Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
Questions and Answers About Dietary 
Guidance Statements in Food Labeling: 
Guidance for Industry 
 
Draft Guidance 
 
This guidance is being distributed for comment purposes only. 
 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure 
that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 
within 90 days of publication in the Federal Register of the notice announcing the availability of 
the draft guidance.  Submit electronic comments to http://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 FDA-2023-D-1027 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 
 
March 2023 
   
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Table of Contents 
I. Introduction
   
II. Background
   
III. Definitions
   
IV. Recommendations for How to Use Dietary Guidance 
 
Statements in Food Labeling
 
V. Recommendations for the Source of the Dietary Guidance 
 
Statement
 
VI. Recommendations for Meaningful Amounts of Recommended 
 
Foods or Food Groups a Product Should Contain When 
Making a Dietary Guidance Statement
 
VII. Recommendations for Nutrient Levels When A Product Bears 
 
a Dietary Guidance Statement
 
VIII.References
   
Appendix 1. Examples of Dietary Guidance Statements
 
Appendix 2. Recommendations for the Amount of Food that Should 
be Present per RACC by the Form of Food and Food Group If 
a Product Bears a Dietary Guidance Statement
 
Appendix 3. Recommendations for Products Bearing Dietary 
Guidance Statements
 
 
   
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Dietary Guidance Statements in Food 
Labeling: 
Guidance for Industry1 
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 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 at the phone number listed on the title page. 
I.  Introduction 
 
This guidance provides questions and answers on the use of Dietary Guidance Statements on 
packaged food labels or in the labeling of conventional foods.  It is intended to provide our 
current thinking on the use of Dietary Guidance Statements (i.e., statements relating a food or 
food group to a nutritious dietary pattern2 defined in greater detail below in Q&A III.1) on 
packaged food labels and more broadly in the labeling of foods, including any written, printed, or 
graphic material accompanying a food, such as labeling on websites.  
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe FDAs 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 FDA guidances means that something is suggested or recommended, but not 
required.   
II.  Background  
 
FDA seeks to improve dietary patterns in the United States to help reduce the burden of 
nutrition-related chronic diseases and advance health equity.  We are committed to 
accomplishing this by promoting healthy starts through improved maternal, infant, and child 
health, creating a healthier food supply for all, and empowering consumers with more 
informative and accessible labeling to choose healthier diets.  One key component of this work 
focuses on claims and nutrition-related statements, such as Dietary Guidance Statements, on food 
 
1 This draft 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.  
2 The Dietary Guidelines for Americans, 2020-2025 refer to healthy dietary patterns, however in our discussion of 
the use of Dietary Guidance Statements in this document we refer to nutritious dietary patterns so as not to cause 
confusion with the healthy nutrient content claim, which has specific regulatory criteria for its use (see Q&A 
III.9). 
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labeling.  Claims and Dietary Guidance Statements act as quick signals on the front of packages 
to help consumers, particularly consumers with lower nutrition or healthy literacy, better 
understand nutrition information. They also can encourage industry to reformulate products to 
create healthier products that consumers seek. 
 
Typically, labeling claims have focused on specific nutrients and nutrient-disease relationships.  
However, scientific knowledge and evidence in the field of nutrition has advanced, and dietary 
recommendations have evolved from those based on specific nutrient-disease relationships to 
those that take into account the entirety of the diet.  Current nutrition recommendations focus on 
the importance of healthy dietary patterns as a whole, and how foods and beverages act 
synergistically to affect health (Ref. 1).  One way in which we are modernizing our approach to 
food labeling is by providing guidance and regulations (e.g., the proposed rule titled, Food 
Labeling: Nutrient Content Claims; Definition of the Term Healthy(87 FR 59168)) that help 
facilitate the use of more claims and nutrition-related statements in food labeling that focus on 
providing more information to consumers about healthy dietary patterns.  The use of Dietary 
Guidance Statements (e.g., fruits and vegetables are part of a nutritious dietary pattern) in food 
labeling is one such tool to provide consumers with information to further this understanding.   
 
FDA has a broad mandate for nutrition labeling that includes the provision of regulations and 
policy for the use of voluntary labeling claims.  We have regulatory requirements for the use of 
certain nutrient content claims, such as healthy, which are claims that expressly or implicitly 
characterize the level of a nutrient in a food (21 CFR 101.13(b)).  Dietary Guidance Statements 
are not nutrient content claims, instead they are a type of voluntary labeling statement that can be 
used on labels that represent or suggest that an individual food or food group may contribute to 
or help maintain a nutritious dietary pattern (see Section III.1 below for definition).  Dietary 
Guidance Statements provide manufacturers with a broad range of messages beyond 
characterizing the nutrient content of the food (compared with nutrient content claims) and 
communicate to consumers that a food or food group may contribute to or help maintain a 
nutritious dietary pattern.  This guidance provides industry with our current thinking on the 
appropriate use of Dietary Guidance Statements in food labeling.  
 
On July 26, 2018, we held a public meeting where we sought input on key elements of the 
agencys Nutrition Innovation Strategy.  Among other things, we sought input on: (1) what types 
of claims or other nutrition-related labeling statements are most helpful in facilitating product 
innovation to promote healthful eating patterns; and (2) what types of claims and other labeling 
statements are most helpful to consumers in selecting foods consistent with recommendations in 
the Dietary Guidelines for Americans (Dietary Guidelines).  The comments we received during 
the public meeting and to the public meeting docket (docket number FDA-2018-N-2381) from a 
variety of stakeholders, including industry, consumers, trade associations, and consumer groups 
demonstrated that there is a clear interest in labeling claims, statements, symbols, and vignettes 
that will allow consumers to determine how foods and food groups can contribute to nutritious 
dietary patterns. 
 
This draft guidance provides recommendations on how and when manufacturers should use key 
or principal recommendations from consensus reports, such as the Dietary Guidelines, as the 
basis for labeling statements that represent or suggest that an individual food or food group may 
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contribute to or help maintain nutritious dietary patterns.  We consider these types of labeling 
statements to be Dietary Guidance Statements.  In this draft guidance, we define Dietary 
Guidance Statements and provide information to help industry determine ways to use Dietary 
Guidance Statements in labeling to make consumers aware of how their product contributes to a 
nutritious dietary pattern.  In addition, we provide recommendations for the source of the Dietary 
Guidance Statement, recommendations for the amount of the food or food group that is the 
subject of the statement that a product should contain if it bears a Dietary Guidance Statement 
(e.g., food group equivalent), and recommendations for the amount of sodium, saturated fat, 
and added sugars that a product should not exceed if it bears a Dietary Guidance Statement.  
These recommendations are based upon current nutrition science and dietary recommendations, 
such as the Dietary Guidelines, 2020-2025 (Ref. 1).    
 
The U.S. Department of Health and Human Services (HHS) and the U.S. Department of 
Agriculture (USDA) jointly publish the Dietary Guidelines every 5 years.  When developing the 
Dietary Guidelines, HHS and USDA are informed by the science-based recommendations of a 
panel of experts called the Dietary Guidelines Advisory Committee.  The Dietary Guidelines is 
based on the preponderance of current scientific and medical knowledge, and it provides federal 
recommendations for healthy dietary patterns for Americans.  They serve as the foundation for 
federal nutrition policy.  Although the Dietary Guidelines is issued every 5 years, the objectives 
of the majority of the recommendations, such as limiting intake of saturated fat, sodium, and 
sugars, and consuming foods with adequate amounts of fiber, have remained consistent since the 
first edition was released in 1980 (Ref. 2).  
 
The Dietary Guidelines, 2020-2025 includes recommended amounts of food from food groups 
found in three different healthy dietary patterns: the Healthy U.S.-Style Dietary Pattern, the 
Healthy Mediterranean-Style Dietary Pattern, and the Healthy Vegetarian Dietary Pattern.  All 
three nutritious dietary patterns provide intake recommendations for the following food groups: 
vegetables, fruits, grains, dairy, protein foods, as well as oils3 (Ref. 1).  We used information 
from the Healthy U.S.- Style Dietary Pattern to develop recommendations for food group 
equivalents for products bearing a Dietary Guidance Statement because this dietary pattern 
provides federal recommendations for the amounts of foods that most children and adults in the 
U.S. population 2 years of age and older should consume in order to meet nutritional needs.   
While the Dietary Guidelines, 2020-2025 provides recommendations for infants and children 
under the age of 2 years, for the purposes of this guidance document, we are providing 
recommendations for the use of Dietary Guidance Statements for individuals aged 2 and older.  
We also based our recommendations for the amount of sodium, saturated fat, and added sugars 
that a product should not exceed if it bears a Dietary Guidance Statement on key 
recommendations from the Dietary Guidelines, 2020-2025 for individuals aged 2 and older.   
 
On November 25, 2003, we published an Advance Notice of Proposed Rulemaking (ANPRM) in 
the Federal Register (68 FR 66040) that requested comment on, among other things, the use of 
Dietary Guidance Statements.  We received 18 comments from industry, trade associations, 
health professional organizations, consumer groups, and a Federal government agency.  Nutrition 
science has evolved as has our thinking on Dietary Guidance Statements since we issued the 
 
3 The Dietary Guidelines, 2020-2025 do not refer to oils as a food group, but they emphasize oils as part of a 
healthy dietary pattern.  For the purposes of this guidance, we refer to oils as a food group.   
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ANPRM, so some comments we received on Dietary Guidance Statements are not relevant to the 
draft guidance.  We have taken relevant comments to the ANPRM, as well as comments we 
received during and after the public meeting, into consideration when developing this draft 
guidance.  
 
III.  Definitions 
 
1.  What is a Dietary Guidance Statement? 
For the purposes of this guidance, Dietary Guidance Statements are written or graphic material, 
based on key or principal recommendations from a consensus report, in food labeling that 
represent or suggest that a food or a food group may contribute to or help maintain a nutritious 
dietary pattern (e.g., make half your grains whole; choose fat-free or low-fat dairy products 
instead of full-fat dairy options; or the Dietary Guidelines for Americans recommends eating 
fruits and vegetables as part of a balanced diet.  This food has 12 cup of broccoli per serving.).  
A Dietary Guidance Statement is not a nutrient content claim. We include several examples of 
Dietary Guidance Statements throughout this guidance and in Appendix 1.    
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Figure 1. Examples of Dietary Guidance Statements in Food Labeling  
 
 
 
Close-up of Dietary Guidance Statement: 
 
 
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Close-up of Dietary Guidance Statement: 
 
 
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2.  May a symbol or vignette be a Dietary Guidance Statement?  
Yes.  A Dietary Guidance Statement in food labeling may be graphic material, including 
symbols or vignettes, that convey to consumers that a food or a food group may contribute to 
or help maintain a nutritious dietary pattern.  For example, a symbol showing a 1/2 cup 
measure with vegetables in it accompanied by a statement that says, Vegetables are part of a 
nutritious dietary pattern may suggest that the food product contains  12 cup vegetables, 
which contribute to or helps maintain a nutritious dietary pattern.  
 
Figure 2: Examples of a Symbols/Vignettes on a Food Label that Would be Considered a 
Dietary Guidance Statement  
 
 
Close-up of Dietary Guidance Statement:
  
 
     
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3.  What is a Food Group? 
A food group is a group of foods recommended for consumption by a consensus report (see 
section V).  For example, the Dietary Guidelines, 2020-2025 explains that a healthy dietary 
pattern includes foods from the following food groups (Ref. 1): 
 
  Vegetables of all types; 
  Fruits, especially whole fruits;   
  Grains, at least half of which are whole grains; 
  Dairy, including fat-free or low-fat milk, yogurt, and cheese, and/or lactose-free versions 
and fortified soy beverages and soy yogurt alternatives;   
  Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; 
and nuts, seeds, and soy products; 
  Oils, including vegetable oils and oils in food, such as seafood and nuts.   
 
4.  What is an Individual Food? 
An individual food is a food that is comprised entirely, or almost entirely, of one food group 
(e.g., milk or a package of frozen mixed vegetables).  In cases where the food is comprised of 
more than one food group and one food group predominates (e.g., oatmeal with a very small 
amount of raisins added), it is also considered an individual food.      
 
5.  What is a Main Dish Product? 
Main dish products, defined at 21 CFR  101.13(m),4 are larger in size (weighing at least 6 
ounces (oz) per labeled serving) than individual foods and are intended to make a major 
contribution to a meal.  A main dish product might include, for example, a frozen entree that is 
intended to be eaten with additional items to form a full meal.   
 
4  Our regulations at 21 CFR  101.13(m) define a main dish product for the purposes of making a claim as a food 
that: (1) makes a major contribution to a meal by (i) weighing at least 6 ounces per labeled serving; and (ii) contains 
not less than 40 grams of food, or combinations of foods, from each of at least two of the following four food 
groups, except as noted in  101.13(m)(1)(ii)(E): (A) bread, cereal, rice, and pasta group; (B) fruits and vegetables 
group; (C) milk, yogurt, and cheese group; (D) meat, poultry, fish, dry beans, eggs, and nuts groups; except that: (E) 
these foods shall not be sauces (except for foods in the above four food groups that are in the sauces), gravies, 
condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and (2) is represented as, or is in a 
form commonly understood to be a main dish (e.g., not a beverage or dessert).  Such representations may be made 
either by statements, photographs, or vignettes.  
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6.  What is a Meal Product? 
Meal products, defined at 21 CFR  101.13(l)5, are larger in size (weighing at least 10 oz per 
labeled serving) than main dish products and are intended to provide all of the food for a single 
eating occasion (i.e., a full meal).  An example of a meal product is a frozen dinner. 
 
7.  What is the Difference Between Dietary Guidance Statements and Health 
Claims?  
Health claims describe a relationship between a food substance and reduced risk of a disease or 
health-related condition.  Dietary Guidance Statements differ from health claims because they do 
not contain both basic elements of a health claim: (1) substance; and (2) disease or health-related 
condition (21 CFR  101.14(a)(1)).  Dietary Guidance Statements also do not describe a 
relationship between the consumption of a food and a reduced risk of a disease or health-related 
condition.   
 
Table 1.Health Claim versus Dietary Guidance Statement Comparison 
Health Claim  Dietary Guidance Statement 
Basic elements   Basic elements  
1. Substance- a specific food or component of  1. A food or food group 
food, regardless of whether the food is in  2. Contributing to or maintaining a nutritious 
conventional food form or dietary supplement  dietary pattern.  
that includes vitamins, minerals, herbs, or 
other similar nutritional substances.   
2. Disease or health-related condition 
Focus:  Disease risk reduction   Focus:  Contributing to or maintaining 
nutritious dietary patterns  
Truthful and not misleading  Truthful and not misleading 
Generally undergoes review by FDA through  Does not undergo review by FDA prior to use 
a petition process6  in the marketplace  
Example: Diets low in sodium may reduce  Example: Eat broccoli as part of a nutritious 
the risk of high blood pressure, a disease  dietary pattern. 
associated with many factors.   
 
5 Our regulations at 21 CFR  101.13(l) define meal products for the purposes of making a claim to be food that: (1) 
makes a major contribution to the total diet by: (i) weighing at least 10 ounces (oz) per labeled serving; and (ii) 
contains not less than three 40 gram portions of food, or combinations of foods, from two or more of the following 
four food groups, except as noted in paragraph (l)(1)(ii)(E) of this section. (A) bread, cereal, rice, and pasta group; 
(B) fruits and vegetables group; (C) milk, yogurt, and cheese group; (D) meat, poultry fish, dry beans, eggs, and nuts 
group; except that; (E) these foods shall not be sauces (except for foods in the above four food groups that are in the 
sauces), gravies, condiments, relishes, pickles, olives, jams, jellies, syrups, breadings, or garnishes; and (2) is 
represented as, or is in a form commonly understood to be, a breakfast, lunch, dinner, or meal. Such representations 
may be made either by statements, photographs, or vignettes. 
6 See 21 U.S.C. 343(r) and 21 CFR  101.14.  For health claims based on an authoritative statement by a U.S. 
government scientific body, notification is required in accordance with 21 U.S.C. 343(r)(3)(C). 
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8.  What is the Difference Between Dietary Guidance Statements and Nutrient 
Content Claims?  
Dietary Guidance Statements are labeling statements that represent or suggest that an individual 
food or food group may contribute to or help maintain a nutritious dietary pattern.  In contrast, 
nutrient content claims expressly or implicitly characterize the level of a nutrient in a food (21 
CFR  101.13(b)).  For example, a claim that a food is low in fat content or high in Vitamin 
D content is considered a nutrient content claim.  The term healthy is also considered to be an 
implied nutrient content claim. Therefore, Dietary Guidance Statements provide manufacturers 
with a broader range of messages to communicate to consumers that a food or food group may 
contribute to or help maintain a nutritious dietary pattern.   
 
9.  What is the Difference Between Dietary Guidance Statements and the 
Implied Nutrient Content Claim Healthy? 
Healthy is an implied nutrient content claim in certain situations because it characterizes the 
level of nutrients in that food.  Healthy suggests that a food, because of its nutrient content, 
may help consumers maintain healthy dietary practices.  The implied nutrient content claim 
healthy is narrow in scope and only applies to certain uses of the specific term healthy and 
related terms (health, healthful, healthfully, healthfulness, healthier, healthiest, and 
healthiness).  Therefore, when the word healthy or a related term is used in the labeling of a 
food in connection with an explicit or implicit claim or statement about a nutrient, the product 
must meet the requirements for the use of the healthy nutrient content claim under 21 CFR  
101.65(d).7  In contrast, Dietary Guidance Statements do not characterize the nutrient content of 
a food and, instead, provide manufacturers with a broader range of messages to communicate to 
consumers how the product contributes to or helps maintain a nutritious dietary pattern.  
 
There are some foods (e.g., whole fruits and vegetables) that may be eligible to bear both the 
healthy implied nutrient content claim and also include a Dietary Guidance Statement in the 
product labeling.  Manufacturers could choose to use the healthy claim because of the foods 
nutrient profile or they may choose to use a Dietary Guidance Statement to convey to consumers 
that the product fits into a nutritious dietary pattern based on current recommendations.  There 
are other foods (e.g., certain whole grain snacks and flavored yogurt) that may be eligible to 
include a Dietary Guidance Statement in the product labeling, but not the healthy implied 
nutrient content claim.  Both types of labeling can assist consumers with making healthful 
dietary choices.  
 
 
7 FDA is in the process of updating the definition for the implied nutrient content claim healthy.  On September 
29, 2022, we published a proposed rule titled the Definition of Term Healthy (87 FR 59168).   
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IV.  Recommendations for How to Use Dietary Guidance 
Statements in Food Labeling 
 
1.  What Are Some Ways for Manufacturers to Use Dietary Guidance 
Statements in Food Labeling to Convey Healthful Attributes of Their 
Product?  
Manufacturers are encouraged to convey healthful attributes of their products to consumers by 
using Dietary Guidance Statements directly on packaged food labels or in other food labeling.  
For example, manufacturers may want to use Dietary Guidance Statements in written, printed, or 
graphic materials that accompany a food (e.g., on a company website or in brochures that 
accompany the food product).  
 
2.  Should Dietary Guidance Statements be Made on Dietary Supplements? 
No.  Current consensus report recommendations, including the Dietary Guidelines, encourage 
Americans to meet nutrient requirements through the consumption of whole foods (e.g., whole 
fruits and vegetables).  Therefore, manufacturers should not use Dietary Guidance Statements on 
products labeled as or purporting to be dietary supplements.  
 
3.  Should Dietary Guidance Statements be Made on Foods Represented or 
Purported to be for Infants and Children Under 2 Years of Age?  
While the Dietary Guidelines, 2020-2025 and other sources provide recommendations for infants 
and children under the age of 2 years, we are only providing recommendations for the use of 
Dietary Guidance Statements for individuals aged 2 and older at this time.  Infants and children 
younger than 2 years of age have different nutritional needs that apply to their particular life 
stages.  Furthermore, the recommendations in current consensus reports for amounts of foods to 
consume and limits on certain nutrients (e.g., added sugars) are very different for children under 
the age of two than they are for the general U.S. population 2 years and older. We intend to 
consider the new recommendations for infants and toddlers and whether or how to apply the 
recommendations to the use of Dietary Guidance Statements on products specifically intended 
for infants and children under the age of 2 years.  
 
 
 
 
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V.  Recommendations for the Source of the Dietary Guidance 
Statement  
 
1.  What is a Consensus Report? 
For purposes of this guidance document, a consensus report is a report that represents the 
consensus produced by a group of qualified experts whose bias and conflicts of interest have 
been minimized and that are convened to study a specific issue.  The consensus report 
conveys agreed-upon recommendations that reflect widely-accepted, objective views of 
current scientific evidence.  The information presented in a consensus report about nutrition 
should reflect an objective view of the scientific evidence, should have been thoroughly 
reviewed for scientific rigor, and should be consistent with sound nutrition science. Some 
examples of appropriate sources of consensus reports are listed in question V.5 below.  
 
2.  Why Should Dietary Guidance Statements be Based on Consensus 
Reports?  
The public health goal of dietary guidance is to improve the health of consumers by 
providing information through nutrition statements that are based on the best evidence-based 
scientific research on dietary patterns.  To achieve this goal, it is important that Dietary 
Guidance Statements be based on widely accepted dietary recommendations developed by 
qualified experts after conducting a comprehensive review of current scientific evidence 
(e.g., the Dietary Guidelines). Otherwise, Dietary Guidance Statements could be based on 
recommendations that are not generally accepted as beneficial to good nutrition and public 
health, and consumers would not be assured that the food or food group recommended in the 
Dietary Guidance Statement contributes to a nutritious dietary pattern.   
 
3.  May Any Statement or Phrase in a Consensus Report be Used as the Basis 
of a Dietary Guidance Statement?  
We recommend using only key or principal recommendations from consensus reports as the 
basis of a Dietary Guidance Statement.  The key or principal recommendations of a 
consensus report are easily identifiable because they are typically emphasized in some way 
(e.g., enclosed in a box or highlighted in the executive summary, or in a conclusion at the end 
of the report).  The key or principal recommendations of a report contain the consensus of the 
group of experts convened to develop the report and the endorsement of the scientific body 
or health organization that issued the report.  Use of key or principal recommendations rather 
than other individual phrases or statements in a consensus report helps ensure that 
information is not taken out of context and that the recommendations used as the basis for the 
Dietary Guidance Statement reflect the views of the organization responsible for issuing the 
report rather than the views of a minority of contributors or even a single person.   
 
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For example, the Dietary Guidelines, 2020-2025 includes several key recommendations that 
are set off in a box within the Executive Summary, such as the core elements that make up a 
healthy dietary pattern include fruits, especially whole fruit and the core elements that 
make up a healthy dietary pattern include fat-free or low-fat milk, yogurt, and cheese, and/or 
lactose-free versions and fortified soy beverages and yogurts as alternatives (Ref. 1).  These 
key recommendations from the Dietary Guidelines, 2020-2025 could accurately provide the 
basis for a Dietary Guidance Statement in food labeling.   
 
Basing Dietary Guidance Statements on a key or principal recommendation from a consensus 
report is also consistent with the Federal Food, Drug, and Cosmetic Acts (FD&C Act) 
requirements for the use of certain health claims and nutrient content claims that are based on 
an authoritative statement from U.S. scientific bodies with public health and nutrition 
expertise (sections 403(r)(2)(G) and 403(r)(3)(C) of the FD&C Act).  The FD&C Act sets 
forth requirements for the use of certain health and nutrient content claims if such claims are 
based on current, published, authoritative statements from certain federal scientific bodies, as 
well as from the National Academy of Sciences.  The FD&C Act requires that an 
authoritative statement shall not include a statement of an employee of the scientific body 
made in the individual capacity of the employee (section 403(r)(2)(G) of the FD&C Act).  
In addition, we have stated that authoritative statements should reflect a consensus within the 
identified scientific body if published by a subdivision of one of the Federal scientific bodies 
and be based on a deliberative review by the scientific body of the scientific evidence (Ref. 
3).  We are recommending a similar approach when determining the types of 
recommendations upon which Dietary Guidance Statements should be based.   
 
4.  Should the Dietary Guidance Statement Use the Same Wording as the Key 
or Principal Recommendation from the Consensus Report? 
We do not expect Dietary Guidance Statements to use the exact language of key or principal 
recommendations from the consensus report upon which they are based.  Dietary Guidance 
Statements may paraphrase the key or principal recommendations of a report as long as the 
paraphrase is true to the original recommendation and is not otherwise false or misleading.  
We understand manufacturers want to use Dietary Guidance Statements that are short, 
simple, and easily understood, and we encourage the use of simplified statements to help 
convey important nutrition information and healthful attributes about a product to consumers.  
For example, if the key or principal recommendation says that A healthy dietary pattern 
includes a variety of vegetables from all of the subgroups- dark green, red and orange, 
legumes (beans and peas), starchy, and other, a manufacturer may simplify the key or 
principal recommendation, while keeping in the spirit of the report, by using a Dietary 
Guidance Statement on a can of vegetables that says, Eat a variety of vegetables. 
 
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5.  What are Appropriate Sources of Consensus Reports for Use as the Basis 
for Dietary Guidance Statements?  
We recommend that consensus reports used as the basis for Dietary Guidance Statements be 
published, for example, by U.S. Federal government agencies or U.S. scientific bodies or 
U.S. health organizations outside the Federal government.  Consensus reports could be 
published by the Centers for Disease Control and Prevention (CDC), National Institutes of 
Health (NIH), and the Office of the Surgeon General and the Office of Disease Prevention 
and Health Promotion (ODPHP) within HHS; the Food Safety and Inspection Service (FSIS), 
Agricultural Research Service (ARS), Food and Nutrition Service (FNS), the Center for 
Nutrition Policy and Promotion (CNPP), and the National Institute of Food and Agriculture 
(NIFA) within USDA; and two of the National Academies of Sciences, Engineering, and 
Medicine (NASEM) (the National Academy of Sciences and the National Academy of 
Medicine, formerly the Institute of Medicine (IOM)).   
 
In addition to reports from these scientific bodies, appropriate sources could also include a 
consensus report from a public or private source that: (1) is a U.S. scientific body or health 
organization that was established with the purpose of protecting and promoting the public 
health of Americans and whose work directly relates to human nutrition; and (2) is neutral 
and objective without any conflicts of interest that may bias its review of the scientific 
evidence.  For example, if a consensus group of nutrition experts convened by the U.S. 
Preventive Service Task Force develops a report with nutrition recommendations for the 
general healthy U.S. population that reflects the totality of the publicly available evidence, 
such a group could be an appropriate source for a consensus report.  A key or principal 
recommendation from such a report could be used as the basis for a Dietary Guidance 
Statement.   
 
6.  What are Some Important Factors in Determining Whether a Dietary 
Guidance Statement is Based on a Consensus Report?  
We consider the following factors to be important when determining whether a Dietary 
Guidance Statement is based on a consensus report and recommend these be considered in 
evaluating the statements:  
 
a.  Individuals developing a report that is used as a source of a Dietary Guidance 
Statement should be knowledgeable of the subject matter.   
b.  The report should be developed by a group of experts who, by their knowledge and 
expertise, are qualified to evaluate the evidence on the subject of the Dietary 
Guidance Statement and who have minimal bias and conflicts of interest.  
c.  The report should be developed by a group of experts who were convened to 
address a specific scientific issue or topic related to the Dietary Guidance 
Statement.  
d.  The report should be based on sound nutrition science that is the result of a 
comprehensive review of available scientific evidence on the topic that is the 
subject of the Dietary Guidance Statement.  
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e.  The report recommendations used to develop a Dietary Guidance Statement should 
be based on data that have been replicated and fully examined in well-designed, 
peer-reviewed research studies.  
f.  Evidence to support a relationship between consumption of a food or food groups 
and its benefit to health should be well-established and widely accepted in the 
scientific community. 
g.  The report should make its sources of scientific information publicly available (e.g., 
through citations or a bibliography). 
h.  The report recommendations used to develop a Dietary Guidance Statement should 
reflect the current thinking and consensus of the scientific community on the topic. 
 
7.  May a Dietary Guidance Statement be Based upon Information in a 
Consensus Report Published Many Years Ago? 
The key or principal recommendations from a consensus report used to develop a Dietary 
Guidance Statement should reflect the current thinking of the scientific community on the 
topic.  Therefore, we recommend using only consensus reports that are currently in effect 
(i.e., have not been superseded by more recent reports or recommendations that address 
similar subjects) and are based on current science to develop the Dietary Guidance 
Statement.   
VI.    Recommendations for Meaningful Amounts of Recommended 
Foods or Food Groups a Product Should Contain When Making a 
Dietary Guidance Statement  
 
1.  Why Should a Product Bearing a Dietary Guidance Statement Contain a 
Meaningful Amount of the Food That is the Subject of the Statement?  
It is important that foods bearing Dietary Guidance Statements contain a meaningful amount of 
the food or food groups that are the subject of the Dietary Guidance Statement so that consumers 
can be assured that the product bearing the Dietary Guidance Statement contributes to a 
nutritious dietary pattern when consumed.  If a product bearing a Dietary Guidance Statement 
about a food group (e.g., fruit) contains little or no amount of that food group (e.g., only 1 
teaspoon fruit per serving), we would consider this information when evaluating if a Dietary 
Guidance Statement may be misleading or imply something false in product labeling.  We are 
concerned that if a product bears such a Dietary Guidance Statement in those circumstances, 
consumers could be persuaded to purchase and consume the food believing that the product 
makes a meaningful contribution to a nutritious dietary pattern, when in fact, it does not.  To 
ensure that products bearing a Dietary Guidance Statement contain a meaningful amount of the 
food that is the subject of the claim, we are providing  food group equivalents 
recommendations.  
 
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2.  What are Food Group Equivalents? 
Food group equivalents represent a way of calculating a meaningful amount of the food or 
food group that is the subject of the Dietary Guidance Statement.  As the Dietary Guidelines 
serves as the cornerstone of Federal nutrition policy, our concept for food group equivalents is 
based on the amount of food from different food groups recommended for consumption at the 
2,000 calorie level in the Healthy U.S.-Style Dietary Pattern in the Dietary Guidelines, 2020-
2025 (Ref. 4).  We are developing our food group equivalent recommendations based on 
amounts recommended at the 2,000 calorie level because 2,000 calories is often used for general 
nutrition advice, and it also is used for other purposes in nutrition labeling (e.g., when 
determining the Daily Values for some nutrients declared on the Nutrition Facts label).   
 
The Healthy U.S.-Style Dietary Pattern establishes specific daily food group and subgroup 
amounts in cup-equivalents, ounce-equivalents, or grams, depending on the type of food.  Cup- 
and ounce-equivalents identify the amounts of foods from each food group with similar 
nutritional content.  For example, while the forms of whole-wheat bread and brown rice are very 
different, the Dietary Guidelines, 2020-2025 considers one slice of whole wheat bread to be 
nutritionally similar to one half cup of cooked brown rice, and both represent an ounce-
equivalent of grains. 
 
The Dietary Guidelines, 2020-2025 says (Ref. 4):  
 
  Vegetables and fruits, 1 cup-equivalent is: 1 cup raw or cooked vegetable or fruit, 1 cup 
100% fruit juice or vegetable juice, 2 cups leafy salad greens, 12 cup dried fruit or 
vegetable. 
  Grains, 1 ounce-equivalent is: 12 cup cooked rice, pasta, or cereal; 1 ounce dry pasta or 
rice; 1 medium (1 ounce) slice bread, tortilla, or flatbread; 1 ounce of ready-to-eat cereal 
(about 1 cup of flaked cereal). 
  Dairy, 1 cup-equivalent is: 1 cup milk, yogurt, or fortified soymilk; 112 ounces natural 
cheese such as cheddar cheese or 2 ounces of processed cheese. 
  Protein Foods, 1 ounce-equivalent is: 1 ounce lean meats, poultry, or seafood; 1 egg; 14 
cup cooked beans or tofu; 1 tablespoon (Tbsp) nut or seed butter; 12 ounce nuts or seeds.  
 
3.  What are the Food Group Equivalent Recommendations When an 
Individual Food or Food Group is the Subject of the Dietary Guidance 
Statement? 
We recommend that when the subject of the Dietary Guidance Statement is an individual food or 
food group (e.g., apples or fruit), the product should provide 14 of the daily recommended 
amount of the food or food group at the 2,000 calorie level in the Healthy U.S.-Style Dietary 
Pattern found in the Dietary Guidelines, 2020-2025 per Reference Amount Customarily 
Consumed (RACC).   
 
In the past, we have assumed that the typical American eating pattern is three meals and one 
snack per day, i.e., four eating occasions (see final rules on general requirements for health 
claims and nutrient content claims in food labeling, 58 FR 2478 at 2495, January 6, 1993, and 58 
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FR 2302 at 2379 to 2380, January 6, 1993).  In other words, we assume that individuals generally 
have four opportunities in a day to meet the recommended daily food group amounts in the 
Healthy U.S.-Style Dietary Pattern.  Consistent with this assumption and our past approach, our 
current thinking on food group equivalents is based on four eating occasions per day.   
 
To calculate the recommended food group equivalents, we divided the recommended daily food 
group amounts in the 2,000-calorie dietary pattern by four eating occasions and rounded to the 
nearest half cup, ounce, or gram.  For example, because the recommended daily amount of fruit 
in the 2,000-calorie level pattern is 2 cup equivalents, we determined that the food group 
equivalent for fruit would be 12 cup equivalent (i.e., 2 cup equivalents divided by four).  This 
would mean that when the subject of the Dietary Guidance Statement is fruit, the product (e.g., 
frozen berries) should contain 12 cup equivalent of fruit per RACC for packaged foods.  The 
default food group equivalent was adjusted for certain protein subgroups to reflect different 
subgroup recommendations.  We provide our thinking on the adjustment of the default amounts 
for the protein subgroups further in Question VI.4.   
 
The recommended amounts of a food or food group that should be present in a food product per 
RACC when it is the subject of a Dietary Guidance Statement (food group equivalents) are 
provided in the following table:  
 
Table 2.--Food Group Equivalents 
Food Group and/or Subgroup  Food Group Equivalent 
Vegetables  12 cup equivalent vegetetable 
Fruits  12 cup equivalent fruit 
Whole Grain  12 grams whole grains 
Dairy   34 cup equivalent dairy 
Protein Foods   
                 Game Meats  1.5 ounce (oz) equivalent 
                 Seafood  1 oz equivalent 
                 Egg  1 oz equivalent 
                 Beans, peas, and soy products  1 oz equivalent 
                 Nuts and seeds  1 oz equivalent 
Oils  7 grams 
Appendix 2 provides recommendations for the amount of food that should be present in a food 
per RACC for the different forms that foods take within each food group (e.g., cooked vs. raw) 
when the product bears a Dietary Guidance Statement.   
 
4.  How Were the Food Group Equivalent Recommendations for Protein 
Foods Adjusted? 
Because specific recommendations for foods within the protein foods group vary, the protein 
foods group is divided into subgroups.  We are providing food group equivalent calculations 
only for subgroups of protein foods that are regulated by FDA under the FD&C Act.  The 
subgroups that we include in this draft guidance include beans, peas, and soy products, nuts and 
seeds, and the animal sources of protein that we regulate (i.e., game meats, shell eggs, and 
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seafood (excluding catfish), but not all meats and poultry).  After applying the calculations used 
for the food group equivalents for other food groups (i.e. recommended daily food group 
amounts in the 2,000-calorie dietary pattern divided by four eating occasions), we rounded the 
resulting values.  To make it easier for manufacturers to follow, the food group equivalents are 
stated in half and whole ounces rather than fractions of ounces.  To determine if the food group 
equivalent value should be rounded up or down, we took into consideration information about 
foods that are encouraged by the Dietary Guidelines, 2020-2025.  
The recommendation for protein foods in the Healthy U.S.-Style Dietary Pattern at the 2,000-
calorie level is 5 12 ounce-equivalents per day.  As one fourth of 5 12 is 1 14 (assuming 4 eating 
occasions per day), based on standard rounding rules, we have calculated the food group 
equivalent for game meat to be 1 12 ounce- equivalent.  We are rounding down to 1 ounce-
equivalent for beans, peas, and soy products, nuts and seeds, and seafood to increase the number 
of products containing these subgroups that would be eligible to bear a Dietary Guidance 
Statement, and therefore encourage consumption of these foods.  This approach is consistent 
with the Dietary Guidelines, 2020-2025 strategy to increase the variety of choices made by 
replacing some meats, poultry, and egg intake with seafood, legumes, nuts, and seeds.  We are 
rounding down to 1 ounce-equivalent for eggs because one egg is typically 1 ounce, and one egg 
is a common serving size. 
 
5.  How Was the Food Group Equivalent for Whole Grains Derived?  
 
According to the Dietary Guidelines, 2020-2025, 1 ounce-equivalent of 100 percent whole grains 
has 16 grams of whole grains (Ref. 1).  Therefore, we used 16 grams of whole grains in 
calculating the food group equivalent for whole grain foods.  The food group equivalent 
recommendation for whole grains is provided in grams rather than in ounce equivalents because, 
when whole grains are added as an ingredient to a product, it may be easier for manufacturers to 
determine the number of grams added rather than the number of ounce equivalents added to the 
product in formulation.  The recommended intake of whole grains per day for a 2,000 calorie diet 
in the Healthy US-Style Dietary Pattern is 3 ounce-equivalents per day.  Assuming 4 eating 
occasions, the food group equivalent for whole grains is calculated as follows:  
 
3 ounce-equivalents x 16 grams per ounce-equivalent = 48 grams whole grains recommended per 
day 
 
48 grams/4 eating occasions = 12 grams whole grains 
   
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6.  What are the Food Group Equivalent Recommendations For a Mixed 
Product or When More than One Food or Food Group is the Subject of the 
Dietary Guidance Statement? 
Mixed products are products that are similar in size to an individual food, but they contain 
significant amounts of food from more than one food group.  Within the mixture of foods, no one 
food group predominates.  For example, a mixed product could include granola that contains 
whole grains and nuts.  Another example is a trail mix that contains dried fruit and nuts.  
  
If the subject of the Dietary Guidance Statement is the entire mixed product (e.g., trail mix), we 
recommend that the product contain at least half of one food group equivalent from two different 
food groups.  For example, a bag of trail mix with fruit and nuts bearing a Dietary Guidance 
Statement about the entire product (e.g., Trail mix can be part of a well-balanced diet.) should 
contain 14 cup-equivalent of fruit and 12 ounce-equivalent of nuts. 
 
If the subject of the Dietary Guidance Statement, however, is about more than one food or food 
group (e.g., fruits and vegetables) that are ingredients of the overall food product, we recommend 
that the product contain at least one food group equivalent from each of the different foods or 
food groups that are the subject of the Dietary Guidance Statement.  For example, if a frozen 
dinner bears a Dietary Guidance Statement about whole grains and seafood, we recommend the 
product contain 12 grams of whole grains and 1 ounce-equivalent of seafood.  
 
7.  What are the Food Group Equivalent Recommendations For Main Dishes 
and Meals? 
Due to the larger size and purpose in the diet of main dishes and meals, we recommend that, if 
the subject of a Dietary Guidance Statement is about a main dish product (e.g., baked chicken), 
the product contain at least one food group equivalent each from at least two different food 
groups.  If the subject of the Dietary Guidance Statement is the entire meal product (e.g., a 
frozen dinner), the product should contain at least one food group equivalent each from at least 
three different food groups.    
 
8.  What if a Product Bearing a Dietary Guidance Statement Does Not Meet 
the Food Group Equivalents Recommendations?  
We recommend that foods bearing a Dietary Guidance Statement meet the food group equivalent 
recommendations set forth in this draft guidance.  However, we recognize that some foods or 
food groups that are the subject of a key or principal recommendation from a consensus report 
may not meet the recommendations for food group equivalents, but nonetheless food 
manufacturers should not be discouraged from using Dietary Guidance Statements on these types 
of products.  For example, current dietary recommendations encourage Americans to increase 
their consumption of all whole fruits and vegetables (Ref. 1).  Despite the long-standing 
recommendation to consume fruits and vegetables, more than three-fourths of the population has 
a dietary pattern low in vegetables and fruits (Ref. 1).  Manufacturers may use Dietary Guidance 
Statements to encourage consumption of whole fruits and vegetables.  Therefore, while we are 
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providing food group equivalent recommendations for most foods, raw, whole fruits and raw, 
whole vegetables8 may not meet any food group equivalent recommendations but may still bear 
Dietary Guidance Statements.  For example, an apple should be able to bear a Dietary Guidance 
Statement even though it may not always contain 12 cup equivalent of fruit.   
 
9.  What about Plant-Based Milk Alternatives and Plant-based Yogurt 
Alternatives? 
According to the Dietary Guidelines, 2020-2025, soy beverages (commonly known as soy 
milk) and soy yogurt  which are fortified with calcium, vitamin A, and vitamin D  are 
included as part of the dairy group because they are similar to milk and yogurt based on nutrient 
composition and in their use in meals.  The nutritional profiles of fortified soy beverages and 
fortified soy yogurt alternatives are similar to the nutritional profile of the dairy food group.  The 
Dietary Guidelines, 2020-2025 does not include other products and beverages made from plants 
(e.g., almond, rice, coconut, oat, and hemp products) as part of the dairy group nor do they 
contribute to meeting the dairy group recommendation because their overall nutritional content is 
not similar to dairy foods.  However, it is possible that in the future, these types of products may 
be formulated or fortified to have nutritional profiles that are more similar to the profile of the 
dairy food group.  To support the availability of non-dairy choices for individuals who are 
lactose intolerant or allergic to dairy or choose not to consume dairy, it is appropriate for 
products labeled as plant-based alternatives to milk and yogurt to bear Dietary Guidance 
Statements when these products are fortified to have an overall nutritional content similar to 
products in the dairy group.  If the subject of the Dietary Guidance Statement is dairy, we believe 
that consumers could reasonably expect that a plant-based alternative to milk or yogurt makes 
meaningful contributions of the nutrient(s) found in milk or yogurt.  According to the Dietary 
Guidelines, 2020-2025, soy beverages (commonly known as soy milk) and soy yogurt  
which are fortified with calcium, vitamin A, and vitamin D  are included as part of the dairy 
group because they are similar to milk and yogurt based on nutrient composition and their use in 
meals.  However, to support the availability of non-dairy choices, we support the use of Dietary 
Guidance Statements on all plant-based milk and yogurt alternatives  not just soy based 
alternatives  that have an overall nutritional content that provides similar amounts of nutrients 
as found in the dairy group.9  For example, a fortified almond beverage could bear a Dietary 
Guidance Statement saying, Drink fortified almond beverages as part of a nutritious dietary 
pattern.  These products should adhere to the recommended nutrient levels not to exceed when 
bearing Dietary Guidance Statements (see Section VII.).  
 
 
8 The Dietary Guidelines describe whole fruit as fruit in their complete form, in contrast to fruit in the form of fruit 
juice.  They describe that whole fruits include fresh, canned, frozen, and dried fruits and can be eaten in a variety of 
forms, such as cut, sliced, diced, or cubed.   For the purpose of Dietary Guidance Statements, we are similarly using 
the  phrase whole fruits and vegetables  to include fresh, canned, frozen, and dried forms and to exclude fruit 
juice, to be consistent with the Dietary Guidelines. 
9 To determine whether a plant-based milk or yogurt alternative has an overall nutritional content that provides 
similar amounts of nutrients as found in the dairy group, FDA recommends using USDAs FNS fluid milk 
substitutes nutrient criteria (e.g., calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, 
riboflavin, and vitamin B12).  These are the same nutrients that the Dietary Guidelines identify in the Dairy Group 
as key contributors of nutrients, except for zinc, choline, and selenium (Ref. 1).   
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10. If a Food Product Bears a Dietary Guidance Statement on the Label, May 
the Label Also Include a Statement About How Much of the Food or Food 
Group the Product Contains in Addition to the Dietary Guidance 
Statement?  
As an option, the product may include a statement on its label near or adjacent to the Dietary 
Guidance Statement that tells consumers the amount of the food or food group that is the subject 
of the Dietary Guidance Statement present in one serving of the product (e.g., This food has 12 
cup vegetables per serving).  Many nutrition-related consensus reports provide information 
about the amounts of food from each food group one should strive to consume per day for a 
healthy dietary pattern (e.g., USDA Food Patterns).  Statements about how much of the food or 
food group the product contains provide additional quantitative information about the amount of 
a recommended food or food group in a product.  This information can help consumers 
determine how the food contributes to recommended amounts of foods in nutritious dietary 
patterns and how the food fits into their overall dietary patterns.   
 
11. What Information Should a Statement About How Much of the Food or 
Food Group the Product Contains Include?  
When a statement about the amount of a recommended food or food group in a serving of a 
product is made alongside a Dietary Guidance Statements on a food label, we recommend that 
the statement include the amount of the food or food group that is the subject of the Dietary 
Guidance Statement in one labeled serving of the product.  For example, if a statement is made 
on the label of a product that contains a meaningful amount of whole grains, the statement could 
say, This food has 12 grams of whole grains per serving.  A statement about the amount of 
broccoli might say, This food has 12 cup of broccoli per serving.  If the subject of the Dietary 
Guidance Statement is a food group, the statement may be about the amount of the broader food 
group in a serving of the product (e.g., This food has 12 cup fruit per serving).  
 
Consumers in the United States generally measure oils using teaspoons or tablespoons rather 
than in grams.  Serving size amounts on the Nutrition Facts label are given in tablespoons.  
Consumers may understand a statement about oils better if the amount of oil provided in a 
labeled serving of a food is given in teaspoons or tablespoons as well as in grams.  Therefore, we 
recommend that when a statement is made about oils, both the gram amount and the number of 
teaspoons or tablespoons of oil per serving be stated (e.g., This food has ___tablespoon(s) or 
____gram(s) of oil per serving).  The first blank would contain the number of teaspoons or 
tablespoons of oil in the food and the second blank would contain the number of grams of oil in 
the food.  
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Figure 3: Examples of Dietary Guidance Statements with a  Statement About the Amount 
of the Recommended Food or Food Group in a Serving of the Product 
 
 
 
Close-up of Dietary Guidance Statement with a Food or Food Group Statement: 
 
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Close-up of Dietary Guidance Statement with a Food or Food Group Statement: 
 
 
 
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VII.    Recommendations for Nutrient Levels When A Product Bears 
a Dietary Guidance Statement 
 
1.  Why Should Products Not Exceed Certain Nutrient Levels When Bearing a 
Dietary Guidance Statement?  
Along with containing a meaningful amount of a recommended food or food group, it is 
important that food products bearing Dietary Guidance Statements not exceed certain nutrient 
levels that are inconsistent with healthy dietary patterns.  If they do, the Dietary Guidance 
Statement may cause consumers to believe that the product will contribute to a diet that promotes 
better health, when, in fact, the product contains levels of certain nutrients that are inconsistent 
with nutritious dietary patterns.   
Recommending foods adhere to certain nutrient limits when a product bears a Dietary Guidance 
Statement is consistent with FDAs existing claims requirements.  For example, our health claim 
regulations establish disqualifying nutrient limits at 20 percent of the Daily Value (DV) (21 CFR 
 101.14(a)(4)).  This means foods that exceed one of those nutrient limits are disqualified from 
bearing a health claim.  Similarly, our nutrient content claim regulations require products bearing 
a nutrient content claim to also bear a disclosure statement when the product exceeds 20 percent 
of the DV for certain nutrients (21 CFR  101.13(h)).  Additionally, foods must adhere to certain 
nutrient requirements to bear the nutrient content claim healthy (21 CFR  101.65(d)).   
We considered these nutrient requirements as well as the Dietary Guidelines, 2020-2025 
recommendations for nutrients to limit while determining the recommended nutrient levels for 
Dietary Guidance Statements.  We also wanted to ensure that a wide variety of products 
containing foods or food groups consistent with dietary recommendations fall below the 
recommended nutrient levels for Dietary Guidance Statements.  We note that the recommended 
nutrient levels for Dietary Guidance Statements provide greater flexibility than the healthy 
claim nutrient requirements.  We would consider whether a product falls below the 
recommended nutrient levels in this guidance when evaluating if a Dietary Guidance Statement 
is truthful and not misleading.  
 
2.  What Nutrients Should be Limited in Products that Bear a Dietary 
Guidance Statement? 
Products bearing a Dietary Guidance Statement should not exceed certain nutrient levels for 
saturated fat, sodium, and added sugars.  Most Americans exceed the Dietary Guidelines, 2020-
2025 recommended intake of saturated fat, sodium, and added sugars.  Excess consumption of 
these nutrients can increase caloric intake and/or the risk of chronic disease and, therefore, 
diminish the potential public health impact of Dietary Guidance Statements.  There is a well-
established relationship between the consumption of saturated fat and its effect on blood 
cholesterol levels (Ref. 5).  Evidence shows that diets lower in saturated fat are associated with a 
decreased risk of cardiovascular disease (CVD) (Ref. 6).  Dietary recommendations have also 
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long emphasized lowering sodium intake because there is a relationship between sodium 
consumption and blood pressure, and sodium consumption and CVD risk (Ref. 7).  Additionally, 
scientific evidence shows that healthy dietary patterns characterized, in part, by lower intakes of 
sugar-sweetened foods and beverages are associated with a decreased risk of CVD (Ref. 6).  
Further, the Dietary Guidelines, 2020-2025 recommends limiting consumption of saturated fats, 
sodium, and added sugars as part of its key or principal recommendations for a healthy dietary 
pattern.   
 
3.  What is the Recommended Level of Saturated Fat an Individual Food 
Should Not Exceed When the Product Label Bears a Dietary Guidance 
Statement? 
To ensure a variety of products containing foods or food groups as well as help Americans 
identify foods lower in saturated fat to achieve a healthy dietary pattern, we recommend that 
individual foods (including mixed products as described in Section VI, Question 6) bearing 
Dietary Guidance Statements not contain more than 10 percent of the DV for saturated fat (2 
grams) per RACC.  Foods with inherently higher levels of saturated fat which are recommended 
by, for example, the Dietary Guidelines, such as low-fat dairy products, eggs, seafood, and oils, 
fall below this recommended level.  Additionally, we recommend this saturated fat level for 
products bearing a Dietary Guidance Statement because this level is consistent with other 
consensus report recommendations (Ref. 5 and 8) and the Dietary Guidelines, 2020-2025 
saturated fat recommendation (less than 10 percent of calories per day).   
We are not recommending maximum nutrient levels for trans fat and cholesterol because the 
trans fat and cholesterol contents of food products are already sufficiently limited by the 
recommended saturated fat level.  Further, in 2015, we issued a final determination that partially 
hydrogenated oils (PHOs), the primary dietary source of industrially produced trans fat, are no 
longer recognized as safe for use in food (80 FR 34650, June 17, 2015), resulting in the 
elimination of the majority of uses of PHOs.  The compliance date for this determination was 
June 18, 2018, for most foods, with extended compliance dates to 2019, 2020, and 2021 for 
certain uses of PHOs (83 FR 23358, May 21, 2018).  As a result, the primary dietary source of 
trans fat has been largely removed from the food supply.  
 
4.  Should Nut or Seed Products that Exceed the Recommended Saturated Fat 
Level Bear Dietary Guidance Statements? 
We do not want to discourage the use of Dietary Guidance Statements on nut and seed products 
that are recommended as part of a nutritious dietary pattern but that may exceed the 
recommended saturated fat level for products bearing a Dietary Guidance Statement. Unsalted 
nuts and seeds are considered nutrient dense protein foods due to their nutrient profiles (e.g., they 
provide important nutrients such as unsaturated fatty acids and vitamin E). While nuts and seeds 
contain saturated fat, they have a fat profile of predominately monounsaturated and 
polyunsaturated fats and are recommended by the Dietary Guidelines as part of a healthy dietary 
pattern.  Numerous studies have demonstrated that replacing other sources of saturated fat in the 
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diet with nuts has beneficial effects on cardiovascular disease risk, including nuts with higher 
saturated fat content (Ref. 9 and Ref. 10).  Some nuts are higher in saturated fat than other nuts.  
However, the Dietary Guidelines, 2020-2025 recommends consuming nuts without 
differentiating between types.  Specifically, the Dietary Guidelines, 2020-2025 recommends 
reducing saturated fat by substituting certain ingredients with sources of unsaturated fats, 
including using nuts and seeds in a dish instead of cheese.   
Recommending that the saturated fats contributed from nuts and seeds count towards the 
recommended saturated fat limits for the use of Dietary Guidance Statements would be 
inconsistent with the scientific evidence demonstrating a beneficial effect of nut consumption on 
health outcomes, which is the basis for current dietary recommendations that nuts and seeds are 
part of a healthy dietary pattern. Therefore, when considering whether a product exceeds the 
recommended saturated level for Dietary Guidance Statements, the saturated fat content of the 
nuts and seeds should not contribute towards the overall recommended saturated fat level.  For 
example, a peanut butter product containing peanuts, sugar, vegetable oil, and salt should not 
contain more than 10 percent of the DV for saturated fat per RACC when it bears a Dietary 
Guidance Statement, but the saturated fat from the peanuts would not contribute to the 
recommended level.  Additionally, if a product only contains nuts, such as a jar of raw, unsalted 
peanuts, the product may exceed the recommended saturated fat level of 10 percent DV per 
RACC and bear a Dietary Guidance Statement.  Although, we are not recommending that nut 
and seed products meet the recommended saturated fat level for all other products bearing a 
Dietary Guidance Statement, we do recommend that nut and seed products as well as products 
containing nuts and seeds not exceed the recommended levels of sodium and added sugars 
discussed below.   
 
5.  What is the Recommended Level of Sodium an Individual Food Should 
Not Exceed When the Product Label Bears a Dietary Guidance Statement? 
Americans consume, on average, 3,400 milligrams (mg) of sodium per day  nearly 50 percent 
more than the 2,300 mg intake level per day, and even less for children younger than age 14, the 
Dietary Guidelines, 2020-2025 and NASEM recommend not to exceed as part of a nutritious 
dietary pattern.  Therefore, it is important to help consumers identify foods lower in sodium.  To 
ensure a variety of products containing foods or food groups recommended by the Dietary 
Guidelines may bear Dietary Guidance Statements and that those foods fit within a nutritious 
dietary pattern that is consistent with recommended sodium intake levels, individual foods 
(including mixed products as described in Section VI, Question 6) bearing Dietary Guidance 
Statements should not contain more than 15 percent of the DV for sodium (345 milligrams) per 
RACC.  This sodium level for products bearing Dietary Guidance Statements is recommended 
because a lower level would restrict the number of products that could bear a Dietary Guidance 
Statement, and a higher level could perpetuate sodium intakes above the Dietary Guidelines, 
2020-2025 and NASEMs recommendations.   
 
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6.  What Is the Recommended Level of Added Sugars an Individual Food 
Should Not Exceed When the Product Label Bears a Dietary Guidance 
Statement? 
Healthy dietary patterns can accommodate nutrient-dense foods with small amounts of added 
sugars.  However, as the amount of added sugars increases in the diet, it becomes more difficult 
to stay within calorie limits.  To help Americans identify foods lower in added sugars while also 
ensuring that a variety of products fall below the recommended added sugars level for products 
bearing Dietary Guidance Statements, we recommend that individual foods (including mixed 
products as described in Section VI, Question 6) bearing Dietary Guidance Statements not 
contain more than 10 percent of the DV for added sugars (5 grams) per RACC.  This level is 
recommended because a lower level would prevent foods that may contribute to a nutritious 
dietary pattern and are recommended by the Dietary Guidelines from bearing Dietary Guidance 
Statements.  
7.  What Are the Recommended Levels of Nutrients for Main Dish and Meal 
Products Bearing Dietary Guidance Statements? 
Because of their larger size and because the products represent a whole meal or substantial 
proportion of a meal, the recommended levels of nutrients for main dish and meal products 
bearing Dietary Guidance Statements are more flexible.  Consistent with the disqualifying 
nutrient limits for health claims and nutrient content claim nutrient levels for disclosure 
statements, main dishes bearing a Dietary Guidance Statement ideally should not exceed 30 
percent of the saturated fat and sodium DVs per RACC.  Main dishes bearing a Dietary 
Guidance statement should also not exceed 20 percent of the DV per RACC for added sugars.  
Similarly, consistent with the disqualifying nutrient limits for health claims and the nutrient 
content claim nutrient limits for disclosure statements, we recommend that meals bearing a 
Dietary Guidance Statement not exceed 40 percent of the saturated fat and sodium DVs per 
RACC.  Meal products bearing Dietary Guidance Statements should also not exceed 30 percent 
of the DV per RACC for added sugars.  These nutrient levels balance the goal of promoting 
consumption of products that contain foods or food groups that contribute to or help maintain a 
nutritious dietary pattern while helping consumers limit their intake of nutrients that can increase 
their risk of chronic disease.  
 
8.  What If a Product Exceeds the Recommended Nutrient Levels for Dietary 
Guidance Statements, but is Recommended as Part of a Nutritious Dietary 
Pattern in a Consensus Report? 
We recognize that some foods recommended by a consensus report as part of a nutritious dietary 
pattern may exceed the recommended nutrient levels for Dietary Guidance Statements.  
Ingredients added to some food products may help increase the consumption of foods 
recommended as part of nutritious dietary pattern.  For example, sugar is often added to fat-free 
and low-fat yogurt products, and these products are among the dairy foods encouraged by the 
Dietary Guidelines.   
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In situations when a food is recommended by a consensus report as part of a nutritious dietary 
pattern and the food has a nutrient profile that exceeds the recommended nutrient levels in this 
guidance, we continue to find it appropriate for such a product to bear a Dietary Guidance 
Statement.  However, when products exceed a recommended nutrient level set forth in this 
guidance, we recommend that these products bear a disclosure statement about the recommended 
nutrient level(s) it exceeds.  For example, a yogurt product bearing a Dietary Guidance Statement 
that contains 20 percent of the DV of added sugars should also bear a disclosure statement, such 
as:  
This product contains 10g (20% Daily Value) of Added Sugars per serving. Alternatively, 
manufacturers may choose to direct consumers to the Nutrition Facts label by using a disclosure 
statement such as: See nutrition information for ___________ content.   
We recommend placing the disclosure statement on the label near and visually connected to the 
Dietary Guidance Statement.  The statement will help ensure consumers have the information 
necessary to maintain nutritious dietary patterns.   
Figure 4: Example of Product Bearing a Dietary Guidance Statement with a Disclosure 
Statement  
 
Close-up of Dietary Guidance Statement with a Disclosure Statement: 
 
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9.  If a Nut or Seed Product Exceeds the Recommended Saturated Fat Level 
and Bears a Dietary Guidance Statement, Should it also Bear a Disclosure 
Statement? 
 
We do not want to discourage manufacturers from providing a disclosure statement about the 
saturated fat content of a nut or seed product when it exceeds the recommended saturated fat 
level because it would provide additional nutrition information to consumers.  However, we 
recommend manufacturers not include such a disclosure statement when a nut or seed product 
exceeds the recommended saturated fat level due to the saturated fat content of the nut or seed 
itself.  As described in Question 4 of this Section, while nuts and seeds contain saturated fats, 
they have a fat profile of predominately monounsaturated and polyunsaturated fat and are 
recommended by the Dietary Guidelines without distinguishing between different types.  When 
considering whether a product exceeds the recommended saturated fat level for Dietary 
Guidance Statements, the saturated fat content of the nuts and seeds should not contribute 
towards the overall recommended saturated fat level.  Therefore, we do not think a nut or seed 
product that bears a Dietary Guidance Statement and exceeds the recommended saturated fat 
level due to the saturated fat of the nut or seeds in the product should bear a disclosure statement 
about the saturated fat level of the product.  However, if a nut or seed product bearing a Dietary 
Guidance Statement exceeds the saturated fat level due to the saturated fat content of other 
ingredients (e.g., vegetable oil in peanut butter), or exceeds the recommended sodium level or 
added sugar level outlined in this guidance, we recommend that the product bear a disclosure 
statement as described in Question 8 of this Section.  
   
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VIII. References 
1.  U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary 
Guidelines for Americans, 20202025. 9th Edition. December 2020. Available at: 
https://www.dietaryguidelines.gov.  
 
2.  U.S. Department of Health and Human Services and U.S. Department of Agriculture. 1980 
Dietary Guidelines for Americans. February 1980. Available at: 
https://health.gov/dietaryguidelines/1980.asp. 
 
3.  U.S. Food and Drug Administration. Guidance for Industry: Notification of a Health Claim 
or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 1998.  
Available at:  https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-
authoritative-statement. 
 
4.  U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary 
Guidelines for Americans, 20202025, Table A3-2. 9th Edition. December 2020. Available 
at: https://www.dietaryguidelines.gov. 
 
 
5.  Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on 
Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment 
Panel III) Final Report. Circulation. 2002;106:3134-3421. Available at:  
https://www.nhlbi.nih.gov/files/docs/resources/heart/atp-3-cholesterol-full-report.pdf. 
 
6.  U.S. Department of Agriculture, Agricultural Research Service, Dietary Guidelines Advisory 
Committee,  Scientific Report of the 2020 Dietary Guidelines Advisory Committee: 
Advisory Report to the Secretary of Agriculture and the Secretary of Health and Human 
Services.  Washington, DC. (2020) Available at: https://www.dietaryguidelines.gov/2020-
advisory-committee-report.  
 
7.  IOM of the National Academies. Sodium Intake in Populations: Assessment of Evidence, 
Washington, DC: National Academies Press; 2013, pp. 235-284. 
 
8.  IOM of the National Academies.  Dietary Reference Intakes for Energy, Carbohydrate, 
Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 8:  
Dietary Fats:  Total Fat and Fatty Acids: Washington, DC:  National Academies Press; 
2002. 
 
9.  12. Coates, A.M., A.M. Hill, and S.Y. Tan.  Nuts and Cardiovascular Disease Prevention.  
Current Atherosclerosis Reports, 20:48, 2018.  Retrieved from: 
https://doi.org/10.1007/s11883-018-0749-3. 
 
10. 13. Bitok E & Sabate J. Nuts and cardiovascular disease. Progress in Cardiovascular 
Diseases, 61(1):33-37, 2018. doi: https://doi.org/10.1016/j.pcad.2018.05.003.
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Appendix 1. Examples of Dietary Guidance Statements 
  Make half your grains whole grain.  
  Make half your plate fruits and vegetables. 
  Focus on whole fruit. 
  Vary your veggies. 
  Choose fat-free or low-fat dairy products instead of full-fat dairy options. 
  Eat a variety of protein foods, including nuts and seeds. 
  Vary your protein routine. 
  Eat leafy green vegetables as part of a nutritious dietary pattern. 
  The Dietary Guidelines for Americans recommends eating fruits and vegetables as part of 
a nutritious dietary pattern.  This food has 12 cup of broccoli per serving.  
  Use vegetable oils instead of solid fats, when cooking.    
  Seafood, including shrimp, is part of a nutritious dietary pattern. 
 
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Example Graphics of Products Bearing Dietary Guidance Statements 
 
Close-up of Dietary Guidance Statement: 
 
 
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Close-up of Dietary Guidance Statement: 
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MyPlate visuals:  
 
   
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Close-up of Dietary Guidance Statement with a Food Group Equivalent Statement: 
 
 
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Close-up of Dietary Guidance Statement with a Food Group Equivalent Statement: 
 
 
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Close-up of Dietary Guidance Statement:  
 
 
 
 
 
 
 
 
 
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Close-up of Dietary Guidance Statement with a Disclosure Statement: 
 
 
 
 
 
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Appendix 2. Recommendations for the Amount of Food that Should 
be Present per RACC by the Form of Food and Food Group If a 
Product Bears a Dietary Guidance Statement 
 
Food Group  Recommended Amount per RACC 
Vegetables and Fruits   
Raw or cooked  12 cup 
Vegetable or fruit juice  12 cup 
Leafy salad greens  1 cup 
Dried fruit or vegetable  14 cup 
Whole Grains  12 grams  
Dairy   
Milk, yogurt or fortified plant-based  3/4 cup 
beverage 
Natural cheese such as cheddar  1 ounce 
cheese 
                Processed cheese  1.5 ounces 
Protein foods   
Seafood  1 ounce 
Game Meats  1.5 ounces 
Egg  1 egg 
Cooked beans or tofu   14 cup  
Nut butter  1 Tbsp 
Nuts or seeds  12 ounce 
Oils  7 grams 
 
 
 
 
 
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Appendix 3. Recommendations for Products Bearing Dietary Guidance Statements 
 
Product  The subject of the  Then the food group  And the recommended  The recommended  The recommended 
DGS is...  equivalent (FGE)  saturated fat level per  sodium level per  added sugar level 
recommendation is...  RACC is...  RACC is...  per RACC is... 
Individual food  A food, food group,  At least 1 FGE per 
or the entire food  RACC from 1 food group  10% DV (2 g)  15% DV (345 mg)  10% DV (5 g) 
product 
Mixed product  Entire product  At least 1/2 FGE per 
RACC each from 2  10% DV (2 g)  15% DV (345 mg)  10% DV (5 g) 
different food groups 
Main dish  A food or food group  At least 1 FGE per 
30% DV (6 g)  30% DV (690 mg)  20% DV (10 g) 
RACC from 1 food group 
Main dish  Two or more food  At least 1 FGE per 
groups  RACC from each of the 
30% DV (6 g)  30% DV (690 mg)  20% DV (10 g) 
food or food groups in 
the DGS 
Main dish  Entire product   At least 1 FGE per 
RACC each from 2  30% DV (6 g)  30% DV (690 mg)  20% DV (10 g) 
different food groups  
Meal  A food or food group  At least 1 FGE per 
40% DV (8 g)  40% DV (920 mg)  30% DV (15 g) 
RACC from 1 food group 
Meal  Two or more food  At least 1 FGE per 
groups  RACC from each of the 
40% DV (8 g)  40% DV (920 mg)  30% DV (15 g) 
food or food groups 
mentioned in the DGS 
Meal  Entire product  At least 1 FGE per 
RACC each from 3  40% DV (8 g)  40% DV (920 mg)  30% DV (15 g) 
different food groups 
 
 
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