81_FR_84821 81 FR 84595 - Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments

81 FR 84595 - Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 226 (November 23, 2016)

Page Range84595-84596
FR Document2016-27950

The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would help us evaluate the beneficial physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods. We are requesting such scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of ``dietary fiber'' for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label.

Federal Register, Volume 81 Issue 226 (Wednesday, November 23, 2016)
[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84595-84596]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27950]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3389]


Evaluation of the Beneficial Physiological Effects of Isolated or 
Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, 
Information, and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for scientific data, information, and comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is requesting 
scientific data, information, and comments that would help us evaluate 
the beneficial physiological effects to human health of isolated or 
synthetic non-digestible carbohydrates that are added to foods. We are 
requesting such scientific data, information, and comments to help us 
determine whether a particular isolated or synthetic non-digestible 
carbohydrate should be added to our definition of ``dietary fiber'' for 
purposes of being declared as dietary fiber on a Nutrition Facts or 
Supplement Facts label.

DATES: Submit either electronic or written scientific data, 
information, and comments by January 9, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic scientific data, information, and comments in the 
following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comments 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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-N-3389 for ``Evaluation of the Beneficial Physiological 
Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request 
for Scientific Data, Information, and Comments.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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

[[Page 84596]]

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 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 http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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

    FDA regulations did not define the term ``dietary fiber'' before 
2016. In the Federal Register of May 27, 2016 (81 FR 33742), we 
published a final rule amending our Nutrition and Supplement Facts 
label regulation. The final rule, among other things, defines 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 (21 CFR 101.9(c)(6)(i)). 
The final rule also identifies seven isolated or synthetic non-
digestible carbohydrates that we determined to have beneficial effects 
for human health when added to foods (Sec.  101.9(c)(6)(i)). The seven 
isolated or synthetic non-digestible carbohydrates are: [beta]-glucan 
soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)); psyllium husk 
(as described in Sec.  101.81(c)(2)(ii)); cellulose, guar gum, pectin, 
locust bean gum; and hydroxypropyl methylcellulose. Foods and dietary 
supplements that contain any of these seven isolated or synthetic non-
digestible carbohydrates must include the amounts of these dietary 
fibers in a serving of food in the dietary fiber declarations on the 
products' Nutrition and Supplement Facts labels.
    Interested parties can ask us to list additional isolated or 
synthetic non-digestible carbohydrates in the definition of dietary 
fiber in Sec.  101.9(c)(6)(i) if we determine that the new isolated or 
synthetic non-digestible carbohydrate meets our dietary fiber 
definition. For example, a manufacturer who wants FDA to amend the 
definition of dietary fiber to include another added non-digestible 
carbohydrate could submit a citizen petition under 21 CFR 10.30. 
Elsewhere in this issue of the Federal Register, we have published a 
notice announcing the availability of a draft guidance document 
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): Guidance 
for Industry.'' The draft guidance describes the type of evidence and 
the scientific evaluation process we plan to use in determining the 
strength of the evidence for the relationship between an isolated or 
synthetic non-digestible carbohydrate that is added to food and a 
physiological effect that is beneficial to human health.
    In addition to issuing the draft guidance and determining that the 
seven isolated or synthetic non-digestible carbohydrates identified in 
the final rule's definition of dietary fibers have physiological 
effects that are beneficial to human health, we have conducted a 
scientific literature review of clinical studies associated with 26 
isolated or synthetic non-digestible carbohydrates, such as gum acacia, 
carboxymethyl cellulose, inulin, polydextrose, and xanthan gum, that 
are not listed as a dietary fiber in Sec.  101.9(c)(6)(i). Our review 
is consistent with the factors we provide in the draft guidance 
entitled, ``Scientific Evaluation of the Evidence on the Beneficial 
Physiological Effects of Isolated or Synthetic Non-Digestible 
Carbohydrates Submitted as a Citizen Petition (Sec.  10.30); Guidance 
for Industry'' to evaluate whether the available scientific evidence is 
sufficient to support a physiological effect that is beneficial to 
human health, based on the factors set forth in the draft guidance. We 
have summarized the clinical studies that we have identified for these 
26 non-digestible carbohydrates and have provided summaries of the 
studies and related references in a document entitled ``Evaluation of 
the Beneficial Physiological Effects of Isolated or Synthetic Non-
Digestible Carbohydrates.'' The purpose of this Federal Register notice 
is to invite interested parties to submit additional scientific data, 
information, and comments regarding:
     The physiological endpoints that we have addressed in the 
science review for each of the 26 non-digestible carbohydrates, and
     Other beneficial physiological endpoints and the relevant 
scientific data for a particular fiber. We have identified the main 
endpoints, such as cholesterol or glucose levels, but ask for 
scientific data on additional physiological endpoints (blood pressure) 
for which a non-digestible carbohydrate may have a beneficial 
physiological effect.

II. Reference

    The following reference is on display at the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA, 2016. ``Evaluation of the Beneficial Physiological Effects 
of Isolated or Synthetic Non-Digestible Carbohydrates.'' Available 
at: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm525656.htm.

    Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27950 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                          Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices                                            84595

                                                  guidance entitled ‘‘Over-the-Counter                    II. The Paperwork Reduction Act of                     Electronic Submissions
                                                  Sunscreens: Safety and Effectiveness                    1995                                                     Submit electronic scientific data,
                                                  Data’’ that was issued on November 23,                                                                         information, and comments in the
                                                  2015 (see 80 FR 72975) and incorporates                   This guidance contains collections of
                                                                                                          information that are exempt from the                   following way:
                                                  editorial changes and clarifying
                                                                                                          Paperwork Reduction Act of 1995 (the                     • Federal eRulemaking Portal: http://
                                                  language based on FDA’s consideration                                                                          www.regulations.gov. Follow the
                                                                                                          PRA) (44 U.S.C. 3501–3520). Section
                                                  of comments received on that draft                                                                             instructions for submitting comments.
                                                                                                          586D(a)(1)(C) of the FD&C Act, as
                                                  guidance. The draft guidance and                                                                               Comments submitted electronically,
                                                                                                          amended by the SIA, states that the PRA
                                                  related public comments are available at                shall not apply to collections of                      including attachments, to http://
                                                  http://www.regulations.gov by searching                 information made for purposes of                       www.regulations.gov will be posted to
                                                  Docket No. FDA–2015–D–4021.                             guidance under that subsection.                        the docket unchanged. Because your
                                                     This guidance addresses the current                                                                         comments will be made public, you are
                                                                                                          III. Electronic Access                                 solely responsible for ensuring that your
                                                  thinking of FDA about the safety and
                                                  effectiveness data needed to determine                                                                         comment does not include any
                                                                                                            Persons with access to the Internet                  confidential information that you or a
                                                  whether a nonprescription sunscreen                     may obtain the guidance at either http://              third party may not wish to be posted,
                                                  active ingredient or combination of                     www.fda.gov/Drugs/Guidance                             such as medical information, your or
                                                  active ingredients evaluated under the                  ComplianceRegulatoryInformation/                       anyone else’s Social Security number, or
                                                  SIA (Pub. L. 113–195), enacted                          Guidances/default.htm or http://                       confidential business information, such
                                                  November 26, 2014, which amended the                    www.regulations.gov.                                   as a manufacturing process. Please note
                                                  Federal Food, Drug, and Cosmetic Act                      Dated: November 17, 2016.                            that if you include your name, contact
                                                  (the FD&C Act) (21 U.S.C. 351 et seq.),                 Leslie Kux,                                            information, or other information that
                                                  is GRASE and not misbranded when                                                                               identifies you in the body of your
                                                                                                          Associate Commissioner for Policy.
                                                  used under specified conditions. The                                                                           comments, that information will be
                                                                                                          [FR Doc. 2016–28124 Filed 11–22–16; 8:45 am]
                                                  guidance also addresses FDA’s current                                                                          posted on http://www.regulations.gov.
                                                                                                          BILLING CODE 4164–01–P
                                                  thinking about an approach to safety-                                                                            • If you want to submit a comment
                                                  related final formulation testing that it                                                                      with confidential information that you
                                                  anticipates adopting in the future. FDA                 DEPARTMENT OF HEALTH AND                               do not wish to be made available to the
                                                  is issuing this guidance in partial                     HUMAN SERVICES                                         public, submit the comment as a
                                                  implementation of the SIA which,                                                                               written/paper submission and in the
                                                  among other things, established new                     Food and Drug Administration                           manner detailed (see ‘‘Written/Paper
                                                  procedures and review timelines for                                                                            Submissions’’ and ‘‘Instructions’’).
                                                  FDA to determine whether a                              [Docket No. FDA–2016–N–3389]                           Written/Paper Submissions
                                                  nonprescription sunscreen active
                                                  ingredient or combination of active                     Evaluation of the Beneficial                              Submit written/paper submissions as
                                                  ingredients is GRASE and not                            Physiological Effects of Isolated or                   follows:
                                                                                                          Synthetic Non-Digestible                                  • Mail/Hand delivery/Courier (for
                                                  misbranded when used under the
                                                                                                          Carbohydrates; Request for Scientific                  written/paper submissions): Division of
                                                  conditions specified in a final sunscreen
                                                                                                          Data, Information, and Comments                        Dockets Management (HFA–305), Food
                                                  order, in accordance with sections
                                                                                                                                                                 and Drug Administration, 5630 Fishers
                                                  586A, 586B, and 586C of the FD&C Act                                                                           Lane, Rm. 1061, Rockville, MD 20852.
                                                  (21 U.S.C. 360fff–1, 360fff–2, and                      AGENCY:    Food and Drug Administration,
                                                                                                          HHS.                                                      • For written/paper comments
                                                  360fff–3). The SIA directed FDA to issue                                                                       submitted to the Division of Dockets
                                                  guidance on four topics, including                      ACTION:  Notice; request for scientific                Management, FDA will post your
                                                  guidance regarding safety and                           data, information, and comments.                       comment, as well as any attachments,
                                                  effectiveness data in accordance with                                                                          except for information submitted,
                                                  section 586D of the FD&C Act (21 U.S.C.                 SUMMARY:    The Food and Drug                          marked and identified, as confidential,
                                                  360ffff–4). Many of the safety topics                   Administration (FDA or we) is                          if submitted as detailed in
                                                  addressed in this guidance were                         requesting scientific data, information,               ‘‘Instructions.’’
                                                  discussed at a public Nonprescription                   and comments that would help us                           Instructions: All submissions received
                                                  Drug Advisory Committee meeting held                    evaluate the beneficial physiological                  must include the Docket No. FDA–
                                                  on September 4 and 5, 2014, http://                     effects to human health of isolated or                 2016–N–3389 for ‘‘Evaluation of the
                                                  www.fda.gov/AdvisoryCommittees/                         synthetic non-digestible carbohydrates                 Beneficial Physiological Effects of
                                                  CommitteesMeetingMaterials/Drugs/                       that are added to foods. We are                        Isolated or Synthetic Non-Digestible
                                                  NonprescriptionDrugsAdvisory                            requesting such scientific data,                       Carbohydrates; Request for Scientific
                                                  Committee/ucm380890.htm.                                information, and comments to help us                   Data, Information, and Comments.’’
                                                                                                          determine whether a particular isolated                Received comments will be placed in
                                                     This guidance is being issued                        or synthetic non-digestible carbohydrate               the docket and, except for those
                                                  consistent with FDA’s good guidance                     should be added to our definition of                   submitted as ‘‘Confidential
                                                  practices regulation (21 CFR 10.115).                   ‘‘dietary fiber’’ for purposes of being                Submissions,’’ publicly viewable at
                                                  The guidance represents FDA’s current                   declared as dietary fiber on a Nutrition               http://www.regulations.gov or at the
mstockstill on DSK3G9T082PROD with NOTICES




                                                  thinking on the topics it addresses. This               Facts or Supplement Facts label.                       Division of Dockets Management
                                                  guidance does not establish any rights                                                                         between 9 a.m. and 4 p.m., Monday
                                                  for any person and is not binding on                    DATES: Submit either electronic or
                                                                                                                                                                 through Friday.
                                                                                                          written scientific data, information, and
                                                  FDA or the public. You can use an                                                                                 • Confidential Submissions—To
                                                  alternative approach if it satisfies the                comments by January 9, 2017.
                                                                                                                                                                 submit a comment with confidential
                                                  requirements of the applicable statutes                 ADDRESSES:        You may submit comments              information that you do not wish to be
                                                  and regulations.                                        as follows:                                            made publicly available, submit your


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                                                  84596                   Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices

                                                  comments only as a written/paper                        beneficial to human health (21 CFR                    Isolated or Synthetic Non-Digestible
                                                  submission. You should submit two                       101.9(c)(6)(i)). The final rule also                  Carbohydrates Submitted as a Citizen
                                                  copies total. One copy will include the                 identifies seven isolated or synthetic                Petition (§ 10.30); Guidance for
                                                  information you claim to be confidential                non-digestible carbohydrates that we                  Industry’’ to evaluate whether the
                                                  with a heading or cover note that states                determined to have beneficial effects for             available scientific evidence is sufficient
                                                  ‘‘THIS DOCUMENT CONTAINS                                human health when added to foods                      to support a physiological effect that is
                                                  CONFIDENTIAL INFORMATION.’’ The                         (§ 101.9(c)(6)(i)). The seven isolated or             beneficial to human health, based on the
                                                  Agency will review this copy, including                 synthetic non-digestible carbohydrates                factors set forth in the draft guidance.
                                                  the claimed confidential information, in                are: [beta]-glucan soluble fiber (as                  We have summarized the clinical
                                                  its consideration of comments. The                      described in 21 CFR 101.81(c)(2)(ii));
                                                                                                                                                                studies that we have identified for these
                                                  second copy, which will have the                        psyllium husk (as described in
                                                                                                                                                                26 non-digestible carbohydrates and
                                                  claimed confidential information                        § 101.81(c)(2)(ii)); cellulose, guar gum,
                                                                                                          pectin, locust bean gum; and                          have provided summaries of the studies
                                                  redacted/blacked out, will be available
                                                                                                          hydroxypropyl methylcellulose. Foods                  and related references in a document
                                                  for public viewing and posted on http://
                                                                                                          and dietary supplements that contain                  entitled ‘‘Evaluation of the Beneficial
                                                  www.regulations.gov. Submit both
                                                  copies to the Division of Dockets                       any of these seven isolated or synthetic              Physiological Effects of Isolated or
                                                  Management. If you do not wish your                     non-digestible carbohydrates must                     Synthetic Non-Digestible
                                                  name and contact information to be                      include the amounts of these dietary                  Carbohydrates.’’ The purpose of this
                                                  made publicly available, you can                        fibers in a serving of food in the dietary            Federal Register notice is to invite
                                                  provide this information on the cover                   fiber declarations on the products’                   interested parties to submit additional
                                                  sheet and not in the body of your                       Nutrition and Supplement Facts labels.                scientific data, information, and
                                                  comments and you must identify this                        Interested parties can ask us to list              comments regarding:
                                                  information as ‘‘confidential.’’ Any                    additional isolated or synthetic non-                   • The physiological endpoints that
                                                  information marked as ‘‘confidential’’                  digestible carbohydrates in the
                                                                                                                                                                we have addressed in the science review
                                                  will not be disclosed except in                         definition of dietary fiber in
                                                                                                                                                                for each of the 26 non-digestible
                                                  accordance with 21 CFR 10.20 and other                  § 101.9(c)(6)(i) if we determine that the
                                                                                                          new isolated or synthetic non-digestible              carbohydrates, and
                                                  applicable disclosure law. For more
                                                  information about FDA’s posting of                      carbohydrate meets our dietary fiber                    • Other beneficial physiological
                                                  comments to public dockets, see 80 FR                   definition. For example, a manufacturer               endpoints and the relevant scientific
                                                  56469, September 18, 2015, or access                    who wants FDA to amend the definition                 data for a particular fiber. We have
                                                  the information at: http://www.fda.gov/                 of dietary fiber to include another added             identified the main endpoints, such as
                                                  regulatoryinformation/dockets/                          non-digestible carbohydrate could                     cholesterol or glucose levels, but ask for
                                                  default.htm.                                            submit a citizen petition under 21 CFR                scientific data on additional
                                                     Docket: For access to the docket to                  10.30. Elsewhere in this issue of the                 physiological endpoints (blood
                                                  read background documents or the                        Federal Register, we have published a                 pressure) for which a non-digestible
                                                  electronic and written/paper comments                   notice announcing the availability of a               carbohydrate may have a beneficial
                                                  received, go to http://                                 draft guidance document entitled,                     physiological effect.
                                                  www.regulations.gov and insert the                      ‘‘Scientific Evaluation of the Evidence
                                                                                                          on the Beneficial Physiological Effects               II. Reference
                                                  docket number, found in brackets in the
                                                  heading of this document, into the                      of Isolated or Synthetic Non-Digestible
                                                                                                          Carbohydrates Submitted as a Citizen                     The following reference is on display
                                                  ‘‘Search’’ box and follow the prompts                                                                         at the Division of Dockets Management
                                                  and/or go to the Division of Dockets                    Petition (21 CFR 10.30): Guidance for
                                                                                                          Industry.’’ The draft guidance describes              (see ADDRESSES) and is available for
                                                  Management, 5630 Fishers Lane, Rm.                                                                            viewing by interested persons between
                                                                                                          the type of evidence and the scientific
                                                  1061, Rockville, MD 20852.                                                                                    9 a.m. and 4 p.m., Monday through
                                                                                                          evaluation process we plan to use in
                                                  FOR FURTHER INFORMATION CONTACT:                        determining the strength of the evidence              Friday; it is also available electronically
                                                  Paula R. Trumbo, Center for Food Safety                 for the relationship between an isolated              at http://www.regulations.gov. FDA has
                                                  and Applied Nutrition (HFS–830), Food                   or synthetic non-digestible carbohydrate              verified the Web site address, as of the
                                                  and Drug Administration, 5001 Campus                    that is added to food and a physiological             date this document publishes in the
                                                  Dr., College Park, MD 20740, 240–402–                   effect that is beneficial to human health.            Federal Register, but Web sites are
                                                  2579.                                                      In addition to issuing the draft                   subject to change over time.
                                                  SUPPLEMENTARY INFORMATION:                              guidance and determining that the
                                                                                                          seven isolated or synthetic non-                      1. FDA, 2016. ‘‘Evaluation of the Beneficial
                                                  I. Background                                                                                                     Physiological Effects of Isolated or
                                                                                                          digestible carbohydrates identified in
                                                     FDA regulations did not define the                   the final rule’s definition of dietary                    Synthetic Non-Digestible
                                                  term ‘‘dietary fiber’’ before 2016. In the              fibers have physiological effects that are                Carbohydrates.’’ Available at: http://
                                                  Federal Register of May 27, 2016 (81 FR                 beneficial to human health, we have                       www.fda.gov/Food/IngredientsPackaging
                                                  33742), we published a final rule                       conducted a scientific literature review                  Labeling/LabelingNutrition/ucm
                                                  amending our Nutrition and                              of clinical studies associated with 26                    525656.htm.
                                                  Supplement Facts label regulation. The                  isolated or synthetic non-digestible                    Dated: November 14, 2016.
                                                  final rule, among other things, defines                 carbohydrates, such as gum acacia,                    Leslie Kux,
                                                  dietary fiber as non-digestible soluble                 carboxymethyl cellulose, inulin,
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                Associate Commissioner for Policy.
                                                  and insoluble carbohydrates (with three                 polydextrose, and xanthan gum, that are
                                                                                                                                                                [FR Doc. 2016–27950 Filed 11–22–16; 8:45 am]
                                                  or more monomeric units), and lignin                    not listed as a dietary fiber in
                                                  that are intrinsic and intact in plants;                                                                      BILLING CODE 4164–01–P
                                                                                                          § 101.9(c)(6)(i). Our review is consistent
                                                  isolated or synthetic non-digestible                    with the factors we provide in the draft
                                                  carbohydrates (with three or more                       guidance entitled, ‘‘Scientific
                                                  monomeric units) determined by FDA to                   Evaluation of the Evidence on the
                                                  have physiological effects that are                     Beneficial Physiological Effects of


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Document Created: 2016-11-23 05:30:29
Document Modified: 2016-11-23 05:30:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for scientific data, information, and comments.
DatesSubmit either electronic or written scientific data, information, and comments by January 9, 2017.
ContactPaula 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.
FR Citation81 FR 84595 

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