[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Rules and Regulations]
[Pages 66217-66219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2019-D-0725]
The Declaration of Allulose and Calories From Allulose on
Nutrition and Supplement Facts Labels; 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
[[Page 66218]]
Declaration of Allulose and Calories from Allulose on Nutrition and
Supplement Facts Labels.'' The guidance describes FDA's views on the
declaration of allulose on Nutrition Facts and Supplement Facts labels
and the caloric content of allulose. The guidance also announces our
intent to exercise enforcement discretion for the exclusion of allulose
from the amount of Total Sugars and Added Sugars declared on the
Nutrition Facts and Supplement Facts label and use of a general factor
of 0.4 calories per gram (kcal/g) for allulose when calculating
declarations on Nutrition and Supplement Facts labels.
DATES: The announcement of the guidance is published in the Federal
Register on October 19, 2020.
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.''
Instructions: All submissions received must include the Docket No.
FDA-2019-D-0725 for ``The Declaration of Allulose and Calories from
Allulose on Nutrition and Supplement Facts Labels.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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, 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, Food and Drug Administration, 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 Allulose and Calories from Allulose on
Nutrition and Supplement Facts Labels.'' 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 alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
In the Federal Register of April 18, 2019 (84 FR 16272), we
published a notice announcing the availability of a draft guidance for
industry entitled ``The Declaration of Allulose and Calories from
Allulose on Nutrition and Supplement Facts Labels.'' The draft
guidance: (1) Described our tentative views on the declaration of
allulose on Nutrition Facts and Supplement Facts labels and on the
caloric content of allulose; and (2) announced our tentative intent to
exercise enforcement discretion for the exclusion of allulose from the
amount of Total Sugars and Added Sugars declared on the label and use
of a general factor of 0.4 kcal/g for allulose when calculating
declarations on Nutrition and Supplement Facts labels pending review of
the issues in a rulemaking.
The draft guidance gave interested parties an opportunity to submit
comments by June 17, 2019, for us to consider before beginning work on
the final version of the guidance. We received approximately 30
comments from industry, health professionals, consumer advocacy groups,
scientists, trade associations, and consumers. We are finalizing the
positions in the draft guidance and have made technical corrections and
editorial changes throughout the guidance to improve clarity. We also
added language clarifying that allulose must still be declared in the
ingredient statement
[[Page 66219]]
even if it is excluded from certain label declarations. Finally, we
reorganized the section detailing our consideration of allulose as a
sugar.
The guidance announced in this notice finalizes the draft guidance
with respect to: (1) Our views on the declaration of allulose on
Nutrition Facts and Supplement Facts labels and on the caloric content
of allulose; and (2) our intent to exercise enforcement discretion for
the exclusion of allulose from the amount of Total Sugars and Added
Sugars declared on the label and use of a general factor of 0.4 kcal/g
for allulose when calculating declarations on Nutrition and Supplement
Facts labels pending review of the issues in a rulemaking.
II. Paperwork Reduction Act of 1995
This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
However, this guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR part 101 have been approved under OMB control number 0910-
0381.
II. 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: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22901 Filed 10-16-20; 8:45 am]
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