FDA Signals Interest in Defining Ultraprocessed Foods

In June 2025, the U.S. Food and Drug Administration announced it is evaluating whether to formally define the term ultraprocessed food (UPF)—a move that could influence future labeling regulations, public health guidance, and state or federal legislative efforts. No rulemaking or formal definition has been issued to date, but the agency confirmed that it is considering how processing level might fit into the broader regulatory framework.

The effort comes amid growing international and domestic interest in UPFs, including from organizations such as the World Health Organization and the Pan American Health Organization, and a recent uptick in state-level bills proposing limits on UPFs in school nutrition programs.

Although FDA has not yet opened a public comment docket, food companies should begin preparing for the possibility of policy action by evaluating how their products might be viewed under prevailing UPF classification systems—particularly the NOVA system, which defines UPFs broadly as ready-to-eat products made with industrial ingredients and additives not commonly used in home kitchens.

Why Defining UPFs May Prove Challenging

Unlike nutrient-specific standards (e.g., sodium or saturated fat limits), UPF classifications rely on the extent and purpose of food processing—a less objective metric that can vary across contexts. The NOVA system, widely referenced in the public health literature, places items as diverse as yogurt, breakfast cereals, meal replacement shakes, and packaged breads in the UPF category—regardless of their nutrient density or dietary role.

Scientific consensus on health effects is still evolving. While some studies associate high UPF consumption with increased risk of chronic disease, others—especially those controlling for confounding variables—find weaker or inconsistent links. Critics have also noted the difficulty of separating processing effects from those of energy density, portion size, and ingredient content.

This definitional ambiguity mirrors other FDA struggles—such as its long-delayed effort to define the term “natural”—and may slow progress. Still, FDA’s interest suggests that UPFs may become a future focus of nutrition labeling, consumer education, or regulatory oversight.

What to Expect Next

Though no regulatory proposal has been issued, companies should expect increased scrutiny of food processing and its place in dietary policy. Key developments may include:

• Stakeholder Input – FDA could seek public comment or host stakeholder meetings to assess views on UPF definitions and implications.
• Alignment with Other Policies – A UPF definition may intersect with FDA’s ongoing work on front-of-pack nutrition labeling and the voluntary “Healthy” label criteria.
• State-Level Momentum – Utah and Arizona have recently introduced bills limiting or labeling UPFs in schools. While not yet law, such efforts reflect a growing appetite among lawmakers to regulate based on processing, not just nutrient profiles.

How Industry Can Engage

FDA-regulated companies should consider taking the following steps:

• Audit Products: Identify which SKUs could be categorized as “ultraprocessed” under prevailing definitions (e.g., NOVA or WHO).
• Monitor Regulatory Language: Follow developments from the FDA, USDA, and international health organizations for emerging standards.
• Prepare to Comment: Assemble scientific, marketing, and regulatory teams to contribute meaningful input if and when a public docket opens.
• Clarify Health Benefits: Ensure that marketing and labeling claims for nutrient-enriched or reformulated foods are substantiated and clearly communicated.

As Gardner Law senior counsel David Graham puts it:

Food processing is not inherently harmful. What matters is transparency, accuracy, and scientific rigor in how we talk about—and regulate—these foods. We’re encouraging clients to stay informed, stay involved, and stay ahead of the curve.

How Gardner Law Can Help

Gardner Law counsels FDA-regulated companies across food, dietary supplement, and medical product industries. We can assist your team in:

• Interpreting evolving definitions of UPFs
• Assessing risk exposure from state and federal proposals
• Drafting and submitting effective public comments
• Evaluating labeling and reformulation strategies

If your company is navigating questions around ultraprocessed foods—or preparing for what’s next—contact our team. We’re here to help you make informed, pragmatic decisions that support compliance, risk mitigation, and business success.