[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
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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.
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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
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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.
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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.
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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.
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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.
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Effects on wages.
Effects on growth.
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II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation/acronym What it means
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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.
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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
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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
[[Page 5442]]
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
[[Page 5446]]
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
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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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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.
* * * * *
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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