[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


