Contains Nonbinding Recommendations 
 
Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels: Guidance for 
Industry 
Small Entity Compliance Guide 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
Nutrition Programs Staff, HFS-830 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
(Tel) 240-402-1450 
http://www.fda.gov/FoodGuidances 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov.  Submit written comments to the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number listed in the 
notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-1450. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
January 2020 
 
 
 
   
 
  Contains Nonbinding Recommendations 
Table of Contents 
I. Introduction
   
II.Who Is Subject to the Rule?
   
III. What Foods Are Covered by the Rule?
   
III.A  Does the Rule Cover Foods for the General Food Supply? 
III.B  Does the Rule Cover Foods for Infants and Young Children 1 Through 3 Years 
of Age? 
III.C  Does the Rule Cover Foods for Pregnant Women and Lactating Women? 
III.D  Does the Rule Cover Dietary Supplements? 
IV.  What Foods Are Not Covered by the Rule?
   
V. Which Nutrients Must Newly be Declared, and What Changes 
 
Have Been Made to Nutrients Previously Required or Allowed to 
be Declared?
 
V.A  Which Nutrients Are Newly Required to be Declared? 
V.B  Have There Been Any Changes to the Definition or Presentation of Nutrients 
That Were Already Required to Be Declared? 
V.C  Which Nutrients Can I Still Voluntarily Declare, Even Though They Are No 
Longer Mandatory? 
V.D  Which Nutrients Are Newly Allowed to be Voluntarily Declared? 
V.E  Which Nutrients Can I No Longer Declare? 
VI. How Do I Comply with the Recordkeeping Requirements?
   
VI.A  When Are Records Necessary? 
VI.B  What Counts as a Record? 
VI.C  How Long Must Records be Kept? 
 
  Contains Nonbinding Recommendations 
VII. How Have the Values of Nutrients Been Updated?
   
VII.A  How Have the Calculations of Caloric Content Changed? 
VII.B  How Have the Daily Reference Values (DRVs) Changed? 
VII.C  How Have the Reference Daily Intakes (RDIs) Changed? 
VII.D  How Do the Nutrient Requirements for Supplement Facts Labels Differ? 
VII.E  Has Nutrient Compliance or the Level of Variance Allowed Changed? 
VII.F  Which Version of the Official Methods of Analysis of the AOAC International 
Should be Used? 
VIII.How Do I Comply with the Formatting Requirements?
   
VIII.A How Do I Comply with the Standard Version of the Nutrition Facts Label? 
VIII.B When Can I Use the Tabular Format? 
VIII.C How Do I Comply with These Requirements if My Food Packaging Only Has a 
Total Surface Area Available to Bear Labeling of 40 or Less Square Inches? 
VIII.D How Do I Comply with the Nutrition Labeling Formatting Requirements when 
Dual Column Labeling is Required or Provided Voluntarily? 
VIII.E When Can the Simplified Format Be Used? 
VIII.F Are Foods in Small Packages with a Total Surface Area Available to Bear 
Labeling of Less than 12 Square Inches Exempt from the Nutrition Facts 
Labeling Requirements? 
VIII.G How Do These New Formatting Rules Affect the Percentage Juice Declaration? 
VIII.H Are There Specific Formatting Requirements for Supplement Facts Labels? 
IX. When Must I Comply with the Rule?
   
X.Why Must I Comply with the Rule?
   
XI. References
   
   
 
  Contains Nonbinding Recommendations 
Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels: Guidance for 
1
Industry
 
Small Entity Compliance Guide 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page.  
 
 
I.  Introduction 
 
In the Federal Register of May 27, 2016 (81 FR 33742), FDA (we) published a final rule entitled 
Food Labeling: Revision of the Nutrition and Supplement Facts Labels (the final rule).  The 
final rule amends the labeling regulations for conventional foods and dietary supplements to 
provide updated nutrition information on the label to assist consumers in maintaining healthy 
dietary practices and set a compliance date of July 26, 2018, for manufacturers with $10 million 
or more in annual food sales, and July 26, 2019, for manufacturers with less than $10 million in 
annual food sales.  We subsequently extended the compliance dates to January 1, 2020, and 
January 1, 2021, respectively (83 FR 19619).  We have prepared this Small Entity Compliance 
Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness 
Act (Public Law 104-121, as amended by Public Law 110-28).  This guidance document restates 
in plain language the revisions made in the final rule and is intended to help small entities 
comply with the requirements established in 21 CFR 101.9, 101.30, and 101.36. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in our guidances means that something is suggested or 
recommended, but not required. 
 
In the remainder of this guidance, you and I refer to food manufacturers that are subject to 
the rule.  Many answers in this guidance are followed by citations to show where a specific 
requirement can be found in either the Federal Food, Drug, and Cosmetic Act (FD&C Act) or 
Title 21 of the Code of Federal Regulations. 
                                                           
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
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  Contains Nonbinding Recommendations 
 
II.  Who Is Subject to the Rule? 
 
You are subject to the rule if you manufacture food that is subject to our nutrition labeling 
requirements.  The nutrition labeling requirements apply to both conventional foods under 21 
CFR 101.9(a) and dietary supplements under 21 CFR 101.9(j)(6). 
 
III.  What Foods Are Covered by the Rule? 
 
III.A  Does the Rule Cover Foods for the General Food Supply? 
 
Yes.  Foods for the general food supply are foods eaten by persons 4 years of age and older.  
 
III.B  Does the Rule Cover Foods for Infants and Young Children 1 Through 3 Years of 
Age? 
 
Yes.  Foods, other than infant formula, represented or purported to be specifically for infants 
through 12 months of age and children 1 through 3 years of age are subject to nutrition labeling 
(21 CFR 101.9(j)(5)(i)).  Manufacturers of foods represented or purported to be specifically for 
infants through 12 months and/or children 1 through 3 years of age must use the Reference Daily 
Intakes (RDIs) and Daily Reference Values (DRVs) that are specified for this intended group 
when calculating percent Daily Values (DVs) for labels (21 CFR 101.9(c)(8) and (9)).  The 
previous categories of infants (or infants 7 to 12 months) and children less than 4 years 
have been changed to infants through 12 months and children 1 through 3 years of age 
throughout 21 CFR 101.9. 
 
III.C  Does the Rule Cover Foods for Pregnant Women and Lactating Women? 
 
Yes.  Manufacturers of foods represented or purported to be specifically for pregnant women and 
lactating women must use the RDIs and DRVs that are specified for this intended group when 
calculating percent DVs for labels (21 CFR 101.9(c)(8) and (9)). 
 
III.D  Does the Rule Cover Dietary Supplements? 
 
Yes.  Section 201(f) of the FD&C Act defines food as: (1) articles used for food or drink for 
man or other animals, (2) chewing gum, and (3) articles used for components of any such 
article.  Further, section 201(ff) of the FD&C Act explains that dietary supplements are deemed 
to be foods within the meaning of the FD&C Act except for the purposes of sections 201(g) 
(definition of drug) and 417 (reportable food registry) of the FD&C Act.  Nutrition labeling 
information for food must be provided for all products intended for human consumption and 
offered for sale, unless an exemption is provided (21 CFR 101.9(a)).  As dietary supplements fall 
under the definition of food, they are therefore subject to nutrition labeling.  Specific nutrition 
labeling requirements and guidelines for dietary supplements can be found in 21 CFR 101.36. 
 
IV.   What Foods Are Not Covered by the Rule? 
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Under 21 CFR 101.9(j), numerous foods are exempt from nutrition labeling requirements or are 
subject to special labeling requirements.  Such products generally include: (1) foods offered for 
sale by a retailer who has annual gross sales made or business done in sales to consumers that is 
not more than $500,000; (2) foods offered for sale by a retailer who has annual gross sales made 
or business done in sales of food to consumers of not more than $50,000; (3) medical foods; and 
(4) foods that contain insignificant amounts of all nutrients (e.g., coffee beans, tea leaves).  For 
more information on foods not covered by the rule and for further information about exemptions 
from these requirements, see 21 CFR 101.9(j). 
 
V.  Which Nutrients Must Newly be Declared, and What Changes 
Have Been Made to Nutrients Previously Required or Allowed to be 
Declared? 
 
V.A  Which Nutrients Are Newly Required to be Declared? 
 
V.A.1  Added Sugars 
 
V.A.1.(a)  How Are Added Sugars Defined? 
 
Added sugars are defined as sugars that are either added during the processing of foods, or are 
packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and 
honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be 
expected from the same volume of 100 percent fruit or vegetable juice of the same type (21 
CFR 101.9(c)(6)(iii)).  This definition includes single ingredient foods, such as individually 
packaged table sugar (see Section V.A.1.(a).(i) and Ref. 1). 
 
The following do not fall under the definition of added sugars: 
 
  Sugars in fruit or vegetable juice concentrated from 100 percent juices that are sold to 
consumers (e.g., frozen 100 percent fruit juice concentrate) (21 CFR 101.9(c)(6)(iii)); 
  Sugars in fruit juice concentrates that are used to formulate the fruit component of 
jellies, jams, or preserves in accordance with the standards of identities set forth in 21 
CFR 150.140 and 150.160 (21 CFR 101.9(c)(6)(iii)); 
  Sugars in the fruit component of fruit spreads (21 CFR 101.9(c)(6)(iii)); 
  Sugar alcohols; 
  Sugars in juice concentrates that are counted towards percentage juice label declaration 
under 21 CFR 101.30 for 100 percent juice or 21 CFR 102.33 for juice beverages (21 
CFR 101.9(c)(6)(iii)); 
  Sugars in juice concentrates that are used to standardize the Brix values of a single 
species juice consisting of juice directly expressed from a fruit or vegetable in 
accordance with 21 CFR 102.33(g)(2) (21 CFR 101.9(c)(6)(iii)); 
  Naturally-occurring sugars found in milk and dairy ingredients, except lactose as defined 
in 21 CFR 168.122; and 
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  Naturally-occurring sugars found in whole fruits and vegetables or dried fruits which 
have not had any sugar added to them. 
 
The amount of added sugars declared on the label should never exceed the amount of total sugars 
on the label. 
 
V.A.1.(a).(i)  Do Honey, Maple Syrup, and Other Single-Ingredient Sugars and Syrups Have to 
be Declared as Added Sugars? 
 
In the Federal Register of June 20, 2019 (84 FR 28726), we announced the availability of a final 
guidance for industry entitled The Declaration of Added Sugars on Honey, Maple Syrup, Other 
Single-Ingredient Sugars and Syrups, and Certain Cranberry Products, which provides clarity 
on the labeling of added sugars for such products (Ref. 1).  In that guidance, we discuss section 
12516 of the Agriculture Improvement Act of 2018 (Pub. L. 115-334) (the Farm Bill), which 
states that the food labeling requirements cannot require the declaration Includes Xg Added 
Sugars in a serving of these single-ingredient products.  While these products are not required to 
have this declaration of the gram amount of added sugars, the Farm Bill did not change the 
requirement under the Nutrition Facts label final rule to include the percent DV for the 
contribution of sugars from these products to the added sugars in the diet, so the percent DV for 
added sugars must still be included consistent with 21 CFR 101.9(d)(7)(ii).  We stated that we 
intend to exercise enforcement discretion by permitting the use of the  symbol immediately 
following the percent DV declaration for added sugars on packages and containers of single-
ingredient sugars and syrups.  This symbol would lead to a footnote inside the Nutrition Facts 
label, explaining the amount of added sugars that one serving of the product contributes to the 
diet, as well as the contribution of a serving of the product toward the percent DV for added 
sugars.  This symbol and footnote are not required; however, we encourage you to use them. 
 
V.A.1.(a).(ii)  Do Added Sugars in Dried Cranberry Products and Cranberry Beverage Products 
Have to be Declared as Added Sugars? 
 
You must still declare added sugars in grams and the corresponding percent DV on labels for all 
dried cranberry products and cranberry beverage products (21 CFR 101.9(c)(6)(iii)).  In the 
Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and 
Syrups, and Certain Cranberry Products guidance, we said that we intend to exercise 
enforcement discretion for these cranberry products to allow the use of a symbol immediately 
following the added sugars percent DV declaration which would lead to a truthful and not 
misleading statement outside the Nutrition Facts label explaining that sugars are added to 
improve the palatability of naturally tart cranberries (see Ref. 1).  This symbol can be used for 
cranberry products that are sweetened with added sugars and that contain total sugars per serving 
at levels no greater than comparable products with no added sugars (i.e. unsweetened grape 
juice) (Ref. 1). 
 
V.A.1.(a).(iii) Does Allulose Count as an Added Sugar? 
 
The final rule does not reach a decision as to whether allulose should be excluded from the 
labeling of carbohydrate, sugars, and/or added sugars.  We stated that, as a monosaccharide, it 
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must be included in the declaration of each, pending any future rulemaking that would otherwise 
exclude it from the declaration (81 FR 33742 at 33796; 21 CFR 101.9(c)(i) through (iii)).   
 
In the Federal Register of April 18, 2019 (84 FR 16272), we announced the availability of a 
draft guidance for industry entitled The Declaration of Allulose and Calories from Allulose on 
Nutrition and Supplement Facts Labels.  This guidance, when finalized, would advise 
manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from 
the amount of Total Sugars and Added Sugars declared on the label and the use of a general 
factor of 0.4 calories per gram for allulose when determining Calories on the Nutrition and 
Supplement Facts labels, pending review of the issues in a rulemaking (Ref. 2). 
 
V.A.1.(b)  How Do I Calculate Added Sugars? 
 
In the Federal Register of November 5, 2018 (83 FR 55266), we announced the availability of a 
final guidance for industry entitled Nutrition and Supplement Facts Labels: Questions and 
Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative 
Amounts of Vitamins and Minerals.  This guidance provides questions and answers (Q&A) on 
topics related to compliance with the labeling of added sugars.  The Q&A discusses how you 
should determine the amount of added sugars in a serving of a product, as well as which 
ingredients need to be taken into consideration when calculating the added sugars declaration for 
a serving of a product (Ref. 3).   
 
This guidance also provides a detailed discussion on the calculation of added sugars for 
ingredients and products such as concentrated fruit and vegetable purees, fruit and vegetable 
pastes, fruit and vegetable powders, juice cocktails, or juice blends, which often contain juice 
concentrates (Q&A IV. 7-12), products for which manufacturers employ a hydrolysis step (Q&A 
IV. 14-16), and products that undergo non-enzymatic browning or fermentation (Q&A IV. 18
21) (Ref. 3).  Please refer to this guidance for questions you may have regarding the calculation 
and declaration of added sugars for a serving of your product. 
 
V.A.2  Vitamin D 
 
Vitamin D is now considered a nutrient of public health significance for the general 
population, and its declaration is now mandatory (81 FR 33742 at 33884).  Both the gram 
amount and the percent DV for Vitamin D must be declared at the bottom of the label, directly 
preceding the calcium declaration (21 CFR 101.9(c)(8)(ii)).  While only the term vitamin D 
can be used on the food labels (21 CFR 101.9(c)(8)(iv)), the specific form that is added to a food 
must be listed in the ingredient list statement (21 CFR 101.4).  For Supplement Facts labels, the 
source ingredient may be identified within the nutrition label in parentheses immediately 
following or indented beneath the name of a dietary ingredient and preceded by the word as or 
from (21 CFR 101.36(d)).  When you do not identify a source ingredient within the nutrition 
label, you must list it in an ingredient statement (21 CFR 101.4(g)).  You should not list it in both 
places (81 FR 33742 at 33891). 
 
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  Contains Nonbinding Recommendations 
V.A.3  Potassium 
 
Potassium is also now considered a nutrient of public health significance for the general 
population (81 FR 33742 at 33884).  It has been assigned an RDI, instead of a DRV (21 CFR 
101.9(8)(iv)).  We now require the declaration of both the gram amount and the percent DV for 
potassium at the bottom of the label, directly following the iron declaration.  Potassium is now 
covered under the term mineral that appears in each section of 21 CFR 101.9.  Any listing of 
potassium on the Nutrition Facts label must meet the specific nutrient declaration requirements 
for minerals under 21 CFR 101.9(g)(4), 101.9(g)(4)(i), 101.9(g)(4)(ii), and 101.9(g)(6).  These 
requirements are discussed further in section VII.E Has Nutrient Compliance or the Level of 
Variance Allowed Changed? below. 
 
V.B  Have There Been Any Changes to the Definition or Presentation of Nutrients That 
Were Already Required to Be Declared?  
 
V.B.1  Dietary Fiber 
 
Any dietary fiber declared on the label must meet the new definition of dietary fiber (21 CFR 
101.9(c) and (c)(6)(i)), which is discussed in the following section.  This definition includes a 
listing of dietary fiber that FDA has determined should be in the calculation of dietary fiber for 
declaration on Nutrition Facts labels.  The new definition and process to amend the listing of 
dietary fiber is discussed in this section. 
 
V.B.1.(a)  How Is Dietary Fiber Defined? 
 
Dietary fiber is now defined as non-digestible soluble and insoluble carbohydrates (with 3 or 
more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic 
non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have 
physiological effects that are beneficial to human health (21 CFR 101.9(c)(6)(i)).  Soluble fiber 
and insoluble fiber both must meet this new definition of dietary fiber (21 CFR 101.9(c)(6)(i)(A) 
and (B)). 
 
V.B.1.(a).(i)  Which Isolated or Synthetic Non-Digestible Carbohydrate(s) Qualify as Dietary 
Fiber? 
 
The following isolated or synthetic non-digestible carbohydrate(s) should be included in the 
calculation of the amount of dietary fiber, as FDA has determined that they have physiological 
effects that are beneficial to human health:  
 
  Beta-glucan soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)(A)); 
  Psyllium husk (as described in 21 CFR 101.81(c)(2)(ii)(A)(6)); 
  Cellulose; 
  Guar gum; 
  Pectin; 
  Locust bean gum; and 
  Hydroxypropylmethylcellulose.  (21 CFR 101.9(c)(6)(i)). 
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In the Federal Register of June 15, 2018 (83 FR 27894), we announced the availability of a final 
guidance for industry entitled The Declaration of Certain Isolated or Synthetic Non-Digestible 
Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels, where we stated that 
we intend to propose that the following eight non-digestible carbohydrates be added to the 
definition of dietary fiber, as well: 
 
  Mixed plant cell wall fibers (a broad category that includes fibers like sugar cane fiber 
and apple fiber, among many others); 
  Arabinoxylan; 
  Alginate; 
  Inulin and inulin-type fructans; 
  High amylose starch (resistant starch 2); 
  Galactooligosaccharide; 
  Polydextrose; and 
  Resistant maltodextrin/dextrin (see Ref. 4). 
 
Until we complete rulemaking to add any additional non-digestible carbohydrates to the 
regulatory definition of dietary fiber, we intend to exercise enforcement discretion to allow 
manufacturers to include the eight recognized fibers when calculating the amount of dietary fiber 
to declare on the Nutrition and Supplement Facts labels. 
 
Additionally, in March of 2019 and January of 2020, we granted citizen petition requests and 
announced our intent to propose that cross-linked phosphorylated RS4 and glucomannan, 
respectively, be added to the definition of dietary fiber (Refs. 5 and 6).  For up-to-date 
information on the additional non-digestible carbohydrates that FDA intends to propose to be 
added to the definition of dietary fiber, see Questions and Answers on Dietary Fiber, available 
at http://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-dietary-
fiber#synthetic_fibers. 
 
V.B.1.(a).(ii)  What If There is an Additional Isolated or Synthetic Non-Digestible Carbohydrate 
I Want to be Included in the List of Dietary Fibers?  
 
There are two ways that the list of dietary fiber can be amended to include additional isolated or 
synthetic non-digestible carbohydrates in the definition.  The first way is by submitting a citizen 
petition to request an amendment to the dietary fiber definition (see 21 CFR 10.30(b)).  The 
second way involves the petition process for the authorization of a health claim.  For further 
information regarding the petition process for the authorization of a health claim, refer to 21 CFR 
101.70.  Once an isolated or synthetic non-digestible carbohydrate is added to the dietary fiber 
definition, all manufacturers must include it as part of the total dietary fiber declaration if it is 
present in their product (21 CFR 101.9(c)(6)(i)). 
 
In the Federal Register of March 2, 2018 (83 FR 8997), we announced the availability of a final 
guidance entitled Scientific Evaluation of the Evidence on the Beneficial Physiological Effects 
of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 
10.30) (Ref. 7).  For further information on this topic, please refer to that final guidance, as it 
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goes further in explaining FDAs current thinking on information needed when submitting a 
citizen petition and the scientific review approach we plan to use for evaluating scientific 
evidence to determine whether an isolated or synthetic non-digestible carbohydrate that is added 
to food has a physiological effect that is beneficial to human health. 
 
V.B.1.(b)  How Do I Calculate Dietary Fiber? 
 
Compliance with any declaration of dietary fiber is determined using the appropriate Official 
Methods of Analysis of the AOAC International (21 CFR 101.9(g)(2)).  AOAC 2009.01, 
AOAC 2011.25, or an equivalent AOAC method of analysis may be used to measure the amount 
of dietary fiber in a serving of a product.  The methods used must support the dietary fiber 
definition and therefore must measure lower molecular weight non-digestible oligosaccharides 
(DP 3-9) if present in a food (see 21 CFR 101.9(c)(6)(i)).  We consider AOAC 2009.01 and 
AOAC 2011.25 to be reliable and appropriate methods to measure the amount of dietary fiber in 
a serving of a product.  AOAC 2011.25 is a newer method that can measure low molecular 
weight non-digestible carbohydrates and is considered a reliable and appropriate method to 
measure the amount of soluble and insoluble fiber in a serving of a product, if declared 
separately (81 FR 33742 at 33960).  
 
If a food contains a mixture of non-digestible carbohydrates that do and do not meet the 
proposed dietary fiber definition, and the label of the food declares dietary fiber content, then 
you must make and keep records to verify the amount of non-digestible carbohydrates that do not 
meet the proposed definition of dietary fiber that have been added to the food (21 CFR 
101.9(g)(10)(i) through (iii); see also section VI. How Do I Comply with the Recordkeeping 
Requirements?).  
 
V.B.2  Total Sugars 
 
Sugars has changed to Total Sugars, which includes both Added Sugars and sugars that 
are naturally occurring in food.  The label declaration of Total Sugars is not required if the 
product contains less than one gram of sugars per serving and no claims are made about sugars, 
sweeteners, or sugar alcohol content.  If the total sugars content is not required and therefore not 
declared, the statement Not a significant source of total sugars must be placed at the bottom of 
the table of nutrient values (see 21 CFR 101.9(c)(6)(ii)). 
 
V.B.3  Sugar Alcohol 
 
In addition to preexisting regulations, sugar alcohol content must now also be declared when a 
claim is made on the label or in labeling about added sugars when sugar alcohols are present in 
the food (21 CFR 101.9(c)(6)(iv)). 
 
V.C  Which Nutrients Can I Still Voluntarily Declare, Even Though They Are No Longer 
Mandatory? 
 
While the declarations of vitamins A and C are no longer mandatory, you can declare this 
information voluntarily.  Declaration of vitamins A and C can be provided for foods for adults 
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and children 4 years or more of age, as well as on foods represented or purported to be 
specifically for infants through 12 months, children 1 through 3 years of age, pregnant women, 
and lactating women.  However, vitamin A and vitamin C declaration is mandatory when the 
respective nutrient is added as a nutrient supplement or claims are made about it on the label or 
in the labeling of foods (21 CFR 101.9(c)(8)(ii)).  There have been no changes to the prior 
provision that allowed for voluntary declaration of the percent of vitamin A that is present as -
carotene (101.9(c)(8)(vi)). 
 
V.D  Which Nutrients Are Newly Allowed to be Voluntarily Declared? 
 
Declaration of fluoride is voluntary whether it is intentionally added or naturally present, unless 
a claim is made about fluoride content, which would trigger mandatory declaration.  When 
fluoride content is declared, it must be expressed as zero when a serving contains less than 0.1mg 
of fluoride, to the nearest 0.1mg increment when a serving contains less than or equal to 0.8mg 
of fluoride, and the nearest 0.2mg when a serving contains more than 0.8mg of fluoride (21 CFR 
101.9(c)(5)). 
 
For bottled water that bears a statement about added fluoride, as permitted under 21 CFR 
101.13(q)(8), nutrition labeling that complies with the simplified format requirements (21 CFR 
101.9(f)) is required (21 CFR 101.9(c)(5)). 
 
V.E  Which Nutrients Can I No Longer Declare? 
 
V.E.1  Calories From Fat 
 
While the declaration of Calories from fat used to be required, it is no longer required nor is it 
allowed to be declared voluntarily (81 FR 33742 at 33780).  Any reference to this declaration has 
been removed from the updated regulations (81 FR 33742 at 33780). 
 
V.E.2  Other Carbohydrate 
 
The voluntary declaration of Other Carbohydrate is also no longer allowed.  Any reference to 
this declaration has been removed from the updated regulations (81 FR 33742 at 33868). 
 
VI.  How Do I Comply with the Recordkeeping Requirements? 
 
VI.A  When Are Records Necessary? 
 
For certain nutrients, there are no AOAC official methods of analysis or other reliable or 
appropriate analytical procedures available to verify the amount of the declared nutrient on the 
Nutrition Facts or Supplement Facts label.  Verification is important because it ensures that the 
declared nutrient amount is truthful, accurate, and complies with all applicable labeling 
requirements.  In such situations, we require you to make and keep records that are necessary to 
verify the declaration of these nutrients, as you are in the best position to verify how you arrived 
at this determination and to know which of your records provide the necessary documentation for 
us to determine compliance.   
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Records are needed to verify the declaration of the following: 
 
  The amount of added sugars added to the food during processing, when both naturally 
occurring and added sugars are present in a food (21 CFR 101.9(g)(10)(iv)); 
  The amount of added sugars, if packaged as a separate ingredient, as packaged (whether 
as part of a package containing one or more ingredients or packaged as a single 
ingredient) when both naturally occurring and added sugars are present in a food (21 
CFR 101.9(g)(10)(iv)); 
  The amount of added non-digestible carbohydrate(s) that does not meet the definition of 
dietary fiber when the dietary fiber present in a food is a mixture of non-digestible 
carbohydrates that do and that do not meet the definition of dietary fiber (21 CFR 
101.9(g)(10)(i)); 
  The amount of added soluble non-digestible carbohydrate(s) that does not meet the 
definition of dietary fiber when the soluble dietary fiber present in a food is mixture of 
soluble non-digestible carbohydrates that do and that do not meet the definition of 
dietary fiber (21 CFR 101.9(g)(10)(ii)); 
  The amount of added insoluble non-digestible carbohydrate(s) that does not meet the 
definition of dietary fiber when the insoluble dietary fiber present in a food is a mixture 
of insoluble non-digestible carbohydrates that do and that do not meet the definition of 
dietary fiber (21 CFR 101.9(g)(10)(iii)); 
  The amount of all rac--tocopherol added to the food and RRR--tocopherol in the 
finished food when a mixture of both forms of vitamin E are present in a food (21 CFR 
101.9(g)(10)(vi)); and 
  The amount of synthetic folate and/or folic acid added to the food and the amount of 
naturally-occurring folate in the finished food when a mixture of both forms is present in 
a food (21 CFR 101.9(g)(10)(vii)). 
 
For example, if you manufacture products containing fruit and vegetable juice concentrates as an 
ingredient that have not been reconstituted to 100 percent juice in the finished food, you must 
provide documentation that shows how you determined how much of the sugars provided by the 
juice concentrate should be declared as added sugars in the finished product (21 CFR 
101.9(g)(10)(iv)). 
 
Similar verification is needed regarding the amount of added sugars in specific foods, alone or in 
combination with naturally occurring sugars, where the added sugars are subject to non-
enzymatic browning and/or fermentation.  In such situations, you must: 
 
1.  make and keep records of all relevant scientific data and information relied upon to 
demonstrate the amount of added sugars in the food after non-enzymatic browning and/or 
fermentation, and a narrative explaining why the data and information are sufficient to 
demonstrate the amount of added sugars declared in the finished food, provided the data 
and information used is specific to the type of food manufactured; or 
2.  make and keep records of the amount of sugars added to the food before and during the 
processing of the food, and if packaged as a separate ingredient, as packaged (whether as 
part of a package containing one or more ingredients or packaged as a single ingredient) 
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and in no event will the amount of added sugars declared exceed the amount of total 
sugars on the label; or 
3.  submit a citizen petition requesting alternative means of compliance. The petition must 
provide scientific data or other information for why the amount of added sugars in a 
serving of the product is likely to have a significant reduction in added sugars compared 
to the amount added prior to non-enzymatic browning and/or fermentation.  A significant 
reduction is a reduction in added sugars after non-enzymatic browning and/or 
fermentation that may be significant enough to impact the label declaration for added 
sugars by an amount that exceeds the reasonable deficiency acceptable within good 
manufacturing practice under 101.9(g)(6).  You must include the reason that you are 
unable to determine a reasonable approximation of the amount of added sugars in a 
serving of your finished product and a description of the process that you used to come to 
that conclusion. 
 
(See 21 CFR 101.9(g)(10)(v)(A) through (C).) 
 
VI.B  What Counts as a Record? 
 
Records can include, for example, analyses of databases, recipes or formulations, or batch 
records (21 CFR 101.9(g)(10)).  They can be kept either as original records, true copies (e.g. 
photocopies, pictures, scanned copies), or electronic records in accordance with 21 CFR part 11 
(21 CFR 101.9(g)(11)).  The records requirements provide flexibility in what records you make 
available to FDA to verify the declared amounts of these nutrients.  As our regulations pertaining 
to disclosure of public information, at part 20, include provisions that protect trade secrets and 
commercial or financial information which is privileged or confidential, you should mark the 
information as such before providing the records to FDA (81 FR 33742 at 33962). 
 
VI.C  How Long Must Records be Kept? 
 
Records must be kept for a period of two years after introduction or delivery for introduction of 
the food into interstate commerce, and they must be provided to FDA upon request during an 
inspection for official review and copying (or other means of reproduction) (21 CFR 
101.9(g)(11)).  Records need to be reasonably accessible to FDA during an inspection at each 
manufacturing facility, even if not stored onsite, to determine compliance with labeling 
requirements (81 FR 33742 at 33963).  These recordkeeping requirements are the same for 
foreign and domestic firms. 
 
VII.  How Have the Values of Nutrients Been Updated? 
 
VII.A  How Have the Calculations of Caloric Content Changed? 
 
While the final rule still allows for the calculation of caloric content using a variety of methods, 
there has been an update to the prior method of using the general factors of 4, 4, and 9 calories 
per gram for protein, total carbohydrate less the amount of insoluble dietary fiber, and total fat, 
respectively.  Now, as stated in 21 CFR 101.9(c)(1)(i)(C), calories from carbohydrate are 
required to be calculated using a general factor of 4 kcal/gram of total carbohydrate less the 
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amount of non-digestible carbohydrates, which includes soluble and insoluble non-digestible 
carbohydrates that do and do not meet the definition of dietary fiber, and sugar alcohols.  A 
general factor of 2 calories per gram is to be used for soluble non-digestible carbohydrates, but 
insoluble non-digestible carbohydrates (0 calories per gram) are not included in the caloric 
calculation.  The calorie contribution of soluble non-digestible carbohydrate would be added to 
that sum to determine the total carbohydrate calorie contribution (81 FR 33742 at 33867).  The 
following general factors are to be used for the caloric value of sugar alcohols: 
 
  Isomalt  2.0 calories per gram; 
  Lactitol  2.0 calories per gram; 
  Xylitol  2.4 calories per gram; 
  Maltitol  2.1 calories per gram; 
  Sorbitol  2.6 calories per gram; 
  Hydrogenated starch hydrolysates  3.0 calories per gram; 
  Mannitol  1.6 calories per gram; and 
  Erythritol  0 calories per gram (21 CR 101.9(c)(1)(i)(F)). 
 
VII.B  How Have the Daily Reference Values (DRVs) Changed? 
 
The following table (Figure 1) reflects the updated DRVs for each population group that have 
been established for fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, 
protein, and added sugars (see also 21 CFR 101.9(c)(9)). 
 
Figure 1: Table 1  Daily Reference Values Used to Calculate Percent DV 
 
Nutrient  Unit of Measure  Adults  Infants  Children  Pregnant 
and  through  1  women and 
Children  12  through  lactating 
 4 years  months  3 years  women 
Fat  Grams (g)  781  30  392  781 
Saturated Fat  Grams (g)  201  N/A  102  201 
Cholesterol  Milligrams (mg)  300  N/A  300  300 
Sodium  Milligrams (mg)  2,300  N/A  1,500  2,300 
Total  Grams (g)  2751  95  1502  2751 
Carbohydrate 
Dietary Fiber  Grams (g)  281  N/A  142  281 
Protein  Grams (g)  501  N/A  132  N/A 
Added Sugars  Grams (g)  501  N/A  252  501 
1 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for 
pregnant women and lactating women. 
2 Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age. 
 
We did not establish a reference calorie intake for infants through 12 months of age.  We also did 
not establish DRVs for trans fat, polyunsaturated fat, monounsaturated fat, insoluble fiber, total 
sugars, or sugar alcohol for any population group. 
 
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VII.C  How Have the Reference Daily Intakes (RDIs) Changed? 
 
Certain RDIs used in the declaration of the percent DV of nutrients on Nutrition and Supplement 
Facts labels have been updated, which may affect the percent DV declared on such labels.2  
Figure 2 below reflects the list of ordered nutrients and their RDIs, which are used to calculate 
the percent DVs (see also 21 CFR 101.9(c)(8)(iv)).  RDIs have now been established for infants 
through 12 months, children 1 through 3 years of age, and pregnant women and lactating women 
for the following nutrients: vitamin A, vitamin D, vitamin E, vitamin C, vitamin K, vitamin B12, 
vitamin B6, folate, choline, riboflavin, niacin, calcium, iron, thiamin, biotin, pantothenic acid, 
phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, 
chloride, potassium (21 CFR 101.9(c)(8)(i) through (iv)).  While we have not established a DRV 
for protein for infants through 12 months or for pregnant women and lactating women, we have 
established an RDI for protein of 11 grams and 71 grams, respectively, for these groups (see 
Figure 2).  We did not establish DVs for infants less than 7 months of age.  Therefore, nutrition 
information on foods purported for infants less than 7 months would not reflect DVs for that age 
group (81 FR 33742 at 33917). 
 
Figure 2: Table 2  Reference Daily Intakes Used to Calculate Percent DV 
 
Nutrient  Unit of Measure  Adults  Infants1  Children  Pregnant 
and  through  1  women 
Children  12  through  and 
 4 years  months  3 years  lactating 
women 
Vitamin D  Micrograms (mcg)  20  10  15  15 
Calcium  Milligrams (mg)  1,300  260  700  1,300 
Iron  Milligrams (mg)  18  11  7  27 
Potassium  Milligrams (mg)  4,700  700  3,000  5,100 
Vitamin A  Micrograms RAE2  900  500  300  1,300 
(mcg) 
Vitamin C  Milligrams (mg)  90  50  15  120 
Vitamin E  Milligrams (mg)3  15  5  6  19 
Vitamin K  Micrograms (mcg)  120  2.5  30  90 
Thiamin  Milligrams (mg)  1.2  0.3  0.5  1.4 
Riboflavin  Milligrams (mg)  1.3  0.4  0.5  1.6 
Niacin  Milligrams NE4 (mg)  16  4  6  18 
Vitamin B   Milligrams (mg)  1.7  0.3  0.5  2 
6
Folate5  Micrograms DFE6  400  80  150  600 
(mcg) 
Vitamin B   Micrograms (mcg)  2.4  0.5  0.9  2.8 
12
                                                           
2 We updated the RDIs for the following nutrients and minerals based on their RDAs: calcium, copper, folate, 
iodine, iron, magnesium, molybdenum, niacin, phosphorus, riboflavin, selenium, thiamin, vitamin A, vitamin B6, 
vitamin B12, vitamin C, vitamin D, vitamin E, and zinc (81 FR 33742 at 33897 through 33901).  Updated RDIs 
based on AIs are available for the following nutrients and minerals: biotin, chloride, choline, chromium, manganese, 
pantothenic acid, potassium, and vitamin K (81 FR 33742 at 33926). 
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Nutrient  Unit of Measure  Adults  Infants1  Children  Pregnant 
and  through  1  women 
Children  12  through  and 
 4 years  months  3 years  lactating 
women 
Biotin  Micrograms (mcg)  30  6  8  35 
Pantothenic Acid  Milligrams (mg)  5  1.8  2  7 
Phosphorus  Milligrams (mg)  1,250  275  460  1,250 
Iodine  Micrograms (mcg)  150  130  90  290 
Magnesium  Milligrams (mg)  420  75  80  400 
Zinc  Milligrams (mg)  11  3  3  13 
Selenium  Micrograms (mcg)  55  20  20  70 
Copper  Milligrams (mg)  0.9  0.2  0.3  1.3 
Manganese  Milligrams (mg)  2.3  0.6  1.2  2.6 
Chromium  Micrograms (mcg)  35  5.5  11  45 
Molybdenum  Micrograms (mcg)  45  3  17  50 
Chloride  Milligrams (mg)  2,300  570  1,500  2,300 
Choline  Milligrams (mg)  550  150  200  550 
Protein  Grams (g)  n/a  11  n/a  717 
1 RDIs are based on dietary reference intake recommendations for infants through 12 months of age. 
2 RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 micrograms supplemental -
carotene, 12 micrograms dietary -carotene, 24 micrograms dietary -carotene, or 24 micrograms dietary -
cryptoxanthin. 
31 mg -tocopherol (label claim) = 1 mg -tocopherol = 1 mg RRR- -tocopherol = 2 mg all rac- -tocopherol. 
4 NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan. 
5 Folate and Folic Acid must be used for purposes of declaration in the labeling of conventional foods and 
dietary supplements.  The declaration for folate must be in mcg DFE (when expressed as a quantitative amount by 
weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE.  Folate may be 
expressed as a percent DV in conventional foods.  When folic acid is added or when a claim is made about the 
nutrient, folic acid must be declared in parentheses, as mcg of folic acid. 
6 DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid. 
7 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for 
pregnant women and lactating women. 
 
VII.C.1  Which Units of Measure Have Changed? 
 
The units of measure have changed for vitamin A, vitamin D, vitamin E, folate, and niacin.  
Where previously international units, or IU, was used for vitamin A, vitamin D, and vitamin 
E, we now require the use of a metric unit of measure (mcg RAE for vitamin A, mcg for vitamin 
D, and mg -tocopherol for vitamin E).  The declarations of vitamin A and vitamin D will be 
expressed in mcg on the nutrition and supplement facts labels, and vitamin E will be expressed in 
mg (21 CFR 101.9(c)(8)(iv)).  The amount of vitamin D may also be expressed in IU, in addition 
to the mandatory declaration in mcg.  Any declaration of the amount of vitamin D in IU must 
appear in parentheses after its declaration in mcg (21 CFR 101.9(c)(8)(iv)).  This is allowed 
because vitamin D is a nutrient of public health significance, the National Academy of Medicine 
(formerly the Institute of Medicine (IOM)) uses IU for vitamin D, and voluntary labeling in IU 
will assist consumers in maintaining healthy dietary practices (81 FR 33742 at 33912).  For 
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vitamin E, the use of this new unit of measure would account for the difference in activity 
between naturally occurring and synthetic vitamin E (81 FR 33742 at 33913).   
 
Changes regarding the labeling of folate have been made so that there is now consistency 
between conventional foods and dietary supplements.  When the amount of folate is declared in 
the labeling of a conventional food or a dietary supplement, the name folate is to be listed for 
products containing folate (both natural and synthetic), folic acid, or a mixture of folate and folic 
acid.  Folate is to be declared in mcg Dietary Folate Equivalents (DFE).  The terms folic acid or 
folacin are no longer allowed to be used as synonyms for folate.  They cannot be listed without 
parentheses in place of folate, and they cannot be added in parentheses immediately following 
folate, unless synthetic folic acid is added as a nutrient supplement to a product or a claim is 
made about it.  In that case, the declaration of folic acid must be included, in parentheses after 
the declaration of folate, as a quantitative amount by weight (21 CFR 101.9(c)(8)(ii)). 
 
The unit of measure has changed for niacin, from mg to milligrams NE, where NE stands 
for niacin equivalents (21 CFR 101.9(c)(8)(iv)).  However, only the amount will continue to be 
declared on the Nutrition and Supplement Facts labels.  The declaration of niacin content 
requires products to include both preformed niacin (from nicotinic acid and nicotinamide in the 
diet or niacin) and tryptophan, including those that may not contain preformed niacin.  
Compliance can be determined by measuring niacin and tryptophan separately; AOAC methods 
exist for both niacin and tryptophan (81 FR 33742 at 33915). 
 
VII.C.2  How Do I Know if the Declaration of Vitamins and Minerals is Mandatory or 
Voluntary? 
 
Declaration is mandatory for the vitamins and minerals of public health significance, which have 
been updated and now are vitamin D, calcium, iron, and potassium.  They must be listed in that 
order, and their declaration is mandatory on foods for adults and children 4 years of age and 
older, as well as on foods represented or purported to be specifically for infants through 12 
months, children 1 through 3 years of age, or pregnant women and lactating women (21 CFR 
101.9(c)(8)(ii)). 
 
Voluntary declaration is allowed for any other essential nutrient presented in Figure 2.  However, 
if any of these nutrients is added to food as a nutrient supplement or if a claim is made about it 
on the label or in the labeling of foods, then mandatory declaration is required (21 CFR 
101.9(c)(8)(ii)). 
 
VII.C.3  What Information Has to be Declared for Vitamins and Minerals? 
 
For the vitamins and minerals of public health significance (vitamin D, calcium, iron, and 
potassium), the inclusion of both absolute amounts (quantitative amount by weight) and percent 
DV are required (except as described for labels in 21 CFR 101.9(j)(13)).  However, if these 
nutrients are present at an amount less than 2 percent of the RDI, then the quantitative amounts 
and percentages of these nutrients are not required to be declared.  They may be declared by a 
zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that 
is placed at the bottom of the table and that is followed by the statement Contains less than 2 
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percent of Daily Value of this (these) nutrient (nutrients).  Alternatively, except as provided in 
21 CFR 101.9(f), if vitamin D, calcium, iron, or potassium is present in amounts less than 2 
percent of the RDI, label declaration of the nutrient(s) is not required if the statement Not a 
significant source of (listing the vitamins or minerals omitted) is placed at the bottom of the 
table of nutrient values (21 CFR 101.9(c)(8)(iii)). 
 
When any other nutrient listed in Figure 2 is added to a food as a nutrient supplement or when a 
claim is made about it (therefore triggering mandatory declaration), the declaration must include 
the amount per serving, expressed as percent DV, unless otherwise stated as both the quantitative 
amount by weight and percent DV (21 CFR 101.9(c)(8)(ii)).  Any nutrient (except folic acid) that 
is voluntarily declared must be declared as a percent of the RDI (21 CFR 101.9(c)(8)(ii)) but 
declaring the quantitative amount by weight is voluntary (81 FR 33742 at 33947-48).  The 
quantitative amount of folic acid must always be declared (21 CFR 101.9(c)(8)(ii)).  You must 
use the appropriate RDI, depending on which population group your food is represented or 
purported to be for (21 CFR 101.9(c)(8)(i)). 
 
Zeros following the decimal points may be dropped, and additional levels of significance may be 
used when the number of decimal places indicated is not sufficient to express lower amounts 
(e.g., the RDI for zinc is given in whole milligrams, but the quantitative amount may be declared 
in tenths of a milligram) (21 CFR 101.9(c)(8)(iii)).  The phrase levels of significance refers to 
the degree of accuracy when rounding nutrients for purposes of declaring quantitative amounts 
of vitamins and minerals on the label.  For example, the RDIs for some vitamins and minerals 
are small numerical values, and nutrients with an RDI of less than 5 (i.e. thiamin, riboflavin, 
vitamin B , vitamin B , copper, and manganese) would not be able to be declared on the 
6 12
Supplement Facts label if they contain less than 2 percent of the RDI and the amount is declared 
to the nearest mg or mcg.  In such situations, manufacturers could declare the quantitative 
amounts to the nearest hundredth of a mg or mcg per serving, provided that such a level of 
specificity does not represent a greater level of precision in the amount of the nutrient present 
than can be scientifically supported.  These rounding recommendations are explained in further 
detail in FDAs guidance for industry entitled Nutrition and Supplement Facts Labels: 
Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of 
Quantitative Amounts of Vitamins and Minerals (Ref. 3). 
 
VII.D  How Do the Nutrient Requirements for Supplement Facts Labels Differ? 
 
Both the content and format of the Supplement Facts label have been updated to correspond to 
the Nutrition Facts label, wherever possible.  However, there are still some differences between 
the two.  On the Supplement Facts label, information on calories and serving size was not made 
more prominent through increased type size, as it has been on the Nutrition Facts label.  While 
the percentage of the RDI for protein for foods purported to be for infants through 12 months of 
age is allowed on Nutrition Facts labels, this declaration must be omitted for Supplement Facts 
labels (21 CFR 101.36(b)(2)(iii)). 
 
In addition, the new ordering for vitamins and minerals on the Supplement Facts label is as 
follows: vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, 
vitamin B6, folate and folic acid, vitamin B12, biotin, pantothenic acid, choline, calcium, iron, 
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phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, 
chloride, sodium, potassium, and fluoride (21 CFR 101.36(b)(2)(B)). 
 
VII.E  Has Nutrient Compliance or the Level of Variance Allowed Changed? 
 
There are still two classes of nutrients for compliance purposes.  Class I covers those added 
nutrients in fortified or fabricated foods (21 CFR 101.9(g)(3)(i)), and Class II nutrients are those 
that are naturally occurring, or indigenous, nutrients (21 CFR 101.9(g)(3)(ii)).  For compliance 
purposes, if both Class I and Class II nutrients are present in the final food product, then the total 
amount of the nutrient (both indigenous and exogenous) is subject to class I requirements. 
 
The updated rule does not change the level of variances allowed in 21 CFR 101.9(g)(4) and 
101.9(g)(5), but the rule also now includes soluble fiber and insoluble fiber in 21 CFR 
101.9(g)(4) and added sugars in 21 CFR 101.9(g)(5).  Therefore, 21 CFR 101.9(g)(4) now states 
that a food with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary 
fiber, soluble fiber, insoluble fiber, polyunsaturated or monounsaturated fat will be deemed to be 
misbranded under section 403(a) of the FD&C Act, unless the nutrient content of the composite 
is formulated to be at least equal to the declared value for the vitamin, mineral, protein, or dietary 
fiber meeting the definition of a Class I nutrient (potassium has been removed), or the nutrient 
content of the composite is at least equal to 80 percent of the declared value for the vitamin, 
mineral, protein, total carbohydrate, polyunsaturated or monounsaturated fat, or dietary fiber 
meeting the definition of a Class II nutrient (potassium and other carbohydrate have been 
removed).  Our regulations, at 21 CFR 101.9(g)(5), state that a food with a label declaration of 
calories, sugars, added sugars (when the only source of sugars in the food is added sugars), total 
fat, saturated fat, trans fat, cholesterol, or sodium will be deemed to be misbranded under section 
403(a) of the FD&C Act if the nutrient content of the composite is greater than 20 percent in 
excess of the value for that nutrient declared on the label.  Reasonable excesses of soluble fiber, 
insoluble fiber and sugar alcohols, and reasonable deficiencies of added sugars are also now 
acceptable within current good manufacturing practices. 
 
VII.F  Which Version of the Official Methods of Analysis of the AOAC International 
Should be Used? 
 
The final rule now incorporates by reference the Official Methods of Analysis of the AOAC 
International, 19th edition (2012) (21 CFR 101.9(l)(1)(i)). 
 
VIII. How Do I Comply with the Formatting Requirements? 
 
There are required formats for Nutrition and Supplement Facts labels.  We strongly recommend 
that the nutrition information be presented using the graphic specifications below (see also 
Appendix B to 21 CFR part 101 and Ref. 8). 
 
VIII.A How Do I Comply with the Standard Version of the Nutrition Facts Label? 
 
Figures 3 through 5 reflect what a standard vertical Nutrition Facts label must look like (see 21 
CFR 101.9(d)(12)).  This format is to be used except on foods where the tabular display is 
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permitted, where dual columns are required or voluntarily used, where the simplified format is 
used, where the aggregate display is used, and on foods in small or intermediate-sized packages.  
These formats, except for the aggregate display, as no changes to this format were made, are 
discussed in detail below. 
 
Figures 3 and 4 show a Nutrition Facts label including only those nutrient declarations which are 
mandatory.  Figure 5 shows a Nutrition Facts label that includes both mandatory and voluntary 
nutrient declarations. 
 
Figure 3: Standard Vertical with Mandatory Nutrients 
 
1. Heading set to 
full width, unless  2.Thin hairline beneath 
impractical  heading 
3. Type size of 
word Calories 
is no smaller 
than 16 point 
4. Mandatory 
  vitamins and 
minerals listed 
vertically 
 
 
Figure 4: Standard vertical, Side-by-side 
 
 
1. Serving size 
numerical value is right 
justified 
 
2. Type size of 
numerical value is no 
smaller than 22 point 
 
3. Added Sugars 
Declaration 
 
4. Mandatory 
vitamins and 
.  minerals listed 
side-by-side 
   
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Figure 5: Standard Vertical, Mandatory and Voluntary Nutrients 
 
1. Caloric 
conversion 
information may be 
declared 
 
 
 
VIII.A.1  How Has the Formatting Changed for the Nutrition Facts Header on a 
Standard Vertical Label? 
 
The Nutrition Facts heading must be in a type size no smaller than all other print size in the 
nutrition label, except for the numerical information for Calories, which according to 21 CFR 
101.9(d)(1)(iii) must be in a type size no smaller than 22 point for the standard label (21 CFR 
101.9(d)(2)).  It must be set the full width of the nutrient information, unless impractical (21 
CFR 101.9(d)(2)).  It is not required to be set the full width of the nutrient information for labels 
presented according to the following formats: tabular display, aggregate display, tabular dual 
column display, tabular display for small or intermediate-sized packages, and linear display for 
small or intermediate-sized packages (21 CFR 101.9(d)(2)). 
 
A thin horizontal line (i.e., a hairline rule) is to be inserted directly beneath the Nutrition Facts 
heading, before the servings per container statement (except on the linear display discussed 
below) (21 CFR 101.9(d)(1)(v)). 
 
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VIII.A.2  How Has the Formatting Changed for the Declaration of Calories on a 
Standard Vertical Label? 
 
The type size has increased for Calories and the numeric value of Calories.  On the standard 
vertical display of the Nutrition Facts label, the numeric value of Calories must be listed in a 
type size no smaller than 22 point, as well as in bold or extra bold type highlighting (21 CFR 
101.9(d)(1)(iii)).  The word Calories must be listed in a type size no smaller than 16 point, as 
well as in bold or extra bold type highlighting (21 CFR 101.9(d)(1)(iii)).  See Figures 3 through 
5. 
 
VIII.A.3  How Has the Formatting Changed for the Declarations of Serving Size and 
Servings Per Container on a Standard Vertical Label? 
 
The ___ servings per container declaration now immediately follows the Nutrition Facts 
heading and must be in a type size no smaller than 10 point (21 CFR 101.9(d)(3)(i)). 
 
Below ___ servings per container is the declaration of Serving size.  Serving size is to be 
highlighted in bold or extra bold and in a type size no smaller than 10 point (21 CFR 
101.9(d)(3)(ii)).  While the Serving size declaration is still left-justified, the corresponding 
numerical value is now right-justified on Nutrition Facts labels only (not on Supplement Facts 
labels), provided that adequate space is available (21 CFR 101.9(d)(3)(ii)).  If the Serving size 
declaration does not fit in the allocated space, then a type size no smaller than 8 point may be 
used on packages of any size. 
 
For further information on the updates made to the Reference Amounts Customarily Consumed 
and Serving Size regulations, please reference the Small Entity Compliance Guide entitled Food 
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; 
Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts 
Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments: Guidance 
for Industry (Ref. 9), as well as the final guidance entitled Food Labeling: Serving Sizes of 
Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts 
Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous 
Topics (Ref. 10). 
 
VIII.A.4  How Has the Formatting Changed for the Declaration of Vitamins and 
Minerals on a Standard Vertical Label? 
 
Nutrient information for vitamins and minerals (except sodium) are to be separated from 
information regarding other nutrients by a bar (21 CFR 101.9(d)(8)).  They may be listed 
vertically (Figures 3 and 5) or horizontally (Figure 4).  If listed horizontally in two columns, then 
vitamin D and calcium should be listed on the first line, and iron and potassium should be listed 
on the second line (21 CFR 101.9(d)(8)).  Nutrient information must be in a type size no smaller 
than 8 point (21 CFR 101.9(d)(1)(iii)). 
 
VIII.A.5  Where Can I Declare Calories from Saturated Fat on a Standard Vertical 
Label? 
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While Calories from fat can no longer be declared, Calories from saturated fat is still 
allowed (21 CFR 101.9(c)(1)(ii)).  When declared, it is to be indented under the statement of 
calories and must be in a type size no smaller than 8 point (21 CFR 101.9(d)(5)). 
 
VIII.A.6  Where, and How, Do I Declare Added Sugars on a Standard Vertical 
Label? 
 
The statement Includes X g Added Sugars must be used to declare added sugars content 
(except on packages of single ingredient sugars), and this statement must be indented directly 
beneath the listing for Total Sugars on the Nutrition Facts label (21 CFR 101.9(c)(6)(iii)).  The 
X will be filled in with the respective added sugar content (21 CFR 101.9(c)(6)(iii)).  In 
Appendix B to 21 CFR 101, we illustrate our recommendation to shorten the length of the 
hairline requirement between total sugars and added sugars to help denote that added sugars 
are a subcomponent of total sugars.  As mentioned above, a DRV has been established for 
added sugars for most population groups, and the % Daily Value declaration is required as well 
(21 CFR 101.9(d)(7)(ii)).  Added sugars must also be declared on the Supplement Facts label (21 
CFR 101.36(b)(2)(i)). 
 
Added sugars content must be expressed to the nearest gram, except in the following 
circumstances: 
 
  The statement Contains less than 1 gram or, alternatively, less than 1 gram may be 
used if a serving contains less than 1 gram added sugars; or 
  The added sugars content may be expressed as zero if the serving contains less than 0.5 
gram.   
 
See 21 CFR 101.9(c)(6)(iii). 
 
If a product contains less than 1 gram of added sugars per serving and no claims are made about 
sweeteners, sugars, or sugar alcohol content, then the declaration of the amount of added sugars 
is not required.  If the added sugars content is therefore not declared, you must place the 
statement Not a significant source of added sugars at the bottom of the table of nutrient values 
(except as provided for in 101.9(f)) (21 CFR 101.9(c)(6)(iii)). 
 
VIII.A.7  How Has the % Daily Value* Footnote Been Changed? 
 
The final rule modified the footnote that refers to the % Daily Value* column heading to 
provide clarity and a better explanation.  The modified footnote now states that *The % Daily 
Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 
calories a day is used for general nutrition advice on all Nutrition Facts label formats on foods 
for the general population (21 CFR 101.9(d)(9)), with the exception of foods having minimal 
calories and with certain formats (i.e., the simplified display, infants through 12 months of age, 
children 1-3 years, and the linear and tabular displays for small or intermediate-sized packages), 
as described below.  The footnote table listing DRVs for total fat, saturated fat, cholesterol, 
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sodium, total carbohydrate, and dietary fiber for 2,000 and 2,500 calorie diets is no longer 
included as part of this footnote (81 FR 33742 at 33950). 
 
The footnote may be omitted for products that can use the terms calorie free, free of calories, 
without calories, trivial source of calories, negligible source of calories, or dietary 
insignificant source of calories on the label or in the labeling of foods.  However, the voluntary 
use of the first part of the footnote (*The % Daily Value tells you how much a nutrient in a 
serving of food contributes to a daily diet.) is allowed for these foods (21 CFR 101.9(d)(9)). 
 
VIII.A.8  What Changes Need to be Made on Labels for Foods Represented or 
Purported to be Specifically for Infants Through 12 Months of Age or for 
Children 1 Through 3 Years of Age? 
 
The next two figures reflect the Nutrition Facts labels for foods represented or purported to be 
specifically for infants through 12 months of age (Figure 6) and for children 1 through 3 years of 
age (Figure 7).  The nutrients declared for these subgroups must include calories, total fat, 
saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added 
sugars, protein, vitamin D, calcium, iron, and potassium (21 CFR 101.9(j)(5)(i)).  Calories from 
saturated fat, polyunsaturated fat, and monounsaturated fat can now be voluntarily declared, if 
desired (see 21 CFR 101.9(c)). 
 
Percent DVs for total fat and potassium on the labeling of foods, other than infant formula, 
represented or purported to be for infants through 12 months of age are now required (see 21 
CFR 101.9(d)(7) and (j)(5)).  However, a percent DV declaration for saturated fat, cholesterol, 
sodium, dietary fiber, and added sugars is not allowed on such foods.  In addition, as with foods 
for all other populations, a percent DV declaration for trans fat and total sugars is not allowed, as 
no DRVs have been established for those nutrients (21 CFR 101.9(j)(5)(ii)(A)).  No % Daily 
Value* footnote is to be declared either (21 CFR 101.9(j)(5)(ii)(A)). 
 
On labels of foods, other than infant formula, represented or purported to be for children 1 
through 3 years of age, the % Daily Value* footnote statement must read: *The % Daily 
Value tells you how much a nutrient in a serving of food contributes to a daily diet. 1,000 
calories a day is used for general nutrition advice (21 CFR 101.9(d)(9)), and a type size no 
smaller than 6 point must be used for the footnote (21 CFR 101.9(d)(1)(iii)). 
 
   
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Figure 6: Infants through 12 Months of Age (21 CFR 101.9(j)(5)(ii)(B)) 
 
1. No % Daily Value is 
declared for: saturated 
fat, trans fat, cholesterol, 
sodium, dietary fiber, 
total sugars, or added 
sugars 
2. Note the absence 
of a footnote at the 
bottom  
 
 
 
Figure 7: Children 1 through 3 Years (21 CFR 101.9(j)(5)(ii)(B)) 
 
1. % Daily Value 
declared for the required 
nutrients per 21 CFR 
101.9(c)(9) 
2. The footnote replaces 2,000 calories 
with 1,000 calories  
And  
3. Type size for footnote no smaller 
than 6 point 
 
   
VIII.B When Can I Use the Tabular Format? 
 
The tabular format can be used when there is not sufficient continuous vertical space to 
accommodate the required components of the nutrition label, up to and including the mandatory 
declaration of potassium (21 CFR 101.9(d)(11)(iii)).  This is different than the tabular format for 
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small or intermediate-sized packages (see Section VIII.C below).  Figure 8 reflects the tabular 
format. 
 
Figure 8: Tabular Display 
 
 
 
2. Quantitative amounts of Thiamin, 
1. Nutrition Facts header is 
 
Riboflavin, and Niacin are not declared, 
not set across the entire width 
  as only % DV is required if voluntarily 
of the label 
  declared 
   
 
 
VIII.B.1  How Does the Declaration of Calories in the Tabular Format Differ from 
that of the Standard Vertical Label Version? 
 
In the tabular format, the word Calories must be in a type size no smaller than 10 point, instead 
of 16 point as required for the standard vertical label (21 CFR 101.9(d)(1)(iii)).  The 10-point 
type size for calories is also required for the tabular display for small and intermediate-sized 
packages (see section VIII.C) and the tabular dual column display (see section VIII.D) (21 CFR 
101.9(d)(1)(iii)). 
 
VIII.B.2  How Do the Declarations of Serving Size and Servings Per Container in the 
Tabular Format Differ from the Standard Vertical Label Version? 
 
The ___ servings per container declaration is the same as required for the standard vertical 
label version.  However, the declaration of Serving size, which is listed below the ___ 
servings per container declaration, must be highlighted in bold or extra bold and in a type size 
no smaller than 9 point (21 CFR 101.9(d)(3)(i)).  This format is also the same for the tabular 
display for small and intermediate-sized packages (see section VIII.C) and the tabular dual 
column display (see section VIII.D) (21 CFR 101.9(d)(3)(i)). 
 
VIII.C How Do I Comply with These Requirements if My Food Packaging Only Has a 
Total Surface Area Available to Bear Labeling of 40 or Less Square Inches? 
 
We allow modifications of the Nutrition Facts label for foods in packages with a total surface 
area available to bear labeling of 40 or less square inches.  One modification is allowing the use 
of the tabular display for small packages or intermediate-sized packages if the product has a total 
surface area available to bear labeling of 40 or less square inches and neither the standard 
vertical display (see Figures 3-5) nor the tabular display (see Figure 8) can be accommodated (21 
CFR 101.9(j)(13)(ii)(A)).  See Figure 9. 
 
 
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  Contains Nonbinding Recommendations 
Figure 9: Tabular Display for Small Packages 
 
 
 
Another modification is the use of a linear display.  For products with a total surface area 
available to bear labeling of 40 or less square inches, nutrition information can be presented in a 
linear format, but only if the label will not accommodate a tabular display (21 CFR 
101.9(j)(13)(ii)(A)).  However, when there is less than 12 square inches of available labeling 
space, either the small tabular or linear display can be used (21 CFR 101.9(j)(13)(ii)(A)).  We 
retained the preexisting linear label format to provide flexibility for labels on small packages 
with various shapes and sizes.  However, we adapted it to maintain consistency with the other 
formatting changes that have been finalized.  As discussed in detail below, the Calories 
information has increased in type size (see Section VIII.C.1) and the serving size and serving per 
container declarations have been updated (see Section VIII.C.2).  In addition, Sugars has 
changed to Total Sugars (21 CFR 101.9(d)(6)(ii)), Added Sugars declaration is now 
mandatory (21 CFR 101.9(d)(6)(iii)), and the abbreviated footnote % DV = % Daily Value is 
optional on some formats (see Section VIII.C.3).  Note that the hairline that separates the 
Nutrition Facts header from the rest of the label is not present on the linear display.  Figure 10 
shows the updated linear format. 
 
Figure 10: Linear Display for Small and Intermediate-Sized Packages 
(101.9(j)(13)(ii)(A)(2)) 
 
 
1. Nutrition Facts header is    2. Serv. size, Sat. fat, Cholest., Total 
not set across the entire width    carb., Fiber, Incl., Vit., and Potas. 
of the label    are all acceptable abbreviations for the 
linear display 
 
 
 
 
 
 
3. The abbreviated footnote % DV = % 
  Daily Value is not shown on this label, 
  as it is not mandatory (see Section 
  VIII.D.3) 
 
 
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The third modification is the use of abbreviations, as listed in 21 CFR 101.9(j)(13)(ii)(B).  We 
now allow for the following additional abbreviations on labels for small and intermediate-sized 
packages: vitamin may be abbreviated as Vit., potassium may be abbreviated as Potas., 
and Includes may be abbreviated as Incl.  These abbreviations will further conserve label 
space.  In addition, we allow the abbreviations of Total carb. and Incl. to be used on dual-
column display labels (see section VIII.D).  
 
VIII.C.1  What Type Size Must be Used for the Declaration of Calories on the Tabular 
or Linear Displays for Small or Intermediate-Sized Packages? 
 
The numeric value for Calories must be in a type size no smaller than 14 point, and the word 
Calories must be in a type size no smaller than 10 point (21 CFR 101.9(d)(1)(iii)).  See Figures 
9 and 10. 
 
VIII.C.2  How Do the Declarations of Serving Size and Servings Per Container on the 
Tabular or Linear Displays for Small or Intermediate-Sized Packages Differ 
from the Standard Label Version? 
 
The ___ servings per container declaration immediately follows the Nutrition Facts heading, 
as in the standard label version; however, it must be in a type size no smaller than 9 point on the 
tabular or linear display for small packages (21 CFR 101.9(d)(3)(i)).  If a linear display is used, 
then the actual number of servings (i.e., Servings as shown in Fig 10) may be listed instead of 
the servings per container declaration. 
 
The declaration of Serving size, which follows below the ___ servings per container or 
servings declaration, is to be highlighted in bold or extra bold and in a type size no smaller 
than 9 point on the tabular or linear display for small or intermediate-sized packages.  See 
Figures 9 and 10. 
 
VIII.C.3  Is the % Daily Value* Footnote Required on Foods in Small and 
Intermediate-Sized Packages? 
 
For products in small and intermediate-sized packages that qualify for the use of the tabular or 
linear format as specified in 21 CFR 101.9(j)(13)(ii)(A)(1) and (2), there is no longer a 
requirement to place an asterisk, followed by the statement Percent Daily Values are based on a 
2,000 calorie diet, at the bottom of the label if the footnote corresponding to % Daily Value is 
omitted.  If Daily Value is not spelled out in the heading, then an asterisk can be placed at the 
bottom of the label followed by the statement % DV = % Daily Value in a type size no smaller 
than 6 point (21 CFR 101.9(d)(1)(iii)).  See Figures 9 and 10. 
 
VIII.D How Do I Comply with the Nutrition Labeling Formatting Requirements when Dual 
Column Labeling is Required or Provided Voluntarily? 
 
Dual column labeling is required under certain conditions, and can be used in other situations.  In 
the Federal Register of March 2, 2018 (83 FR 9003), we announced the availability of a separate 
Small Entity Compliance Guide entitled Food Labeling: Serving Sizes of Foods That Can 
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  Contains Nonbinding Recommendations 
Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, 
Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size 
for Breath Mints; and Technical Amendments: Guidance for Industry, which, among other 
topics, discusses a new requirement regarding the use of dual-column labeling (Ref. 9).  In the 
Federal Register of December 31, 2019 (84 FR 72230), we announced the availability of a final 
guidance for industry entitled Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-
Related Issues, Dual-Column Labeling, and Miscellaneous Topics.  This final guidance also 
discusses formatting issues for dual-column labeling (Ref. 10). 
 
Regarding specific formatting for dual column labeling, the final rule updates certain 
requirements.  Directly following the serving size declarations, each column of nutrition 
information must contain a heading that accurately describes why a dual column is being 
utilized.  For example, a product may provide nutrition information for two different RDI 
groups, like in Figure 11 below.  A product may also provide nutrition information for two 
different forms of the same food (e.g., Per 14 cup mix and Per prepared portion), as in Figure 
12 below (21 CFR 101.9(e)).  The quantitative information by weight and percent DV must be 
presented for each column, and the columns are to be separated by vertical lines (21 CFR 
101.9(e)(3)).  Nutrient information for vitamins and minerals must be separated from the 
information on other nutrients by a bar and be arrayed vertically in the required order (21 CFR 
101.9(e)(4)).  Note that the Amount per serving statement is not required for the dual column 
formats (21 CFR 101.9(d)(4)).  See Figures 11 through 15 (see also 21 CFR 101.9(e)(5) and 
(e)(6)(i)). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Figure 11: Dual Column Display for 2 different RDI Groups (101.9(e)(5)) 
 
1. Serving Size and 
Servings Per 
Container reflect the 
different RDI 
groups for the 
product 
2. Abbreviations of 
Total Carb. and 
Incl. are allowed 
on this label 
 
3. Vitamins and 
minerals are 
separated from 
information on other 
nutrients by a bar 
4. The appropriate 
% Daily Value 
footnote for each 
population group is 
  included 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  Contains Nonbinding Recommendations 
Figure 12: Dual Columns, Two Forms of the Same Food (101.9(e)(5)) 
 
1. Amount per 
serving declaration 
is not required 
 
 
Figure 13: Dual Column Display, Per Serving and Per Container (101.9(e)(6)(i)) 
 
1. Two column 
headings describing 
why the dual 
column display is 
being used 
 
 
 
 
 
 
 
 
 
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  Contains Nonbinding Recommendations 
Figure 14: Dual Column Display, Per Serving and Per Unit (101.9(e)(6)(i)) 
 
 
 
Figure 15 shows the use of dual columns in a tabular display format for products.  As mentioned 
above, Calories must be in a type size no smaller than 10 point, and the numeric amount for 
Calories must be in a type size no smaller than 22 point (21 CFR 101.9(d)(1)(iii)).  Serving 
size declaration must be in a type size no smaller than 9 point; however, the ___ servings per 
container declaration must be in a type size no smaller than 10 point, as with the standard label 
version (21 CFR 101.9(d)(3)(i) and (ii)).  Amount per serving is not required (21 CFR 
101.9(d)(4)). 
 
Figure 15: Tabular Dual Column Display (101.9(e)(6)(ii)) 
 
 
 
VIII.E When Can the Simplified Format Be Used? 
 
You can use the simplified format when a food product contains insignificant amounts of eight 
or more of the following: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total 
carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and 
potassium (21 CFR 101.9(f)).  For foods intended for infants through 12 months of age and 
children 1 through 3 years of age, you can use the simplified format when a food product 
contains insignificant amounts of six or more of the following: Calories, total fat, sodium, total 
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  Contains Nonbinding Recommendations 
carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, or 
potassium (21 CFR 101.9(f)).  The definition of insignificant amount has not changed.   
 
The footnote requirement which states, Not a significant source of ___ (listing the name(s) of 
any nutrients listed in this paragraph that are present in insignificant amounts) still exists (21 
CFR 101.9(f)(4)).  While the full % Daily Value footnote (see 21 CFR 101.9(d)(9)) is not 
required for the simplified format, the column header % Daily Value can be abbreviated as % 
DV.  If this abbreviation is used, then an asterisk must be placed at the end of the abbreviation 
and the corresponding footnote must read, % DV = % Daily Value (21 CFR 101.9(f)(5)).  No 
footnote is required if Daily Value is spelled out in the column header (21 CFR 101.9(f)(5)).  
Figure 16 displays an example of a simplified format label. 
 
Figure 16: Simplified Format Label (101.9(f)) 
 
 
 
VIII.F Are Foods in Small Packages with a Total Surface Area Available to Bear Labeling 
of Less than 12 Square Inches Exempt from the Nutrition Facts Labeling 
Requirements? 
 
Not always.  Foods in small packages that have a total surface area available to bear labeling of 
less than 12 square inches are not exempt from bearing a Nutrition Facts label if a nutrition claim 
or other nutrition information in any context on the label or in labeling or advertising (21 CFR 
101.9(j)(13)(i)) is used or as outlined for covered vending machine food (see 21 CFR 101.8(c)).  
However, as previously allowed, if your product qualifies for and uses the exemption (i.e., 
claims or other nutrition information are not presented on the label or in labeling or advertising), 
then you must list an address or telephone number that a consumer can use to obtain the required 
nutrition information (21 CFR 101.9(j)(13)(i)(A)). 
 
VIII.G  How Do These New Formatting Rules Affect the Percentage Juice Declaration? 
 
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With the changes to some type size requirements on the Nutrition Facts label, it is permissible if 
the percentage juice declaration for foods purporting to be beverages that contain fruit or 
vegetable juice is smaller in height than the declaration of Serving size, Calories, and the 
numerical value for Calories, in addition to already being permitted to be smaller in height 
than the brand name, product name, logo, universal product code, and Nutrition Facts heading  
(21 CFR 101.30(e)(2)). 
 
VIII.H  Are There Specific Formatting Requirements for Supplement Facts Labels? 
 
Information other than the title, headings, and footnotes must be in uniform type size no smaller 
than 8 point (21 CFR 101.36(e)).  Column headings (e.g., Amount Per Serving and % Daily 
Value) and footnotes (e.g., Percent Daily Values are based on a 2,000 calorie diet) must be in 
a type size no smaller than 6 point (21 CFR 101.36(e)).  Because many dietary supplement 
products may contribute a negligible amount of calories, we do not require information about 
calories to be displayed in a larger type size or highlighted on Supplement Facts labels (81 FR 
33742 at 33939). 
 
For small packages which have a total surface area available to bear labeling of less than 12 
square inches, all information within the nutrition label must be in type size no smaller than 4.5 
point (21 CFR 101.36(i)(2)(i)).   
 
Intermediate-sized packages, which have from 12 to 40 square inches of surface area available to 
bear labeling, have different type size requirements.  All information within the nutrition label 
must be in a type size no smaller than 6 point (21 CFR 101.36(i)(2)(ii)).  However, type size no 
smaller than 4.5 point may be used on packages that have less than 20 square inches available for 
labeling and more than eight dietary ingredients to be listed (21 CFR 101.36(i)(2)(ii)).  Similarly, 
type size no smaller than 4.5 point may be used on packages that have 20 to 40 square inches 
available for labeling and more than 16 dietary ingredients to be listed (21 CFR 101.36(i)(2)(ii)). 
 
The footnote stating that the Percent Daily Values are based on a 2,000 calorie diet is required 
if the percent DV is declared for total fat, saturated fat, total carbohydrate, dietary fiber, protein, 
or added sugars (21 CFR 101.36(b)(2)(iii)(D)).  On labels of products represented or purported to 
be for use by children 1 through 3 years of age, the footnote statement must read: Percent Daily 
Values are based on a 1,000 calorie diet if the % Daily Value is declared for total fat, total 
carbohydrate, dietary fiber, protein, or added sugars (21 CFR 101.36(b)(2)(iii)(D)). 
 
If there is inadequate space to list the required information vertically, the list may be split.  The 
list to the right must be set off by a line that distinguishes it and sets it apart from the dietary 
ingredients and percent DV information given to the left (21 CFR 101.36(e)(12)).  The column 
headings are also repeated (21 CFR 101.36(e)(12)).  Figure 17 reflects this label formatting. 
 
 
 
 
 
 
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Figure 17: Supplement Facts Label  Split List (101.36(e)(12))  
 
 
 
IX.  When Must I Comply with the Rule? 
 
If you have $10 million or more in annual food sales, your compliance date is January 1, 2020.  
If you have less than $10 million in annual food sales, your compliance date is January 1, 2021. 
 
If you manufacture single-ingredient packages and/or containers of pure honey, pure maple 
syrup, or other pure sugars and syrups, as well as the cranberry products discussed in the Final 
Guidance (Ref. 1), we intend to exercise enforcement discretion until July 1, 2021, for 
compliance with the labeling changes outlined in the Nutrition Facts label rule and the Serving 
Size rule. 
 
If you manufacture certain dried cranberry products with added flavorings (Ref. 11), we intend to 
exercise enforcement discretion until July 1, 2020, for compliance with the labeling changes 
outlined in the Nutrition Facts label final rule and the Serving Size final rule. 
 
X.  Why Must I Comply with the Rule? 
 
Failure to comply with the final rule will render the covered food misbranded under section 
403(q) of the FD&C Act and potentially other sections as well.  The introduction or delivery for 
introduction into interstate commerce of any food that is misbranded constitutes a prohibited act 
under section 301(a) of the FD&C Act.  Among potential consequences, committing a prohibited 
act can result in injunction and/or seizure (see sections 302 and 304 of the FD&C Act (21 U.S.C. 
332 and 334)). 
 
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  Contains Nonbinding Recommendations 
XI.  References 
 
The following references are on display at the Dockets Management Staff ((HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov.  FDA has verified the website addresses, 
as of the date this document publishes in the Federal Register, but websites are subject to change 
over time. 
 
1.  U.S. Food and Drug Administration. 2019. The Declaration of Added Sugars on Honey, 
Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products: 
Guidance for Industry. Accessed online at https://www.fda.gov/media/127928/download. 
 
2.  U.S. Food and Drug Administration. 2019. The Declaration of Allulose and Calories from 
Allulose on Nutrition and Supplement Facts Labels: Guidance for Industry. Accessed online 
at https://www.fda.gov/media/123342/download. 
 
3.  U.S. Food and Drug Administration. 2019. Nutrition and Supplement Facts Labels: 
Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of 
Quantitative Amounts of Vitamins and Minerals: Guidance for Industry. Accessed online at 
https://www.fda.gov/media/117402/download. 
 
4.  U.S. Food and Drug Administration. 2018. The Declaration of Certain Isolated or Synthetic 
Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels: 
Guidance for Industry. Accessed online at https://www.fda.gov/media/113663/download. 
 
5.  U.S. Food and Drug Administration. 2019. FDA Grants Citizen Petition for Dietary Fiber. 
Accessed online at https://www.fda.gov/food/cfsan-constituent-updates/fda-grants-citizen-
petition-dietary-fiber. 
 
6.  U.S. Food and Drug Administration. 2020. FDA Grants Citizen Petition on Glucomannan as 
a Dietary Fiber. Accessed online at https://www.fda.gov/food/cfsan-constituent-updates/fda-
grants-citizen-petition-glucomannan-dietary-fiber. 
 
7.  U.S. Food and Drug Administration. 2018. Scientific Evaluation of the Evidence on the 
Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates 
Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry. Accessed online at 
https://www.fda.gov/media/101183/download. 
 
8.  U.S. Food and Drug Administration. 2019. The New Nutrition Facts Label: Examples of 
Different Label Formats. Accessed online at https://www.fda.gov/media/99151/download. 
 
9.  U.S. Food and Drug Administration. 2018. Food Labeling: Serving Sizes of Foods That Can 
Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, 
Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Service 
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  Contains Nonbinding Recommendations 
Size for Breath Mints; and Technical Amendments: Guidance for Industry. Accessed online 
at https://www.fda.gov/media/111144/download. 
 
10. U.S. Food and Drug Administration. 2019. Food Labeling: Serving Sizes of Foods That Can 
Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily 
Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics: 
Guidance for Industry. Accessed online at https://www.fda.gov/media/133699/download. 
 
11. U.S. Food and Drug Administration. 2019. Policy Related to Cranberry Products with Added 
Flavorings: Guidance for Industry. Accessed online at 
https://www.fda.gov/media/130373/download. 
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