Ultra-Processed Food: FDA Request for Information & Regulatory Outlook

Overview

Ultra-processed foods have become the dominant force in the American diet and the subject of an unprecedented federal regulatory push. In July 2025, the FDA and USDA jointly published a Request for Information seeking public input on how to define "ultra-processed food" for regulatory purposes — the first time the U.S. government has formally moved toward establishing a legal definition for the term. The RFI marks the opening salvo in what the administration frames as a public health intervention against foods that now constitute an estimated 57-60% of caloric intake for American adults and roughly 67% for children and adolescents.

The initiative is propelled by the Make America Healthy Again (MAHA) Commission, established by executive order in February 2025 and chaired by Health and Human Services Secretary Robert F. Kennedy Jr. The MAHA Report, released in May 2025, identified the prevalence of ultra-processed foods in the U.S. food system as a driver of diet-related chronic disease — a position backed by a rapidly expanding body of epidemiological research. Former FDA Commissioner David Kessler has called the situation urgent, telling CBS's 60 Minutes that human "biology was never intended to handle" ultra-processed foods at current consumption levels.

For food manufacturers, this is a high-stakes definitional exercise. A federal definition of "ultra-processed food" would establish the legal foundation for labeling requirements, procurement restrictions, marketing limitations, and potentially ingredient-level regulatory action. The outcome will affect virtually every company that manufactures packaged food in the United States.

Current Regulatory Status

The Request for Information

On July 25, 2025, the FDA and USDA published a joint Request for Information in the Federal Register (90 FR 35305, Docket No. FDA-2025-N-1793) soliciting data and public comment to inform the development of a uniform federal definition of ultra-processed foods. The RFI poses a series of specific questions organized around three core areas:

1. Definitional criteria — What attributes should define an ultra-processed food? Should the definition be based on ingredients, processing methods, nutritional attributes, or some combination?
2. Scientific evidence — What research links ultra-processed food consumption to adverse health outcomes, and what are the mechanisms?
3. Practical application — How would a definition be operationalized for labeling, dietary guidance, and federal food programs?

The notice explicitly references the NOVA classification system developed by researchers at the University of Sao Paulo as a starting framework, while acknowledging its limitations and inviting alternative approaches.

Comment Period

The original comment deadline was September 23, 2025. On September 19, 2025, the agencies published a Federal Register notice (90 FR 45229) extending the comment period by 30 days to October 23, 2025, citing the complexity of the questions and the volume of extension requests received from industry, academic, and public health stakeholders.

MAHA Commission Context

The RFI is one component of a broader regulatory strategy. The MAHA Commission's 100-day report (due May 2025) assessed threats that food ingredients pose to children's health, and its 180-day strategy (due August 2025) laid out an action plan. The FDA's Human Foods Program 2026 Priority Deliverables, published in January 2026, explicitly list ultra-processed food definition development as a deliverable, alongside a joint research agenda with NIH to study the mechanisms by which ultra-processed foods cause harm.

Key Deadlines

Date	Event	Status
February 13, 2025	Executive Order establishing MAHA Commission	Completed
May 2025	MAHA Report released, identifying UPF health risks	Completed
July 25, 2025	FDA/USDA RFI published in Federal Register	Completed
September 23, 2025	Original comment period deadline	Extended
October 23, 2025	Extended comment period deadline	Closed
January 2026	FDA Human Foods Program 2026 priorities published; UPF definition listed as deliverable	Completed
February 2026	Kennedy announces FDA will "act on" Kessler petition on UPF ingredients	Completed
2026 (TBD)	FDA/USDA analyze RFI comments and develop proposed definition	Pending
2026-2027 (TBD)	Potential proposed rulemaking on UPF definition and/or labeling	Anticipated

Detailed Analysis

The NOVA Classification System

The dominant framework for classifying food by degree of processing is the NOVA system, developed in 2009 by Carlos Monteiro and colleagues at the University of Sao Paulo, Brazil. NOVA divides all foods into four groups:

• Group 1 — Unprocessed or minimally processed foods. Fresh fruits, vegetables, grains, legumes, nuts, eggs, plain milk, fresh meat and fish. Processing is limited to removal of inedible parts, drying, crushing, grinding, pasteurization, freezing, or vacuum packaging.

• Group 2 — Processed culinary ingredients. Oils, butter, sugar, salt, flour, and other substances extracted and purified from Group 1 foods. Used in home or restaurant cooking, rarely consumed alone.

• Group 3 — Processed foods. Group 1 foods modified by Group 2 ingredients through simple methods like canning, bottling, or fermenting. Examples: canned vegetables, artisan bread and cheese, smoked meats. Typically two or three ingredients.

• Group 4 — Ultra-processed foods. Industrial formulations made mostly or entirely from substances derived from foods and additives. Characterized by ingredients rarely or never used in home cooking — high-fructose corn syrup, hydrogenated oils, modified starches, protein isolates, emulsifiers, humectants, flavor enhancers, and colorants. Examples: soft drinks, packaged snacks, reconstituted meat products, instant noodles, frozen meals, industrial bread, breakfast cereals.

The NOVA system has been adopted by the Pan American Health Organization, referenced in Brazil's national dietary guidelines since 2014, and used by the World Health Organization in its policy recommendations. The FDA's RFI explicitly references NOVA while acknowledging that the U.S. regulatory framework may require modifications or an entirely different approach.

Criticism of the NOVA Framework

The food industry and some nutrition scientists have raised substantive objections to NOVA as a regulatory tool:

Classification inconsistency. Critics point out that NOVA produces counterintuitive classifications. Industrially produced whole-wheat bread is "ultra-processed" (Group 4), while artisan white bread with identical nutritional content is merely "processed" (Group 3). Infant formula is classified as ultra-processed, despite being an essential product.

Confounding variables. The Institute of Food Technologists (IFT), in its RFI response, argued that health associations attributed to ultra-processed foods may be driven by the nutritional profiles of those foods (high sugar, sodium, and saturated fat) rather than the processing itself. If nutritional composition is the actual driver, existing nutrient-based regulatory tools may be more effective than a processing-based classification.

Regulatory ambiguity. The term "ultra-processed" conflates diverse products — a protein bar and a soda occupy the same NOVA group despite radically different nutritional profiles. Industry groups argue that a regulatory definition based on NOVA would be unworkable for enforcement because the classification depends on qualitative judgments about ingredient purpose that are difficult to codify into law.

Innovation disincentives. Several industry comments argued that classifying all "industrial formulations" as harmful could discourage reformulation efforts and the development of healthier processed foods. The National Chicken Council and National Pork Producers Council specifically discouraged FDA and USDA from legally defining ultra-processed foods.

The Definitional Challenge

The core difficulty facing the FDA is that "ultra-processed" is not a single, objectively measurable property — it is a characterization of how a food is formulated. Any regulatory definition must answer several thorny questions:

Where does "processed" end and "ultra-processed" begin? A canned tomato is processed. Tomato sauce with salt and olive oil is processed. Ketchup with high-fructose corn syrup, modified food starch, and "natural flavors" is ultra-processed. But what about ketchup made with sugar instead of HFCS and no modified starch? Drawing legally enforceable lines across a continuum of processing intensity is the central challenge.

Should the definition be ingredient-based or process-based? The RFI explicitly asks this question. An ingredient-based approach (listing prohibited or flagged ingredients) would be simpler to enforce but could be gamed through substitution. A process-based approach (defining types of industrial processing) would be harder to enforce and harder to define with legal precision.

How should reformulated products be treated? If a manufacturer removes emulsifiers and modified starches from a frozen meal, does it cease to be ultra-processed? The answer has enormous implications for whether the definition incentivizes meaningful reformulation or merely ingredient swaps.

The FDA's 2026 deliverables indicate that the agency is still in the data-gathering and analysis phase. The interagency collaboration with USDA adds complexity because USDA regulates meat and poultry products — a significant portion of the ultra-processed category — under separate statutory authority.

The Health Evidence

The scientific case against ultra-processed foods has strengthened considerably in recent years:

Mortality. A 2024 umbrella review published in the BMJ, analyzing data from 45 meta-analyses and nearly 10 million participants, found that higher ultra-processed food consumption was associated with increased risk of 32 adverse health outcomes. Participants with the highest UPF consumption had a 15% increased risk of all-cause mortality compared to the lowest consumers. A 2025 dose-response meta-analysis of 18 prospective cohort studies (1,148,387 participants, 173,107 deaths) found a 10% higher risk of all-cause mortality for each 10% increment in UPF consumption, with a positive linear relationship.

Cardiovascular disease. Convincing evidence (Class I) supports a direct association between ultra-processed food exposure and cardiovascular disease-related mortality.

Type 2 diabetes. Convincing evidence (Class I) also supports a direct association with incident type 2 diabetes.

Mental health. Highly suggestive evidence links UPF consumption to depressive outcomes and anxiety. No study to date has reported an association between UPF intake and a beneficial health outcome.

Mechanistic concerns. Beyond nutritional composition, researchers have identified potential mechanisms related to additives (emulsifiers disrupting gut microbiome), neo-formed contaminants from industrial processing, and packaging chemicals (phthalates, bisphenols). The FDA/NIH joint research agenda for 2026 is specifically designed to investigate these mechanisms.

The Kessler Petition

In August 2025, former FDA Commissioner David Kessler filed a citizen petition urging the FDA to revoke the GRAS (Generally Recognized as Safe) status of certain refined carbohydrates used in industrial food processing, including corn syrups, high-fructose corn syrup, maltodextrin, and extrusion-modified flours. The petition argues that the GRAS determinations for these ingredients are based on outdated safety data that did not account for their use at current consumption volumes in ultra-processed formulations.

In February 2026, Kennedy publicly stated on CBS's 60 Minutes that the FDA "will act on" the Kessler petition. However, in subsequent statements, Kennedy clarified that the administration is not planning to "regulate ultra-processed food" as a category — instead focusing on specific ingredients. The FDA issued an "interim response" to the petition, stating it had not yet reached a final decision.

This distinction is significant: the RFI aims to define ultra-processed food as a category, while the Kessler petition targets specific ingredients within those foods. Both tracks are advancing simultaneously, but they represent different regulatory strategies with different legal pathways.

GRAS Reform as a Parallel Track

The ultra-processed food initiative intersects with the broader GRAS reform effort. Kennedy has publicly described the GRAS (Generally Recognized as Safe) framework as "the biggest lie of all," arguing that the self-determination pathway — where manufacturers can unilaterally declare ingredients as GRAS without FDA review — has allowed thousands of food chemicals into the supply with inadequate safety evidence. The FDA's 2026 priorities include a proposed rule to reform the GRAS notification process.

If both GRAS reform and a UPF definition advance, food manufacturers could face a dual compliance burden: reformulating products to avoid the "ultra-processed" classification while simultaneously providing enhanced safety documentation for ingredients that previously relied on self-affirmed GRAS status. The convergence of these two regulatory tracks represents the most significant potential restructuring of U.S. food ingredient regulation in decades.

Affected Product Categories

A federal definition of ultra-processed food would potentially affect the broadest swath of the U.S. food supply of any recent regulatory action. Based on NOVA Group 4 criteria, affected categories include:

• Conventional packaged foods — Breakfast cereals, packaged breads, chips, crackers, cookies, frozen meals, instant noodles, reconstituted meat products
• Beverages — Soft drinks, energy drinks, sweetened juices, flavored waters, sweetened dairy beverages
• Snack foods — Packaged snack cakes, candy bars, flavored popcorn, extruded snacks
• Baked goods — Industrial bread, pastries, frozen doughs
• Confections — Candy, chocolate products with additives, frostings
• Condiments and sauces — Many industrial dressings, sauces, and marinades with emulsifiers and flavor enhancers
• Infant and toddler foods — Some commercial infant formulas and packaged baby foods
• Dietary supplements — Certain formulated nutrition bars and meal replacement products

The breadth of the category is precisely what makes the definitional exercise so contentious. An estimated 73% of the U.S. food supply meets the NOVA Group 4 criteria. Any regulatory action based on a broad ultra-processed definition would affect virtually every major food manufacturer, retailer, and food service operator in the country.

State-Level Momentum

Federal action is not happening in isolation. Several states have already moved to restrict ultra-processed foods, primarily in school settings:

• Arizona banned ultra-processed food from school lunches beginning with the 2026-2027 school year
• Texas banned 17 listed ingredients from school lunches beginning with the 2026-2027 school year
• Louisiana banned 15 listed ingredients from school lunches beginning with the 2028-2029 school year

These state actions create a patchwork of varying requirements that increases pressure on the federal government to establish a uniform national definition.

International Precedents

The United States is a latecomer to ultra-processed food regulation. Several countries have already implemented restrictions:

• Brazil — Overhauled national dietary guidelines in 2014 to explicitly recommend minimally processed foods over ultra-processed products. Implemented front-of-package warning labels (black octagonal icons) for foods high in sugar, sodium, and saturated fat.
• Chile — Enacted Ley 20,606 in 2016, requiring stop-style warning labels on foods exceeding nutritional thresholds. Studies found the labels led to a 24% reduction in calories purchased from labeled foods, 37% less sodium, and 27% less saturated fat.
• Colombia and Mexico — Adopted similar black octagonal front-of-pack warning label systems.
• WHO — The World Health Organization has endorsed the NOVA framework and recommended that countries develop policies to reduce ultra-processed food consumption.

What Companies Should Do

The FDA has not proposed any rules, and a formal definition is likely months or years away. However, the regulatory trajectory is clear. Companies manufacturing products that would fall under a broad ultra-processed classification should take action now:

1. Audit your product portfolio. Classify your products under the NOVA framework. Identify which products would be classified as Group 4 and which are borderline. Understanding your exposure is the first step toward managing it.

2. Review ingredient lists. The Kessler petition targets specific GRAS ingredients — high-fructose corn syrup, maltodextrin, modified starches, and extrusion-modified flours. Products containing these ingredients face the most immediate regulatory risk, independent of the broader UPF definition.

3. Monitor the definition development. The FDA will analyze RFI comments and develop a proposed definition through interagency collaboration. The agency's 2026 priorities commit to this work. Companies should track FDA announcements and participate in any subsequent comment periods.

4. Evaluate reformulation opportunities. Regardless of the regulatory outcome, consumer awareness of ultra-processed foods is rising sharply. Companies that can reduce additive counts, replace industrial ingredients with whole-food alternatives, or simplify formulations will be better positioned — both for regulatory compliance and market differentiation.

5. Prepare for labeling changes. Whether through a UPF-specific label, expanded front-of-package warnings, or modifications to existing nutrition facts, some form of enhanced consumer disclosure is likely. Companies should assess their packaging and labeling pipeline for flexibility.

6. Track state-level action. Even if federal rulemaking takes years, state-level bans on specific ingredients and UPF categories in schools and public institutions are accelerating. Companies supplying school food programs, government cafeterias, or state-regulated food service operations face near-term compliance requirements.

7. Engage trade associations. Industry response to the RFI was substantial and varied. The IFT, NCC, NPPC, and other groups have articulated industry positions. Companies should ensure their specific concerns are represented as the regulatory process advances.

The ultra-processed food issue is not a question of whether regulatory change is coming — it is a question of scope, timeline, and mechanism. The convergence of federal executive action, bipartisan congressional interest, state-level legislation, and mounting scientific evidence makes inaction the riskiest posture a food manufacturer can take.