Your Complete Guide to Navigating the FDA’s Human Foods Program: Key Changes from 2024 to 2025 | JD Supra

FDA’s New Structure for Food Regulation

In 2024, the FDA made a big change in how it regulates food. They replaced the Center for Food Safety and Applied Nutrition with a new Human Foods Program. This new setup combines food policy, response functions, and field operations. The aim? To have a better way to oversee food safety.

A significant addition is the Office of Inspections and Investigations, which will collaborate more closely with state food agencies. The Office of Nutrition and Labeling continues to operate as well, tackling issues related to food labeling and nutrition.

Jim Jones is the new Deputy Commissioner for Human Foods. He reports directly to the FDA Commissioner and oversees all parts of the Human Foods Program. The management is divided into three key offices:

• Nutrition Center of Excellence: This office focuses on human nutrition and its link to diseases.
• Office of Microbiological Food Safety: Here, the emphasis is on monitoring and addressing risks related to microbes in both American and global food supplies.
• Office of Food Chemical Safety, Dietary Supplements, and Innovation: This office aims to ensure ingredient safety and encourage innovation.

Guidance Updates for 2024

This year, the FDA issued several significant guidelines rather than strict regulations. Here are a few highlights:

Hazard Analysis and Preventive Controls

In January, the FDA released guidance on hazard analysis and risk-based preventive controls. It provides clear steps on preparing a food safety plan and implementing corrective actions. This guidance aims to help companies comply with the Food Safety Modernization Act. You can find more about this here.

Genome Editing in Plant Foods

In February, the FDA updated its rules for using biotechnology in plant-based foods. The guidance stresses the need to identify any unintended effects from genome editing, including potential allergen introduction. You can read more about this update here.

Dietary Ingredient Notifications

The March guidance clarified how manufacturers should notify the FDA about new dietary ingredients and their timelines. More details can be found here.

In April, insights on using master files for new dietary ingredients were shared here.

Partially Hydrogenated Oils

Also in April, the FDA explained the recent rule on banning partially hydrogenated oils (PHOs) in foods. PHOs are no longer recognized as safe ingredients. More information can be found here.

Sodium Levels in Food

In August, a draft guidance suggested voluntary limits on sodium levels in food products. While these limits aren’t mandatory, they signal to the industry what the FDA views as healthy. Check out the draft guidance here.

Infant Formula Notifications

In December, the FDA provided details for manufacturers of infant formula regarding notifying the agency about production interruptions or discontinuations here.

Healthy Food Claims

Finally, there was significant discussion about the term “healthy” on food labels. The FDA published a rule clarifying what qualifies as healthy, which you can read about here. This rule becomes effective three years after being published, which gives time for manufacturers to ensure their products meet the new criteria.

What Lies Ahead in 2025

Looking to the future, the FDA’s Human Foods Program is prioritizing several key areas:

• Strengthening safety measures for microbiological hazards, especially in produce and seafood.
• Publishing data on food-borne illnesses.
• Implementing front-of-package labeling.
• Reviewing processes for introducing new ingredients in foods and supplements.
• Establishing guidelines for contaminants in baby food and infant formulas.
• Monitoring potential impacts of bird flu on the food supply.

The future of FDA regulation will depend on the agency’s leadership and evolving priorities. The implementation of many new rules is currently on hold for review. It will be interesting to see how these plans develop in the coming years.