`[Federal Register Volume 90, Number 10 (Thursday, January 16, 2025)]
[Proposed Rules]
[Pages 5426-5463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00778]



[[Page 5425]]

Vol. 90

Thursday,

No. 10

January 16, 2025

Part XI





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 101





Food Labeling: Front-of-Package Nutrition Information; Proposed Rule

  Federal Register / Vol. 90 , No. 10 / Thursday, January 16, 2025 / 
Proposed Rules  

[[Page 5426]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2024-N-2910]
RIN 0910-AI80


Food Labeling: Front-of-Package Nutrition Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) proposes to 
require front-of-package nutrition labels on most foods that must bear 
a Nutrition Facts label. This action, if finalized, would require the 
display of a compact informational box containing certain nutrient 
information on the principal display panel. The box would provide 
consumers, including those who have lower nutrition knowledge, with 
standardized, interpretive nutrition information that can help them 
quickly and easily identify how foods can be part of a healthy diet. We 
also propose to amend certain nutrient content claim regulations to 
align with current nutrition science and avoid within-label 
inconsistencies.

DATES: Either electronic or written comments on the proposed rule must 
be submitted by May 16, 2025. Submit comments (including 
recommendations) on the collection of information under the Paperwork 
Reduction Act of 1995 by May 16, 2025.

ADDRESSES: You may submit comments 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 May 16, 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 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-2024-N-2910 for ``Food Labeling: Front-of-Package Nutrition 
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, the 
plain language summary of the proposed rule of not more than 100 words 
as required by the ``Providing Accountability Through Transparency 
Act,'' 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 and/or go to the Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Under the Paperwork Reduction Act (PRA), comments on the 
information collection provisions are best assured of consideration if 
your comments are received by May 16, 2025. Submit your comments on 
FDA's need for this information, the accuracy of the provided burden 
estimates, and any suggested methods for minimizing respondent burden 
to FDA using the docket identified at the beginning of this rulemaking. 
FDA will respond to any information collection-related comments in the 
final rule. You may also send your information collection-related 
comments to OMB's Office of Information and Regulatory Affairs using 
the interface at https://www.reginfo.gov/public/do/PRAMain. Find this 
particular information collection by selecting ``Currently Under 
Review--Open for Public Comments'' or by using the search function. The 
title of this proposed collection is ``Food Labeling: Front-of-Package 
Nutrition Information.''

FOR FURTHER INFORMATION CONTACT: 
    With regard to the proposed rule: Claudine Kavanaugh, Office of 
Nutrition and Food Labeling, Human Foods Program, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450; 
or Deirdre Jurand or Alexandra Beliveau, Office of Policy, Regulations, 
and Information, Human Foods Program, Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2378.

[[Page 5427]]

    With regard to the information collection: JonnaLynn Capezzuto, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation
    B. Regulatory and Research History
    C. Citizen Petition
    D. Updated FDA Literature Review and New Research Overview
IV. Legal Authority
    A. Statutory Framework
    B. Current Proposal
    C. Legal Basis for the Proposal
    D. Inapplicability of Nutrient Content Claim Provisions to 
Proposed Sec.  101.6
    E. Severability
V. Description of the Proposed Rule
    A. Scope/Applicability (Proposed Sec.  101.6(a)(1))
    B. Content (Proposed Sec.  101.6(a)(2))
    C. Format (Proposed Sec.  101.6(a)(3))
    D. No Other Information Allowed in the Nutrition Info Box 
(Proposed Sec.  101.6(a)(4))
    E. Special Labeling Provisions (Proposed Sec.  101.6(b))
    F. Exemptions (Proposed Sec.  101.6(c))
    G. Low Sodium and Low Saturated Fat Nutrient Content Claims 
(Revised Sec. Sec.  101.61(b)(4) and (5) and 101.62(c)(2) and (3))
    H. Authority Citation
    I. Conforming Amendments
    J. Technical Amendments
VI. Proposed Effective/Compliance Dates
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Proposed Rule

    This proposed rule, if finalized, would amend our regulations by 
adding a requirement for certain nutrition information to appear in a 
compact informational box on the principal display panel or bulk food 
labeling (for purposes of this document, referred to collectively as 
the front of the food package, principal display panel, or similar) of 
most foods bearing a Nutrition Facts label (by statute, ``food'' is 
defined as, among other things, articles used for food or drink for man 
(21 U.S.C. 321(f))). The scientific literature on nutrition labeling, 
including on the Nutrition Facts label, demonstrates that providing 
context for the levels of certain nutrients to limit that is 
interpretive rather than solely numeric--to communicate the relative 
significance in the context of a total daily diet--and requiring that 
interpretive information appear on the front of the package helps 
consumers notice and use the nutrition information presented on food 
packages. The box we are proposing would give consumers additional 
standardized context on the front of most food packages about certain 
nutrients that appear on the Nutrition Facts label and allow them to 
compare this nutrition information across foods. An example of the 
proposed front-of-package (FOP) nutrition information box (Nutrition 
Info box) that reflects all proposed requirements is as follows:
[GRAPHIC] [TIFF OMITTED] TP16JA25.005

    The proposed rule would provide consumers, including those who have 
lower nutrition knowledge, with interpretive nutrition information that 
can help them quickly and easily identify how foods can be part of a 
healthy diet. We also propose to amend the nutrient content claim 
definitions for low sodium (which includes the terms ``low sodium,'' 
``low in sodium,'' ``little sodium,'' ``contains a small amount of 
sodium,'' and ``low source of sodium'') and low saturated fat (which 
includes the terms ``low in saturated fat,'' ``low saturated fat,'' 
``contains a small amount of saturated fat,'' ``low source of saturated 
fat,'' and ``a little saturated fat'') to align with current nutrition 
science and to avoid within-label inconsistencies.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule, if finalized, would:
     Require most foods that must display a Nutrition Facts 
label to bear an FOP Nutrition Info box on the principal display panel 
that details and interprets the relative amount of certain nutrients to 
limit (i.e., saturated fat, sodium, and added sugars) in a serving of 
the food;
     Detail how to determine the interpretive descriptions 
(i.e., ``Low,'' ``Med,'' and ``High'') of such nutrients for the 
Nutrition Info box;
     Specify the required contents of the Nutrition Info box, 
such as the headings and nutrients;
     Specify the required format of the Nutrition Info box, 
such as placement, size, and use of dividing lines to separate 
information;
     Detail special labeling provisions for certain foods to 
modify or alternatively display the Nutrition Info box;
     Specify certain foods that are exempt from the requirement 
to display the Nutrition Info box;
     Provide examples of Nutrition Info boxes;
     Revise the low sodium and low saturated fat nutrient 
content claim definitions; and

[[Page 5428]]

     Establish a compliance date of 3 years after the final 
rule's effective date for businesses with $10 million or more in annual 
food sales, and a compliance date of 4 years after the final rule's 
effective date for businesses with less than $10 million in annual food 
sales.

C. Legal Authority

    We are issuing this proposed rule consistent with the Nutrition 
Labeling and Education Act of 1990 (NLEA) (Pub. L. 101-535, 104 Stat. 
2353, Section 2(b)(1) (21 U.S.C. 343 note (1990))) and sections 403(f) 
and 403(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). We 
are also issuing this proposed rule consistent with our authorities in 
sections 701(a), 403(a)(1), and 201(n) of the FD&C Act (21 U.S.C. 
371(a), 21 U.S.C. 343(a)(1), and 21 U.S.C. 321(n), respectively).

D. Costs and Benefits

    The proposed rule, if finalized, would require certain nutrition 
information to appear in a compact informational box on the front of 
most foods bearing a Nutrition Facts label. The proposed rule would 
also amend the low sodium and low saturated fat nutrient content claim 
regulations to align with current nutrition science and avoid within-
label inconsistencies. The proposed rule, if finalized, may result in 
industry reformulating products based on the interpretive label 
information or to maintain nutrient content claims, if some 
manufacturers choose to do so.
    We quantify costs to the packaged food industry from updating 
labeling to meet the proposed requirements. Annualized costs from 
relabeling over 10 years would range from $66 million to $154 million 
at a 2 percent discount rate, with a primary estimate of $105 million 
per year. Although reformulation is not a requirement or goal of the 
proposed rule, we also quantify the costs of reformulation, as the rule 
may result in some food manufacturers reformulating some food products. 
We estimate that the annualized costs of reformulation over 10 years 
would range from $125 million to $377 million at a 2 percent discount 
rate, with a primary estimate of $227 million. Combined, we estimate 
the annualized costs of the proposed rule over 10 years would range 
from $191 to $530 million at a 2 percent discount rate, with a primary 
estimate of $333 million. Note that, in general, this rule would impose 
few requirements on retailers. If a food that a retailer manufactures 
or packages either bears nutrition information or makes nutrition 
claims, and therefore is required to bear a Nutrition Facts label, the 
food would be subject to this rule's requirements.
    Benefits of this proposed rule, if finalized, would come from the 
value consumers receive from the information provided by the 
interpretive FOP label on food packages. If some packaged food 
manufacturers chose to reformulate products to maintain current 
nutrient content claims or move into a ``Low'' or ``Med'' interpretive 
description, consumers whose nutritional intake changes accordingly 
would also benefit from a healthier food supply.

                                Table 1--Summary of the Benefits, Costs, and Distributional Effects of the Proposed Rule
                                                               [Millions of 2023 dollars]
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                                                  Primary       Low        High       Dollar     Discount      Time
                   Category                      estimate    estimate    estimate      year      rate (%)     horizon                 Notes
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Benefits:
    Annualized monetized benefits.
    Annualized quantified, but non-monetized,
     benefits.
                                               ---------------------------------------------------------------------------------------------------------
    Unquantified benefits.....................  The benefits of this proposed rule would come from the value consumers receive from the information
                                                provided in the interpretive label on food packages.
                                               ---------------------------------------------------------------------------------------------------------
Costs:
    Annualized monetized costs................        $333        $191        $530        2023           2   2025-2034  Although reformulation is not a
                                                                                                                         requirement or goal of the
                                                                                                                         proposed rule, reformulation
                                                                                                                         costs are estimated to be 68%
                                                                                                                         of total quantified costs.
                                                                                                                         Costs may, at least partially,
                                                                                                                         be passed through to consumers
                                                                                                                         in the form of price increases.
    Annualized quantified, but non-monetized,
     costs.
    Unquantified costs.
Transfers:
    Annualized monetized Federal budgetary
     transfers.
    Other annualized monetized transfers.
Net Benefits:
    Annualized monetized net benefits.........
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                   Category                                   Effects
                                                                     Notes
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Effects on State, local, or Tribal
 governments.
 
                                               ---------------------------------------------------------------------------------------------------------
Effects on small businesses...................  The total discounted cost of the proposed rule per entity (including large firms) is approximately
                                                $100,253. We cannot estimate the exact cost per small entity because we do not know how many UPCs on
                                                average are owned by small entities as defined using the SBA definition.
                                               ---------------------------------------------------------------------------------------------------------
Effects on wages.
 
Effects on growth.
 
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[[Page 5429]]

II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
       Abbreviation/acronym                     What it means
------------------------------------------------------------------------
Dietary Guidelines................  Dietary Guidelines for Americans.
Dietary Guidelines, 2020-2025.....  Dietary Guidelines for Americans,
                                     2020-2025.
DRV...............................  Daily Reference Value.
DV................................  Daily Value.
FDA...............................  Food and Drug Administration.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
FOP...............................  Front-of-package.
G.................................  Gram(s).
GDA...............................  Guideline Daily Amount.
HHS...............................  U.S. Department of Health and Human
                                     Services.
IOM...............................  Institute of Medicine (now NASEM).
Med...............................  Medium.
Mg................................  Milligram(s).
NASEM.............................  National Academies of Sciences,
                                     Engineering, and Medicine.
NLEA..............................  Nutrition Labeling and Education Act
                                     of 1990.
OMB...............................  Office of Management and Budget.
PRIA..............................  Preliminary Regulatory Impact
                                     Analysis.
RACC..............................  Reference Amount Customarily
                                     Consumed.
RDI...............................  Reference Daily Intake.
------------------------------------------------------------------------

III. Background

    The United States faces a growing prevalence of preventable diet-
related chronic diseases and conditions (for purposes of this document, 
we use the term ``diseases'' to cover both diseases and conditions), 
which can include hypertension, cardiovascular disease, type 2 
diabetes, and certain forms of cancer. These diseases are leading 
causes of death and disability in the United States (Ref. 1). Data show 
that about one in 10 Americans has diabetes, and 90 to 95 percent of 
those have type 2 diabetes (Ref. 2); at least one in three people will 
have cancer in their lifetime (Ref. 3); and nearly half of American 
adults have high blood pressure, which is linked to leading causes of 
death for Americans: heart disease and stroke (Refs. 4 and 5). While 
these diseases can result from a mix of risk factors, such as genetic, 
biological, behavioral, socioeconomic, and environmental factors, 
unhealthy dietary patterns increase the risk of developing chronic 
diseases (Ref. 6). Diet-related chronic diseases are experienced 
disproportionately by certain racial and ethnic populations and those 
with lower socioeconomic status (Refs. 7 to 12).
    The Dietary Guidelines for Americans, 2020-2025 (Dietary 
Guidelines, 2020-2025) recommends, among other things, that Americans 
limit their intake of saturated fat, sodium, and added sugars to 
achieve healthy dietary patterns (Ref. 6). Under the National Nutrition 
Monitoring and Related Research Act of 1990 (Pub. L. 101-445, 104 Stat. 
1034), the U.S. Department of Agriculture and the U.S. Department of 
Health and Human Services (HHS) must publish the Dietary Guidelines for 
Americans (Dietary Guidelines) at least every 5 years and must base 
them on the preponderance of the current scientific and medical 
knowledge. Development of the Dietary Guidelines entails a rigorous 
process and includes appointment of a federal advisory committee of 
external scientific experts, review of the scientific evidence by the 
committee, public meetings, issuance of a scientific report by the 
advisory committee, and a public comment process (Ref. 13). With those 
requirements and practices in place, the Dietary Guidelines, 2020-2025 
concludes that healthy dietary patterns are based on, among other 
things, ``consuming foods and beverages in their nutrient-dense forms--
forms with the least amounts of added sugars, saturated fat, and 
sodium'' (Ref. 6).
    FDA, as part of a whole-of-government approach, broadly seeks to 
help reduce the burden of diet-related chronic diseases. We are 
committed to accomplishing this goal by, in part, prioritizing 
nutrition initiatives that can help improve dietary patterns in the 
United States. Americans' choice of foods is influenced by, among other 
things, their knowledge about and understanding of the foods available 
to them. As consumers make their food purchases and daily food choices, 
food labeling provides them with valuable information about nutrients 
and how a particular food fits into their daily diet. Congress 
recognized this and passed the NLEA, which gave the Secretary of HHS, 
and by delegation, FDA, authority to require certain nutrition 
information to be conveyed in a manner that allows the public to 
readily observe and comprehend such information and to understand its 
relative significance in the context of a total daily diet (21 U.S.C. 
343 note).
    The NLEA, which added section 403(q) of the FD&C Act, specifies 
certain nutrients to be declared in nutrition labeling, including 
saturated fat and sodium, and authorizes FDA to require the declaration 
of other nutrients if we determine that the declaration will provide 
information regarding the nutritional value of such food that will 
assist consumers in maintaining healthy dietary practices.
    We have established various requirements under the NLEA related to 
nutrition information on food labels, such as the declaration of 
nutrients (including saturated fat and sodium), the format for 
nutrition labeling (including the Nutrition Facts label), reference 
values for use in declaring a food's nutrient content, and allowances 
for specified products to be exempt from nutrition labeling (Sec.  
101.9 (21 CFR 101.9)). We first issued regulations related to the 
Nutrition Facts label in 1993 in a final rule entitled ``Food Labeling: 
Mandatory Status of Nutrition Labeling and Nutrient Content Revision, 
Format for Nutrition Label'' (58 FR 2079, January 6, 1993) (1993 
Nutrition Facts label final rule) and amended them in 1995 (60 FR 
67164, December 28, 1995)) and in 2003 (68 FR 41434, July 11, 2003). In 
2016, we again amended our regulations related to the Nutrition Facts 
label in a final rule entitled ``Food Labeling: Revision of the 
Nutrition and Supplement Facts Labels'' (81 FR 33742, May 27, 2016) 
(2016 Nutrition Facts label final rule) to, among other things, require 
the declaration of added sugars (codified at

[[Page 5430]]

Sec.  101.9(c)(6)(iii)). We took this action, in part, because of 
scientific evidence demonstrating a strong association between a 
healthy dietary pattern low in sugar-sweetened foods and a reduced risk 
of cardiovascular disease, evidence showing it is difficult to meet 
nutrient needs within calorie limits when added sugars consumption is 
high, and consumption data showing that Americans consume too many 
calories from added sugars (81 FR 33742 at 33759 and 33768 through 
33770).

A. Need for the Regulation

    In developing this proposed rule, FDA examined the scientific 
literature on nutrition labeling, including on the Nutrition Facts 
label. The Nutrition Facts label provides valuable, standardized 
nutrition information to consumers. Eighty-seven percent of U.S. 
consumers report ever looking at the Nutrition Facts label, and nearly 
80 percent of U.S. consumers use it sometimes or often (Ref. 14). It 
focuses on numerical information: The quantitative amount per serving 
of each declared nutrient and the corresponding percent Daily Value 
(DV), when applicable, tell consumers how much a nutrient in a 
specified serving of food contributes to a total daily diet.
    Using the Nutrition Facts label frequently is associated with 
healthier dietary patterns (Ref. 15). However, while many consumers use 
and benefit from the Nutrition Facts label, fewer people who ever look 
at the Nutrition Facts label look at nutrients to limit (including 
sodium, saturated fat, and added sugars) in that label (Ref. 14). Use 
of the Nutrition Facts label use also differs by sex, race/ethnicity, 
education level, and household income. Specifically, regular use of the 
Nutrition Facts label is lower among men, those with lower education 
levels, and those with lower incomes (Refs. 15 to 17). Additional 
nutrition labeling that is interpretive and prominently displayed on 
the front of food packaging could help improve consumer awareness of 
nutrients to limit by providing a more accessible description of 
certain information contained in the Nutrition Facts label.
    The scientific literature on nutrition labeling also demonstrates 
that some consumers struggle to understand the numerical values used to 
represent the nutrient content of the food or use the information in 
the labeling to make their food selections (Refs. 18 and 19). 
Additionally, information FDA has collected shows that providing 
context for the levels of certain nutrients to limit that is 
interpretive rather than solely numeric--to communicate the relative 
significance of the nutrients in the context of a total daily diet--and 
requiring that interpretive information appear on the front of the 
package helps consumers notice and use the nutrition information 
presented on food packages (Refs. 20 and 21). Based on this data and 
other information referenced in this document, we have tentatively 
determined that an interpretive FOP nutrition label is needed to help 
consumers readily observe and comprehend information about certain 
nutritional attributes of a food at the point of decision-making (i.e., 
when a consumer is deciding whether to buy, use, or eat the food) that 
will assist them in maintaining healthy dietary practices.

B. Regulatory and Research History

    FDA has considered the possible use of FOP nutrition labeling under 
its NLEA and FD&C Act authorities since at least 2007. In the Federal 
Register of July 20, 2007 (72 FR 39815), we issued a notice of public 
hearing and request for comment about symbols then in use to 
communicate nutrition information on food labels. In the Federal 
Register of December 1, 2009 (74 FR 62786), we announced that we had 
submitted two experimental studies for Office of Management and Budget 
(OMB) review and clearance under the Paperwork Reduction Act of 1995, 
with the intent to quantitatively assess consumer reactions to various 
FOP nutrition labeling schemes. We discussed how we completed a focus 
group study in April 2008 to obtain comments and information about many 
consumer issues related to FOP nutrition labeling schemes (id.). We 
noted that the information available to us left gaps in our 
understanding of the impacts of FOP nutrition labeling schemes on U.S. 
consumers and commented that there was a lack of publicly available 
quantitative consumer research on the relative effectiveness of 
existing and alternative nutrition labeling schemes (id.).
    In a Federal Register notice entitled ``Front-of-Pack and Shelf Tag 
Nutrition Symbols; Establishment of Docket; Request for Comments and 
Information'' (75 FR 22602, April 29, 2010), we established a docket to 
ask questions and obtain data and other information about ways to 
enhance the usefulness of point-of-purchase nutrition information, such 
as through FOP nutrition labeling. We stated that we were working with 
interested parties to develop a voluntary FOP nutrition label that was 
driven by sound nutrition criteria, consumer research, and design 
expertise (id. at 22603). In 2011, we issued a letter (Ref. 22) to the 
Grocery Manufacturers Association (now the Consumer Brands Association) 
and the Food Marketing Institute (now the Food Industry Association) 
announcing our intent to exercise enforcement discretion with respect 
to certain FDA nutrition labeling regulations so that the associations 
could introduce and use their Facts Up Front (FUF) FOP nutrition 
labeling program (Ref. 23). We recognized in the letter that the 
standardized, non-selective presentation of calories, saturated fat, 
sodium, and total sugar content on a company's entire product line, if 
widely adopted by the food industry in a uniform manner, could 
contribute to FDA's public health goals by fostering awareness of the 
nutrient content of foods in the marketplace and helping consumers in 
making quick, informed, and healthy food choices (Ref. 22).
    Congress has also demonstrated its interest in FOP nutrition 
labeling. In 2009, Congress directed the Centers for Disease Control 
and Prevention to commission a study by the Institute of Medicine (IOM) 
(now the National Academies of Sciences, Engineering, and Medicine 
(NASEM)) to examine and provide recommendations regarding FOP nutrition 
symbols (Refs. 24 and 25). In 2010, the IOM released a Phase I report 
(Ref. 26), which found, among other things, that FOP systems had been 
established internationally as far back as 1989, may have the greatest 
potential benefit if the nutrition components included are limited to 
those most closely related to prominent public health conditions, and 
that research was needed to determine the most effective way of 
presenting nutrition ratings to consumers so they could make food 
choices that contribute to a healthy diet. In 2012, the IOM released a 
Phase II report (Ref. 27), which addressed the potential benefits of a 
single, standardized front-label food guidance system regulated by FDA, 
assessed which systems are most effective with consumer audiences, 
considered which systems best promote health, and recommended ways to 
maximize the use of such systems. The IOM concluded that a single, 
standardized system that is easily understood by most age groups and 
appears on all products would be the best option (id.).
    Further, in 2011, we commissioned a literature review (Ref. 28) to 
look at scientific studies, including, e.g., experimental and real-
world studies, on FOP and Shelf Label Nutrition Systems (i.e., tags set 
on grocery store shelves rather than directly on food packaging) and 
learn which types of systems were most effective at informing consumers 
about the relative healthfulness of foods.

[[Page 5431]]

This literature review found that summary systems incorporating text 
and color worked better than those using only numeric information in 
attracting consumer attention and informing them about the relative 
healthfulness of foods (id.).
    In 2016, FDA commissioned an update to our previous literature 
review (Ref. 29), which captured more recent scientific literature on 
FOP nutrition labeling from 2010 to August 2016. Like previous reviews, 
the update reported that, among other things, consumers, no matter 
their nutrition knowledge, preferred visually simple labels that were 
quick and easy to read over those that have more complex numerical 
information.
    The White House released a National Strategy (Ref. 30) at the 
September 2022 Conference on Hunger, Nutrition, and Health that 
outlined the goal of ending hunger and increasing healthy eating and 
physical activity by 2030, so that fewer Americans experience diet-
related diseases such as type 2 diabetes, hypertension, and certain 
cancers. The strategy highlighted several FDA initiatives to help 
empower consumers with information and help create a healthier food 
supply. The National Strategy included FDA's work to, among other 
things, conduct research on and propose a standardized FOP system for 
food packages to help consumers, particularly those with lower 
nutrition literacy, quickly and easily identify foods that are part of 
a healthy eating pattern.

C. Citizen Petition

    On August 5, 2022, the Center for Science in the Public Interest, 
the Association of SNAP Nutrition Education Administrators, and the 
Association of State Public Health Nutritionists submitted a citizen 
petition asking that we amend our regulations to require an easy-to-
understand, standardized system of nutrition labeling on the principal 
display panel of foods (Citizen Petition from Peter Lurie, MD, MPH, 
Executive Director and President, and Eva Greenthal, Senior Science 
Policy Associate, Center for Science in the Public Interest, Amy 
Branham, Immediate Past Co-chair, ASNNA Leadership Team, Association of 
SNAP Nutrition Education Administrators, and Jamie Stang, Ph.D., MPH, 
RDN, President, Association of State Public Health Nutritionists, to 
Dockets Management Staff, Food and Drug Administration, dated August 5, 
2022, Docket No. FDA-2022-P-1832 (petition) at page 1). The petition 
requested that such a system be mandatory, nutrient-specific, inclusive 
of calories, and interpretive with respect to the levels of added 
sugars, sodium, and saturated fat per serving (id.).
    The petition claimed that experimental and real-world evidence 
shows that policies that aim to give consumers information about the 
healthfulness of foods that is clear, quick, and easy to access and 
understand, such as interpretive FOP nutrition labeling, can improve 
consumer understanding and encourage healthier diets (id. at page 4). 
The petition provided various examples of FOP systems that would meet 
its criteria. We have considered this citizen petition in proposing 
this rule.

D. Updated FDA Literature Review and New Research Overview

    We have seen rising global interest in FOP nutrition labeling 
schemes in recent years, and many countries have implemented, or are 
implementing, their own versions amid growing concern about the impact 
of diet-related chronic diseases, which can include cardiovascular 
disease, diabetes, and certain forms of cancer (Refs. 20 and 31). As of 
2024, countries in North America, South America, Asia, and Africa have 
implemented, or are implementing, mandatory FOP nutrition label 
schemes, while several other countries in Africa, Europe, Asia, and 
Oceania have voluntary schemes (Refs. 32 to 34). The schemes in these 
countries represent a variety of types, such as warning-type schemes 
(e.g., where a triangle and exclamation point on the FOP call attention 
to nutrients above a certain threshold in a serving size) and nutrient 
summary schemes (e.g., where a letter grade is determined and displayed 
to represent the healthfulness of a food's nutrient profile), among 
other types of schemes. We examined these various schemes in the 
literature review we conducted, which informed our consumer research 
studies. We describe our literature review and consumer research in the 
sections that follow.
1. Literature Review
    To inform our proposed Nutrition Info box, we first conducted a 
systematic review of the scientific literature on FOP nutrition labels, 
the most recent version of which we made public in April 2023 (Ref. 
20). Results of the scientific literature review showed that FOP 
nutrition labels have been extensively studied and some large-scale 
literature reviews on FOP nutrition labels have been conducted. As 
mentioned elsewhere in this document, the IOM conducted a two-phase 
literature review on FOP nutrition labels, concluding that such FOP 
nutrition labeling schemes benefit consumers and that consumers prefer 
simple, interpretive schemes, which are also rated most helpful to 
consumers (Refs. 26 and 27). The body of research after the IOM reviews 
has been consistent with the IOM findings. Specifically, certain 
overarching themes emerged from our updated literature review, 
including that an FOP nutrition label can help consumers identify and 
select healthy foods, consumers generally prefer simple labels, and 
government endorsement of logos may be related to greater confidence in 
the label (Ref. 20). Moreover, recent literature on FOP nutrition 
labeling schemes suggests that familiarity with these schemes will make 
them even more useful as time passes, and that these schemes are useful 
across all demographics and levels of nutrition knowledge, can help 
consumers understand the nutrition quality of food, and can positively 
impact consumers' intention to purchase healthful foods (id.). The 
scientific literature on consumers' use of FOP nutrition labels has 
strongly and consistently found that FOP nutrition labels attract 
consumer attention, and any FOP nutrition label communicates something 
more about the product's nutrient content to consumers than no FOP 
nutrition label (id.). FDA began its most recent round of consumer 
research exploration of FOP nutrition labeling schemes using the 
findings from the literature review (id.) and continued to monitor the 
literature throughout the research process.
2. First Focus Group Testing
    In 2022, FDA conducted its first set of focus groups (OMB control 
number 0910-0497, ``Front-of-Pack Focus Groups'') to test FOP concepts 
and draft FOP labels, some of which we had included in the 2008 focus 
group testing (see Refs. 32 and 33; see also https://www.reginfo.gov/public/do/PRAViewIC?ref_nbr=202008-0910-021&icID=253321). We tested 
variations of four FOP nutrition labeling schemes in these focus 
groups, which were composed of U.S. adult food shoppers whose race/
ethnicity, age, sex, and education reflected U.S. population 
demographics (Ref. 35). The schemes were based on those currently found 
in the U.S. and international marketplace: (1) Guideline Daily Amount 
(GDA); (2) Nutrition Tips; (3) Nutrition Tips--High In; and (4) High In 
(id.). The GDA scheme listed calories, quantitative amount of nutrients 
(sometimes including both nutrients to limit (those

[[Page 5432]]

that may be associated with adverse health effects and that Americans 
generally consume too much of--e.g., saturated fat, sodium, added 
sugars) and nutrients to get enough of (those that Americans generally 
do not get the recommended amount of--e.g., fiber, calcium)), and the 
adult proportion recommended for daily consumption represented by a 
serving of the food in both numerical (i.e., percent DV) and 
interpretive (i.e., ``Low,'' ``Med,'' and ``High'') form. This scheme 
resembled the voluntary FUF scheme developed by the U.S. food industry. 
The Nutrition Tips scheme mimicked the design of the Nutrition Facts 
label and included low, medium, and high interpretive descriptions 
about nutrient levels for saturated fat, sodium, and added sugars (and, 
in certain test schemes, fiber and calcium). The Nutrition Tips--High 
In scheme also mimicked the Nutrition Facts label design, but it only 
listed a nutrient, its interpretive description, and corresponding 
percent DV when a serving of the product was ``high in'' saturated fat, 
sodium, or added sugars. The High In scheme showed the nutrient(s) 
(and, in certain test schemes, the percent DV) in the product that, per 
serving, were considered high. In total, we tested 41 variations of 
these schemes--14 GDA schemes, 12 Nutrition Tips schemes, 9 Nutrition 
Tips--High In schemes, and 6 High In schemes (Ref. 36). We used these 
varied schemes to learn more about consumer reactions to the elements 
depicted (e.g., use of color, use of interpretive words, use of 
numbers) and to help us understand which FOP nutrition labeling schemes 
may be most useful to consumers.
    Within the GDA category, we tested schemes that included both 
nutrients to limit (i.e., saturated fat, sodium, and added sugars) and 
nutrients to get enough of (i.e., fiber and calcium), schemes that used 
colors beyond black and white (i.e., red, yellow, and green), schemes 
that included interpretive descriptions (i.e., low, medium, and high) 
of nutrient levels, schemes that included quantitative nutrient level 
information (e.g., how much a nutrient in a single serving of food 
contributes to your daily diet (i.e., percent DV), quantitative 
declaration of grams (g) or milligrams (mg) of a nutrient), and schemes 
that included descriptive terms (i.e., ``avoid too much'' or ``get 
enough''). In the Nutrition Tips category, we tested schemes that 
included both nutrients to limit and nutrients to get enough of, 
schemes that used either black and white colors only or colors beyond 
black and white (i.e., red, yellow, and green), schemes that included 
and excluded interpretive descriptions regarding nutrient levels, 
schemes that included and excluded quantitative nutrient level 
information (i.e., percent DV), and schemes that included and excluded 
an ``FDA.gov'' statement in the FOP nutrition label. In the Nutrition 
Tips--High In category, we tested schemes that included only nutrients 
to limit, different color variations (i.e., black on white compared to 
white on black), and the use of an abbreviated heading for ``% Daily 
Value.'' In the High In category, we tested schemes that included only 
nutrients to limit and schemes that included and excluded quantitative 
percent DV information.
    These focus groups provided FDA with qualitative feedback and 
insight into the varying ways that consumers react to and comprehend 
FOP nutrition information and helped us understand which schemes might 
be most helpful for U.S. consumers to quickly and easily identify how 
foods can be part of a healthy diet (Ref. 37). Among other things, 
participants reported they believed that products bearing ``High In'' 
labels without quantitative percent DV information were not healthy 
(id.). Participants were also confused by the colors red, yellow, and 
green when schemes contained both nutrients to limit and nutrients to 
get enough of (e.g., they had trouble interpreting the scheme when red 
indicated a high amount of a nutrient to limit and a low amount of a 
nutrient to get enough of) (id.). These focus group participants also 
preferred differing amounts of information in the FOP schemes we tested 
and reacted positively to neutrally about the inclusion of ``FDA.gov'' 
in the scheme (id.). For example, when ``FDA.gov'' appeared in a 
scheme, some participants thought it made the scheme more credible or 
trustworthy and understood it to mean that the information on the FOP 
nutrition label was not marketing, but rather information provided by a 
government source, while others reported they would not notice the FDA 
attribution in a label (id.). We considered this information, as well 
as the literature review, in identifying FOP scheme types for 
quantitative testing.
3. Experimental Study
    We used our learnings from the focus group testing and the 
information from the literature reviews to help inform the scheme types 
we chose to test in the experimental study (OMB Control Number 0910-
0920, ``Quantitative Research on Front of Package Labeling on Packaged 
Foods'') to further explore consumer responses to various FOP nutrition 
labeling schemes. In the experimental study, we tested a smaller subset 
of FOP nutrition labeling schemes from the focus group testing, with 
additional variations informed by, among other things, focus group 
results. The study was a controlled, randomized experiment, using a 15-
minute web-based questionnaire to collect information from 9,200 U.S. 
adult members of an online consumer panel maintained by a contractor 
(Ref. 38). The sample reflected U.S. Census data on sex, education, 
age, and race/ethnicity, in a balanced manner (id.). A measure of 
nutrition literacy was also used to balance the sample to ensure a 
variety of nutrition literacy levels for each condition (id.). The 
``Quantitative Research on Front of Package Labeling on Packaged Foods, 
Final Study Report'' has been peer reviewed by independent external 
experts. Taking into consideration comments from this peer review, we 
revised the final report, which is available in the docket for this 
proposed rule (Ref. 38). The findings from the experimental study 
informed the development of this proposed rule.
    We tested three FOP scheme categories with various features (e.g., 
one scheme category, shown both with and without percent DV), for a 
total of eight FOP schemes, in our experimental study (id.). Each 
scheme displayed information about the three nutrients of interest 
(i.e., saturated fat, sodium, and added sugars) in the three scheme 
categories: (1) GDA; (2) Nutrition Info (formerly ``Nutrition Tips'' 
but renamed in the experimental study to better align with the 
Nutrition Facts label and to underscore that the FOP nutrition label 
contains fact-based disclosures, including additional nutrient content 
interpretation); and (3) High In (id.). The ``Low,'' ``Med,'' and 
``High'' interpretive descriptions included in the study for the three 
nutrients were based on our longstanding general approach for 
interpreting the percent DV of a nutrient (i.e., 5% DV or less for 
``Low,'' 20% DV or more for ``High'') (see section V.B.3 of this 
document for further discussion).
    The study guided participants through two independent tasks (id.). 
In the first task, participants viewed three different nutrient 
profiles (healthiest, middle, and least healthy, which for study 
purposes was based on saturated fat, sodium, and added sugars levels) 
of a single FOP nutrition scheme and were asked to select the most and 
least healthy nutrient profile, based only on the levels of saturated 
fat, sodium, and added sugars displayed (id.). If participants wanted 
additional nutrition information when reviewing the

[[Page 5433]]

nutrient profiles, instructions indicated they could click anywhere on 
the profiles for more detail. By doing so, the corresponding Nutrition 
Facts label was displayed (we note, however, that our data showed that 
participants rarely did this (id.)). The nutrient profiles were 
similarly based on our longstanding general approach for interpreting 
the percent DV of a nutrient as either ``low'' or ``high'' (88 FR 
39257) (see section V.B.3 of this document for further discussion). 
Each participant viewed a total of three randomly assigned FOP 
nutrition schemes (Ref. 38). In the second task, participants viewed an 
FOP nutrition scheme that varied by nutrient profile on one of three 
mock food product labels (cereal, frozen meal, or canned soup). 
Participants answered questions about the product and the FOP nutrition 
scheme, including questions about perceptions of healthfulness and 
nutrient content, and also answered questions about their attitudes 
toward the scheme (id.).
    a. Nutrition Info. Similar to the ``Nutrition Tips'' design tested 
in the first focus groups, the Nutrition Info scheme mimicked the 
design of the Nutrition Facts label and provided interpretive nutrition 
information by identifying the level of the three nutrients per serving 
as ``Low,'' ``Med,'' or ``High.'' The nutrient information was 
displayed vertically, using contrasting colors. We tested versions 
that:
     Included and excluded quantitative percent DV amounts;
     Used either black and white colors only or used black, 
white, green, yellow, and red, with the latter three colors 
representing low, medium, and high, respectively; and
     Included and excluded a magnifying glass icon.
    The Nutrition Info schemes performed best overall in helping 
consumers identify healthier nutrient profiles (id.). Specifically, the 
Nutrition Info schemes produced more correct answers regarding the 
healthfulness of the product shown than the other schemes tested, and 
participants were generally able to correctly identify the level of 
saturated fat, sodium, and added sugars in products (id.). Participants 
viewing the Nutrition Info schemes also spent significantly less time 
evaluating the nutrient profile of a product than those viewing the 
other schemes tested (i.e., they felt confident enough to answer 
questions in a shorter amount of time) (id.). In the various Nutrition 
Info schemes described elsewhere in this document that were tested 
against each other, none performed better than the others across all 
measures, but the versions that were black and white with percent DV 
performed best in most instances (id.).
    b. High In. The High In scheme only displayed any of the three 
nutrients to limit that fell into the ``High'' description according to 
our longstanding general approach for interpreting a nutrient's percent 
DV per serving of a product. For example, if a test product was medium 
in saturated fat, high in sodium, and low in added sugars per the 
established criteria, the High In scheme for that product would only 
include ``Sodium,'' and, in some instances, additional information 
about the sodium content. Specifically, we tested High In schemes both 
with and without a quantitative percent DV.
    While the High In schemes seemed to emphasize to participants 
higher levels of nutrients to limit, they performed the worst among the 
schemes tested when participants were asked to identify a product's 
healthfulness (id.). Participants viewing the High In schemes were 
significantly less likely to correctly identify the healthiest and 
least healthy nutrient profiles and were more likely to rank the 
products as less healthy than those who viewed the GDA and Nutrition 
Info schemes (id.). Participants viewing the High In schemes also spent 
significantly more time evaluating the information provided before 
answering questions about the healthiest and least healthy nutrient 
profiles (i.e., they were not as confident in providing an answer in 
the same amount of time as compared to their responses when using other 
schemes) (id.). Although very few participants overall clicked to see 
the Nutrition Facts label when responding to the study questions, those 
viewing the High In schemes were significantly more likely to do so 
than those viewing either the GDA or the Nutrition Info schemes, 
suggesting that participants needed or wanted additional nutrition 
information before providing a response (id.). Most of the ratings on 
the attitude and perception questions were significantly lower for the 
High In schemes than they were for the GDA and Nutrition Info schemes 
(id.).
    c. Guideline daily amounts. The GDA scheme we tested was a set of 
icons placed horizontally that displayed nutrition information per 
serving. This scheme was quantitative-only and did not include any 
interpretive descriptions, such as whether nutrient levels were low, 
medium, or high. Each icon displayed the number of grams or milligrams 
of a nutrient in its center and the nutrients' corresponding percent DV 
at the bottom.
    While participants had a positive reaction to and perception of the 
GDA scheme (e.g., liking its look), it tested lower than the other 
schemes on several important factors we measured. In contrast to 
participants' reactions to the Nutrition Info and High In schemes, they 
were significantly less likely to correctly identify the level of 
saturated fat, sodium, and added sugars when viewing the GDA scheme 
(id.). Additionally, participants viewing the GDA scheme spent more 
time evaluating the information provided before answering questions 
about the healthiest and least healthy nutrient profile as compared to 
the Nutrition Info schemes (id.).
4. Second Focus Group Testing
    In Fall 2023, we conducted a second set of focus groups (OMB 
control number 0910-0497, ``Front-of-Package Nutrition Labeling Focus 
Groups 2'') as a follow-on to the experimental study to gather 
additional input on our assumption that consumers would react to FOP 
nutrition labeling on beverage products and non-beverage products in 
the same way (Ref. 39). Almost all participants reported that they 
viewed the FOP nutrition information on beverage and non-beverage 
products similarly (Ref. 21).
5. Summary of FDA's Research and How It Relates to Our Current Proposal
    We are proposing the Nutrition Info box, which would be a 
mandatory, compact, standardized FOP nutrition label that closely 
aligns with the Nutrition Info scheme tested in our quantitative 
research. An example Nutrition Info box that reflects all proposed 
requirements is as follows:

[[Page 5434]]

[GRAPHIC] [TIFF OMITTED] TP16JA25.006

    This Nutrition Info box would address our public health goal of 
providing consumers with interpretive nutrition information that can 
help them quickly and easily identify, at the point of decision-making, 
how foods can be part of a healthy diet--including by allowing them to 
compare nutrition information across foods.
    Including interpretive information on the label or labeling of a 
food is expected to provide a more accessible description of the 
numerical information contained in the Nutrition Facts label, thereby 
helping to address the differences in use that we see with the 
Nutrition Facts label (Refs. 15 to 17). For example, our experimental 
study, which included a diverse sample of participants that varied by 
age, sex, geography, race/ethnicity, and education, showed that all 
groups tested can use interpretive FOP nutrition information equally 
well (Ref. 38), and the scientific literature indicates that 
interpretive FOP nutrition information is helpful for all consumers 
(Ref. 20). Moreover, in our consumer research, participants reported 
that using interpretive descriptions, such as ``Low,'' ``Med,'' and 
``High,'' put the percent DV of a nutrient into context by helping 
consumers understand whether that number contributes a little or a lot 
of that nutrient to the daily diet (Ref. 21). Additionally, the 
scientific literature shows that making this information available on 
the front of food packages, so it is immediately visible at the point 
of decision-making, captures consumers' attention, which could further 
help address these differences (Ref. 20). Thus, interpretive FOP 
nutrition labeling, such as the Nutrition Info box proposed here, would 
supplement the Nutrition Facts label by providing additional context 
that consumers could use to help them quickly and easily identify how 
foods can be part of a healthy diet.

IV. Legal Authority

    We are proposing to require FOP nutrition labeling consisting of an 
informational FOP nutrition label that includes interpretive content 
regarding the levels of certain nutrients to limit, consistent with our 
general food labeling and nutrition labeling authorities in the NLEA 
and the FD&C Act. Specifically, this rule proposes a mandatory label 
element on the principal display panel that details and interprets--
using low, medium, and high descriptions--the percent DV for saturated 
fat, sodium, and added sugars in a serving of food. This rule also 
proposes updates to the low sodium and low saturated fat nutrient 
content claims.

A. Statutory Framework

    Congress authorized FDA to require that certain information be 
included on food labels or labeling and that the information presented 
assists consumers in maintaining healthy dietary practices. The NLEA 
added section 403(q) to the FD&C Act, which specifies, in part and with 
certain exceptions, that food is deemed misbranded unless its label or 
labeling bears nutrition information regarding certain nutrients. The 
statute lists certain information that must be included in food 
labeling and authorizes the Secretary, and by delegation, FDA to 
specify additional requirements by regulation. Under section 403(q)(1) 
of the FD&C Act, FDA may issue regulations to require that any required 
nutrition information be highlighted with larger type, bold type, or 
contrasting color after determining that such highlighting will help 
consumers in maintaining healthy dietary practices. Further, sections 
403(q)(2)(A) and 403(q)(2)(B) of the FD&C Act provide a process for 
adding nutrition information to or removing statutorily required 
nutrition information from the label if FDA determines that such 
actions would help consumers maintain healthy dietary practices. In 
addition, section 403(f) of the FD&C Act specifies, in part, that a 
food is misbranded if any information required under the authority of 
the FD&C Act is not prominent on the label with such conspicuousness 
and in such terms as to render it likely to be read and understood by 
the ordinary individual under customary conditions of purchase and use. 
These provisions demonstrate that Congress intended that nutrition 
information required to be on the label be presented in a way that 
helps consumers use that information to maintain healthy dietary 
practices. To that end, Congress gave FDA authority to determine what 
information is required and how it is presented to achieve this aim.
    Additionally, the NLEA specifically directs FDA to require 
nutrition information be presented in a way that makes it observable, 
understandable, and useful to consumers. Under the NLEA, FDA must 
require the information to be disclosed on the label in a way that 
enables consumers to readily observe and comprehend the information and 
to understand its relative significance in the context of a total daily 
diet (NLEA Sec.  2(b)(1)(A), Pub. L. 101-535, 104 Stat. 2353, 2357; 21 
U.S.C. 343 note). This provision gives us the authority to require that 
interpretive information about the relative amount of certain nutrients 
required to be included in the Nutrition Facts label be displayed in a 
readily observable and understandable format so that consumers can 
quickly and easily determine how a food fits into their daily diet, as 
we are proposing in this rule. Additionally, the NLEA does not specify 
where on the label the nutrition information must appear to enable the 
public to readily observe the information, and, for decades, industry 
has been able to place the required Nutrition Facts labels on different 
panels (e.g., principal display panel, information panel) and in 
various locations on different products throughout the food 
marketplace.

[[Page 5435]]

    In enacting the NLEA, Congress ``expressly delegate[d]'' the 
authority to the Secretary (subsequently delegated to FDA) ``to 
prescribe rules to `fill up the details' of a statutory scheme'' (Loper 
Bright Enters. v. Raimondo, 144 S. Ct. 2244, 2263 (2024), throughout 
section 403(q) of the FD&C Act, and in 21 U.S.C. 343 note). As most 
relevant here, section 403(q)(1) of the FD&C Act provides that ``if 
[FDA] determines'' that certain highlighting ``will assist consumers in 
maintaining healthy dietary practices,'' FDA ``may by regulation 
require'' the required nutrition information ``to be highlighted'' with 
``larger type, bold type, or contrasting color.'' Section 403(q)(2)(A) 
of the FD&C Act provides that ``if [FDA] determines'' that information 
about an additional nutrient ``will assist consumers in maintaining 
healthy dietary practices,'' FDA ``may by regulation require that 
information relating to such additional nutrient be included'' in the 
food label. Section 403(q)(2)(B) of the FD&C Act provides that ``if 
[FDA] determines'' that information about a nutrient is ``not necessary 
to assist consumers in maintaining healthy dietary practices,'' ``[FDA] 
may by regulation'' remove the requirement to include such information. 
In 21 U.S.C. 343 note, Congress directed FDA to issue regulations ``to 
implement section 403(q)'' of the FD&C Act and specifically to 
``require the required information to be conveyed to the public in a 
manner which enables the public to readily observe and comprehend such 
information and to understand its relative significance in the context 
of a total daily diet.'' Therefore, the best reading of section 403(q) 
of the FD&C Act is that Congress delegated discretionary authority to 
FDA to decide, as appropriately informed by its technical expertise and 
within the limits of its statutory authority, how to fill up the 
details regarding the presentation of nutrition information to assist 
consumers in comprehending the information and maintaining healthy 
dietary practices.
    The NLEA's legislative history affirms that Congress contemplated 
that FDA require labeling information to help consumers understand the 
nutrient levels in a food in the context of a daily diet. For example, 
the legislative history explicitly contemplates the use of the terms 
``low,'' ``medium,'' and ``high'' to achieve this goal. The House 
report for the bill states that, in order to present nutrition 
information in a manner that facilitates the public's understanding, 
FDA may choose among a variety of options, for example, including 
information about the recommended daily intake on the label or 
including the use of descriptive terms such as ``low,'' ``medium,'' and 
``high,'' or universal symbols to indicate desirable or undesirable 
levels of particular nutrients (Ref. 40). According to the report, 
while the bill would not (and the enacted provision did not) mandate 
that FDA adopt any particular approach, it would (and does) require FDA 
to specify requirements that would permit the consumer to understand 
the nutrition information pertaining to a particular food in relation 
to recommended dietary information (id.). This report language further 
affirms Congressional intent that FDA must issue regulations 
implementing the NLEA that would help consumers place the amounts of 
particular nutrients in a context that would help them build their 
daily diets (see NLEA Sec.  2(b)(1)(A), Pub. L. 101-535, 104 Stat. 
2353, 2357; 21 U.S.C. 343 note).
    The NLEA also created section 403(r)(1)(A) of the FD&C Act, which 
provides specifications for a claim made in the label or labeling of 
the food which expressly or by implication characterizes the level of 
any nutrient which is of the type required by section 403(q)(1) or (2) 
of the FD&C Act to be in the label or labeling of the food. The statute 
permits the use of these label and labeling claims that expressly or by 
implication characterize the level of any nutrient in a food, but only 
if the claims are made in accordance with FDA's authorizing regulations 
(section 403(r)(1)(A) and (r)(2)(A) of the FD&C Act).
    Additional authorities for this rulemaking can be found in section 
701(a) of the FD&C Act regarding efficient enforcement of the FD&C Act, 
as well as in sections 403(a)(1) and 201(n) of the FD&C Act regarding 
our general food labeling authority.

B. Current Proposal

    Since the Nutrition Facts label was last updated in May 2016, FDA 
has tentatively determined that additional, interpretive nutrition 
information on the front of food packages--to provide context for 
certain nutrient declarations--is necessary to help consumers more 
easily observe and better understand and use this information when 
building their diets.
    As mentioned elsewhere in this document, nearly 80 percent of U.S. 
food shoppers use the Nutrition Facts label sometimes or often (Ref. 
14), and it is a valuable tool to help consumers maintain healthy 
dietary practices. However, the information, including scientific 
literature on nutrition labeling, that FDA has received on the 
Nutrition Facts label after decades of use has demonstrated that 
certain consumers do not look at the Nutrition Facts label (Refs. 15 to 
17), and some struggle to understand the numerical values used to 
represent the nutrient content of the food or use the information 
presented there to make their food selections (Refs. 18 and 19). 
Additionally, information FDA has collected shows that providing 
context for the levels of certain nutrients to limit that is 
interpretive rather than solely numeric--to communicate the relative 
significance in the context of a total daily diet--and requiring that 
interpretive information appear on the front of the package helps 
consumers notice and use the nutrition information presented on food 
packages (Refs. 20 and 21).
    Therefore, based on this data and other information referenced in 
this document, we have tentatively determined that an interpretive FOP 
nutrition label is needed to ensure that consumers can readily observe 
and comprehend information about certain nutritional attributes of a 
food at the point of decision-making that will assist them in 
maintaining healthy dietary practices. We similarly relied on our 
authority in section 2(b)(1)(A) of the NLEA to require the declaration 
of percent DV of a nutrient in a food in the 1993 Nutrition Facts label 
final rule establishing the Nutrition Facts label, stating that percent 
DV is needed to help consumers understand the relative significance of 
nutrition information presented on the label in the context of the 
total daily diet (58 FR 2206 at 2213, January 6, 1993). We have 
additionally determined that we have the authority under the NLEA and 
FD&C Act, as further explained in section IV.C of this document, to 
specifically require that certain additional interpretive nutrition 
information be presented on the principal display panel that can help 
consumers quickly and easily identify how foods can be part of a 
healthy diet.
    As our research study and the broader literature demonstrate, the 
use of an FOP scheme with interpretive nutrition information allows 
consumers to make quick and informed decisions about the foods they 
choose for themselves and their families by making these additional 
disclosures readily observable and understandable. In our experimental 
research study, people of different sexes and ages and of all races, 
ethnicities, education levels, and nutrition knowledge levels were able 
to understand the nutrients to limit for products bearing the Nutrition 
Info box that most closely aligns with this

[[Page 5436]]

proposal, which includes low, medium, and high interpretive information 
(displayed as ``Low,'' ``Med,'' and ``High''), as well as percent DV 
information, and to use that box to correctly identify products with 
the healthiest or least healthy nutrition profile based on the 
displayed nutrients (Ref. 38). Further, this Nutrition Info box 
performed generally better than other schemes that were tested on both 
of these measures (id.). Additionally, participants viewing this 
Nutrition Info box were able to answer questions more quickly about a 
product's healthfulness compared with the other schemes tested (id.). 
Participants also reported that the box would help them easily find 
nutrition information on a food package and easily compare nutrition 
information across foods (id.).
    The proposed Nutrition Info box would consist of factual 
disclosures about the nutrient content of a food that provide 
additional context to the information currently required to be declared 
in the Nutrition Facts label. The three nutrients that would be 
required in the Nutrition Info box--saturated fat, sodium, and added 
sugars--are recommended to be limited by current nutrition science and 
Federal dietary guidance, including the Dietary Guidelines, 2020-2025, 
to achieve a nutrient-dense diet within calorie limits (Ref. 6). 
Current nutrition science emphasizes the consumption of healthy dietary 
patterns. While all foods can be incorporated into a healthy dietary 
pattern to some extent, current nutrition science highlights nutrient-
dense foods as playing an important role in building a healthy dietary 
pattern, and those foods are, in part, characterized by limited amounts 
of saturated fat, sodium, and added sugars (id.). Findings from the 
2019 Food Safety and Nutrition Survey (FSANS) found that 87 percent of 
U.S. consumers reported looking at the Nutrition Facts label. However, 
of those, fewer than half usually looked for saturated fat and added 
sugars, and slightly more than half usually looked for sodium, 
demonstrating that there is a gap in how consumers are currently 
noticing or using the declarations for these important nutrients (Ref. 
14). As such, current dietary recommendations based on nutrition 
science and recent survey findings further support a need to provide 
consumers with additional, interpretive information about these 
important nutrients that can help them quickly and easily identify how 
the levels of these nutrients in a particular food fit in the context 
of a total daily diet. Further, manufacturers are able to make claims 
and provide truthful and non-misleading information about the 
beneficial nutritional attributes of food products on food labels and 
labeling including on the principal display panel. Requiring the 
Nutrition Info box would provide consumers with standardized and 
factual context about important nutrients on the front of food packages 
that can be compared across products. To streamline the amount of 
information provided in, as well as the space we require manufacturers 
to use for, the proposed Nutrition Info box, we are focusing on the 
three nutrients to limit to ensure that consumers have this additional 
context about these three important nutrients on the front of food 
packages to help inform their food choices.
    The descriptions of the level of the nutrients that would be 
required in the Nutrition Info box (``Low,'' ``Med,'' and ``High'') are 
similarly science-based and reflective of FDA's long-established use of 
the nutrition advice regarding how to interpret percent DV declarations 
on products--that 5 percent or less of a nutrient in a food product is 
``low'' and 20 percent or more of a nutrient is ``high'' (see section 
V.B.3 of this document for further discussion). They are further 
generally consistent with the levels in the ``low'' and ``high'' 
nutrient content claims. See, e.g., Sec. Sec.  101.62(b)(2) (``low'') 
and 101.54(b) (``high''), and our discussion of updating the low sodium 
nutrient content claim to align with current nutrition science in 
section IV.E of this document. We have tentatively determined that the 
standardized descriptions of the level of the nutrients that would be 
required in the Nutrition Info box along with the percent DV would help 
facilitate consumer understanding of a food's nutrient profile and help 
consumers in identifying foods that can help them build a healthy diet. 
See, e.g., 58 FR 2302 at 2334 (January 6, 1993) (1993 nutrient content 
claim rule) (stating FDA's belief that the selection of a food bearing 
the term ``low'' should help consumers in assembling a prudent daily 
diet and in meeting overall dietary recommendations to limit the intake 
of certain nutrients). This is borne out by our recent research study, 
which found that, when shown a grouping of three distinct nutrient 
profiles, the vast majority of study participants were able to 
correctly identify the healthiest and least healthy nutrient profiles 
(95 percent and 92 percent, respectively) using the proposed Nutrition 
Info box, which includes the ``Low,'' ``Med,'' and ``High'' 
descriptions (Ref. 38).
    We also note that previous research we conducted further supports 
the more recent findings. In 1992, in arriving at the use of the 
percent DV on the current Nutrition Facts label, we tested a variety of 
options, including the use of adjective descriptions (e.g., ``low,'' 
``medium,'' and ``high'') with percent DV (Ref. 41). In the 1993 
Nutrition Facts label final rule first establishing the Nutrition Facts 
label, we stated that the declaration of nutrient amount as percent DV 
or the placement of adjectival descriptors such as ``high'' and ``low'' 
next to the nutrient amount were both effective ways to help consumers 
understand the significance of product nutrition information in the 
context of a total daily diet (58 FR 2079 at 2118). Although we 
reported in 1993 that adjective formats (i.e., those featuring ``low,'' 
``medium,'' and ``high'') alone led consumers to miss quantitative 
differences between products when different nutrient levels were 
described using the same adjective (see, e.g., 58 FR 2079 at 2117), our 
current research shows that the use of the interpretive low, medium, 
and high descriptions together with the percent DV in the proposed 
Nutrition Info box would better inform consumers about where certain 
foods fall within the ranges of each term than a strictly quantitative 
label would (Ref. 38).
    Further, with regard to the low sodium nutrient content claim and 
as discussed later in sections V.B.3 and V.G of this document, the low 
sodium claim may currently be used on the label or in the labeling of a 
food other than a meal product or main dish if it contains 140 mg or 
less sodium per reference amount customarily consumed (RACC) (and per 
50 g if the food has a RACC of 30 g or less or 2 tablespoons or less) 
and on the label or labeling of a food that is a meal product or main 
dish if it contains 140 mg or less sodium per 100 g (see Sec.  
101.61(b)(4) and (5)). Consistent with our authority in section 403(r) 
of the FD&C Act, we are proposing to update the low sodium nutrient 
content claim so that it may be used on the label or in the labeling of 
a food other than a meal product or main dish if it contains 115 mg or 
less sodium per RACC (115 mg or less per 50 g if the food has a RACC of 
30 g or less or 2 tablespoons or less) and on the label or labeling of 
a food that is a meal product or main dish if it contains 115 mg or 
less sodium per 100 g. The updated definition for the low sodium 
nutrient content claim is aligned with the regulation that provides a 
DRV for sodium of 2,300 mg, which was updated in the 2016 Nutrition 
Facts label final rule, based on scientific evidence and consensus 
recommendations (see 81 FR

[[Page 5437]]

33742 at 33874 and Sec.  101.9(c)(9)). The proposed updated definition 
for the low sodium claim (at 115 mg or less sodium per RACC) also 
generally aligns with the proposed definition for the ``Low'' 
interpretive description in the Nutrition Info box (at 5% DV or less).
    In addition, as outlined in section V.G, to prevent inconsistency 
on food labeling that could result in consumer confusion, we are 
relying on our authority in section 403(r) of the FD&C Act to propose 
to revise the definitions for the low sodium nutrient content claim and 
low saturated fat nutrient content claim to require that, in order to 
bear a low sodium nutrient content claim or low saturated fat nutrient 
content claim, a food must display ``Low'' in accordance with proposed 
Sec.  101.6 for sodium or saturated fat in the Nutrition Info box, 
respectively. Note that we are not proposing to update the gram amount 
for the low saturated fat nutrient content claim, as the gram amount 
for the low saturated fat nutrient content claim (1 g saturated fat) 
already aligns with the proposed definition for the ``Low'' 
interpretive description in the Nutrition Info box (at 5% DV or less) 
and we have not currently identified another need to update it. See 
section V.B.3 of this document for a further discussion.

C. Legal Basis for the Proposal

    The purpose of the Nutrition Info box and this proposed rule is to 
implement the congressional mandate set forth by the NLEA that FDA must 
implement regulations to help consumers readily observe and comprehend 
the nutrition information pertaining to a particular food in the 
context of a total daily diet. More specifically, the proposed 
Nutrition Info box would provide consumers with interpretive nutrition 
information that can help them quickly and easily identify how foods 
can be part of a healthy diet--which includes the consumption of foods 
that contain little or no saturated fat, sodium, and added sugars (Ref. 
6)--and that allows them to quickly make comparisons of the levels of 
such nutrients across foods. As contemplated by section 2(b)(1)(A) of 
the NLEA, the proposed Nutrition Info box, including its interpretive 
descriptions of certain nutrient levels, would present nutrition 
information required to be placed on the label or labeling of foods 
under section 403(q) in a manner that allows consumers to readily 
observe and comprehend such information and to understand its relative 
significance in the context of the total daily diet (21 U.S.C. 343 
note). The presentation of such interpretive information on the 
principal display panel is designed to draw attention to and highlight 
information about certain nutrients that play an important role in the 
building of healthy dietary patterns, thereby assisting consumers in 
maintaining healthy dietary practices (see 21 U.S.C. 343(q)). 
Importantly, we note that the Supreme Court has considered and rejected 
narrow readings of the FD&C Act, instead embracing broad constructions 
of the FD&C Act based on the Court's understanding of its text, 
congressional intent, and remedial purpose. See, e.g., United States v. 
Bacto-Unidisk, 394 U.S. 784, 798 (1969) (``Congress fully intended that 
the [FD&C] Act's coverage be as broad as its literal language 
indicates.''); United States v. Dotterweich, 320 U.S. 277, 280 (1943) 
(``The purposes of [the FD&C Act] thus touch phases of the lives and 
health of people which, in the circumstances of modern industrialism, 
are largely beyond self-protection. Regard for these purposes should 
infuse construction of the legislation if it is to be treated as a 
working instrument of government and not merely as a collection of 
English words.'').
    As explained in the sections elsewhere in this document, data and 
other information referenced that FDA has assembled and assessed 
supports that the proposed Nutrition Info box would be readily 
observable and comprehensible to consumers; allow them to understand 
the required information's relative significance in the context of the 
total daily diet; and assist them in maintaining healthy dietary 
practices. As discussed, current nutrition science and Federal dietary 
guidance, including the Dietary Guidelines, 2020-2025, emphasize the 
role of overall healthy dietary patterns and the consumption of 
nutrient-dense foods containing little or no saturated fat, sodium, and 
added sugars. Meanwhile, 2019 FSANS findings demonstrate that, of those 
who look at the Nutrition Facts label, the majority do not look at 
saturated fat and added sugars, and slightly more than half look at 
sodium (Ref. 14). Furthermore, in FDA's experimental study, the 
proposed Nutrition Info box performed best among all schemes tested in 
helping consumers identify healthier nutrient profiles and led them to 
correctly describe the level of such nutrients (Ref. 38). Additionally, 
participants spent less time correctly responding to questions about 
the nutrient profile of a food when viewing the proposed FOP nutrition 
labeling scheme and reported that the scheme would help them easily 
find nutrition information on a food and easily compare nutrition 
information between foods (id.). Taken together, this data and other 
referenced information support the inclusion and interpretation of the 
levels of saturated fat, sodium, and added sugars in the proposed 
Nutrition Info box and help demonstrate that the box would allow 
consumers to readily observe and comprehend the information conveyed 
and assist them in maintaining healthy dietary practices, in line with 
section 2(b)(1)(A) of the NLEA and section 403(q) of the FD&C Act.
    We are also issuing this rulemaking consistent with our authorities 
in sections 701(a), 403(a)(1), and 201(n) of the FD&C Act, 
respectively). Sections 403(a)(1) and 201(n) of the FD&C Act represent 
our general labeling authority and describe when a product label would 
be misbranded as misleading for failing to include material facts 
regarding the food. In the context of nutrition labeling, we have 
considered the declaration of meaningful sources of nutrients to be a 
material fact (see 55 FR 29487 at 29491 through 29492, July 19, 1990, 
and 68 FR 41434 at 41438, July 11, 2003). Similarly, here, FDA finds 
that the relative amounts of these nutrients to limit in food products 
is material information that consumers must have as they select foods 
as part of their daily diet. Absent this mandatory, interpretive 
labeling on the front of food packages to complement the existing 
nutrition data on the label or labeling of food, data and other 
referenced information we have gathered show that consumers face 
challenges in understanding the relative contribution that individual 
foods make to their total daily intake of these nutrients to limit. 
Further, under section 701(a) of the FD&C Act, we may issue regulations 
for the efficient enforcement of the FD&C Act to ``effectuate a 
congressional objective expressed elsewhere in the [FD&C] Act'' 
(Association of American Physicians and Surgeons, Inc. v. FDA, 226 F. 
Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. 
Supp. 1179, 1183 (D. Del. 1980))).

D. Inapplicability of Nutrient Content Claim Provisions to Proposed 
Sec.  101.6

    Some of the information that would appear in the Nutrition Info box 
would be a nutrient content claim if a manufacturer chose to 
voluntarily include it elsewhere on a food label. But we have 
determined that the proposed information in the Nutrition Info box, 
when it appears in the Nutrition Info box, is not a nutrient content 
claim and would not be subject to the requirements for nutrient content 
claims in section 403(r) of the FD&C Act and

[[Page 5438]]

its implementing regulations. Nutrient content claims are voluntary 
statements used by manufacturers to describe the level of nutrients in 
a food product. They are permitted by section 403(r) of the FD&C Act 
and FDA's nutrient content claim regulations. The 1993 nutrient content 
claim rule stated that the information about the nutrient content of a 
food be presented in standardized form, using uniform terms defined by 
FDA, so that consumers will not be misled (58 FR 2302 at 2394). Section 
403(r)(1)(A) of the FD&C Act specifies that claims made in the label or 
labeling of the food that expressly or by implication characterize the 
level of any nutrient which is of the type required by section 
403(q)(1) or (2) of the FD&C Act to be in the label or labeling of the 
food are only permitted if they are made in accordance with FDA's 
authorizing regulations. In brief, pursuant to section 403(r) of the 
FD&C Act and our nutrient content claim regulations, defined nutrient 
content claims (e.g., ``lite,'' ``free,'' ``low,'' ``high'') may be 
voluntarily used only on certain food products that meet the 
established criteria for such claims, as described at part 101, subpart 
D. However, section 403(r)(1) of the FD&C Act provides that a statement 
that appears as part of the nutrition information required or permitted 
under section 403(q) of the FD&C Act is not a nutrient content claim.
    As explained elsewhere in this document, we are proposing this 
Nutrition Info box in line with our authorities in section 2(b)(1)(A) 
of the NLEA and section 403(q) of the FD&C Act, and therefore, it is 
not a nutrient content claim under section 403(r) of the FD&C Act. The 
proposed Nutrition Info box would include additional contextual 
information that conveys certain nutrition information required by 
section 403(q) of the FD&C Act in a manner that the public can readily 
observe and comprehend. This additional contextual information about 
the three nutrients to limit would appear on nearly all packaged foods, 
thereby providing such information to consumers about how they can 
place these foods into their diets. Similar to the required declaration 
of percent DV in the Nutrition Facts label, which must appear on nearly 
all food packages and allows consumers to understand the required 
nutrition information's relative significance in the context of a total 
daily diet, the information included in the proposed Nutrition Info 
box, including the interpretive descriptions ``Low,'' ``Med,'' and 
``High,'' would be required to be displayed on all foods subject to the 
rule. For these reasons, we find that the proposed required information 
in the Nutrition Info box would not constitute a nutrient content claim 
and would not be subject to the requirements for nutrient content 
claims in section 403(r) of the FD&C Act.
    Thus, we have proposed amending Sec.  101.13(c) to specify that the 
information proposed to be required as part of this Nutrition Info box 
would not be a nutrient content claim. This is consistent with our 
determination that the information in the Nutrition Facts label, 
including percent DV, is not a nutrient content claim. As noted in more 
detail elsewhere in this document, other voluntary statements, such as 
``100 calories,'' that do not appear as part of the nutrition 
information required or permitted by section 403(q) of the FD&C Act are 
expressly permitted by Sec.  101.13 as nutrient content claims. We note 
that any claims about the nutrient levels of a food outside of the 
Nutrition Facts label and proposed Nutrition Info box would be nutrient 
content claims, which must meet applicable statutory and regulatory 
requirements (see section 403(r) of the FD&C Act and the relevant 
nutrient content claim regulations (for example, those in Sec.  
101.13)).

E. Severability

    Although we believe that each of the elements of the Nutrition Info 
box that would be established by this rule, when applied collectively, 
would best help consumers to identify how foods fit into a healthy 
diet, each element independently enhances the manner of presentation to 
increase the likelihood that consumers would be able to readily observe 
and comprehend the required interpretive nutrition information on the 
front of food packages. In the event of a stay or invalidation of 
certain element(s) of the box, the other elements would continue to 
function sensibly to advance the statutory objectives. See, e.g., 
Belmont Mun. Light Dep't v. FERC, 38 F.4th 173, 188 (D.C. Cir. 2022) 
(finding severability of a portion of an administrative action, 
applying the principle that severability is appropriate where ``the 
agency prefers severability to overturning the entire regulation'' and 
where the remainder of the regulation ``could function sensibly without 
the stricken provision'') (citations omitted). For example, if the 
proposed requirement regarding the location of the Nutrition Info box 
on the upper third of the principal display panel were invalidated, we 
have tentatively determined that the substantive elements of the box, 
such as the requirements to include the interpretive descriptions and 
percent DV of saturated fat, sodium, and added sugars, would still 
function sensibly and be needed to provide important context to 
consumers elsewhere on the principal display panel. Likewise, in the 
absence of the proposed type style requirement, for example, each of 
the other features of the Nutrition Info box would continue to function 
and contribute to consumers readily observing and comprehending the 
nutrition information provided by the box and assist them in 
maintaining healthy dietary practices. Overall, it is FDA's intent to 
preserve each of the rule's aspects to the fullest possible extent, to 
help advance the important interests described in section IV.A.

V. Description of the Proposed Rule

    We propose to add new Sec.  101.6 to part 101, ``Food Labeling.'' 
The proposed rule would require the inclusion of the Nutrition Info box 
on the principal display panel of most foods that are required to 
display the Nutrition Facts label. The Nutrition Info box is intended 
to complement the Nutrition Facts label and would provide consumers 
with interpretive information on the front of food packages for three 
nutrients to limit that would allow consumers to compare the levels of 
these three important nutrients among foods and quickly and easily 
identify how foods can be part of a healthy diet.
    An example Nutrition Info box that reflects all proposed 
requirements is as follows:

[[Page 5439]]

[GRAPHIC] [TIFF OMITTED] TP16JA25.007

    We also propose two overall amendments to certain nutrient content 
claims: (1) revising Sec.  101.61(b)(4) and (5) to update the limit for 
the low sodium nutrient content claim to 115 mg per RACC or 100 g, 
which aligns with current nutrition science; and (2) adding 
requirements to Sec. Sec.  101.61 and 101.62 specifying that food 
subject to this rule must bear ``Low'' in accordance with proposed 
Sec.  101.6 for sodium and saturated fat, respectively, in the 
Nutrition Info box for the food's labeling to qualify to bear the 
related low in nutrient content claim, which would avoid within-label 
inconsistencies with the proposed FOP scheme.

A. Scope/Applicability (Proposed Sec.  101.6(a)(1))

    Proposed Sec.  101.6(a)(1) would require that this rule apply to 
all food covered under Sec.  101.9 (Nutrition labeling of food) that is 
marketed for people ages 4 and older unless a specific exemption 
applies. The congressional record for the NLEA indicates that mandatory 
nutrition labeling was intended to solve problems with voluntary 
disclosure--the standard at the time--including that a significant 
percentage of food was sold without any nutrition information (Ref. 
40). Section 403(q) of the FD&C Act therefore specifies, in part and 
with certain exceptions, that a food is misbranded unless its label or 
labeling bears nutrition information for certain nutrients, and Sec.  
101.9 details these requirements. Most foods we regulate (i.e., all 
foods not specified in Sec.  101.9(j)) must bear a Nutrition Facts 
label as described in Sec.  101.9 (see Sec.  101.9(a)).
    In addition, we relied on our authority in section 2(b)(1)(A) of 
the NLEA to require the percent DV declaration in the Nutrition Facts 
label. In the preamble to one of our first regulations related to the 
Nutrition Facts label, we noted that the percent DV of a nutrient 
present in food is declared on food labels to help consumers understand 
the relative significance of nutrition information in the context of a 
total daily diet, compare the nutritional values of food products, and 
plan general diets (58 FR 2206 at 2213).
    Our research shows that 87 percent of adults living in the United 
States look at the Nutrition Facts label, and at least 76 percent use 
the Nutrition Facts label when buying a food for the first time (Ref. 
14). However, only 49 percent of adults report looking at the percent 
DV on the Nutrition Facts label (id.). Data also suggest that up to 40 
percent of Americans ages 16 and older do not understand the meaning of 
percent DV (Ref. 42). Accordingly, and consistent with our statutory 
direction in section 2(b)(1)(A) of the NLEA to require that certain 
information be conveyed in a manner that consumers can readily observe 
and comprehend, we are proposing a mandatory labeling scheme that would 
complement the Nutrition Facts label by providing additional, easy-to-
use, interpretive context in the form of descriptive terms for the 
percent DV of certain nutrients (discussed later in section V.B.4 of 
this document) on the principal display panel (e.g., the front of the 
package) of most foods. We discuss exemptions to this requirement later 
in section V.F of this document.
    We propose that the scope of this rule cover foods marketed for the 
general population. In the 2016 Nutrition Facts label final rule, we 
updated the Daily Reference Values (DRVs) and Reference Daily Intakes 
(RDIs) (the recommended amounts of nutrients to meet or not to exceed 
each day, which are often referred to collectively as the Daily Values) 
for adults and children ages 4 years and older to be consistent with 
the data on the associations between nutrients and chronic diseases, 
health related conditions, physiological endpoints, and maintaining a 
healthy dietary pattern (81 FR 33742). We have traditionally used this 
age category as representative of the general population for nutrition 
labeling purposes (id.). We note that the DRVs for saturated fat, 
sodium, and added sugars for pregnant and lactating people are the same 
as those for the general population (see Sec.  101.9(c)(9)). Therefore, 
for purposes of this proposed rule, we consider pregnant and lactating 
people to be part of the general population.
    We are not including foods marketed for children under 4 years old 
within the scope of this proposed rule. We recognize that infants and 
children ages 1 to 3 years are vulnerable subpopulations and have 
specific nutritional needs. The 2016 Nutrition Facts label final rule 
established mandatory labeling requirements to include specific DRVs 
for children ages 1 through 3 years (81 FR 33742 at 33927-31, codified 
at Sec.  101.9(c)(9)). FDA has not established DRVs or percent DVs 
(i.e., how much a nutrient in a single serving of food contributes to 
the DRV) for saturated fat, sodium, or added sugars for infants through 
age 12 months.
    Our proposed interpretive descriptions for these nutrients are 
based on percent DVs. Therefore, for food products marketed for infants 
through age 12 months (i.e., jars of baby food, teething crackers), we 
tentatively determine that it currently would not be feasible to 
provide consumers with additional interpretation--the purpose of the 
proposed Nutrition Info box--about the relative amounts of saturated 
fat, sodium, or added sugars in the products.
    Additionally, since publication of the 2016 Nutrition Facts label 
final rule, there have been changes to Federal dietary guidance for 
children ages 1 to 3 years. The Dietary Guidelines, 2020-2025 
established daily nutrition goals for two subpopulations of children: 
ages 12 to 23 months and 2 to 3 years. This included goals for sodium 
for children ages 12 to 23 months and goals for saturated fat, sodium, 
and added sugars for children ages 2 to 3 years (Ref. 6). These 
categorizations do not align with current FDA regulations that provide 
DRVs for saturated fat, sodium, and added sugars for the single 
category of children ages 1 to 3 years (see

[[Page 5440]]

Sec.  101.9(c)(9)). Additionally, in some cases, the Dietary 
Guidelines, 2020-2025 calculated daily nutrition goals using a 
different methodology than FDA used when establishing DRVs. For 
example, the Dietary Guidelines, 2020-2025 established recommendations 
for daily sodium limits based on the Chronic Disease Risk Reduction 
level established by NASEM (Ref. 6). However, current FDA regulations 
include a DRV for sodium for children ages 1 to 3 (see Sec.  
101.9(c)(9)) that we derived using the upper limit for sodium 
established by the IOM for this age group (81 FR 33742 at 33929). The 
Dietary Guidelines, 2020-2025 indicate that saturated fat should not be 
restricted in children younger than 2 years (Ref. 6).
    Because we continue to evaluate the information on the nutritional 
needs of these subpopulations, as well as our DRVs for saturated fat, 
sodium, and added sugars for children ages 1 to 3 years (given the 
daily nutrition goals included in the Dietary Guidelines, 2020-2025), 
we are not currently proposing to require FOP nutrition labeling on 
foods marketed for infants and children ages 1 to 3 years. We invite 
comment, including data and other information, related to: (1) the 
nutritional needs of these subpopulations; and (2) the need for or 
value of interpretive nutrition information that can help consumers 
quickly and easily identify how foods can be part of a healthy diet for 
these subpopulations. We expect such feedback could help inform any 
future FOP policy for foods marketed for infants and children ages 1 to 
3 years.
    We are also proposing to exempt most dietary supplements from 
bearing a Nutrition Info box. Dietary supplements labeled in accordance 
with the special nutrition labeling provisions in Sec.  101.36 are 
exempt from Nutrition Facts labeling under Sec.  101.9(j)(6) and would 
therefore be exempt from Nutrition Info box labeling under proposed 
Sec.  101.6(c)(1), discussed elsewhere in this document. Dietary 
supplements are products intended for ingestion, that, among other 
requirements, contain at least one dietary ingredient intended to 
supplement the diet (21 U.S.C. 321(ff)). Dietary ingredients include 
vitamins and minerals; herbs and other botanicals; amino acids; dietary 
substances that are part of the food supply, such as enzymes and live 
microbials (commonly called ``probiotics''); and concentrates, 
metabolites, constituents, extracts, or combinations of any dietary 
ingredient from the preceding categories (21 U.S.C. 321(ff)(1)). While 
dietary supplements are considered foods, they serve a different 
purpose than conventional foods when it comes to building a healthy 
dietary pattern; they often provide individual nutrients (e.g., Vitamin 
C) and are intended to supplement, rather than constitute a core part 
or foundation of, the diet. Given the distinct role of dietary 
supplements in the overall diet, we propose to exempt such products 
from this proposed rule. Many dietary supplements do not contain 
saturated fat, sodium, and added sugars, and they are not required to 
have these nutrients declared on their nutrition label unless the 
supplement contains quantitative amounts by weight that exceed the 
amount that can be declared as zero (see 21 CFR 101.36(b)(2)). However, 
we are aware that some dietary supplements may contain what this 
proposed rule would describe as ``High'' levels of saturated fat, 
sodium, or added sugars per serving. We therefore invite comment on our 
proposed exemption of dietary supplements from the requirements of this 
rule.

B. Content (Proposed Sec.  101.6(a)(2))

1. Headings and Subheadings (Proposed Sec.  101.6(a)(2)(i) and (ii))
    Proposed Sec.  101.6(a)(2)(i) would require using ``Nutrition 
Info'' as the heading, or title, for the Nutrition Info box. This title 
describes what the box would convey and should be familiar in 
appearance to the ``Nutrition Facts'' title of the Nutrition Facts 
label (see Sec.  101.9(d)(2)). We are proposing ``Info'' rather than 
``Information'' to keep the title shorter and, therefore, the box 
smaller. This title reflects our intent to provide, in a convenient 
format, interpretive nutrition information to consumers that can help 
them quickly and easily identify how foods can be part of a healthy 
diet. The title would be displayed across the same distance of the box 
as the ``Nutrition Info'' header to orient the consumer and make it 
clear that the nutrition information that follows is part of this 
Nutrition Info box.
    For the Nutrition Info box to be useful, consumers need to 
understand what nutrition information is being conveyed. Proposed Sec.  
101.6(a)(2)(ii)(A) would require using the subheading ``Per serving'' 
to help consumers understand that the Nutrition Info box, like the 
Nutrition Facts label, provides information about one serving of the 
food. We also propose including a statement of the serving size, 
expressed in household measures, alongside the ``Per serving'' 
subheading (e.g., ``Per serving (whole package)'' or ``Per serving (\1/
2\ cup)'') to further help consumers understand what one serving is. 
The inclusion of both ``Per serving'' and the serving size expressed in 
household measures would be consistent with the information required in 
the Nutrition Facts label (see Sec.  101.9(b)) and would help consumers 
understand whether the product is ``Low,'' ``Med,'' or ``High'' in the 
three nutrients disclosed for a specific amount of the product. 
Further, listing ``Per serving'' with a statement of the serving size 
expressed in household measures would help improve awareness that the 
information presented in the Nutrition Info box does not refer to the 
contents of the entire package when the package contains multiple 
servings.
    While the Nutrition Facts label includes a statement of the 
serving's gram amount (see Sec.  101.9(b)(7)), the proposed Nutrition 
Info box would include only the serving's household measure. Section 
403(q)(1)(A)(i) of the FD&C Act specifies that a food is misbranded 
unless its nutrition labeling bears the serving size, which is an 
amount customarily consumed and which is expressed in a common 
household measure that is appropriate to the food. In our proposed rule 
to implement this and other labeling requirements, entitled ``Food 
Labeling; Serving Sizes'' (56 FR 60394, November 27, 1991), we proposed 
requiring that manufacturers provide the equivalent metric quantity, in 
parentheses, after the common household measure (e.g., 1 cup (28 g)), 
on what would become the Nutrition Facts label (id. at 60410). We 
finalized that requirement in the 1993 Nutrition Facts label final rule 
and clarified that the gram declaration was for compliance purposes (58 
FR 2079 at 2163) (codified at Sec.  101.9(g)(7) (``Compliance will be 
based on the metric measure specified in the label statement of serving 
size.'')).
    This Nutrition Info box would reflect the serving size, in common 
household measures, declared in the Nutrition Facts label, and only the 
Nutrition Facts label would also declare the serving size's metric 
measure. The inclusion of a metric measure would unnecessarily increase 
the Nutrition Info box's size, and inclusion of a second statement of 
serving size measurement could increase the box's complexity. 
Therefore, we are not proposing to include a second statement of the 
serving size's metric measure, as its inclusion would not align with 
our goal of providing consumers with interpretive nutrition information 
that can help them quickly and easily identify how foods can be part of 
a healthy diet.

[[Page 5441]]

    Proposed Sec.  101.6(a)(2)(ii)(B) would require including the 
subheading ``% Daily Value'' in the Nutrition Info box. This heading 
would appear above the declaration of the quantitative percent DV and 
the interpretive ``Low,'' ``Med,'' and ``High'' descriptions for the 
three nutrients included. We propose using the ``%'' symbol instead of 
the word ``percent'' due to spacing considerations and for consistency 
with the Nutrition Facts label (see Sec.  101.9(d)(6)).
2. Nutrients to Limit (Proposed Sec.  101.6(a)(2)(iii))
    Proposed Sec.  101.6(a)(2)(iii) would require that the Nutrition 
Info box include information on saturated fat, sodium, and added 
sugars. We propose that saturated fat, sodium, and added sugars be the 
only nutrients in the Nutrition Info box, given their significance in 
building healthy dietary patterns, the scientific research on FOP 
nutrition labeling, and the current food labeling landscape, in which 
consumers report being familiar with a wide variety of industry claims 
(Ref. 14). This Nutrition Info box would be a continuation of our 
efforts to help consumers by providing information that can help them 
improve their dietary patterns by providing them with interpretive 
nutrition information presented on the front of food packages in a 
consistent, uniform way about the amounts of the three nutrients in 
covered products so they can quickly and easily understand their 
relative significance in the context of a total daily diet.
    In the 2016 Nutrition Facts label final rule, we noted that 
nutrition science supports limiting intake of saturated fat, sodium, 
and added sugars (see 81 FR 33847). Similarly, the Dietary Guidelines, 
2020-2025 includes recommendations to choose nutrient-dense foods 
across and within food groups while limiting foods (including 
beverages) higher in saturated fat, sodium, and added sugars as a key 
strategy in emphasizing healthy overall dietary patterns (Ref. 6). For 
instance, research shows that people with diets characterized, in part, 
by lower intake of saturated fat, sodium, and added sugars were at 13 
to 27 percent decreased risk for dying from any cause, cancer, or 
cardiovascular disease (Ref. 43). Still, most Americans exceed the 
recommended intake limits for saturated fat, sodium, and added sugars 
(Ref. 6).
    FDA has been prioritizing nutrition initiatives that can help 
improve dietary patterns as part of a broader effort to help reduce the 
burden of diet-related chronic diseases in the United States and 
advance health equity, as diet-related chronic diseases are experienced 
disproportionately by certain racial and ethnic populations and those 
with lower socioeconomic status. Our initiatives include those that 
support consumer understanding of nutrients to limit in the diet. For 
example, on December 27, 2024, FDA published a rule amending the 
``healthy'' implied nutrient content claim (89 FR 106064). The 
framework for the updated ``healthy'' definition includes criteria for 
nutrients to limit. We state in the rule that these criteria are 
consistent with current nutrition science and the Dietary Guidelines, 
2020-2025 recommendations to limit intake of saturated fat, sodium, and 
added sugars, and help ensure that foods bearing the ``healthy'' claim 
do not contain excess amounts of these nutrients, which can, among 
other things, increase the risk of chronic disease (id. at 106091, 
106093, 106104, and 106110). Additionally, in 2021, FDA published 
short-term (2.5-year) voluntary sodium reduction targets for the food 
industry, as part of a gradual, iterative approach to help reduce 
sodium in the food supply and support reducing sodium intakes over time 
(see 86 FR 57156, October 14, 2021). We published draft Phase II (3-
year) goals in 2024 (see 89 FR 66727, August 16, 2024).
    Regarding the scientific research on FOP nutrition labeling, our 
research found, and the scientific literature we considered confirms, 
that simpler schemes are easier for consumers to understand and that 
consumers often have access to information about nutrients to get 
enough of on the front of food packages. The Dietary Guidelines, 2020-
2025 names five nutrients of public health concern (i.e., nutrients to 
get enough of) (dietary fiber, vitamin D, calcium, iron, and potassium 
(Ref. 6)) as well as the three nutrients to limit, and the scientific 
research and literature on FOP nutrition labeling indicate that the 
inclusion of nutrients to get enough of with nutrients to limit may not 
lead to simple schemes that help consumers. For example, we tested FOP 
nutrition labeling schemes that included fiber and calcium, along with 
saturated fat, sodium, and added sugars, in our first focus groups 
(Ref. 36), given that these nutrients to get enough of may be included 
in certain industry-based, voluntary FOP initiatives in the United 
States (Ref. 20) and in certain international schemes (Ref. 32). The 
feedback we collected through our first focus group research indicated 
that participants were confused by the inclusion of both nutrients to 
limit and nutrients to get enough of in the same FOP scheme (Ref. 44). 
This focus group testing helped inform our experimental study, which 
included schemes with only the three nutrients to limit.
    Regarding the current food labeling landscape, we note that 
manufacturers have many ways to communicate information on the front of 
a food package about nutrients to get enough of. Use of nutrient 
content claims can inform consumers interested in intake of specific 
nutrients. Health claims (i.e., claims that have been reviewed by FDA 
and are authorized on food products to state that a food or food 
component may reduce the risk of a disease or a health-related 
condition) can also highlight the content of specific nutrients in a 
food and their relation to the risk of various diseases. Other claims 
can highlight nutrients and provide context to their role in the normal 
structure or function of the body. In addition to these claims, 
manufacturers may voluntarily include truthful and non-misleading 
information about their products on food labels or labeling.
    As discussed elsewhere in this document, the proposal would provide 
consumers with a quick- and easy-to-use scheme immediately visible on 
the label or labeling that would state relative amounts of the three 
disclosed nutrients. We tentatively conclude that a scheme that focuses 
only on certain nutrients to limit would provide consumers with 
important information to help them build and maintain healthy dietary 
practices without including additional information that could lessen 
the effectiveness of a nutrition label designed for quick, easy use. 
This would also make the scheme simpler, which research shows consumers 
prefer (Refs. 20 and 27).
    We also considered whether to include or allow a calorie disclosure 
in the proposed Nutrition Info box. We are aware that some interested 
parties would prefer the inclusion of a quantitative calorie statement 
in the Nutrition Info box. However, a quantitative calorie statement 
would not provide consumers with new, interpretive information. 
Regarding an interpretive description of calories, our regulations, at 
Sec.  101.9(c)(9), specify the DRVs for, among other things, saturated 
fat, sodium, and added sugars. While these DRVs are based on the 
reference caloric intake of 2,000 calories, which we use for general 
nutrition advice, we note that there is no DRV, and therefore no 
percent DV, for calories. In the 2014 proposed rule to update the 
Nutrition Facts label, we explained that setting a DRV for calories 
would necessitate determining a quantitative intake recommendation for 
calories, but also

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noted that there is no appropriate quantitative intake recommendation 
for calories and that we were not aware of any other data or 
information on which a DRV for calories could be determined (79 FR 
11880 at 11892-93). We maintained this position in the 2016 Nutrition 
Facts label final rule. We noted that quantitative intake 
recommendations for calories are called estimated energy requirements 
(EERs), and they are based on healthy individuals of defined age, sex, 
weight, height, and level of physical activity (81 FR 33742 at 33782). 
We explained that it would be difficult to combine the EERs into a 
single reference calorie level applicable to the general population 
because calorie needs vary based on many factors (id.). Therefore, we 
did not establish a DV for calories and have continued to use the 
reference caloric intake of 2,000 calories for general nutrition advice 
(id.). We are aware of no new data or other information published after 
the 2016 Nutrition Facts label final rule that changes our 
determination. Therefore, we tentatively conclude that it would not be 
appropriate to provide consumers with an interpretation of the 
quantitative calorie information currently required on the Nutrition 
Facts label.
    We acknowledge that some food manufacturers are voluntarily 
providing calorie information on the front of food labels, including to 
help vending machine operators comply with FDA's calorie labeling 
requirements for articles of food sold from certain vending machines 
(see Sec.  101.8(c)(2)(ii)), and have an interest in continuing this 
practice. Our existing regulations allow manufacturers to voluntarily 
include such a statement on the principal display panel (see Sec.  
101.13(i)(3)). Our proposal would not change that. Examples of what 
such labeling might look like are as follows:
[GRAPHIC] [TIFF OMITTED] TP16JA25.008

[GRAPHIC] [TIFF OMITTED] TP16JA25.009

    We invite comment on the inclusion of a mandatory or voluntary 
quantitative statement of calories in the Nutrition Info box. We also 
invite comment on any ways we could consider inclusion of an 
interpretation of quantitative calorie information in the Nutrition 
Info box, including any new data or other information on which to base 
such an interpretation.
3. ``Low,'' ``Medium,'' and ``High'' Interpretive Descriptions 
(Proposed Sec.  101.6(a)(2)(iv))
    Proposed Sec.  101.6(a)(2)(iv) would require low, medium, and high 
(``Low,'' ``Med,'' and ``High'') descriptions for each nutrient to 
limit in the Nutrition Info box. These descriptions would interpret the 
percent DV of saturated fat, sodium, and added sugars per product 
serving. We propose a range of 5% DV or less for ``Low''; 6% to 19% DV 
for ``Med''; and 20% DV or more for ``High.'' Because the percent DV 
declarations will have already been calculated and appropriately 
rounded for the Nutrition Facts label according to Sec.  101.9(c)(9) 
and (d)(7)(ii), we do not address calculation or rounding 
considerations in this proposed rule.
    In proposing ranges for the low, medium, and high interpretive 
descriptions, we considered the regulatory history related to 
establishment of the percent DV and such descriptions; our longstanding 
consumer education activities designed to help consumers understand the 
percent DV in the context of the total daily diet; the nutrition 
education initiatives of other groups; and our existing regulatory 
definitions for nutrient content claims, including definitions 
established for ``low'' and ``high'' claims. The ranges we propose for 
determining interpretive descriptions for saturated fat, sodium, and 
added sugars--in particular, the designation of 5% DV or less to be 
``Low'' and 20% DV or more to be ``High''--align with our longstanding 
general approach for interpreting the percent DV.

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    First, percent DV declarations use a common numeric reference 
standard (i.e., 0 through 100), and interpretive descriptions help to 
put those numeric values into the context of a total daily diet using 
easily understood terms (e.g., ``Low,'' ``Med,'' ``High''). As 
discussed elsewhere in this document, the NLEA's legislative history 
explicitly mentions using the terms ``low,'' ``medium,'' and ``high'' 
to help consumers place the nutrient levels in a food into the context 
of a daily diet (Ref. 40). As early as 1993, we considered the addition 
of interpretive descriptions to the Nutrition Facts label next to the 
percent DV to help consumers understand a food's nutrient profile and 
identify foods that could fit into healthy dietary patterns (see, e.g., 
58 FR 2079 at 2118). While we concluded in the 1993 Nutrition Facts 
label final rule that both percent DV and interpretive descriptions 
next to the nutrient amount information were effective in helping 
consumers understand the significance of nutrition information in the 
context of a total daily diet, we ultimately finalized contextualizing 
nutrient amount information as percent DV (58 FR 2079 at 2118 and 
2125), stating our belief that consumers would be able to use percent 
DV declarations more effectively than any other format we tested. 
However, recent data show that up to 40 percent of American consumers 
misinterpret or do not understand the meaning of percent DV (Ref. 42). 
Additionally, our recent research found that, when shown a grouping of 
three distinct nutrient profiles, the vast majority of participants 
were able to correctly identify the healthiest and least healthy 
nutrient profiles (95 percent and 92 percent, respectively) using the 
Nutrition Info scheme, which included low, medium, and high 
descriptions and percent DVs (Ref. 38).
    Second, for many decades, FDA has publicized a general framework 
designed to help consumers interpret nutrient levels in a product. This 
framework (5/20 principle) has informed consumers that 5% DV or less of 
a nutrient per serving is considered low and 20% DV or more of a 
nutrient per serving is considered high (Refs. 45 and 46). In 2011, as 
part of a ``Food Label and You'' campaign, we released several videos 
to promote consumer awareness and understanding of the 5/20 principle 
for interpreting percent DV on a food label (Ref. 47). We continued 
publicizing this general framework on our website as a component of our 
consumer education campaign, ``The New Nutrition Facts Label: What's in 
it for You,'' after the 2016 Nutrition Facts label final rule published 
(id.).
    Third, diverse groups, including health agencies, academic 
institutions, medical and public health groups, and media outlets, have 
also relied on the 5/20 principle for decades. For example, the 
American Heart Association, American Diabetes Association, Mayo Clinic, 
Johns Hopkins University, The Ohio State University, National Institute 
on Aging, International Food Information Council, Public Broadcasting 
Service, New York Times, and Business Insider provide this advice in 
education initiatives designed to help consumers understand and 
interpret information on food labels (id.). Food retailers and industry 
groups have also adopted this general approach in public-facing 
materials when discussing nutrition information on the food label 
(id.). As such, the designation of 5% DV or less to be ``Low'' and 20% 
DV or more to be ``High'' for the nutrients required to be listed in 
the Nutrition Info box aligns with widely adopted and used definitions 
for low and high in nutrition-related consumer education initiatives.
    Fourth, the NLEA and FD&C Act permit claims on a food label that 
are authorized by FDA regulations and characterize the level of a 
nutrient in a food (i.e., nutrient content claims). Nutrient content 
claims can be voluntarily used by manufacturers to describe the level 
of a nutrient in a food using terms such as ``low'' and ``high,'' and 
most are applicable only to nutrients that have an established DV. When 
we first established the regulatory definitions for nutrient content 
claims, we stated that our objectives included consistency among 
definitions, claims that aligned with public health goals, and claims 
that consumers could use to maintain healthy dietary practices (58 FR 
2302 at 2319).
    FDA has nutrient content claims regulations for low saturated fat 
(Sec.  101.62(c)(2) and (3)) and low sodium (Sec.  101.61(b)(4) and 
(5)). These regulations provide criteria for ``low'' and its specified 
equivalent terms. Our regulatory definitions for ``low'' claims provide 
absolute amounts (i.e., grams, milligrams); however, we have long 
applied the general principle that 5% DV or less is considered ``low'' 
in consumer education (Refs. 45 to 47), and the relevant gram amounts 
are generally consistent with that principle, as discussed further 
here.
    In 1993, we established a DRV of 20 g for saturated fat, which was 
based on the 1990 Dietary Guidelines recommendation that consumption of 
saturated fat should be less than 10 percent of calories (58 FR 2206 at 
2217). In the 1993 nutrient content claim final rule, we noted that 
using an average level of 1 g in 16 to 20 servings of food per day 
would supply 16 to 20 g of saturated fat daily, which is within the DRV 
of 20 g (58 FR 2302 at 2338 through 2340). In addition to this 1 g or 
less per RACC criterion, we also established a second criterion for low 
saturated fat of 15 percent or less of calories from saturated fat for 
individual foods and 10 percent or less of calories from saturated fat 
for meals and main dishes. This second criterion was established to 
limit ``low'' claims on foods with small serving sizes because these 
foods do not contain especially low levels of saturated fat (58 FR 2338 
at 2339). Our analysis highlighted that saturated fat was present in 
more than half of 18 United States Department of Agriculture-defined 
food categories (58 FR 2302 at 2338). We also noted that very little 
saturated fat was found in most fruit, vegetables, and grains. In the 
2016 Nutrition Facts label final rule, we retained the DRV of 20 g for 
saturated fat because consensus reports continued to recommend 
saturated fat intakes of no more than 10 percent of calories, based on 
risk of cardiovascular disease (81 FR 33786). The low saturated fat 
claim of 1 g or less per RACC is 5% DV or less.
    We established the nutrient content claim for low sodium in a final 
rule entitled ``Food Labeling; Declaration of Sodium Content of Foods 
and Label Claims for Foods on the Basis of Sodium Content'' (49 FR 
15510, April 18, 1984) (1984 final rule). In the proposed rule entitled 
``Food Labeling; Declaration of Sodium Content of Foods and Label 
Claims for Foods on the Basis of Sodium Content'' (47 FR 26580, June 
18, 1982), we estimated that the consumption of 20 low-sodium foods 
would contribute about 2,800 mg of sodium per day (using 20 servings 
per day as a reasonable average number of servings for adults and 140 
mg of sodium per serving--considered to be low in sodium), which at the 
time fell into the National Academy of Sciences (now NASEM) and 
National Research Council's range for a mildly restricted sodium diet 
(id. at 26581 through 26585) (we proposed using the term ``moderately 
low sodium'' for this nutrient content claim but finalized the term 
``low sodium'' to characterize nutrient content claims for foods 
containing 140 mg or less of sodium per serving--see 49 FR 15510 at 
15519). Assuming 20 servings per day, 140 mg sodium per serving equaled 
5 percent of 2,800 mg sodium per day for a mildly

[[Page 5444]]

restricted sodium diet. In the 1984 final rule, we concluded that a 
significant proportion of the food supply would be eligible to bear the 
low sodium claim (49 FR 15510). We noted that foods that could be 
labeled ``low sodium'' included some hot and cold cereals, many cuts of 
fresh meat and poultry, some fish, frozen vegetables, and some desserts 
and snacks such as cookies, cakes, and candy (id.).
    In the 1993 Nutrition Facts label final rule, we established a DRV 
for sodium of 2,400 mg per day (58 FR 2206 at 2217). However, in the 
1993 nutrient content claim final rule, we retained the definition for 
the low sodium claim as 140 mg or less sodium, highlighting that 
comments related to the rulemaking and at public hearings did not 
indicate a need for change and supported the existing criteria (58 FR 
2302 at 2335 through 2336). We also established weight-based criteria 
for low claims for products with small serving sizes--RACCs of 30 g or 
less or 2 tablespoons or less--stating that this would prevent 
misleading claims on certain nutrient-dense foods (we stated in the 
proposed rule entitled ``Food Labeling: Nutrient Content Claims, 
General Principles, Petitions, Definition of Terms'' (56 FR 60421, 
November 27, 1991) (one of two proposed rules underlying the 1993 
nutrient content claim final rule) that (1) without the weight-based 
criterion, low claims would be allowed on certain foods that are 
nutrient dense on a weight basis yet still qualify for a low claim 
because of their small serving size, and (2) that nutrient-dense foods 
with small serving sizes could be consumed frequently throughout the 
day and ultimately make substantial contributions to the diet despite 
their low claims (id. at 60430)). We also established a weight-based 
criterion for meal products and main dishes in the 1993 nutrient 
content claim final rule, stating that providing for the level of a 
nutrient per 100 g of food is generally sufficient to prevent 
misleading claims on meal-type products (58 FR 2302 at 2315 through 
2320 and 2379 through 2381).
    In the 2016 Nutrition Facts label final rule, we updated the DRV 
for sodium from 2,400 mg to 2,300 mg based on consensus recommendations 
to reduce sodium intake because there is a direct relationship between 
sodium intake and increased blood pressure (81 FR 33742 at 33875 
through 33880). With these updates, the low sodium threshold of 140 mg 
or less per serving equals 6% DV or less for low sodium nutrient 
content claims.
    Given the updated 2,300 mg DRV for sodium in the 2016 Nutrition 
Facts label final rule, and in line with FDA's ongoing efforts to 
support reducing sodium intake in the United States (https://www.fda.gov/food/food-labeling-nutrition/sodium-reduction, accessed 
June 13, 2024), we propose to update the low sodium nutrient content 
claim limit to 115 mg sodium (20 servings at 115 mg equals 2,300 mg). 
With this update, the low sodium nutrient content claim could be used 
on the label or in the labeling of a food other than a meal product or 
main dish if it contains 115 mg or less sodium per RACC (115 mg or less 
per 50 g if the food has a RACC of 30 g or less or 2 tablespoons or 
less) and on the label or labeling of a food that is a meal product or 
main dish if it contains 115 mg or less sodium per 100 g. This updated 
definition for the low sodium nutrient content claim would generally 
align with the 5% DV or less range that we are proposing for ``Low'' 
for sodium in the proposed Nutrition Info box. Additionally, the 
revised definition would apply to foods that are not subject to the 
proposed requirement to display a Nutrition Info box.
    We are aware of limited exceptions to this alignment. For example, 
foods with RACCs greater than 30 g that have 116 mg to 125 mg sodium 
per serving (e.g., certain reduced sodium canned vegetables) would fall 
under the ``Low'' categorization for sodium in the proposed Nutrition 
Info box but would not qualify to bear a low sodium nutrient content 
claim. Additionally, meal products or main dishes that contain 115 mg 
or less sodium per 100 g might fall into the ``Med'' categorization for 
sodium in the proposed Nutrition Info box and therefore would not be 
able to bear a low sodium nutrient content claim. However, in most 
cases, the updated definition for the low sodium nutrient content claim 
(115 mg sodium or less) would align with the 5% DV or less that we are 
proposing for ``Low'' for sodium in the proposed Nutrition Info box. We 
also note that, in all cases in which the Nutrition Info box would be 
required, labeling would be consistent, as we are proposing an update 
to the low sodium nutrient content claim that would require consistency 
between the Nutrition Info box and use of a low sodium nutrient content 
claim (see section V.G of this document).
    While FDA has nutrient content claim regulations for low sodium and 
low saturated fat, we do not have a nutrient content claim regulation 
for low added sugars. However, the Dietary Guidelines for Americans, 
2020-2025 recommends limiting intake of added sugars to less than 10 
percent of calories per day, or 50 g for a 2,000 calorie per day diet 
(which we use for general nutrition advice) (Ref. 6). In the 2016 
Nutrition Facts label final rule, we established a DRV for added sugars 
of 50 g (see 81 FR 33742 at 33982, codified at Sec.  101.9(c)(9)). As 
we stated in that final rule, small amounts of added sugars found in 
many different foods and ingredients can add up throughout the day and 
can contribute empty calories in the diet at levels that exceed what 
would otherwise be reasonable within recommended calorie limits (id. at 
33813). With this information in mind, and consistent with our 
longstanding advice regarding how to interpret the percent DV, we 
propose using 5% DV or less as the range for ``Low'' for added sugars 
to provide consumers with interpretive nutrition information that can 
help them quickly and easily identify how foods can be part of a 
healthy diet, which includes limiting their overall intake of added 
sugars.
    Applying a range of 20% DV or more for ``High'' is consistent with 
our nutrient content claim regulations (Sec.  101.54(b)(1)) for 
nutrients having either an RDI established in Sec.  101.9(c)(8)(iv) or 
a DRV established in Sec.  101.9(c)(9). While we are not aware that 
industry uses the claim for nutrients to limit, a ``high'' nutrient 
content claim for saturated fat, sodium, and added sugars is permitted 
under our existing regulations (see Sec.  101.54). Moreover, under our 
general requirements for health claims, we use 20% DV to derive 
disqualifying levels (i.e., the levels of these nutrients above which 
the label or labeling of a food may not bear a related health claim) 
for saturated fat and sodium (Sec.  101.14(a)(4)) (58 FR 2478 at 2494). 
Twenty percent DV is also used to establish the disclosure levels for, 
among other nutrients, saturated fat and sodium when a food bears a 
nutrient content claim about one of the other enumerated nutrients 
under Sec.  101.13(h)(1) (58 FR 2302 at 2308). For example, if a food 
displays a low sodium nutrient content claim and also has 4 g saturated 
fat (i.e., 20% DV saturated fat), the food would be required to display 
a disclosure such as ``See nutrition information for saturated fat 
content.''
    FDA does not have a regulation for a nutrient content claim of 
``medium'' for any nutrient. However, we are proposing a range of 6% to 
19% DV for ``Med'' for purposes of the Nutrition Info box. This range 
falls between the proposed low and high ranges for saturated fat, 
sodium, and added sugars and provides a categorization for such 
nutrients that are too high to fall into ``Low'' but too low to fall 
into ``High.''

[[Page 5445]]

The adjective ``medium'' is defined as, for example, ``being in the 
middle between an upper and lower amount, size, degree, or value'' 
(Ref. 48) and ``intermediate in quantity, quality, position, size, or 
degree'' (Ref. 49). The common meaning of the adjective ``medium,'' 
then, aligns with the meaning of the interpretive description ``Med'' 
we are proposing. Additionally, many participants in our experimental 
study recognized that 15% DV of a nutrient fell somewhere in between 
``High'' and ``Low'' (Ref. 38), and we provided no form of consumer 
education before they responded.
    We recognize that some other countries use more than one value to 
establish their categorizations and provide different categorizations 
based on product type. For example, foods with smaller serving sizes, 
such as peanut butter, might fall under the ``High'' categorization at 
a lower percent DV than most other foods, while foods with larger 
serving sizes, such as prepackaged main dishes, might fall under the 
``High'' categorization at a higher percent DV. We have established a 
similar tiered approach for certain nutrient content claims that would 
meet a ``low'' criterion for amount per serving but still, on a weight 
basis, contain a substantial amount of the nutrient. For example, to 
use the ``low fat'' claim, we require foods with small RACCs of less 
than 30 g or 2 tablespoons or less to be calculated at a 50 g basis 
(Sec.  101.62(b)(2)(i)(B)). Without this weight-based criterion, a 
dessert topping that contains 2 g fat per serving would meet the 
definition of ``low fat'' but contain as much as 25 g fat per 100 g of 
food. We invite comment on this serving size issue and welcome data and 
other information on possible different approaches.
    Additionally, we request data and other information on any 
alternative criteria for the proposed interpretive ``Low,'' ``Med,'' 
and ``High'' descriptions that could support our goals of providing 
consumers with interpretive information for the levels of the three 
nutrients to limit in the Nutrition Info box that can help them quickly 
and easily identify how foods can be part of a healthy diet. We also 
invite comment on use of the ``Low'' categorization for products that 
declare 0% DV for any of these three nutrients, rather than a fourth 
categorization, such as ``Zero'' or ``Free,'' to indicate that the 
product is not simply ``Low'' for that nutrient but contributes zero 
percent to the DV.
    In FDA's experimental study, we tested variations of the Nutrition 
Info box that included the colors green, yellow, and red to help 
communicate to consumers that a product was low, medium, or high, 
respectively, in the listed nutrients to limit. While there is some 
information in our literature review suggesting that color coding with 
text can lead to improved understanding of nutrition information, our 
experimental study found that colors neither significantly increased 
the utility of the Nutrition Info box for U.S. consumers nor increased 
understanding of the interpretive information provided in a 
statistically significant way (Ref. 38). Additionally, we have heard 
concerns from interested parties about potential difficulty with using 
color coding for consumers with red-green color blindness (which is the 
most common form (Ref. 50)) and that mandating colors would 
substantially increase the cost of complying with the rule. Given these 
factors, the importance of maintaining consistency for consumers, and 
to facilitate comparisons between products, our proposal would not 
require or allow such colors.
4. Inclusion of Percent Daily Value (Proposed Sec.  101.6(a)(2)(v))
    Proposed Sec.  101.6(a)(2)(v) would require that the Nutrition Info 
box include the corresponding quantitative percent DV for people ages 4 
and older for each nutrient listed, which will have already been 
calculated for the Nutrition Facts label according to Sec.  101.9(c)(9) 
and (d)(7)(ii). We propose that these values be placed in a column 
underneath the ``% Daily Value'' subheading and to the left of the 
interpretive descriptions (see section V.B.3 of this document). As we 
stated in the 2016 Nutrition Facts label final rule, a percent DV 
declaration helps consumers understand the nutrient information on the 
product label in the context of the total diet (81 FR 33742 at 33748). 
Including the quantitative percent DV in the Nutrition Info box for 
each nutrient would therefore allow consumers to quickly compare the 
nutrient levels between products, particularly if the products have the 
same interpretive description (e.g., comparing two products that are 
``High'' in added sugars, where one contains 30% DV and the other 
contains 60% DV). As noted elsewhere in this document, we reported in 
1993 that adjective formats (i.e., those featuring ``low,'' ``medium,'' 
and ``high'') alone led consumers to miss quantitative differences 
between products when different nutrient levels were described using 
the same adjective (see, e.g., 58 FR 2079 at 2117). However, our 
current research shows that quantitative percent DV together with 
interpretive descriptions in the Nutrition Info box may help consumers 
better understand why a serving of food has the interpretive 
description it does and would better inform consumers about where 
certain foods fall within the ranges of each term than a strictly 
interpretive label would (Ref. 38). In addition, we believe that 
including percent DV along with the interpretive descriptions in the 
Nutrition Info box could result in additional consumers understanding 
the meaning of percent DV when it is displayed on food labels, 
including in the Nutrition Facts label.
    Moreover, including the quantitative percent DV in addition to the 
``Low,'' ``Med,'' and ``High'' descriptions may help consumers better 
understand why a serving of a food has the interpretive descriptions it 
does. In our second set of focus groups, many participants said they 
liked seeing the percent DV next to the interpretive description 
because it provided some context for the interpretation (Ref. 33). In 
addition, of the Nutrition Info schemes we tested in our experimental 
study, those that included percent DV declarations performed better in 
measures assessing ease of use and understanding (Ref. 38). Therefore, 
we are proposing to require both percent DV and interpretive 
descriptions for the nutrients to limit in the Nutrition Info box to 
help consumers quickly and easily identify how foods can be part of a 
healthy diet.
5. Inclusion of an Attribution Banner (Proposed Sec.  101.6(a)(2)(vi))
    Proposed Sec.  101.6(a)(2)(vi) would require the inclusion of a 
banner at the bottom of the Nutrition Info box that includes an 
``FDA.gov'' attribution statement. Several studies on FOP nutrition 
labeling found that inclusion of an attribution for the FOP nutrition 
label increases consumers' trust in and the credibility of the 
information. For example, in their experimental study to test 
variations of a ``High In'' FOP nutrition label, Canadian researchers 
found that the presence of a Health Canada attribution resulted in 
higher trust in and credibility of the FOP nutrition symbol (Ref. 51). 
Almost all participants who saw the FOP nutrition symbol with the 
Health Canada attribution found it helpful to include because it 
engendered trust in the FOP nutrition symbol, drew their attention to 
the FOP nutrition symbol, and made the FOP nutrition symbol look more 
official (id.). Other studies found that government attribution or 
endorsement by health organizations increased the believability and 
credibility of the label (Refs. 52 to 54). In our first set of focus 
groups, participants expressed mixed

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reactions to the inclusion of an attribution statement (Ref. 37). 
However, most participants viewed ``FDA.gov'' as making the scheme 
credible and trustworthy (Ref. 44). Informed by the literature 
findings, as well as this feedback, we propose to include the 
attribution statement ``FDA.gov'' in the Nutrition Info box to indicate 
that the proposed Nutrition Info box appears as required by FDA and to 
signal to consumers where they can find additional information 
regarding the Nutrition Info box, nutrition information, and our 
nutrition labeling requirements.

C. Format (Proposed Sec.  101.6(a)(3))

    Proposed Sec.  101.6(a)(3) would require nutrition information to 
be presented on food labels or labeling in a specific format for the 
standard Nutrition Info box (we discuss our proposal to allow an 
alternative intermediate-package Nutrition Info box in section V.E.7 of 
this document). The proposed Nutrition Info box's format elements 
include type style (i.e., a single font); size (i.e., point); color; 
justification (i.e., left, right, or centered); and use of boldface and 
hairlines.
    We considered many factors when designing the proposed Nutrition 
Info box's format, including findings from consumer research and 
literature reviews (Refs. 20, 21, 26, 27, 37, 38, and 44); places where 
we expect people would use the Nutrition Info box (i.e., at the point 
of decision-making); and the diversity of the intended audience (e.g., 
level of nutrition knowledge, time available to make a purchase or 
consumption decision). Studies consistently confirm that simple formats 
are easier to comprehend and require less consumer effort than complex 
formats (Refs. 28 and 55). In our view, a simple format is one that 
minimizes clutter and enables the public to readily observe and 
comprehend the required nutrition information (21 U.S.C. 343 note). Use 
of a simple format aligns with our goal for FOP nutrition labeling, 
which is to provide consumers, including those who have lower nutrition 
knowledge, with interpretive nutrition information that can help them 
quickly and easily identify how foods can be part of a healthy diet. 
Thus, our proposed Nutrition Info box is designed to serve as a visual 
cue to the reader that the information it contains is quickly and 
easily understandable interpretive nutrition information about the 
three nutrients to limit.
    Additionally, while we are committed to the flexible application of 
graphic techniques to make the required nutrition information easy to 
read and comprehend, we want to ensure that all Nutrition Info boxes, 
regardless of the products they reflect, look similar so that consumers 
will immediately recognize them and understand what they are. To 
accomplish this, our proposed rule would set requirements for certain 
key graphic elements of the Nutrition Info box. In the interest of 
uniformity of presentation, FDA strongly recommends that the Nutrition 
Info box mirrors the examples found throughout proposed Sec.  101.6.
    During FDA's experimental study, we tested variations of the 
Nutrition Info box that included a magnifying glass icon (see Ref. 34). 
This icon is used in some international High In FOP schemes (e.g., 
those in Canada and Brazil), and we tested the icon to help us 
determine whether a graphic image could increase consumer attention to 
and understanding of the information in the scheme. We are aware that 
current FOP nutrition schemes in U.S. and international markets use a 
variety of shapes and symbols to help draw attention to information 
included in the FOP nutrition label (Ref. 32). We are not proposing to 
require a graphic image in the Nutrition Info box because our 
experimental study did not find that the inclusion of a graphic (i.e., 
the magnifying glass icon) in this particular scheme yielded 
statistically significant results (Ref. 38). Because the addition of a 
graphic image did not meaningfully affect U.S. consumers' attention to 
or use of the Nutrition Info box, we tentatively conclude that 
including a graphic image, such as a magnifying glass icon, could add 
unnecessary complexity and clutter to the Nutrition Info box, and 
therefore our proposal would not require or allow the inclusion of a 
graphic image.
1. Location (Proposed Sec.  101.6(a)(3)(i))
    Our existing regulations include various label and labeling 
requirements regarding placement of information, such as the 
declaration of net quantity of contents, which generally must appear on 
the lower 30 percent of the principal display panel (see Sec.  
101.7(f)). Proposed Sec.  101.6(a)(3)(i) would require the Nutrition 
Info box to appear on the upper third of the principal display panel. 
We reviewed four consumer research studies on FOP nutrition label 
placement that tested placement on the upper left, upper right, bottom 
left, and bottom right of the principal display panel (Refs. 51 and 56 
to 58). Each study showed that FOP nutrition labels are most effective 
when placed in the upper left or right of the principal display panel. 
While study results were mixed on the best orientation (i.e., left or 
right placement), the studies found that consumers had improved 
attention, reaction time, and label understanding when the FOP 
nutrition label was in the upper left or right of the principal display 
panel compared to the lower left or right (id.).
    However, we are aware that foods' principal display panels often 
contain other informational and graphic design elements in addition to 
the information we require and that certain foods come in packages of 
different shapes. We want to balance our goal of providing consumers 
with interpretive nutrition information that can help them quickly and 
easily identify how foods can be part of a healthy diet with 
maintaining flexibility for industry in the design of their principal 
display panels. Therefore, we propose to require placement of the 
Nutrition Info box somewhere in the top third of the principal display 
panel, without specifying the exact location (e.g., upper right corner, 
`x' inches from any side or design element).
    We invite comment, including studies or other research, on the 
location and specifically on whether to take a flexible approach rather 
than designating the proposed Nutrition Info box's exact location.
2. Type Style (Proposed Sec.  101.6(a)(3)(ii))
    Proposed Sec.  101.6(a)(3)(ii) would require use of a single, easy-
to-read type style in the Nutrition Info box. Information required 
under the FD&C Act must be prominent, conspicuous, and in such terms as 
to render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use (see section 
403(f) of the FD&C Act). We tentatively conclude that a single, easy-
to-read type style would be easier for consumers to read and 
understand, while not proposing to require a specific type style would 
maintain flexibility for industry. The proposed type style requirement 
aligns with the Nutrition Facts label's type style requirements (see 
Sec.  101.9(d)(1)(ii)(A)). Similarly, we use Helvetica in our example 
proposed Nutrition Info box (see proposed Sec.  101.6(a)(5))--the same 
type style we use in our example Nutrition Facts label (Ref. 59)--which 
is recognized as a very readable type style (Ref. 60).
3. Type Size (Proposed Sec.  101.6(a)(3)(iii))
    Proposed Sec.  101.6(a)(3)(iii) would require the use of a minimum 
type size (at least 8 point) in the Nutrition Info box that is no 
smaller than the size of the required net quantity of contents 
declaration specified in Sec.  101.7(h) and

[[Page 5447]]

(i). Our existing food labeling regulations for packaged foods, at 
Sec.  101.7(i), require, among other things, that the declaration of 
net quantity be in letters and numerals in a type size that is 
established in relation to the area of the principal display panel of 
the package. The regulation prescribes the following size 
specifications for net quantity declarations:
     Not less than one-sixteenth inch in height on packages the 
principal display panel of which has an area of 5 square inches or 
less;
     Not less than one-eighth inch in height on packages the 
principal display panel of which has an area of more than 5 but not 
more than 25 square inches;
     Not less than three-sixteenths inch in height on packages 
the principal display panel of which has an area of more than 25 but 
not more than 100 square inches; and
     Not less than one-fourth inch in height on packages the 
principal display panel of which has an area of more than 100 square 
inches, except not less than \1/2\ inch in height if the area is more 
than 400 square inches.
    If the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, then the 
lettering sizes are to be increased by one-sixteenth of an inch (Sec.  
101.7(i)).
    In our proposed rule entitled ``Food Labeling: Calorie Labeling of 
Articles of Food Sold From Certain Vending Machines; Front of Package 
Type Size'' (83 FR 32221, July 12, 2018) (vending FOP proposed rule), 
we discussed industry comments noting the existence of several 
voluntary FOP nutrition labeling programs where nutrition information--
in that case, calories--is presented in an FOP type size that ranges 
from 100 to 150 percent of the size of the net quantity of contents 
statement on the principal display panel (id. at 32223). We considered 
those comments when proposing the revised requirement that calorie 
disclosures on the principal display panel of foods sold from certain 
vending machines must be at least 150 percent of the size of the net 
quantity of contents declaration on the front of the package. We also 
sought comment on an alternative approach of requiring the calorie 
disclosure to be at least 100 percent of the size of the net quantity 
of contents statement.
    We ultimately finalized our 150 percent proposal (see 84 FR 57603, 
October 28, 2019) (vending FOP final rule). In the vending FOP final 
rule, we noted that the area of the principal display panel (calculated 
in square inches or square centimeters) determines the minimum type 
size permitted for the net quantity declaration (as described elsewhere 
in this section). As such, both the 150 percent requirement we were 
finalizing and the 100 percent requirement we asked for comment on 
would be based on the size of the principal display panel (id. at 
57606). In other words, the size of both the net quantity of contents 
declaration and the vending FOP disclosure scale proportionately to the 
size of the principal display panel. We are proposing the same scaling, 
based on the net quantity of contents type size, for the minimum type 
size in the Nutrition Info box. We tentatively conclude that such 
scaling would help ensure that the Nutrition Info box will be prominent 
on the label or labeling and its contents readable, while not mandating 
a size that would occupy an unnecessarily large part of the principal 
display panel.
    In the vending FOP final rule, we also explained that, when a 
vending machine food is in a vending machine, a prospective purchaser 
cannot handle the product to make it easier for the purchaser to read 
the nutrition information. Therefore, visible nutrition information on 
the front of a package must be large enough, and prominent enough, for 
prospective purchasers to see and use the information (id. (internal 
citation omitted)). We stated that the 150 percent type size 
requirement for FOP calorie disclosures on foods sold from glass-front 
vending machines, rather than the 100 percent type size alternative 
approach, will ensure that the declarations are visible, clear, and 
conspicuous and able to be easily read by a prospective purchaser 
(id.).
    Unlike in the vending machine context, consumers would usually be 
able to pick up, walk up to, or otherwise closely inspect a food's 
Nutrition Info box at a comfortable reading distance. Therefore, we 
tentatively conclude that mandating a type size no smaller than that 
which is used in the net quantity of contents declaration--essentially, 
the alternative we requested comment on in the vending FOP proposed 
rule--would generally allow consumers to easily read and comprehend the 
information in the Nutrition Info box.
    We are also proposing an absolute minimum type size of 8 point, 
regardless of the size of the net quantity of contents statement. It is 
our tentative view that this is the minimum type size necessary to 
allow for quick and easy readability of the Nutrition Info box and for 
the Nutrition Info box's information to be read and understood by the 
ordinary individual under customary conditions of purchase and use (see 
section 403(f) of the FD&C Act). Eight point is the same minimum type 
size allowed for the information in the Nutrition Facts label (see 
Sec.  101.9(d)(1)(iii)). We established this minimum type size 
requirement in the 1993 Nutrition Facts label final rule, noting that 
we were committed to the flexible application of graphic techniques to 
achieve an acceptable level of readability for the required nutrition 
information. However, we noted that minimum standards, including a 
minimum 8-point type, would ensure that the nutrition information was 
conveyed so that the public could readily observe and comprehend the 
information (58 FR 2079 at 2136). We maintained the minimum 8-point 
type size in the 2016 Nutrition Facts label final rule. Therefore, we 
propose a minimum 8-point type size for the Nutrition Info box to help 
ensure readability and to be consistent with the type size requirements 
in the Nutrition Facts label.
4. Type and Hairline Color (Proposed Sec.  101.6(a)(3)(iv)), Background 
Color (Proposed Sec.  101.6(a)(3)(v)), and Attribution Banner Color 
(Proposed Sec.  101.6(a)(3)(xv))
    Proposed Sec.  101.6(a)(3)(iv) would require the use of one color 
(e.g., black) for all type and hairlines in the Nutrition Info box, and 
proposed Sec.  101.6(a)(3)(v) would require the use of a neutral 
contrasting background color (e.g., white) to the print in the box. 
Contrast levels between text and background that exceed 70 percent, 
which we would expect from the use of a single type color and a neutral 
contrasting background color, and dark text on light backgrounds 
provide for optimal legibility (Ref. 61).
    For the attribution banner, proposed Sec.  101.6(a)(3)(xv) would 
require that the background be the same color as used for the rest of 
the box's type and hairlines and that the ``FDA.gov'' statement be the 
same color as used for the rest of the box's background. We tentatively 
conclude that the use of an opposite color scheme to the rest of the 
box would help visually differentiate the attribution banner from the 
food's nutrition information. The attribution banner would appear 
effectively the same on every Nutrition Info box--it would be at the 
bottom of the box, in an opposite color scheme, and would always 
contain ``FDA.gov'' right-justified in the banner. That would provide 
consistency among all Nutrition Info boxes and signal that the 
Nutrition Info box is an FDA requirement, while

[[Page 5448]]

not drawing attention away from the nutrition information above it.
    The proposal would allow flexibility for industry to choose 
background and type colors that meet the requirements in our 
regulations. However, we believe that some contrasting color 
combinations might render the proposed Nutrition Info box's text 
difficult to read. We would consider difficult-to-read type to be 
unclear, and therefore violative of proposed Sec.  101.6(a)(3)(ii)'s 
requirement that type be clear and easy to read, which could 
potentially cause the product to be misbranded under section 403(f) of 
the FD&C Act. If a particular color combination makes the type unclear, 
there are other graphic techniques, such as increased type size, 
bolding, and tracking (the small space between letters) that could be 
used to overcome this concern.
5. Hairlines (Proposed Sec.  101.6(a)(3)(vi), (vii), and (viii))
    Consistent with the Nutrition Facts label design, proposed Sec.  
101.6(a)(3)(vi) would require the use of hairlines to delineate the 
outer box, and proposed paragraphs (vii) and (viii) would require the 
use of hairlines to distinguish information within the Nutrition Info 
box. We first introduced the use of hairlines to set the Nutrition 
Facts label off in a box in the 1993 Nutrition Facts label final rule 
to preserve a readily identifiable look for the label (see 58 FR 2079 
at 2136). Horizontal lines are used throughout the Nutrition Facts 
label as a key graphic element to divide space, direct the eye, and 
similarly give the label a unique and identifiable look (id.).
    We propose using hairlines in the same way for the Nutrition Info 
box. Proposed Sec.  101.6(a)(3)(vii) would require the use of a thick, 
horizontal hairline, centered within the box, and of the same length 
across the box as the ``Nutrition Info'' heading to distinguish the 
heading and subheadings (``Nutrition Info,'' ``Per serving,'' and ``% 
Daily Value'') from the nutrient information that follows them. This 
horizontal line would divide space and give the box an identifiable 
look similar to that of the Nutrition Facts label. It would also direct 
the reader's eye to the nutrition information that follows and help 
break the information into small chunks, thus making it easier to 
process and remember the information (Ref. 62). Proposed Sec.  
101.6(a)(3)(viii) would require the use of a horizontal hairline, 
centered within the box, and of the same length across the box as the 
``Nutrition Info'' heading to distinguish each row of nutrient 
information. The repeated use of horizontal lines within the box would 
help with the organization of the Nutrition Info box and consistency 
with the Nutrition Facts label (Refs. 60 and 61).
6. Bold or Extra Bold Type (Proposed Sec.  101.6(a)(3)(ix), (xi), 
(xii), and (xiii))
    Proposed Sec.  101.6(a)(3)(ix), (xi), and (xiii) would require the 
use of extra-bold type print and proposed Sec.  101.6(a)(3)(xii) would 
require the use of bold type print to highlight certain text. In our 
proposed rule entitled ``Food Labeling: Format for Nutrition Label'' 
(57 FR 32058, July 20, 1992), we noted that the graphic presentation of 
the label had the potential to improve effective communication. We 
stated that graphic techniques, which included bold typeface to call 
attention to certain information on the label, go directly to the 
requirements in section 2(b)(1)(A) of the NLEA that the required 
nutrition information be presented in a way that enables consumers to 
readily observe the information (id.). In the 1993 Nutrition Facts 
final rule, we finalized certain bolding requirements for the Nutrition 
Facts label, noting that graphic elements such as bolding would, among 
other things, benefit consumers who have difficulty reading nutrition 
information on food packages and might otherwise be effectively denied 
access to that information (58 FR 2079 at 2136). We again used bolding 
in the 2016 Nutrition Facts label final rule to emphasize the 
importance of, and draw attention to, certain information (see, e.g., 
81 FR 33742 at 33942).
    Bold or extra bold type print for certain Nutrition Info box 
elements would help consumers notice and locate the box and use the 
information the box contains, according to design principles of 
highlighting information in bold type (Ref. 62). We propose the use of 
bold or extra-bold type print for all type in the box other than the 
``Per serving'' subheading, the household measurement declaration, and 
the quantitative percent DV. An extra-bold ``Nutrition Info'' heading 
would call attention to the box itself (see proposed Sec.  
101.6(a)(3)(ix)), and an extra-bold ``% Daily Value'' subheading and 
the interpretive descriptions underneath the subheading would call 
attention to the nutrition information the Nutrition Info box would 
provide (see proposed Sec.  101.6(a)(3)(xi) and (xiii), respectively). 
Additionally, bold nutrient names would call attention to each nutrient 
separately (see proposed Sec.  101.6(a)(3)(xii)). In line with our 
prior rulemakings, we tentatively conclude that the bolding of these 
elements in the Nutrition Info box would help consumers readily observe 
the required nutrition information and assist them in maintaining 
healthy dietary practices. We note that, in our example proposed 
Nutrition Info box (see Sec.  101.6(a)(5)), we use both standard 
bolding (for the nutrient names and ``FDA.gov'') and the type style 
Helvetica Black (for the ``Nutrition Info'' heading, the ``% Daily 
Value'' subheading, and the interpretive descriptions), which is an 
extra-bold version of Helvetica.
7. Text Justification (Proposed Sec.  101.6(a)(3)(ix) through (xv))
    Proposed Sec.  101.6(a)(3)(ix) through (xv) would require the use 
of left, right, and center text justification as a design technique to 
help consumers read the Nutrition Info box. Proposed Sec.  
101.6(a)(3)(x) and (xii) would require left justification for the ``Per 
serving'' subheading and the nutrient names, respectively. Proposed 
Sec.  101.6(a)(3)(xi) and (xiii) would require right justification for 
the ``% Daily Value'' subheading and the interpretive descriptions, 
respectively, and proposed Sec.  101.6(a)(3)(xv) would require right 
justification for ``FDA.gov'' in the bottom banner. Proposed Sec.  
101.6(a)(3)(vi) would require center justification for the ``Nutrition 
Info'' heading. Proposed Sec.  101.6(a)(3)(xiv) would require that the 
quantitative percent DVs be right-justified with each other, in a 
column to the left of the interpretive descriptions. This design would 
create white spaces in the box, which would help isolate elements of 
the Nutrition Info box and provide information pacing for the reader 
(Ref. 63). Left-justifying the ``Per serving'' subheading and right-
justifying the ``% Daily Value'' subheading would create white space 
that would result in a less cluttered appearance, heightened focus and 
emphasis, and improved readability (id.). Similarly, left-justifying 
the nutrient names, right-justifying the interpretive descriptions, and 
right-justifying the quantitative percent DVs in each of their 
respective columns in their own, unbroken row would provide a logical 
flow of information and create a sense of unity and cohesion, which 
contributes to overall aesthetic and perceived stability (Ref. 62). 
Right-justifying ``FDA.gov'' in the banner at the bottom of the 
Nutrition Info box would similarly provide unity and cohesion (id.).
8. Other Considerations
    We considered whether to set off the Nutrition Info box, e.g., by 
requiring blank space around it. Such a formatting technique could help 
ensure that the information in the box would be

[[Page 5449]]

prominent and conspicuous to consumers. However, we are not proposing 
to require such a set-off in an effort to provide flexibility for 
design considerations. Additionally, section 403(f) of the FD&C Act 
already requires prominence, conspicuousness, readability, and 
understandability for any information, such as the proposed Nutrition 
Info box, required under the authority of the FD&C Act. We similarly 
considered proposing leading, kerning, font weight, tracking, and other 
typographical requirements, and are not proposing to require any, for 
the same reasons. While any of these elements might help meet the 
prominence, conspicuousness, readability, and understandability 
requirements of section 403(f) of the FD&C Act, we have tentatively 
concluded that setting specific requirements is not necessary. 
Throughout this document, we provide examples of Nutrition Info boxes 
that would comply with the proposed requirements of this rule and also 
satisfy the requirements of section 403(f) of the FD&C Act. We invite 
comment on this approach.

D. No Other Information Allowed in the Nutrition Info Box (Proposed 
Sec.  101.6(a)(4))

    Proposed Sec.  101.6(a)(4) would prohibit any information in the 
Nutrition Info box other than what proposed Sec.  101.6 would require. 
As we discuss elsewhere in this document, our research has found that 
too much information can be confusing to consumers. Additionally, our 
focus with the Nutrition Info box is to provide consumers with 
standardized, interpretive nutrition information that can help them 
quickly and easily identify how foods can be part of a healthy diet and 
allow them to compare nutrition information across foods. See section 
V.B.2 of this document for a discussion about why we would only 
require--and only allow--information about saturated fat, sodium, and 
added sugars in the Nutrition Info box.

E. Special Labeling Provisions (Proposed Sec.  101.6(b))

    Proposed Sec.  101.6(b) would describe ways to modify or 
alternatively display the Nutrition Info box for certain labels and 
labeling. This section of the preamble also describes additional 
products for which we considered proposing to establish special 
labeling provisions but have tentatively concluded must display the 
Nutrition Info box as required in Sec.  101.6(a)(2) through (4).
1. Packaged Foods That May Use an Aggregate Display in Accordance With 
Sec.  101.9(d)(13)(i) (Proposed Sec.  101.6(b)(1))
    Our regulations, at Sec.  101.9(d)(13)(i) and (h)(2)(ii), allow the 
use of an aggregate display for the Nutrition Facts label on the outer 
label of packages of products that contain two or more separately 
packaged foods that are intended to be eaten individually (e.g., 
variety packs of cereals or snack foods) or of packages that are used 
interchangeably for the same type of food (e.g., round ice cream 
containers). Proposed Sec.  101.6(b)(1) would require packages that may 
use this aggregate display to display a Nutrition Info box for each 
different product the package contains or could contain. An example of 
what such labeling might look like is as follows (see also proposed 
Sec.  101.6(b)(1)(iii)):
[GRAPHIC] [TIFF OMITTED] TP16JA25.010

    For Nutrition Facts labels, the aggregate display can use less 
label space than multiple individual Nutrition Facts labels because the 
``Nutrition Facts'' heading, most serving size information, and all 
declared nutrient, vitamin, and mineral names appear only once. While 
we are aware that the required display of multiple individual Nutrition 
Info boxes may occupy more space than an aggregate display, we 
reiterate that our public health goal with the Nutrition Info box is to 
provide consumers, including those who have lower nutrition knowledge, 
with interpretive nutrition information, at the point of decision-
making, that can help them quickly and easily identify how foods can be 
part of a healthy diet. Separate, rather than aggregate, Nutrition Info 
boxes would better help consumers to quickly view this information 
since consumers would not need to refer back to nutrient names, among 
other information, to understand the interpretive information in the 
box. We are also concerned that an aggregate Nutrition Info box would 
appear cluttered and unclear, because we designed the proposed box to 
occupy as little space on the label as possible while still giving 
consumers information, including the interpretive high, medium, and low 
categorizations that can help them quickly and easily identify how 
foods can be part of a healthy diet.
    Proposed Sec.  101.6(b)(1)(i) would require the Nutrition Info 
boxes to appear together in either horizontal or vertical lines. This 
would mean that all Nutrition Info boxes on packages that may use an 
aggregate display for the Nutrition Facts label would appear on the 
label in an unbroken line or set of lines that run either vertically or 
horizontally. Grouping the boxes consistently and together on the 
package, rather than allowing them to appear in different locations on 
a label or labeling, would help consumers more easily find the boxes 
and reduce the likelihood that they might not see one of the boxes 
because it appeared in a different location. While we are proposing to 
require placement of all boxes in the upper third of the principal 
display panel, in accordance with and for the same reasons as proposed 
Sec.  101.6(a)(3)(i), we are not proposing to require any specific 
location within that upper third to allow flexibility for industry in 
the design of their labels.
    Proposed Sec.  101.6(b)(1)(ii) would require each individual food's 
name to appear right-justified at the top of the food's Nutrition Info 
box, separated from the ``Nutrition Info'' header by a horizontal, 
centered hairline rule.

[[Page 5450]]

Inclusion of each individual food's name at the top of its Nutrition 
Info box would clarify which individual food's nutrition information is 
represented by which Nutrition Info box. Consistent placement of each 
individual food's name at the top of its Nutrition Info box on a given 
package would best help consumers quickly and easily identify the 
interpretive nutrition information for foods at the point of decision-
making because consumers would not need to search for that information. 
Right-justification of each individual food's name would provide an 
alignment cue and create a sense of unity and cohesion, contributing to 
the box's overall aesthetic and perceived stability (Ref. 62). Use of a 
horizontal hairline to separate the individual food's name from the 
``Nutrition Info'' header would divide space and give the box an 
identifiable look similar to that of the Nutrition Facts label.
    We invite comment, particularly data and other information, on this 
approach.
2. Packaged Foods That Present Nutrition Facts Labeling for Two or More 
Population Groups Consistent With Sec.  101.9(e) (Proposed Sec.  
101.6(b)(2))
    Our regulations, at Sec.  101.9(e), allow the display of multiple 
sets of nutrition information for multiple groups for which RDIs are 
established (e.g., both ``infants'' and ``people ages 4 and older''). 
We call this type of labeling ``dual-column labeling'' and provide an 
example at Sec.  101.9(e)(5).
    Proposed Sec.  101.6(b)(2) would require the Nutrition Info box for 
products that present a dual-column Nutrition Facts label for multiple 
age groups to reflect only the nutrition information for people ages 4 
and older. As we described when discussing the scope of this rule (see 
section V.A of this document), we propose that this rule apply only to 
the foods covered under Sec.  101.9 that are marketed for the general 
population. Therefore, the Nutrition Info box would only represent 
nutrition information for this population.
3. Packaged Foods That Present Nutrition Facts Labeling for Both ``Per 
Serving'' and ``Per Individual Unit'' Consistent With Sec.  
101.9(b)(2)(i)(D) (Proposed Sec.  101.6(b)(3))
    Our regulations, at Sec.  101.9(b)(2)(i)(D), require the display of 
a dual-column Nutrition Facts label when products are packaged and sold 
individually and contain at least 200 percent and up to and including 
300 percent of the applicable RACC. The first column is required to 
list the quantitative amounts and percent DVs for a serving of the 
food, and the second column is required to list the quantitative 
amounts and percent DVs for the entire package (see Sec.  
101.9(b)(2)(i)(D)). This is another example of dual-column labeling 
(see Sec.  101.9(e)(5)).
    Proposed Sec.  101.6(b)(3) would require the Nutrition Info box for 
products that present a dual-column Nutrition Facts label for ``per 
serving'' and ``per individual unit'' nutrition information to reflect 
only the nutrition information ``per serving.'' This is consistent with 
how the standard Nutrition Info box reflects nutrition information 
``per serving'' when the individual unit contains more than one 
serving. Inclusion of the required ``Per serving'' subheading with a 
statement of the serving size expressed in household measure would 
inform consumers that the package contains more than a single serving.
4. Packaged Foods That Present Nutrition Facts Labeling for Both ``As 
Packaged'' and ``As Prepared'' Forms of the Food Consistent With Sec.  
101.9(e) (Proposed Sec.  101.6(b)(4))
    Our regulations, at Sec.  101.9(e), allow the display of multiple 
sets of nutrition information for, among other things, multiple forms 
of the same food (e.g., both ``as packaged'' and ``as prepared'' for 
packaged cake mixes) and for common combinations of food as provided 
for in Sec.  101.9(h)(4) (e.g., both ``as packaged'' and ``with \1/2\ 
cup of reduced-fat milk'' for cereal). This is also an example of dual-
column labeling (see Sec.  101.9(e)(5)).
    Proposed Sec.  101.6(b)(4) would require that the Nutrition Info 
box for products that present a dual-column Nutrition Facts label for 
multiple forms of the same food and for common combinations of food 
reflect the food ``as packaged.'' We also propose that a statement 
clarifying that the box represents ``as packaged'' nutrition 
information appear right-justified at the top of the Nutrition Info box 
and separated from the ``Nutrition Info'' header by a horizontal, 
centered hairline rule, similar to aggregate display information as 
described in section V.E.1 of this document. This would help ensure 
that consumers know the Nutrition Info box always represents the food 
as it is at the point of decision-making, without any additional 
ingredients that would change the percent DV or interpretive 
descriptions. As with the information for boxes that may use an 
aggregate display for the Nutrition Facts label, as described in 
section V.E.1 of this document, right-justification of ``as packaged'' 
at the top of the box would provide a sense of unity and cohesion, 
contributing to the box's overall aesthetic and perceived stability 
(Ref. 62). Use of a horizontal hairline to separate ``as packaged'' 
from the ``Nutrition Info'' header would divide space and give the box 
an identifiable look similar to that of the Nutrition Facts label. An 
example of what such labeling might look like is as follows (see also 
proposed Sec.  101.6(b)(4)):
[GRAPHIC] [TIFF OMITTED] TP16JA25.011


[[Page 5451]]


    Because the proposed Nutrition Info box would appear on the label 
of most foods--for instance, on both cereal boxes and cartons of milk, 
or on dry cake mixes and egg cartons--consumers would have the box's 
information readily available on the principal display panel of each 
food that may be combined in whatever way they prefer. Additionally, 
each Nutrition Info box would reflect unique information (i.e., there 
would be no overlap or duplication of information), which would help 
ensure that the Nutrition Info box can help consumers quickly and 
easily identify how individual foods can be part of a healthy diet.
5. Foods in Packages That Have a Total Surface Area Available To Bear 
Labeling of 40 or Fewer Square Inches (Proposed Sec.  101.6(b)(5))
    Our regulations, at Sec.  101.9(j)(13)(ii)(A), provide that foods 
in packages that have a total surface area available to bear labeling 
of 40 or fewer square inches may present the required Nutrition Facts 
label in a tabular fashion (see Sec.  101.9(j)(13)(ii)(A)(1)) or, if 
the product's package shape or size cannot accommodate a standard or 
tabular display, in a linear fashion (see Sec.  
101.9(j)(13)(ii)(A)(2)). We established this upper limit of 40 square 
inches of surface area available to bear labeling to define an 
intermediate-sized package in the 1993 Nutrition Facts label final 
rule. We noted there that we reviewed comment suggestions, examined the 
space requirements of the Nutrition Facts label, reviewed data on 
available label area for a sample of packaged foods, and considered 
what would make the label readily observable and easily comprehensible 
to arrive at 40 square inches (58 FR 2079 at 2155). In the 2016 
Nutrition Facts label final rule, we declined to increase that number, 
stating that the promulgation of other space-saving requirements would 
preclude the necessity of doing so (81 FR 33742 at 33957). We propose 
to allow similar flexibility for such intermediate packages for the 
purposes of this rule.
    Recognizing the increased need for flexibility for packages with 40 
or fewer square inches available to bear labeling, and to help ensure 
the Nutrition Info box is readily observable and easily comprehensible, 
proposed Sec.  101.6(b)(5) would allow foods in packages with a total 
surface area available to bear labeling of 40 or fewer square inches to 
use an alternative Nutrition Info box (intermediate-package Nutrition 
Info box). This box would be smaller than our proposed Nutrition Info 
box and is designed to balance our public health goal of providing 
consumers with interpretive nutrition information that can help them 
quickly and easily identify how foods can be part of a healthy diet 
with the reduced amount of space available to bear labels on 
intermediate-sized packages relative to larger packages. Consumers have 
decades of experience with alternate Nutrition Facts label formatting 
for products that have 40 or fewer square inches of surface area 
available to bear labeling. Providing flexibility for these 
intermediate-sized packages to display a modified Nutrition Info box 
would be consistent with our Nutrition Facts label regulations. An 
example of an intermediate-package Nutrition Info box is as follows:
[GRAPHIC] [TIFF OMITTED] TP16JA25.012

    We considered whether to propose allowing the use of the 
intermediate-package Nutrition Info box only when a package uses the 
tabular or linear Nutrition Facts label format as specified in Sec.  
101.9(j)(13)(ii)(A). In other words, we considered proposing to require 
the display of a standard Nutrition Info box if an intermediate package 
did not use the flexibilities provided in Sec.  101.9(j)(13)(ii)(A) and 
chose instead to display the standard Nutrition Facts label. However, 
given the labeling space constraints with packages of this size, we 
think it would be appropriate to extend this flexibility to all 
products with 40 or fewer square inches available to bear labeling that 
would be subject to this rule.
    Proposed Sec.  101.6(b)(5)(i) would establish the intermediate-
package Nutrition Info box, which would omit the ``Per serving'' and 
``% Daily Value'' subheadings and the quantitative percent DV 
declarations. The ``Per serving'' subheading, including the statement 
of the serving size expressed in household measures, would be omitted 
because doing so would reduce the amount of space needed for the 
intermediate-package Nutrition Info box. Given the smaller package 
size, our intent is to help ensure the readability of the interpretive 
information provided in the Nutrition Info box.
    We propose that the intermediate-package Nutrition Info box would 
also not include the quantitative percent DV declarations for the same 
space and readability considerations as with the ``Per Serving'' 
subheading. Without the quantitative percent DV declarations, the ``% 
Daily Value'' subheading would be unnecessary, and we therefore also 
propose to exclude it from the intermediate-package Nutrition Info box. 
However, as discussed in section V.B.4 of this document, we recognize 
that consumers could use the percent DV declarations to, among other 
things, quickly compare products that have the same interpretive 
description for a given nutrient. For example, two products may both 
have ``high'' added sugars interpretive descriptions, but one may 
contain 30% DV added sugars, while the other contains 60% DV added 
sugars. We also recognize that the quantitative percent DV, in addition 
to the interpretive descriptions, may help consumers better understand 
why a serving of a food has the interpretive description it does. We 
invite comment on the exclusion of the quantitative percent DV and on 
other design factors or choices we could make to balance our public 
health mission and FOP nutrition labeling goals with the space 
constraints on intermediate-sized packages.
    While we propose certain modifications for the intermediate-package 
Nutrition Info box, we are

[[Page 5452]]

keeping the remaining design elements the same as in the standard 
Nutrition Info box. This would create consistency between the box 
types, as well as with the Nutrition Facts label, the design of which 
underlays our proposed Nutrition Info box formats.
    Proposed Sec.  101.6(b)(5)(ii) would require the use of 
abbreviations for saturated fat (``Sat. Fat'') and added sugars (``Add. 
Sugar'') to help with potential overcrowding issues in the 
intermediate-package Nutrition Info box and to help ensure readability. 
The proposed abbreviation for saturated fat would be consistent with 
our Nutrition Facts label regulations (see Sec.  101.9(j)(13)(ii)(B)). 
An abbreviation for added sugars would also help sizing considerations 
for the intermediate-sized packages, while still providing the 
information to consumers.
6. Foods Sold From Bulk Containers (Proposed Sec.  101.6(b)(6))
    Our existing regulations allow the Nutrition Facts label for foods 
sold from bulk containers, which do not have a principal display panel, 
to appear on the labeling of the bulk container plainly in view (Sec.  
101.9(j)(16)), clearly at the point of purchase (Sec.  101.9(a)(2)), or 
available in another format consistent with Sec.  101.9(a)(2) (such as 
in a booklet at the point of purchase). Proposed Sec.  101.6(b)(6) 
would require that the labeling of foods sold to consumers from bulk 
containers display the Nutrition Info box plainly in view of the 
consumer at the point of purchase. This presentation is the best way to 
ensure that consumers would have immediate access to that information 
at the point of decision-making--the same way they would have that 
information on the principal display panel of most packaged foods (see 
proposed Sec.  101.6(a)(3)(i)). While the Nutrition Facts label may be 
displayed elsewhere, such as in a booklet, for bulk foods, we 
tentatively conclude that any such display for the Nutrition Info box 
would not be consistent with placement on the principal display panel 
and would not provide consumers with interpretive nutrition information 
that can help them quickly and easily identify how foods can be part of 
a healthy diet. We invite comment on this approach.
7. Game Meats (Proposed Sec.  101.6(b)(7))
    Our regulations, at Sec.  101.9(j)(11), allow the Nutrition Facts 
label for packaged single-ingredient products that consist of game meat 
(i.e., animal products not covered under the Federal Meat Inspection 
Act or the Poultry Products Inspection Act, such as flesh products from 
deer, bison, rabbit, quail, wild turkey, or ostrich) to present 
nutrition information either as packaged or as prepared (unless such 
products make claims that are based on values as packaged and therefore 
must provide nutrition information on an as packaged basis). Proposed 
Sec.  101.6(b)(7)(i) would require game meats to display a Nutrition 
Info box that reflects how the nutrition information is presented under 
Sec.  101.9. If the Nutrition Facts label for a game meat presents 
nutrition information as packaged as required under Sec.  101.9(b)(7), 
then the Nutrition Info box would reflect the nutrition information as 
packaged. However, if the Nutrition Facts label presents nutrition 
information as prepared, following the special labeling provision at 
Sec.  101.9(j)(11), then the Nutrition Info box also would reflect the 
nutrition information as prepared. We are proposing this because the 
percent DVs used to determine the interpretive descriptions for each 
nutrient in the Nutrition Info box are based on a serving's amount, in 
grams, of each nutrient. The values may differ between the nutrition 
information presented as packaged versus as prepared. We tentatively 
conclude that this approach would ensure that the Nutrition Facts label 
and the Nutrition Info box provide consistent information.
    Our existing regulations, at Sec.  101.9(j)(12), also allow the 
Nutrition Facts label for game meats not in packages to appear clearly 
at the point of purchase (Sec.  101.9(a)(2)) or available in another 
format consistent with Sec.  101.9(a)(2) (such as in a booklet at the 
point of purchase) if it does not appear on the label. Proposed Sec.  
101.6(b)(7)(ii) would require these game meats to display the Nutrition 
Info box plainly in view of the consumer at the point of purchase. 
Similar to our proposed exemption for bulk foods, providing such 
information clearly in view of the consumer on the labeling of game 
meat not in packages is the best way to ensure that consumers would 
have immediate access to that information at the point of decision-
making--the same way they would have that information on the principal 
display panel of most packaged foods (see proposed Sec.  
101.6(a)(3)(i)). While the Nutrition Facts label may be displayed 
elsewhere, such as in a booklet, for game meats not in packages, we 
tentatively conclude that any such display for the Nutrition Info box 
would not be consistent with placement on the principal display panel 
and would not provide consumers with interpretive nutrition information 
that can help them quickly and easily identify how foods can be part of 
a healthy diet.
8. Other Products Considered for Special Labeling Provisions
    While we are proposing special labeling provisions for some 
products, we also considered but rejected such proposed provisions for 
other products. For example, our regulations, at Sec.  101.9(h)(1), 
allow for foods to display a Nutrition Facts label per serving for each 
component or as a composite value when separately packaged ingredients 
(e.g., a salad kit) or assortments of the same type of food (e.g., a 
package of mixed nuts) are intended to be eaten at the same time (see 
Sec.  101.9(h)(1)). We considered establishing a special labeling 
provision for such foods to display either a Nutrition Info box per 
component or composite value, consistent with the flexibility provided 
in Sec.  101.9(h)(1). However, such a provision might result in the 
inconsistent display of Nutrition Info boxes for these products, which 
would not be consistent with the goal of this proposed rule. For 
example, consumers would not be able to easily compare a composite 
Nutrition Info box on one food to multiple Nutrition Info boxes for 
individual components on another food. Additionally, we tentatively 
conclude that allowing component Nutrition Info boxes instead of a 
single, composite box would prevent consumers from quickly and easily 
identifying how the food can be part of a healthy diet (e.g., the salad 
kit as a whole). We therefore are not proposing any special labeling 
provisions for these foods.

F. Exemptions (Proposed Sec.  101.6(c))

    Proposed Sec.  101.6(c) would exempt certain foods from the 
requirement to display a Nutrition Info box. This section of the 
document also describes additional products we considered proposing to 
exempt but have tentatively concluded would be subject to the 
requirements of this rule.
1. Foods Exempt From Sec.  101.9 Under Sec.  101.9(j), Unless Otherwise 
Stated in This Section (Proposed Sec.  101.6(c)(1))
    Our regulations, at Sec.  101.9(j), exempt certain foods, such as 
raw fruits and vegetables, from bearing a Nutrition Facts label. 
Proposed Sec.  101.6(c)(1) would similarly exempt those foods from 
bearing a Nutrition Info box. We are proposing to base the interpretive 
descriptions of the relative amount of each declared nutrient per 
serving on the quantitative percent DV, which foods exempt under Sec.  
101.9(j) do not have to bear (which, in turn, means that industry would 
not need to calculate the

[[Page 5453]]

percent DVs). Any proposal to change the exemptions in Sec.  101.9(j) 
would be outside the scope of this rulemaking. Even if it were not, we 
are not aware of data indicating that we should propose changes to the 
exemptions.
    We note that Sec.  101.9(j) also includes foods subject to special 
labeling requirements. We propose that only foods exempt under Sec.  
101.9(j) would be exempt from bearing a Nutrition Info box, unless 
otherwise specified in this section.
2. Foods in Small Packages That Have a Total Surface Area Available To 
Bear Labeling of Less Than 12 Square Inches (Proposed Sec.  
101.6(c)(2))
    Our regulations, at Sec.  101.9(j)(13)(i), provide that foods in 
small packages that have a total surface area available to bear 
labeling of less than 12 square inches are exempt from Nutrition Facts 
labeling, unless nutrition information, such as a claim, is presented 
on the label. We first proposed this exemption in 1991 (see 56 FR 
60366). At that time, we noted our belief that relatively few food 
packages would qualify as ``small'' under the proposed exemption, 
namely candy rolls, breath sweeteners, and a few very small individual-
serving size canned foods (id. at 60377). We finalized this exemption 
in the 1993 Nutrition Facts label final rule (58 FR 2079) and kept this 
exemption in the 2016 Nutrition Facts label final rule (81 FR 33742).
    Proposed Sec.  101.6(c)(2) would exempt foods in small packages 
that have a total surface area available to bear labeling of less than 
12 square inches from the requirement to display the Nutrition Info 
box. While such a small package must bear the appropriately sized 
Nutrition Facts label if its label includes any other nutrition 
information, we tentatively conclude that there would not also be 
enough room to fit a Nutrition Info box on its label that would be 
legible to consumers without occupying much of the available space to 
bear labeling. We invite comment, and particularly data and other 
information, on this approach.
3. Packages Marketed as Gifts That Contain a Variety or Assortment of 
Foods (Proposed Sec.  101.6(c)(3))
    Our regulations, at Sec.  101.9(h)(3), provide special labeling 
requirements for a package that contains a variety of foods, or an 
assortment of foods, and is in a form intended to be used as a gift 
(gift package). For example, the Nutrition Facts label for foods in 
such a package may be presented on the label of the outer package or in 
labeling within or attached to the outer package (Sec.  
101.9(h)(3)(i)). We defined ``outer package'' in the 1993 Nutrition 
Facts final rule to mean the container directly within which component 
items are packed (58 FR 2079 at 2159), and we maintain that definition 
here.
    Proposed Sec.  101.6(c)(3) would exempt the outer packaging of gift 
packages from the requirement to display Nutrition Info boxes. Our 
purpose in proposing the Nutrition Info box is to provide consumers 
with interpretive nutrition information at the point of decision-making 
that can help them quickly and easily identify how foods can be part of 
a healthy diet. We tentatively conclude that the point of decision-
making for gift packages is generally after the package is opened, when 
a consumer is considering which food from the gift package to eat. 
While we propose that the outer wrapping be exempt, we note that the 
inner food products would be subject to the requirements in this rule, 
unless otherwise exempted.
4. Unit Containers in a Multiunit Retail Food Package (Proposed Sec.  
101.6(c)(4))
    Our regulations, at Sec.  101.9(j)(15), provide that the unit 
containers in a multiunit retail food package are exempt from Nutrition 
Facts labeling so long as certain requirements are met (i.e., the 
multiunit retail food package labeling contains all nutrition 
information in accordance with Sec.  101.9; the unit containers are 
securely enclosed within and not intended to be separated from the 
retail package under conditions of retail sale; and each unit container 
is labeled with the statement ``This Unit Not Labeled For Retail Sale'' 
as described in Sec.  101.9(j)(15)(iii)). We first proposed this 
exemption in the 1990 Nutrition Facts label proposed rule after 
receiving a comment requesting such an exemption and agreeing that it 
would be reasonable to exempt unit containers from Nutrition Facts 
labeling requirements, provided they meet certain requirements (55 FR 
29487 at 29505). In the 1993 Nutrition Facts label final rule, we 
finalized this exemption. We did not discuss or change this exemption 
when updating the Nutrition Facts label regulations in 2016.
    Proposed Sec.  101.6(c)(4) would similarly exempt the unit 
containers in a multiunit retail food package from FOP nutrition 
labeling, so long as the unit containers fall under the exemption for 
Nutrition Facts labeling in accordance with Sec.  101.9(j)(15); and the 
multiunit retail food package bears the Nutrition Info box in 
accordance with Sec.  101.6. If those conditions are met, we 
tentatively conclude that it is unnecessary for the unit containers to 
also bear the Nutrition Info box. This is consistent with our similar 
exemption for the Nutrition Facts label, and it is the Nutrition Info 
box on the outside of a multiunit retail food package that consumers 
would use to quickly and easily identify how foods can be part of a 
healthy diet.
5. Other Products Considered for Exemption
    We considered whether to exempt foods that contain insignificant 
amounts of saturated fat, sodium, and added sugars and use the 
simplified format of the Nutrition Facts label from the requirement to 
display the Nutrition Info box. Our regulations, at Sec.  101.9(f), 
allow for the use of a simplified format for the Nutrition Facts label 
when a food contains insignificant amounts of, among other things, 
saturated fat, sodium, and added sugars. We define ``insignificant 
amount'' in this context as the amount that allows a declaration of 
zero in nutrition labeling (Sec.  101.9(f)(1)). If a food contains 
insignificant amounts of saturated fat, sodium, and added sugars and 
uses the simplified Nutrition Facts label format, sodium is the only 
nutrient that would be required to be declared in the Nutrition Facts 
label--saturated fat and added sugars would not be declared (see Sec.  
101.9(f)(2)). However, a proposed exemption from the requirements of 
this rule would not be consistent with our goal to provide consumers 
with interpretive nutrition information that can help them quickly and 
easily identify how foods can be part of a healthy diet. An exemption 
would also make quick comparisons between products more difficult. We 
tentatively conclude that requiring these foods to bear a Nutrition 
Info box would provide consumers with interpretive information about 
the amounts of the three nutrients so they could quickly and easily 
identify how foods can be part of a healthy diet. Therefore, we are not 
proposing to exempt foods that use the simplified format of the 
Nutrition Facts label and that contain insignificant amounts of 
saturated fat, sodium, and added sugars from the requirement to display 
the Nutrition Info box.
    We also considered whether to exempt products such as electrolyte 
drinks, glucose products, and nutrition shakes that are required to 
bear Nutrition Facts labels from the requirement to display a Nutrition 
Info box. These products are often conventional foods and are marketed 
and used for a variety of purposes, such as rehydration during or after 
exercise, providing energy, or general meal

[[Page 5454]]

replacement. When these products are conventional foods and are 
required to bear Nutrition Facts labels, they are often used by healthy 
individuals and the general population; accordingly, we are not 
proposing to exempt such products from bearing a Nutrition Info box.

G. Low Sodium and Low Saturated Fat Nutrient Content Claims (Revised 
Sec. Sec.  101.61(b)(4) and (5) and 101.62(c)(2) and (3))

    We are proposing to revise Sec.  101.61(b)(4)(i)(A) and 
(b)(4)(i)(B) so that a food other than a meal product or main dish 
product may bear a low sodium nutrient content claim if a serving of 
the food contains 115 mg or less sodium per RACC rather than 140 mg or 
less sodium per RACC; and Sec.  101.61(b)(5)(i) so that meal products 
and main dish products may bear a low sodium nutrient content claim if 
a serving of the food contains 115 mg or less sodium per 100 g rather 
than 140 mg or less sodium per 100 g. This revision is consistent with 
the updated DRV for sodium in the 2016 Nutrition Facts label final rule 
and with FDA's ongoing sodium reduction efforts (see section V.B.3 of 
this document). It also generally aligns with the 5% DV or less range 
that we are proposing for ``Low'' for sodium in the proposed Nutrition 
Info box.
    We are also proposing to amend Sec. Sec.  101.61(b)(4) and (5) and 
101.62(c)(2) and (3) to specify that a food subject to this rule must 
display ``Low'' in accordance with Sec.  101.6 for sodium or saturated 
fat in the Nutrition Info box to qualify for a low sodium or low 
saturated fat nutrient content claim, respectively. A food bearing a 
low sodium or low saturated fat nutrient content claim but falling into 
the ``Med'' or ``High'' categorization for that nutrient in the 
Nutrition Info box would lead to inconsistency in the labeling of such 
food and could result in consumer confusion (see Ref. 64). Therefore, 
we tentatively conclude that a food subject to this rule must display 
``Low'' in accordance with Sec.  101.6 for the respective nutrient in 
the Nutrition Info box to qualify for a low sodium or low saturated fat 
nutrient content claim. In addition to updating the claim to reflect 
current nutrition science and helping to avoid consumer confusion by 
aligning with the Nutrition Info box's ``Low'' description, this 
amendment would also address products that are not subject to the 
proposed requirement to display a Nutrition Info box.
    We are not proposing to amend the definitions of the low sodium and 
low saturated fat nutrient content claims to be ``5% DV or less'' 
because our regulations define other ``low'' nutrient content claims 
based on g or mg amounts of a nutrient and RACC and weight-based 
criteria. Proposing to change the units for the amount of sodium and 
saturated fat from mg or g amounts to a percent DV and proposing to 
change the additional criteria for nutrient content claims that are 
based on a per RACC (per 50 g of food if the RACC is small) or a 
weight-based criteria (e.g., per 100 g of food for meals and main 
dishes) to a per labeled serving basis for the low sodium and low 
saturated fat nutrient content claims in this proposed rule would make 
their definitions inconsistent with the definitions for other ``low'' 
nutrient content claims. We invite comment on this approach.

H. Authority Citation

    The proposed rule would add the statutory authority 21 U.S.C. 343 
note as a regulatory authority for part 101. Specifically, 21 U.S.C. 
343 note gives FDA authority to issue regulations that require certain 
nutrition information to be conveyed in a manner that allows the public 
to readily observe and comprehend such information and to understand 
its relative significance in the context of a total daily diet.

I. Conforming Amendments

    The proposed rule would necessitate several conforming changes to 
our food labeling regulations found in part 101. Because we would 
establish new requirements for an FOP Nutrition Info box in proposed 
Sec.  101.6, we are proposing updates to the following sections to 
cross-reference the new nutrition labeling requirement:
     Section 101.2: Information panel of package form food 
(proposing to add Sec.  101.6 to the list of sections the information 
in which must appear either on a food's principal display panel or on 
the information panel, unless otherwise specified by regulation) (see 
also section V.J of this document, where we propose a technical 
amendment to the title of this section).
     Section 101.13: Nutrient content claims--general 
principles (proposing that the information required by Sec.  101.6 
would not be a nutrient content claim). We recognize that our 
regulations, at Sec.  101.13(c), provide that information required or 
permitted in the Nutrition Facts label is not a nutrient content claim 
and is not subject to the requirements regarding nutrient content 
claims. However, Sec.  101.13(c) further states that if the information 
in the Nutrition Facts label appears elsewhere on the label, it is a 
nutrient content claim, and any package bearing such a claim must 
comply with our nutrient content claim requirements. We propose 
amending Sec.  101.13(c) to specify that the information in the 
proposed Nutrition Info box would not be a nutrient content claim, like 
the information in the Nutrition Facts label is not a nutrient content 
claim. However, we would still consider all other quantitative calorie 
or nutrient declarations outside of those in proposed amended Sec.  
101.13(c) to be nutrient content claims, unless an exception applies 
under Sec.  101.13. For example, under Sec.  101.13, the label or 
labeling of a product may contain a statement about the amount of a 
nutrient without any disclaimer if the statement does not in any way 
implicitly characterize the level of the nutrient in the food and it is 
not false or misleading in any respect (e.g., ``150 calories'') (see 
Sec.  101.13(i)(3)).
     Section 101.15: Food; prominence of required statements 
(proposing to exempt the proposed Nutrition Info box from foreign 
language declarations due to space considerations).
     Section 101.61: Nutrient content claims for the sodium 
content of foods (proposing to add Sec.  101.6 to Sec.  101.61(a)(3) so 
that a claim about the level of sodium or salt in a food may only be 
made on the label or in the labeling of the food if the food is labeled 
in accordance with, among other things, Sec.  101.6).
     Section 101.62: Nutrient content claims for fat, fatty 
acid, and cholesterol content of foods (proposing to add Sec.  101.6 to 
Sec.  101.62(a)(3) so that a claim about the level of fat, fatty acid, 
and cholesterol in a food may only be made on the label or in the 
labeling of the food if the food is labeled in accordance with, among 
other things, Sec.  101.6).
     Section 101.65: Implied nutrient content claims and 
related label statements (proposing to add Sec.  101.6 to Sec.  
101.65(a)(3) so that an implied nutrient content claim may only be made 
on the label or in the labeling of the food if the food is labeled in 
accordance with, among other things, Sec.  101.6).
J. Technical Amendments
    We propose certain technical amendments in Sec. Sec.  101.12, 
101.13, and 101.15 to make non-substantive edits for purposes of plain 
language. The Plain Writing Act of 2010 requires that Federal agencies 
use clear communication that the public can understand and use. Section 
1 of Executive Order 13563, ``Improving Regulation and Regulatory 
Review'' (76 FR 3821, January 21, 2011)), sets forth

[[Page 5455]]

``General principles of regulation,'' which include ensuring that 
regulations are ``accessible, consistent, written in plain language, 
and easy to understand.'' To make the requirements of part 101 easier 
to understand, we are proposing to make editorial changes that do not 
change the meaning or intent of the language in Sec.  101.2(b), 
(c)(1)(ii)(B)(1), and (f); Sec.  101.13(n); and Sec.  101.15(c)(2). 
Specifically, the proposed rule would:
     Revise the title of Sec.  101.2 and paragraph (b) of that 
section to read ``packaged food,'' instead of ``package form food'' or 
``package of food,'' respectively. We propose these changes for 
consistency with how we refer to these products throughout our 
nutrition labeling regulations.
     Replace ``shall'' with ``must'' in Sec.  101.2(b), 
(c)(1)(ii)(B)(1), and (f); Sec.  101.13(n); and Sec.  101.15(c)(2). We 
propose this change to align with the Federal Plain Language 
Guidelines, which state that Federal Agencies should use ``must'' and 
not ``shall'' to impose requirements, as ``shall'' is ambiguous and 
rarely occurs in everyday conversation (Ref. 65).

VI. Proposed Effective/Compliance Dates

    We intend that any final rule resulting from this rulemaking become 
effective 60 days after the date of the final rule's publication in the 
Federal Register. We propose staggered compliance dates:
     3 years after the final rule's effective date for 
businesses with $10 million or more in annual food sales; and
     4 years after the final rule's effective date for 
businesses with less than $10 million in annual food sales.
    We recognize that it may take industry time to design and print new 
labels. A 3-year compliance date for businesses with $10 million or 
more in annual food sales and a 4-year compliance date for businesses 
with less than $10 million in annual food sales are intended to provide 
industry time to revise labeling to come into compliance with the new 
labeling requirements while balancing the need for consumers to timely 
have the proposed information in the Nutrition Info box. We invite 
comment on these proposed compliance dates.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Rules are ``significant'' under Executive Order 12866 
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.'' OIRA has determined that this proposed rule is a 
significant regulatory action under Executive Order 12866 Section 
3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because we estimate that the annual economic impact of this 
proposed rule is less than 3 percent of annual revenue, we propose to 
certify that this proposed rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes estimates of 
anticipated impacts, before proposing ``any rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $183 
million, using the most current (2023) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would result in an 
expenditure in any year that meets or exceeds this amount.
    The proposed rule, if finalized, would require certain nutrition 
information to appear in a compact informational box on the front, or 
principal display panel, of most foods bearing a Nutrition Facts label. 
The Nutrition Info box would provide consumers with interpretive 
nutrition information that can help them quickly and easily identify 
how foods can be part of a healthy diet, thereby promoting public 
health. The proposed rule would also amend low sodium and low saturated 
fat nutrient content claim regulations to align with current nutrition 
science and avoid within-label inconsistencies. The proposed rule, if 
finalized, may result in some industry reformulating some products 
based on the interpretive label information or to maintain nutrient 
content claims, if some manufacturers choose to do so.
    We quantify costs to packaged food manufacturers from updating 
labeling to meet the proposed requirements. Although it is not a 
requirement or goal of the proposed rule, we also quantify the costs of 
reformulation as the rule could result in some food manufacturers 
reformulating some food products. Over 10 years, the total undiscounted 
cost is $3.2 billion. Updating labeling to meet the proposed 
requirements accounts for 32 percent of total costs ($1 billion) while 
voluntary reformulation accounts for the other 68 percent of total 
costs over 10 years ($2.2 billion). The present value of costs over 10 
years would range from $1.7 billion to $4.9 billion at a 2 percent 
discount rate, with a primary estimate of $3.1 billion. Annualized 
costs over 10 years would range from $191 to $530 million at a 2 
percent discount rate, with a primary estimate of $333 million.
    The proposed Nutrition Info box would give consumers additional 
standardized context about certain nutrients that appear in the 
Nutrition Facts label and allow them to compare this nutrition 
information across foods. Benefits of this proposed rule would come 
from the value consumers receive from the information provided by the 
FOP label. If some packaged food manufacturers chose to reformulate 
products to maintain current nutrient content claims or move into a 
``Low'' or ``Med'' interpretive description, consumers whose 
nutritional intake changes accordingly would also benefit from a 
healthier food supply. The proposed rule, if finalized, would provide 
consumers, including those who have lower nutrition knowledge, with 
interpretive nutrition information that can help them quickly and 
easily identify how foods can be part of a healthy diet, thereby 
promoting public health. We undertake a break-even calculation to 
describe the magnitude of non-quantified benefits for the benefits to 
equal or exceed the costs of the regulation.
    This is only a summary of our preliminary analysis of the proposed 
rule. We have developed a Preliminary Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. The full preliminary 
analysis of economic impacts is available in the docket for this 
proposed rule (Ref. 66) and at https://www.fda.gov/about-fda/

[[Page 5456]]

economics-staff/regulatory-impact-analyses-ria.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3521). A description of these provisions is given in 
the Description section below with an estimate of the annual third-
party disclosure burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Food Labeling: Front-of-Package Nutrition Information
    Description: This information collection would support statutory 
and regulatory requirements that govern food labeling. FDA authorities 
include the NLEA (21 U.S.C. 343 note (1990)) and sections 403(f) and 
403(q) of the FD&C Act. This information collection also would support 
sections 701(a), 403(a)(1), and 201(n) of the FD&C Act.
    The proposed rule, if finalized, would add Sec.  101.6 to require 
the food industry to disclose certain nutrition information in a 
compact informational box on the principal display panel of most foods 
bearing a Nutrition Facts label. The Nutrition Info box would give 
consumers additional context on the front of most food packages about 
certain nutrients that appear on the Nutrition Facts label. The 
Nutrition Info box would provide consumers with interpretive nutrition 
information that can help them quickly and easily identify how foods 
can be part of a healthy diet, thereby promoting public health.
    Description of Respondents: The respondents to this information 
collection are manufacturers, packers, and distributors of food 
products subject to statutory and regulatory food labeling 
requirements.
    We estimate the burden of this collection of information as 
follows:

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Number of
              Activity; 21 CFR section                  Number of      disclosures per     Total annual   Average  burden   Total hours   Total capital
                                                       respondents      respondent \2\     disclosures    per  disclosure                   costs \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Front of Package Labeling; 101.6...................          30,413                 11          322,378                4     1,289,512     $143,220,186
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ For purposes of this table, we have rounded up to use whole numbers when calculating the number of disclosures per respondent. All other figures are
  consistent with the Preliminary Regulatory Impact Analysis.
\3\ One-time capital cost to relabel.

    The estimates in table 2 are consistent with the estimates found in 
the Preliminary Regulatory Impact Analysis (PRIA) (Ref. 66). In table 
21 of the PRIA, we estimate that approximately 30,413 manufacturers 
will need to add the informational Nutrition Info box to the principal 
display panel of their food product package. In table 4 of the PRIA, we 
estimate that approximately 322,326 products will need to be relabeled. 
For the purpose of this analysis, we used the estimates for the number 
of manufacturers and disclosures to calculate that each manufacturer 
will need to relabel about 11 products (322,378 disclosures / 30,413 
manufacturers = 10.6). In the existing information collection for Food 
Labeling Requirements approved under OMB control number 0910-0381, we 
estimated that an establishment would spend 4 hours per label for 
labeling requirements for disclosure of nutrition information (21 CFR 
101.9). We use the 4-hour estimate for the purpose of this analysis. 
Each disclosure will take an estimated 4 hours to complete for an 
annual third-party disclosure burden of 1,289,512 hours (322,378 
disclosures x 4 hours). Based on table 6 of the PRIA, we estimate each 
product that will be relabeled will cost $1,333 assuming a 3-year 
compliance period. That calculates to an annual capital cost of 
$143,220,186 ($1,333 x 107,442 products) over 3 years associated with 
relabeling with the total capital cost being $429,660,558. This is the 
cost of designing a revised label and incorporating it into the 
manufacturing process. We believe that this will be a one-time capital 
cost.
    To ensure that comments on this information collection are 
received, OMB recommends that written comments be submitted through 
reginfo.gov (see ADDRESSES). All comments should be identified with the 
title of the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), we have submitted the information collection provisions of 
this proposed rule to OMB for review. These information collection 
requirements will not be effective until FDA publishes a final rule, 
OMB approves the information collection requirements, and the rule goes 
into effect. FDA will announce OMB approval of these requirements in 
the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 403A of the FD&C 
Act (21 U.S.C. 343-1) is an express preemption provision. Section 
403A(a)(3) of the FD&C Act provides that no State or political 
subdivision of a State may directly or indirectly establish under any 
authority or continue in effect as to any food in interstate commerce 
with respect to any requirement for nutrition labeling of food that is 
not identical to the requirement of section 403(q) of the FD&C Act.
    The express preemption provision of section 403A(a) of the FD&C Act 
does not preempt any State or local

[[Page 5457]]

requirement respecting a statement in the labeling of food that 
provides for a warning concerning the safety of the food or component 
of the food (section 6(c)(2) of the NLEA). If this proposed rule is 
finalized, the rule would create requirements that fall within the 
scope of section 403A(a) of the FD&C Act to the extent that these 
provisions are consistent with section 403(q) of the FD&C Act.
    Further, uniformity in FOP nutrition labeling is critical to 
achieving the goal of this proposed regulation so that consumers are 
provided with interpretive nutrition information that can help them 
quickly and easily identify how foods can be part of a healthy diet. If 
States were able to establish their own FOP nutrition labeling systems 
with different requirements, consumers would not be able to rely on a 
single standardized box to compare products and may be confused by 
conflicting or different information on a separate state FOP nutrition 
label. Different State or local requirements for FOP nutrition labeling 
would not be consistent with the NLEA, which directs FDA to require 
nutrition information be presented in a way that makes it observable, 
understandable, and useful to consumers and which established section 
403A of the FD&C Act with regard to ``National Uniform Nutrition 
Labeling.''
    Section 4(c) of Executive Order 13132 instructs us to restrict any 
Federal preemption of State law to the minimum level necessary to 
achieve the objectives of the statute that provided the authority to 
issue the regulations. The proposed rule, if finalized, would meet the 
preceding requirement because it would preempt State law narrowly, only 
to the extent required to achieve uniform national labeling with 
respect to the requirements related to the contents and design of the 
FOP Nutrition Info box.
    Section 4(d) of Executive Order 13132 states that when an agency 
foresees the possibility of a conflict between State law and federally 
protected interests within the agency's area of regulatory 
responsibility, the agency must consult with appropriate State and 
local officials, as practicable, in an effort to avoid such a conflict. 
Section 4(e) of Executive Order 13132 provides that when an agency 
proposes to act through adjudication or rulemaking to preempt State 
law, the agency must provide all affected State and local officials 
notice and an opportunity for appropriate participation in the 
proceedings. FDA's Office of Partnerships will invite the States' 
participation in this rulemaking by providing notice via email to State 
health commissioners, State agriculture commissioners, and State food 
program directors as well as FDA field personnel of the publication of 
the proposed rule. The notice will give the States further opportunity 
for input on the proposed rule, advise the States of FDA's possible 
action, and invite State and local governments to provide any comments.
    Consequently, we have included Sec.  101.6(d) in the proposed 
regulatory text stating that a State or political subdivision of a 
State may not establish or continue into effect any law, rule, 
regulation, or other requirement that is different from the 
requirements in this rule. Preemption may also arise regarding other 
FOP nutrition labeling if a State requirement is found to obstruct the 
federal purpose articulated in this rule.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, or the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. FDA invites comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

XII. 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.

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53. Feunekes, G.I.J., I.A. Gortemaker, A.A. Willems, et al. ``Front-
of-Pack Nutrition Labelling: Testing Effectiveness of Different 
Nutrition Labelling Formats Front-of-Pack in Four European 
Countries.'' Appetite, 50(1):57-70, 2008. Accessed January 12, 2025. 
Available at https://doi.org/10.1016/j.appet.2007.05.009.
54. Vyth, E.L., I.H.M. Steenhuis, S.F. Mallant, et al. ``A Front-of-
Pack Nutrition Logo: A Quantitative and Qualitative Process 
Evaluation in the Netherlands.'' Journal of Health Communications, 
14(7):631-645, 2009. Accessed January 12, 2025. Available at https://doi.org/10.1080/10810730903204247.
* 55. Shrestha, A., K. Cullergon, K. White, et al. ``Impact of 
Front-of-Pack Nutrition Labelling in Consumer Understanding and Use 
Across Socio-Economic Status: A Systematic Review.'' 
Appetite,187:106587, 2023. Accessed January 12, 2025. Available at 
https://doi.org/10.1016/j.appet.2023.106587.
56. Bialkova, S. and H. van Trijp. ``What Determines Consumer 
Attention to Nutrition Labels?'' Food Quality and Preference, 
21(8):1042-1051, 2010. Accessed January 12, 2025. Available at 
https://doi.org/10.1016/j.foodqual.2010.07.001.
57. Bialkova, S., K.G. Grunert, and H. van Trijp. ``Standing Out in 
the Crowd: The Effect of Information Clutter on Consumer Attention 
for Front-of-Pack Nutrition Labels.'' Food Policy, 41:65-74, 2013. 
Accessed January 12, 2025. Available at https://doi.org/10.1016/j.foodpol.2013.04.010.
58. Cabrera, M., L. Mach[iacute]n, A. Arr[uacute]a, et al. 
``Nutrition Warnings as Front-of-Pack Labels: Influence of Design 
Features on Healthfulness Perception and Attentional Capture.'' 
Public Health Nutrition, 20(18):3360-3371, 2017. Accessed January 
12, 2025. Available at https://doi.org/10.1017/s136898001700249x.
* 59. U.S. Food and Drug Administration. ``The New Nutrition Facts 
Label: Examples of Different Label Formats.'' FDA.gov. Accessed 
January 12, 2025. Available at https://www.fda.gov/media/99151/download.
60. Craig, J. and I.K. Scala. Designing with Type: The Essential 
Guide to Typography. 5th ed. Watson-Guptill, 2006; p. 78.
61. Lidwell, W., K. Holden, and J. Butler (Eds.). Universal 
Principles of Design. 3rd Ed. Rockport Publishers, 2023; section 
006.
62. Lidwell, W., K. Holden, and J. Butler (Eds.). Universal 
Principles of Design. 1st Ed. Rockport Publishers, 2003.
63. Gomez-Palacio, B. and A. Vit. Graphic Design Referenced: A 
Visual Guide to the Language, Applications, and History of Graphic 
Design. 1st Ed. Rockport Publishers, 2012; pp. 50-54.
64. Acton, R. and D. Hammond. ``Do Manufacturer `Nutrient Claims' 
Influence the Efficacy of Mandated Front-of-Package Labels?'' Public 
Health Nutrition, 21(18):3354-3359, 2018. Accessed December 23, 
2024. Available at https://doi.org/10.1017/S1368980018002550.
* 65. U.S. General Services Administration. Federal Plain Language 
Guidelines. Plainlanguage.gov. Accessed January 12, 2025. Available 
at https://www.plainlanguage.gov/guidelines/.
* 66. U.S. Food and Drug Administration, ``Preliminary Regulatory 
Impact Analysis: Food Labeling: Front-of-Package Nutrition 
Information (Proposed Rule).'' Accessed January 12, 2025. Available 
at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

List of Subjects in 21 CFR Part 101

    Food labeling, nutrition, reporting and record keeping 
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, FDA 
proposes to amend part 101 as follows:

PART 101--FOOD LABELING

0
1. The authority citation for part 101 is revised to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 343 note, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Amend Sec.  101.2 by:
0
a. Revising paragraph (b);
0
b. Revising paragraph (c)(1)(ii)(B)(1);
0
c. Adding paragraph (d)(2)(iv); and
0
d. Revising paragraph (f).
    The revisions and addition read as follows:


Sec.  101.2  Information panel of packaged food.

* * * * *
    (b) All information required to appear on the label of any packaged 
food under Sec. Sec.  101.4, 101.5, 101.6, 101.8, 101.9, 101.13, 
101.17, 101.36, subpart D of this part, and part 105 of this chapter 
must appear either on the principal display panel or on the information 
panel, unless otherwise specified by regulations in this chapter.
* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (B) * * *
    (1) Neither the bottle nor the closure is required to bear 
nutrition labeling in compliance with Sec.  101.9, except that any 
multiunit retail package in which it is contained must bear nutrition 
labeling if required by Sec.  101.9 and the Nutrition Info box if 
required by Sec.  101.6; and any vending machine in which it is 
contained must bear nutrition labeling if nutrition labeling is not 
present on the bottle or closure, if required by Sec.  101.9.
* * * * *

[[Page 5460]]

    (d) * * *
    (2) * * *
    (iv) The Nutrition Info box required by Sec.  101.6 is not required 
on the lid if this information appears on the container body in 
accordance with this section.
* * * * *
    (f) If the label of any package of food is too small to accommodate 
all of the information required by Sec. Sec.  101.4, 101.5, 101.6, 
101.8, 101.9, 101.13, 101.17, 101.36, subpart D of this part, and part 
105 of this chapter, the Commissioner may establish by regulation an 
acceptable alternative method of disseminating such information to the 
public, e.g., a type size smaller than one-sixteenth inch in height, or 
labeling attached to or inserted in the package or available at the 
point of purchase. A petition requesting such a regulation, as an 
amendment to this paragraph, must be submitted under part 10 of this 
chapter.
0
3. Add Sec.  101.6 to read as follows:


Sec.  101.6  Front-of-package Nutrition Info box.

    (a) General provisions--(1) Scope. All food covered under Sec.  
101.9 that is marketed for people ages 4 and older must bear the 
Nutrition Info box described in paragraphs (a)(2) through (4) of this 
section on its label, unless the product is subject to special labeling 
provisions under paragraph (b) of this section or exempt under 
paragraph (c) of this section.
    (2) Content. The Nutrition Info box must:
    (i) Contain the heading ``Nutrition Info,'' which must be across 
the top of the Nutrition Info box and in a larger type than all other 
words in the Nutrition Info box;
    (ii) Include two column subheadings under ``Nutrition Info'':
    (A) ``Per serving,'' which must be accompanied by a statement of 
the serving size expressed in household measures as described in Sec.  
101.9(b)(5) (e.g., ``Per serving (whole package)'' or ``Per serving 
(\1/2\ cup)''); and
    (B) ``% Daily Value'';
    (iii) Vertically list ``Saturated Fat,'' ``Sodium,'' and ``Added 
sugars,'' in that order, under the ``Per serving'' subheading as 
described in paragraph (a)(2)(ii)(A) of this section;
    (iv) Specify, under the ``% Daily Value'' subheading as described 
in paragraph (a)(2)(ii)(B) of this section and to the right of the 
quantitative percent Daily Value (% DV) declaration as described in 
paragraph (a)(2)(v) of this section, whether the amount of the nutrient 
per serving, expressed as % DV as established in Sec.  101.9(c)(9) and 
(d)(7)(ii), is ``Low,'' ``Med,'' or ``High.'' The ranges corresponding 
to ``Low,'' ``Med,'' and ``High'' are as follows:
    (A) Low: 5% DV or less.
    (B) Med: 6% to 19% DV.
    (C) High: 20% DV or more.
    (v) Declare the quantitative % DV for people ages 4 and older, as 
established in Sec.  101.9(c)(9) and (d)(7)(ii), in its own column 
immediately under the ``% Daily Value'' subheading as described in 
paragraph (a)(2)(ii)(B) of this section and to the left of the ``Low,'' 
``Med,'' and ``High'' categorization as described in paragraph 
(a)(2)(iv) of this section; and
    (vi) Include a banner at the bottom with an ``FDA.gov'' 
attribution.
    (3) Formatting. The Nutrition Info box must:
    (i) Appear on the upper third of the principal display panel, as 
defined in Sec.  101.1;
    (ii) Use a single, easy-to-read type style;
    (iii) Use a minimum type size (at least 8 point) that is no smaller 
than the size of the required net quantity of contents declaration, as 
specified in Sec.  101.7(h) and (i);
    (iv) Use all black or one color type for text and hairlines;
    (v) Use a white or other neutral contrasting background to the 
print in the box;
    (vi) Use hairlines to create the outer box;
    (vii) Use a thick, horizontal, centered, hairline rule the same 
distance across the box as the ``Nutrition Info'' heading as described 
in paragraph (a)(2)(i) of this section to distinguish the heading and 
subheadings as described in paragraphs (a)(2)(i) and (ii) of this 
section from the information underneath them;
    (viii) Use a horizontal, centered hairline rule the same distance 
across the box as the ``Nutrition Info'' heading as described in 
paragraph (a)(2)(i) of this section to distinguish each row of nutrient 
information as described in paragraph (a)(2)(iii) of this section;
    (ix) Use extra-bold type and center-justify the ``Nutrition Info'' 
heading as described in paragraph (a)(2)(i) of this section;
    (x) Left-justify the ``Per serving'' subheading as described in 
paragraph (a)(2)(ii)(A) of this section;
    (xi) Use extra-bold type and right-justify the ``% Daily Value'' 
subheading as described in paragraph (a)(2)(ii)(B) of this section;
    (xii) Use bold type and left-justify the nutrient names as 
described in paragraph (a)(2)(iii) of this section;
    (xiii) Use extra-bold type and right-justify the ``Low,'' ``Med,'' 
and ``High'' categorizations as described in paragraph (a)(2)(iv) of 
this section;
    (xiv) Right-justify, within its own column to the left of the 
``Low,'' ``Med,'' and ``High'' categorizations as described in 
paragraph (a)(2)(iv) of this section, the quantitative percent DV 
declarations as described in paragraph (a)(2)(v) of this section; and
    (xv) Use the same color as used for the text and hairlines as 
specified under paragraph (a)(3)(iv) of this section for the banner 
background, with ``FDA.gov'' right-justified, in bold or extra-bold 
type, and in the same color as used for the rest of the box's 
background as described in paragraph (a)(3)(v) of this section.
    (4) No other information allowed in the Nutrition Info box. No 
other information may be included in the Nutrition Info box.
    (5) Example. The following example label illustrates the provisions 
of paragraphs (a)(2) through (a)(4) of this section.

[[Page 5461]]

Figure 1 to Paragraph (a)(5)--Example Standard Nutrition Info Box
[GRAPHIC] [TIFF OMITTED] TP16JA25.013

    (b) Special labeling provisions. (1) Packaged foods that may use an 
aggregate display under Sec.  101.9(d)(13)(i) and (h)(2)(ii) must 
display a Nutrition Info box as described in paragraph (a) of this 
section for each different product the package contains or could 
contain.
    (i) The Nutrition Info boxes must appear together in either 
horizontal or vertical lines and must appear in the upper third of the 
principal display panel in accordance with Sec.  101.6(a)(3)(i).
    (ii) The package must specify the name of each food right-justified 
at the top of each food's Nutrition Info box, separated from the 
``Nutrition Info'' header by a horizontal, centered hairline rule.
    (iii) The following example label illustrates these requirements:

Figure 2 to Paragraph (b)(1)(iii)--Example Nutrition Info Box Modified 
for Aggregate Display
[GRAPHIC] [TIFF OMITTED] TP16JA25.014

    (2) Packaged foods that present Nutrition Facts labeling for two or 
more population groups must display a Nutrition Info box as described 
in paragraph (a) of this section, or Nutrition Info boxes as described 
in this paragraph (b)(2), that only reflect(s) the information for 
people ages 4 and older.
    (3) Packaged foods that present Nutrition Facts labeling for both 
``per serving'' and ``per individual unit'' in accordance with Sec.  
101.9(b)(2)(i)(D) must display a Nutrition Info box as described in 
paragraph (a) of this section that reflects the nutrition information 
``per serving.''
    (4) Packaged foods that present Nutrition Facts labeling for both 
``as packaged'' and ``as prepared'' forms of the food consistent with 
Sec.  101.9(e) must display a Nutrition Info box as described in 
paragraph (a) of this section that reflects the nutrition information 
for the ``as packaged'' form and must include a statement right-
justified at the top of the box and separated from the ``Nutrition 
Info'' header by a horizontal, centered hairline rule to clarify that 
the box represents ``as packaged'' nutrition information (e.g., 
``Represents product ``as packaged'' '' or ``See Nutrition Facts for 
``As Prepared'' information'').

[[Page 5462]]

Figure 3 to Paragraph (b)(4)--Example Nutrition Info Box Modified for 
``As Packaged''
[GRAPHIC] [TIFF OMITTED] TP16JA25.015

    (5) Foods in packages that have a total surface area available to 
bear labeling of 40 or fewer square inches may display an alternative 
(intermediate-package) Nutrition Info box as described in this 
paragraph.
    (i) The intermediate-package Nutrition Info box omits the following 
content from the Nutrition Info box described in paragraphs (a)(2) 
through (4) of this section:
    (A) The ``Per serving'' and ``% Daily Value'' subheadings; and
    (B) The quantitative percent DV declarations.
    (ii) The intermediate-package Nutrition Info box uses the 
abbreviations ``Sat. Fat'' for ``Saturated Fat'' and ``Add. Sugar'' for 
``Added Sugars.''
    (iii) The following example label illustrates the provisions of 
paragraphs (b)(6)(i) and (ii) of this section.

Figure 4 to Paragraph (b)(5)(iii)--Example Intermediate-Package 
Nutrition Info Box
[GRAPHIC] [TIFF OMITTED] TP16JA25.016

    (6) Foods sold from bulk containers must display a Nutrition Info 
box as described in paragraph (a) of this section plainly visible to 
consumers on the bulk container's labeling at the point of purchase.
    (7) Game meats (i.e., animal products not covered under the Federal 
Meat Inspection Act or the Poultry Products Inspection Act, such as 
flesh products from deer, bison, rabbit, quail, wild turkey, or 
ostrich) must display a Nutrition Info box as described in paragraph 
(a) of this section:
    (i) That reflects how the nutrition information is shown under 
Sec.  101.9; and
    (ii) Is plainly visible to consumers at the point of purchase if 
the food is unpackaged.
    (c) Exemptions. The following foods are exempt from the 
requirements in this section:
    (1) Any food exempt from Sec.  101.9 under Sec.  101.9(j), unless 
otherwise stated in this section;
    (2) Foods in small packages that have a total surface area 
available to bear labeling of less than 12 square inches;
    (3) Packages marketed as gifts that contain a variety or assortment 
of foods; and
    (4) The unit containers in a multiunit retail food package where:
    (i) The unit containers are exempt from Nutrition Facts labeling in 
accordance with Sec.  101.9(j)(15); and
    (ii) The multiunit retail food package label bears the Nutrition 
Info box in accordance with this section.
    (d) Preemption. A State or political subdivision of a State may not 
establish or continue into effect any law, rule, regulation, or other 
requirement that is different from the requirements in this section for 
the Nutrition Info box.
0
4. Amend Sec.  101.13 by revising paragraphs (c), (i) introductory 
text, and (n) to read as follows:


Sec.  101.13  Nutrient content claims--general principles.

* * * * *
    (c) Information that is required or permitted by Sec.  101.9 or 
Sec.  101.36 as applicable, to be declared in nutrition labeling, and 
that appears as part of the nutrition label, or that is required by 
Sec.  101.6, is not a nutrient content claim and is not subject to the 
requirements of this section. If such information is declared elsewhere 
on the label or in labeling, it is a nutrient content claim and is 
subject to the requirements for nutrient content claims.
* * * * *
    (i) Except as provided in Sec.  101.6, Sec.  101.9, or Sec.  
101.36, as applicable, or in

[[Page 5463]]

paragraph (q)(3) of this section, the label or labeling of a product 
may contain a statement about the amount or percentage of a nutrient 
if:
* * * * *
    (n) Nutrition labeling in accordance with Sec.  101.6, Sec.  101.9, 
Sec.  101.10, or Sec.  101.36, as applicable, must be provided for any 
food for which a nutrient content claim is made.
* * * * *
0
5. Amend Sec.  101.15 by revising paragraph (c)(2) to read as follows:


Sec.  101.15  Food; prominence of required statements.

* * * * *
    (c) * * *
    (2) If the label contains any representation in a foreign language, 
all words, statements, and other information required by or under 
authority of the act to appear on the label must appear thereon in the 
foreign language, except for labeling in accordance with Sec.  101.6: 
Provided, however, That individual serving-size packages of foods 
containing no more than 1\1/2\ avoirdupois ounces or no more than 1\1/
2\ fluid ounces served with meals in restaurants, institutions, and 
passenger carriers and not intended for sale at retail are exempt from 
the requirements of this paragraph (c)(2), if the only representation 
in the foreign language(s) is the name of the food.
* * * * *
0
6. Amend Sec.  101.61 by:
0
a. Revising paragraphs (a)(3) and (b)(4)(i);
0
b. Redesignating paragraph (b)(4)(ii) as (b)(4)(iii) and revising it;
0
c. Adding new paragraph (b)(4)(ii);
0
d. Revising paragraph (b)(5)(i);
0
e. Redesignating paragraph (b)(5)(ii) as (b)(5)(iii) and revising it; 
and
0
f. Adding new paragraph (b)(5)(ii).
    The revisions and additions read as follows:


Sec.  101.61  Nutrient content claims for the sodium content of foods.

    (a) * * *
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.6, Sec.  101.9, Sec.  101.10, or Sec.  101.36, as 
applicable.
    (b) * * *
    (4) * * *
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and contains 115 mg or less 
sodium per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and contains 115 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
foods that must be reconstituted before typical consumption with water 
or a diluent containing an insignificant amount, as defined in Sec.  
101.9(f)(1), of all nutrients per reference amount customarily 
consumed, the per 50-g criterion refers to the ``as prepared'' form);
    (ii) The food must display ``Low'' in accordance with Sec.  101.6 
for sodium in the front-of-package Nutrition Info box, if the food 
label or labeling must comply with the requirements in Sec.  101.6; and
    (iii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to vary 
the sodium content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which the label attaches 
(e.g., ``fresh spinach, a low sodium food'').
    (5) * * *
    (i) The product contains 115 mg or less sodium per 100 g;
    (ii) The product must display ``Low'' in accordance with Sec.  
101.6 for sodium in the front-of-package Nutrition Info box, if the 
food label or labeling must comply with the requirements in Sec.  
101.6; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, reformulation to lower the 
sodium content, it is labeled to clearly refer to all foods of its type 
and not merely to the particular brand to which the label attaches.
* * * * *
0
7. Amend Sec.  101.62 by:
0
a. Revising paragraphs (a)(3) and (c)(2)(i);
0
b. Redesignating paragraph (c)(2)(ii) as paragraph (c)(2)(iii) and 
revising it;
0
c. Adding new paragraph (c)(2)(ii);
0
d. Revising paragraph (c)(3)(i);
0
e. Redesignating paragraph (c)(3)(ii) as paragraph (c)(3)(iii); and
0
f. Adding new paragraph (c)(3)(ii).
    The revisions and additions read as follows:


Sec.  101.62  Nutrient content claims for fat, fatty acid, and 
cholesterol content of foods.

    (a) * * *
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.6, Sec.  101.9, Sec.  101.10, or Sec.  101.36, as 
applicable; and
* * * * *
    (c) * * *
    (2) * * *
    (i) The food contains 1 g or less of saturated fatty acids per 
reference amount customarily consumed and not more than 15 percent of 
calories from saturated fatty acids;
    (ii) The food must display ``Low'' in accordance with Sec.  101.6 
for saturated fat in the front-of-package Nutrition Info box, if the 
food label or labeling must comply with the requirements in Sec.  
101.6; and
    (iii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all foods of 
its type and not merely to the particular brand to which the label 
attaches (e.g., ``raspberries, a low saturated fat food'').
    (3) * * *
    (i) The product contains 1 g or less of saturated fatty acids per 
100 g and less than 10 percent of calories from saturated fat;
    (ii) The product must display ``Low'' in accordance with Sec.  
101.6 for saturated fat in the front-of-package Nutrition Info box, if 
the food label or labeling must comply with the requirements in Sec.  
101.6; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all foods of 
its type and not merely to the particular brand to which the label 
attaches.
* * * * *
0
8. Amend Sec.  101.65 by revising paragraph (a)(3) to read as follows:


Sec.  101.65  Implied nutrient content claims and related label 
statements.

    (a) * * *
    (3) The food or which the claim is made is labeled in accordance 
with Sec.  101.6, Sec.  101.9, Sec.  101.10, or Sec.  101.36, as 
applicable.
* * * * *

    Dated: January 10, 2025.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2025-00778 Filed 1-14-25; 8:45 am]
BILLING CODE 4164-01-P`