and American Academy of Pediatrics. Safe handling practices help prevent germs from getting into infant formula and causing infections in infants.
Transforming the Human Foods Program
While the HFP was officially established on October 1, 2024, significant work will continue through FY 2025 to fully operationalize the program. First, the FDA is prioritizing hiring of permanent leadership of HFP offices. Next, once leadership is in place, the HFP will develop and release a multi-year strategic plan. Further, there are operational changes to integrate critical processes and systems to better support the mission of the HFP.
- Leveraging Enhanced Risk Modeling to Drive Allocation of Field Resources: In collaboration with the Office of Inspections and Investigations we will improve the planning and tracking of domestic and foreign facility, farm, and port-of-entry inspections, investigations, and sampling activities, including the development and use of enhanced risk modeling and other data analytics tools. This data-driven and dynamic approach will strengthen our response to risk signals and further maximize risk-informed allocation of resources.
- Integrating FDA’s Food Laboratories: We will align regulatory and surveillance testing outputs for the new unified HFP laboratories with the risk priorities of the program to advance the science needed to inform our decision-making for microbiological, food chemical, and nutrition issues. We will also align documentation practices with expected use of data to reduce documentation burdens and gain efficiencies while continuing to comply with ISO 17025 certification requirements.
- Advancing One Integrated Workforce: We will collaborate with a working group of regulatory agencies and academic and industry stakeholders to conduct and publish a comprehensive environmental scan of current efforts across the country to train new regulators. Aligning inspectorate training across the Integrated Food Safety System will better ensure a highly competent federal, state, local, tribal, and territorial regulatory workforce.
- Establishing the Human Foods Advisory Committee: We will target publishing notices in the Federal Register announcing the establishment of the advisory committee and soliciting new members so that we can hold meetings in FY 2026. The Human Foods Program will use the advisory committee to obtain external experts’ advice on challenging and emerging issues in food safety, nutrition, new and innovative food technologies, and other foods-related scientific, technical, and policy matters.
- Recall Modernization: We will improve the reach and clarity of our recall communications by leveraging focus group research and other stakeholder feedback on risk communication strategies and improve the speed of recall classification through process improvements. These efforts will help ensure that harmful products are removed from the market more quickly and effectively.
- HFP Performance Management: We will develop a coordinated performance management framework utilizing the existing Food Safety Dashboard and publish new measures related to the FSMA Final Rule on Produce Safety. The framework will leverage existing measures, including those developed to help evaluate how FDA is implementing FSMA, while also allowing for space to develop measures that are aligned to the HFP strategic plan.
Posted in FDA and USDA Regulatory Update.