[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Notices]
[Pages 66335-66338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1359]


Sugars that Are Metabolized Differently Than Traditional Sugars

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information and comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is establishing a 
docket and invites information about and comments on the nutrition 
labeling of sugars that are metabolized differently than traditional 
sugars. We are taking this action to inform our regulatory approach to 
these distinctly metabolized sugars to promote the public health and 
help consumers make informed dietary decisions.

DATES: Submit either electronic or written comments on the notice by 
December 18, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,

[[Page 66336]]

untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 18, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 18, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2020-N-1359 for ``Sugars that are Metabolized Differently than 
Traditional Sugars.'' Received comments, those filed in a timely manner 
(see ADDRESSES), 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Office of 
Nutrition and Food Labeling, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    In general, under section 403(q) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(q)) (FD&C Act), a food is deemed misbranded 
unless its label or labeling bears nutrition information for certain 
nutrients. To implement section 403(q) of the FD&C Act, we have issued 
regulations related to:
     The declaration of nutrients on food labeling, including 
nutrients that are required or permitted to be declared and the format 
for such declaration;
     Daily Values (DVs) for nutrients, which are used to 
declare nutrient contents as percent DVs (%DVs) on the Nutrition Facts 
label; and
     Exemptions for certain specified products.
    These regulations are at Sec.  101.9 (21 CFR 101.9). Additionally, 
section 403(q)(2)(A) of the FD&C Act provides discretion to the 
Secretary of Health and Human Services, and, by delegation, to FDA, to 
determine whether providing nutrition information regarding a nutrient 
will assist consumers in maintaining healthy dietary practices.
    In the Federal Register of May 27, 2016 (81 FR 33742), we issued a 
final rule titled ``Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels'' (``Nutrition Facts final rule''). The 
Nutrition Facts final rule revised the Nutrition Facts label to reflect 
new scientific information by, among other things: (1) Requiring the 
declaration of the gram amount of ``Added Sugars'' in a serving of a 
product, establishing a Daily Reference Value (DRV), and requiring the 
%DV declaration for ``Added Sugars'' and (2) changing ``Sugars'' to 
``Total Sugars'' and requiring that ``Includes `X'g Added Sugars'' be 
indented and declared directly below ``Total Sugars'' on the label. We 
discussed our rationale for the required declaration of ``Added 
Sugars'' in the preamble to both the Nutrition Facts final rule (81 FR 
33742 at 33799 through 33801) and the proposed rule in the Federal 
Register of March 3, 2014 (79 FR 11880 at 11902 through 11905), and 
explained our establishment of a DRV of 10 percent of total energy 
intake from ``Added Sugars'' and requirement of a %DV for ``Added 
Sugars'' in the preamble to the supplemental proposed rule in the 
Federal Register of July 27, 2015 (80 FR 44303 at 44307 through 
44309).\1\
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    \1\ We also recognize that with the requirement for the 
mandatory declaration of added sugars on the label, there is an 
interest in the use of nutrient content claims that convey to 
consumers information about the amount of sugars or added sugars in 
a product. In the Nutrition Facts final rule, we said that we plan 
to revisit our nutrient content claims regulations as appropriate 
and as time and resources permit (81 FR 33742 at 33751). We intend 
to address nutrient content claims related to sugars and added 
sugars at a later date.
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    In the Nutrition Facts final rule, we confirmed that our definition 
of ``Total Sugars'' remains the same as the previously existing 
definition of ``Sugars'' at Sec.  101.9(c)(6)(ii)--

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specifically, as the sum of all free mono- and disaccharides (such as 
glucose, fructose, lactose, and sucrose). We defined ``Added Sugars,'' 
in part, as sugars that are either added during the processing of foods 
or are packaged as such. We codified this definition in our regulations 
at Sec.  101.9(c)(6)(iii).
    In determining which sugars should be included in the definition of 
``Added Sugars'' in the Nutrition Facts final rule, we considered the 
presence of added sugars as a component of dietary intake and whether 
it was consistent with the concept of ``empty calories'' (81 FR 33742 
at 33835). (The Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee noted that sugars that are added to foods either by 
the consumer or by food manufacturers are referred to as ``empty 
calories'' because they provide calories, but few or no nutrients. See 
United States Department of Agriculture and HHS, Scientific Report of 
the 2015 Dietary Guidelines Advisory Committee, 2015, Part D. ``Chapter 
1: Food and Nutrient Intakes, and Health: Current Status and Trends,'' 
pg. 69, available at https://health.gov/dietaryguidelines/2015-scientific-report/pdfs/scientific-report-of-the-2015-dietary-guidelines-advisory-committee.pdf.) We noted, in the preamble to the 
Nutrition Facts final rule, that it would be extremely difficult for 
individuals consuming large amounts of empty calories from sugar-
sweetened foods and beverages to be able to consume enough other 
components of a healthy dietary pattern (81 FR 33742 at 33807). In part 
because of this, current dietary recommendations include limiting the 
consumption of added sugars in the diet, which we explained in the 
preamble to the supplemental proposed rule (80 FR 44303 at 44308).
    We are aware that some members of the food industry are looking for 
ways to reformulate products to reduce the sugar content of foods while 
still providing products that meet consumer preferences. The use of 
sugars that provide fewer calories, that are not associated with dental 
caries, and that result in a lower glycemic and insulinemic response 
than other sugars could be one way for industry to provide products 
that meet both current dietary recommendations and consumer 
preferences.
    There are several sugars that are not metabolized by the body like 
other substances that are traditionally known as sugars. The sugars 
that many consumers are most familiar with (``traditional sugars''), 
such as sucrose, are associated with an increased risk of dental 
caries, have 4 calories per gram, and cause an increase in blood 
glucose and insulin levels after consumption. Some sugars (e.g., 
allulose, D-tagatose, isomaltulose) do not have all of the same effects 
in the body as traditional sugars. Because of that, we have received 
multiple requests from industry to treat these sugars that are 
metabolized differently than traditional sugars as distinct from 
traditional sugars for purposes of nutrition labeling. For example, 
some asked that we exempt certain sugars from inclusion as a 
carbohydrate, sugar, or added sugar on the Nutrition Facts label for 
foods and beverages (see, e.g., 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); some asked that we use a lower general factor 
for the caloric value of certain sugars (see, e.g., 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); and others asked that we 
define ``Total Sugars'' as the sum of all free mono- and disaccharides 
that contain at least one unit of glucose or fructose (see, e.g., 
Citizen Petition Submitted by Bonumose LLC for Consideration of D-
tagatose as Dietary Fiber, November 19, 2018, Docket Number FDA-2018-P-
4454).
    In the preamble to the Nutrition Facts final rule, we stated that 
we needed additional time to fully consider certain information 
provided about one of these sugars that is metabolized differently than 
traditional sugars--specifically, allulose (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,'' 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 declarations. We also noted that D-tagatose and isomaltulose 
are chemically sugars. Because these sweeteners are chemically sugars, 
and other substances are included or excluded from the definition of 
``Total Sugars'' and ``Added Sugars'' based on whether they are a free 
mono- or disaccharide rather than on their physiological effects, 
including D-tagatose and isomaltulose in the declaration of added 
sugars is consistent with how we have characterized other sugars. As 
such, we did not exclude D-tagatose and isomaltulose from the ``Added 
Sugars'' declaration in the Nutrition Facts final rule (81 FR 33742 at 
33837).
    In the Federal Register of April 18, 2019 (84 FR 16272), we 
announced the publication of a draft guidance that provided our view on 
the declaration of allulose on Nutrition and Supplement Facts labels, 
as well as on the caloric content of allulose. We announce our final 
guidance elsewhere in this edition of the Federal Register. The 
guidance states 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) for allulose when determining ``Calories'' 
on the Nutrition and Supplement Facts labels pending review of the 
issues in a rulemaking.
    We are interested in learning more about the kinds of sugars that 
are metabolized differently than traditional sugars and that are used 
in foods, any distinct physiological effects in the body caused by 
those sugars, and how we should treat those sugars for purposes of food 
labeling.

II. Request for Comments and Information

    We invite comment, particularly scientific data and other evidence, 
about the following topics:

A. General Information About Sugars That Are Metabolized Differently 
Than Traditional Sugars

    1. We are aware of three sugars that are metabolized differently in 
the body than traditional sugars: allulose, D-tagatose, and 
isomaltulose. What other sugars are metabolized differently in the body 
than traditional sugars? Please provide any studies that examine the 
chemical properties or physiological effects of these other sugars.
    2. What research on consumer awareness or understanding of the 
differences between sugars that are metabolized differently than 
traditional sugars and traditional sugars is available? Please provide 
any data or other information that supports your response.

B. Declaration of Total Sugars

    1. We could take one of various approaches to account for sugars 
that are metabolized differently than traditional sugars in the 
declaration of ``Total Sugars.'' For example, we could require them to 
be declared within the

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``Total Sugars'' declaration, we could exclude them from the ``Total 
Sugars'' declaration, or we could adjust the gram amount of the ``Total 
Sugars'' declaration based on their caloric contribution to the diet. 
What considerations could inform our approach? Please explain your 
reasoning, and provide data or other information that would support 
these considerations and any recommended approach.
    2. In the guidance regarding allulose, we discuss factors that we 
considered when determining whether a sugar should be excluded from the 
declaration of ``Total Sugars,'' including pH of dental plaque after 
consumption, caloric value, and glycemic and insulinemic response. 
What, if any, other factors impact whether a sugar should be excluded 
from the declaration of ``Total Sugars''? Please provide any data or 
other information that supports your response.

C. Declaration of Added Sugars

    1. We could take one of various approaches to account for sugars 
that are metabolized differently than traditional sugars in the 
declaration of ``Added Sugars.'' For example, we could require them to 
be declared within the ``Added Sugars'' declaration, we could exclude 
them from the ``Added Sugars'' declaration, or we could adjust the gram 
amount of the ``Added Sugars'' or the %DV declaration based on their 
caloric contribution to the diet. What considerations could inform our 
approach? Please explain your reasoning, and provide data or other 
information that would support these considerations and any recommended 
approach.
    2. In the guidance regarding allulose, we discuss factors that we 
considered when determining whether a sugar should be excluded from the 
declaration of ``Added Sugars,'' including caloric value and glycemic 
and insulinemic response. What other factors, if any, impact whether a 
sugar should be excluded from the declaration of ``Added Sugars''? 
Please provide any data or other information that supports your 
response.
    3. We might adjust the %DV for ``Added Sugars'' for the U.S. 
population 4 years of age and older based on the caloric contribution 
of the sugar. For example:

    Assume a product contains 5 g of sucrose and 10 g of another sugar 
with a caloric value of 2 kcal/g per serving.

Step 1. Calculate the Total Caloric Contribution of Sugars (amount of 
sucrose (g/serving) x caloric value (kcal/g)) + (amount of other sugar 
(g/serving) x caloric value (kcal/g))
    a. Sucrose: 5 g/serving x 4 kcal/g (caloric value of sucrose) = 20 
kcal/serving
    b. Other sugar: 10 g/serving x 2 kcal/g (caloric value of other 
sugar) = 20 kcal/serving
    c. Total Caloric Contribution = 20 kcal/serving (sucrose) + 20 
kcal/serving (other sugar) = 40 kcal/serving
Step 2. Calculate Total Amount of Sugars Adjusted for the Total Caloric 
Contribution (Total Caloric Contribution of Sugars (kcal/serving) / 4 
kcal/g))
    Amount of Sugars Adjusted for Caloric Contribution = 40 kcal/
serving / 4 kcal/g = 10 g-equivalent/serving
Step 3. Calculate %DV for Added Sugars (Amount of Sugars Adjusted for 
Caloric Contribution (g-equivalent) / 50 g/day (DV for Added Sugars for 
the general U.S. population 4 years of age and older) x 100))
    %DV = (10 g-equivalent / 50 g/day) x 100 = 20%

    What considerations are there with respect to adjusting the %DV 
declaration based on the caloric contribution of the sugar?

D. Label Declarations

    1. We currently require the disclosure of sugar alcohols and sugars 
that are metabolized differently than traditional sugars in the 
ingredient statement in accordance with Sec.  101.4(a), but also allow 
for the voluntary declaration of sugar alcohols on the Nutrition Facts 
label (Sec.  101.9(c)(6)(iv)). Please provide any data or other 
information that we could consider when determining whether we should 
allow for the voluntary declaration on the Nutrition Facts label of 
sugars that are metabolized differently than traditional sugars.
    2. Sugar alcohols fall into a separate category of labeling and are 
excluded from the ``Total Sugars'' and ``Added Sugars'' declarations. 
Please provide any data or other information that we could consider 
when determining whether sugars that are metabolized differently than 
traditional sugars should be combined with sugar alcohols into one 
declaration within the Nutrition Facts label.
    3. If sugars that are metabolized differently than traditional 
sugars are excluded from the ``Total Sugars'' and ``Added Sugars'' 
declarations and are combined with sugar alcohols in a separate 
labeling category within the Nutrition Facts label, what names would be 
scientifically appropriate for such a category? Please provide any data 
or other information that supports your recommendation.

    Dated: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22900 Filed 10-16-20; 8:45 am]
BILLING CODE 4164-01-P