Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 18149-18153 [2023-06304]
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Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices
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and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
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Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lola
Fashoyin-Aje, Oncology Center of
Excellence, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2352, Silver Spring,
MD 20993, 240–402–0205; or Diane
Maloney, Center for Biologics
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Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7242,
Silver Spring, MD 20993, 240–402–
8113.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Clinical Trial Considerations to
Support Accelerated Approval of
Oncology Therapeutics.’’ The purpose
of this guidance is to provide
recommendations to sponsors of anticancer drugs or biological products on
considerations for designing trials
intended to support accelerated
approval. The accelerated approval
pathway is commonly used for approval
of oncology drugs in part due to the
serious and life-threatening nature of
cancer and because of available
surrogate or intermediate clinical
endpoints considered reasonably likely
to predict clinical benefit. Single-arm
trial designs and response rate
endpoints (with duration of response as
supportive) have most commonly been
used in oncology because response rate
is a marker of drug activity since
malignant tumors do not typically
regress on their own, and response rate
can be interpreted in single-arm trials
for monotherapy drug regimens.
However, there are limitations to the use
of single-arm trials in support of
accelerated approval, including but not
limited to: small safety datasets, low
magnitude response rates that may not
be reasonably likely to predict clinical
benefit, and the inability to establish
differential contribution of effect for
combination regimens. Additionally, the
reliance on cross-trial comparisons to
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historical trials to assess whether the
observed treatment effect represents an
improvement over available therapy is
challenging. These limitations add
uncertainty to the assessment of the
safety and/or effectiveness of a drug
such that accelerated approval based on
a single-arm trial may not be justified in
a given clinical setting.
Given the limitations of single-arm
trials, FDA considers a randomized
controlled trial to be the most
appropriate trial design to support
accelerated approval of oncology drugs.
When properly designed and executed,
a randomized controlled trial provides a
more robust efficacy and safety
assessment and allows for direct
comparisons to a concurrent control
arm. Sponsors can, as appropriate, elect
to conduct a single randomized
controlled trial to support an
accelerated approval and to verify
clinical benefit (i.e., follow the ‘‘onetrial’’ approach), or they can conduct
separate trials—one to support the
accelerated approval and another, a
confirmatory trial, to verify clinical
benefit. The ‘‘one-trial’’ approach
maintains efficiency in drug
development by providing early access
to an investigational drug using the
accelerated approval pathway, while
ensuring that a postmarketing trial is
fully accrued and well underway to
verify longer term benefit in a timely
fashion.
This guidance describes
considerations for designing,
conducting, and analyzing data for trials
intended to support accelerated
approval of oncology drugs.
Specifically, the guidance provides
recommendations addressing the
design, conduct, and analyses of data for
either two separate randomized
controlled trials or for using the ‘‘onetrial’’ approach for accelerated approval.
The guidance also provides
recommendations for designing,
conducting, and analyzing data from a
single-arm trial intended to support
accelerated approval (when
appropriate), and the considerations for
determining whether the data may be
adequate for this purpose. Regardless of
the approach under consideration, FDA
recommends early discussion before
study initiation and during trials, as
appropriate.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Clinical Trial Considerations to
Support Accelerated Approval of
Oncology Therapeutics.’’ It does not
establish any rights for any person and
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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.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; and the collections
of information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: March 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05910 Filed 3–24–23; 8:45 am]
BILLING CODE 4164–01–P
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.
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:
SUMMARY:
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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:
ddrumheller on DSK120RN23PROD with NOTICES1
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.’’
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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-201509-18/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
PO 00000
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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, PRAStaff@fda.hhs.gov.
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
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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
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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
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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
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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
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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:
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TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Total
capital
costs 1 2
Labeling following recommendations in
‘‘Questions and Answers About Dietary
Guidance Statements in Food Labeling’’ .......................................................
556
4
2,224
1
2,224
$3,422,736
ddrumheller on DSK120RN23PROD with NOTICES1
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 × 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 × 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.
1980.asp.
2. HHS and USDA. Dietary Guidelines for
Americans, 2020–2025. 9th Edition.
December 2020. Available at: https://
www.dietaryguidelines.gov/.
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/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
AGENCY:
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/
VerDate Sep<11>2014
19:19 Mar 24, 2023
Jkt 259001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2021–D–1118 and FDA–
2020–D–1138]
Transition Plan for Medical Devices
That Fall Within Enforcement Policies
Issued During the Coronavirus Disease
2019 (COVID–19) Public Health
Emergency; Guidance for Industry,
Other Stakeholders, and Food and
Drug Administration Staff; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Transition Plan for
Medical Devices That Fall Within
Enforcement Policies Issued During the
Coronavirus Disease 2019 (COVID–19)
Public Health Emergency.’’ FDA
recognizes that it will take time for
device manufacturers, device
distributors, healthcare facilities,
healthcare providers, patients,
consumers, and FDA to adjust from
policies adopted and operations
implemented during the COVID–19
public health emergency (PHE) to
‘‘normal operations.’’ To provide a clear
policy for all stakeholders and FDA
staff, the Agency is issuing this
guidance to describe FDA’s general
recommendations for a phased
transition process with respect to
devices that fall within certain
enforcement policies issued during the
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
COVID–19 PHE declared by the
Secretary of Health and Human Services
(the Secretary) under the Public Health
Service Act (PHS Act), including
recommendations regarding submitting
a marketing submission, as applicable,
and taking other actions with respect to
these devices. This guidance applies to
devices that fall within enforcement
policies in guidances included in List 1
of this guidance. The phased transition
process outlined in this guidance will
begin on the ‘‘implementation date.’’
The implementation date is the day the
PHE expires or 45 days after the
finalization of this guidance, whichever
comes later. Because the COVID–19
section 319 PHE declaration is
anticipated to expire at least 45 days
after the finalization of this guidance, or
May 11, 2023, the implementation date
is that date. The guidances in List 1 of
this guidance will no longer be in effect
after the 180-day transition period ends.
DATES: The announcement of the
guidance is published in the Federal
Register on March 27, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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:
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
[[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 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
