[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18149-18153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1027]


Questions and Answers About Dietary Guidance Statements in Food 
Labeling: Draft Guidance for Industry; Availability; Agency Information 
Collection Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Questions and 
Answers About Dietary Guidance Statements in Food Labeling:

[[Page 18150]]

Draft Guidance for Industry.'' The draft guidance, when finalized, will 
provide FDA's current thinking on the use of Dietary Guidance 
Statements 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. This draft guidance is not final 
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by June 26, 2023 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 
guidance. Submit electronic or written comments on the proposed 
collection of information in the draft guidance by June 26, 2023.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-D-1027 for ``Questions and Answers About Dietary Guidance 
Statements in Food Labeling: Draft Guidance for Industry.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Nutrition and Food Labeling, Food Labeling and Standards 
Staff, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
Blakeley Fitzpatrick, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-1450 or Denise See, Center for Food Safety and Applied 
Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Questions and Answers About Dietary Guidance Statements in 
Food Labeling: Draft Guidance for Industry.'' We are issuing this draft 
guidance consistent with our good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent the current 
thinking of FDA 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 
alternate approach if it satisfies the requirements of the applicable 
statutes and regulations.
    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 labeling. 
Claims and Dietary Guidance Statements act as quick signals on the 
front of the package to help consumers, particularly consumers with 
lower nutrition or health literacy, better understand nutrition 
information. They also can encourage industry to reformulate products 
to create healthier options that consumers seek.
    On July 26, 2018, we held a public meeting where we sought input on 
the

[[Page 18151]]

Agency's Nutrition Innovation Strategy (public meeting). 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) (Ref. 1). The 
comments we received during the public meeting and to the public 
meeting docket (Docket No. FDA-2018-N-2381) from a variety of 
stakeholders, including industry, consumers, trade associations, and 
consumer groups, on the use of food labeling claims and statements 
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. We considered those comments in the development of 
this draft guidance.
    After the public meeting, we revisited prior work we had undertaken 
on the use of statements in food labeling that would signal to 
consumers how foods and food groups can contribute to nutritious 
dietary patterns that also informed the development of this draft 
guidance. For example, in December 2002, we announced our Consumer 
Health Information for Better Nutrition Initiative. The purpose of this 
initiative was to make available more and better information about 
conventional foods and dietary supplements to help consumers improve 
their health and decrease the risk of diet-related diseases by making 
sound dietary decisions. As part of this initiative, we established the 
Task Force on Consumer Health Information for Better Nutrition (the 
Task Force). The Task Force recommended that FDA seek opportunities to 
promote the development and use of Dietary Guidance Statements in food 
labeling to assist consumers to make better food choices and to 
establish healthier eating patterns. To further the goals of the 
Consumer Health Information for Better Nutrition Initiative, on 
November 25, 2003, we published an Advance Notice of Proposed 
Rulemaking (ANPRM) in the Federal Register (68 FR 66040) requesting 
comment on, among other things, the use of Dietary Guidance Statements 
in food labeling. Although the ANPRM also discussed various issues 
regarding health claims in the labeling of conventional foods and 
dietary supplements, this guidance document addresses only Dietary 
Guidance Statements used in the labeling of conventional foods because 
Dietary Guidance Statements are based on key or principal 
recommendations from consensus reports, and current consensus report 
recommendations encourage Americans to meet nutrient requirements 
through the consumption of whole foods (e.g., fruits and vegetables).
    We received 18 comments on the ANPRM from industry, trade 
associations, health professional organizations, consumer groups, and a 
Federal government agency in response to the ANPRM. Nutrition science 
has evolved as well as our thinking on Dietary Guidance Statements 
since we issued the ANPRM, so some comments we received on Dietary 
Guidance Statements are not relevant to the draft guidance. We 
considered the relevant comments in the development of this draft 
guidance.
    Consistent with current nutrition science, we are working on 
multiple ways we can modernize our approach to claims and nutrition-
related statements that focus on helping consumers understand which 
foods and food groups can contribute to a nutritious dietary pattern. 
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. To 
provide another tool to assist consumers in making informed choices 
that are consistent with a healthy dietary pattern, we are working on 
updating the definition for the implied nutrient content claim 
``healthy.'' In the Federal Register of September 29, 2022, we issued a 
proposed rule entitled ``Food Labeling: Nutrient Content Claims; 
Definition of Term `Healthy'.'' The proposed regulation, when 
finalized, would update the definition for the implied nutrient content 
claim ``healthy'' to specify when the claim can be used on human food 
products. The definition would revise the requirements for foods that 
can bear the claim. Consistent with the advances in nutrition science 
and evolution of dietary guidance, specifically the Dietary Guidelines 
for Americans, 2020-2025 (Dietary Guidelines, 2020-2025) (Ref. 2), the 
proposed framework for the updated definition of the ``healthy'' claim 
uses a food group-based approach in addition to nutrients to limit. The 
proposed, updated ``healthy'' claim criteria emphasize healthy dietary 
patterns by requiring that food products contain a certain amount of 
food from at least one of the food groups or subgroups recommended by 
the Dietary Guidelines, 2020-2025. The proposed regulation would also 
require a food product to be limited in certain nutrients, including 
saturated fat, sodium, and added sugars. The proposed rule would also 
add certain recordkeeping requirements for foods bearing the claim 
where compliance cannot be verified through information on the product 
label.
    The Dietary Guidelines is developed jointly by the U.S. Department 
of Agriculture (USDA) and the U.S. Department of Health and Human 
Services (HHS) and provides recommendations on healthy eating and the 
consumption of foods from various food groups, as well as the intake of 
specific macronutrients, such as saturated fats and added sugars, and 
micronutrients such as vitamins and minerals. They are developed every 
5 years and are informed by the 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 they currently provide 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, and while the emphasis on dietary 
patterns has evolved, the underlying recommendations have largely 
remained consistent since the first edition was released in 1980, such 
as limiting intake of saturated fat, sodium, and sugars, and consuming 
foods with adequate amounts of fiber (Ref. 1). The Dietary Guidelines 
is designed for nutrition and health professionals to help all 
individuals and their families consume a healthy, nutritionally 
adequate diet. The Dietary Guidelines is the foundation of Federal 
nutrition guidance and are intended to inform policymakers when they 
implement Federal policies and programs related to food, nutrition, and 
health. The Dietary Guidelines, in addition to other consensus reports 
and scientific information, helps FDA to shape regulations on 
nutrition-related claims and other information that is permitted on a 
food label.
    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 (Ref. 2). All three healthy dietary patterns provide intake

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recommendations for the following food groups: vegetables, fruits, 
grains, dairy, protein foods, as well as oils. (The Dietary Guidelines, 
2020-2025 does not refer to oils as a ``food group,'' but it emphasizes 
oils as part of a healthy dietary pattern. In the draft guidance, we 
refer to oils as a food group). We have used information from the 
Healthy U.S.-Style Dietary Patterns when developing recommendations for 
the amount of the food or category of food that is the subject of the 
statement that a product should contain if it bears a Dietary Guidance 
Statement (referred to as meaningful amounts or food group 
equivalents). We have 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.
    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 contribute to or help maintain nutritious dietary 
patterns. We consider these types of labeling statements to be 
``Dietary Guidance Statements.'' The draft guidance defines Dietary 
Guidance Statements and provides information to help industry determine 
how they may use Dietary Guidance Statements 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, the amount of the food or food group that is the 
subject of the statement that a product should contain (``meaningful 
amount'' or ``food group equivalent'') if it bears a Dietary Guidance 
Statement, and 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. 2). While our draft guidance encourages the consumption 
of whole grains consistent with nutrition science and Federal dietary 
guidance, we request comment on the use of Dietary Guidance Statements 
on refined grains that are staples of cultural cuisines that are not 
high in added sugars, saturated fat, and sodium. In addition, while our 
draft guidance provides recommendations for how to calculate 
``meaningful amounts'' or ``food group equivalents'' of a food or food 
group that is the subject of the Dietary Guidance Statement, we request 
comment on other possible options to help ensure products bearing 
Dietary Guidance Statements contain meaningful amounts of recommended 
foods or food groups so that consumers can be assured that the product 
bearing the statement contributes to a nutritious dietary pattern, when 
consumed. Further, as discussed in the draft guidance, 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 set forth in the 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 the guidance, we recommend that these 
products bear a disclosure statement about the recommended nutrient 
level(s) it exceeds. We are seeking comment on the disclosure statement 
recommendations. Lastly, we are seeking comment on whether we should 
include recommendations in this guidance for the use of dietary 
guidance statements on bottles or containers of plain water and other 
calorie-free beverages (e.g., flavored carbonated water, coffee, and 
tea).

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Questions and Answers About Dietary Guidance Statements in Food 
Labeling: Draft Guidance for Industry

OMB Control Number 0910-0381

    This draft guidance provides recommendations on how and when 
manufacturers may use Dietary Guidance Statements for labeling 
statements that represent or suggest that an individual food or food 
group may contribute to or help maintain nutritious dietary patterns. 
The draft guidance provides information to help industry determine how 
they may use Dietary Guidance Statements in labeling to make consumers 
aware of how their product contributes to a nutritious dietary pattern. 
As an option, the draft guidance provides recommendations for a product 
that 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 (also known as ``Food Group 
Equivalent Statements''). In addition, for foods that exceed a 
recommended nutrient level set forth in this guidance, the draft 
guidance provides recommendations that these products bear a disclosure 
statement about the recommended nutrient level(s) it exceeds.
    We estimate the burden of this collection of information as 
follows:

[[Page 18153]]



                                                    Table 1--Estimated Third-Party Disclosure Burden
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                                                                        Number of
                     Activity                          Number of       disclosures     Total  annual   Average  burden    Total hours     Total  capital
                                                      respondents    per  respondent    disclosures    per  disclosure                    costs \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling following recommendations in ``Questions              556                4            2,224                1            2,224       $3,422,736
 and Answers About Dietary Guidance Statements in
 Food Labeling''..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
One time relabeling costs.
There are no operating and maintenance costs associated with this collection of information.

    The estimates in table 1 are based on our experience with similar 
labeling programs. We estimate that each year 556 manufacturers will 
relabel their products following recommendations found in the draft 
guidance. This estimate assumes manufacturers will remove Dietary 
Guidance Statements from their labels following recommendations in the 
draft guidance, as well as those that will add Dietary Guidance 
Statements to their labels. We estimate that each manufacturer will 
relabel 4 products for 2,224 total annual disclosures (556 
manufacturers x 4 labels). Each disclosure will take an estimated 1 
hour to complete for an annual third-party disclosure burden of 2,224 
hours (2,224 disclosures x 1 hour). We estimate that there will be an 
annual capital cost of $3,422,736 associated with relabeling. This is 
the cost of designing a revised label and incorporating it into the 
manufacturing process. We believe that this will be a one-time burden.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

IV. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they 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. HHS and USDA. 1980 Dietary Guidelines for Americans. February 
1980. Available at: https://health.gov/dietaryguidelines/1980.asp.
2. HHS and USDA. Dietary Guidelines for Americans, 2020-2025. 9th 
Edition. December 2020. Available at: https://www.dietaryguidelines.gov/.

    Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06304 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P