Human Foods Program 2025 guidance agenda released 

On June 30, the U.S. Food and Drug Administration’s (FDA’s) Human Foods Program (HFP) published its proposed guidance agenda, which outlines possible new topics for guidance documents or revisions to existing guidance documents that the agency expects to tackle in the second half of 2025.

Priority topics

The FDA included seven topics on the HFP agenda. This is more than were included in the January 2024 update. The agency will prioritize the following documents for publication by the end of the year:

• Guidance on New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI
• Draft Guidance on Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food
• Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
• Draft Guidance on Action Levels for Inorganic Arsenic in Food Intended for Babies and Young Children
• Draft Guidance on Action Level for Opiate Alkaloids on Poppy Seeds
• Draft Guidance on The Food Traceability Rule: Questions and Answers
• Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards

The latest publication includes three new topics: opiate alkaloids on poppy seeds, food colors derived from natural sources such as fruit and vegetable juice, and identity and safety information about an NDI. The FDA released a Request for Information (RFI) in January on industry practices related to poppy seeds, specifically seeking to better understand current practices and whether any of them may increase or reduce the presence of opiate alkaloids on poppy seeds.

As has been consistent for the past several years, many of the agenda topics address food that is intended for consumption by younger consumers (i.e., infants, babies, and young children). Heavy metals in food intended for children have been a priority for the FDA, as evidenced by the recent Final Guidance for Industry on Action Levels for Lead in Processed Food Intended for Babies and Young Children that was released in January 2025. While that guidance was added to the program’s priority agenda in January 2024 and was achieved within a year, the draft guidance addressing cadmium and arsenic have been on the agenda since July 2023.

Operation Stork Speed, which the FDA announced in March 2025, includes plans for increased testing for heavy metals and other contaminants in infant formula and other foods children consume.

The Make America Healthy Again (MAHA) Commission report on childhood chronic disease also identified exposure to environmental chemicals, including heavy metals, as one of four root causes regulators should prioritize. The Commission’s post-report strategy may help push forward the long-awaited guidance for cadmium and arsenic.

Attorneys with Michael Best & Friedrich LLP note that two of the other new topics are also a focus of the MAHA Commission: natural food colorings and ingredient panels. As such, we may see those agenda items prioritized or incorporated into broader regulatory updates related to the recommendations the Commission is expected to release to address childhood chronic disease.

Looking ahead

The Trump Administration has placed an emphasis on reducing the number of overburdensome regulations while still maintaining product safety. Executive Order 14192, which mandates that federal agencies eliminate 10 regulations for every new regulation issued. Some experts have voiced concerns that this will mean fewer FDA guidance documents. 

However, the Deputy Commissioner for Policy, Legislation, and International Affairs at the FDA said, “I think if you look at the executive order, it’s very broad, a number of things can qualify as deregulatory and so we are still working on it and looking at it, but you will continue to see guidance come out of the agency, as you would have in the past.” The publication of a formal HFP guidance agenda seems to support that statement. 

It is worth emphasizing that any draft or final guidance documents released to address the FDA HFP’s priorities do not impose legally enforceable requirements. However, at a time when consumers and regulators alike are viewing the food industry with stricter scrutiny, it is important that companies closely review the FDA’s guidance documents and take necessary efforts to implement their suggestion. 

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