Federal Register, Volume 90 Issue 141 (Friday, July 25, 2025)

[Federal Register Volume 90, Number 141 (Friday, July 25, 2025)]
[Notices]
[Pages 35305-35309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-14089]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-1793]

DEPARTMENT OF AGRICULTURE

Ultra-Processed Foods; Request for Information

AGENCY: Food and Drug Administration (FDA), U.S. Department of Health
and Human Services (HHS); U.S. Department of Agriculture (USDA).

ACTION: Notice; request for information.

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SUMMARY: 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.

DATES: Either electronic or written comments on the notice must be
submitted by September 23, 2025.

ADDRESSES: You may submit comments and information as follows. Please
note that late, untimely filed comments will not be considered. The
https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of September 23,
2025. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or
before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a

[[Page 35306]]

third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-1793 for ``Ultra-Processed Foods; Request for Information.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts or go to the Dockets Management Staff, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
FDA: Claudine Kavanaugh, Office of Nutrition and Food Labeling,
Human Foods Program, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 301-796-4647; or Meadow Platt, Office of
Policy, Regulations, and Information, Human Foods Program, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378.
USDA: Eve Stoody, Food and Nutrition Service, United States
Department of Agriculture, 1320 Braddock Place, Alexandria, VA 22314,
703-305-2062.

SUPPLEMENTARY INFORMATION:

I. Background

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.
(Ref. 1). Improving nutrition is therefore one of the most important
public health interventions for reducing chronic illnesses and
premature death, and for helping make Americans healthier.
Over the last decade, concerns have grown significantly about the
increased availability and consumption of foods that researchers have
termed ``ultra-processed.'' Researchers have found links between
consumption of these foods and a range of negative health outcomes,
including cardiovascular disease, obesity, and certain cancers (see,
e.g., Refs. 2, 3, 4). Consumption of these foods may also be associated
with lower diet quality, increased caloric intake, and the intake of
food additives (see, e.g., Refs. 5, 6, 7). 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 (Refs. 8, 9).
In May 2025, the President's Make America Healthy Again (MAHA)
Commission released ``The MAHA Report: Make Our Children Healthy Again:
Assessment'' (MAHA Report) (Ref. 7). Among other topics, the MAHA
Report highlights the prevalence of certain processed foods in the U.S.
food system and notes the health concerns associated with their
consumption (Ref. 7; see also Refs. 8, 9). FDA and the National
Institutes of Health (NIH) have also announced plans to invest in gold
standard science through the new NIH-FDA Nutrition Regulatory Science
Program to help better understand how and why consumption of ultra-
processed foods can harm people's health (Ref. 10).
There is no single, universally accepted definition of UPFs, and
the definition of such foods has varied considerably over time (see,
e.g., Ref. 11). Classification systems may use either the terms
``ultra-processed'' or ``highly processed,'' and the classification of
a food can vary between systems due to differing approaches to the
definition (Refs. 12, 13).
The most common classification, developed by Brazilian researchers
in 2009, is the ``Nova'' system (Ref. 14). In its latest iteration, the
Nova system classifies foods into four food categories: group 1,
unprocessed or minimally processed foods; group 2, processed culinary
ingredients; group 3, processed foods; and group 4, ultra-processed
foods (Ref. 15). The Nova system identifies ultra-processed foods
(group 4) based on multiple factors; these factors include things like
the use of certain ingredients and substances (such as emulsifiers,
bulking agents, or thickeners), industrial processing technologies, as
well as sophisticated packaging, that result in a palatable and
appealing product (Refs. 15, 16, 17).
However, concerns have been raised about the full ability of UPF
classification systems to accurately capture the characteristics of
UPFs that may impact health. For example, on one hand, there is overlap
between foods considered to be ultra-processed and foods that are high
in added sugars, sodium, and saturated fat, which independently are
recommended to be limited by the Dietary Guidelines for Americans,
2020-2025 (Refs. 6, 18). Foods commonly considered to be ultra-
processed encompass a broad range of industrially processed foods, such
as soft drinks and many packaged snacks.

[[Page 35307]]

On the other hand, foods considered to be 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 (see Ref. 18). It is important therefore to
consider unintended consequences of an overly-inclusive definition of
UPFs that could discourage intake of potentially beneficial foods.
Recently, some U.S. states have sought to establish their own
definitions of ``ultra-processed foods,'' with proposed definitions
varying. These proposed state definitions include, among others:
Proposals to define UPFs as foods that include substances
intended to have a certain effect on food (such as stabilizers and
thickeners, coloring or flavoring agents) (see, e.g., Pennsylvania,
2025 Bill Text PA H.B. 1132; California, 2025 Bill Text CA A.B. 1264);
Proposals to define UPFs as foods that have undergone
certain processing steps (such as hydrogenation of oils or hydrolysis
of proteins) (see, e.g., Massachusetts, 2025 Bill Text MA H.B. 539);
and
Proposals to define UPFs as foods that include one of
anywhere between 10 and 15 listed ingredients (see, e.g., Florida, 2025
Bill Text FL S.B. 1826 (seeking to define UPFs as foods that include
one of 11 listed ingredients); Louisiana, 2025 Bill Text LA S.B. 117
(seeking to define UPFs as foods that include one of 15 listed
ingredients); North Carolina, 2025 Bill Text NC H.B. 874 (seeking to
define UPFs as foods that include one of 11 listed ingredients);
Arkansas, 2025 Bill Text AR H.B. 1962 (seeking to define UPFs as foods
that contain one of 10 listed ingredients); Alabama, 2025 Bill Text AL
H.B. 580 (seeking to define UPFs as foods that contain one of 11 listed
ingredients); South Carolina, 2025 Bill Text SC S.B. 589 (seeking to
define UPFs as foods that contain one of 11 listed ingredients);
Kentucky, 2025 Bill Text KY H.B. 439 (seeking to define UPFs as foods
that contain one of 11 listed ingredients)).
Additionally, some third-party organizations are starting to
develop their own definitions for UPFs.
There is a clear need for a uniform definition of UPFs to allow for
consistency in research and policy. With this Request for Information,
we seek data and information that would enable us, as part of a joint
federal agency effort, to define UPFs.

II. Issues for Consideration and Request for Information

We invite comment on the questions below. Please explain your
answers and provide references and data, if possible. To the extent
that you rely on an existing definition of UPFs (or a facet of such
definition) to inform your responses, please state which specific
definition it is.
(1) What, if any, existing classification systems or policies
should we consider in defining UPFs? What are the advantages and
challenges in applying these systems (or aspects of them) to classify a
food as ultra-processed? What are characteristics that would or would
not make a given system (or aspect of the system) particularly suitable
for the U.S. food supply? Please provide supporting data and explain
your rationale in your response.
(2) FDA-required ingredient labeling provides important information
to consumers about what is in packaged foods. The ingredient
declaration on a food label lists each ingredient by its common or
usual name (21 CFR 101.4(a)(1)). This ingredient name sometimes
provides information on specific forms of the ingredient used, such as
``flour'' versus ``whole grain flour.'' Additionally, ingredients are
declared in descending order of predominance by weight (21 CFR
101.4(a)), which may help a consumer determine the relative proportion
of whole versus processed ingredients. For certain types of
ingredients, such as flavorings, colorings, and chemical preservatives,
labeling must also provide the function of the ingredient (see 21 CFR
101.22). The following questions focus on the ingredient list on the
labeling of packaged foods.
a. In considering ingredients that appear toward the beginning of
an ingredient list (that is, ingredients that likely form most of a
finished food by weight), what types of ingredients (e.g., ingredients
that may share a similar composition, function, or purpose) might be
used to characterize a food as ultra-processed? Please provide
supporting data and explain your rationale in your response.
b. Ingredients that appear toward the end of an ingredient list may
contribute minimally to the overall composition and weight of a
finished food (for example, ingredients may sometimes be listed as
containing 2% or less by weight of the finished food (21 CFR
101.4(a)(2))). What types of these less prominent ingredients (e.g.,
ingredients that may share a similar composition, function, or purpose)
might be used to characterize a food as ultra-processed?
Further, ingredients that function as flavorings are either natural
flavors or artificial flavors; colorings are either certified (for
instance, ``FD&C Red No. 40'') or non-certified (for instance,
``colored with beet juice'') (21 CFR 101.22). Should these various
types of flavors and colors be considered separately when
characterizing a food as ultra-processed? Please provide supporting
data and explain your rationale in your response.
c. To what extent, if any, should the relative amount of an
ingredient used in a food influence whether the food should be
characterized as ultra-processed? Please provide supporting data and
explain your rationale in your response.
d. What, if any, other ingredients or ingredient-related criteria
not discussed previously should or should not be used to characterize a
food as ultra-processed? Please provide supporting data and explain
your rationale in your response.
(3) FDA defines ``manufacturing/processing,'' in part, to mean
making food from one or more ingredients, or synthesizing, preparing,
treating, modifying, or manipulating food, including food crops or
ingredients (21 CFR 117.3; see also 21 U.S.C. 321(gg) for the statutory
definition of ``processed food''). Certain FDA regulations, such as
standards of identity, may prescribe methods of production or
formulation (see, e.g., 21 CFR part 133). Processing of a food is often
achieved by a combination of physical, biological, and chemical
methods; however, while processing information is sometimes found on
food labeling, manufacturers are not always required to disclose
processing information on food labeling. The following questions focus
on the processing of an ingredient or a mixture of ingredients into the
finished food and whether certain processing methods may contribute to
a food being considered ultra-processed.
a. Processing a food through physical means may include cutting,
extracting juice by an application of force, heating, freezing,
extrusion, and other physical manipulations. What physical processes
might be used to characterize a food as ultra-processed? Please provide
supporting data and explain your rationale in your response.
b. Processing a food through biological means may include non-
alcoholic fermentations of the food by microorganisms (for example,
bacteria and yeasts), enzymatic treatment, and other biological
manipulations. What biological processes might be used to characterize
a food as ultra-processed?

[[Page 35308]]

Please provide supporting data and explain your rationale in your
response.
c. Processing a food through chemical means may include pH
adjustment and other chemical manipulations. What chemical processes
might be used to characterize a food as ultra-processed? Please provide
supporting data and explain your rationale in your response.
d. What, if any, other processing-related techniques should or
should not be used to characterize a food as ultra-processed? Please
provide supporting data and explain your rationale in your response.
(4) Is the term ``ultra-processed'' the best term to use, or is
there other terminology that would better capture the concerns
associated with these products? If there is another term to consider,
please name and define that term and provide specific scenarios and
citations (if available) to support its use.
(5) FDA and USDA are aware of ongoing research on nutrition and
other attributes relating to the health outcomes associated with
consumption of UPFs. As noted in the background, FDA is also initiating
a joint effort with NIH to answer questions such as how and why UPFs
can harm people's health.
a. In considering nutritional attributes (such as information
presented on the Nutrition Facts label), to what extent, if any, and
how, should nutritional composition or the presence of certain
nutrients be incorporated in a definition of UPFs? Please provide
supporting data and explain your rationale in your response.
b. What other attributes, such as energy density or palatability,
might be used to characterize a food as ultra-processed? Please provide
supporting data and explain your rationale in your response. If
relevant to your answer, please also provide suggestions on how these
attributes can be measured and/or potentially be incorporated into a
definition of UPFs, if they are not readily apparent on the food
labeling.
(6) FDA and USDA are exploring whether and how to incorporate
various factors, such as the ones discussed in the questions above,
into a uniform definition of UPFs. How might these factors be
integrated in the classification of a food as ultra-processed in a way
that can be systematically measured and applied to foods sold in the
U.S.? And what considerations should be taken into account in
incorporating such a classification in food and nutrition policies and
programs?

III. References

The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.

* 1. Murphy, S.L., Kochanek, K.D., et al., ``Mortality in the United
States, 2023.'' NCHS Data Brief, No. 521. Hyattsville, MD: National
Center for Health Statistics. 2024. Accessed June 6, 2025. Available
at https://stacks.cdc.gov/view/cdc/170564.
2. Lane M.M., Davis, J.A., et al., ``Ultraprocessed food and chronic
noncommunicable diseases: a systematic review and meta-analysis of
43 observational studies.'' Obesity Reviews. 2021;22(3):e13146.
Accessed June 6, 2025. Available at https://doi.org/10.1111/obr.13146.
3. Cordova R., Viallon, V., et al., ``Consumption of ultra-processed
foods and risk of multimorbidity of cancer and cardiometabolic
diseases: a multinational cohort study.'' Lancet Regional Health
Europe. 2023;35:100. Accessed June 6, 2025. Available at https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00190-4/
fulltext.
4. Lane M.M., Gamage, E., et al., ``Ultra-processed food exposure
and adverse health outcomes: umbrella review of epidemiological
meta-analyses.'' BMJ. 2024;384:e077310. Accessed June 6, 2025.
Available at https://doi.org/10.1136/bmj-2023-077310.
5. Hall, K.D., Ayuketah, A., et al., ``Ultra-Processed Diets Cause
Excess Calorie Intake and Weight Gain: An Inpatient Randomized
Controlled Trial of Ad Libitum Food Intake.'' Cell Metabolism. 2019;
30:67-77. Accessed June 2, 2025. Available at: https://doi.org/10.1016/j.cmet.2019.05.008.
6. Popkin, B., Miles, D., et al., ``A policy approach to identifying
food and beverage products that are ultra-processed and high in
added salt, sugar and saturated fat in the United States: a cross-
sectional analysis of packaged foods,'' The Lancet Regional Health--
Americas. 2024; 32: 100713. Accessed June 2, 2025. Available at
https://doi.org/10.1016/j.lana.2024.100713.
* 7. Make America Healthy Again Commission, ``The MAHA Report: Make
Our Children Healthy Again,'' The White House. 2025. Accessed June
2, 2025. Available at https://www.whitehouse.gov/maha/.
8. Juul, F., Parekh, N., Martinez-Steele, E., et al., ``Ultra-
processed food consumption among US adults from 2001 to 2018,'' The
American Journal of Clinical Nutrition. 2022; 115: 211-221. Accessed
June 2, 2025. Available at https://doi.org/10.1093/ajcn/nqab305.
9. Wang, L., Martinez-Steele, E., et al., ``Trends in Consumption of
Ultraprocessed Foods Among US Youths Aged 2-19 Years, 1999-2018,''
Journal of the American Medical Association. 2021; 326(6):519-530.
Accessed June 2, 2025. Available at https://doi.org/10.1001/jama.2021.10238.
* 10. U.S. Food and Drug Administration and National Institutes for
Health (NIH). ``FDA and NIH Announce Innovative Joint Nutrition
Regulatory Science Program.'' Accessed June 2, 2025. Available at
https://www.fda.gov/news-events/press-announcements/fda-and-nih-announce-innovative-joint-nutrition-regulatory-science-program.
11. Gibney, M.J., ``Ultra-Processed Foods: Definitions and Policy
Issues.'' Current developments in nutrition. 2019; 3:nzy077.
Accessed June 2, 2025. Available at https://doi.org/10.1093/cdn/nzy077.
12. Crino, M., Barakat T., et al., ``Systematic Review and
Comparison of Classification Frameworks Describing the Degree of
Food Processing,'' Nutrition and Food Technology. 2017; 3(1).
Accessed June 2, 2025. Available at http://dx.doi.org/10.16966/2470-6086.138.
13. de Ara[uacute]jo, T.P., de Moraes, M.M., et al., ``Food
Processing: Comparison of Different Food Classification Systems,''
Nutrients. 2022; 14: 729. Accessed June 2, 2025. Available at
https://doi.org/10.3390/nu14040729.
14. Monteiro, C.A., ``Nutrition and Health. The Issue Is Not Food,
nor Nutrients, so Much as Processing.'' Public Health Nutrition.
2009; 12: 729-731. Accessed June 2, 2025. Available at https://doi.org/10.1017/S1368980009005291.
15. Monteiro, C.A., Cannon, G., et al., ``Ultra-processed foods,
diet quality, and health using the NOVA classification system,''
Food and Agriculture Organization of the United Nations. 2019.
Accessed June 5, 2025. Available at https://openknowledge.fao.org/bitstreams/5277b379-0acb-4d97-a6a3-602774104629/download.
16. Monteiro, C.A., Cannon, G., et al., ``Ultra-Processed Foods:
What They Are and How to Identify Them.'' Public Health Nutrition.
2019; 22: 936-941. Accessed June 2, 2025. Available at https://doi.org/10.1017/S1368980018003762.
17. Monteiro C.A., Cannon G., et al., ``The UN Decade of Nutrition,
the NOVA food classification and the trouble with ultra-
processing,'' Public Health Nutrition. 2018; 21(1):5-17. Accessed
June 2, 2025. Available at https://doi.org/10.1017/s1368980017000234.
* 18. U.S. Department of Agriculture and U.S. Department of Health
and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th
ed. 2020. Accessed June 2, 2025. Available at

[[Page 35309]]

https://www.dietaryguidelines.gov/sites/default/files/2020-12/Dietary_Guidelines_for_Americans_2020-2025.pdf.

Robert F. Kennedy, Jr.,
Secretary, U.S. Department of Health and Human Services.
Brooke L. Rollins,
Secretary, U.S. Department of Agriculture.
[FR Doc. 2025-14089 Filed 7-24-25; 8:45 am]
BILLING CODE 4164-01-P