83 FR 8997 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 42 (March 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 42 (March 2, 2018)
| Page Range | 8997-8998 | |
| FR Document | 2018-04280 |
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)] [Notices] [Pages 8997-8998] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04280] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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
![Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices 8997
Staff, 5630 Fishers Lane, Rm. 1061, asking us to clarify how flavored honey instructions for submitting comments.
Rockville, MD 20852. should be named, we revised the answer Comments submitted electronically,
You may submit comments on any to this question to make it clear that including attachments, to https://
guidance at any time (see 21 CFR honey with a characterizing flavor www.regulations.gov will be posted to
10.115(g)(5)). should be labeled in accordance with 21 the docket unchanged. Because your
Submit written requests for single CFR 101.3(b) and 102.5(a). The guidance comment will be made public, you are
copies of the guidance to the Office of announced in this notice finalizes the solely responsible for ensuring that your
Nutrition and Food Labeling, Center for draft guidance dated April 2014. comment does not include any
Food Safety and Applied Nutrition, confidential information that you or a
II. Electronic Access third party may not wish to be posted,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740. Persons with access to the internet such as medical information, your or
Send two self-addressed adhesive labels may obtain the guidance at either http:// anyone else’s Social Security number, or
to assist that office in processing your www.fda.gov/FoodGuidances or https:// confidential business information, such
request. See the SUPPLEMENTARY www.regulations.gov. Use the FDA as a manufacturing process. Please note
INFORMATION section for electronic website listed in the previous sentence that if you include your name, contact
access to the guidance. to find the most current version of the information, or other information that
FOR FURTHER INFORMATION CONTACT: guidance. identifies you in the body of your
Andrea Krause, Center for Food Safety Dated: February 27, 2018. comments, that information will be
and Applied Nutrition, Food and Drug posted on https://www.regulations.gov.
Leslie Kux,
Administration, 5001 Campus Dr., • If you want to submit a comment
Associate Commissioner for Policy. with confidential information that you
College Park, MD 20740, 240–402–2371. [FR Doc. 2018–04282 Filed 3–1–18; 8:45 am] do not wish to be made available to the
SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P public, submit the comment as a
I. Background written/paper submission and in the
manner detailed (see ‘‘Written/Paper
We are announcing the availability of DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
a guidance for industry entitled ‘‘Proper HUMAN SERVICES
Labeling of Honey and Honey Written/Paper Submissions
Products.’’ We are issuing this guidance Food and Drug Administration Submit written/paper submissions as
consistent with our good guidance [Docket No. FDA–2016–D–3401] follows:
practices regulation (21 CFR 10.115). • Mail/Hand delivery/Courier (for
The guidance represents the current Scientific Evaluation of the Evidence written/paper submissions): Dockets
thinking of FDA on this topic. It does on the Beneficial Physiological Effects Management Staff (HFA–305), Food and
not establish any rights for any person of Isolated or Synthetic Non-Digestible Drug Administration, 5630 Fishers
and is not binding on FDA or the public. Carbohydrates Submitted as a Citizen Lane, Rm. 1061, Rockville, MD 20852.
You can use an alternative approach if Petition; Guidance for Industry; • For written/paper comments
it satisfies the requirements of the Availability submitted to the Dockets Management
applicable statutes and regulations. This Staff, FDA will post your comment, as
guidance is not subject to Executive AGENCY: Food and Drug Administration, well as any attachments, except for
Order 12866. HHS. information submitted, marked and
In the Federal Register of April 4, ACTION: Notification of availability. identified, as confidential, if submitted
2014 (79 FR 19620), we announced the as detailed in ‘‘Instructions.’’
availability of a draft guidance for SUMMARY: The Food and Drug Instructions: All submissions received
industry entitled ‘‘Proper Labeling of Administration (FDA or we) is must include the Docket No. FDA–
Honey and Honey Products’’ and announcing the availability of a 2016–D–3401 for ‘‘Scientific Evaluation
invited comment by June 9, 2014. We guidance for industry entitled of the Evidence on the Beneficial
received numerous comments on the ‘‘Scientific Evaluation of the Evidence Physiological Effects of Isolated or
draft guidance and have modified the on the Beneficial Physiological Effects Synthetic Non-Digestible Carbohydrates
final guidance where appropriate. In of Isolated or Synthetic Non-Digestible Submitted as a Citizen Petition (21 CFR
addition, we made editorial changes to Carbohydrates Submitted as a Citizen 10.30).’’ Received comments will be
improve clarity and to focus on labeling Petition (21 CFR 10.30).’’ The guidance placed in the docket and, except for
issues. The final guidance recognizes a describes our views on the scientific those submitted as ‘‘Confidential
definition of honey that is broader than evidence needed and the approach to Submissions,’’ publicly viewable at
what was noted in the draft guidance evaluating the scientific evidence on the https://www.regulations.gov or at the
and that reflects comments that said that physiological effects to human health of Dockets Management Staff between 9
bees use nectar from plants other than isolated or synthetic non-digestible a.m. and 4 p.m., Monday through
flowers. We declined, however, to carbohydrates that are added to foods. Friday.
further define ‘‘chief floral source’’ (as DATES: The announcement of the • Confidential Submissions—To
suggested by other comments) because it guidance is published in the Federal submit a comment with confidential
is addressed by the Compliance Policy Register on March 2, 2018. information that you do not wish to be
Guide (CPG) 515.300, ‘‘Honey-Source ADDRESSES: You may submit electronic made publicly available, submit your
Declaration’’ (available online at http:// or written comments on Agency comments only as a written/paper
daltland on DSKBBV9HB2PROD with NOTICES
www.fda.gov/iceci/compliancemanuals/ guidances at any time as follows: submission. You should submit two
compliancepolicyguidancemanual/ copies total. One copy will include the
ucm074437.htm), and it is the Electronic Submissions information you claim to be confidential
responsibility of the producer to ensure Submit electronic comments in the with a heading or cover note that states
that the source of its honey, if included following way: ‘‘THIS DOCUMENT CONTAINS
on the label, is not false or misleading. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
In response to multiple comments https://www.regulations.gov. Follow the Agency will review this copy, including
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![8998 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
the claimed confidential information, in current thinking of FDA on this topic. made editorial changes to improve
its consideration of comments. The It does not establish any rights for any clarity. The guidance announced in this
second copy, which will have the person and is not binding on FDA or the notice finalizes the draft guidance dated
claimed confidential information public. You can use an alternative November 2016.
redacted/blacked out, will be available approach if it satisfies the requirements
II. Paperwork Reduction Act of 1995
for public viewing and posted on of the applicable statutes and
https://www.regulations.gov. Submit regulations. This guidance is not subject The guidance refers to previously
both copies to the Dockets Management to Executive Order 12866. approved collections of information
Staff. If you do not wish your name and In the Federal Register of May 27, found in FDA regulations. These
contact information to be made publicly 2016 (81 FR 33742), we published a collections of information are subject to
available, you can provide this final rule amending our Nutrition and review by the Office of Management and
information on the cover sheet and not Supplement Facts label regulations. The Budget (OMB) under the Paperwork
in the body of your comments and you final rule provides a definition of Reduction Act of 1995 (44 U.S.C. 3501–
must identify this information as dietary fiber as non-digestible soluble 3520). The collections of information in
‘‘confidential.’’ Any information marked and insoluble carbohydrates (with three § 101.9 have been approved under OMB
as ‘‘confidential’’ will not be disclosed or more monomeric units), and lignin control number 0910–0813.
except in accordance with 21 CFR 10.20 that are intrinsic and intact in plants; III. Electronic Access
and other applicable disclosure law. For isolated or synthetic non-digestible
more information about FDA’s posting carbohydrates (with three or more Persons with access to the internet
of comments to public dockets, see 80 monomeric units) determined by FDA to may obtain the guidance at either
FR 56469, September 18, 2015, or access have physiological effects that are https://www.fda.gov/FoodGuidances or
the information at: https://www.gpo.gov/ beneficial to human health https://www.regulations.gov. Use the
fdsys/pkg/FR-2015-09-18/pdf/2015- (§ 101.9(c)(6)(i)) (21 CFR 101.9(c)(6)(i)). FDA website listed in the previous
23389.pdf. One mechanism by which a sentence to find the most current
Docket: For access to the docket to manufacturer could request an version of the guidance.
read background documents or the amendment to the list of isolated or Dated: February 27, 2018.
electronic and written/paper comments synthetic non-digestible carbohydrates Leslie Kux,
received, go to https:// that meet the dietary fiber definition is Associate Commissioner for Policy.
www.regulations.gov and insert the by using the citizen petition process in [FR Doc. 2018–04280 Filed 3–1–18; 8:45 am]
docket number, found in brackets in the 21 CFR 10.30. If an isolated or synthetic
BILLING CODE 4164–01–P
heading of this document, into the non-digestible carbohydrate meets the
‘‘Search’’ box and follow the prompts dietary fiber definition, then it would be
and/or go to the Dockets Management added to the list of dietary fibers in DEPARTMENT OF HEALTH AND
Staff, 5630 Fishers Lane, Rm. 1061, § 101.9(c)(6)(i). HUMAN SERVICES
Rockville, MD 20852. In the Federal Register of November
You may submit comments on any 23, 2016, (81 FR 84516), we announced Food and Drug Administration
guidance at any time (see 21 CFR the availability of a draft guidance for
[Docket No. FDA–2018–D–0338]
10.115(g)(5)). industry entitled ‘‘Scientific Evaluation
Submit written requests for single of the Evidence on the Beneficial Definitions of Suspect Product and
copies of the guidance to the Office of Physiological Effects of Isolated or Illegitimate Product for Verification
Nutrition and Food Labeling, Center for Synthetic Non-Digestible Carbohydrates Obligations Under the Drug Supply
Food Safety and Applied Nutrition, Submitted as a Citizen Petition (21 CFR Chain Security Act; Draft Guidance for
Food and Drug Administration, 5001 10.30)’’ and gave interested parties an Industry; Availability
Campus Dr., College Park, MD 20740. opportunity to submit comments by
Send two self-addressed adhesive labels January 23, 2017, for us to consider AGENCY: Food and Drug Administration,
to assist that office in processing your before beginning work on the final HHS.
request. See the SUPPLEMENTARY version of the guidance. In the Federal ACTION: Notice of availability.
INFORMATION section for electronic Register of January 13, 2017 (82 FR
access to the guidance. 4225), we extended the comment period SUMMARY: The Food and Drug
to February 13, 2017. We received Administration (FDA or Agency) is
FOR FURTHER INFORMATION CONTACT:
several comments on the draft guidance announcing the availability of a draft
Paula R. Trumbo, Center for Food Safety
and have modified the final guidance guidance entitled ‘‘Definitions of
and Applied Nutrition (HFS–830), Food
where appropriate. Changes to the Suspect Product and Illegitimate
and Drug Administration, 5001 Campus
guidance include: (1) The inclusion of Product for Verification Obligations
Dr., College Park, MD 20740, 240–402–
studies on diseased populations under Under the Drug Supply Chain Security
2579.
certain circumstances as part of our Act.’’ The draft guidance is intended to
SUPPLEMENTARY INFORMATION: describe FDA’s interpretation of terms
evaluation of the totality of the scientific
I. Background evidence; (2) additional detail and used in the definitions of ‘‘suspect
clarity on the physiological endpoints product’’ and ‘‘illegitimate product’’ in
We are announcing the availability of the Drug Supply Chain Security Act
a guidance for industry entitled that we consider when reviewing the
scientific evidence; and (3) additional (DSCSA), for purposes of trading
‘‘Scientific Evaluation of the Evidence
daltland on DSKBBV9HB2PROD with NOTICES
on the Beneficial Physiological Effects detail regarding factors we consider
when evaluating the strength of the result of the processing of foods and other sources,
of Isolated or Synthetic Non-Digestible to the extent that the ingredients in and of
Carbohydrates Submitted as a Citizen scientific evidence.1 In addition, we themselves have a specific chemical structure
Petition (21 CFR 10.30).’’ We are issuing (carbohydrate composition and non-digestible bond
1 This guidance addresses the scientific linkages). These isolated non-digestible
this guidance consistent with our good evaluation of synthetic non-digestible carbohydrates may or may not vary in size.
guidance practices regulation (21 CFR carbohydrates and isolated non-digestible Examples of isolated non-digestible carbohydrates
10.115). The guidance represents the carbohydrate ingredients that are produced as a include cellulose, guar gum, and pectin.
VerDate Sep<11>2014 18:10 Mar 01, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1](https://thefederalregister.org/doc/83_FR_9039/page/2.svg)
Document Created: 2018-03-01 23:56:47
Document Modified: 2018-03-01 23:56:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on March 2, 2018. | |
| 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. | |
| FR Citation | 83 FR 8997 |
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