[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]
BILLING CODE 4164-01-P


