Contains Nonbinding Recommendations 
 
 
 
The Declaration of Certain Isolated or 
Synthetic Non-Digestible Carbohydrates 
as Dietary Fiber on Nutrition and 
Supplement Facts Labels:  Guidance for 
Industry 
 
 
 
 
  
Additional copies are available from: 
Office of Nutrition and Food Labeling 
Nutrition Program Staff, HFS-830 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-1450 
https://www.fda.gov/FoodGuidances 
  
 
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov.  Submit written comments to the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number FDA-2018-D-
1323 listed in the notice of availability that publishes in the Federal Register. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
 
June 2018 
    Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
 
I. Introduction
   
II. Background
   
III. Discussion
   
IV. References
   
V.  Appendix A  Intrinsic and Intact Non-Digestible 
 
Carbohydrates and Mixed Plant Cell Wall Fiber Ingredients
 
 
 
   
2 
  Contains Nonbinding Recommendations 
 
The Declaration of Certain Isolated or 
Synthetic Non-Digestible Carbohydrates 
as Dietary Fiber on Nutrition and 
Supplement Facts Labels:  Guidance for 
1
Industry   
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
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.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page. 
 
 
 
I.  Introduction 
 
This guidance is intended to identify for manufacturers specific, additional isolated or synthetic 
non-digestible carbohydrates that we intend to propose adding to the list of those that meet our 
regulatory definition of dietary fiber (21 CFR 101.9(c)(6)(i)).  This guidance also is intended 
to advise manufacturers of our intent to exercise enforcement discretion relative to the 
declaration of these isolated or synthetic non-digestible carbohydrates as a dietary fiber on 
Nutrition Facts and Supplement Facts labels, and for the use of a caloric value for polydextrose 
of 1 kcal/g, pending completion of a rulemaking regarding revising our regulations.  The 
following isolated or synthetic non-digestible carbohydrates are subject to our intent to exercise 
enforcement discretion:  mixed plant cell wall fibers; arabinoxylan; alginate; inulin and inulin-
type fructans; high amylose starch (resistant starch 2); galactooligosaccharide; polydextrose; and 
resistant maltodextrin/dextrin. 
 
This guidance is effective immediately because we have determined that prior public 
participation is not feasible or appropriate (21 CFR 10.115(g)(2)).   
 
                                                 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
3 
  Contains Nonbinding Recommendations 
 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
Before 2016, FDA regulations did not define the term dietary fiber for purposes of the 
Nutrition Facts or 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 (21 CFR 101.9(c)(6)(i)).  The final rule also identifies 
seven non-digestible carbohydrates that we have determined have beneficial physiological 
effects for human health and that therefore can be declared as dietary fiber on Nutrition and 
Supplement Facts labels.  The seven non-digestible carbohydrates identified in  101.9(c)(6)(i) 
are:   
 
  [beta]-glucan soluble fiber (as described in  101.81(c)(2)(ii)(A));2 
  psyllium husk (as described in  101.81(c)(2)(ii)(B));  
  cellulose;  
  guar gum;  
  pectin;  
  locust bean gum; and  
  hydroxypropylmethylcellulose. 
   
Interested parties can ask us to list additional isolated or synthetic non-digestible carbohydrates 
that meet the definition of dietary fiber in  101.9(c)(6)(i).  For example, a manufacturer who 
wants FDA to amend the list of isolated or synthetic non-digestible carbohydrates that meet the 
definition of dietary fiber can submit a citizen petition under 21 CFR 10.30.   
 
In the Federal Register of November 23, 2016 (81 FR 84516), we announced the availability of a 
draft guidance titled, 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 (2016 draft guidance).3  We announced the availability of 
                                                 
2 Beta-glucan soluble fiber and psyllium husk are included in the definition of dietary fiber because they are the 
subject of a health claim and not because of their status as an intrinsic or intact or isolated or synthetic non-
digestible carbohydrates. 
3 See Docket No. FDA-2016-D-3401. 
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  Contains Nonbinding Recommendations 
the final guidance in the Federal Register of March 2, 2018 (83 FR 8997).4  The March 2018 
final guidance explains FDAs current thinking on information needed when submitting a citizen 
petition and the scientific review approach we plan to use for evaluating scientific evidence to 
determine whether an isolated or synthetic non-digestible carbohydrate that is added to food has 
a physiological effect that is beneficial to human health. 
 
In the Federal Register of November 23, 2016 (81 FR 84516), we also announced the 
availability of a document titled Science Review of Isolated and Synthetic Non-Digestible 
Carbohydrates (2016 science review), which summarizes clinical studies associated with 26 
isolated or synthetic non-digestible carbohydrates.5  In addition, we published a separate notice 
in the Federal Register requesting the submission of scientific data, information, and comments 
to help us evaluate the beneficial physiological effects to human health of isolated or synthetic 
non-digestible carbohydrates that are added to food (81 FR 84595).   
 
FDA has received several citizen petition requests to list additional isolated or synthetic non-
digestible carbohydrates.  We evaluated the strength of the scientific evidence using the same 
factors that we set forth in the March 2018 final guidance.  We based our scientific evaluation 
for isolated or synthetic non-digestible carbohydrates on data and information provided by:  (1) 
citizen petitions;6 (2) the publicly available scientific literature; (3) comments that we received 
in response to our notice requesting scientific data, information;7 and (4) comments that we 
received on the 2016 science review.8  Our summaries and evaluations of the published clinical 
studies for the non-digestible carbohydrates for which we intend to exercise our enforcement 
                                                 
4 Available at:  
https://www.fda.gov/downloads/Food/GuidanceRegulations/GuidanceDocumentsRegulatoryInformation/UCM5285
33.pdf. 
5 See Docket No. FDA-2016-N-3389.  
6 Docket No. FDA-2016-P-1674, Citizen Petition Regarding the Listing of PROMITOR Soluble Corn Fiber as a 
Source of Dietary Fiber, submitted by Tate & Lyle Ingredients Americas LLC; Docket No. FDA-2016-P-2377, 
Citizen Petition Regarding Nutrition Labeling of Fibersol Resistant Maltodextrin as a Dietary Fiber, submitted 
by Archer Daniels Midland Company; Docket No. FDA-2016-P-2736, A Citizen Petition Requesting that FDA 
Amend 21 CFR 101.9(c)(6)(i) to Recognize that Inulin-Type Fructans Derived from Chicory Root Qualify as 
Dietary Fiber for Purposes of Nutrition Labeling, submitted by Hyman, Phelps & McNamara, P.C. on behalf of 
Beneo, Cosucra Groupe Warcoing, S.A., and Sensus B.V.; Docket No. FDA-2016-P-2860, A Citizen Petition 
Regarding the Inclusion of Inulin-Type Fructans Extracted from Chicory Root in the Definition of Dietary Fiber, 
submitted by General Mills; Docket No. FDA-2016-P-3070, A Citizen Petition to Request the Commissioner of 
Food and Drugs to Add Soy Fiber to the List of Isolated or Synthetic Non-digestible Carbohydrates that Have Been 
Determined by FDA to Have Physiological Effects that Are Beneficial to Human Health at 21 CFR 101.9(c)(6)(i), 
submitted by DuPont Nutrition & Health; Docket No. FDA-2016-P-3311, Citizen Petition Regarding the Listing of 
Polydextrose as a Source of Dietary Fiber and the Caloric Value of Polydextrose for Use in Nutrition Labeling and 
Claims, submitted by Tate & Lyle Ingredients Americas LLC and DuPont Nutrition & Health; Docket No. FDA-P-
2017-0970, A Citizen Petition Requesting that FDA Amend 21 C.F.R.  101.9(c)(6)(i) to Recognize Rice Bran 
Derived Products that Contain Rice Bran Fiber and Other Components of Rice Bran as Containing Dietary Fiber for 
Purposes of Nutrition Labeling, submitted by RiceBran Technologies; and Docket No. FDA-2016-P-4233, A 
citizen petition requesting that PhytocelTM and KfibreTM sugarcane flour made from whole sugarcane be classified as 
a dietary fiber for label declaration purposes, submitted by KFSU Ltd.  
7 FDA. Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; 
Request for Scientific Data, Information, and Comments (81 FR 84595; November 23, 2016), and see Docket No. 
FDA-2016-N-3389.   
8 FDA.  Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates, 
November 2016.  Available at:  https://www.fda.gov/Food/LabelingNutrition/ucm525656.htm. 
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  Contains Nonbinding Recommendations 
discretion appear in a document entitled Review of the Scientific Evidence on the Physiological 
Effects of Certain Non-Digestible Carbohydrates.9   
 
III.  Discussion 
 
Based on our review of the citizen petitions, comments that we have received, and our 
independent evaluation of the available scientific data, we intend to propose to add eight new 
isolated or synthetic non-digestible carbohydrates to  101.9(c)(6)(i) because we have tentatively 
determined that they have physiological effects that are beneficial to human health. 
 
We intend to exercise enforcement discretion for the declaration of dietary fiber, pending 
completion of a rulemaking regarding revising our regulations, if the declaration includes one or 
more of the following eight isolated or synthetic non-digestible carbohydrates, when present in a 
food and included in the amount of dietary fiber declared on the Nutrition or Supplement Facts 
label: 
 
  mixed plant cell wall fibers;10 
  arabinoxylan;   
  alginate;  
  inulin and inulin-type fructans; 
  high amylose starch (resistant starch 2); 
  galactooligosaccharide;  
  polydextrose; and 
  resistant maltodextrin/dextrin. 
 
Many of the 26 non-digestible carbohydrates we reviewed (e.g., sugar cane fiber and oat hull 
fiber) are considered to be mixed plant cell wall fibers.11  While some isolated non-digestible 
carbohydrate ingredients are added to foods and listed as a specific non-digestible carbohydrate 
(e.g., cellulose), they may also be added and listed as part of a mixed plant cell wall fiber (e.g., 
sugar cane fiber).  We have evaluated the beneficial physiological effects of specific, isolated 
non-digestible carbohydrates that also may be part of a mixed plant cell wall fiber (e.g., cellulose 
and pectin).  We have determined that each of these individual isolated non-digestible 
carbohydrates (e.g., cellulose and pectin) has a beneficial physiological effect.  Therefore, we 
intend to consider mixed plant cell wall fibers as a general category of isolated non-digestible 
carbohydrates. 
 
                                                 
9 Available at: https://www.fda.gov/downloads/Food/LabelingNutrition/UCM610139.pdf. 
10 While not an exhaustive list, examples of mixed plant cell wall fibers are provided in our science review (Id.).  
11 For purposes of this guidance, mixed plant cell wall fibers are ingredients that contain two or more of the 
following plant cell wall fibers in varying proportions:  cellulose; pectin; lignin; beta-glucan; and arabinoxylan.  
Mixed plant cell wall fibers may include variable amounts of vitamins, minerals, and macronutrients depending on 
the methods that may be used for isolating and extracting the fiber.  See the discussion of mixed plant cell wall 
fibers in Appendix A and our science review titled Review of the Scientific Evidence on the Physiological Effects 
of Certain Non-Digestible Carbohydrates,  June 2018. Available at: 
https://www.fda.gov/downloads/Food/LabelingNutrition/UCM610139.pdf. 
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  Contains Nonbinding Recommendations 
FDAs regulations at 21 CFR 101.9(c)(1)(i)(C), regarding the required declaration of nutrient 
levels on a food label, provide a caloric value of 2 kcal/g for soluble non-digestible 
carbohydrates.  Based on our review of the scientific evidence,12 including evidence provided in 
a citizen petition,13 we intend to propose to amend this caloric value for polydextrose to 1 kcal/g 
in a future rulemaking.  In the interim, we intend to exercise enforcement discretion with respect 
to the use of a caloric value of 1 kcal/g for polydextrose on Nutrition and Supplement Facts 
labels under  101.9(c)(1)(i)(C). 
 
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. However, 
consistent with our intent to exercise enforcement discretion, 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 non-digestible carbohydrates in the label 
and labeling of food. 
 
IV.  References  
 
We have placed the following reference on display in the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may 
see it at that location between 9 a.m. and 4 p.m., Monday through Friday.  As of June 5, 2018, 
FDA had verified the Web site address for the references as hyperlink from the Internet copy of 
this guidance, but FDA is not responsible for any subsequent changes to Non-FDA Web site 
references after June 5, 2018.  
 
U.S. Department of Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition.  Review of the Scientific Evidence on the Physiological 
Effects of Non-Digestible Carbohydrates.  June 2018.  Available at: 
https://www.fda.gov/downloads/Food/LabelingNutrition/UCM610139.pdf. 
 
   
                                                 
12 Id.  
13 Docket No. FDA-2016-P-3311, Citizen Petition Regarding the Listing of Polydextrose as a Source of Dietary 
Fiber and the Caloric Value of Polydextrose for Use in Nutrition Labeling and Claims, submitted by Tate & Lyle 
Ingredients Americas LLC and DuPont Nutrition & Health. 
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  Contains Nonbinding Recommendations 
 
 
V.   Appendix A  Intrinsic and Intact Non-Digestible 
Carbohydrates and Mixed Plant Cell Wall Fiber Ingredients 
 
In this guidance, we announce our intent to exercise enforcement discretion with respect to eight 
additional non-digestible carbohydrates (NDCs) relative to the declaration of these NDCs as a 
dietary fiber on Nutrition and Supplement Facts labels.  We include a reference in this guidance 
that provides our science review of the eight additional NDCs (titled Review of the Scientific 
Evidence on the Physiological Effects of Certain Non-Digestible Carbohydrates) (2018 
enforcement discretion science review). This Appendix addresses several issues related to NDCs 
that we consider to be intrinsic and intact, or that we consider to be a mixed plant cell wall fiber 
ingredient.  A full discussion of mixed plant cell wall fibers can be found in the document 
entitled Review of the Scientific Evidence on the Physiological Effects of Certain Non-
Digestible Carbohydrates. 
 
The 2016 draft guidance, titled 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, stated that we did not consider NDCs 
obtained from non-food sources, such as stems, branches, and trunks of trees, edible hulls and 
husks, seaweed, and fungus, to be intrinsic and intact.  We recognize that certain seaweeds and 
fungi are considered foods.  Therefore, consistent with the dietary fiber definition, the intrinsic 
and intact NDCs found in seaweed and fungi, consumed as food, meet the dietary fiber 
definition.  There are, however, NDCs that may be isolated from food sources or that are isolated 
from non-food sources that are not intrinsic and intact, such as cellulose from wood pulp.  
Therefore, we intend to review the available scientific evidence for isolated NDCs obtained from 
food and non-food sources to determine whether any of them have a physiological effect that is 
beneficial to human health.  The 2016 draft guidance provided examples of intrinsic and intact 
NDCs (e.g., cereal bran, cocoa powder, flours) and NDCs (e.g., resistant starch) that are created 
during the normal processing of food (e.g., flaked corn cereal).  For many other products, 
determining whether the processing that a plant undergoes would no longer result in an intrinsic 
and intact dietary fiber or would be an isolated NDC would be difficult, unless we evaluated 
the particular NDC and its processing method.  For example, many plants contain a variety of 
NDCs, with common ones primarily being present in plant cell walls (e.g., cellulose, 
hemicelluloses, and pectin), in addition to lignin.14  The content and profile of these mixed plant 
cell wall fibers can vary depending on the processing methods that are used to extract the NDCs 
from a particular type of plant, which, in turn, often makes it difficult to determine whether or 
not a particular NDC is intrinsic and intact, particularly when the processing methods used to 
extract the NDC or the composition of the ingredient are unknown. 
 
                                                 
14 Marlett JA.  Content and composition of dietary fiber in 117 frequently consumed foods. Journal of the American 
Dietetic Association 1992;92:175-186; Kumar V, Sinha AK, Makkar HPS et al. Dietary roles of non-starch 
polysaccharides in human nutrition: A review. Critical Review in Food Science and Nutrition 2012;52:899-935. 
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  Contains Nonbinding Recommendations 
We recognize that different types of processing methods can result in different degrees of 
isolation, even among aqueous or chemical extraction methods.15  In reviewing the literature, the 
plant cell wall fibers, cellulose and pectin, as well as lignin, are present in de-hulled soybeans 
that are used for producing soy protein concentrates.16  Therefore, the plant cell wall fibers 
present in concentrates, such as soy protein concentrates, provide physiological effects that are 
beneficial to human health. 
 
Some NDCs, such as plant cell wall fibers (e.g., corn hull fiber), can have the same name, but are 
subject to different types of processing and the name may not be indicative of whether the NDC 
is intrinsic and intact or isolated.  We have addressed this in this 2018 enforcement 
discretion guidance, where we state that we intend to consider enforcement discretion for mixed 
plant cell wall fibers as dietary fiber. 
 
The 2018 final guidance, titled 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 (2018 final guidance), provides 
additional information regarding the NDCs that we consider to be isolated and not intrinsic and 
intact.  The remaining isolated NDC ingredients, (i.e., not currently listed in the definition of 
dietary fiber or included in the mixed plant cell wall fiber category of isolated fibers) have a 
specific chemical structure as defined by their carbohydrate composition and non-digestible bond 
linkages. Consistent with the 2018 final guidance, the 2018 enforcement discretion science 
review includes the scientific evidence for such chemically specific ingredients (e.g., inulin, 
alginate, and polydextrose). 
 
                                                 
15 Production of soy protein concentrates involves the use of defatted soy flour which is further processed to remove 
other macronutrients, such as sugars, and minerals, resulting in minor changes to the fiber content (Wang H, 
Johnson LS, Wang T.  Preparation of soy protein concentrate and isolate from extruded-expelled soybean meals. 
Journal of the American Oil Chemists Society 2004; 81:713-717). 
16 Li B, Lu F, H Nan et al.  Isolation and structural characterization of okara polysaccharides. Molecules 
2012;17:753-761; Tsai, AC, Mott EL, Owen GM et al.  Effects of soy polysaccharide on gastrointestinal functions, 
nutrient balance, steroid excretions, glucose tolerance, serum lipids, and other parameters in humans.  American 
Journal of Clinical Nutrition 1983;38:504-511.  
 
9