[Federal Register Volume 83, Number 80 (Wednesday, April 25, 2018)]
[Proposed Rules]
[Pages 17961-17962]
[FR Doc No: 2018-08603]

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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, and
Certain Cranberry Products: Draft Guidance for Industry; Extension of
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the notification of availability of a draft guidance
for industry entitled ``The Declaration of Added Sugars on Honey, Maple
Syrup, and Certain Cranberry Products: Guidance for Industry'' that
appeared in the Federal Register of March 2, 2018. The draft guidance,
when finalized, will advise food manufacturers of our intent to
exercise enforcement discretion related to the use in the Nutrition
Facts label of a symbol ``[dagger]'' immediately after the added sugars
percent Daily Value information on certain foods. The symbol would lead
the reader to truthful and non-misleading statements outside the
Nutrition Facts label to provide additional information regarding the
added sugars present in particular foods. We are taking this action in
response to requests for an extension to allow interested persons
additional time to submit comments.

DATES: We are extending the comment period on the document that
published in the Federal Register of March 2, 2018 (83 FR 8953). Submit
either electronic or written comments by June 15, 2018.

ADDRESSES: You may submit comments 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-2018-D-0075 for ``The Declaration of Added Sugars on Honey, Maple
Syrup, 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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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.

FOR FURTHER INFORMATION CONTACT: Blakely Fitzpatrick, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 2, 2018 (83 FR 8953), we published
a document announcing the availability of a draft guidance for industry
entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, and
Certain Cranberry Products: Guidance for Industry.'' The draft guidance
is intended to advise food manufacturers of our intent to exercise
enforcement discretion related to the use in the Nutrition Facts label
of a symbol ``[dagger]'' immediately after the added sugars percent
Daily Value information on certain foods. The symbol would lead the
reader to truthful and non-misleading statements outside the Nutrition
Facts label to provide additional information regarding the added
sugars present in particular foods. The draft guidance explains that we
intend to consider exercising enforcement discretion for the use of
this symbol on single ingredient packages and/or containers of pure
honey or pure maple syrup, and certain dried cranberry and cranberry
juice products that are sweetened with added sugars, and that contain
total sugars at levels no greater than comparable products with
endogenous (inherent) sugars, but no added sugars. We provided a 60-day
comment period that was scheduled to close on May 1, 2018.
    We have received requests to extend the comment period for the
draft guidance (Refs. 1 and 2). The requests conveyed concern that the
current 60-day comment period does not allow sufficient time to develop
meaningful or thoughtful comments to the draft guidance.
    We have considered the requests and are extending the comment
period for the draft guidance for 45 additional days, until June 15,
2018. We believe that this extension allows adequate time for
interested persons to submit comments without significantly delaying
finalizing the guidance.

II. 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.

1. Letter from Margaret Lombard, Chief Executive Officer, National
Honey Board, to FDA Dockets Management Staff (April 3, 2018).
2. Letter from Ray Bonenberg, President, International Maple Syrup
Institute, to Dr. Scott Gottlieb, Commissioner of Food and Drugs,
FDA (April 4, 2018).

    Dated: April 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08603 Filed 4-24-18; 8:45 am]
BILLING CODE 4164-01-P