[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.
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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