[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Proposed Rules]
[Pages 8953-8955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04281]


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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Certain Cranberry Products; Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``The 
Declaration of Added Sugars on Honey, Maple Syrup, and Certain 
Cranberry Products: Guidance for Industry.'' The draft guidance, when 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.

DATES: Submit either electronic or written comments by May 1, 2018 to 
ensure that we consider your comment before we take further action.

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.

[[Page 8954]]

     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.'' 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 draft 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 draft guidance.

FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Office of Foods 
and Veterinary Medicine, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-1450.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are 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.'' We are issuing the 
draft guidance 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 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. This guidance is not subject to Executive 
Order 12866.
    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 would explain that we intend to consider exercising our 
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.

II. Electronic Access

    Persons with access to the internet may obtain the draft 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.

III. Other Issues for Consideration

    We invite interested persons to comment on topics related to the 
draft guidance. However, we are particularly interested in responses to 
the following questions:
    1. 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. Should 
we use a different symbol? If so, what symbol should we use and what is 
the rationale for using an alternative? Also, should the placement or 
location of the symbol be elsewhere on the Nutrition Facts label? For 
example, should the symbol appear after ``Includes X g Added Sugars'' 
instead? Please explain where the symbol should appear and your reasons 
for placing the symbol elsewhere on the label.
    2. We are considering giving an additional year to come into 
compliance with the changes required by the final rule for the labeling 
of packages or containers of pure honey and maple syrup, and for the 
dried cranberry and cranberry juice products described in this draft 
guidance. Consumers will likely become more acclimated and educated on 
having an added sugars declaration on the Nutrition Facts label during 
this time period, based in part on other products in the marketplace 
bearing the new Nutrition Facts label. Should FDA consider this period 
of enforcement discretion given that, in the Federal Register of 
October 2, 2017 (82 FR 45753), FDA has proposed to extend the Nutrition 
Facts label compliance date from July 26, 2018, to January 1, 2020, for 
manufacturers with $10 million or more in annual food sales and from 
July 26, 2019, to January 1,

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2021, for manufacturers with less than $10 million in annual food 
sales? Please explain your reasoning.

    Dated: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04281 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P


