The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability, 27894-27895 [2018-12867]
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Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Burlington, Massachusetts, on
June 8, 2018.
Robert J. Ganley,
Manager, Engine and Propeller Standards
Branch, Aircraft Certification Service.
[FR Doc. 2018–12873 Filed 6–14–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA–2018–D–1323]
The Declaration of Certain Isolated or
Synthetic Non-Digestible
Carbohydrates as Dietary Fiber on
Nutrition and Supplement Facts
Labels; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a final
guidance for industry entitled ‘‘The
Declaration of Certain Isolated or
Synthetic Non-Digestible Carbohydrates
as Dietary Fiber on Nutrition and
Supplement Facts Labels; Guidance for
Industry.’’ The guidance identifies eight
specific, additional isolated or synthetic
non-digestible carbohydrates that we
intend to add to our regulatory
definition of ‘‘dietary fiber’’ through our
regular rulemaking process. In the
interim, the guidance also advises
manufacturers of our policy for when
one or more of these eight nondigestible carbohydrates, present in a
food, are included in the declared
amount of ‘‘dietary fiber,’’ and for the
use of a caloric value for polydextrose
of 1 kilocalorie per gram (kcal/g).
DATES: The announcement of the
guidance is published in the Federal
Register on June 15, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
sradovich on DSK3GMQ082PROD with RULES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
VerDate Sep<11>2014
15:57 Jun 14, 2018
Jkt 244001
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–
2018–D–1323 for ‘‘The Declaration of
Certain Isolated or Synthetic NonDigestible Carbohydrates as Dietary
Fiber on Nutrition and Supplement
Facts Labels; Guidance for Industry.’’
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.’’ We
will review this copy, including the
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
(HFS–830), Food and Drug
Administration, 5100 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Paula R. Trumbo, Center for Food Safety
and Applied Nutrition (HFS–830), Food
and Drug Administration, 5100 Campus
Dr., College Park, MD 20740, 240–402–
2579.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry entitled ‘‘The
Declaration of Certain Isolated or
Synthetic Non-Digestible Carbohydrates
as Dietary Fiber on Nutrition and
Supplement Facts Labels; Guidance for
Industry.’’ We are issuing this guidance
consistent with our good guidance
practices (GGP) regulation (§ 10.115 (21
E:\FR\FM\15JNR1.SGM
15JNR1
sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations
CFR 10.115)). We are implementing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
appropriate (§ 10.115(g)(2)). We made
this determination because this
guidance sets out compliance policy
that reduces burden and is consistent
with the public health. Although this
guidance document is immediately in
effect, it remains subject to comment in
accordance with FDA’s GGP regulation.
Before 2016, FDA regulations did not
define the term ‘‘dietary fiber’’ for
purposes of the Nutrition Facts and
Supplement Facts labels. In the Federal
Register of May 27, 2016 (81 FR 33742),
we published a final rule amending our
Nutrition Facts and Supplement Facts
Labels regulations (hereafter referred to
as ‘‘the final rule’’). The final rule,
among other things, defines dietary fiber
as non-digestible soluble and insoluble
carbohydrates (with 3 or more
monomeric units), and lignin that are
intrinsic and intact in plants; isolated or
synthetic non-digestible carbohydrates
(with 3 or more monomeric units)
determined by FDA to have
physiological effects that are beneficial
to human health (§ 101.9(c)(6)(i) (21
CFR 101.9(c)(6)(i))). The final rule also
identifies seven isolated or synthetic
non-digestible carbohydrates, each of
which has a physiological effect that is
beneficial to human health and that
must be declared as dietary fiber on
Nutrition and Supplement Facts labels
when present in a food.
Interested parties can ask us to list
additional isolated or synthetic nondigestible carbohydrates in the
definition of dietary fiber in
§ 101.9(c)(6)(i). For example, a
manufacturer can request FDA to
include another added isolated or
synthetic non-digestible carbohydrate in
the listing of dietary fibers by
submitting a citizen petition under 21
CFR 10.30. FDA would review the
scientific evidence to determine
whether the evidence supports the nondigestible carbohydrate as having a
physiological effect that is beneficial to
human health. If so, FDA would
propose a rule to include the nondigestible carbohydrate in the listing of
dietary fibers.
Based on our review of citizen
petitions that FDA has received
requesting that we identify additional
isolated or synthetic non-digestible
carbohydrates in the listing of dietary
fibers, and comments that we have
received on a draft guidance entitled
‘‘Scientific Evaluation of the Evidence
on the Beneficial Physiological Effects
of Isolated or Synthetic Non-Digestible
Carbohydrates Submitted as a Citizen
VerDate Sep<11>2014
15:57 Jun 14, 2018
Jkt 244001
Petition (21 CFR 10.30)’’ and an
accompanying document titled
‘‘Evaluation of the Beneficial
Physiological Effects of Isolated or
Synthetic Non-Digestible
Carbohydrates,’’ the availability of
which we announced in the Federal
Register of November 23, 2016 (81 FR
84516 and 81 FR 84595), in addition to
our independent evaluation of the
available scientific data, we intend to
add certain isolated or synthetic nondigestible carbohydrates to the dietary
fiber definition in § 101.9(c)(6)(i)
through our regular rulemaking process.
The eight non-digestible carbohydrates
that we intend to add are: Mixed plant
cell wall fibers; arabinoxylan; alginate,
inulin and inulin-type fructans; high
amylose starch (resistant starch 2);
galactooligosaccharide; polydextrose;
and resistant maltodextrin/dextrin. One
category of non-digestible carbohydrate
that we intend to add to § 101.9(c)(6)(i)
through our regular rulemaking
process—mixed plant cell wall fibers—
encompasses a number of fiber
ingredients, such as rice bran fibers, soy
fibers, and sugar cane fibers. We have
tentatively determined that each of
these isolated or synthetic nondigestible carbohydrates has a
physiological effect that is beneficial to
human health. Several petitions are still
pending with FDA and reviewing this
information is a very high priority for
FDA. Firms also can submit new citizen
petitions, and we will review the
petitions on a rolling basis. Firms whose
non-digestible carbohydrates do not
meet our regulatory definition of
‘‘dietary fiber’’ and are not one of the
eight non-digestible carbohydrates
identified in the guidance can still use
those non-digestible carbohydrates in
foods. Although those non-digestible
carbohydrates cannot be listed as
dietary fiber in the Nutrition Facts label,
they would still be declared as part of
the amount of total carbohydrate and
listed by name in the ingredients on the
food package. In addition, based on our
review of the scientific evidence,
including evidence we received in a
citizen petition, we intend to establish
a caloric value for polydextrose at 1
kcal/g in § 101.9(c)(1)(i)(C).
Pending completion of the rulemaking
process, we are announcing a policy for
the eight identified isolated or synthetic
non-digestible carbohydrates when one
or more are present in food and declared
in the amount of ‘‘dietary fiber’’ on
Nutrition Facts and Supplement Facts
labels and when the caloric value of 1
kcal/g is used to determine the calorie
contribution of polydextrose. Section
101.9(g) requires manufacturers to make
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
27895
and keep records to verify the amount
of non-digestible carbohydrates added
to food that do not meet the definition
of dietary fiber. Under our policy, when
a mixture of dietary fiber and one or
more of these eight added non-digestible
carbohydrates (that are not currently
listed as a ‘‘dietary fiber’’ in the
definition in § 101.9(c)(6)(i)) are present
in a food, we do not expect
manufacturers to make and keep records
in accordance with § 101.9(g)(10) and
(11) to verify the declared amount of
one or more of these eight added nondigestible carbohydrates in the label and
labeling of food.
This guidance is being issued
consistent with FDA’s 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.
II. Electronic Access
Persons with access to the internet
may obtain the document 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: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12867 Filed 6–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2018–N–1894]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Fluid Jet System for Prostate Tissue
Removal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the fluid jet system for
prostate tissue removal into class II
(special controls). The special controls
that apply to the device type are
identified in this order and will be part
of the codified language for the fluid jet
SUMMARY:
E:\FR\FM\15JNR1.SGM
15JNR1
]]>Agencies
[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Rules and Regulations]
[Pages 27894-27895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12867]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2018-D-1323]
The Declaration of Certain Isolated or Synthetic Non-Digestible
Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts
Labels; 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 final guidance for industry entitled ``The
Declaration of Certain Isolated or Synthetic Non-Digestible
Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts
Labels; Guidance for Industry.'' The guidance identifies eight
specific, additional isolated or synthetic non-digestible carbohydrates
that we intend to add to our regulatory definition of ``dietary fiber''
through our regular rulemaking process. In the interim, the guidance
also advises manufacturers of our policy for when one or more of these
eight non-digestible carbohydrates, present in a food, are included in
the declared amount of ``dietary fiber,'' and for the use of a caloric
value for polydextrose of 1 kilocalorie per gram (kcal/g).
DATES: The announcement of the guidance is published in the Federal
Register on June 15, 2018.
ADDRESSES: You may submit either 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-2018-D-1323 for ``The Declaration of Certain Isolated or Synthetic
Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and
Supplement Facts Labels; Guidance for Industry.'' 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.'' 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.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 (HFS-830), Food and Drug Administration, 5100 Campus
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Campus Dr., College Park, MD 20740, 240-402-2579.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``The Declaration of Certain Isolated or Synthetic Non-
Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement
Facts Labels; Guidance for Industry.'' We are issuing this guidance
consistent with our good guidance practices (GGP) regulation (Sec.
10.115 (21
[[Page 27895]]
CFR 10.115)). We are implementing this guidance without prior public
comment because we have determined that prior public participation is
not feasible or appropriate (Sec. 10.115(g)(2)). We made this
determination because this guidance sets out compliance policy that
reduces burden and is consistent with the public health. Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with FDA's GGP regulation.
Before 2016, FDA regulations did not define the term ``dietary
fiber'' for purposes of the Nutrition Facts and Supplement Facts
labels. In the Federal Register of May 27, 2016 (81 FR 33742), we
published a final rule amending our Nutrition Facts and Supplement
Facts Labels regulations (hereafter referred to as ``the final rule'').
The final rule, among other things, defines dietary fiber as non-
digestible soluble and insoluble carbohydrates (with 3 or more
monomeric units), and lignin that are intrinsic and intact in plants;
isolated or synthetic non-digestible carbohydrates (with 3 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))). The final rule also identifies seven isolated or
synthetic non-digestible carbohydrates, each of which has a
physiological effect that is beneficial to human health and that must
be declared as dietary fiber on Nutrition and Supplement Facts labels
when present in a food.
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). For example, a manufacturer can request
FDA to include another added isolated or synthetic non-digestible
carbohydrate in the listing of dietary fibers by submitting a citizen
petition under 21 CFR 10.30. FDA would review the scientific evidence
to determine whether the evidence supports the non-digestible
carbohydrate as having a physiological effect that is beneficial to
human health. If so, FDA would propose a rule to include the non-
digestible carbohydrate in the listing of dietary fibers.
Based on our review of citizen petitions that FDA has received
requesting that we identify additional isolated or synthetic non-
digestible carbohydrates in the listing of dietary fibers, and comments
that we have received on a 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 (21 CFR 10.30)'' and an accompanying document titled
``Evaluation of the Beneficial Physiological Effects of Isolated or
Synthetic Non-Digestible Carbohydrates,'' the availability of which we
announced in the Federal Register of November 23, 2016 (81 FR 84516 and
81 FR 84595), in addition to our independent evaluation of the
available scientific data, we intend to add certain isolated or
synthetic non-digestible carbohydrates to the dietary fiber definition
in Sec. 101.9(c)(6)(i) through our regular rulemaking process. The
eight non-digestible carbohydrates that we intend to add are: Mixed
plant cell wall fibers; arabinoxylan; alginate, inulin and inulin-type
fructans; high amylose starch (resistant starch 2);
galactooligosaccharide; polydextrose; and resistant maltodextrin/
dextrin. One category of non-digestible carbohydrate that we intend to
add to Sec. 101.9(c)(6)(i) through our regular rulemaking process--
mixed plant cell wall fibers--encompasses a number of fiber
ingredients, such as rice bran fibers, soy fibers, and sugar cane
fibers. We have tentatively determined that each of these isolated or
synthetic non-digestible carbohydrates has a physiological effect that
is beneficial to human health. Several petitions are still pending with
FDA and reviewing this information is a very high priority for FDA.
Firms also can submit new citizen petitions, and we will review the
petitions on a rolling basis. Firms whose non-digestible carbohydrates
do not meet our regulatory definition of ``dietary fiber'' and are not
one of the eight non-digestible carbohydrates identified in the
guidance can still use those non-digestible carbohydrates in foods.
Although those non-digestible carbohydrates cannot be listed as dietary
fiber in the Nutrition Facts label, they would still be declared as
part of the amount of total carbohydrate and listed by name in the
ingredients on the food package. In addition, based on our review of
the scientific evidence, including evidence we received in a citizen
petition, we intend to establish a caloric value for polydextrose at 1
kcal/g in Sec. 101.9(c)(1)(i)(C).
Pending completion of the rulemaking process, we are announcing a
policy for the eight identified isolated or synthetic non-digestible
carbohydrates when one or more are present in food and declared in the
amount of ``dietary fiber'' on Nutrition Facts and Supplement Facts
labels and when the caloric value of 1 kcal/g is used to determine the
calorie contribution of polydextrose. Section 101.9(g) requires
manufacturers to make and keep records to verify the amount of non-
digestible carbohydrates added to food that do not meet the definition
of dietary fiber. Under our policy, when a mixture of dietary fiber and
one or more of these eight added non-digestible carbohydrates (that are
not currently listed as a ``dietary fiber'' in the definition in Sec.
101.9(c)(6)(i)) are present in a food, we do not expect manufacturers
to make and keep records in accordance with Sec. 101.9(g)(10) and (11)
to verify the declared amount of one or more of these eight added non-
digestible carbohydrates in the label and labeling of food.
This guidance is being issued consistent with FDA's 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.
II. Electronic Access
Persons with access to the internet may obtain the document 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: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12867 Filed 6-14-18; 8:45 am]
BILLING CODE 4164-01-P
