5426 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

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. 

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: Frontof-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 collectionrelated 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS5
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 5427 

With regard to the information 

collection: JonnaLynn Capezzuto, Office 

of Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

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 § 101.6 

E. Severability 

V. Description of the Proposed Rule 

A. Scope/Applicability (Proposed 

§ 101.6(a)(1)) 

B. Content (Proposed § 101.6(a)(2)) 

C. Format (Proposed § 101.6(a)(3)) 

D. No Other Information Allowed in the 

Nutrition Info Box (Proposed 

§ 101.6(a)(4)) 

E. Special Labeling Provisions (Proposed 

§ 101.6(b)) 

F. Exemptions (Proposed § 101.6(c)) 

G. Low Sodium and Low Saturated Fat 

Nutrient Content Claims (Revised 

§§ 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: 

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 withinlabel 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 


ddrumheller on DSK120RN23PROD with PROPOSALS5EP16JA25.005</GPH>

Nutrition Info 

Per serving o/o Dally 

5 cookies Value 

Saturated Fat 25% High 

Sodium 5% Low 

Added Sugars 10% Med 

FDA.gov 
5428 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

• 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] 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Dollar 

year 

Discount 

rate 

(%) 

Time 

horizon Notes 

Benefits: 

Annualized monetized benefits. 

Annualized quantified, but 

non-monetized, benefits. 

Unquantified benefits. .......... The benefits of this proposed rule would come from the value consumers receive from the information provided in the interpretive 

label on food packages. 

Costs: 

Annualized monetized costs. $333 $191 $530 2023 2 2025–2034 Although reformulation is not a requirement or 

goal of the proposed rule, reformulation costs 

are estimated to be 68% of total quantified 

costs. Costs may, at least partially, be passed 

through to consumers in the form of price increases. 

Annualized quantified, but 

non-monetized, costs. 

Unquantified costs. 

Transfers: 

Annualized monetized Federal budgetary transfers. 

Other annualized monetized 

transfers. 

Net Benefits: 

Annualized monetized net 

benefits.

Category Effects Notes 

Effects on State, local, or Tribal 

governments. 

Effects on small businesses ....... The total discounted cost of the proposed rule per entity (including large firms) is approximately $100,253. We cannot estimate the 

exact cost per small entity because we do not know how many UPCs on average are owned by small entities as defined using the 

SBA definition. 

Effects on wages. 

Effects on growth. 


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Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 5429 

II. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

Abbreviation/acronym What it means 

Dietary Guidelines ............................................... Dietary Guidelines for Americans. 

Dietary Guidelines, 2020–2025 ........................... Dietary Guidelines for Americans, 2020–2025. 

DRV ..................................................................... Daily Reference Value. 

DV ....................................................................... Daily Value. 

FDA ..................................................................... Food and Drug Administration. 

FD&C Act ............................................................ Federal Food, Drug, and Cosmetic Act. 

FOP ..................................................................... Front-of-package. 

G .......................................................................... Gram(s). 

GDA ..................................................................... Guideline Daily Amount. 

HHS ..................................................................... U.S. Department of Health and Human Services. 

IOM ...................................................................... Institute of Medicine (now NASEM). 

Med ..................................................................... Medium. 

Mg ....................................................................... Milligram(s). 

NASEM ................................................................ National Academies of Sciences, Engineering, and Medicine.

NLEA ................................................................... Nutrition Labeling and Education Act of 1990. 

OMB .................................................................... Office of Management and Budget. 

PRIA .................................................................... Preliminary Regulatory Impact Analysis. 

RACC .................................................................. Reference Amount Customarily Consumed. 

RDI ...................................................................... Reference Daily Intake. 

III. Background 

The United States faces a growing 

prevalence of preventable diet-related 

chronic diseases and conditions (for 

purposes of this document, we use the 

term ‘‘diseases’’ to cover both diseases 

and conditions), which can include 

hypertension, cardiovascular disease, 

type 2 diabetes, and certain forms of 

cancer. These diseases are leading 

causes of death and disability in the 

United States (Ref. 1). Data show that 

about one in 10 Americans has diabetes, 

and 90 to 95 percent of those have type 

2 diabetes (Ref. 2); at least one in three 

people will have cancer in their lifetime 

(Ref. 3); and nearly half of American 

adults have high blood pressure, which 

is linked to leading causes of death for 

Americans: heart disease and stroke 

(Refs. 4 and 5). While these diseases can 

result from a mix of risk factors, such as 

genetic, biological, behavioral, 

socioeconomic, and environmental 

factors, unhealthy dietary patterns 

increase the risk of developing chronic 

diseases (Ref. 6). Diet-related chronic 

diseases are experienced 

disproportionately by certain racial and 

ethnic populations and those with lower 

socioeconomic status (Refs. 7 to 12). 

The Dietary Guidelines for Americans, 

2020–2025 (Dietary Guidelines, 2020– 

2025) recommends, among other things, 

that Americans limit their intake of 

saturated fat, sodium, and added sugars 

to achieve healthy dietary patterns (Ref. 

6). Under the National Nutrition 

Monitoring and Related Research Act of 

1990 (Pub. L. 101–445, 104 Stat. 1034), 

the U.S. Department of Agriculture and 

the U.S. Department of Health and 

Human Services (HHS) must publish the 

Dietary Guidelines for Americans 

(Dietary Guidelines) at least every 5 

years and must base them on the 

preponderance of the current scientific 

and medical knowledge. Development 

of the Dietary Guidelines entails a 

rigorous process and includes 

appointment of a federal advisory 

committee of external scientific experts, 

review of the scientific evidence by the 

committee, public meetings, issuance of 

a scientific report by the advisory 

committee, and a public comment 

process (Ref. 13). With those 

requirements and practices in place, the 

Dietary Guidelines, 2020–2025 

concludes that healthy dietary patterns 

are based on, among other things, 

‘‘consuming foods and beverages in 

their nutrient-dense forms—forms with 

the least amounts of added sugars, 

saturated fat, and sodium’’ (Ref. 6). 

FDA, as part of a whole-ofgovernment 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 (§ 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 


ddrumheller on DSK120RN23PROD with PROPOSALS5
5430 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

§ 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, nonselective 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. 


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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-tounderstand, 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 largescale literature reviews on FOP 

nutrition labels have been conducted. 

As mentioned elsewhere in this 

document, the IOM conducted a twophase 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 


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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 webbased 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 


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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: 


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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 § 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. 


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Nutrition Info 

Per serving %Daily 

5 cookies Value 

Saturated Fat 25% High 

Sodium 5% Low 

Added Sugars 10% Med 

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


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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., §§ 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 § 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 


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33742 at 33874 and § 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 

§ 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 § 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 


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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 

§ 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 § 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 § 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 § 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: 


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We also propose two overall 

amendments to certain nutrient content 

claims: (1) revising § 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 §§ 101.61 and 

101.62 specifying that food subject to 

this rule must bear ‘‘Low’’ in accordance 

with proposed § 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 

§ 101.6(a)(1)) 

Proposed § 101.6(a)(1) would require 

that this rule apply to all food covered 

under § 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 § 101.9 details these 

requirements. Most foods we regulate 

(i.e., all foods not specified in § 101.9(j)) 

must bear a Nutrition Facts label as 

described in § 101.9 (see § 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 

§ 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 § 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 


ddrumheller on DSK120RN23PROD with PROPOSALS5EP16JA25.007</GPH>

Nutrition Info 

Per serving 

5 cookies 

Saturated Fat 

%Daily 

Value 

25% High 

Sodium 5% Low 

Added Sugars 10% Med 

FDA.gov 
5440 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

§ 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 § 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 § 101.36 

are exempt from Nutrition Facts labeling 

under § 101.9(j)(6) and would therefore 

be exempt from Nutrition Info box 

labeling under proposed § 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 § 101.6(a)(2)) 

1. Headings and Subheadings (Proposed 

§ 101.6(a)(2)(i) and (ii)) 

Proposed § 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 

§ 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 § 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 

§ 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 § 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 § 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS5
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 5441 

Proposed § 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 § 101.9(d)(6)). 

2. Nutrients to Limit (Proposed 

§ 101.6(a)(2)(iii)) 

Proposed § 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 nutrientdense 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 dietrelated 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 industrybased, 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 healthrelated 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 § 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 


ddrumheller on DSK120RN23PROD with PROPOSALS5
5442 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

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 § 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 § 101.13(i)(3)). Our 

proposal would not change that. 

Examples of what such labeling might 

look like are as follows: 

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 

§ 101.6(a)(2)(iv)) 

Proposed § 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 

§ 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS5EP16JA25.008</GPH> EP16JA25.009</GPH>

Nutrition Info 

Per serving %Daily 450 

1 container Value CALORIES 

Saturated Fat 18% Med 

Sodium 37% High 

Added Sugars 5% Low 

FDA.gov 

Nutrition Info 

Per serving %Daily 

5 cookies Value 

Saturated Fat 25% High 

Sodium 5% Low 

Added Sugars 10% Med 

FDA.gov 

l 450 Calories I 
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 5443 

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 publicfacing 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 

(§ 101.62(c)(2) and (3)) and low sodium 

(§ 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 


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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 nutrientdense 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/foodlabeling-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 

§ 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 

(§ 101.54(b)(1)) for nutrients having 

either an RDI established in 

§ 101.9(c)(8)(iv) or a DRV established in 

§ 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 § 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 (§ 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 § 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.’’ 


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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 

(§ 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 § 101.6(a)(2)(v)) 

Proposed § 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 § 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 § 101.6(a)(2)(vi)) 

Proposed § 101.6(a)(2)(vi) would 

require the inclusion of a banner at the 

bottom of the Nutrition Info box that 

includes an ‘‘FDA.gov’’ attribution 

statement. Several studies on FOP 

nutrition labeling found that inclusion 

of an attribution for the FOP nutrition 

label increases consumers’ trust in and 

the credibility of the information. For 

example, in their experimental study to 

test variations of a ‘‘High In’’ FOP 

nutrition label, Canadian researchers 

found that the presence of a Health 

Canada attribution resulted in higher 

trust in and credibility of the FOP 

nutrition symbol (Ref. 51). Almost all 

participants who saw the FOP nutrition 

symbol with the Health Canada 

attribution found it helpful to include 

because it engendered trust in the FOP 

nutrition symbol, drew their attention to 

the FOP nutrition symbol, and made the 

FOP nutrition symbol look more official 

(id.). Other studies found that 

government attribution or endorsement 

by health organizations increased the 

believability and credibility of the label 

(Refs. 52 to 54). In our first set of focus 

groups, participants expressed mixed 


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reactions to the inclusion of an 

attribution statement (Ref. 37). However, 

most participants viewed ‘‘FDA.gov’’ as 

making the scheme credible and 

trustworthy (Ref. 44). Informed by the 

literature findings, as well as this 

feedback, we propose to include the 

attribution statement ‘‘FDA.gov’’ in the 

Nutrition Info box to indicate that the 

proposed Nutrition Info box appears as 

required by FDA and to signal to 

consumers where they can find 

additional information regarding the 

Nutrition Info box, nutrition 

information, and our nutrition labeling 

requirements. 

C. Format (Proposed § 101.6(a)(3)) 

Proposed § 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 § 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 § 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 § 101.7(f)). 

Proposed § 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 § 101.6(a)(3)(ii)) 

Proposed § 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, easyto-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 § 101.9(d)(1)(ii)(A)). Similarly, we 

use Helvetica in our example proposed 

Nutrition Info box (see proposed 

§ 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 § 101.6(a)(3)(iii)) 

Proposed § 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 § 101.7(h) and 


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(i). Our existing food labeling 

regulations for packaged foods, at 

§ 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 

(§ 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 

§ 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 

§ 101.6(a)(3)(iv)), Background Color 

(Proposed § 101.6(a)(3)(v)), and 

Attribution Banner Color (Proposed 

§ 101.6(a)(3)(xv)) 

Proposed § 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 

§ 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 

§ 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’’ rightjustified in the banner. That would 

provide consistency among all Nutrition 

Info boxes and signal that the Nutrition 

Info box is an FDA requirement, while 


ddrumheller on DSK120RN23PROD with PROPOSALS5
5448 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

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 

§ 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 § 101.6(a)(3)(vi), 

(vii), and (viii)) 

Consistent with the Nutrition Facts 

label design, proposed § 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 § 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 § 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 

§ 101.6(a)(3)(ix), (xi), (xii), and (xiii)) 

Proposed § 101.6(a)(3)(ix), (xi), and 

(xiii) would require the use of extra-bold 

type print and proposed 

§ 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 

§ 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 

§ 101.6(a)(3)(xi) and (xiii), respectively). 

Additionally, bold nutrient names 

would call attention to each nutrient 

separately (see proposed 

§ 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 § 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 

§ 101.6(a)(3)(ix) through (xv)) 

Proposed § 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 

§ 101.6(a)(3)(x) and (xii) would require 

left justification for the ‘‘Per serving’’ 

subheading and the nutrient names, 

respectively. Proposed § 101.6(a)(3)(xi) 

and (xiii) would require right 

justification for the ‘‘% Daily Value’’ 

subheading and the interpretive 

descriptions, respectively, and proposed 

§ 101.6(a)(3)(xv) would require right 

justification for ‘‘FDA.gov’’ in the 

bottom banner. Proposed 

§ 101.6(a)(3)(vi) would require center 

justification for the ‘‘Nutrition Info’’ 

heading. Proposed § 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 rightjustifying 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). Rightjustifying ‘‘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 


ddrumheller on DSK120RN23PROD with PROPOSALS5
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 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 

§ 101.6(a)(4)) 

Proposed § 101.6(a)(4) would prohibit 

any information in the Nutrition Info 

box other than what proposed § 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 

§ 101.6(b)) 

Proposed § 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 § 101.6(a)(2) 

through (4). 

1. Packaged Foods That May Use an 

Aggregate Display in Accordance With 

§ 101.9(d)(13)(i) (Proposed § 101.6(b)(1)) 

Our regulations, at § 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 § 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 

§ 101.6(b)(1)(iii)): 

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 decisionmaking, 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 § 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 

§ 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 § 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS5EP16JA25.010</GPH>

Mixed Grain Flakes 

Wheat Squares Sweetened Corn Flakes Not Sweetened Sweetened 

Nutrition Info Nutrition Info Nutrition Info 

Per serving %Dally Per serving %Dally Per serving o/oDally 

1 cup Value 1 112 cup Value 1 cup Value 

Saturated Fat 0% Low Saturated Fat 0%, Low Saturated Fat 0% Low 

Sodium 0% Low Sodium 13% Med Sodium 7% Med 

Added Sugars 22% High Added Sugars 6'%, Med Added Sugars 10% Med 

FDA.gov FDA.gov FDA.gov 
5450 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

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. Rightjustification 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 § 101.9(e) (Proposed § 101.6(b)(2)) 

Our regulations, at § 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 § 101.9(e)(5). 

Proposed § 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 

§ 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 § 101.9(b)(2)(i)(D) 

(Proposed § 101.6(b)(3)) 

Our regulations, at § 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 

§ 101.9(b)(2)(i)(D)). This is another 

example of dual-column labeling (see 

§ 101.9(e)(5)). 

Proposed § 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 § 101.9(e) 

(Proposed § 101.6(b)(4)) 

Our regulations, at § 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 § 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 § 101.9(e)(5)). 

Proposed § 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 decisionmaking, 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, rightjustification 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 § 101.6(b)(4)): 


ddrumheller on DSK120RN23PROD with PROPOSALS5EP16JA25.011</GPH>

As packaged 

Nutrition Info 

Per serving % Daily 

1 /4 package mix Value 

Saturated Fat 8% Med 

Sodium 5% Low 

Added Sugars 34% High 

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

§ 101.6(b)(5)) 

Our regulations, at 

§ 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 § 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 

§ 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 § 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: 

We considered whether to propose 

allowing the use of the intermediatepackage Nutrition Info box only when a 

package uses the tabular or linear 

Nutrition Facts label format as specified 

in § 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 

§ 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 § 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 intermediatepackage 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 intermediatepackage Nutrition Info box, we are 


ddrumheller on DSK120RN23PROD with PROPOSALS5EP16JA25.012</GPH>

Nutrition Info 

Sat. Fat Med 

Sodium High 

Add. Sugar Low 

FDA.gov 
5452 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

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 § 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 

§ 101.9(j)(13)(ii)(B)). An abbreviation for 

added sugars would also help sizing 

considerations for the intermediatesized packages, while still providing the 

information to consumers. 

6. Foods Sold From Bulk Containers 

(Proposed § 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 (§ 101.9(j)(16)), clearly at 

the point of purchase (§ 101.9(a)(2)), or 

available in another format consistent 

with § 101.9(a)(2) (such as in a booklet 

at the point of purchase). Proposed 

§ 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 

§ 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 § 101.6(b)(7)) 

Our regulations, at § 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 § 101.6(b)(7)(i) would 

require game meats to display a 

Nutrition Info box that reflects how the 

nutrition information is presented under 

§ 101.9. If the Nutrition Facts label for 

a game meat presents nutrition 

information as packaged as required 

under § 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 § 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 

§ 101.9(j)(12), also allow the Nutrition 

Facts label for game meats not in 

packages to appear clearly at the point 

of purchase (§ 101.9(a)(2)) or available 

in another format consistent with 

§ 101.9(a)(2) (such as in a booklet at the 

point of purchase) if it does not appear 

on the label. Proposed § 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 

§ 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 

§ 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 § 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 § 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 § 101.6(c)) 

Proposed § 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 § 101.9 Under 

§ 101.9(j), Unless Otherwise Stated in 

This Section (Proposed § 101.6(c)(1)) 

Our regulations, at § 101.9(j), exempt 

certain foods, such as raw fruits and 

vegetables, from bearing a Nutrition 

Facts label. Proposed § 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 § 101.9(j) do not 

have to bear (which, in turn, means that 

industry would not need to calculate the 


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percent DVs). Any proposal to change 

the exemptions in § 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 § 101.9(j) also includes 

foods subject to special labeling 

requirements. We propose that only 

foods exempt under § 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 § 101.6(c)(2)) 

Our regulations, at § 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 § 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 § 101.6(c)(3)) 

Our regulations, at § 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 

(§ 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 § 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 § 101.6(c)(4)) 

Our regulations, at § 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 § 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 § 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 § 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 § 101.9(j)(15); and the 

multiunit retail food package bears the 

Nutrition Info box in accordance with 

§ 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 § 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 

(§ 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 

§ 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 


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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 

§§ 101.61(b)(4) and (5) and 101.62(c)(2) 

and (3)) 

We are proposing to revise 

§ 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 

§ 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 

§§ 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 § 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 § 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 § 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 

§ 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 § 101.6 

would not be a nutrient content claim). 

We recognize that our regulations, at 

§ 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, § 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 § 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 § 101.13(c) to be 

nutrient content claims, unless an 

exception applies under § 101.13. For 

example, under § 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 § 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 § 101.6 to 

§ 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, 

§ 101.6). 

• Section 101.62: Nutrient content 

claims for fat, fatty acid, and cholesterol 

content of foods (proposing to add 

§ 101.6 to § 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, § 101.6). 

• Section 101.65: Implied nutrient 

content claims and related label 

statements (proposing to add § 101.6 to 

§ 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, 

§ 101.6). 

J. Technical Amendments 

We propose certain technical 

amendments in §§ 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 


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‘‘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 § 101.2(b), 

(c)(1)(ii)(B)(1), and (f); § 101.13(n); and 

§ 101.15(c)(2). Specifically, the

proposed rule would:

• Revise the title of § 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

§ 101.2(b), (c)(1)(ii)(B)(1), and (f);

§ 101.13(n); and § 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/ 


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economics-staff/regulatory-impactanalyses-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 § 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

Activity; 21 CFR section Number of 

respondents 

Number of 

disclosures per 

respondent 2

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours Total capital 

costs 3

Front of Package Labeling; 101.6 ........... 30,413 11 322,378 4 1,289,512 $143,220,186 

1There are no operating and maintenance costs associated with this collection of information. 

2For 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. 3One-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 × 

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 × 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 


ddrumheller on DSK120RN23PROD with PROPOSALS5
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 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 

§ 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. 

* 1. Xu, J., S.L. Murphy, K.D. Kochanek, et al. 

‘‘Mortality in the United States, 2021.’’ 

NCHS Data Brief, No. 456. Hyattsville, 

MD: National Center for Health 

Statistics. 2022. Accessed January 12, 

2025. Available at https://dx.doi.org/ 

10.15620/cdc:122516. 

* 2. Centers for Disease Control and 

Prevention. ‘‘Type 2 Diabetes.’’ CDC.gov. 

Accessed January 13, 2025. https://

www.cdc.gov/diabetes/about/about-type2-diabetes.html?CDC_AAref_Val=https://

www.cdc.gov/diabetes/basics/ 

type2.html. 

* 3. Centers for Disease Control and 

Prevention. ‘‘Cancer Characteristics, 

Definitions, and Recent Investigations.’’ 

CDC.gov. Accessed January 12, 2025. 

Available at https://www.cdc.gov/cancerenvironment/php/guidelines/ 

characteristics.html?CDC_AAref_

Val=https://www.cdc.gov/nceh/cancerenvironment/guidelines/cancercharacteristics.html. 

* 4. Centers for Disease Control and 

Prevention. ‘‘High Blood Pressure Facts.’’ 

CDC.gov. Accessed January 12, 2025. 

https://www.cdc.gov/high-bloodpressure/data-research/facts-stats/?CDC_

AAref_Val=https://www.cdc.gov/ 

bloodpressure/facts.htm. 

* 5. National Center for Health Statistics. 

‘‘Multiple Cause of Death 2018–2022 on 

CDC WONDER Database.’’ Accessed 

January 10, 2025. Available at https://

wonder.cdc.gov/mcd.html. 

* 6. U.S. Department of Agriculture and U.S. 

Department of Health and Human 

Services. Dietary Guidelines for 

Americans, 2020–2025. 9th ed. 2020. 

Accessed January 12, 2025. Available at 

https://www.dietaryguidelines.gov/sites/ 

default/files/2020-12/Dietary_

Guidelines_for_Americans_2020- 

2025.pdf. 

7. Kirkpatrick, S.I., K.W. Dodd, J. Reedy, et 

al. ‘‘Income and Race/Ethnicity Are 

Associated with Adherence to FoodBased Dietary Guidance Among U.S. 

Adults and Children.’’ Journal of the 

Academy of Nutrition and Dietetics, 

112(5):624–635.e6, 2012. Accessed 

January 12, 2025. Available at https://

doi.org/10.1016/j.jand.2011.11.012. 

* 8. Zhang, F.F., F. Cudhea, Z. Shan, et al. 

‘‘Preventable Cancer Burden Associated 

with Poor Diet in the United States.’’ 

Journal of the National Cancer Institute 

Cancer Spectrum, 3(2): pkz034, 2019. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1093/jncics/pkz034. 

9. Micha, R., J.L. Pen ̃ alvo, F. Cudhea, et al. 

‘‘Association Between Dietary Factors 

and Mortality From Heart Disease, 

Stroke, and Type 2 Diabetes in the 

United States.’’ Journal of the American 

Medical Association, 317(9):912–914, 

2017. Accessed January 12, 2025. 

Available at https://doi.org/10.1001/ 

jama.2017.0947. 

10. Ogden, C.L., C.D. Fryar, C.B. Martin, et 

al. ‘‘Trends in Obesity Prevalence by 

Race and Hispanic Origin—1999–2000 to 

2017–2018.’’ Journal of the American 

Medical Association, 324(12):1208–1210, 

2020. Accessed January 12, 2025. 

Available at https://doi.org/10.1001/ 

jama.2020.14590. 

*11. Centers for Disease Control and 

Prevention. ‘‘National Diabetes Statistics 

Report.’’ CDC.gov. Accessed January 12, 

2025. Available at https://www.cdc.gov/ 

diabetes/php/data-research/ 


ddrumheller on DSK120RN23PROD with PROPOSALS5
5458 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

?CDC_AAref_Val=https://www.cdc.gov/ 

diabetes/data/statistics-report/ 

index.html. 

* 12. Stierman, B., J. Afful, M.D. Carroll, et 

al.. ‘‘National Health and Nutrition 

Examination Survey 2017-March 2020 

Prepandemic Data Files-Development of 

Files and Prevalence Estimates for 

Selected Health Outcomes.’’ National 

Health Statistics Reports, No. 158, 2021. 

Accessed January 12, 2025. Available at 

https://www.cdc.gov/nchs/data/nhsr/ 

nhsr158-508.pdf. 

* 13. U.S. Department of Agriculture and U.S. 

Department of Health and Human 

Services. ‘‘Dietary Guidelines for 

Americans: Approaches to Examine the 

Science.’’ Dietaryguidelines.gov. 

Accessed January 12, 2025. Available at 

https://www.dietaryguidelines.gov/ 

about-dietary-guidelines/approachesexamine-science. 

* 14. U.S. Food and Drug Administration. 

‘‘FSANS: FDA’s Food Safety and 

Nutrition Information, 2019 Survey.’’ 

March 2021. Accessed January 12, 2025. 

Available at https://www.fda.gov/media/ 

146532/download?attachment. 

15. Christoph, M.J., N. Larson, M.N. Laska, et 

al. ‘‘Nutrition Facts Panels: Who Uses 

Them, What Do They Use, and How 

Does Use Relate to Dietary Intake?’’ 

Journal of the Academy of Nutrition and 

Dietetics, 118(2):217–228, 2018. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1016/ 

j.jand.2017.10.014. 

* 16. Storz, M.A. ‘‘Nutrition Facts Labels: 

Who is Actually Reading Them and Does 

it Help in Meeting Intake 

Recommendations for Nutrients of 

Public Health Concern?’’ BMC Public 

Health, 23(1), 1947, 2023. Accessed 

January 12, 2025. Available at https://

doi.org/10.1186/s12889-023-16859-2. 

17. Ollberding, N.J., R.L. Wolf, and I. 

Contento. ‘‘Food Label Use and Its 

Relation to Dietary Intake Among US 

Adults.’’ Journal of the American 

Dietetic Association, 110(8):1233–1237, 

2010. Accessed December 23, 2024. 

Available at https://dx.doi.org/10.1016/ 

j.jada.2010.05.007. 

18. Campos, S., J. Doxey, and D. Hammond. 

‘‘Nutrition Labels on Pre-Packaged 

Foods: A Systematic Review.’’ Public 

Health Nutrition, 14(8):1496–1506, 2011. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1017/ 

s1368980010003290. 

19. Kim, E.J., B. Ellison, M.P. Prescott, et al. 

‘‘Consumer Comprehension of the 

Nutrition Facts Label: A Comparison of 

the Original and Updated Labels.’’ 

American Journal of Health Promotion, 

35(5):648–657, 2021. Accessed January 

12, 2025. Available at https://doi.org/ 

10.1177/0890117120983128. 

* 20. U.S. Food and Drug Administration. 

‘‘Front of Package Labeling Literature 

Review.’’ 2023. 

* 21. U.S. Food and Drug Administration 

Memorandum, ‘‘Consumer Reactions to 

Front-of-Package (FOP) Nutrition 

Labeling Schemes on Foods Versus 

Beverages—2023 Focus Group 

Findings.’’ HHS, FDA, Center for Food 

Safety and Applied Nutrition. Prepared 

by L. Verrill, J. Behm, F. Wu, and K. 

Meadows, 2024. 

* 22. U.S. Food and Drug Administration. 

Letter of Enforcement Discretion to 

GMA/FMI re ‘‘Facts Up Front.’’ January 

12, 2025. Accessed December 23, 2024. 

Available at https://www.fda.gov/food/ 

food-labeling-nutrition/letterenforcement-discretion-gmafmi-re-factsfront. 

* 23. Consumer Brands Association. ‘‘Facts 

Up Front.’’ 

Consumerbrandsassociation.org. 

Accessed January 12, 2025. Available at 

https://www.factsupfront.org/. 

* 24. U.S. Congress. House. House 

Appropriations Committee. H.R. 1105, 

Omnibus Appropriations Act, 2009: 

Division F—Departments of Labor, 

Health and Human Services, and 

Education, and Related Agencies 

Appropriations Act, 2009. Explanatory 

Statement Submitted by Mr. Obey, 

Chairman of the House Committee on 

Appropriations, Regarding H.R. 1105, 

Omnibus Appropriations Act, 2009. 

111th Cong., XX sess., 2009. p. 1398. 

Accessed January 12, 2025. Available at 

https://www.gpo.gov/fdsys/pkg/CPRT111JPRT47494/pdf/CPRT111JPRT47494-DivisionF.pdf. 

* 25. U.S. Congress. House. Departments of 

Transportation and Housing and Urban 

Development and Related Agencies 

Appropriations Act, 2010 (H.R. 3288). 

House Report Number 111–366, 

Conference Report to accompany H.R. 

3288. 111th Cong., 1st sess., December 8, 

2009. P. 1021. Accessed December 23, 

2024. Available at https://www.gpo.gov/ 

fdsys/pkg/CRPT-111hrpt366/pdf/CRPT111hrpt366.pdf. 

26. Institute of Medicine. ‘‘Front-of-Package 

Nutrition Rating Systems and Symbols: 

Phase I Report.’’ Washington, DC: The 

National Academies Press, 2010. 

Accessed January 12, 2025. Available at 

https://doi.org/10.17226/12957. 

27. Institute of Medicine. ‘‘Front-of-Package 

Nutrition Rating Systems and Symbols: 

Promoting Healthier Choices.’’ 

Washington, DC: The National 

Academies Press, 2012. Accessed 

January 12, 2025. Available at https://

doi.org/10.17226/13221. 

28. Hersey, J.C., K.C. Wohigenant, J.E. 

Arsenault, et al. ‘‘Effects of Front-ofPackage and Shelf Nutrition Labeling 

Systems on Consumers.’’ Nutrition 

Reviews, 71(1),1–14, 2013. Accessed 

January 12, 2025. Available at https://

doi.org/10.1111/nure.12000. 

29. Research Triangle Institute. ‘‘Addendum 

to Policy Research for Front of Package 

Nutrition Labeling: Environmental Scan 

and Literature Review.’’ Report prepared 

for FDA, 2016. 

* 30. The White House. ‘‘Biden-Harris 

Administration National Strategy on 

Hunger, Nutrition, and Health.’’ 2022. 

Accessed January 12, 2025. Available at 

https://www.whitehouse.gov/wp-content/ 

uploads/2022/09/White-House-NationalStrategy-on-Hunger-Nutrition-andHealth-FINAL.pdf. 

31. Roberto, C.A., SW Ng, M. GanderatsFuentes, et al. ‘‘The Influence of Frontof-Package Nutrition Labeling on 

Consumer Behavior and Product 

Reformulation.’’ Annual Review of 

Nutrition, 41(10):529–550, 2021. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1146/annurev-nutr111120-094932. 

* 32. University of North Carolina-Chapel 

Hill. ‘‘Front-of-Package Labels Around 

the World.’’ Global Food Resource 

Program, 2023. Accessed January 12, 

2025. Available at https://

www.globalfoodresearchprogram.org/ 

wp-content/uploads/2023/02/GFRPUNC_FOPL_maps_2023_02.pdf. 

33. Kenya Bureau of Standards. Draft Kenya 

Standard: Front of Pack Nutrition 

Labelling—Requirements. 2021. 

Accessed January 12, 2025. Available at 

https://members.wto.org/ 

crnattachments/2022/TBT/KEN/22_

0069_00_e.pdf. 

34. Republic of South Africa. Government 

Notices: Foodstuffs, Cosmetics and 

Disinfectants Act, 1972 (Act No. 54 of 

1972), Regulations Relating to the 

Labelling and Advertising of Foodstuffs. 

April 14, 2023. Accessed January 12, 

2025. Available at https://

members.wto.org/crnattachments/2023/ 

TBT/ZAF/23_9235_01_e.pdf. 

* 35. U.S. Food and Drug Administration. 

‘‘FDA Documentation for the Generic 

Clearance of Focus Groups (0910–0497): 

Front-of-Pack Focus Groups.’’ Accessed 

January 12, 2025. Available at https://

www.reginfo.gov/public/do/ 

DownloadDocument

?objectID=121245301. 

* 36. U.S. Food and Drug Administration. 

‘‘Front of Pack (FOP) Schemes to Test.’’ 

April 27, 2022. Accessed January 12, 

2025. Available at https://

www.reginfo.gov/public/do/ 

DownloadDocument

?objectID=121242801. 

* 37. U.S. Food and Drug Administration. 

‘‘Quantitative Research on Front of 

Package Labeling on Packaged Foods: 

Part A.’’ Accessed January 12, 2025. 

Available at https://www.reginfo.gov/ 

public/do/PRAViewDocument?ref_

nbr=202306-0910-004. 

* 38. U.S. Food and Drug Administration. 

‘‘Quantitative Research on Front of 

Package Labeling on Packaged Foods, 

Final Study Report.’’ 2024. 

* 39. U.S. Food and Drug Administration. 

‘‘FDA Documentation for the Generic 

Clearance of Focus Groups (0910–0497): 

Front-of-Package Nutrition Labeling 

Focus Groups 2.’’ Accessed January 12, 

2025. Available at https://

www.reginfo.gov/public/do/ 

PRAViewIC?ref_nbr=202008-0910- 

021&icID=262002. 

* 40. U.S. Congress. House. Committee on 

Energy and Commerce. Conference 

Report to accompany H.R. 3562. House 

Report No. 101–538, 101st Cong., 2nd 

sess., June 13, 1990. 

* 41. Levy, A.S., S.B. Fein, and R.E. 

Schucker. ‘‘Evaluation of Nutrition Label 

Formats: FDA Study 2.’’ Washington, 


ddrumheller on DSK120RN23PROD with PROPOSALS5
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 5459 

DC: HHS, FDA, Center for Food Safety 

and Applied Nutrition, 1992. 

* 42. U.S. Food and Drug Administration 

Memorandum, ‘‘Research Findings on 

Consumer Understanding of the Meaning 

of Percent Daily Value (% DV) on the 

Nutrition Facts Fabel.’’ HHS, FDA, 

Center for Food Safety and Applied 

Nutrition. Prepared by C.T. Jordan Lin 

and A. Lando, 2024. 

* 43. Liese, A.D., S.M. Krebs-Smith, A.F. 

Subar, et al. ‘‘The Dietary Patterns 

Methods Project: Synthesis of Findings 

Across Cohorts and Relevance to Dietary 

Guidance.’’ Journal of Nutrition, 

145(3):393–402, 2015. Accessed January 

12, 2025. Available at https://doi.org/ 

10.3945/jn.114.205336. 

* 44. U.S. Food and Drug Administration 

Memorandum, ‘‘Consumer Reactions to 

Four Different Front-of-Package (FOP) 

Nutrition Labeling Schemes—2022 

Focus Group Findings.’’ HHS, FDA, 

Center for Food Safety and Applied 

Nutrition. Prepared by L. Verrill, J. 

Behm, F. Wu, and K. Meadows, 2024. 

45. Taylor, C.L. and V.L. Wilkening. ‘‘How 

the Nutrition Food Label Was 

Developed, Part 1: The Nutrition Facts 

Panel.’’ Journal of American Dietetic 

Association, 108(3):437–442, 2008. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1016/ 

j.jada.2007.12.010. 

* 46. U.S. Food and Drug Administration. 

‘‘The Lows and Highs of Percent Daily 

Value on the Nutrition Facts Label.’’ 

FDA.gov. Accessed January 12, 2025. 

Available at https://www.fda.gov/food/ 

nutrition-facts-label/lows-and-highspercent-daily-value-nutrition-facts-label. 

* 47. U.S. Food and Drug Administration 

Memorandum. ‘‘Breadth of 

Documentation of the 5/20 rule.’’ HHS, 

FDA, Center for Food Safety and Applied 

Nutrition. Prepared by Mark Kantor, 

2024. 

* 48. Cambridge Dictionary. ‘‘Medium.’’ 

Dictionary.cambridge.org. Accessed 

January 12, 2025. Available at https://

dictionary.cambridge.org/us/dictionary/ 

english/medium. 

* 49. Merriam-Webster Dictionary. 

‘‘Medium.’’ Merriam-webster.com. 

Accessed January 12, 2025. Available at 

https://www.merriam-webster.com/ 

dictionary/medium#dictionary-entry-2. 

* 50. National Eye Institute. ‘‘Color 

Blindness.’’ NEI.NIH.gov. Accessed 

January 12, 2025. Available at https://

www.nei.nih.gov/learn-about-eye-health/ 

eye-conditions-and-diseases/colorblindness. 

51. Health Canada. ‘‘Consumer Research on 

Front of Package Nutrition Labeling.’’ 

Prepared by Leger for Health Canada, 

2018. Accessed January 12, 2025. 

Available at https://epe.lac-bac.gc.ca/ 

100/200/301/pwgsc-tpsgc/por-ef/health/ 

2018/073-17-e/report.pdf. 

52. Acton, R.B., L. Vanderlee, C.A. Roberto, 

et al. ‘‘Consumer Perceptions of Specific 

Design Characteristics for Front-ofPackage Nutrition Labels.’’ Health 

Education Research, 33(2):167–174, 

2018. Accessed January 12, 2025. 

Available at https://doi.org/10.1093/her/ 

cyy006. 

53. Feunekes, G.I.J., I.A. Gortemaker, A.A. 

Willems, et al. ‘‘Front-of-Pack Nutrition 

Labelling: Testing Effectiveness of 

Different Nutrition Labelling Formats 

Front-of-Pack in Four European 

Countries.’’ Appetite, 50(1):57–70, 2008. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1016/ 

j.appet.2007.05.009. 

54. Vyth, E.L., I.H.M. Steenhuis, S.F. Mallant, 

et al. ‘‘A Front-of-Pack Nutrition Logo: A 

Quantitative and Qualitative Process 

Evaluation in the Netherlands.’’ Journal 

of Health Communications, 14(7):631– 

645, 2009. Accessed January 12, 2025. 

Available at https://doi.org/10.1080/ 

10810730903204247. 

* 55. Shrestha, A., K. Cullergon, K. White, et 

al. ‘‘Impact of Front-of-Pack Nutrition 

Labelling in Consumer Understanding 

and Use Across Socio-Economic Status: 

A Systematic Review.’’ 

Appetite,187:106587, 2023. Accessed 

January 12, 2025. Available at https://

doi.org/10.1016/j.appet.2023.106587. 

56. Bialkova, S. and H. van Trijp. ‘‘What 

Determines Consumer Attention to 

Nutrition Labels?’’ Food Quality and 

Preference, 21(8):1042–1051, 2010. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1016/ 

j.foodqual.2010.07.001. 

57. Bialkova, S., K.G. Grunert, and H. van 

Trijp. ‘‘Standing Out in the Crowd: The 

Effect of Information Clutter on 

Consumer Attention for Front-of-Pack 

Nutrition Labels.’’ Food Policy, 41:65– 

74, 2013. Accessed January 12, 2025. 

Available at https://doi.org/10.1016/ 

j.foodpol.2013.04.010. 

58. Cabrera, M., L. Machı ́n, A. Arru ́ a, et al. 

‘‘Nutrition Warnings as Front-of-Pack 

Labels: Influence of Design Features on 

Healthfulness Perception and 

Attentional Capture.’’ Public Health 

Nutrition, 20(18):3360–3371, 2017. 

Accessed January 12, 2025. Available at 

https://doi.org/10.1017/ 

s136898001700249x. 

* 59. U.S. Food and Drug Administration. 

‘‘The New Nutrition Facts Label: 

Examples of Different Label Formats.’’ 

FDA.gov. Accessed January 12, 2025. 

Available at https://www.fda.gov/media/ 

99151/download. 

60. Craig, J. and I.K. Scala. Designing with 

Type: The Essential Guide to 

Typography. 5th ed. Watson-Guptill, 

2006; p. 78. 

61. Lidwell, W., K. Holden, and J. Butler 

(Eds.). Universal Principles of Design. 

3rd Ed. Rockport Publishers, 2023; 

section 006. 

62. Lidwell, W., K. Holden, and J. Butler 

(Eds.). Universal Principles of Design. 1st 

Ed. Rockport Publishers, 2003. 

63. Gomez-Palacio, B. and A. Vit. Graphic 

Design Referenced: A Visual Guide to the 

Language, Applications, and History of 

Graphic Design. 1st Ed. Rockport 

Publishers, 2012; pp. 50–54. 

64. Acton, R. and D. Hammond. ‘‘Do 

Manufacturer ‘Nutrient Claims’ Influence 

the Efficacy of Mandated Front-ofPackage 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-ofPackage Nutrition Information (Proposed 

Rule).’’ Accessed January 12, 2025. 

Available at https://www.fda.gov/aboutfda/reports/economic-impact-analysesfda-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 

■ 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. 

■ 2. Amend § 101.2 by: 

■ a. Revising paragraph (b); 

■ b. Revising paragraph (c)(1)(ii)(B)(1); 

■ c. Adding paragraph (d)(2)(iv); and 

■ d. Revising paragraph (f). 

The revisions and addition read as 

follows: 

§ 101.2 Information panel of packaged 

food. 

* * * * * 

(b) All information required to appear 

on the label of any packaged food under 

§§ 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 § 101.9, except that 

any multiunit retail package in which it 

is contained must bear nutrition 

labeling if required by § 101.9 and the 

Nutrition Info box if required by § 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 § 101.9. 

* * * * * 


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5460 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

(d) * * * 

(2) * * * 

(iv) The Nutrition Info box required 

by § 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 §§ 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. 

■ 3. Add § 101.6 to read as follows: 

§ 101.6 Front-of-package Nutrition Info 

box. 

(a) General provisions—(1) Scope. All 

food covered under § 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 § 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 § 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 § 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 

§ 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 § 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 centerjustify 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 rightjustify 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 rightjustify 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. 


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Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 5461 

Figure 1 to Paragraph (a)(5)—Example 

Standard Nutrition Info Box 

(b) Special labeling provisions. (1) 

Packaged foods that may use an 

aggregate display under § 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 

§ 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 

(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 § 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 § 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 rightjustified 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’’). 


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Wheat Squares Sweetened 

Nutrition Info 

Per serving 0/oDaily 

1 cup Value 

Saturated Fat 0% Low 

Sodium 0% Low 

Added Sugars 22% High 

FDA.gov 

Nutrition Info 

Per serving 

1 container 

Saturated Fat 

Sodium 

Added Sugars 

0/oDaily 

Value 

18% Med 

37% High 

5% Low 

FDA.gov 

Corn Flakes Not Sweetened_ 

Nutrition Info 

Per serving 0/oDally 

1 1/2 cup Value 

Saturated Fat 0% Low 

Sodium 13% Med 

Added Sugars 8% Med 

FDA.gov 

Mixed Grain Flakes 

Sweetened 

Nutrition Info 

Per serving 0/oDaily 

1 cup Value 

Saturated Fat 0% Low 

Sodium 7% Med 

Addet:fSugars .. 10% Med 

FDA.gov 
5462 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 

Figure 3 to Paragraph (b)(4)—Example 

Nutrition Info Box Modified for ‘‘As 

Packaged’’ 

(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 

(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 § 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 § 101.9 

under § 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 § 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. 

■ 4. Amend § 101.13 by revising 

paragraphs (c), (i) introductory text, and 

(n) to read as follows: 

§ 101.13 Nutrient content claims—general 

principles. 

* * * * * 

(c) Information that is required or 

permitted by § 101.9 or § 101.36 as 

applicable, to be declared in nutrition 

labeling, and that appears as part of the 

nutrition label, or that is required by 

§ 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 § 101.6, 

§ 101.9, or § 101.36, as applicable, or in 


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As packaged 

Nutrition Info 

Per serving o/o Dally 

1 /4 package mix Value 

Saturated Fat 8% Med 

Sodium 5% Low 

Added Sugars 34% High 

FDA.gov 

Nutrition Info 

Sat. Fat Med 

Sodium High 

Add. Sugar Low 

FDA.gov 
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Proposed Rules 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 § 101.6, § 101.9, § 101.10, or 

§ 101.36, as applicable, must be 

provided for any food for which a 

nutrient content claim is made. 

* * * * * 

■ 5. Amend § 101.15 by revising 

paragraph (c)(2) to read as follows: 

§ 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 § 101.6: Provided, 

however, That individual serving-size 

packages of foods containing no more 

than 11⁄2 avoirdupois ounces or no more 

than 11⁄2 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. 

* * * * * 

■ 6. Amend § 101.61 by: 

■ a. Revising paragraphs (a)(3) and 

(b)(4)(i); 

■ b. Redesignating paragraph (b)(4)(ii) as 

(b)(4)(iii) and revising it; 

■ c. Adding new paragraph (b)(4)(ii); 

■ d. Revising paragraph (b)(5)(i); 

■ e. Redesignating paragraph (b)(5)(ii) as 

(b)(5)(iii) and revising it; and 

■ f. Adding new paragraph (b)(5)(ii). 

The revisions and additions read as 

follows: 

§ 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 

§ 101.6, § 101.9, § 101.10, or § 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 § 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 § 101.6 for sodium in 

the front-of-package Nutrition Info box, 

if the food label or labeling must comply 

with the requirements in § 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 § 101.6 for sodium 

in the front-of-package Nutrition Info 

box, if the food label or labeling must 

comply with the requirements in 

§ 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. 

* * * * * 

■ 7. Amend § 101.62 by: 

■ a. Revising paragraphs (a)(3) and 

(c)(2)(i); 

■ b. Redesignating paragraph (c)(2)(ii) as 

paragraph (c)(2)(iii) and revising it; 

■ c. Adding new paragraph (c)(2)(ii); 

■ d. Revising paragraph (c)(3)(i); 

■ e. Redesignating paragraph (c)(3)(ii) as 

paragraph (c)(3)(iii); and 

■ f. Adding new paragraph (c)(3)(ii). 

The revisions and additions read as 

follows: 

§ 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 

§ 101.6, § 101.9, § 101.10, or § 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 § 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 

§ 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 § 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 

§ 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. 

* * * * * 

■ 8. Amend § 101.65 by revising 

paragraph (a)(3) to read as follows: 

§ 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 

§ 101.6, § 101.9, § 101.10, or § 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 


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