FDA and USDA Seek a Definition of Ultra-Processed Foods (2025)

Table of Contents

1. What the FDA and USDA Did
2. Why the Agencies Say a Definition Is Needed
3. The Nova System and Other Ways of Classifying Food
4. State Bills With Their Own Definitions
5. The Concern About a Definition That Is Too Broad
6. The Questions the Agencies Asked
7. The Figures and Statements in the Press Release
8. The Research Program Running Alongside
9. What the Request Does Not Do
10. The Comment Period and the Docket
11. Dates and Status as of October 11, 2026
12. How It Fits Other FDA Food Actions
13. Primary Documents
14. Key Research Papers
15. Connections

1. What the FDA and USDA Did

The announcement. The FDA news release “HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods” is dated 23 July 2025. It states that the two agencies were “announcing a joint Request for Information (RFI) to gather information and data to help establish a federally recognized uniform definition for ultra-processed foods,” which it calls “a critical step in providing increased transparency to consumers about the foods they eat.” The release said the RFI would be publicly available on 24 July; the FDA program page also gives 24 July 2025 as the issue date.

The formal notice. The Federal Register is the U.S. government’s daily journal of official agency actions. The notice appeared there on 25 July 2025, pages 35305–35309 of volume 90, with the action line “Notice; request for information.” It is issued jointly by the FDA (part of the Department of Health and Human Services, HHS) and the USDA, and is signed by the two department heads: Robert F. Kennedy, Jr., Secretary of Health and Human Services, and Brooke L. Rollins, Secretary of Agriculture. The FDA contacts named are in the Human Foods Program’s Office of Nutrition and Food Labeling and its Office of Policy, Regulations, and Information; the USDA contact is in the Food and Nutrition Service.

What it asks for. Its summary reads: “FDA and USDA (we) are requesting data and information to help develop a uniform definition of ultra-processed foods (UPF or UPFs) for human food products in the U.S. food supply. A uniform UPF definition, developed as part of a joint effort by federal agencies, would allow for consistency in research and policy to pave the way for addressing health concerns associated with the consumption of UPFs.”

The docket. A docket is the public file in which an agency collects the comments and background documents for one action. This one is Docket No. FDA-2025-N-1793 at regulations.gov, where submitted comments are posted.

Back to Table of Contents

2. Why the Agencies Say a Definition Is Needed

The notice’s background section opens with chronic disease: “The United States faces a growing epidemic of preventable diet-related chronic diseases, such as cardiovascular disease, and type 2 diabetes, which are leading causes of death and disability in the U.S.” It describes improving nutrition as one of the most important public health interventions for reducing chronic illness and premature death.

On the foods themselves, the notice reports that concern has grown over the last decade about the availability and consumption of foods “that researchers have termed ‘ultra-processed.’” It states that researchers have found links between eating these foods and “a range of negative health outcomes, including cardiovascular disease, obesity, and certain cancers,” and that such consumption may also be associated with lower diet quality, higher calorie intake and greater intake of food additives. It adds that “some researchers have estimated that more than half of calories consumed by adults and children in the U.S. are from foods that the researchers classified as ultra-processed,” citing two national dietary-survey analyses (listed under Key Research Papers below).

The notice cites the May 2025 report of the President’s Make America Healthy Again (MAHA) Commission, “The MAHA Report: Make Our Children Healthy Again: Assessment,” which it says highlights the prevalence of certain processed foods in the U.S. food system and the health concerns tied to them.

The central problem the notice names is the absence of an agreed meaning: “There is no single, universally accepted definition of UPFs, and the definition of such foods has varied considerably over time.” Systems use either “ultra-processed” or “highly processed,” and the same food can land in different groups depending on the system. The notice concludes: “There is a clear need for a uniform definition of UPFs to allow for consistency in research and policy.”

Back to Table of Contents

3. The Nova System and Other Ways of Classifying Food

The notice calls the Nova system, developed by Brazilian researchers in 2009, “the most common classification.” In its latest form Nova sorts foods into four groups:

1. group 1 — unprocessed or minimally processed foods;
2. group 2 — processed culinary ingredients;
3. group 3 — processed foods;
4. group 4 — ultra-processed foods.

According to the notice, Nova identifies group-4 foods on several factors, including the use of certain ingredients and substances (“such as emulsifiers, bulking agents, or thickeners”), industrial processing technologies, and sophisticated packaging, which together “result in a palatable and appealing product.” Emulsifiers keep oil and water mixed; bulking agents and thickeners add volume or body.

The notice also records that “concerns have been raised about the full ability of UPF classification systems to accurately capture the characteristics of UPFs that may impact health,” and that some third-party organizations have begun writing definitions of their own.

Back to Table of Contents

4. State Bills With Their Own Definitions

The notice reports that “some U.S. states have sought to establish their own definitions” of ultra-processed foods, and that the proposed definitions vary. It groups the 2025 state bills it cites into three approaches:

• By the purpose of added substances — foods containing substances meant to have a certain effect on the food, such as stabilizers, thickeners, or coloring or flavoring agents (bills cited from Pennsylvania and California).
• By processing steps — foods that have undergone certain steps, such as hydrogenation of oils or hydrolysis of proteins (a Massachusetts bill). Hydrogenation hardens liquid oils by adding hydrogen; hydrolysis breaks proteins into smaller pieces.
• By a fixed ingredient list — foods containing any one of 10 to 15 listed ingredients (bills cited from Florida, Louisiana, North Carolina, Arkansas, Alabama, South Carolina and Kentucky; Louisiana’s listed 15 ingredients, Arkansas’s 10, and the others 11).

Directly after the state bills and the third-party definitions, the notice states: “There is a clear need for a uniform definition of UPFs to allow for consistency in research and policy.”

Back to Table of Contents

5. The Concern About a Definition That Is Too Broad

The notice sets out two sides of the classification problem. On one side, it says there is overlap between foods considered ultra-processed and foods high in added sugars, sodium and saturated fat — nutrients that the Dietary Guidelines for Americans, 2020–2025, recommend limiting — and that foods commonly considered ultra-processed take in “a broad range of industrially processed foods, such as soft drinks and many packaged snacks.”

On the other side, it notes that foods considered ultra-processed “may also include foods such as whole grain products or yogurt, which are known to have beneficial effects on health and are recommended as part of healthy dietary patterns.” The agencies conclude: “It is important therefore to consider unintended consequences of an overly-inclusive definition of UPFs that could discourage intake of potentially beneficial foods.”

Back to Table of Contents

6. The Questions the Agencies Asked

The notice invited comment on six numbered questions, asking commenters to explain their answers, give references and data where possible, and name any existing definition they relied on. In summary:

1. Existing systems. Which classification systems or policies, if any, are worth considering; what advantages and challenges each has; and what would make one suitable or unsuitable for the U.S. food supply.
2. The ingredient list. The notice explains that packaged-food labels list ingredients by their common name and in descending order by weight, and that flavorings, colorings and chemical preservatives must also state their function. It asks what types of ingredients near the start of the list (which likely make up most of the food) and near the end (which may be 2% or less by weight) might mark a food as ultra-processed; whether natural versus artificial flavors, and certified colors (such as FD&C Red No. 40) versus non-certified colors (such as “colored with beet juice”), ought to be treated separately; how much the amount of an ingredient matters; and what other ingredient criteria might apply.
3. Processing methods. Citing the FDA’s regulatory meaning of manufacturing/processing (21 CFR 117.3), the notice notes that manufacturers are not always required to disclose processing on the label. It asks which physical processes (examples given: cutting, juice extraction by force, heating, freezing, extrusion), biological processes (non-alcoholic fermentation by bacteria or yeasts, enzyme treatment) and chemical processes (such as pH adjustment) might characterize a food as ultra-processed, and what other techniques might or might not count.
4. The term itself. Whether “ultra-processed” is the best term, or whether other terminology would better capture the concerns about these products.
5. Nutrition and other attributes. Whether and how nutrient content (such as the Nutrition Facts information) belongs in a definition, and whether attributes such as energy density (calories per gram) or palatability could be used, and how they could be measured if they do not appear on the label.
6. Putting it together. How these factors could be combined into a classification that can be “systematically measured and applied to foods sold in the U.S.,” and what considerations matter in using such a classification in food and nutrition policies and programs.

Back to Table of Contents

7. The Figures and Statements in the Press Release

The FDA’s estimates. The press release states: “It is estimated that approximately 70% of packaged products in the U.S. food supply are foods often considered ultra-processed, and that children get over 60% of their calories from such foods.” These are FDA estimates given in the press release; they do not appear in the Federal Register notice, which instead reports researchers’ estimates that more than half of calories eaten by U.S. adults and children come from foods they classified as ultra-processed. The FDA program page words the first figure differently, as “70% of the U.S. food supply.”

Health outcomes. The release says that “dozens of scientific studies have found links” between eating foods often considered ultra-processed and “numerous adverse health outcomes, including cardiovascular disease, Type 2 diabetes, cancer, obesity and neurological disorders.”

The officials’ statements. The release quotes three officials:

• The Secretary of Health and Human Services: “Ultra-processed foods are driving our chronic disease epidemic … Defining ultra-processed foods with a clear, uniform standard will empower us even more to Make America Healthy Again.”
• The Secretary of Agriculture called a unified, widely understood definition “long overdue” and said she would make certain that people across “the agriculture value chain are part of the conversation.”
• The FDA Commissioner: “The threats posed to our health by foods often considered ultra-processed are clear and convincing, making it imperative that we work in lockstep with our federal partners to advance, for the first time ever, a uniform definition of ultra-processed foods.”

The release also states that the MAHA assessment “recognizes that the overconsumption of ultra-processed foods is one of the driving factors of the childhood chronic disease crisis.” These statements are the officials’ and the release’s own characterizations; the RFI itself is a request for data, not a scientific finding.

Back to Table of Contents

8. The Research Program Running Alongside

The notice states that the FDA and the National Institutes of Health (NIH) announced plans to invest through a new NIH–FDA Nutrition Regulatory Science Program “to help better understand how and why consumption of ultra-processed foods can harm people’s health,” and question 5 refers to this joint effort. The FDA program page dates the partnership to May 2025 and says the program is, among other things, “examining the role that consumption of ultra-processed foods may play in people’s health.”

The program page acknowledges that “while a substantial body of research has been conducted on UPFs, there are still many unanswered questions about how and why consumption of these foods may harm people’s health.” It also records that in December 2024 the FDA and NIH hosted a Nutrition Regulatory Science Workshop that included a session on ultra-processed foods.

Back to Table of Contents

9. What the Request Does Not Do

• It sets no definition. The notice asks for data and information; it does not propose or adopt any definition of ultra-processed food.
• It creates no label requirement. Nothing in it requires any food to be labeled ultra-processed or to carry new information.
• It restricts no food or ingredient. It bans, limits or reclassifies nothing, and makes no finding about any particular food or additive.
• It is not a proposed rule. A request for information is an early, information-gathering step. Any definition would come through a later action, and the notice’s final question asks only what considerations matter if a classification were used in food and nutrition policies and programs.

Back to Table of Contents

10. The Comment Period and the Docket

• Original deadline: 23 September 2025, by 11:59 p.m. Eastern Time for electronic comments at regulations.gov; mailed or hand-delivered comments counted if received by that date. The notice states that late comments would not be considered.
• Extension: a second notice, published 19 September 2025 at 90 FR 45229 (FR Doc. 2025-18169), extended the period to 23 October 2025. It states the agencies did so “in response to requests for an extension” to give “interested persons additional time to submit comments.” The FDA program page describes it as a 30-day extension.
• How comments were filed: electronically through the Federal eRulemaking Portal under Docket No. FDA-2025-N-1793, where they are posted unchanged and are public; or on paper to the FDA’s Dockets Management Staff (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Confidential information could be filed only on paper, in a marked copy and a redacted public copy.
• Reading the docket: received comments are viewable on regulations.gov under the docket number, or at the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday to Friday.

Back to Table of Contents

11. Dates and Status as of October 11, 2026

• 23 July 2025 — FDA press release announces the joint RFI.
• 25 July 2025 — notice published, 90 FR 35305; comments due 23 September 2025.
• 19 September 2025 — extension published, 90 FR 45229; comments due 23 October 2025.
• 23 October 2025 — comment period closed.
• 3 August 2026 — the federal regulatory review website (reginfo.gov) lists an item titled “White Paper: Proposed Definition of Ultra-Processed Food,” RIN 0910-ZD60, from HHS/FDA, received for review under Executive Order 12866 at the stage “Notice.” Executive Order 12866 review is the step in which the White House Office of Management and Budget (OMB), through its Office of Information and Regulatory Affairs (OIRA), examines a significant agency document before it is issued. The listing marks it as not economically significant.

Legal status as of 11 October 2026: open, with no definition in force. The request for information is closed to comment. No federal definition of ultra-processed food has been published, and no Federal Register document on this docket has appeared since the September 2025 extension. The white paper remains pending at OMB, and its text has not been released. It is a white paper, not a proposed or final rule. The site’s page FDA Proposal to Make GRAS Notices Mandatory (2026) describes how this definition step was announced alongside the August 2026 proposal on food-ingredient safety notices.

Back to Table of Contents

12. How It Fits Other FDA Food Actions

The FDA program page presents the definition effort as one of several actions on foods “that may be considered ultra-processed,” and the press release says HHS would continue pursuing “other key policies and programs that seek to, collectively, dramatically reduce chronic disease.” Several other 2025 FDA food actions touch the same territory, each with its own page on this site:

• Front-of-package labels (January 2025). A proposed “Nutrition Info box” showing saturated fat, sodium and added sugars — the nutrients the RFI says overlap with foods considered ultra-processed. See FDA Proposal for Front-of-Package Nutrition Labels (2025).
• Food dyes (January and April 2025). The revocation of Red No. 3 and the plan to phase out petroleum-based dyes. The RFI’s question 2 asks whether certified colors such as FD&C Red No. 40 are to be weighed separately from non-certified colors. See FDA Revokes Red No. 3 in Food and Ingested Drugs (2025) and FDA Plan to Phase Out Petroleum-Based Food Dyes (2025).
• Food chemical oversight (March–August 2025). Steps on self-affirmed “GRAS” (generally recognized as safe) ingredients — additives a company can judge safe without notifying the FDA — and on reviewing chemicals already on the market. See FDA Moves on Self-Affirmed GRAS and Chemical Reviews (2025).

The 2026 proposal to make GRAS notices mandatory, and the ultra-processed food definition step that its page reports alongside it, are covered on FDA Proposal to Make GRAS Notices Mandatory (2026) (see also section 11). All the year’s actions are listed on the Major FDA Actions of 2025 hub.

Back to Table of Contents

13. Primary Documents

1. U.S. Food and Drug Administration (2025). HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods. FDA News Release, 23 July 2025 — fda.gov press announcement
2. Food and Drug Administration, HHS; Department of Agriculture (2025). Ultra-Processed Foods; Request for Information. Federal Register 90:35305–35309, 25 July 2025. Docket No. FDA-2025-N-1793 — FR Doc. 2025-14089 (official PDF, govinfo.gov)
3. Food and Drug Administration, HHS; Department of Agriculture (2025). Ultra-Processed Foods; Request for Information; Extension of Comment Period. Federal Register 90:45229–45230, 19 September 2025. Docket No. FDA-2025-N-1793 — FR Doc. 2025-18169 (official PDF, govinfo.gov)
4. U.S. Food and Drug Administration. Ultra-Processed Foods (program page, content current as of 18 September 2025) — fda.gov program page
5. Public docket FDA-2025-N-1793 — regulations.gov docket FDA-2025-N-1793
6. Office of Information and Regulatory Affairs (2026). White Paper: Proposed Definition of Ultra-Processed Food. HHS/FDA, RIN 0910-ZD60, received 3 August 2026, EO 12866 review pending, stage: Notice — reginfo.gov review record

Back to Table of Contents

Key Research Papers

1. Monteiro CA, Cannon G, Levy RB, Moubarac JC, Louzada ML, Rauber F, Khandpur N, Cediel G, Neri D, Martinez-Steele E, Baraldi LG, Jaime PC (2019). Ultra-processed foods: what they are and how to identify them. Public Health Nutrition 22(5):936-941 — PubMed PMID: 30744710
2. Gibney MJ (2019). Ultra-Processed Foods: Definitions and Policy Issues. Current Developments in Nutrition 3(2):nzy077 — PubMed PMID: 30820487
3. Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, et al. (2019). Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metabolism 30(1):67-77.e3 — PubMed PMID: 31105044
4. Lane MM, Davis JA, Beattie S, Gómez-Donoso C, Loughman A, O’Neil A, Jacka F, Berk M, Page R, Marx W, Rocks T (2021). Ultraprocessed food and chronic noncommunicable diseases: A systematic review and meta-analysis of 43 observational studies. Obesity Reviews 22(3):e13146 — PubMed PMID: 33167080
5. Lane MM, Gamage E, Du S, Ashtree DN, McGuinness AJ, Gauci S, Baker P, Lawrence M, Rebholz CM, Srour B, Touvier M, Jacka FN, O’Neil A, Segasby T, Marx W (2024). Ultra-processed food exposure and adverse health outcomes: umbrella review of epidemiological meta-analyses. BMJ 384:e077310 — PubMed PMID: 38418082
6. Wang L, Martínez Steele E, Du M, Pomeranz JL, O’Connor LE, Herrick KA, Luo H, Zhang X, Mozaffarian D, Zhang FF (2021). Trends in Consumption of Ultraprocessed Foods Among US Youths Aged 2-19 Years, 1999-2018. JAMA 326(6):519-530 — PubMed PMID: 34374722
7. Juul F, Parekh N, Martinez-Steele E, Monteiro CA, Chang VW (2022). Ultra-processed food consumption among US adults from 2001 to 2018. American Journal of Clinical Nutrition 115(1):211-221 — PubMed PMID: 34647997

All seven papers appear in the reference list of the Federal Register notice (section III); the last two are the dietary-survey analyses it cites for the estimate that more than half of U.S. calories come from foods classified as ultra-processed.

PubMed Topic Searches

1. PubMed: ultra-processed food definition and classification
2. PubMed: the Nova classification
3. PubMed: ultra-processed food consumption in the United States

Back to Table of Contents

Connections

• Major FDA Actions of 2025
• FDA and Regulation
• FDA Proposal to Make GRAS Notices Mandatory (2026)
• FDA Proposal for Front-of-Package Nutrition Labels (2025)
• FDA Moves on Self-Affirmed GRAS and Chemical Reviews (2025)
• FDA Plan to Phase Out Petroleum-Based Food Dyes (2025)
• FDA Revokes Red No. 3 in Food and Ingested Drugs (2025)
• Ultra-Processed Foods
• Ultra-Processed Foods and Weight Gain
• Seed Oils
• Food Preservatives and High Blood Pressure (News, 28 September 2026)

Back to Table of Contents