The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products; Guidance for Industry; Availability, 28726-28728 [2019-12983]
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Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Rules and Regulations
Authority: 45 U.S.C. 231f (b)(5) and 45
U.S.C. 362; § 200.4 also issued under 5 U.S.C.
552; § 200.5 also issued under 5 U.S.C. 552a;
§ 200.6 also issued under 5 U.S.C. 552b; and
§ 200.7 also issued under 31 U.S.C. 3717.
2. Section 200.1 is amended by
revising paragraph (b) to read as follows:
■
§ 200.1 Designation of central and field
organization.
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(b) Internal organization. (1)
Reporting directly to the Board
Members is the seven member Executive
Committee. The Executive Committee is
comprised of the General Counsel, the
Director of Administration, the Director
of Programs, the Chief Financial Officer,
the Chief Information Officer, and the
Director of Field Service. The Chief
Actuary is a non-voting member. The
Board members will designate a member
of the Executive Committee as Senior
Executive Officer.
(2) The Executive Committee is
responsible for the day to day
operations of the agency. The Senior
Executive Officer is responsible for the
direction and oversight of the Executive
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legislation, representing the Board in
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provisions of the Railroad Retirement
and Railroad Unemployment Insurance
Acts. The Director of Administration is
responsible for managing, coordinating
and controlling certain administrative
operations of the Board including the
Division of Acquisition Management,
the Bureau of Human Resources, the
Office of Public Affairs, and the
Division of Real Property Management.
The Chief Financial Officer is
responsible for the financial
management of the agency, and the
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The Chief Actuary is responsible for
the actuarial program of the Board, and
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(3) The Office of Equal Employment
Opportunity is responsible for equal
employment opportunity and
affirmative employment programs.
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By Authority of the Board
Stephanie Hillyard,
Secretary to the Board.
[FR Doc. 2019–13050 Filed 6–19–19; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA–2018–D–0075]
The Declaration of Added Sugars on
Honey, Maple Syrup, Other SingleIngredient Sugars and Syrups, and
Certain Cranberry Products; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a final
guidance for industry entitled ‘‘The
Declaration of Added Sugars on Honey,
Maple Syrup, Other Single-Ingredient
Sugars and Syrups, and Certain
Cranberry Products.’’ This guidance
provides clarification on the labeling
requirements for single-ingredient
packages and/or containers of pure
honey, pure maple syrup, and other
pure sugars and syrups, which are not
required to bear the words ‘‘Includes Xg
Added Sugars,’’ but must still include
the percent Daily Value for added sugars
on their labels. This guidance is also
intended to advise food manufacturers
of our intent to exercise enforcement
discretion related to the use of a ‘‘†’’
symbol immediately following the
percent Daily Value for added sugars on
single-ingredient packages and/or
containers of pure honey, pure maple
syrup, and other pure sugars and
syrups; the ‘‘†’’ symbol would lead the
consumer to a statement that is truthful
and not misleading in a footnote at the
bottom of the Nutrition Facts label. The
guidance also advises food
manufacturers of our intent to exercise
enforcement discretion with respect to
the use of a ‘‘†’’ symbol immediately
after the added sugars percent Daily
Value information that leads the
consumer to a statement that is truthful
and not misleading outside of the
Nutrition Facts label on certain dried
SUMMARY:
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cranberry and cranberry beverage
products that are made up of cranberry
juice sweetened with added sugars and
that contain total sugars at levels no
greater than comparable products with
endogenous (inherent) sugars, but no
added sugars. Further, this guidance
advises of our intent to exercise
enforcement discretion regarding
compliance with Nutrition Facts label
final rule and Serving Size final rule
requirements until July 1, 2021, for the
single-ingredient sugars and syrups as
well as the cranberry products
discussed in the guidance document.
DATES: The announcement of the
guidance is published in the Federal
Register on June 20, 2019.
ADDRESSES: You may submit either
electronic or written comments on FDA
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
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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Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Rules and Regulations
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–0075 for ‘‘The Declaration of
Added Sugars on Honey, Maple Syrup,
Other Single-Ingredient Sugars and
Syrups, and Certain Cranberry Products:
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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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 guidance to the Office of
Nutrition and Food Labeling, Nutrition
Programs Staff, Center for Food Safety
and Applied Nutrition, Food and Drug
VerDate Sep<11>2014
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Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition, Office of
Nutrition and Food Labeling, 5001
Campus Dr., College Park, MD 20740,
240–402–1450.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry entitled ‘‘The
Declaration of Added Sugars on Honey,
Maple Syrup, Other Single-Ingredient
Sugars and Syrups, and Certain
Cranberry Products.’’ We are issuing
this guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The guidance represents 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 alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
This guidance provides clarification
on the labeling requirements for singleingredient packages and/or containers of
pure honey, pure maple syrup, and
other pure sugars and syrups, which are
not required to bear the words ‘‘Includes
Xg Added Sugars’’ but must still include
the percent Daily Value for added sugars
on their labels. This guidance is also
intended to advise food manufacturers
of our intent to exercise enforcement
discretion related to use of a ‘‘†’’ symbol
on single-ingredient packages and/or
containers of pure honey, pure maple
syrup, and other pure sugars and syrups
immediately following the percent Daily
Value for the contribution of added
sugars to the diet obtained from these
products. This would lead the consumer
to a statement that is truthful and not
misleading in a footnote at the bottom
of the Nutrition Facts label. We also
intend to exercise our enforcement
discretion with respect to the use of a
‘‘†’’ symbol immediately after the added
sugars percent Daily Value information
that would lead the consumer to a
statement outside of the Nutrition Facts
label on certain dried cranberry and
cranberry beverage products that are
made up of cranberry juice sweetened
with added sugars and that contain total
sugars at levels no greater than
comparable products with endogenous
(inherent) sugars, but no added sugars.
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28727
In the Federal Register of May 27,
2016, FDA issued a final rule entitled
‘‘Food Labeling: Revision of the
Nutrition and Supplement Facts Labels’’
(81 FR 33742; the ‘‘Nutrition Facts label
final rule’’). The Nutrition Facts label
final rule amended the regulations for
the nutrition labeling of conventional
foods and dietary supplements to
provide updated nutrition information
and to improve how the nutrition
information is presented to consumers.
The Nutrition Facts label final rule also
revised the Nutrition Facts label to
replace ‘‘sugars’’ with ‘‘total sugars’’ and
to include the declaration of added
sugars. The Nutrition Facts label final
rule defines ‘‘added sugars,’’ in part, to
include sugars that are either added
during the processing of foods or are
packaged as such. The definition
includes free sugars (free mono- and
disaccharides), sugars from syrups and
honey, and sugars from concentrated
fruit or vegetable juices that are in
excess of what would be expected from
the same volume of 100 percent fruit or
vegetable juice of the same type. The
Nutrition Facts label final rule requires
added sugars to be declared on the food
label by stating ‘‘Includes Xg Added
Sugars’’ indented directly below ‘‘Total
Sugars,’’ where X represents the
amount, in grams, of added sugars (see
21 CFR 101.9(c)(6)(ii)).
On December 20, 2018, the President
signed into law the Agriculture
Improvement Act of 2018 (Pub. L. 115–
334) (‘‘the Farm Bill’’). Section 12516 of
the Farm Bill states that the food
labeling requirements under section
403(q) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343(q)) shall
not require that the Nutrition Facts label
of any single-ingredient sugar, honey,
agave, or syrup, including maple syrup,
that is packaged and offered for sale as
a single-ingredient food bear the
declaration ‘‘Includes Xg Added
Sugars.’’ Therefore, single-ingredient
sugars, honey, agave, and syrups,
including maple syrup, do not need to
have the statement ‘‘Includes Xg Added
Sugars’’ on their label. At the same time,
the Farm Bill did not change the
requirement under the final rule to
include the percent Daily Value for the
contribution of added sugars to the diet
obtained from these products.
In the Federal Register of March 2,
2018 (83 FR 8953), we made available
a draft guidance for industry entitled
‘‘The Declaration of Added Sugars on
Honey, Maple Syrup, and Certain
Cranberry Products’’ (hereafter referred
to as ‘‘the draft guidance’’) and gave
interested parties an opportunity to
submit comments by May 1, 2018. In
response to requests for more time to
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Federal Register / Vol. 84, No. 119 / Thursday, June 20, 2019 / Rules and Regulations
comment on the draft guidance, we
issued a notice in the Federal Register
of April 25, 2018 (83 FR 17961)
extending the comment period to June
15, 2018. We received over 3,600
comments to the draft guidance from
industry, consumer advocacy groups,
trade associations, members of
Congress, State governments, and
private citizens.
After consideration of the comments
to the draft guidance, as well as Public
Law 115–334, we have made changes in
the final guidance to clarify the
requirements for the labeling of added
sugars on packages and/or containers of
single ingredient honey, maple syrup,
and other single ingredient sugars and
syrups. The final guidance clarifies that
the line representing added sugars on
the Nutrition Facts label, as well as the
percent Daily Value on that line, are
retained for single-ingredient sugars and
syrup, however these products do not
need to have the statement ‘‘Includes Xg
Added sugars’’ on that line. The final
guidance also explains our intent to
exercise enforcement discretion for all
single ingredient sugars and syrups with
respect to the inclusion of a ‘‘†’’ symbol
after the percent Daily Value, which
leads the reader to a truthful and not
misleading statement within a footnote
at the bottom of the Nutrition Facts label
that includes a description of the gram
amount of sugar added to the diet by
one serving of the product and its
contribution to the percent Daily Value
for added sugars in the diet.
We are finalizing the guidance
without any changes with respect to our
intent to exercise enforcement
discretion for the use of a ‘‘†’’ symbol
that would direct consumers to truthful
and not misleading statements on the
package outside the Nutrition Facts
label on certain cranberry products
sweetened with added sugars that
provide an amount of total sugars in a
serving that does not exceed the level of
total sugars in a serving of a comparable
product with no added sugars.
At this time, we are not aware of
products, other than the cranberry
products discussed in the guidance
document, for which the addition of
sugars is intended to increase
palatability, and for which the amount
of total sugars per serving is at a level
that does not exceed the amount of total
sugars in a comparable product with no
added sugars. Therefore, at this time we
do not intend to exercise enforcement
discretion with respect to the use of the
‘‘†’’ that would direct consumers to
truthful and not misleading statements
on the package outside the Nutrition
Facts label on products, including dairy
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products and whole grain products,
other than the cranberry products
discussed in the guidance document.
We specifically note that we do not
intend to exercise enforcement
discretion with respect to beverages
made from ac
¸aı´ berries because it
appears that ac
¸aı´ berry beverages are
made, at least in part, from ac¸aı´ berries
combined with water. Therefore, we do
not consider ac
¸aı´ berry beverages to be
a comparable product to other naturally
sweet juices. Furthermore, we do not
have sufficient evidence to show that
sugars are added to ac
¸aı´ berries to
increase palatability like the naturally
tart fruit described in the 2015–2020
Dietary Guidelines for Americans
(available at https://
www.dietaryguidelines.gov/currentdietary-guidelines). We note that we
would consider whether the same type
of enforcement discretion discussed
with respect to certain cranberry
products might be warranted for other
products for which the addition of
sugars is intended to increase
palatability, such as naturally tart fruits,
and for which the amount of total sugars
per serving is at a level that does not
exceed the amount of total sugars in a
comparable product with no added
sugars.
Further, the final guidance announces
our intent to exercise enforcement
discretion, until July 1, 2021, regarding
the compliance with the Nutritional
Facts Label final rule and Serving Size
final rule (81 FR 33742 and 81 FR 34000
(May 27, 2016)) requirements for singleingredient packages and/or containers of
pure honey, pure maple syrup, and
other pure sugars and syrups, as well as
certain dried cranberry and cranberry
beverage products. We recognize the
importance of giving manufacturers of
such products additional time to make
appropriate label changes consistent
with the Farm Bill and this final
guidance. With respect to our
enforcement discretion policy
pertaining to compliance with updated
Nutrition Facts label and serving size
requirements, this part of the guidance
is being implemented without prior
public comment because we have
determined that prior public
participation is not feasible or
appropriate (21 CFR 10.115(g)(2)).
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
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3521). The collections of information in
21 CFR part 101 have been approved
under OMB control number 0910–0813.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12983 Filed 6–18–19; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2012–1036]
Special Local Regulations: Recurring
Marine Events in Captain of the Port
Long Island Sound Zone
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
eight special local regulations for
marine events in the Sector Long Island
Sound area of responsibility on the
dates and times listed in the table
below. This action is necessary to
provide for the safety of life on
navigable waterways during the events.
During the enforcement periods, no
person or vessel may enter the safety
zones without permission of the Captain
of the Port (COTP) Sector Long Island
Sound or designated representative.
DATES: The regulation in 33 CFR
100.100, Table 1 will be enforced during
the dates and times listed in the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice of
enforcement, call or email Chief Petty
Officer Katherine Linnick, Waterways
Management Division, U.S. Coast Guard
Sector Long Island Sound; telephone
203–468–4565, email
Katherine.E.Linnick@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the special local
regulations listed in 33 CFR 100.100
Table 1 on the specified dates and
times:
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Rules and Regulations]
[Pages 28726-28728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12983]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2018-D-0075]
The Declaration of Added Sugars on Honey, Maple Syrup, Other
Single-Ingredient Sugars and Syrups, and Certain Cranberry Products;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``The
Declaration of Added Sugars on Honey, Maple Syrup, Other Single-
Ingredient Sugars and Syrups, and Certain Cranberry Products.'' This
guidance provides clarification on the labeling requirements for
single-ingredient packages and/or containers of pure honey, pure maple
syrup, and other pure sugars and syrups, which are not required to bear
the words ``Includes Xg Added Sugars,'' but must still include the
percent Daily Value for added sugars on their labels. This guidance is
also intended to advise food manufacturers of our intent to exercise
enforcement discretion related to the use of a ``[dagger]'' symbol
immediately following the percent Daily Value for added sugars on
single-ingredient packages and/or containers of pure honey, pure maple
syrup, and other pure sugars and syrups; the ``[dagger]'' symbol would
lead the consumer to a statement that is truthful and not misleading in
a footnote at the bottom of the Nutrition Facts label. The guidance
also advises food manufacturers of our intent to exercise enforcement
discretion with respect to the use of a ``[dagger]'' symbol immediately
after the added sugars percent Daily Value information that leads the
consumer to a statement that is truthful and not misleading outside of
the Nutrition Facts label on certain dried cranberry and cranberry
beverage products that are made up of cranberry juice sweetened with
added sugars and that contain total sugars at levels no greater than
comparable products with endogenous (inherent) sugars, but no added
sugars. Further, this guidance advises of our intent to exercise
enforcement discretion regarding compliance with Nutrition Facts label
final rule and Serving Size final rule requirements until July 1, 2021,
for the single-ingredient sugars and syrups as well as the cranberry
products discussed in the guidance document.
DATES: The announcement of the guidance is published in the Federal
Register on June 20, 2019.
ADDRESSES: You may submit either electronic or written comments on FDA
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 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.''
[[Page 28727]]
Instructions: All submissions received must include the Docket No.
FDA-2018-D-0075 for ``The Declaration of Added Sugars on Honey, Maple
Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry
Products: 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.
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.gpo.gov/fdsys/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.
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 guidance to the
Office of Nutrition and Food Labeling, Nutrition Programs 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
guidance.
FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition, Office of Nutrition and Food Labeling,
5001 Campus Dr., College Park, MD 20740, 240-402-1450.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, Other
Single-Ingredient Sugars and Syrups, and Certain Cranberry Products.''
We are issuing this guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The guidance represents 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
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
This guidance provides clarification on the labeling requirements
for single-ingredient packages and/or containers of pure honey, pure
maple syrup, and other pure sugars and syrups, which are not required
to bear the words ``Includes Xg Added Sugars'' but must still include
the percent Daily Value for added sugars on their labels. This guidance
is also intended to advise food manufacturers of our intent to exercise
enforcement discretion related to use of a ``[dagger]'' symbol on
single-ingredient packages and/or containers of pure honey, pure maple
syrup, and other pure sugars and syrups immediately following the
percent Daily Value for the contribution of added sugars to the diet
obtained from these products. This would lead the consumer to a
statement that is truthful and not misleading in a footnote at the
bottom of the Nutrition Facts label. We also intend to exercise our
enforcement discretion with respect to the use of a ``[dagger]'' symbol
immediately after the added sugars percent Daily Value information that
would lead the consumer to a statement outside of the Nutrition Facts
label on certain dried cranberry and cranberry beverage products that
are made up of cranberry juice sweetened with added sugars and that
contain total sugars at levels no greater than comparable products with
endogenous (inherent) sugars, but no added sugars.
In the Federal Register of May 27, 2016, FDA issued a final rule
entitled ``Food Labeling: Revision of the Nutrition and Supplement
Facts Labels'' (81 FR 33742; the ``Nutrition Facts label final rule'').
The Nutrition Facts label final rule amended the regulations for the
nutrition labeling of conventional foods and dietary supplements to
provide updated nutrition information and to improve how the nutrition
information is presented to consumers. The Nutrition Facts label final
rule also revised the Nutrition Facts label to replace ``sugars'' with
``total sugars'' and to include the declaration of added sugars. The
Nutrition Facts label final rule defines ``added sugars,'' in part, to
include sugars that are either added during the processing of foods or
are packaged as such. The definition includes free sugars (free mono-
and disaccharides), sugars from syrups and honey, and sugars from
concentrated fruit or vegetable juices that are in excess of what would
be expected from the same volume of 100 percent fruit or vegetable
juice of the same type. The Nutrition Facts label final rule requires
added sugars to be declared on the food label by stating ``Includes Xg
Added Sugars'' indented directly below ``Total Sugars,'' where X
represents the amount, in grams, of added sugars (see 21 CFR
101.9(c)(6)(ii)).
On December 20, 2018, the President signed into law the Agriculture
Improvement Act of 2018 (Pub. L. 115-334) (``the Farm Bill''). Section
12516 of the Farm Bill states that the food labeling requirements under
section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343(q)) shall not require that the Nutrition Facts label of any single-
ingredient sugar, honey, agave, or syrup, including maple syrup, that
is packaged and offered for sale as a single-ingredient food bear the
declaration ``Includes Xg Added Sugars.'' Therefore, single-ingredient
sugars, honey, agave, and syrups, including maple syrup, do not need to
have the statement ``Includes Xg Added Sugars'' on their label. At the
same time, the Farm Bill did not change the requirement under the final
rule to include the percent Daily Value for the contribution of added
sugars to the diet obtained from these products.
In the Federal Register of March 2, 2018 (83 FR 8953), we made
available a draft guidance for industry entitled ``The Declaration of
Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products''
(hereafter referred to as ``the draft guidance'') and gave interested
parties an opportunity to submit comments by May 1, 2018. In response
to requests for more time to
[[Page 28728]]
comment on the draft guidance, we issued a notice in the Federal
Register of April 25, 2018 (83 FR 17961) extending the comment period
to June 15, 2018. We received over 3,600 comments to the draft guidance
from industry, consumer advocacy groups, trade associations, members of
Congress, State governments, and private citizens.
After consideration of the comments to the draft guidance, as well
as Public Law 115-334, we have made changes in the final guidance to
clarify the requirements for the labeling of added sugars on packages
and/or containers of single ingredient honey, maple syrup, and other
single ingredient sugars and syrups. The final guidance clarifies that
the line representing added sugars on the Nutrition Facts label, as
well as the percent Daily Value on that line, are retained for single-
ingredient sugars and syrup, however these products do not need to have
the statement ``Includes Xg Added sugars'' on that line. The final
guidance also explains our intent to exercise enforcement discretion
for all single ingredient sugars and syrups with respect to the
inclusion of a ``[dagger]'' symbol after the percent Daily Value, which
leads the reader to a truthful and not misleading statement within a
footnote at the bottom of the Nutrition Facts label that includes a
description of the gram amount of sugar added to the diet by one
serving of the product and its contribution to the percent Daily Value
for added sugars in the diet.
We are finalizing the guidance without any changes with respect to
our intent to exercise enforcement discretion for the use of a
``[dagger]'' symbol that would direct consumers to truthful and not
misleading statements on the package outside the Nutrition Facts label
on certain cranberry products sweetened with added sugars that provide
an amount of total sugars in a serving that does not exceed the level
of total sugars in a serving of a comparable product with no added
sugars.
At this time, we are not aware of products, other than the
cranberry products discussed in the guidance document, for which the
addition of sugars is intended to increase palatability, and for which
the amount of total sugars per serving is at a level that does not
exceed the amount of total sugars in a comparable product with no added
sugars. Therefore, at this time we do not intend to exercise
enforcement discretion with respect to the use of the ``[dagger]'' that
would direct consumers to truthful and not misleading statements on the
package outside the Nutrition Facts label on products, including dairy
products and whole grain products, other than the cranberry products
discussed in the guidance document. We specifically note that we do not
intend to exercise enforcement discretion with respect to beverages
made from a[ccedil]a[iacute] berries because it appears that
a[ccedil]a[iacute] berry beverages are made, at least in part, from
a[ccedil]a[iacute] berries combined with water. Therefore, we do not
consider a[ccedil]a[iacute] berry beverages to be a comparable product
to other naturally sweet juices. Furthermore, we do not have sufficient
evidence to show that sugars are added to a[ccedil]a[iacute] berries to
increase palatability like the naturally tart fruit described in the
2015-2020 Dietary Guidelines for Americans (available at https://www.dietaryguidelines.gov/current-dietary-guidelines). We note that we
would consider whether the same type of enforcement discretion
discussed with respect to certain cranberry products might be warranted
for other products for which the addition of sugars is intended to
increase palatability, such as naturally tart fruits, and for which the
amount of total sugars per serving is at a level that does not exceed
the amount of total sugars in a comparable product with no added
sugars.
Further, the final guidance announces our intent to exercise
enforcement discretion, until July 1, 2021, regarding the compliance
with the Nutritional Facts Label final rule and Serving Size final rule
(81 FR 33742 and 81 FR 34000 (May 27, 2016)) requirements for single-
ingredient packages and/or containers of pure honey, pure maple syrup,
and other pure sugars and syrups, as well as certain dried cranberry
and cranberry beverage products. We recognize the importance of giving
manufacturers of such products additional time to make appropriate
label changes consistent with the Farm Bill and this final guidance.
With respect to our enforcement discretion policy pertaining to
compliance with updated Nutrition Facts label and serving size
requirements, this part of the guidance is being implemented without
prior public comment because we have determined that prior public
participation is not feasible or appropriate (21 CFR 10.115(g)(2)).
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 101 have been approved under
OMB control number 0910-0813.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12983 Filed 6-18-19; 11:15 am]
BILLING CODE 4164-01-P
