[Federal Register Volume 83, Number 80 (Wednesday, April 25, 2018)]
[Proposed Rules]
[Pages 17961-17962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Certain Cranberry Products: Draft Guidance for Industry; Extension of 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comment period for the notification of availability of a draft guidance 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 The draft guidance, 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

[[Page 17962]]

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, 240-402-1450.

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


