FDA Issues Fiscal Year 2025 Priority Deliverables for the Human Foods Program

Key Transformational Initiatives

FDA says that although the HFP was officially established on October 1, significant work will continue through FY 2025 to fully operationalize the program. The recent release summarizes several transformational initiatives that are underway.1 In particular, FDA is prioritizing hiring of permanent leadership for HFP offices, after which the agency will develop and release a multi-year strategic plan. The agency also is working on “operational changes to integrate critical processes and systems to better support the mission of the HFP, such as improving the planning and tracking of facility, farm, and port-of-entry inspections, investigations, and sampling activities.”  FDA also plans to establish a new Human Foods Advisory Committee, which will be announced through notices in the Federal Register, with the goal of obtaining 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 beginning in FY 2026. Finally, FDA will continue its work on recall modernization, including work related to communication strategies and improving the speed of recall classification.

Key Microbiological Safety Initiatives

FDA’s microbiological safety initiatives include the following:

• Traceability: Implementing FDA’s Food Traceability final rule, including by “advance[ing] traceability tools and other resources.”
• FSMA Guidance: Issuing additional guidance to support the requirements of the FDA Food Safety Modernization Act (FSMA). Note that FDA says it is targeting issuance of the final guidance for the Produce Safety Rule but does not otherwise identify which microbiological safety-related guidance is a priority for FY 2025.
• Use of Genomics to Better Identify Foodborne Pathogens: Integrating GenomeTrakr data from food and facility inspections and sampling by FDA and the states into the Centers for Disease Control and Prevention’s (CDC’s) new outbreak surveillance platform, which will help regulators better identify and respond to outbreaks.
• Data-Sharing: Establishing formal data-sharing agreements with industry related to fresh produce and seafood, which is intended to address trends contributing to contamination in these commodities.
• Engagement on Risk Management Strategies: Meeting with stakeholders to inform strategies for preventing and mitigating microbiological risks, including a goal of “learn[ing] from those who grow, produce, manufacture and sell foods to appreciate the challenges on the ground,” particularly with respect to “complex issues” such as control of Listeria monocytogenes. 

Key Chemical Safety Initiatives

FDA’s chemical safety initiatives include the following:

• Pre-market Review:  Completing a review to “identify efficiencies” in the current pre-market review processes for manufacturer submissions for food and color additives, food contact substances, and GRAS substances.
• Post-Market Assessment of Chemicals in Food: Updating the assessment framework based on feedback from the recent public meeting on a systematic approach for post-market assessments of chemicals in food and publishing an updated list of substances prioritized for reassessment with projected timelines.
• Closer to Zero Action Levels: Targeting issuance of guidance to establish action levels for environmental contaminants in foods intended for infants and young children, including final guidance on action levels for lead.
• FSMA Guidance: Targeting issuance of guidance for Preventive Controls for Human Food specific to chemical hazards.
• Consumer Education and Outreach: Developing plain language educational materials to inform parents and caregivers of infants and young children about the importance and nutritional benefits of vegetables, fruits, whole grains, and seafood compared to the risks posed by environmental contaminants.

Key Nutrition Initiatives

FDA’s nutrition initiatives include: 

• “Healthy” Nutrient Content Claim:  Targeting issuance of the final rule to establish an updated definition of the claim “healthy” and continuing work on a proposed design for a symbol that could be used voluntarily on products that meet the definition.
• Front-of-Package (FOP) Nutrition Labeling:  Targeting issuance of a proposed rule to establish a mandatory FOP nutrition labeling scheme.
• Sodium Reduction:  Continuing to assess progress on sodium reduction across the food supply to inform a formal evaluation of the Phase I voluntary sodium reduction targets, review public comments as the agency works to finalize the draft Phase II targets, and continuing to work to finalize the proposed rule on the use of salt substitutes in standardized foods.
• Collaborating on a Nutrition Research Agenda: Collaborating with other federal agencies to accelerate “high-quality research to better understand the mechanisms between ultra-processed foods and poor health outcomes,” including hosting a joint workshop with the National Institutes of Health in December.

Attached is an appendix that provides a more in depth summary of the Priority Deliverables across each of the three risk management areas. We will continue to monitor the HFP’s priorities. Should you have any questions, please do not hesitate to contact us.

APPENDIX

Transforming the HFP

• Leveraging Enhanced Risk Modeling to Drive Allocation of Field Resources: In collaboration with the Office of Inspections and Investigations, the HFP 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.
• Integrating FDA’s Food Laboratories: The HFP 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 its decision-making for microbiological, food chemical, and nutrition issues. It 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: The HFP 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.
• Establishing the Human Foods Advisory Committee: The HFP will target publishing notices in the Federal Register announcing the establishment of the advisory committee and soliciting new members so that it 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: The HFP will leverage focus group research and other stakeholder feedback on risk communication strategies and improve the speed of recall classification through process improvements.
• HFP Performance Management: The HFP will develop a coordinated performance management network using the existing Food Safety Dashboard and publish new measures related to the FSMA Final Rule on Produce Safety.

Microbiological Safety

Strengthening Regulatory Oversight

• Pre-harvest Agricultural Water: The HFP will educate industry and other partners on the Food Safety Modernization Act (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: HFP will advance traceability tools and other resources to work toward implementation of the FDA Food Traceability final rule.
• FSMA Guidance for Industry: The HFP will target issuance of the final guidance for the Produce Safety Rule and continue to prioritize development of key resources to support FSMA requirements.

Advancing Science

• Impacts of Environmental Conditions on Produce Safety: The HFP will initiate a new study in Southwest Indiana to better understand the source of human pathogens in the environment, with the goal of better understanding how human pathogens transfer through the region’s growing environment.
• Using Genomics to Better Identify Foodborne Pathogens: The HFP 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, in order to better identify and respond to outbreaks.

Leveraging Partnerships and Engagement

• Focused Engagement on Risk Management Strategies: The HFP will meet with stakeholders to help inform, develop, and implement strategies for the prevention and mitigation of microbiological foodborne risks, including approaches for controlling Listeria monocytogenes in facilities and bacterial and viral contamination in fresh produce and other commodities.
• Post-Outbreak Report: The HFP 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.
• Data-Sharing: The HFP 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.
• Imported Seafood Safety: The HFP will implement its regulatory partnership agreement with Ecuador for shrimp and work towards establishing additional agreements with India and Indonesia for seafood by assessing their regulatory frameworks.
• Expanding Surveillance of Foodborne Pathogens: The HFP 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: The HFP will advance the Highly Pathogenic Avian Influenza (HPAI) silo study in collaboration with the U.S. Department of Agriculture, the CDC, the National Conference on Interstate Milk Shipments, and state partners to monitor the safety of dairy and milk products.

Food Chemical Safety

Strengthening Regulatory Oversight

• Pre-market Review: The HFP will complete a review to identify efficiencies in their 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.
• Post-Market Assessment of Chemicals in Food: The HFP 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.
• Closer to Zero Action Levels: The HFP will advance its Closer to Zero initiative 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.
• New Dietary Ingredient Notification (NDIN) Guidance: The HFP will continue work to release additional sections of final guidance to better inform industry on how and when to submit new dietary ingredient notifications.
• FSMA Guidance for Industry: The HFP will target issuance of the draft guidance for Preventive Controls for Human Food specific to Chemical Hazards.

Advancing Science

• Use and Development of New Methods: The HFP 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.
• Post-market Signal Detection and Prioritization: The HFP will continue to develop artificial intelligence approaches to enhance its oversight, including implementation of the Warp Intelligent Learning Engine (WILEE), a horizon-scanning monitoring tool for signal detection and surveillance of the food supply.
• Better Understanding PFAS Exposure: The HFP will expand the use of new methods to better understand exposure to PFAS chemicals.

Leveraging Partnerships and Engagement

• Consumer Education and Outreach: The HFP will develop educational materials to increase awareness about nutritious foods for infants and young children while minimizing dietary exposure to unavoidable contaminants.
• International Collaboration: The HFP 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.

Nutrition

Promoting Priority Policy Initiatives

• Updating FDA’s Nutrient Content Claim “Healthy”: The HFP 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.
• Proposing Front-of-Package Nutrition Labeling: The HFP will target issuance of a proposed rule to establish a mandatory FOP nutrition labeling scheme and will consider public input on the proposal.
• Supporting Reductions in Sodium in the Food Supply: The HFP 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 it works 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.
• Increasing the Resiliency of the U.S. Infant Formula Market: The HFP 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.

Advancing Science

• Collaborating on a Nutrition Research Agenda: The HFP 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.

Leveraging Partnerships and Engagement

• Focused Engagement on Nutrition Initiatives: The HFP 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.
• Safe Handling Practices for Infant Formula: The HFP 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 the American Academy of Pediatrics.
   

Authored by Maile Gradison and Chigozie Akah.