[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