FDA’s Human Foods 2025 goals: Microbiological safety, food chemical safety & nutrition

With the establishment of the new Human Foods Program Oct. 1, the US food supply will be broadly viewed as a “vehicle for wellness” rooted in science-based approaches to prevent foodborne illness, reduce diet-related chronic disease and safeguard chemicals in food, Jim Jones, deputy commissioner Human Foods Program, said during an Alliance for a Stronger FDA webinar last week.

Historically, FDA allocated funding for state agencies to perform critical food safety inspections, mostly in retail, produce farms and manufactured products. This funding was set to $83 million with additional funds included from unspent federal salaries and other resources. With recent flat federal budgets and rising costs, FDA anticipates that these additional funds will no longer be available, leading to a reduction in state support by approximately 30% this fiscal year.

FDA is working with states to prioritize their inspection efforts to sustain the highest priority activities, Jones said.

FDA’s deliverables will focus on three priority areas: microbiological safety, nutrition and food chemical safety.

FDA’s chemical safety program aims to enhance pre-market and post-market processes​

The Human Foods Program will focus on food additives, contact substances​ and GRAS (Generally Recognized as Safe) substances. The agency plans to improve efficiencies in its pre-market review system, ensuring a smoother alignment under the new organization, Jones said.  

On the post-market side, FDA is updating its assessment framework and incorporating public feedback to develop a systematic approach for chemical assessment. An updated list of prioritized substances for reassessment will be published, including a projected timeline on milestones for issuing new guidance, Jones said.

Technology and scientific advancements are also a priority. The FDA will use AI-based approaches like the Warp Intelligent Learning Engine (WILE) to classify chemicals by toxicity potential for food supply monitoring and risk detection. The agency also will enhance its methods to evaluate PFAS (per- and polyfluoralkyl substances) exposure.

To promote awareness of nutritional benefits and the potential chemical risks in foods for infants and young children, FDA will develop and distribute educational materials to inform parents about nutritional benefits “of vegetables, fruits, whole grains, seafood” and the potential risks “posed from environmental contaminants,” Jones said.

On the international front, FDA will pursue formal agreements with global regulator counterparts on harmonizing science-based food chemical safety standards.

New standards around healthy claims, sodium reduction, infant formula supply stability​

FDA plans to finalize an updated definition of the “healthy” nutrient claim, along with a voluntary symbol for front-of-pack labeling. The symbol can be used by manufacturers as long as their product fits the criteria, Jones explained.

A mandatory front-of-pack nutrition labeling scheme is also in the works with plans to gather public input on the proposal, he added.

Additionally, the FDA plans to bolster nutrition research in partnership with the National Institute for Health, focusing on the health impacts of ultra-processed foods.

Sodium reduction is a critical priority for the agency. FDA will evaluate the Phase I voluntary sodium reduction targets as it continues “assessing progress in sodium reduction across the food supply​,” Jones said. This also includes finalizing the draft Phase II targets.

FDA also will finalize the rule on the use of salt substitutes “to help reduce sodium content and standardize foods” and collaborate with federal and stakeholder partners to improve sodium-related data sharing, said Jones.

For infant formula, FDA is preparing a long-term national strategy to boost supply stability and address potential shortages. It will launch a continuing medical education program on safe formula handling for pediatricians in collaboration with USDA, Women, Infant and Children Supplemental Nutrition Program (WIC) and the American Academy of Pediatrics.

Safety compliance and research to strengthen pathogen prevention in produce​

Within microbiological safety, Human Foods Program is working to ensure stakeholders have the information to comply with the Pre-Harvest Agricultural Water and the Food Traceability​ rules, with compliance dates beginning April 2025 and January 2026, respectively. FDA also will ensure that the Food Safety Modernization Act (FSMA) guidance documents related to the product safety rule are available.

“If you do not know how a pathogen is moving in the environment, it can be very challenging to identify how to intervene to prevent it from happening again," said Jones.

Longitudinal studies on pathogen movement in the environment, including two studies on leafy greens, will be conducted to identify effective mitigation strategies, Jones said.

He added, “If you do not know how a pathogen is moving in the environment, it can be very challenging to identify how to intervene to prevent it from happening again.”

One of the studies will take place in southwest Indiana where several salmonella outbreaks were linked to melons. Additionally, FDA is working to integrate genetic data from environmental samples into the Center for Disease Control and Prevention’s PulseNet system, which combines environmental and clinical pathogen data. This integration will speed identification of environmental pathogens linked to human illnesses, improving outbreak response and prevention efforts, Jones said.

Enhancing safety, efficiency, regulatory training​

On a broader level, FDA is shaping the Human Foods Program to align food labs with risk priorities, streamline documentation and strengthen inspection and resource allocation. Recall processes will be improved through modernized communication and faster classification speed — meaning FDA will more swiftly categorize recalls by risk level (Class I, II or III) based on potential health impact.

Finally, a Human Foods Advisory Committee will be established with member recruitment targeted for FY ’26. The committee will work with regulatory agencies and academic and industry stakeholders “to develop and publish a comprehensive environmental scan of current efforts across the country to train new regulators,” Jones added.