Document ID: FDA-2016-D-3401-0046
Agency: fda
Document Type: Notice
Title: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Guidance for Industry; Availability
Posted Date: 2018-03-02T05:00Z

[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 8997-8998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04280]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3401]

Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition; 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 guidance for industry entitled ``Scientific 
Evaluation of the Evidence on the Beneficial Physiological Effects of 
Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a 
Citizen Petition (21 CFR 10.30).'' The guidance describes our views on 
the scientific evidence needed and the approach to evaluating the 
scientific evidence on the physiological effects to human health of 
isolated or synthetic non-digestible carbohydrates that are added to 
foods.

DATES: The announcement of the guidance is published in the Federal 
Register on March 2, 2018.

ADDRESSES: You may submit electronic or written comments on Agency 
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-2016-D-3401 for ``Scientific Evaluation of the Evidence on the 
Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 
10.30).'' 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

[[Page 8998]]

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 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, 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: Paula R. Trumbo, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2579.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' 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.
    In the Federal Register of May 27, 2016 (81 FR 33742), we published 
a final rule amending our Nutrition and Supplement Facts label 
regulations. The final rule provides a definition of dietary fiber as 
non-digestible soluble and insoluble carbohydrates (with three or more 
monomeric units), and lignin that are intrinsic and intact in plants; 
isolated or synthetic non-digestible carbohydrates (with three or more 
monomeric units) determined by FDA to have physiological effects that 
are beneficial to human health (Sec.  101.9(c)(6)(i)) (21 CFR 
101.9(c)(6)(i)). One mechanism by which a manufacturer could request an 
amendment to the list of isolated or synthetic non-digestible 
carbohydrates that meet the dietary fiber definition is by using the 
citizen petition process in 21 CFR 10.30. If an isolated or synthetic 
non-digestible carbohydrate meets the dietary fiber definition, then it 
would be added to the list of dietary fibers in Sec.  101.9(c)(6)(i).
    In the Federal Register of November 23, 2016, (81 FR 84516), we 
announced the availability of a draft guidance for industry entitled 
``Scientific Evaluation of the Evidence on the Beneficial Physiological 
Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted 
as a Citizen Petition (21 CFR 10.30)'' and gave interested parties an 
opportunity to submit comments by January 23, 2017, for us to consider 
before beginning work on the final version of the guidance. In the 
Federal Register of January 13, 2017 (82 FR 4225), we extended the 
comment period to February 13, 2017. We received several comments on 
the draft guidance and have modified the final guidance where 
appropriate. Changes to the guidance include: (1) The inclusion of 
studies on diseased populations under certain circumstances as part of 
our evaluation of the totality of the scientific evidence; (2) 
additional detail and clarity on the physiological endpoints that we 
consider when reviewing the scientific evidence; and (3) additional 
detail regarding factors we consider when evaluating the strength of 
the scientific evidence.\1\ In addition, we made editorial changes to 
improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated November 2016.
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    \1\ This guidance addresses the scientific evaluation of 
synthetic non-digestible carbohydrates and isolated non-digestible 
carbohydrate ingredients that are produced as a result of the 
processing of foods and other sources, to the extent that the 
ingredients in and of themselves have a specific chemical structure 
(carbohydrate composition and non-digestible bond linkages). These 
isolated non-digestible carbohydrates may or may not vary in size. 
Examples of isolated non-digestible carbohydrates include cellulose, 
guar gum, and pectin.
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II. Paperwork Reduction Act of 1995

    The 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. 3501-3520). The 
collections of information in Sec.  101.9 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: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04280 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P