Notice2023-06304
Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry." The draft guidance, when finalized, will provide FDA's current thinking on the use of Dietary Guidance Statements on packaged food labels and more broadly in the labeling of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 This draft guidance is not final nor is it in effect at this time.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 58 (Monday, March 27, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18149-18153]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06304]
-----------------------------------------------------------------------
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Labeling: Draft Guidance for Industry; Availability; Agency Information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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Questions and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Draft Guidance for Industry.'' The draft guidance, when finalized, will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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#f6a6a4b7a582979090b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="550507140621343333153331347b3d3d267b323a23">[email protected]</span></a>.
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
[[Page 18152]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://health.gov/dietaryguidelines/1980.asp">https://health.gov/dietaryguidelines/1980.asp</a>.
2. HHS and USDA. Dietary Guidelines for Americans, 2020-2025. 9th
Edition. December 2020. Available at: <a href="https://www.dietaryguidelines.gov/">https://www.dietaryguidelines.gov/</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 27, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.