construct an overall healthy dietary pattern that has less than 10
percent of calories from added sugars.
    i. How added sugars are declared. Many comments provided
recommendations for how information about added sugars in products
should be conveyed to consumers on the label.
(i) Changing ``Sugars'' to ``Total Sugars''
    In the preamble to the proposed rule (79 FR 11879 at 11902), we
said that we were considering whether to use the term ``Total Sugars''
instead of ``Sugars'' on the label if we finalize a declaration of
added sugars. We also said that we planned to conduct consumer research
that would include, among other things, questions regarding the
declaration of added sugars on the Nutrition Facts label in order to
help or enhance our understanding of how consumers would comprehend and
use this new information, and to inform our education activities and
outreach. In the preamble to the supplemental proposed rule (80 FR
44303 at 44306), we discussed the results of our consumer research
which showed that when an ``Added Sugars'' declaration was indented
below a ``Total Sugars'' declaration on the label, participants
appeared to be better able to comprehend the total amount of sugars in
a food than if an ``Added Sugars'' declaration was indented below a
``Sugars'' declaration. In the preamble to the supplemental proposed
rule (id. at 44304), we asked for comment on whether the term ``Total
Sugars'' should be declared on the label instead of ``Sugars.''
    (Comment 187) Many comments to both the proposed rule and the
supplemental proposed rule addressed this topic. The comments generally
preferred the term ``Total Sugars'' rather than ``Sugars'' on the
label. Although some comments did not support a declaration of added
sugars on the label, the comments said that, if we require the
declaration of added sugars in the final rule, the term ``Total
Sugars'' should be used on the label rather than ``Sugars.'' The
comments said that such a change to the terminology used will likely
increase consumer understanding that ``Added Sugars'' are included in
the ``Total Sugars'' declaration. The comments would change the
``Sugars'' declaration to ``Total Sugars'' to provide a clearer
distinction between total and added sugars and to prevent consumers
from adding the ``Added Sugars'' and ``Sugars'' declarations together.
The comments said that this change would be consistent with the
declarations for ``Total Fat'' and ``Total carb.'' Other comments
suggested that using the heading ``Total Sugars'' would provide
interpretive data that is consistent with the need to make information
clearer for consumers with lower levels of health literacy, numeracy,
and English language limitations. One comment said that an analysis of
our research indicates that replacing the term ``Sugars'' with ``Total
Sugars'' on the label will enhance the consumers' ability to discern
the overall nutritional value and compare nutrient density of food
products at the point of selection (Ref. 109).
    Other comments provided evidence that consumer's understanding of
label information about sugars is improved when the ``Sugars'' term is
replaced with ``Total Sugars.'' One comment provided the results of a
qualitative and quantitative study that it conducted showing that, when
``Total Sugars'' was declared on a label rather than ``Sugars,''
participants were more likely to understand that the sugars in an
``Added Sugars'' line would be included in a ``Total Sugars'' line
(Ref. 107). These results are consistent with our findings. Another
comment cited a study by Laquatra et al., which the comment said
suggests that consumers' understanding of the amount of sugar indicated
on a food label was improved when the term ``total sugars'' was used
rather than ``sugars'' (Ref. 107).
    One comment said that our consumer research results are ambiguous,
and requested that we undertake sufficient education activities to
ensure that consumers understand that ``Added Sugars'' are included in
the ``Total Sugars'' declaration. Another comment also said that it is
premature to comment on using the term ``Total Sugars'' instead of
``Sugars'' on the label because additional consumer research that
includes a label format that represents our proposed added sugars
labeling declarations (including a percent DV declaration) is needed to
gauge consumer understanding and usage of the new label information.
    (Response) Since the publication of the supplemental proposed rule,
our finding that participants appear have better comprehension of the
total amount of sugars in a food when ``Sugars'' is replaced with
``Total Sugars'' on the label has been replicated by others, as noted
in some comments. We disagree that additional consumer research testing
the proposed label format with a percent DV declaration for added
sugars is needed before we can finalize a change to the label which
replaces the term ``Sugars'' with ``Total Sugars.'' ``Total Sugars''
will help improve comprehension of information on the label related to
total and added sugars (see part II.H.2.c). Therefore, we are replacing
``Sugars'' with ``Total Sugars'' throughout Sec. Sec.  101.9 and
101.36.
    (Comment 188) Many comments raised concerns about our proposal to
require added sugars declarations due to findings from consumer
research conducted by FDA and others. The comments said consumer
research showed that added sugars declarations decreased the ability of
some participants to correctly identify the quantity of total sugars in
a food. Specifically, FDA's studies as well as other studies cited in
the comments showed that when viewing nutrition labels with added
sugars declarations, some participants mistakenly summed the value for
total sugars and the value for added sugars when they were asked to
identify the total amount of sugars in a serving of a product. Some
comments also said that the research suggests that the proposed label
is more likely than the current label to mislead or confuse consumers
with regard to total grams of sugars in the product; the comments would
exclude an added sugars declaration from the label. Another comment
suggested that FDA should conduct additional research to find other
ways to present added sugars and total sugars declarations to reduce
consumer confusion.
    (Response) We acknowledge that our consumer research and those
referenced in the comments showed statistically significant decreases
in participants' understanding of total sugars in a serving of a
product when a label included an added sugars declaration, either with
or without the corresponding percent Daily Value of added sugars,
compared to when a label did not include an added sugars declaration.
Our study showed that the most common error was for our study
participants to overestimate the quantity of total sugars in the
product by summing the product's ``total sugars'' (or just ``sugars,''
depending on which label format was used) and ``added sugars.'' We
note, however, that in our study and in a study conducted by IFIC,
including ``total'' in front of ``sugars'' helped study participants
better comprehend the total amount of sugars in a serving of a product.
Therefore, the final rule includes ``total'' in front of ``sugars'' to
better enable consumers to correctly assess the quantity of total
sugars in a product.
    We also note that in our research, when compared to the control
group viewing the current label with no ``added sugars'' declaration,
some study participants still did not report the correct amount of
``sugars'' in one serving of the product, even when the

word ``total'' was included in front of ``sugars.'' It is also
important to note that when using the sugars declaration on the current
label, some participants were unable to determine the total amount of
sugars, even when only ``sugars'' was listed on the label.
Additionally, our research found that the majority of study
participants could not identify the correct amount of ``added sugars''
on the label when it was not declared, thereby not giving participants
a key piece of information needed to maintain healthy dietary
practices.
    We plan to include ``added sugars'' in our consumer education and
outreach efforts on the Nutrition Facts label. This will address some
consumer confusion. However, to the extent some confusion was
identified in the studies, we want to correct this potential confusion
by adding the word ``includes'' in front of added sugars. The added
sugars declaration will now read ``Includes X g Added Sugars'' below
the ``Total Sugars'' line. The addition of ``includes'' will enable
consumers to understand that ``added sugars'' are a sub-component of
``total sugars.'' We also are minimizing the hairline between total
sugars and added sugars to help denote that ``added sugars'' are a
subcomponent of ``total sugars.'' Minimizing the hairline between the
two sugars will ``chunk'' the sugars together instead of them being
distinct and separate. We base our decision on the expert opinion of
two scientists in the fields of consumer research and risk
communication and a review of literature as explained below surrounding
the use of connecting words to clarify relationships between subject
matter.
    We enlisted the aid of two independent FDA experts, one whose
expertise is in consumer research and the other whose expertise is in
risk communication. These experts were not affiliated with our current
consumer studies work on added sugars and were asked to evaluate
whether using the word ``includes'' as well as minimizing the line
between ``total sugars and ``added sugars'' are likely to ameliorate
the consumer confusion found in our consumer research as well as the
research of others. The experts independently agreed that these changes
should help consumers better understand that ``added sugars'' is a
subcomponent of ``total sugars'' (Refs. 110-111). The consumer research
expert noted that including the word ``total'' in front of ``sugars''
should be particularly helpful to regular label users since this format
is consistent with what is used for ``total fat'' and ``total
carbohydrate.'' The expert also suggested that use of the word
``includes'' should reinforce for consumers that ``added sugars'' is a
component of ``total sugars'' and not merely a complement. The expert
also noted that any lingering confusion with the format related to
determining total amount of sugars in a serving of a product should
dissipate over time as users of the Nutrition Facts label become
accustomed to the new label.
    The second expert in risk communication noted that the presence of
the word ``includes'' provides clarity that she expects will reduce
confusion among those consumers who summed ``Added Sugars'' and ``Total
Sugars'' and allow consumers to determine the total amount of sugars in
one serving of a product.
    In addition to the expert opinion, some literature suggests linking
terms (words or phrases that reveal relationships between ideas in
content) are useful for increasing comprehension, indicating that using
the word ``includes'' may help consumers understand that ``added
sugars'' are a subcomponent of ``total sugars.'' Comprehension of
information in text takes place when the reader can identify new text
information and relate it to the information already given or known.
The more information that coincides with what readers already know, the
easier it will be for them to integrate new information into their
existing knowledge base, hence coming to understand the material
presented in the information (Ref. 112). One principle commonly used to
facilitate comprehension is to make each sentence explicitly related to
the next. One possible approach to implement this principle is to use
sentence connectors to clarify relationships between sentences.
Similarly, Spyridakis 1989 (Ref. 113) suggested that because
comprehension of text requires readers to make inferences, a text that
provides clues to the links between discrete units of information can
help readers make appropriate inferences and therefore contribute to
overall learning of the content of the text. There are different types
of ``connector'' or ``signal'' words, phrases, or statements that
preannounce content and/or reveal a relationship between ideas in
content (Ref. 114). The latter, sometimes called logical connectors,
can be words or phrases such as ``first,'' ``moreover,'' ``because,''
``for example,'' and ``in other words.'' The literature has
demonstrated that logical connectors can be helpful in improving text
comprehension (Refs. 113-115). We acknowledge that text and tables are
different formats of presentation, however the understanding of tabular
information and understanding of textual information share similar
psychological processes (Ref. 116). The literature thus lends support
that a linking word such as ``includes'' may help consumers better
comprehend that ``added sugars'' are a sub-component of ``total
sugars.''
    Furthermore, in the previous final rule implementing the NLEA (57
FR 32070 at 32071), we noted that several comments suggested using
terms such as ``includes,'' ``including,'' and ``of which,'' before the
subcomponent for fats and carbohydrates to indicate that the
subcomponent is a part of a broader classification. We agreed that
these words would add clarity to the label but declined to include them
at that time because they could ``clutter'' the label. While label
clutter is a concern, decreasing potential consumer confusion outweighs
any cluttering of the label that would result from the addition of a
word before ``added sugars.'' We also note that the European Union, in
its new nutritional labeling requirements, is requiring ``of which'' to
help denote the sub-components of fats and carbohydrates, which is a
similar linking phrase.
    With regard to the comment that asked us to conduct further
consumer research on this topic, we decline to do so at this time.
While we may consider additional consumer research in the future to
help inform consumer education regarding the ``added sugars'' or other
declarations, we have incorporated changes intended to minimize
consumer confusion regarding the ``added sugars'' declaration on the
label and have finalized this requirement. We have sufficient
information to move forward with the requirement for the added sugars
declaration based on a review of the scientific evidence and other
available data and information which support the need for added sugars
information to be available to the consumer as part of the nutrition
label.
(ii) Declaration of Added Sugars in Teaspoons
    (Comment 189) While one comment said that a gram disclosure for
added sugars would be more readily understood by consumers because it
is consistent with the manner in which total sugars are disclosed on
the label, a number of comments suggested that added sugars should be
declared in teaspoons or in teaspoons as well as grams. The comments
said Americans understand household measures better than they do the
metric system because they use household measures at home.

The comments said that listing the amount of added sugars in both grams
and teaspoons would improve the clarity of the information provided
about added sugars. The comments also suggested that a gram and
teaspoon declaration for added sugars would help consumers readily
observe and comprehend the information on sugars and to understand its
relative significance in the context of a total daily diet.
    The comments provided the results of survey data to support an
added sugars declaration in teaspoons. One comment provided the results
of a 2010 telephone survey which it said showed that 72 percent of
respondents favored listing teaspoons of sugar on the label. Another
comment referenced the results of a 2012 survey of readers by Consumer
World, an Internet-based publisher of a consumer resource guide. The
comment said that, when exposed to label information in which the
amount of added sugars in a product was expressed in grams, up to 80
percent of survey participants could not accurately say how much sugar
was contained in a product, and many participants underestimated the
actual amount of sugar in the product.
    (Response) We decline to revise the rule as suggested by the
comments. We address issues regarding the use of household measures
(such as teaspoons) in part II.B.3.
    Additionally, we note that there are many ingredients that supply
added sugar, so it would be difficult, if not impossible, for a
manufacturer to determine the volume contribution that each ingredient
provides towards the added sugars declaration. For example, a cookie
made with white chocolate chips and dried fruit would have added sugars
in the form of sugar in the batter as well as in the white chocolate
chips and the dried fruit.
    Because many products would not have amounts of added sugars in a
serving of a product that would result in the declaration of an even
teaspoon or multiple thereof, the requirement to declare added sugars
in teaspoons rather than in grams would result in fractional
declarations of teaspoons of added sugars. Indeed, under Sec.
101.9(c)(6)(iii) of the final rule, a statement of added sugars content
is not required for products that contain less than 1 gram of added
sugars in a serving if no claims are made about sweeteners, sugars, or
sugar alcohol content. The final rule also states that if a product
contains an insignificant amount of added sugars, the added sugars
content may be expressed as zero.
    Additionally, the USDA Food Patterns provide limits for added
sugars that can be reasonably consumed while meeting all other nutrient
and food group requirements that are listed in grams rather than in
teaspoons. The declaration of added sugars in teaspoons rather than in
grams would make it difficult for consumers to determine how their
consumption of added sugars relates to the recommended limits in the
USDA Food Patterns.
    There is limited space on the label, so the declaration of both
gram and teaspoon amounts of added sugars on the label could cause
clutter and make the label more difficult to read. We have determined
that the amount of other nutrients on the label should not be declared
in teaspoons, so if added sugars were declared in both grams and
teaspoons, it could draw the reader's attention to the added sugars
declaration and make it appear as though the information should be more
important or considered in a different way than declarations of other
nutrients when the declarations of other nutrients are just as
important to consider when constructing a healthful dietary pattern.
    While we take into consideration consumer preference, manufacturers
must provide information on the label that is as accurate as possible.
Although consumers may prefer the declaration of added sugars in
teaspoons because household measures are more familiar to them than
gram amounts, the need for accurate labeling of added sugars is of
greater importance.
    We have conducted our own research, and that research showed that
when the gram amount of added sugars is declared on the label, study
participants are able to determine the amount of added sugars in a
serving of a product. Furthermore, the percent DV declaration for added
sugars is also required. Therefore, we disagree that consumers are
unable to determine the amount of added sugars when the gram amount is
declared on the label.
(iii) Distinguishing Between Naturally Occurring and Added Sugars on
the Label
    (Comment 190) Some comments thought that we proposed to require
both a declaration for naturally occurring and added sugars. Other
comments suggested that the Nutrition Facts label include separate
declarations for naturally occurring and added sugars so that consumers
could clearly identify the amount of both naturally occurring and added
sugars on the label.
    (Response) We did not propose to require separate declarations for
naturally occurring and added sugars on the label. The comments did not
provide a basis upon which we can rely to support a separate
declaration of naturally occurring sugars, and so we decline to revise
the rule as suggested by the comments.
    (Comment 191) One comment recommended that we propose a Nutrition
Facts label format that clearly distinguishes added sugars from
naturally occurring sugars in whole fruit and from sugars from dairy
ingredients. The comment also recommended replacing ``sugars'' with
``fruit & milk sugars''.
    (Response) We address this comment in part II.H.2.
(iv) Replacing ``Sugars'' With ``Added Sugars''
    (Comment 192) Some comments would replace ``Sugars'' with ``Added
Sugars.'' One comment said that foods like fruits have natural sugars
in them, but when people see the amount of sugars they may think the
food is bad for them.
    (Response) We decline to revise the rule as suggested by the
comment. The consumption of sugars continues to be associated with an
increased risk of dental caries (Ref. 75); thus, a declaration of the
total amount of sugars in a serving of a product continues to be
necessary to assist consumers in maintaining healthy dietary practices.
(v) Distinguishing Between Different Types of Sugars or Sweeteners
    (Comment 193) One comment suggested listing all sugars separately
on the label.
    (Response) We decline to revise the rule as suggested by the
comment. There are many different kinds of sugars and ingredients
containing sugars. The declaration of the amount of each type of sugar
in a serving of a product would result in a very large and cluttered
Nutrition Facts label. While all nutrient declarations are important to
build healthy dietary patterns, current science focuses on added sugars
in total rather than focusing on specific sugars. If consumers are
interested in knowing whether certain sugars are in a product, specific
sugars are listed in the ingredient list.
    (Comment 194) One comment requested that we allow the inclusion of
``nutritive sweetener'' in a parenthetical after added sugars so
manufacturers could identify the name of the added sugar. The comment
also requested that, if the added sugar is high fructose corn syrup, we
allow manufacturers to identify the percentage of fructose on the
Nutrition Facts label (e.g., high fructose corn syrup-42 or high
fructose

corn syrup-55). The comment said that listing ``nutritive sweetener,''
the name of the added sugar, and the percentage of fructose in high
fructose corn syrup is essential for the consumer to make a fully
informed choice about the caloric contribution of sweeteners and the
composition of ingredients in the product they are consuming.
    Other comments supported the declaration of the amount of fructose
in a serving of a product on the label. One comment said that the
information is needed because metabolizing fructose puts an extra load
on the liver. The comment suggested that adding fructose and deleting
added sugars in the quantitative information would add value without
adding complexity.
    (Response) We decline to revise the rule as suggested by the
comments. Added sugars are nutritive sweeteners, so it is not clear why
``nutritive sweetener'' needs to be declared in parentheses behind the
words ``added sugars'' on the label. As previously discussed in our
response to comment 193, current science focuses on added sugars in
total rather than focusing on specific sugars.
    (Comment 195) One comment objected to the use of the term ``added
sugars'' because, according to the comment, it improperly combines
compositionally and metabolically distinct caloric sweeteners.
    (Response) We are not basing our declaration of added sugars on an
independent relationship between added sugars, or different types of
added sugars, and risk of chronic disease. To the extent that the
comment is suggesting that different types of sugars are chemically
distinct, so the term added sugars is inappropriate, there are
different types of naturally occurring sugars as well as different
types of carbohydrates, but we use the terms ``total sugars'' and
``total carbohydrate'' to capture all sugars and all carbohydrates
respectively. Therefore, using one broad term to capture all sugars
that have been added to a food is consistent with the approach that we
have taken for other nutrients. Furthermore, caloric sweeteners that
have been added to a food are added sugars, therefore we do not agree
that it is inappropriate to use the term added sugars to include
caloric sweeteners that have different chemical structures.
(vi) Warning Statements
    (Comment 196) Several comments suggested that we require various
warning statements on the label related to added sugars to warn
consumers of the negative health effects of added sugars. One comment
suggested that we require a warning statement that says ``WARNING: THIS
PRODUCT CONTAINS A SIGNIFICANT AMOUNT OF ADDED TEASPOONS OF SUGAR WHICH
STUDIES HAVE LINKED TO OBESITY, TYPE II DIABETES, CARDIOVASCULAR
DISEASE AND CERTAIN CANCERS. CONSULT YOUR PHYSICIAN ABOUT AN
APPROPRIATE DIET WITH A REDUCED AMOUNT OF ADDED SUGAR.'' Another
comment suggested that we should require a warning label that says ``IT
[added sugar] IS ADDICTIVE. IT CAN LEAD TO OBESITY. OBESITY CAN LEAD TO
DIABETES, HEART DISEASE, ETC.''
    One comment suggested that we require, or offer an incentive for, a
disclaimer about added sugars and sodium. The disclaimer would explain
the health effects on the body and connections to disorders such as
diabetes and hypertension. The comment said that, similar to cigarette
packets, consumers should be warned of the health effects of added
sugars.
    (Response) We decline to revise the rule as suggested by the
comments. The statements are not consistent with our review of the
evidence (see our response to comments 136 and 137), and we do not
require warning labels or disclaimers for other nutrients on the label.
Furthermore, some added sugars can be included as part of a healthy
dietary pattern.
    (Comment 197) Several comments suggested that we use wording to
convey that the DRV of 10 percent of calories from added sugars is a
maximum amount rather than a recommended amount. One comment would
include language to state that ``no consumption is recommended. But if
you choose to consume, then this absolute maximum should be observed to
avoid increasing adverse health exposure.'' Another comment would
require a statement on the label that the average woman should consume
no more than 24 grams of sugar per day, and the average man should
consume no more than 34 grams of sugar per day.
    (Response) We decline to revise the rule as suggested by the
comments. In response to the comment that would include language to
convey that the DRV is a maximum amount rather than a recommended
amount, such language would not be appropriate because we do not
require this information for other nutrients with DRVs or RDIs that are
based on an amount not to exceed.
    As for a statement regarding ``no consumption,'' the current
evidence does not support a need to eliminate all added sugars from the
diet. In fact, the USDA Food Patterns show that one can carefully
construct a healthful diet that includes calories from added sugars.
    Finally, regarding a statement on the label with limits for the
amount of added sugars that the average man or woman should consume, we
do not provide this information for any other nutrients which are to be
limited in the diet, and it is not clear what the scientific basis is
for the suggested limits.
    j. Variability in sugar content.
    (Comment 198) One comment noted that manufacturers may add varying
amounts of sugars due to variation in maturity of a fruit or vegetable
ingredient during the course of a growing season to attain a consistent
level of soluble solids and a consistent taste profile of the food. The
comment further said that food manufacturers and marketers would not
prepare multiple labels for different batches, so the declared amount
would reflect the highest possible amount of added sugars and may
overstate the actual amount.
    (Response) Variation in the sugar content of fruits and vegetables
due to growing conditions is something that manufacturers have had to
take into account with their labeling of total sugars since 1993.
Manufacturers are in the best position to determine how much of a
nutrient is in their product given the variability of the nutrients in
their product. They are also in the best position to determine when a
label change is needed because the declaration would no longer be in
compliance with our requirements under Sec.  101.9(g).
    k. Non-enzymatic browning and fermentation. In the preamble to the
proposed rule (79 FR 11879 at 11906), we recognized that sugars in some
foods may undergo changes mediated by chemical reactions from non-
enzymatic browning (i.e. Maillard reaction and caramelization) and
fermentation that would result in compounds that are no longer
recognizable or detectable as sugars through conventional analytical
methods. We tentatively concluded that the amount of added sugars
transformed during non-enzymatic browning reactions is insignificant
relative to the initial levels of sugars. We also tentatively concluded
based on the information available to us that the amount of added
sugars present in foods prior to undergoing fermentation, with the
exception of yeast-leavened bakery products, wines with less than 7
percent alcohol by volume, and beers that do not meet the definition of
a ``malt beverage'' as defined by the Federal Alcohol Administration
Act (27 U.S.C. 211(a)(7)) with sugars added during the formation
process, will not be

significantly affected by virtue of the food having undergone
fermentation (79 FR 11879 at 11907). We acknowledged that we do not
have adequate information to assess the degradation of added sugars
during fermentation for yeast-leavened bakery products, wine with less
than 7 percent alcohol by volume, and beers that do not meet the
definition of a malt beverage with sugars added before fermentation. We
requested the submission of available data and information on our
tentative conclusions as well as the submission of data on the amount
of variability that occurs among various types of products where added
sugars are transformed into other compounds as a result of chemical
reactions during food processing.
    The proposed rule, at Sec.  101.9(g)(10)(v), would require a
manufacturer of yeast-leavened bakery products, wines with less than 7
percent alcohol by volume, and beers that do not meet the definition of
a malt beverage with sugars added before and during the fermentation
process to make and keep records of added sugars necessary to determine
the amount of added sugars present in the finished food. The proposed
rule would require manufacturers of such foods to make and keep records
of all relevant scientific data and information relied upon by the
manufacturer that demonstrates the amount of added sugars in the food
after fermentation and a narrative explaining why the data and
information are sufficient to demonstrate the amount of added sugars
declared in the finished food, provided the data and information used
is specific to the type of fermented food manufactured. Alternatively,
under the proposed rule, manufacturers would be able to make and keep
records of the amount of added sugars added to the food before and
during the processing of the food and, if packaged as a separate
ingredient, as packaged. We said that the amount of added sugars
declared should not exceed the amount of total sugars on the label (79
FR 11879 at 11908).
    (Comment 199) One comment said that we have not demonstrated why
distinguishing between a fermented added sugar and a fermented
naturally occurring sugar or why the type of sugar that participates in
reactions due to heat treatment improves the health of consumers. The
comment questioned what the compelling government interest is in
knowing which molecule of sugar participates in these reactions.
    (Response) To the extent that the comment is suggesting that our
focus on added sugars is misplaced because added sugars are not
chemically distinct from naturally occurring sugars and are not
associated with health or the risk of disease, we respond to such
issues in part II.H.3.i. We also have stated, in part II.H.3.a, that
added sugars consumption is a significant public health concern which
warrants mandatory declaration.
    (Comment 200) Several comments suggested that there are a wide
variety of fermented foods (e.g., fermented vegetables, beverages,
fruits, condiments, products made with grains and/or pulses, dairy
replacement products, and meat products) and ingredients (e.g.,
vinegars, enzymes, vitamins, and amino acids in pure form or in
mixtures) to which sugars are added, and where the sugars content is
significantly diminished or entirely removed through fermentation. The
comments also disagreed with our tentative conclusion that the amount
of added sugars transformed by fermentation will be insignificant
relative to the initial levels of sugars in foods and ingredients other
than yeast-leavened bakery products, wines with less than 7 percent
alcohol by volume, and beers that do not meet the definition of a malt
beverage. The comments noted that the effect of fermentation is
variable. According to the comments, the net effect can depend on
details of the starting materials, fermentation process, and length of
fermentation.
    Several comments noted that there are many processing and
ingredient variables that influence the fermentation process in yeast-
leavened bakery products. The comments said that our assumption that
manufacturers have information about reduction of added sugars in
yeast-leavened bakery products is incorrect. One comment stated that,
because manufacturers would be unable to determine the amount of added
sugars consumed during fermentation in yeast-leavened bakery products,
manufacturers would have to declare the amount of sugars added before
leavening under the proposed rule, resulting in an overstatement of the
amount of added sugars in the finished product, which is false and
misleading.
    Other comments suggested that added sugars that are converted
through fermentation to other compounds should be subtracted from the
added sugars declaration, and any sugars produced during fermentation
should be omitted from the declaration of added sugars.
    One comment suggested that proposed Sec.  101.9(g)(10)(v), which
would permit manufacturers of yeast-leavened bakery products, wines
with less than 7 percent alcohol by volume, and beers that do not meet
the definition of a malt beverage to make and keep records of
scientific data and information to demonstrate the amount of added
sugars remaining in the finished food, when that amount is less than
the initial amount of added sugars, be extended to all food
manufacturers that must declare added sugars in the labeling of their
products.
    Other comments disagreed with our tentative conclusion that the
amount of added sugars transformed by non-enzymatic browning reactions
will be insignificant relative to the initial levels of sugars. One
comment provided the example of the manufacture of caramel. The comment
suggested that this process converts sugars into thousands of new
chemical compounds that include oligomers, dehydration and hydration
products, disproportionation products, and colored aromatic products.
The comment noted that the decrease in added sugars in a wide variety
of products undergoing such chemical reactions may depend on the
ingredients, moisture levels, presence of acids or bases, exposure to
heat, etc., but that the decrease is not uniformly insignificant.
    (Response) Although comments said that the amount of added sugars
converted to other compounds during fermentation and non-enzymatic
browning is significant in a wide variety of foods, few comments
provided data to support their conclusions. One comment provided
information about the amount of sugars which are converted to other
compounds in kimchi, a fermented vegetable product (Refs. 117-118).
Another comment provided information about caramel candy (Ref. 119). In
a memo to the file for the proposed rule (Ref. 120), we tentatively
concluded that the amount of added sugars which are converted to other
compounds through Maillard browning, a type of non-enzymatic browning,
is insignificant. Although the comments generally disagreed with our
conclusion that all products participating in non-enzymatic browning
have an insignificant reduction in the amount of added sugars, no
comments specifically disagreed with our conclusion about products that
participate in Maillard browning. Therefore, in products affected by
Maillard browning, the amount of sugars added before Maillard browning
is a reasonable approximation of the amount of added sugars in the
finished product in most, if not all, products.
    With the exception of the comment which cited caramelization as an

example of a non-enzymatic browning process where the reduction in the
amount of added sugars present in a finished food could be significant,
we did not receive any other specific data or information about foods
that undergo non-enzymatic browning to support the comments' position
that the amount of added sugars converted to other compounds is
significant. Therefore, we expect that the amount of sugars added
before non-enzymatic browning in these foods would be a reasonable
approximation of the amount of added sugars in the finished product. We
also expect that manufacturers of such products would be able to make
and keep documentation to show a reasonable basis for how they
determined the declared value for added sugars.
    We recognize that there may be a larger amount of variability in
fermented products with respect to the amount of added sugars that are
converted to other compounds. Although the comments provided examples
of products that participate in fermentation, the comments provided
very little data or information to support the assertion that the added
sugars content is significantly reduced in a large number of fermented
foods. We are aware of only a small number of fermented foods where the
reduction in added sugars may significant (where the reduction in added
sugars after fermentation may be significant enough to impact the label
declaration for added sugars) after fermentation. Therefore, we expect
that the majority of manufacturers would be able to use the amount of
added sugars added as an ingredient as a reasonable approximation of
the amount of added sugars in a serving of their product.
    If a manufacturer has a basis on which to support a declaration of
added sugars based on the amount of added sugars present in a food
after non-enzymatic browning or fermentation, the label declaration
must be supported by records demonstrating the accuracy of the declared
amount. The records should include all relevant scientific data and
information relied upon by the manufacturer that demonstrates the
amount of added sugars in the food after non-enzymatic browning and/or
fermentation and a narrative explaining why the data and information
are sufficient to demonstrate the amount of added sugars declared in
the finished food.
    There may be a small number of foods which undergo non-enzymatic
browning and/or fermentation for which manufacturers have reason to
believe that the amount of added sugars in a serving of the finished
food product is significantly less (i.e., where the reduction in added
sugars after fermentation may be significant enough to impact the label
declaration for added sugars) than the amount added prior to non-
enzymatic browning and/or fermentation, and the manufacturer has no way
to reasonably approximate the amount of added sugars in a serving of
the finished food. Therefore, we have revised Sec.  101.9(g)(10)(v)(C)
to state that manufacturers may submit a petition, under Sec.  10.30
(21 CFR 10.30), to request an alternative means of compliance. The
petition must provide scientific data or other information for why the
amount of added sugars in a serving of the product is likely to have a
significant reduction in added sugars compared to the amount added
prior to non-enzymatic browning and/or fermentation. A significant
reduction would be where reduction in added sugars after non-enzymatic
browning and/or fermentation may be significant enough to impact the
label declaration for added sugars by an amount that exceeds the
reasonable deficiency acceptable within current good manufacturing
practice under Sec.  101.9(g)(6). In addition, the scientific data or
other information must include the reason that the manufacturer is
unable to determine a reasonable approximation of the amount of added
sugars in a serving of their finished product and a description of the
process that they used to come to that conclusion.
    We recognize that labeling of added sugars in products that undergo
fermentation and non-enzymatic browning may not be exact, but
manufacturers of most products that participate in these reactions
should be able to provide a reasonable approximation of the amount of
added sugars in a serving of their product based on information in the
literature and their own analyses. Most manufacturers should be able to
provide documentation to support the value that they declare on the
label. Therefore, the majority of manufacturers of such foods will be
able to provide a reasonable approximation of the amount of added
sugars in a serving of their product as well as documentation showing a
reasonable basis for how they determined the declared value.
    As some comments recommended, we agree that it is appropriate to
allow manufacturers of all products which undergo non-enzymatic
browning and/or fermentation to make and keep records of the type that
we proposed. Therefore, we have revised Sec.  101.9(g)(v) to say that
when the amount of sugars added to food products is reduced through
non-enzymatic browning and/or fermentation, manufacturers must:
     Make and keep records of all relevant scientific data and
information relied upon by the manufacturer that demonstrates the
amount of added sugars in the food after non-enzymatic browning and/or
fermentation and a narrative explaining why the data and information
are sufficient to demonstrate the amount of added sugars declared in
the finished food, provided the data and information used is specific
to the type of food manufactured; or
     Make and keep records of the amount of sugars added to the
food before and during the processing of the food, and if packaged as a
separate ingredient, as packaged (whether as part of a package
containing one or more ingredients or packaged as a single ingredient)
and in no event shall the amount of added sugars declared exceed the
amount of total sugars on the label; or
     Submit a petition, under Sec.  10.30, to request an
alternative means of compliance. The petition must provide scientific
data or other information for why the amount of added sugars in a
serving of the product is likely to have a significant reduction in
added sugars compared to the amount added prior to non-enzymatic
browning and/or fermentation.
    A significant reduction would be where reduction in added sugars
after non-enzymatic browning and/or fermentation may be significant
enough to impact the label declaration for added sugars by an amount
that exceeds the reasonable deficiency acceptable within current good
manufacturing practice under Sec.  101.9(g)(6). In addition, the
scientific data or other information must include the reason that the
manufacturer is unable to determine a reasonable approximation of the
amount of added sugars in a serving of their finished product and a
description of the process that they used to come to that conclusion.
    (Comment 201) One comment noted that sugar content of products can
be increased through hydrolysis and enzymatic reactions using
carbohydrate containing ingredients. The comment questioned what the
classification would be of the sugars (natural or added) produced by
such reactions during food processing. The comment also noted that the
possibility of having sugars produced ``in situ'' (meaning in place or
in position) shows the difficulty of drawing a clear line between the
two types of sugars.
    (Response) Sugars content can be increased through acid, heat, or

enzymatic hydrolysis of complex carbohydrates (e.g. starch). Sometimes,
the increase is incidental as a consequence of other food manufacturing
processes, such as acidification, heating, and/or fermentation. For
example, during yeast bread fermentation, natural enzymes present in
the flour can hydrolyze starch into maltose. Other than sugar syrup
types of products where the sugars are specifically and purposely
produced via hydrolysis, we do not have information suggesting that
sugars produced through incidental hydrolysis of complex carbohydrates
results in a significant increase in the sugar content of foods. Sugars
which are produced through incidental hydrolysis would be captured in
the total sugars declaration, but we do not have any comments or other
information suggesting that these sugars should be captured under the
added sugars declaration. Therefore, they are not included in our
definition of added sugars and would not be declared as added sugars on
the label. In the previous example of the enzymatic hydrolysis of
maltose from starch during bread fermentation, we would not require the
maltose formed during this process to be declared as added sugar.
However, sugar present in corn syrup produced from hydrolysis of corn
starch would be considered added sugar because the hydrolysis was
specifically done to generate mono- and di-glycerides. In addition, if
a manufacturer purposely employs a hydrolysis step as part of a food
manufacturing process to increase the sugar content of a food product
(e.g. enzymatic hydrolysis of corn starch to make corn syrup in the
same facility as part of the cookie-making process), we would consider
the sugar generated from the hydrolysis step to be added sugars, since
hydrolysis was purposely used by the manufacturer to increase the sugar
content of the product.
    l. Impact on nutrient databases.
    (Comment 202) One comment said that we failed to provide a
framework and/or an approved database that harmonizes implementation
across industry. The comment also said that it is unclear how FDA-
approved databases would be revised in order to be used to calculate
added sugars or to distinguish between amounts of naturally occurring
sugars and added sugars, such as how to calculate the varying sugar
content of a food that contains naturally occurring and added sugars
given the common fluctuations in foods containing naturally occurring
sugars.
    (Response) Under Sec.  101.9(g)(8), we allow for compliance with
Sec.  101.9(g)(1) through (g)(6) by use of an FDA approved database
that has been computed following FDA guideline procedures and where
food samples have been handled in accordance with current GMPs to
prevent nutrition loss. Our Guidance for Industry: Nutrition Labeling
Manual--A Guide for Developing and using Data Bases, the manual
provides generic instructions for developing and preparing an
acceptable database, as well as the recommended statistical methodology
to develop nutrition label values. The guide is based on doing
laboratory analyses of food samples. Because added sugars and naturally
occurring sugars are not chemically distinct, it is not possible to do
a laboratory analysis to determine the amount of added sugars in a
product that contains both naturally occurring sugars and added sugars.
If a product contains only added sugars, the procedures outlined in our
guidance could be used by manufacturers to develop a database of values
for added sugars. However, if both naturally occurring and added sugars
are present, manufacturers will have to use other information that they
have to determine a label value. They will also have to make and keep
records to support the declared value, as discussed in part II.H.3.p.
    With respect to calculating the varying sugar content of foods that
contain naturally occurring and added sugars given seasonal variability
and variability due to other growing conditions in products containing
naturally occurring sugars, such as fruits and vegetables,
manufacturers should know how much sugars they add to a product to
account for the variability in the sugars naturally present in a food.
They should be able to use the amount that they add to determine the
value that they declare on the label. The variability in naturally
occurring sugar content would not be a new variable for manufacturers
to consider.
    m. International labeling guidelines.
    (Comment 203) Some comments noted that Codex Alimentarius
Guidelines on Nutrition Labeling require the labeling of total, but not
added sugars (Ref. 121). The comments said that our proposal to require
the mandatory declaration of added sugars is not in line with
international guidelines on nutrition labeling. The comments said that
a revision of the Guidelines was undertaken by a working group within
the Codex Committee on Food Labeling (CCFL) and discussed at the 38th
Session of the CCFL (2010). The comments also said that, based on
reports from that CCFL meeting, the Codex Committee considered the
following evidentiary support for labeling only total sugars: (1) The
body cannot differentiate between added sugars and total sugars in
physiologic response; (2) the absence of any analytical differentiation
between added and inherent sugars, which would create difficulties for
enforcement; and (3) the importance of declaration of total sugars for
certain populations including diabetics. The comment also said that the
WHO advised that ``total sugars is the only practical way of labeling
the sugars content of food since sugars cannot be distinguished
analytically from intrinsic sugars.''
    Other comments said that no other country has adopted mandatory
added sugars declarations as part of nutrition labeling of foods and
beverages. The comments noted that the purpose of the Codex Guidelines
on Nutrition Labeling is to promote fair trade through international
harmonization in the approach to nutrition labeling.
    Other comments said that we need to be in compliance with the TBT
Agreement, which insures that technical regulations ``do not create
unnecessary obstacles to international trade.''
    Some comments referred to previous positions that we have taken
with respect to Codex and said that our proposal to require the
mandatory declaration of added sugars is a total reversal from those
previous positions.
    (Response) The Codex standards are recommendations for voluntary
application by countries. For nutrition labeling, the Codex Guidelines
on Nutrition Labeling provide that where a nutrient declaration is
applied, the declaration of total sugars should be mandatory. Although
Codex does not state or imply that the declaration of added sugars
should be mandatory, the guidelines provide for mandatory declaration
when ``The amount of any other nutrient [is] considered to be relevant
for maintaining a good nutritional status, as required by national
legislation or national dietary guidelines.'' ((Ref. 121) at section
<IP_ADDRESS>). We have determined that the declaration of added sugars in
necessary to assist consumers in maintaining healthy dietary practices,
consistent with our authority in section 403(q) of the FD&C Act for
when the labeling of a nutrient is required. The provision of such
information is necessary to achieve our legitimate objective of
protecting human health. We have established elsewhere in this section
that the mandatory declaration of the amount of added sugars in a
serving of a product is necessary to protect human health because
scientific evidence supports that healthy dietary patterns

characterized, in part, by lower intakes of added sugars are associated
with a decreased risk of CVD, sugar-sweetened beverage consumption is
associated with adiposity in children, added sugars can lead to
displacement of nutrient-dense foods in the diet, and intake data shows
that Americans, on average, are exceeding the recommended limit for
added sugars consumption. As such, our requirements to include the
declaration of added sugars in nutrition labeling and for manufacturers
to make and keep records of the amount of sugars they add to their
products do not constitute an unnecessary obstacle to trade. Firms,
whether domestic or foreign, must include an added sugars declaration
on the label and must make and keep records, as appropriate, to verify
the amount of added sugars in a product.
    Manufacturers already know how much sugar is added to their product
based on the formulation or should be able to reasonably estimate the
amount of sugars added in products that undergo non-enzymatic browning
and fermentation. We also do not consider that the records we are
requiring would be unnecessarily burdensome for manufacturers to make
and keep (see part II.C.1).
    Our position on requiring the labeling of added sugars has
developed in response to additional information that we did not have in
the past. At the time that previous statements with respect to our
official position on labeling of added sugars were made, the 2010 DGA
and 2015 DGAC Report were not yet available. Based on information
provided in the 2010 DGA and the 2015 DGAC Report, such as the
underlying evidence used to support the 2015 DGAC conclusion that there
is strong evidence that healthy dietary patterns characterized, in
part, by lower intakes of sugar-sweetened foods or beverages are
associated with a decreased risk of CVD and evidence that it is
difficult to meet nutrient needs within calorie limits when individuals
consume large amounts of added sugars, we had reason to revisit the
requirement for a declaration of added sugars on the Nutrition and
Supplement Facts labels in the proposed rule and in the supplemental
proposed rule. We considered comments to the proposed rule and the
supplemental proposed rule and have concluded that the evidence
supports the mandatory declaration of added sugars on the label to
fulfill the legitimate objective of protecting human health.
    With respect to the comments that suggest no other country has
adopted mandatory labeling of added sugars, we note that the comments
do not address the relevance of these circumstances with respect to our
objectives and the scientific evidence before us.
    With respect to the comments on the evidentiary support considered
by the CCFL on the reporting of added sugars, we have addressed these
points in response to comments in this final rule. Furthermore, we
require records, as appropriate, to verify the declaration of added
sugars, and do not rely on analytical methods, as addressed by the WHO.
In the six years since that decision, the evidence that has developed
indicates that reporting of added sugars is of clear benefit in terms
of public health.
    n. Definition of added sugars. Added sugars are not currently
defined by regulation. We proposed to define added sugars in Sec.
101.9(c)(6)(iii) as sugars that are either added during the processing
of foods, or are packaged as such, and include sugars (free, mono- and
disaccharides), syrups, naturally occurring sugars that are isolated
from a whole food and concentrated so that sugar is the primary
component (e.g. fruit juice concentrates), and other caloric
sweeteners. We also clarified in preamble to the proposed rule (79 FR
11879 at 11906) that the definition would include single ingredient
foods such as individually packaged table sugar, and that sugar
alcohols are not considered to be added sugars. We provided the
following examples of names for added sugars: Brown sugar, corn
sweetener, corn syrup, dextrose, fructose, fruit juice concentrates,
glucose, high-fructose corn syrup, honey, invert sugar, lactose,
maltose, malt sugar, molasses, raw sugar, turbinado, sugar, trehalose,
and sucrose. We note that this is not an exhaustive list of all added
sugars.
    Although some comments supported the proposed definition, other
comments said that the proposed definition is ambiguous, confusing, and
will lead to inconsistent application across the food industry. As
discussed in the following responses to comments on the definition of
added sugars, the final rule revises the definition of added sugars in
Sec.  101.9(c)(6)(iii) that is specific and provides clarity on issues
raised in the comments. As such, the definition of added sugars can be
applied by the food industry in a consistent manner.
(i) Fruit and Vegetable Juice Concentrates
    (Comment 204) Many comments related to the inclusion of juices and
juice concentrates in the definition of added sugars. Some comments
suggested that the definition include sugars from fruit juice as well
as fruit juice concentrate. However, many other comments disagreed with
the inclusion of both fruit juices and fruit juice concentrates in the
definition of added sugars. The comments said that 100 percent fruit
juices, and 100 percent juice reconstituted from concentrate should not
be considered to be added sugars. The comments suggested that fruit
juice concentrates should be considered an added sugar only if they are
not brought back to single strength by dilution with water in the
product or by the end-user. One comment stated that 100 percent juice
from concentrate and 100 percent juice not from concentrate are
nutritionally identical, and there is no reason to require declaration
of the added sugar content differently. One comment questioned why we
are proposing to require different labeling for fruit juice depending
upon whether it is a stand-alone product or an ingredient in another
product. Another comment stated that a juice product formulated with
juice that is reconstituted from a juice concentrate would appear as if
it is making a greater calorie contribution because the juice
concentrate would be deemed an ``added sugar'' when in fact, the
calorie contribution of these two products is exactly the same. The
comments argued that, if a juice product is sweetened with added
sugars, the underlying juice before sweetening should not be considered
an added sugar.
    (Response) Single strength or 100 percent fruit juices (which, for
purposes of this document, we will refer to collectively as 100 percent
fruit juice) contribute calories from sugars as well as nutrients. The
comments did not provide data or other information to demonstrate that
exclusion of information on sugars from fruit juices would be
scientifically unjustified, potentially disadvantageous for consumers,
and inconsistent with growing expert opinion and international
approach. We note that sugars from 100 percent fruit juices have never
been considered to be added sugars in the DGA. In fact, the USDA Food
Patterns include 100 percent fruit juices in the fruit group, and the
DGA has recommended increased consumption of fruits for many years
(Refs. 28, 30, 78-83). It was not our intent to include the sugars from
100 percent fruit and vegetable juices in the definition of added
sugars in the proposed rule. Therefore, the final rule does not include
100 percent fruit or vegetable juices in the added sugars definition.
    While fruit or vegetable juice concentrates can supply the same

nutrients as single strength or 100 percent fruit juice, they are a
highly concentrated source of sugar. They may be used in small
quantities for purposes other than to sweeten a food; however they are
increasingly added to foods for sweetening purposes. They are
identified in the ingredient list as concentrated fruit or vegetable
juice. Some consumers could assume that the sugars that a concentrated
fruit or vegetable juice contributes to a product are beneficial
because they come from fruits or vegetables rather than from a more
refined source. While foods sweetened with concentrated fruit or
vegetable juices can be a part of a healthful diet, the sugars
contributed by the concentrated fruit or vegetable juice provide
additional calories to a product just as another source of refined
sugar would provide additional calories. Over the course of the day,
small amounts of calories in sugar-sweetened foods and beverages can
add up and can make it difficult to balance the amount of calories
consumed with the amount of calories expended. We consider foods
sweetened with concentrated fruit or vegetable juices to be sugar-
sweetened foods. The 2015 DGAC concluded that healthy dietary patterns
characterized, in part, by lower intakes of sugar-sweetened foods and
beverages are associated with a reduced risk of CVD. Therefore, it is
important for consumers to be aware that when products are sweetened
with concentrated fruit or vegetable juices; the extra sugars and
calories that they contribute to products are like any other source of
added sugars. When added to foods for the purpose of sweetening, we
consider the sugars in a fruit juice concentrated which are used for
sweetening purposes to be added sugars.
    We recognize that juice concentrates may be added to food products
in varying levels of concentration. For example, a product may use
juice concentrate as an ingredient to achieve equivalent juice
percentage as discussed in this section (e.g. a juice drink with 50
percent juice) or at 100 percent juice (e.g. 100 percent juice, from
concentrate) based on our juice percentage declaration regulation in
Sec.  101.30 (also see our response to comment 205). An applesauce may
have concentrated fruit juice added which has not been reconstituted at
all. Because the nutrient profiles of fruit juice concentrates are the
same as 100 percent fruit juices, we consider the amount of sugars
above and beyond what would be contributed by the same volume of the
same type of juice which is reconstituted to 100 percent juice to be
added sugars. For example, if 15 grams of concentrated apple juice,
which has 6 grams of sugars, is added to sweeten an applesauce and the
same amount (15 grams) of 100 percent apple juice contains 1.7 gram of
sugar, we would consider 4.3 grams of the sugars contributed to the
applesauce (6 grams sugar in 15 grams apple juice concentrate 1.7 gram
sugar in 15 grams 100 percent apple juice = 4.3 grams added sugars) by
the apple juice concentrate to be added sugars. Another example to
consider is an apple juice concentrate added to 100 percent pear juice
for the purposes of sweetening. If 30 grams of apple juice concentrate,
which contributes 10 grams of sugars is present in a serving of the
finished product, the amount of added sugars which should be declared
can be calculated by subtracting the amount of sugars present in 30
grams of 100 percent apple juice (3.4 grams) from the amount of sugars
present in 30 grams of the fruit juice concentrate (10 grams of sugar
in 30 grams apple juice concentrate 3.4 grams sugar in 30 grams 100
percent apple juice = 6.6 grams added sugars).
    Fruit juice concentrates made from 100 percent juice that are sold
directly to consumers (e.g. in grocery stores or on the Internet) are
typically reconstituted with water by consumers before consumption. The
packaging of these fruit juice concentrates typically provides
information about the amount of water that consumers should use to
reconstitute the juice. Concentrated juice products must bear a
percentage juice declaration and that declaration may not be greater
than 100 percent (Ref. 122). The label may explain that when the
product is diluted according to label directions, the product yields a
``__ percent juice from concentrate,'' with the blank being filled in
with the correct percentage based on the Brix values set out in 21 CFR
101.30(h)(1), as applicable (Ref. 122). We expect that consumers will
reconstitute these types of fruit juice concentrates to 100 percent
juice based on the instructions provided on the label for
reconstituting frozen fruit juice. Therefore, we do not consider 100
percent juice concentrate sold directly to consumers as added sugar.
    Accordingly, we have revised the definition of added sugars to
exclude frozen fruit juice concentrates from 100 percent juice and to
include only additional sugars contributed by fruit juice concentrates
not reconstituted to full strength to be declared on the label. This
approach is consistent with our position that only the amount of sugar
which is above and beyond what would be expected in the same type of
100 percent juice is considered added sugar. However, concentrated
juice cocktails, drinks, or beverages do not reconstitute to 100
percent juice and often contain sweeteners, such as sugar and syrup.
For these types of products, all sugar except the sugar from the juice
ingredients should be declared as added sugar on the label.
    We note that we are also excluding fruit juice concentrates which
are used to formulate the fruit component of jellies, jams, or
preserves in accordance with the standard of identities set forth in
Sec.  150.140 and Sec.  150.160 as discussed in our response to comment
211.
    As for juice concentrates, juice concentrates may be added for many
different purposes and they may have multiple functions in a food. For
example, an orange juice concentrate could be added to a muffin batter
to give it orange flavor, to add vitamin C, and to provide sweetness.
If one purpose of adding the juice concentrate to a product is to
provide sweetness, manufacturers should declare the amount of sugar
provided from the juice which is in excess of what would be provided
from the same volume of the same type of 100 percent juice as added
sugars on the label.
    We are aware that there are syrup-like products made by
concentrating fruit juice that has been processed specifically to
remove organic acid, minerals, and insoluble fruit materials. These
types of products are not fruit juice concentrates, but are fruit
syrups. All of the sugar contents in these types of ingredients should
be declared as added sugars on the label.
    We proposed to require manufacturers to make and keep records to
verify the amount of added sugars in a serving of a product when the
product contains both naturally occurring and added sugars. If a juice
concentrate is added to a food and is not brought back to 100 percent
juice, we are unable to determine how much of the sugars provided by
the juice is in excess of what would be expected for the same volume of
the same type of 100 percent juice, therefore, manufacturers of such
products must include a calculation of how they determined the amount
of sugars from the juice concentrate that contribute to the added
sugars declaration. Because juice concentrates contain naturally
occurring sugars, all manufacturers of products containing juices that
are not brought back to 100 percent strength in the finished food must
make and keep records to verify how they arrived at their determination
of the amount of added sugars which are contributed by the concentrated
juice.

    (Comment 205) Some comments noted that juice concentrates are
commonly used to adjust the Brix levels of directly expressed juice,
and these juice concentrates are not required to be reflected in the
common or usual name of such juices under the regulation for beverages
that contain fruit or vegetable juice (Sec.  102.33(g)(2)). The
comments said that fruit juice concentrates are not added sugars if
they qualify to be included in the percent juice declaration found on
beverage labels. The comments asked us to clarify that added sugars do
not include fruit or vegetable juice concentrates used to formulate 100
percent juice or 100 percent juice blends, or dilute juice beverages,
and do not include juice concentrates that are added to juices and
dilute juice beverages to adjust soluble solids content in accordance
with Sec.  102.33 (21 CFR 102.33) and the standards of identity in
parts 146 and 156 (21 CFR parts 146 and 156).
    (Response) We do allow for the use of juice concentrates in the
formulation of 100 percent juice, 100 percent juice blends, and diluted
juice beverages under Sec.  101.30 (percentage juice declaration for
foods purporting to be beverages that contain fruit or vegetable
juice), Sec.  102.33 (beverages that contain fruit or vegetable
juices), part 146 (requirements for specific standardized canned fruit
juices and beverage), and part 156 (vegetable juices). For consistency
with our current regulations, we agree that juice concentrates should
be exempt from the definition of added sugars if they are: (1) Counted
towards percentage juice declaration in accordance with Sec.  101.30
for 100 percent juice and juice beverages (Sec.  102.33); and (2) used
to standardize the Brix values of a single species juice consisting
juice directly expressed from a fruit or vegetable in accordance with
Sec.  102.33(g)(2). Therefore, we have revised the definition of added
sugars to make an exception for juice concentrates which contribute to
the percentage juice label declaration under Sec.  101.30 and for Brix
value standardization under Sec.  102.33(g)(2).
    (Comment 206) One comment noted that, under the proposed definition
for added sugars, a fruit juice concentrate that is 45 percent sugar,
50 percent water, and 5 percent other components would not be
considered an added sugar because sugar would not be the primary
component. The comment said that this is a potential loophole that
manufacturers could exploit.
    (Response) The comment is referencing the language in our proposed
added sugars definition which would state that ``naturally occurring
sugars that are isolated from a whole food and concentrated so that
sugar is the primary component (e.g., fruit juice concentrates)'' are
added sugars. We recognize that there could be fruit juice concentrates
that do not have sugar as the primary component. Therefore, we have
revised the definition of added sugars to remove the language regarding
naturally occurring sugars that are isolated from a whole food and
concentrated so that sugar is the primary component (e.g., fruit juice
concentrates), and instead specifically listing the types of fruit
juice concentrates that we consider to be added sugars.
(ii) Intended Purpose of Sweetening
    (Comment 207) Many comments argued that sugars are an ingredient
which may have multiple functions in a food. The comments recommended
that we exclude certain ingredients which are not added for the
intended purpose of sweetening a food. Most comments suggested defining
added sugars based on the intended use of the sugar which has been
added and not exclusively on the nature of the product. The comments
would define added sugars as the sum of all mono- and disaccharides
that are added to a food for purposes of sweetening the food.
    Other comments said that, even when added as an ingredient in foods
(as opposed to beverages), fruit juice concentrates are not always used
for a sweetening purpose. One comment stated that apple juice
concentrates can be added to produce a browning color as the food is
heated and the sugars in the concentrate are caramelized. Many yogurt
manufacturers, for example, use small amounts of fruit juice
concentrates (such as carrot juice concentrate) in their yogurt
products for purposes of coloring or flavoring. The comments suggested
that fruit juice concentrates which are not used to sweeten a food not
be counted as ``added sugars'' given that they: (1) Are not being used
as a sweetener; (2) do not materially sweeten the product when used in
the amounts necessary for their intended purpose of coloring or
flavoring; and (3) only contain naturally occurring sugars derived from
fruit.
    (Response) We acknowledge that fruit juice concentrates, sugars,
honey, or syrups may be added for many reasons to a food, and they may
have many affects in a food other than adding sweetness. As previously
discussed in this part, we have evidence that excess calorie
consumption from added sugars is a public health concern. In
determining which sugars should be included in the definition of added
sugars, we have considered the presence of added sugars as a component
of dietary intake and whether it is consistent with the concept of
empty calories, as discussed in the 2015 DGAC Report.
    (Comment 208) One comment recommended that mono and disaccharides
from any pure (i.e. with no added sugars) fruit ingredient, such as
juices, concentrates, fruit pieces, pulps, and purees should not count
as added sugars if these ingredients are not added for sweetening
purposes.
    (Response) We decline to revise the rule as suggested by the
comment. We agree that whole fruit, fruit pieces, pulps, purees, 100
percent fruit juices, and certain fruit juice concentrates should not
be considered added sugars because they are nutrient rich and maintain
the basic properties of a fruit, which is not considered to be an added
sugar. We have, in the final rule's definition of added sugars,
excluded whole fruits, fruit pieces, pulps, purees, and certain
concentrated fruit juices that are reconstituted to full strength or
that may be added to other fruit juices, jellies, jams, and preserves
under our standards of identity. However, we consider other mono and
disaccharides from fruit ingredients to be added sugars. Sugars from
fruits as well as fruit juices can be isolated (removed from the
fruit), concentrated (decreased in volume by removing water), and
stripped of nutrients such that they are essentially sugars that
provide a concentrated source of calories to a food without other
redeeming qualities (e.g. fruit syrups). Therefore, we are not
excluding all mono and disaccharides from any pure fruit ingredient.
    (Comment 209) Many comments opposed the inclusion of dried and
concentrated dairy ingredients in the definition of added sugars. The
comments explained that a number of dairy-based ingredients are
isolated from milk and concentrated such that lactose, the naturally
occurring sugar in milk, is the primary component. Examples of such
ingredients include non-fat dry milk powder, dry whole milk, some forms
of concentrated whey and dried whey, and milk and whey permeate.
According to the comments, under the proposed definition of added
sugars, the lactose in these dried and concentrated dairy ingredients
would be considered an added sugar because it is the ``primary
ingredient.''
    The comments also explained that lactose is not added to foods for
the purpose of sweetening, and is instead added for other functional
properties. Lactose contributes viscosity and mouthfeel, serves as a
fermentation

source in yogurt, increases shelf-life, provides foaming properties
which are beneficial for cakes and frozen desserts, and serves as an
emulsifier in sausages, soups, sauces, beverages, and salad dressing.
Milk and whey protein concentrates, some of which contain lactose as
the primary component, are typically used to increase the protein
content of foods or as salt replacers to reduce the amount of sodium in
a broad range of foods because of their unique salt enhancement
characteristics.
    The comments said that it would not be possible to make foods if
lactose were used as the sole sweetener in the formulation, replacing
the traditional sugar (e.g., sucrose). Lactose has about one sixth of
the sweetness of sucrose. The amount of lactose required to achieve the
same level of sweetness would compromise basic attributes of the
product itself. For example, if lactose were added to a typical ice
cream, the amount of lactose that would have to be added to sweeten the
product would either depress the freezing point of the ice cream mix
such that the product would not be able to freeze under normal
conditions, or if it did freeze, would result in an extremely gritty
texture defect which would make the product unacceptable to consumers.
    One comment said that the common and usual names for dairy
ingredients would cause confusion with added sugars declarations. For
example, according to the comment, we allow manufacturers to identify
skim milk, concentrated skim milk, and nonfat dry milk as ``skim milk''
or ``nonfat milk'' in an ingredients listing. In addition, two nonfat
yogurt products could be formulated to the same final product
composition, and the ingredient statements for both could read ``nonfat
milk and culture.'' However, under the proposed definition of added
sugars, a yogurt made using fluid skim milk as the sole dairy
ingredient would have no added sugars, while a yogurt made using nonfat
dry milk powder as the sole source of dairy solids would have to
declare added sugars on the Nutrition Facts label.
    One comment said that, when dry milk ingredients are added,
consumers may be confused about the source of added sugar in the food
if the food contains no obvious sweetener. For example, if a food with
a dairy-based ingredient, such as nonfat dry milk or whey protein
concentrate, would be required to declare the inherent lactose as added
sugars on the Nutrition Facts label and the food contained no easily
identifiable source of added sugars, consumers reading the ingredient
list likely would not expect or recognize dairy ingredients as sources
of ``added sugars.''
    The comments noted that dairy ingredients containing lactose may be
added so that a dairy product meets the standards for identity. One
comment stated that California's standard for fluid milk mandates
higher milk solids than the Federal standard of identity, requiring the
addition of nonfat dried milk or condensed skim milk containing
lactose. The comment said that the lactose in these milk solids should
not be considered an added sugar because it is not added for sweetening
purposes. The comments also noted that for standardized dairy products
such as milk and yogurt, current regulations do not require that a
sweetener be added. The comments said that the exclusion of dairy-based
ingredients as sweeteners in the standards is acknowledgement by FDA
that the lactose in these dairy-derived ingredients is not primarily
added to provide sweetness.
    (Response) Lactose is a major component of milk solids. Many common
concentrated or dried dairy ingredients, such as nonfat dry milk and
whey powder contain lactose as the primary component. We agree that
many dairy ingredients, even though high in lactose, are not considered
a source of added sugars. Dairy ingredients and nutritive carbohydrate
sweeteners are often considered to be in two separate ingredient
categories during food formulation. The proposed definition of added
sugars captured such dairy ingredients because it included naturally
occurring sugars that are isolated from a whole food and concentrated
so that sugar (in this case lactose) is the primary component. We did
not intend to capture dairy ingredients under this portion of the
definition. Therefore, we have removed the language from the definition
of added sugars stating that naturally occurring sugars that are
isolated from a whole food and concentrated so that sugar is the
primary component are added sugars.
    FDA regulations, at Sec.  168.122, establish a standard of identity
for lactose. The standard of identity for lactose states that it must
contain not less than 98 percent lactose, mass over mass (m/m),
calculated on a dry basis. We have historically considered purified
lactose as a sweetener as it is included in 21 CFR part 168 under
sweeteners and table syrups. We consider lactose as defined in Sec.
168.122 to be an added sugar. Lactose, as defined under Sec.  168.122
would be captured under the definition of added sugars because it is a
free disaccharide. Therefore, with the revised definition, dairy
ingredients, except lactose as defined in Sec.  168.122, are not
included in the definition of added sugars.
(iii) The ``No Added Sugars'' Nutrient Content Claim
    (Comment 210) Many comments argued that the proposed definition is
inconsistent with the regulation for the ``no added sugars'' nutrient
content claim in Sec.  101.60(c)(2) because the regulation recognizes
that ingredients that contain sugars do not preclude the use of the
claim unless the ingredients ``functionally substitute for added
sugars.'' The comments noted that, if the definition of added sugars is
not consistent with the ``no added sugars'' nutrient content claim
regulation, products could conceivably bear ``no added sugars'' claims
but have a gram amount of added sugars declared on the Nutrition Facts
label, which would be confusing and misleading. One comment provided
the example of a juice that is reconstituted from juice concentrate
which meets the Brix standard for single-strength juices. The comment
said that such a product can factually claim that it is
``unsweetened'', but the manufacturer would have to disclose the amount
of added sugars under the proposed rule.
    Other comments noted that in the 1993 preamble to our rule defining
the ``no added sugars'' nutrient content claim, we clarified that
sugars inherent in a product, such as those found in fruit juices,
would not disallow a no added sugars claim. One comment further noted
that we advised that ``the addition of water to a juice concentrate to
produce a single strength juice would not preclude the use of a ``no
added sugar'' claim; however the other conditions for the claim must
still be met'' (see 58 FR 2328). The comment said that this statement
makes it clear that the presence of a fruit juice concentrate in a food
does not prevent the use of a no added sugar claim. Another comment
suggested that, in addition to fruit juice concentrates that are
reconstituted to single strength in 100 percent juices, juice blends,
juice drinks, and juice drink blends also should be excluded from the
definition of added sugars because doing so would align with the
current definition of no added sugars.
    (Response) The comments expressed concern that fruit juice
concentrates added to a single strength juice or dairy ingredients that
are not added for the intended purpose of sweetening can currently bear
the ``no added sugars'' claim, but sugars from the concentrated fruit
juice or dairy ingredient would have to be declared as added sugars

under the proposed definition. We have revised the rule to exclude
certain fruit juice concentrates that are added to juices and that
dilute juice beverages to adjust soluble solids content in accordance
with Sec.  102.33 and the standards of identity in parts 146 and 156.
We are also excluding fruit juice concentrates that are reconstituted
to 100 percent single strength juice. In addition, we have removed the
language from the definition of added sugars which states that
naturally occurring sugars that are isolated from a whole food and
concentrated so that sugar is the primary component are added sugars.
Therefore, dairy ingredients containing lactose, except lactose as
defined in Sec.  168.122, are no longer captured under the definition
of added sugars. With these revisions to the definition of added
sugars, there is no longer a conflict between the definition of added
sugars and the requirements for use of the ``no added sugars'' nutrient
content claim.
    We decline to define added sugars based on the intended purpose of
the ingredient as suggested by the comments because we are providing
specifics of what we consider to be added sugars in the definition. In
addition, in determining which sugars should be included in the
definition of added sugars, we have considered the presence of added
sugars as a component of dietary intake and whether it is consistent
with the concept of empty calories, as discussed in the 2015 DGAC
Report.
(iv) Fruit Jellies, Jams, and Preserves
    (Comment 211) Several comments suggested that fruit jellies, jams,
and preserves not be considered as added sugars. The comments noted
that fruit jellies, jams, and preserves are subject to standards of
identity set forth in Sec.  150.140 and Sec.  150.160 and are
manufactured using certain fruit and fruit juice ingredients in
combination with added sugars. One comment suggested that it is
appropriate for such ingredients, regardless of whether they are
derived from cane sugar, fruit juice syrup, fruit juice concentrates,
etc., to count towards an added sugars declaration when used as
sweeteners. The comment said that characterizing fruit and fruit juices
in jellies, jams, and preserves (before the addition of sweeteners)
should be excluded from the definition of added sugar because they do
not serve as sugar substitutes, and are not ``added'' to a food for
purposes of sweetening a food.
    (Response) The definition of added sugars excludes fruits and 100
percent fruit juices. However, sugars from certain fruit juice
concentrates fall within what we consider to be added sugars. Because
fruit juice concentrates may be used as ingredients in fruit jellies,
jams, and preserves, we have excluded those fruit juice concentrates
that are used in accordance with the standards of identity in Sec.
150.140 and Sec.  150.160 from the definition of added sugars. However,
any additional sugars that are added to the jelly, jam, or preserve
would need to be declared as added sugars on the label.
(v) Dried Fruits
    (Comment 212) Some comments said that dried fruit added to a
product should not be considered to be an added sugar.
    (Response) We agree that dried fruits which have not had any sugar
added to them should not be considered to be an added sugar because
they are essentially a dehydrated whole fruit and still retain the
nutrients and other components of a whole fruit. However, if additional
sugar is added to a dried fruit, the sugar added to the dried fruit
must be declared on the label as added sugars.
(vi) Other Sugars/Sweeteners
    (Comment 213) One comment would exempt isomaltulose and D-tagatose
from labeling as added sugars due to their effect on reducing the risk
of dental caries. The comment said that the proposed declaration for
added sugars would not allow for adequate information to be provided to
the consumer about carbohydrates such as isomaltulose (a disaccharide)
and D-tagatose (a monosaccharide) that are ``sugars'' from a regulatory
standpoint, but at the same time have very different and beneficial
physiological properties than traditional ``sugars.'' The comment noted
that isomaltulose and D-tagatose are noncariogenic carbohydrate
sweeteners, and products containing these sweeteners can bear the
dietary noncariogenic carbohydrate sweeteners and dental caries health
claim if they meet the requirements of Sec.  101.80. The comment also
stated that these dental health benefits of isomaltulose and D-tagatose
can also be the subject of a health claim under EU regulation 432/2012.
The comment said that, aside from the dental health benefits,
isomaltulose and D-tagatose are low-glycemic carbohydrate(s) resulting
in a reduced blood glucose response and that this health effect is the
subject of EU health claim 432/2012. The comment argued that such a
health benefit provides the basis for a structure-function claim under
the FD&C Act.
    (Response) We have recognized through our health claim for
noncariogenic carbohydrate sweeteners and dental caries that the sugars
D-tagatose and isomaltulose may reduce the risk of dental caries (tooth
decay). However, D-tagatose and isomaltulose are chemically sugars.
Because these sweeteners are chemically sugars, and other substances
are included or excluded from the definition of 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 is
consistent with how we have characterized other sugars. As such, we are
not excluding D-tagatose and isomaltulose from the added sugars
declaration. However, manufacturers may still use the noncariogenic
carbohydrate sweeteners and dental caries health claims on their
products to make consumers aware that sugars contained in a food may
reduce the risk of dental caries.
    (Comment 214) Some comments would exclude Allulose (psicose) from
the definition of added sugars because ketohexose sugars, such as
Allulose, do not provide calories, are not metabolized, and do not
raise blood sugar levels.
    (Response) As discussed in our response to comment 124, we received
a petition on this subject after the comment period closed. We intend
to address this issue at a later date when we have had time to consider
the information presented in the petition.
    (Comment 215) Some comments stated that the proposed language,
which states that ``other caloric sweeteners'' are considered added
sugars, is confusing and unclear. One comment provided the example of
applesauce, which can be used to replace oil in baking. In this
example, unsweetened applesauce contains no added sugars, but can be
used to both replace an oil and sweeten baked goods.
    (Response) We agree that the language that states that ``other
caloric'' sweeteners are considered to be added sugars may not be clear
to manufacturers or consumers. We have removed this language from the
definition of added sugars because caloric sweeteners, which are
chemically sugars, are free mono or disaccharides and are captured
elsewhere in the definition.
(vii) Other Comments
    (Comment 216) Some comments noted that ingredients such as fruit
juice concentrates, high fructose corn syrup, honey, and molasses
contain significant amounts of water (e.g., 30 percent). The

ingredients may contain a range of naturally occurring constituents
besides sugars (e.g., polysaccharides, anthocyanins, vitamins,
minerals, etc.). Therefore, to avoid overstating the amounts of added
sugars, the comments said that it is important to take into account the
actual ``sugars'' content of the ingredients. The comments suggested
adding language to clarify that the quantity of added sugars declared
in labeling will include only the actual ``sugars'' portion of the
ingredient.
    (Response) We agree that some ingredients containing sugars, such
as syrups, contain water and other components that are not sugars, and
that those components should not be considered as part of the added
sugars declaration. Therefore, when such ingredients are included in
foods, only the sugar portion of the ingredient should be declared on
the label. The definition of added sugars states that free mono and
disaccharides are considered added sugars, thus water and other
components of sugar-containing ingredients are not added sugars and
should not be declared as such. We have also revised the definition to
say ``sugars from syrups'' to clarify that only the sugars component of
the product should be declared as added sugars.
    (Comment 217) Several comments would not consider natural sources
of sugar (e.g., honey or maple syrup) to be added sugars. One comment
would exempt natural, unrefined honey and other natural liquid or semi-
liquid, unrefined, un-concentrated, whole-food sweetening agents
because they are whole food products in an unrefined, un-concentrated,
whole-food form. Conversely, the comment suggested that other
sweeteners which are extracted, refined, and concentrated such as agave
syrup, maple syrup, and evaporated cane juice syrup should be
considered added sugars.
    (Response) We disagree that all natural sources of sugar which have
not been processed or refined should not be considered added sugars. In
determining which sugars should be included in the definition of added
sugars, we have considered the presence of added sugars as a component
of dietary intake and whether it is consistent with the concept of
empty calories, as discussed in the 2015 DGAC Report. The processing
history (e.g., concentration or refinement) does not entirely determine
whether or not sugar in an ingredient is added sugar. For example,
natural sources of sugar present in foods, such as whole fruits, 100
percent juice, and dried fruits, are not considered added sugars
because these foods are nutrient rich. However, products such as maple
syrups or honey are included in the ``empty calories'' or ``calories
for other uses'' category in the USDA Food Patterns. Therefore, we
decline to exclude sugars from honey and maple syrup from the added
sugars definition.
    (Comment 218) One comment stated that consistency is needed in the
definition of added sugars across Federal Agencies as well as by
scientists, health professionals, manufacturers, and others. The
comment identified fruit juice concentrate as one example of
inconsistency among Federal Agencies. The comment cited a paper on the
development of USDA estimates of added sugars (Ref. 123).
    (Response) When establishing a regulatory definition for the
purposes of nutrition labeling, we consider other regulatory aspects
such as the impact on other regulations. We expect that establishing a
regulatory definition of added sugars for the purpose of nutrition
labeling will help other Federal Agencies and the scientific community
in determining a definition for added sugars for Federal guidelines,
programs, and research.
    (Comment 219) One comment would not consider incidental additives
or flavors containing sugars, such as dextrose, which are not added for
sweetness as added sugars.
    (Response) The comment did not explain what ``incidental
additives'' are. However, we disagree that dextrose should be excluded
from the definition of added sugars. Dextrose is a sugar, and, when
added to a food, it acts in the same manner as other types of added
sugars.
    (Comment 220) Some comments said it will be difficult for
manufacturers to obtain information about added sugars content of
sourced ingredients that they get from suppliers. The comments
questioned whether ingredients used in the formulation that are not an
isolated sugar but are part of a compound ingredient must be labeled.
One comment noted that, aside from the ingredients used in traditional
food processing, there are ingredients that are used in ``better for
you'' formulated foods that would be required to be listed on the
label.
    (Response) The added sugars declaration in the finished product
includes added sugars present as sub-ingredients. For example, if a
cookie product uses strawberry jams as an ingredient, the added sugar
present in the strawberry jam would count towards the added sugars
declaration for the finished cookie product. Manufacturers need to
collect nutrient information for ingredients in their products from
suppliers. Manufacturers have the ability to select which suppliers
they use. If a supplier is not willing or able to provide information
about the added sugars content of an ingredient, the manufacturer may
wish to consider another supplier.
    With respect to the comment suggesting that manufacturers may have
difficulty obtaining information about the added sugars content of
``better for you'' formulated foods, manufacturers need to obtain
information about the added sugars content of all ingredients in order
to provide accurate labeling, regardless of whether they are used to
formulate ``better for you foods.''
    (Comment 221) One comment would expand the added sugars definition
to encompass all added sweeteners.
    (Response) It is not clear from the comment which sweeteners that
the comment is suggesting are not included in an added sugars
declaration. Therefore, we are not revising the added sugars definition
in response to the comment.
    o. Establishing a DRV and mandatory declaration of the percent DV
for added sugars.
(i) Mandatory Declaration of a Percent DV and Whether a DRV Should Be
Established
    (Comment 222) Many comments both to the proposed rule and the
supplemental proposed rule discussed establishing a DRV that can be
used to calculate a percent DV for added sugars as well as a mandatory
declaration of a percent DV for added sugars on the label. Most
comments favored establishing a DRV and requiring the percent DV
declaration of added sugars. Many comments to the proposed rule
recommended establishing a DRV for added sugars of 10 percent of
calories, and provided several rationales to justify the suggested DRV.
The comments said that, since the 1977 Dietary Goals, health officials
have consistently recommended an upper limit of 10 percent of calories
from added sugars. The comments referred to the WHO recommended limit
of 50 grams or 10 percent of total calories from added sugars and the
American Heart Association recommendation to limit added sugars
consumption to 25 grams per day for women and 37.5 grams per day for
men. The comments also noted that the 1992 USDA Food Guide Pyramid
suggested an upper limit of 6, 12, and 19 teaspoons of sugars,
respectively, for diets of 1,600, 2,200, and 2,800 calories,
respectively. This comes to 7, 10, and 13 percent of calorie

intake, respectively, for an average of 10 percent of total calories
from added sugars. One comment said that the 2010 DGA stated that no
more than 5 to 15 percent of calories should come from a combination of
solid fats and added sugars. The comment stated that this implies that
added sugars should be less than 10 percent of calories. Another
comment quoted a pediatric endocrinologist who says that a ``dose'' of
added sugars of up to 50 grams a day poses little risk for metabolic or
chronic disease, but that the amount consumed by Americans is toxic.
    One comment to the proposed rule suggested that the discretionary
calorie allowance from the USDA Food Patterns presented in the 2005 DGA
could serve as a basis for a DRV. The comment suggested that, using the
food patterns provided in the 2005 DGA at the 2,000 calorie level, one
would have a limit of 267 discretionary calories to use on solid fats
and added sugars (assuming no alcohol consumption). The discretionary
calorie allowance could be divided equally between solid fats and added
sugars resulting in a limit of no more than 133 calories, 33 grams, or
8 teaspoons of added sugars per day. This would result in a DRV for
added sugars of 6 percent of total calories.
    Other comments in favor of a percent DV declaration suggested that
a percent DV declaration is necessary for consumers to be able to put
the amount of added sugars in a serving of a food into the context of
their total daily diet. The comments said that, without a DV, consumers
could only compare the relative amounts of added sugars among products,
but would not know how much of a day's worth of added sugars a food
contains. The comments said that the percent DV advises the consumer of
how much of a recommended intake of that nutrient is provided by a
particular food. The comments also suggested that a percent DV
declaration could help parents and other caregivers make informed
decisions about the food products children consume and be more
confident that their intake of added sugars does not exceed healthy
daily limits. One comment provided survey data showing that consumers
would like to have a DV for added sugars on the label.
    Many comments supporting a mandatory declaration of a percent DV of
added sugars also suggested that the information is necessary because
added sugars consumption is associated with the risk of chronic
diseases and health-related conditions such as diabetes, CVD, and
metabolic syndrome.
    One comment noted that the 2014 IOM workshop summary on Health
Literacy and Health Numeracy documents that most Americans have limited
numeracy skills, and disparities exist in those skills. The comment
further stated that providing simpler, clearer food labeling
information is needed to reach a larger segment of the population, and
suggested that providing a percent DV declaration may be an easier way
for consumers with limited numeracy skills to understand an added
sugars declaration.
    In contrast, many comments opposed establishing a DRV for added
sugars and the mandatory declaration of a percent DV for added sugars.
The comments said there is no scientific basis upon which to base a DRV
for added sugars. Other comments said that we should not establish a
DRV for added sugars or require the percent DV declaration for added
sugars because the declaration of any information related to added
sugars is not scientifically supported. The comments' rationale relates
to our basis for requiring an added sugars declaration, and we address
those topics are provided elsewhere in this part.
    The comments also opposed the mandatory declaration of a percent DV
for added sugars because sugars are converted to other products during
processing (caramelization, Maillard browning, and fermentation), and
thus the amount declared on the label may be inaccurate for some
products. (We respond to comments pertaining to non-enzymatic browning
and fermentation in part II.H.3.k and have determined that it is
possible for manufacturers of products which undergo these chemical
reactions to provide a reasonable approximation of the amount of added
sugars in a serving of their product.)
    Many comments also said that added sugar is not a necessary
nutrient and should be avoided or should not be consumed in any amount.
The comments said that it is inappropriate for us to recommend the
consumption of any amount of added sugars in the diet. One comment
suggested that added sugars should be viewed similarly to trans fats
because they are not essential in the diet and are detrimental to
health. The comment said that we should not set a recommended level of
added sugars because, like trans fats, Americans should be consuming as
little added sugars as possible in their diet.
    One comment said that a percent DV declaration for added sugars
just confuses the public, many of whom have diabetes, and should be
focused on their intake on total carbohydrates rather than sugars or
added sugars. Another comment said that, because there are no studies
which support the proposed value, if the value is determined to be
incorrect at a future date, it will remain in the public's mind long
after it has been proven to be incorrect.
    (Response) Consumers need to know how much added sugars are in a
serving of a product in order to maintain healthy dietary practices. As
discussed in part II.H.3, our rationale for the declaration of added
sugars for the general U.S. population is focused on assisting
consumers in maintaining healthy dietary practices by providing the
information that consumers need to construct a healthful dietary
pattern that meets nutrient needs within calorie limits and is
associated with a decreased risk of chronic disease. While the gram
declaration for added sugars gives consumers the information that they
need to construct a healthy dietary pattern that is low in added
sugars, it does not provide the information that they need in order to
put the amount of added sugars in a serving of a product in the context
of their total daily diet. The gram amount of added sugars also does
not give consumers the information that they need to determine if a
food is relatively high or relatively low in added sugars or a frame of
reference that they can use to determine how to include a food in their
overall diet. The percent DV declaration provides that missing piece of
information that will allow consumers to more easily compare products
and determine the relative contribution that a serving of a food will
provide towards their diet.
    After publication of the proposed rule, the 2015 DGAC recommended
that Americans limit their consumption of added sugars to a maximum of
10 percent of total calories (Ref. 19). The 2015 DGAC based this
recommendation on modeling of dietary patterns, current added sugars
consumption data, and a published meta-analysis on sugars intake and
body weight. We considered the evidence that the 2015 DGAC relied on in
making this recommendation, and tentatively concluded in the
supplemental proposed rule that limiting consumption of added sugars to
10 percent of daily calories is a reasonable goal for consumers to
achieve and would assist consumers in choosing and maintaining a
healthful dietary pattern. We proposed to require the mandatory
declaration of a percent DV for added sugars, and we proposed a DRV of
50 grams for added sugars for children and adults 4 years of age and
older from which the percent DV can be calculated. The DRV of 50 grams
is determined by first multiplying the 2,000 reference calorie intake
by 10

percent (2,000 x 0.1 = 200 calories) and then by dividing the resulting
200 calories by 4 calories per gram for carbohydrates (200 / 4 = 50
grams). We proposed a DRV of 25 grams of added sugars for children 1
through 3 years of age. A 1,000 calorie reference amount would be used
to calculate the DRV for children under the age of 4 (1,000 calories x
0.1 = 100 calories and 100 calories / 4 calories per gram for
carbohydrates = 25 grams).
    Before proposing a DRV for added sugars, we considered the
approaches suggested in comments to the proposed rule for establishing
a DRV of 10 percent of total calories for added sugars, but declined to
accept the comments' various approaches for supporting a DRV of 10
percent of calories from added sugars because the approach provided a
recommended limit for added sugars, which was not based on total added
sugars information (e.g. the WHO recommendations which are based on
``free sugars'' and include fruit juices), because it is not clear how
the recommended limits were derived and whether they were based on any
scientific data or evidence (i.e., AHA recommendation and
recommendation from an endocrinologist), or because the 2015 DGAC
provided updated USDA Food Patterns that are specific to added sugars,
unlike previous editions of the USDA Food Patterns included in the
1992, 2005, and 2010 DGAs.
    With respect to the comments suggesting that we do not have a
scientific basis to establish a DRV for added sugars, we have a
recommended limit for added sugars of no more than 10 percent of total
calories that was developed using food pattern modeling. We address
these issues later in this part.
    We want to clarify that the DRV for added sugars should not be
viewed as a recommended amount for consumption. The percent DV
declaration for nutrients, which is calculated based on the DRV or RDI,
represents a reference value that serves as a general guide to
consumers. It would be inappropriate to view all DRVs and RDIs as
recommended amounts to consume because some are based on amounts to
limit (e.g., sodium and saturated fat) while others are based on
amounts that individuals should strive to consume (e.g., calcium and
potassium). Furthermore, individuals have varying nutrient and calorie
needs, so consumers may need more or less of a particular nutrient
based on their specific nutrient needs. As such, consumers with higher
calorie needs can consume more added sugars in their diet relative to
individuals with lower calorie needs.
    While consumers are interested in seeing a DV for added sugars on
the label, as discussed in part II.C.1, consumer interest alone cannot
be used to justify a label declaration. There is a need for a percent
DV declaration for added sugars so that consumers can put the amount of
added sugars in a serving of a product into the context of their total
daily diet so that they can meet nutrient needs within calorie limits
and construct a healthy dietary pattern that is associated with a
reduced risk of CVD.
    We disagree with the comment suggesting that we should take the
same approach that we have taken with trans fat and not establish a DRV
for added sugars because Americans should be consuming as little added
sugars in their diets as possible. The current evidence on added sugars
does not show a linear relationship with chronic disease risk, and
therefore, the evidence does not support limiting added sugars to as
little in the diet as possible, similar to current recommendations for
trans fat. In fact, individuals can carefully incorporate limited
amounts of added sugars into a healthy diet. The USDA Food Patterns
suggest that individuals who need between 1,000 and 3,200 calories per
day can reasonably consume between 4 to 9 percent of their calories
from added sugars and still meet their nutrient needs within calorie
limits.
    As for the assertion that a percent DV declaration for added sugars
will confuse the public, the comments did not provide evidence to
support the assertion. Some comments submitted consumer research that
included a percent DV declaration for added sugars in the labels, and
the participants were shown the percent DV declaration. However, the
research did not isolate the effect of the percent DV declaration from
that of the gram amount declaration, so it is not possible to determine
if the effects seen in those studies were due to confusion about a
percent DV declaration for added sugars or more generally about
information on the label related to added sugars. Other consumer
research showed that participants reported similar responses about
percent DV declarations for saturated fat and for added sugars, which
suggests that a percent DV declaration for added sugars may not have
specifically caused the confusion shown in the research. In both cases,
it is unclear what conclusions related to confusion about a percent DV
declaration for added sugars can be drawn from the evidence provided in
comments.
    With respect to the suggestion that, if the DRV for added sugars is
determined to be incorrect later, the DRV will remain in the public's
mind long after it has been proven to be incorrect, a change in the
science related to added sugars in the future should not prevent us
from establishing a DRV at this time that is based on currently
available evidence. Science evolves over time, and it is possible that
we could have additional evidence in the future that would lead us to
re-evaluate the DRV for added sugars. In fact, we are updating DRVs and
RDIs for a number of different nutrients on the label based data and
information that has become available since 1993.
    (Comment 223) Some comments to the proposed rule recommended that
we commission the IOM to review the evidence and recommend a figure
that could be used as the basis for a DV. The comments suggested that a
quantitative limit will help consumers reduce added sugars by giving
them a specific target or goal to work towards.
    (Response) We have evidence that added sugars are a public health
concern, and a percent DV declaration that is calculated based on a DRV
for added sugars will assist consumers in putting the amount of added
sugars in a serving of a product into the context of the total daily
diet. We also have scientific evidence to support limiting calories
from added sugars to less than 10 percent of calories that can be used
to establish a DRV. We are acting on the evidence that we currently
have available to us because a percent DV declaration for added sugars
is important to assist consumers in maintaining healthy dietary
practices.
    (Comment 224) Some comments opposed establishing a DRV and
requiring the mandatory declaration of a percent DV for added sugars
when we have not established a DRV for total sugars. The comments said
that establishing a DRV and requiring the percent DV declaration for
added sugars without a DRV or percent DV declaration for total sugars
will cause confusion. One comment questioned our conclusion that there
is adequate evidence to establish a DRV for added sugars but not total
sugars, especially when much data used to support the declaration of
added sugars was based on research looking at total sugars. Another
comment said that a percent DV declaration for total sugars is more
important than one for added sugars because a percent DV for added
sugars does not represent the true caloric or metabolic contributions
of sugars to a food product.

    (Response) As discussed in the preamble to the proposed rule (79 FR
11879 at 11902), we do not have a reference value upon which we can
derive an appropriate DRV for total sugars. The IOM has not set a UL
for sugars. We also do not have scientific evidence to support a
reference value for total sugars from another U.S. consensus report.
However, we have considered the scientific evidence that supports the
2015 DGAC recommendation (which we note is also included in the 2015-
2020 DGA) to limit calories from added sugars to no more than 10
percent of calories. Although this reference level is different than
other scientifically supported quantitative intake recommendations that
have been used to establish DRVs and RDIs for other nutrients, it was
derived from food pattern modeling of a healthy dietary pattern that is
low in added sugars. We are focusing on what healthy dietary patterns
look like and what information is needed for consumers to construct a
healthy dietary pattern. The USDA Food Patterns that support limiting
consumption of calories from added sugars to less than 10 percent of
calories per day, are examples of the type of healthy dietary pattern
that consumers could use to reduce their risk of disease. Therefore,
although a limit of calories to no more than 10 percent of calories
provides a reference value that is different than other scientifically
supported quantitative intake recommendations, it was derived using a
dietary pattern approach, which is consistent with our basis for
requiring the declaration of added sugars on the label.
    In response to the comments suggesting that consumers will be
confused if there is a percent DV declaration for added but not total
sugars, the comments did not provide data or other information to
support this assertion. A declaration of the gram amount of sugars has
been on the label for over 20 years without a declaration of a percent
DV for sugars, so consumers are familiar with the information that will
be on the label for total sugars.
    With respect to the comment stating that it is more important to
require a percent DV declaration for total rather than added sugars
because a percent DV for added sugars would not represent the true
caloric or metabolic contributions of sugars to a food product, we have
concluded that consumption of too many added sugars has health
implications. Consumers need specific information on how much added
sugars is in a serving of a product and the contribution that a serving
of a product makes towards the total daily diet.
    To the extent that comments are suggesting that we should be able
to establish a DRV for total sugars because much evidence which is
being used to support an added sugars declaration is on total sugars,
we disagree. Total sugars includes both naturally occurring and added
sugars. Although a small number of the studies that we are relying on
to support an added sugars declaration included fruit juices, which
contain naturally occurring sugars, the vast majority of the evidence
was on only added sugars, or on foods and beverages to which sugars
have been added. Furthermore, we are basing the DRV on food pattern
modeling and not on the Chapter 2 analysis related to dietary patterns
and health outcomes.
    Although we do not currently have a reference value that can be
used to establish a DRV for total sugars, information could become
available in the future that may cause us to reconsider.
    (Comment 225) One comment said that we should not require a percent
DV declaration for added sugars because other countries have evaluated
added sugars and have concluded that the declaration of added sugars
should not be mandatory as there is little evidence to support such
identification.
    (Response) We address similar comments related to the declaration
of the gram amount of added sugars on the label in part II.H.3.
    (Comment 226) Some comments suggested that additional research
needs to be conducted to determine how much added sugars is harmful
before establishing a DRV for added sugars or requiring a percent DV
declaration on the label.
    (Response) We disagree that additional research on added sugars
should be conducted before we establish a DRV for added sugars or to
require a percent DV declaration on the label. Although a linear
relationship has not been established between added sugars intake and
risk of disease upon which a UL can be based, we do have evidence
showing that consumption of too much added sugars is harmful to health.
We also have scientific evidence that supports limiting added sugars
consumption to less than 10 percent of calories that includes modeling
of healthy dietary patterns.
    (Comment 227) One comment, as part of its argument that the
declaration of added sugars information is not material and provides no
added importance to consumer product purchase or use decisions, stated
that, based on its own research of our eye-tracking study data,
participants spent statistically significantly less time on added
sugars than on carbohydrate on the Proposed label and spent
statistically the same amount of time on carbohydrate and added sugars
on the Proposed label as that on carbohydrate on the Current label. The
comment also asked how we made the distinction between participants'
attention on carbohydrate and on added sugars on the proposed label.
Another comment questioned whether adding percent DV for added sugars
will increase consumer attention to the added sugars declaration,
including the percent DV for added sugars. The comment stated that,
although percent DV for added sugars was not specifically tested in our
eye-tracking study, the study showed that: (1) There were no
statistically significant differences between the current and the
proposed formats in the proportion of participants who noticed percent
DV information or the share of time they spent on the information; and
(2) the added sugars declaration received relatively little attention
(on the proposed label). The comment concluded that these results
suggest that the percent DV information receives low priority from
consumers or the information is not prominent or easy to understand and
it is not clear if including the percent DV for added sugars will
enhance consumer attention to the added sugars declaration.
    (Response) We disagree that our eye-tracking study findings on the
percent DV information and on added sugars declaration mean that adding
percent DV for added sugars will not increase consumer attention to the
added sugars declaration. Our study did not include a percent DV for
added sugars on any labels tested, did not compare participants'
responses to a label with a percent DV declaration for added sugars and
responses to a label without such a declaration, and did not examine
participants' attention to this percent DV information. Therefore, the
cited findings cannot be used to infer the amount of attention the
percent DV for added sugars would receive by consumers if and when it
is present on labels. We also disagree that one can infer from our eye-
tracking study findings that an added sugars declaration, including the
percent DV, is of no value to consumers. Our decision to require the
declaration is not determined by how much attention it receives from
the study participants. Instead, we are requiring the declaration of
added sugars on the label because consumers need the information in
order to maintain healthy dietary

practices. We clarify that, in our eye-tracking study, the label
element ``carbohydrate'' on the Proposed label included these areas of
the label: Total carbohydrate, dietary fiber, sugars and protein.
``Added sugars'' was considered in the study as a separate area on the
label.
(ii) DRV of 10 Percent of Total Calories From Added Sugars
    In the supplemental proposed rule, we proposed to establish a DRV
for added sugars of 10 percent of total calories (50 grams for children
and adults 4 years of age and older and 25 grams for children 1 through
3 years of age). The scientific evidence from the 2015 DGAC Report
supports Americans keep added sugars intake below 10 percent of total
energy intake, based on modeling of dietary patterns, current
consumption data, and a published meta-analysis on sugars intake and
body weight (80 FR 44303 at 44308). We concluded that the scientific
information from the 2015 DGAC Report provides a basis for FDA to
establish a DRV for added sugars. The 2015 DGAC relied on both food
pattern modeling information from the USDA Food Patterns as well as
information from the Te Morenga et al. paper for their recommendation
to limit added sugars to a maximum of 10 percent of total daily caloric
intake.
    (Comment 228) One comment cited work sponsored by ILSI North
America that suggests a lack of strong evidence for a dietary
recommendation to limit added sugars to no more than 10 percent of
calories. The comment cited reviews by ILSI North America related to
dental caries and BMI which led it to conclude that frequency of
consumption of fermentable carbohydrates is a driver of dental caries
along with oral hygiene, exposure to fluoride, and salivary flow and
composition and that sustained overconsumption of energy, irrespective
of the energy sources, leads to weight gain. The comment concluded from
the evidence reviewed that the scientific evidence is lacking with
respect to quantifying a level of sugar or added sugar relative to
health outcomes.
    (Response) The comment provided a review of the evidence related to
a specific relationship between intake of added sugars and risk of
disease. As discussed in our response to comment 224, we are
establishing a DRV for added sugars using a different type of intake
recommendation than what has been used for other nutrients with a
linear relationship with disease risk, which was developed primarily by
food pattern modeling. Our rationale for requiring the mandatory
declaration of added sugars relates to consuming a healthy dietary
pattern that meets nutrient needs within calorie limits and is
associated with a decreased risk of chronic disease. The food pattern
modeling that was done for the USDA Food Patterns provides a conceptual
framework for selecting the kinds and amounts of foods of various
types, which together, provide a nutritionally satisfactory diet.
Therefore, the scientific evidence that supports limiting calories from
added sugars to less than 10 percent of calories per day that was
derived from food pattern modeling is related to our basis for
requiring the mandatory declaration of added sugars for the general
population, which is focused on consumption of a healthy dietary
pattern.
    (Comment 229) Several comments recommended that the IOM re-evaluate
the added sugars intake recommendations. The comments said that the IOM
is the appropriate body to establish a DRI upon which to base a DRV for
added sugars because:
     The scope of work for the IOM DRI committees is
specifically to develop the DRIs, which are intended to inform
nutrition labeling;
     The DRI process provides a rigorous and methodological
process to determine nutrient values used in nutrition labeling and
includes guidance on when a percent DV may be established;
     The IOM DRI considers the risks of adverse effects
associated with low as well as high nutrient intakes;
     The IOM adheres to a structured risk assessment approach
to ensure that the evidence is systematically and consistently
evaluated; and
     The IOM ensures and fosters transparency in decision-
making.
    The comments said that we have based all other DRVs on the IOM DRI
reports. The comments noted that more than a decade has passed since
IOM concluded in 2005 that, based on the data available on dental
caries, behavior, cancer, risk of obesity, and risk of hyperlipidemia,
there is insufficient evidence to set a daily intake for total and
added sugars or to set an upper limit for added sugars. The comments
said that the process the DGAC used to develop its recommendations did
not have the scientific rigor of the IOM process. The comments
recommended that we defer any final rule, especially changes related to
the declaration of added sugars, until the IOM can review the available
evidence and develop a DRI for added sugars.
    (Response) While the IOM has been the source of data that we have
relied upon when setting other DVs, it is not the only source of
information on which we can rely. While we recognize that a DRV that is
derived primarily based on food pattern modeling is different from a UL
that is determined by IOM, a DRV based on food modeling is a valid
approach that provides consumers with a tool that they can use to help
them put the amount of added sugars in a serving of a product into the
context of their total daily diet. In response to the comments
suggesting that the process that is used by the IOM to set ULs is more
scientifically rigorous than food pattern modeling, the IOM process is
different than food pattern modeling, but we have the ability to use
different approaches to set DRVs based on the information we have
available to us if the information will assist consumers in maintaining
healthy dietary practices.
    We also disagree with the comment stating that all other DRVs were
established based on IOM DRI reports. Some DRVs were set based on
scientific evidence from consensus reports or by other means. In the
Reference Daily Intakes and Daily Reference Values proposed rule, we
proposed to establish eight DRVs for persons 4 or more years of age
based on information presented in the ``Diet and Health: Implications
for Reducing Chronic Disease Risk report,'' the ``Surgeon General's
Report on Nutrition and Health,'' and the ``Report of the Expert Panel
on Population Strategies for Blood Cholesterol Reduction'' (55 FR 29476