Contains Nonbinding Recommendations 
 
The Declaration of Allulose and Calories 
from Allulose on Nutrition and 
Supplement Facts Labels:  Guidance for 
Industry 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
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 on the guidance 
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-2019-D-0725. 
 
 
 
 
 
  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
 
October 2020 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
Table of Contents 
 
 
 
 
I. Introduction
   
II. Background
   
III. Declaration of Allulose on the Nutrition and Supplement Facts 
 
Labels
 
1.  FDAs Consideration of the Caloric Value of Allulose 
2.  FDAs Consideration of Allulose as a Carbohydrate 
3.  FDAs Consideration of Allulose as a Sugar 
4.  FDAs Consideration of Allulose as an Added Sugar 
IV. Paperwork Reduction Act of 1995
   
V. References
    Contains Nonbinding Recommendations 
 
The Declaration of Allulose and Calories 
from Allulose on Nutrition and 
Supplement Facts Labels:  Guidance for 
Industry1  
 
 
 
 
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 provides our current view on the declaration of allulose on Nutrition and 
Supplement Facts labels, as well as on the caloric content of allulose.  This guidance also advises 
manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from 
the amount of Total Sugars and Added Sugars declared on the label and the use of a general 
factor of 0.4 calories per gram (kcal/g)2 for allulose when determining Calories on the 
Nutrition and Supplement Facts labels pending review of the issues in a rulemaking.    
 
In arriving at our decision to consider the exercise of enforcement discretion, we considered data 
and information provided in citizen petitions and in comments to the draft guidance, and other 
information submitted to us.  We received a citizen petition requesting the exemption of allulose 
from the declaration of Total Carbohydrate, Total Sugars, and Added Sugars on the 
Nutrition Facts label (Docket Number FDA-2015-P-1201) (Ref. 1).  We also considered a citizen 
petition requesting the use of a general factor for caloric value of allulose of 0.4 calories per 
gram (kcal/g) (Docket Number FDA-2016-P-2030) (Ref. 3), and another citizen petition 
requesting the use of a general factor for the caloric value of allulose of 0.2 kcal/g (Docket 
                                                 
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. 
2 Calories per gram or kilocalories per gram (kcal/g) has been defined as the amount of heat energy needed to raise 
the temperature of a kilogram of water 1oC (determined at 14.5oC to 15.5oC) and is the unit that has been 
traditionally used for expressing the energy value of foods (Ref. 2). 
 
  Contains Nonbinding Recommendations 
 
 
Number FDA-2017-P-1463) (Ref. 4).  We considered these citizen petitions (as well as 
comments submitted to the dockets for these citizen petitions) in conjunction with comments to a 
proposed rule titled Food Labeling: Revision of the Nutrition and Supplement Facts Labels (79 
FR 11880, March 3, 2014) (the proposed rule).  We also conducted an independent review of 
the scientific evidence related to the cariogenic potential, metabolism, and caloric value of, and 
glycemic response to, allulose. 
 
FDAs 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 
 
Allulose or D-psicose (D-ribo-2-hexulose) is a monosaccharide with a molecular formula of 
C H O and is an epimer of D-fructose.  D-psicose occurs naturally and is present in small 
6 12 6, 
amounts in wheat, fruits (e.g., raisins, dried figs) and in many other foods (e.g. molasses, maple 
syrup, and brown sugar).  It can also be synthesized from fructose by enzymatic epimerization 
which converts fructose to D-psicose.  FDA has not objected to three Generally Recognized as 
Safe (GRAS) notifications regarding the use of this substance as a sugar substitute in certain 
conventional foods and beverages (GRAS Notification Number (GRN) 400 (Ref. 5), GRN 498 
(Ref. 6), and GRN 693 (Ref. 7)).  
 
On April 10, 2015, we received a citizen petition from Tate & Lyle Ingredients America LLC 
(Tate & Lyle) (Docket Number FDA-2015-P-1201) (Ref. 1) requesting that we amend 21 CFR 
101.9 to exempt allulose from being included as a carbohydrate, sugar,3 or added sugar on the 
Nutrition Facts label for foods and beverages.  The citizen petition provided data and other 
information suggesting that allulose is different from other sugars in that it is not metabolized by 
the human body, has negligible calories (0.2 kcal/g or less), and does not contribute to increases 
in blood glucose or insulin levels.4   
 
The citizen petition was submitted after the comment period closed for the proposed rule.  The 
proposed rule did not specifically address allulose; however, in a supplemental proposed rule (80 
FR 44303, July 27, 2015), we proposed (among other things) to establish a Daily Reference 
Value (DRV) of 10 percent of total energy intake from added sugars and to require the 
declaration of the percent Daily Value (DV) for added sugars on the label.   
 
                                                 
3 The petition was submitted at a time when the Nutrition Facts label used the term Sugars.  On May 27, 2016, 
FDA issued a final rule to amend the Nutrition Facts and Supplement Facts label regulations.  The final rule, among 
other things, replaced the term Sugars with Total Sugars.  See 81 FR 33742 and 21 CFR 101.9(c)(6)(ii) 
(requiring declaration of Total Sugars on the Nutrition Facts label).  Therefore, in this guidance, we refer to Total 
Sugars. 
4 The petition did not include data or other information on the association between consumption of allulose and 
dental caries.  
2 
  Contains Nonbinding Recommendations 
 
 
While neither the proposed rule nor the supplemental proposed rule addressed the labeling of 
allulose, we received comments on allulose (81 FR 33742 at 33795-96).  According to the 
comments, allulose is approximately 70 percent as sweet as sucrose and contributes less than 0.2 
kcal/g to the diet.  The comments stated that allulose is added to foods and beverages as a partial 
replacement for sugars or high-fructose corn syrup because of its low, near zero, calorie content 
and other organoleptic properties (e.g., mouthfeel, texture, etc.).  One comment said we should 
not include allulose in the declaration for Total Carbohydrate and Added Sugars because of 
the properties mentioned above.  In contrast, another comment said we should include allulose in 
the declaration of Total Carbohydrate for nutrition labeling purposes, but not in the declaration 
of Total Sugars or Added Sugars because allulose does not have the metabolic properties of 
fructose or other sugars and does not contribute calories or raise blood sugar levels like other 
sugars.  The comments said that, upon ingestion, approximately 70 percent of allulose is 
absorbed in the small intestine, passes into the bloodstream and is then excreted intact in the 
urine, without significant metabolism; the other 30 percent, which is not absorbed in the small 
intestine, is transported to the large intestine where it is not fermented and is then excreted intact.    
 
On May 27, 2016, we issued a final rule titled Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels (81 FR 33742) (final rule).  In the final rule, we stated that we 
needed additional time to fully consider the information provided in the citizen petition and the 
comments we received to the proposed rule (81 FR 33742 at 33796).  Therefore, we did not 
reach a decision as to whether allulose should be excluded from the declaration of Total 
Carbohydrate, Total Sugars, and/or Added Sugars.  We stated that allulose, as a 
monosaccharide, must be included in the amount of the declaration of Total Carbohydrate, 
Total Sugars, and Added Sugars pending any future rulemaking that would otherwise 
consider excluding allulose from the declaration.   
 
After we issued the final rule, we received two citizen petitions regarding allulose.  One citizen 
petition, submitted by the Food Lawyers (Docket Number FDA-2016-P-2030) (Ref. 3), 
requested, among other things, that we amend 21 CFR 101.9(c)(1)(i) by adding the following:  
 
(G) Using the following general factor for caloric value of Allulose (also known as D-
Allulose, D-psicose): Allulose  0.4 calories per gram.  
 
The citizen petition included information to support the caloric value of 0.4 kcal/g for allulose. 
  
Another citizen petition, submitted by Tate & Lyle (Docket Number FDA-2017-P-1463) (Ref. 
4), requested, among other things, that we amend 21 CFR 101.9(c)(1)(i) to include the following 
in a new section (G): 
 
(G) Using the following general factor for caloric value of Allulose (also known 
as, D-allulose, D-psicose): Allulose  0.2 calories per gram. 
 
The petition included information to support the caloric value of 0.2 kcal/g for allulose. 
 
In a comment to the Tate & Lyle citizen petition, the Food Lawyers stated that they fully 
supported a caloric value for allulose of 0.2 kcal/g. 
3 
  Contains Nonbinding Recommendations 
 
 
On August 13, 2018, Tate & Lyle submitted the results from a clinical trial that assessed the 
impact of allulose on dental plaque pH.  On August 22, 2018, Matsutani Chemical Industry Co. 
LTD submitted the results of a clinical trial that assessed the impact of allulose consumption on 
dental plaque pH as well as a copy of U.S. Patent No. 8,496,915, including an in vitro study that 
examined the final medium pH and the growth of a bacterial strain that causes dental caries when 
cultured with allulose.5  We considered these studies in our review of the scientific evidence 
related to the cariogenic potential of allulose (Ref. 8).  
 
In the Federal Register of April 18, 2019 (84 FR 16272), we announced the availability of a 
draft guidance titled The Declaration of Allulose and Calories from Allulose on Nutrition and 
Supplement Facts Labels: Guidance for Industry, in which we announced our tentative views on 
the declaration of allulose on Nutrition and Supplement Facts labels and caloric content of 
allulose.  The draft guidance also advised manufacturers of our intent to exercise enforcement 
discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars 
declared on the label, and for use of a general factor of 0.4 kcal/g for allulose when determining 
Calories on the Nutrition and Supplement Facts labels pending review of the issues in a 
rulemaking.  We have considered comments to the draft guidance, and we have made 
modifications, where appropriate, that are reflected in this final guidance.  We also conducted an 
independent review of the scientific evidence on the cariogenic potential, metabolism, and 
caloric value of, and glycemic response to, allulose (Ref. 8). 
 
III.  Declaration of Allulose on the Nutrition and Supplement Facts 
Labels 
 
1.  FDAs Consideration of the Caloric Value of Allulose 
 
We did not determine a specific caloric value for allulose in the final rule.  Therefore, under 21 
CFR 101.9(c)(1)(B), a caloric value of 4 kcal/g must currently be used for allulose because it is a 
carbohydrate.  The citizen petitions from the Food Lawyers (Ref. 3) and from Tate & Lyle (Ref. 
4) identified two human studies on the metabolism of allulose.  Our search of the literature did 
not reveal any additional human studies that determined a caloric value of allulose.  We provide 
a summary of the studies in our memorandum to the file (Ref. 8). 
 
The two citizen petitions (Refs. 4 and 3) provided data supporting the use of 0.2 kcal/g for 
allulose and 0.4 kcal/g for allulose.6  Based on our review of the evidence (Ref. 8), we conclude 
that the caloric contribution of allulose is very low (i.e., no more than 0.4 kcal/g) because the 
majority of allulose is excreted intact in the urine, and because allulose is poorly fermented in the 
gut.  We have limited evidence from human studies, using different methodologies, upon which 
to determine the caloric value of allulose.  Therefore, we intend to exercise enforcement 
discretion for the use of a caloric value of 0.4 kcal/g for allulose because, based on the range of 
data we have, such a caloric value would not underestimate the caloric contribution.  We intend 
                                                 
5 Both the Tate & Lyle and Matsutani Chemical Industry submissions were in support of the 2015 Tate & Lyle 
citizen petition.  The submissions can be found in docket FDA-2015-P-1201. 
6 One petitioner subsequently supported a caloric value of 0.2 kcal/g rather than 0.4 kcal/g. 
4 
  Contains Nonbinding Recommendations 
 
 
to exercise enforcement discretion with respect to the use of a caloric value of 0.4 kcal/g when 
calculating declarations on Nutrition and Supplement Facts labels pending rulemaking to 
consider amending 21 CFR 101.9(c)(1)(i) regarding the use of a general factor for the caloric 
value of allulose.    
 
2.  FDAs Consideration of Allulose as a Carbohydrate 
 
Total Carbohydrate content is determined for the purposes of nutrition labeling by subtraction of 
the sum of the crude protein, total fat, moisture, and ash from the total weight of the food (21 
CFR 101.9(c)(6)).  The calculation method is described in A.L. Merrill and B.K. Watt, Energy 
Value of Foods--Basis and Derivation (Ref. 2).  Carbohydrate as a class captures a variety of 
substances ranging from mono and disaccharides to numerous types of non-digestible 
carbohydrates, some of which are dietary fibers.  As previously mentioned, allulose is a 
monosaccharide.  It has the chemical composition of a carbohydrate and is captured under the 
method for determination of Total Carbohydrate in 21 CFR 101.9(c)(6).   
 
The 2015 Tate & Lyle citizen petition (Ref. 1) suggested that allulose should not be included in 
the Total Carbohydrate definition because, in part, it does not raise blood glucose levels, and thus 
could be confusing for individuals who are interested in monitoring their blood glucose levels, 
such as diabetics.  We have traditionally based our decision on labeling of carbohydrates on 
whether a substance is chemically a carbohydrate (79 FR 11880 at 11900).  As we explained in 
the final rule, we had invited comment on and considered: 
  
whether carbohydrates should be classified and declared in nutrition labeling based on 
their chemical definition (which is the current method) or on their physiological effect 
(e.g., attenuation of blood sugar or laxation), and whether additional types of 
carbohydrates (e.g., starch) should be listed separately on the Nutrition Facts label.  We 
explained that carbohydrates include starch, sugars, sugar alcohols, and dietary fibers and 
that different carbohydrates have different physiological effects [79 FR 11879 at 11901].  
Within the different types of carbohydrate (i.e., starch, sugars, sugar alcohols, and dietary 
fibers), too, specific carbohydrates may have different physiological effects (e.g., 
different types of dietary fibers) making it difficult to apply a definition that is based on 
physiological effects across a category of carbohydrates.  Furthermore, 
analytical methods for measuring different types of carbohydrates are based on chemical 
structure rather than physiological effect.  Given the various components of total 
carbohydrate and different types of physiological effects of each, we decided not to 
change our provisions for the classification or declaration of carbohydrates specified 
in 21 CFR 101.9(c)(6). 
 
81 FR 33742 at 33795. 
 
In summary, we considered whether a physiological effect-based definition was appropriate for 
total carbohydrates and determined that it was not because of the wide variety of effects of 
different types of carbohydrates.  
 
5 
  Contains Nonbinding Recommendations 
 
 
Furthermore, as discussed in the final rule, the information in the Nutrition Facts label is not 
targeted to individuals with acute or chronic disease (e.g., diabetes, chronic kidney disease, or 
cardiovascular disease).  The nutrient declaration and percent Daily Values on the label are to 
help consumers make more informed choices to consume a healthy diet and not intended for the 
clinical management of an existing disease (81 FR 33742 at 33750).  Inclusion of allulose in the 
declaration of Total Carbohydrate on Nutrition and Supplement Facts label is also consistent 
with how we have considered the declaration of other substances that are captured under the 
method that is currently used for the determination of Total Carbohydrate on the label, 
including those that provide few or no calories, such as sugar alcohols and dietary fibers.   
 
Therefore, because allulose is a carbohydrate, it is captured under the calculation method for 
Total Carbohydrate described in 21 CFR 101.9(c)(6), like a number of other substances 
without significant caloric contribution.  We have determined that our existing definition of 
carbohydrate is the most appropriate and allulose must be included in the amount of Total 
Carbohydrate declared on the label under the existing regulations.   
 
3.  FDAs Consideration of Allulose as a Sugar  
 
Total Sugars are defined in 21 CFR 101.9(c)(6)(ii) as the sum of all free mono-and disaccharides 
(such as glucose, fructose, lactose, and sucrose).  Allulose is a monosaccharide that is an epimer 
of D-fructose.  In the final rule, we said that consumption of sugars continues to be associated 
with an increased risk of dental caries; thus, the Total Sugars declaration continues to be 
necessary to assist consumers in maintaining healthy dietary practices (81 FR 33742 at 33798).   
 
The 2015 Tate & Lyle citizen petition (Ref. 1) suggested that allulose should not be included in 
the Total Sugars declaration because it is not metabolized like a sugar, does not raise blood 
glucose levels, and inclusion in the Total Sugars declaration would be confusing to consumers, 
particularly those who monitor their blood glucose levels.  A summary of the evidence related to 
the cariogenic potential, metabolism, and caloric value of, and glycemic response to, allulose is 
provided in a memorandum to the file (Ref. 8).   
 
We have traditionally determined what is captured under the Total Sugars declaration on the 
label by chemical structure.  Due to advances in food technology, novel sugars are now available 
that are not metabolized and that do not contribute 4 kcal/g to the diet like other traditional 
sugars.  Consequently, we need to consider how information about sugars like allulose should be 
captured on the label.      
 
Our current thinking is that, consistent with the goal of section 403(q) of the Federal Food, Drug, 
and Cosmetic Act for the nutrient declarations to assist consumers in maintaining healthy dietary 
practices, we should consider not only the chemical structure of sugars, but also other evidence, 
including their association with dental caries and how they are metabolized in the body (e.g., 
caloric contribution and their effect on blood glucose and insulin levels), when determining 
whether a sugar should be included in the declaration of Total Sugars on the label.   
 
Sugars are known to be associated with an increased risk of dental caries (21 CFR 101.80).  
Sugars that are metabolized by oral bacteria produce polymers that adhere to the tooth surface 
6 
  Contains Nonbinding Recommendations 
 
 
(i.e., dental plaque) and generate acids resulting in a decrease in the pH (Ref. 9) of dental plaque.  
The low pH provides an environment that allows for decalcification of the teeth (e.g., 
solubilization of calcium from dental enamel), increasing the risk of dental caries (or tooth 
decay) (Ref. 10).  The Total Sugars declaration provides consumers with information that they 
can use to evaluate the contribution of sugars in their diet to the risk of dental caries.  We 
therefore believe that evidence related to the association between consumption of a sugar and 
dental caries is an important consideration when determining whether the amount of a particular 
sugar in a serving of a product should be excluded from the Total Sugars declaration on the 
label. 
 
Mono and disaccharides typically provide 4 kcal/g (Ref. 2).  If a consumer wishes to determine 
how many calories are contributed by sugars in their diet, they can multiply the grams of Total 
Sugars per serving by 4 kcal/g.  Current dietary recommendations suggest that Americans should 
limit their consumption of calories from sugars, and particularly added sugars, and stay within 
calorie limits (Ref. 11).  As a result, manufacturers are substituting sugars that provide much less 
than 4 kcal/g, such as allulose, for sugars that provide 4 kcal/g in an effort to reduce caloric 
content.  Including sugars that contribute much less than 4 kcal/g to the diet in the Total Sugars 
declaration would not accurately reflect the caloric contribution to the diet of sugars like allulose 
that contain much less than 4 kcal/g.  Therefore, we consider the caloric contribution of a sugar 
to be an important consideration when determining if the sugar should be excluded from the 
amount of the Total Sugars declaration.   
 
During digestion, disaccharides are hydrolyzed into two monosaccharide units in the upper small 
intestine.  Primarily, the body breaks sugars down into glucose, which is used as energy by cells 
in the body or stored as glycogen (Ref. 12).  Consuming sugar increases circulating glucose in 
the blood stream.  The presence of glucose in the blood triggers the release of the hormone 
insulin from the pancreas.  Insulin stimulates the uptake of glucose by muscle and adipose tissue.  
Therefore, when traditional sugars like glucose, fructose, lactose, and sucrose are consumed, 
there is a rise in blood glucose and insulin levels (Ref. 12).  The Total Sugars declaration 
provides consumers with information that they can use to determine whether a product contains 
sugars that are likely to cause an increase in circulating blood glucose and insulin levels.  Some 
consumers expect that when they eat sugars, the result will be an increase in blood glucose and 
insulin levels.  Therefore, we consider a sugars effect on blood glucose and insulin levels to be 
important considerations when determining whether a sugar should be excluded from the Total 
Sugars declaration.   
 
Allulose, like other non-cariogenic carbohydrate sweeteners listed in 21 CFR 101.80(c)(2)(ii), 
does not result in a decrease in dental plaque pH below 5.7, which is associated with 
decalcification of the dental enamel (Ref. 10).  Therefore, given the low cariogenic potential of 
allulose, we conclude that allulose does not promote dental caries.  Furthermore, based on our 
review of the evidence, we conclude that allulose, once ingested, is rapidly absorbed (within 1 
hour) and cleared from plasma in 24 hours, and 70% of orally consumed allulose is eliminated 
7 
  Contains Nonbinding Recommendations 
 
 
intact in urine and feces within 48 hours (Ref. 8).7  Allulose produces only a negligible increase 
in glycemic and insulinemic responses and is not readily fermented in the large intestine, 
providing no more than 0.4 kcal/g (Ref. 8).  Based on the totality of the available evidence from 
which scientific conclusions can be drawn, allulose does not promote dental caries and is 
virtually unmetabolized in the human body (Ref. 8).  
   
As previously discussed, allulose does not result in a decrease in the dental plaque pH below 5.7, 
at which decalcification of dental enamel may begin, and thus, does not promote dental caries.  It 
provides much less than 4 kcal/g.  Additionally, the consumption of allulose produces only a 
negligible increase in glycemic and insulinemic responses.  Therefore, we intend to exercise 
enforcement discretion with respect to the exclusion of allulose from the amount of Total 
Sugars declared on the label pending future rulemaking regarding amending the definition of 
Total Sugars.  
 
Finally, we note that allulose must be declared in the ingredient statement in accordance with 21 
CFR 101.4 if it is present in a product so that consumers can determine when it is an ingredient 
in a food. 
 
4.  FDAs Consideration of Allulose as an Added Sugar  
 
Added sugars are sugars that are either added during the processing of foods, or are packaged as 
such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and 
sugars from concentrated fruit or vegetable juices that are in excess of what would be expected 
from the same volume of 100 percent fruit or vegetable juice of the same type.   
 
As previously discussed, we did not decide whether allulose should be excluded from the amount 
of Added Sugars declared on the label in the final rule and stated that allulose must be 
included in the declaration of Added Sugars pending any future rulemaking regarding 
excluding allulose from the declaration.  
 
A summary of the evidence related to the metabolism of allulose is provided in our 
memorandum to the file (Ref. 8).  Based on our review of the scientific evidence, we conclude 
that allulose is virtually unmetabolized in the human body.  Based on this, as well as the 
evidence regarding caloric value and dental caries, as previously discussed, we intend to exercise 
enforcement discretion if allulose is not included in the amount of Total Sugars declared on the 
label.  The Added Sugars declaration is a subset of the Total Sugars declaration.  Applying 
similar logic, through the exercise of our enforcement discretion, we consider that allulose 
should not be included in the Added Sugars declaration, including the %DV declaration.  
Furthermore, we note that, based on information about usage levels provided in GRAS notices 
(Refs. 5-7), we expect that the caloric contribution of allulose will be insignificant in most cases 
and will substantially reduce the amount of total calories and calories from added sugars in 
products where it replaces those added sugars.   
                                                 
7 In this mass-balance study, 70.4% of the 14C radiotracer orally administered to seven subjects was eliminated as 
intact allulose in urine and feces, while 1.5 % was identified as glucose and fructose, 11.7% were not identified 
(unknown), and the remaining radioactivity was lost during the process (Ref. 8). 
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  Contains Nonbinding Recommendations 
 
 
Therefore, we intend to exercise enforcement discretion with respect to the exclusion of allulose 
from the gram amount of and the %DV for Added Sugars declared on Nutrition and 
Supplement Facts labels, pending future rulemaking.   
 
We again note that allulose must be declared in the ingredient statement in accordance with  
101.4 if it is present in a product so that consumers can determine when it is an ingredient in a 
food. 
 
IV.  Paperwork Reduction Act of 1995 
 
This guidance contains no collection of information.  Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521) is not required. 
 
However, this guidance refers to previously approved FDA collections of information.  These 
collections of information are subject to review by OMB under the PRA.  The collections of 
information in 21 CFR part 101 have been approved under OMB control number 0910-0381. 
 
V.  References  
 
The following references marked with an asterisk (*) are on display in the Dockets Management 
Staff, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You 
may see them at that location between 9 a.m. and 4 p.m., Monday through Friday.  They also are 
available electronically at https://www.regulations.gov.  References without asterisks are not on 
public display at https://www.regulations.gov because they have copyright restriction.  Some 
may be available at the website address, if listed.  References without asterisks are available for 
viewing only at the Dockets Management Staff.  FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites are subject to change over 
time. 
 
1.  Citizen Petition Submitted by Tate & Lyle Ingredients Americas LLC requesting that 
Allulose be Exempt From Being Included As a Carbohydrate, Sugar, or Added Sugar in the 
Nutrition Facts Label on Foods and Beverages, April 10, 2015.  Docket Number FDA-2015-
P-1201.* 
 
2.  Merrill AL and Watt BK. Energy value of foods...basis and derivation, Human Nutrition 
Research Branch, Agricultural Research Service, U.S. Department of Agriculture, 
Agriculture Handbook No. 74, 1973.* 
 
3.  Citizen Petition Submitted by The Food Lawyers Requesting the Use of a General Factor of 
0.4 Calories Per Gram of Allulose on the Nutrition Facts Label, July 12, 2016.  Docket 
Number FDA-2016-P-2030.* 
 
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4.  Citizen Petition Submitted by Tate & Lyle Ingredients Americas LLC Requesting the Use of 
a General Factor for Caloric Value of Allulose of 0.2 kcal/g, March 8, 2017.  Docket Number 
FDA-2017-P-1463.* 
  
5.  FDA GRAS Notification No. 400. 
https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices&id=400 (accessed 
September 16, 2020).* 
 
6.  FDA GRAS Notification No. 498. 
https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices&id=498 (accessed 
September 16, 2020).* 
 
7.  FDA GRAS Notification No. 693 
https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices&id=693 (accessed 
September 16, 2020).* 
 
8.  U.S. Food and Drug Administration Memorandum to the File: Scientific Review of the 
Evidence on the Cariogenic Potential, Metabolism, and Caloric Value of, and Glycemic 
Response to, Allulose, 2019.* 
 
9.  Newman H.N. The Relation between Plaque and Dental Caries. J R Soc Med. 1986;79 
Suppl 14:1-5. 
 
10.  Selwitz R.H., Ismail A.I., Pitts N.B. Dental Caries. Lancet. 2007;369:51-59. 
 
11. U.S. Department of Health and Human Services and U.S. Department of Agriculture. 
Dietary Guidelines for Americans 2015-2020, 8th Ed. Washington, D.C.: U.S. Government 
Printing Office, 2015.  Retrieved from: https://health.gov/our-work/food-nutrition/2015-
2020-dietary-guidelines/guidelines/ (September 16, 2020).* 
 
12. Gropper, S.S., Smith, J.L., Groff, J.L. (2009). Advanced Nutrition and Human Metabolism 
(5th ed.), Chapter 3: Carbohydrates. Belmont, CA: Wadsworth, Cengage Learning. 
 
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