(Comment 150) Some comments said that the evidence related to
healthy dietary patterns characterized, in part, by lower intakes of
sugar-sweetened foods and beverages is not strong and questioned
whether we relied on the DGAC's analysis and conclusion rather than
doing our own analysis of the studies.
    (Response) We reviewed and considered the evidence that was
considered by the 2015 DGAC when making their conclusions in Chapter 2
of the 2015 DGAC Report. We concluded based on that review and
consideration of the evidence that strong and consistent evidence
demonstrates that healthy dietary patterns are characterized by higher
consumption of vegetables, fruits, whole grains, low-fat dairy, and
seafood, and lower consumption of red and processed meat, and lower
intakes of refined grains, and sugar-sweetened foods and beverages.
    The comments that said that the data does not support a strong and
consistent relationship with CVD risk were looking at the data in more
limited way than we have. They focused their review on a specific
nutrient-disease relationship whereas we considered the whole of the
dietary pattern. Some comments included conclusions from their own
review of the evidence. In those comments, studies were excluded based
on whether the dietary quality index used in each study included a
measure of added sugars, whether the studies were conducted in the
United States, whether a component analysis for a measure of added
sugars was conducted, and whether that analysis showed an association
with CVD risk. As previously discussed in our responses to comments 147
and 148, we do not agree that it is appropriate to discount studies
from the body of evidence considered based on these factors and have
looked at the data and the dietary pattern as a whole rather than a sum
of its parts.
    (Comment 151) One comment questioned the scientific validity of
using hypothesis-based dietary pattern scores for determining health
outcomes. The comment said that the use of adherence scores, cluster or
factor analysis as a science-based measure for predicting health
outcomes is flawed and not an accepted scientific methodology. The
comment provided an example where an analysis based on dietary pattern
scores showed that individuals with higher adherence to the dietary
pattern of interest compared to individuals with lower adherence
actually had an almost 300 percent increased chance of dying from CVD,
which is an incorrect conclusion (Ref. 92).
    (Response) The use of this type of scientifically valid approach to
looking at complex relationships between dietary patterns at health
endpoints is being used by well-established scientific bodies. In fact,
some of the dietary quality scoring indices were developed by Federal
Agencies (e.g., the HEI). Although this is the first time that the DGAC
has conducted a systematic review of the evidence related to dietary
patterns and health outcomes, the use of diet quality indexes to look
at an association between dietary patterns and health outcomes is not
new. For example, the USDA's Center for Nutrition Policy and Promotion
created the HEI in 1995. Dietary pattern analysis is becoming more
widely accepted in the scientific community because there has been a
shift in recent years from focusing on nutrients and their association
with disease risk to a dietary pattern approach that considers the fact
that individuals do not eat nutrients or foods in isolation. The 2015
DGAC based their conclusions and recommendations on the results of this
type of analysis to look at dietary patterns as a whole rather than
specific nutrient and disease relationships, and the DGAC uses
scientifically valid approaches that are widely accepted in the
scientific community.
    Other comments suggested that the use of dietary pattern indices to
assess the relationship between dietary patterns and health outcomes is
flawed for specific reasons. We address those issues in our responses
to comment 143.
    (Comment 152) Several comments cited a number of limitations of how
the dietary intake data was collected in studies included in the
analysis. The comments cited a number of criticisms of the use of Food
Frequency Questionnaires (FFQs), which were used in the observational
studies included in the analysis to assess adherence to scoring
patterns. The comments suggested that added sugars are poorly measured
by FFQs. Another limitation of FFQs mentioned in comments is that they
are based on self-report and may introduce levels of report bias that
can attenuate diet-health relationships. The comments stated that the
extent to which data from FFQs are valid measures of dietary patterns
is not well established. One comment said that FFQs are not designed to
assess absolute intakes of foods, and when used only at baseline, the
assumption is that intake does not change over several years, when
health outcome is measured. The comment also said that FFQs provide
little information on how the food was prepared.
    Other comments said that the dietary patterns do not assess the
frequency of meal and snack consumption, specific combinations of foods
consumed together, and aspects of food purchase and preparation, all of
which may influence an overall dietary pattern.
    One comment said that fats and oils are spread across food groups,
making them difficult to account for.
    (Response) FFQs are a relatively efficient and cost effective way
to collect information about usual intakes in a large population study,
which is why they are often used to assess intake in large-scale cohort
studies. FFQs are often used in studies because they are inexpensive,
can be self-administered, take less time for participants to

complete compared to other dietary assessment methods, and can be read
by machines rather than being hand-entered and analyzed (Ref. 93).
Although there may be more precise ways to assess dietary intake
patterns, other intake methods, such as multiple 24-hour recalls are
often less practical for use in large population studies. There are
many advantages to having a larger sample size when evaluating habitual
intake, which can provide robust results (Ref. 94). FFQs have been
shown to be reasonably accurate in reporting food use (Ref. 93). FFQs
also provide a better estimate of usual intakes that can be used to
assess dietary patterns because they assess intake over a longer period
of time than other dietary assessment techniques, such as 24-hour
recalls, diet histories, and dietary records. FFQs are also almost
always used in retrospective reports about diet (Ref. 95). We accept
the use of data from FFQs in observational studies used to support an
association between a substance and a disease or health-related
condition for health claims (Ref. 85).
    We recognize that there are some limitations to the use of FFQs,
and that one limitation is that in many of the studies FFQs were only
administered at baseline. FFQs do not assess the frequency of meal and
snack consumption, specific food combinations, and food preparation.
Dietary pattern analysis considers combinations of foods and how they
relate to health outcomes, but questions about the frequency of meal
and snack consumption, specific food combinations, and food preparation
would require a more specific analysis. Like other types of dietary
assessment, this type of analysis can only be used to draw general
conclusions about what components are included in a dietary pattern
that is associated with risk of disease and the relative contribution
(higher or lower) of that dietary component to the overall dietary
pattern. Further analyses would be required to answer questions related
to frequency of meal and snack consumption, specific food combinations
that may associated with disease risk, and specific aspects of food
preparation.
    Fats and oils are spread across food groups, which make them more
difficult to account for; however, we are most interested in sugar-
sweetened food and beverages and how they fit into the dietary pattern.
Sugar-sweetened foods and beverages can be isolated from the diet by
the dietary assessment tools used in the studies included in the
dietary pattern and health outcomes analysis.
    (Comment 153) One comment said that the observational data used in
these studies, and the way that they are analyzed, make the findings
highly subjected to residual confounding (error that can occur when
either the categories of the variables related to the outcome of
interest (e.g. CVD risk), called confounding variables, are too broad
or when some confounding variables are not accounted for). The comment
said that even with adjustment for confounders, residual confounding
cannot be eliminated from observational studies. More specifically,
higher/better dietary index scores were associated with a number of
factors, such as higher education, increased physical activity,
non[hyphen]smoker, multivitamin use, hormone therapy (women), and being
married vs. single.
    (Response) Residual confounding is a general limitation of all
observational studies and is not specific to just this type of
analysis. The comment did not provide specifics about individual
studies for which confounders were not appropriately adjusted.
Therefore, the comment does not change our consideration of the data.
    (Comment 154) Some comments said that the patterns may be
population-specific and therefore, are not generalizable. The comments
also noted that some studies were not conducted in the United States
and suggested that these studies cannot be used to draw conclusions
about the general U.S. population.
    (Response) We agree that patterns may be population-specific;
however, care was taken to include studies conducted in populations
that were very similar to the U.S. population (e.g. countries in the
E.U.) and that data was collected in populations that would be
generalizable to the U.S. population (Ref. 19).
    (Comment 155) Some comments said that the NEL project based its
conclusions only on those studies where score adherence was associated
with decreased CVD risk, leaving all of the studies showing no effect
out of the analysis.
    (Response) We disagree with the comment that the NEL and the 2015
DGAC based their conclusions only on studies where score adherence was
associated with decreased CVD risk. As stated in the 2015 DGAC Report,
after the exclusion criteria were applied, a total of 55 studies met
the inclusion criteria for the systematic review. The NEL found that
the majority of the 55 studies that assessed CVD incidence or mortality
reported an inverse association between increased adherence to a
healthy dietary pattern and decreased risk of CVD. The NEL considered
the results of all 55 studies rather just a subset where score
adherence was associated with a decreased CVD risk.
c. Authority for Labeling
(i) Statutory Authority
    (Comment 156) Many comments addressed our authority to require the
mandatory declaration of added sugars on the label. We discuss our
authority under the FD&C Act and our recordkeeping authority in parts
II.C.3 and C.4.
    Many other comments questioned our authority to require added
sugars on the label because the purpose of the Nutrition Facts label is
to help consumers reduce their risk of diet-related disease and added
sugars are not associated with risk of disease. One comment noted that
each of the nutrients currently on the label relate to a disease or
serious health condition. Other comments said that we lack the
authority to require the disclosure of added sugars because our
rationale for requiring labeling, which is related to encouraging
consumers to eat a more nutrient-dense diet or dietary planning, is by
our own admission not related to a disease or health-related condition,
such as obesity.
    One comment suggested that, because there is no scientifically
supported quantitative intake recommendation for added sugars upon
which a DRV can be derived and because no authoritative scientific body
has found a public health need to set an Upper Level (UL) for added
sugars intake, we have not sufficiently shown that there is a public
health need to monitor added sugars intake through labeling for
consumers to maintain healthy dietary practices. The comment further
stated that our admission in the proposed rule that we cannot establish
a DV for added sugars further indicates that added sugars is not the
type of nutrition disclosure that Congress intended for the Agency to
require on the label.
    (Response) As discussed in part II.C.3, under section 403(q)(2)(A)
of the FD&C Act, the Secretary of the Department of Health and Human
Services may require, by regulation, that information related to
additional nutrients be included in the label or labeling of food, if
the Secretary determines that providing information regarding the
nutritional value of such food will assist consumers in maintaining
healthy dietary practices. The FD&C Act requires that nutrition
information on

the label be conveyed to the public in a manner which enables the
public to readily observe and comprehend such information and to
understand its relative significance in the context of the total daily
diet. There is evidence that excess consumption of added sugars is a
public health concern. Healthy dietary patterns characterized, in part,
by lower intakes of foods and beverages which contain added sugars are
associated with a decreased risk of CVD. Current scientific evidence
supports limiting consumption of added sugars. Without a label
declaration of added sugars, consumers are unable to determine how much
added sugars a serving of a particular food would contribute to their
diet and how to fit that food within an overall healthy eating pattern.
We have concluded that the declaration of added sugars will assist
consumers in maintaining healthy dietary practices, as required under
the FD&C Act.
    We disagree with the comment that asserted that added sugars is not
the type of nutrient disclosure Congress intended for FDA to require
because there is no scientifically supported quantitative intake
recommendation for added sugars upon which a DRV can be derived. We are
not limited to establishing a quantitative intake recommendation to
circumstances in which there is a biomarker of risk of disease.
Instead, we are relying on other evidence to support a mandatory
declaration of added sugars for the general population which is not
based on an independent relationship with a chronic disease, health-
related condition, or physiological endpoint, but is based, instead, on
constructing an overall healthy eating pattern that is low in added
sugars.
    As discussed in part II.H.3.o.(i), new evidence has become
available since publication of the proposed rule in March 2014 related
to limiting intake of added sugars to less than 10 percent of calories
(Ref. 19). We have considered the underlying scientific evidence in the
2015 DGAC Report and have determined that the evidence supports
establishing a DRV of 10 percent of total calories. The DRV for added
sugars of 10 percent of calories is based on the amount of added sugars
that can be reasonably accommodated within a healthy dietary pattern.
As discussed in part II.H.3, the evidence that we are relying on for a
mandatory declaration of added sugars for the general population and
for the DRV is based on information related to healthy dietary
patterns. Therefore, the comment's concern about a lack of a
quantitative intake recommendation for added sugars has been addressed.
    (Comment 157) Some comments said that a stronger case can be made
for including whole grains or stearic acid on the label.
    (Response) The FD&C Act gives us the authority to add and remove
nutrients from the label based on whether we determine the nutrients
are necessary to assist consumers in maintaining healthy dietary
practices. We did not consider whether it would be appropriate to
consider whole grains as a nutrient, nor propose a declaration of whole
grains on the nutrition label, in the context of this rulemaking. Whole
grains are made up of a variety of different grains (e.g. amaranth,
barley, buckwheat, whole kernel corn, millet, oats, quinoa, rice, rye,
sorghum, teff, triticale, wheat, and wild rice), and we would need to
give further consideration about whether it would be appropriate to
consider whole grains as a nutrient for purposes of nutrition labeling.
    In the preamble to the proposed rule (79 FR 11879 at 11894), we
considered whether the labeling of stearic acid should be mandatory or
voluntary on the label and concluded that the evidence for a role of
stearic acid in human health (e.g. changes in plasma LDL cholesterol
levels) is not well-established. We tentatively concluded that the
individual declaration of stearic acid is not necessary to assist
consumers in maintaining healthy dietary practices. We also have
declined to exclude stearic acid from the calculation of an individual
food's percent DV for saturated fat elsewhere in this document (see
part II.F.2) because current dietary recommendations for saturated fat,
such as those of the DGA, do not differentiate among the individual
saturated fatty acids in providing the recommended intake levels. In
addition, the DGA recommendation to consume less than 10 percent of
calories from saturated fatty acids makes no specific exclusion of
stearic acid, and instead, relates to the intake of total saturated
fatty acids. Therefore, we have determined that stearic acid should not
be specifically listed on the label and should not be excluded from the
calculation of an individual food's percent DV for saturated fat.
    (Comment 158) One comment discussed how the declaration of the
amount of added sugars in a product ``could compromise legitimate trade
secrets'' based on the declared amount being made public.
    (Response) To the extent that the comment argued that the
declaration of the amount of added sugars could compromise legitimate
trade secrets, we disagree. We are not requiring the public disclosure
of formulations or recipes. We are requiring, for all products, the
declaration of specific nutrients that have been determined to assist
consumers to maintain healthy dietary practices (cf. Philip Morris,
Inc. v. Reilly, 312 F.3d 24 (1st Cir. 2002)). It would be unreasonable
for manufacturers to expect that the nutrients on the Nutrition Facts
label would never change based on updated scientific evidence and the
need to provide information that will assist consumers to maintain
healthy dietary practices (see, e.g., Ruckelhaus v. Monsanto Co., 467
U.S. 986 (1984), Corn Products Refinery Co. v. Eddy, 249 U.S. 427
(1919)).
(ii) Material Fact
    (Comment 159) Some comments said that a declaration of added sugars
is not a material fact because a declaration does not appear to be
necessary for consumers to make healthy dietary choices and that,
absent a declaration of added sugars, the label is not false or
misleading to consumers.
    (Response) Under section 403(a)(1) of the FD&C Act, a food is
misbranded if its labeling is false or misleading in any particular.
Section 201(n) of the FD&C Act further defines misleading labeling. In
determining whether labeling is false or misleading, we take into
account representations made or suggested in the labeling and the
extent to which the labeling fails to reveal facts material in light of
the representations or with respect to consequences that may result
from the use of the food to which the labeling relates under the
conditions of use prescribed in the labeling, or under such conditions
of use as are customary or usual (id.). In the context of nutrition
labeling, we have considered the declaration of meaningful sources of
calories or nutrients to be a material fact (see 55 FR 29487 at 29491
through 29492, July 19, 1990 and 68 FR 41434 at 41438, July 11, 2003).
Nutritive value cannot be determined without a declaration. Thus, the
final rule will ensure that information that relates to the added
sugars content of a serving of food, which is fundamental to people's
food choices, is available on the food label. The added sugars
declaration will provide consumers with information that is material
with respect to the consequences of consuming a particular food (see 55
FR 29487 at 29491 through 29492).
    We have determined that there is adequate evidence to demonstrate
that consumption of added sugars is a public health concern because
evidence shows that heathy dietary patterns associated

with a decreased risk of chronic disease are lower in sugar-sweetened
foods and beverages that have been sweetened with added sugars,
consumption of too much added sugars can impact the nutrient density of
the diet, and consumption of sugar-sweetened foods and beverages is
associated with increased adiposity in children. Furthermore, the
scientific evidence supports that consumers limit their intake of added
sugars to less than 10 percent of total calories. Without information
on the amount of added sugars in a serving of a food, consumers would
not have the information they need to construct a healthy dietary
pattern that contains less than 10 percent of calories from added
sugars. Therefore, we have concluded that this evidence is adequate to
compel a label declaration of added sugars on the Nutrition and
Supplement Facts labels.
(iii) Regulations Must Bear a Reasonable Relationship to the
Requirements and Purposes of the Statute
(A) Consumers Are Eating Too Many Added Sugars
    (Comment 160) Some comments suggested that an added sugars
declaration would be beneficial for consumers because evidence shows
that Americans are consuming too many added sugars. The comments cited
survey data showing that from 2003 to 2006, added sugars, on average,
provided about 14 percent of total calories in the American diet, and
25 percent or more of total calories for over 36 million Americans. The
comments argued that Americans consume an average of 152 pounds of
sugar per year, the average 6- to 11-year-old American boy consumes 22
teaspoons of added sugars per day, and the average girl of that age
consumes 18 teaspoons of added sugars per day. The comments also cited
data on the average per-capita loss-adjusted food availability data
from 2012 showing that, on average, Americans consumed between 18 to 23
teaspoons (about 300 to 390 calories worth) of added sugars per day.
    Other comments suggested that the declaration of added sugars is
not necessary because current evidence shows that consumption of added
sugars is declining in the United States. One comment noted that the
American public is already reducing its consumption of sugar-sweetened
beverages, especially carbonated sweetened beverages, and it is doing
so without having an added sugars declaration on the Nutrition Facts
label. Some comments provided evidence that the decrease in the intake
of added sugars has been pronounced with an approximate decrease of
about 25 percent on a per person basis between 1999 and 2010 (Ref. 96).
One comment noted that sugar/sucrose consumption has declined by 33
percent in the United States and that per capita added sugars
consumption has declined since 1970 when obesity was not a public
health concern.
    One comment suggested that the contribution from added sugars to
the increase in total calories over the past 30 years is relatively
minor. The comment cited evidence from USDA that between 1970 and 2009
there was an increase of 425 calories per person per day, and added
sugars contributed less than 10 percent (38 calories) of this increased
caloric intake.
    One comment suggested that the problem of increasing added sugars
consumption has mainly been a problem with beverages, not food. The
comment said that almost all of the increase in consumption of sugars
between the late 1970s and about 2005 has been in beverages. The total
amount of added sugars consumed in sweet pastry, dairy and non-dairy
desserts, candy, and other sugars-containing foods has remained almost
constant, but the added sugars contributed by sweetened beverages has
doubled. Total sugars consumption increased from about 59 grams per
person per day to about 84 grams per person per day, and added sugars
in sweetened beverages increased from about 17.5 to 41.5 grams per
person per day. Twenty-four of the twenty-five grams of increase were
in sweetened beverages.
    (Response) Although added sugars consumption has decreased in
recent years, consumption of added sugars still remains high at an
average of 13.4 percent of calories among the U.S. population (Ref.
19). The scientific evidence supports Americans limiting their intake
of added sugars to no more than 10 percent of calories (Ref. 19). The
scientific evidence also is included in the 2015-DGA. Current
consumption exceeds the recommended limit for added sugars. Usual
intake data shows that added sugars consumption among some populations,
especially children and young adults, is even higher. Based on food
intakes in the U.S. population from 2007 to 2010, the usual median
intake of added sugars exceeded 15 percent of calories and 300 calories
for males 4 to 50 years old. For males 14 to 18 years old, the usual
median intake was 22.2 teaspoons per day and 492.3 calories per day.
The usual median intake of added sugars for males 19 to 30 years was
21.2 teaspoons per day and 454.6 calories per day. Consumption is also
high in females. The usual median intake exceeds 15 teaspoons and 300
calories per day in females aged 9 through 30 years (Ref. 97). At the
highest calorie level of 3,200 calories per day in the USDA Food
Patterns described in the 2015 DGAC Report, the empty calorie limit
available for added sugars is 275 calories (Ref. 98). This means that
the median usual intake for most age groups based on 2007 to 2010
intake data exceeds the highest empty calorie limits available for
added sugars in the USDA Food Intake Patterns. This information shows
that added sugars intake in the U.S. population continues to be
excessive. Knowing the amount of added sugars in the foods that we eat
may help Americans limit their intake of calories from added sugars and
reduce their overall consumption of calories.
(B) Comments on Whether an Added Sugars Declaration Is Necessary To
Assist Consumers in Limiting Their Added Sugars Consumption
    (Comment 161) Many comments supported mandatory declaration of
added sugars on the label because the information is necessary to
assist consumers in limiting their intake of added sugars. The comments
argued that consumers have no way of knowing the quantity of added
sugars in a product unless they are listed on the label, and such a
declaration would help consumers avoid the consumption of too much
added sugars. The comments stated that, in reading ingredient labels,
consumers may not know all forms of added sugars that can be in a food,
such as concentrated fruit juice, and they may not understand that
ingredients are listed in order of predominance. One comment noted
that, for many programs across the country in schools and other
institutions, the preexisting label makes it difficult for those
developing program guidelines to follow the DGA's recommendations and
limit the amount of added sugars in provided foods. To date, limiting
total sugars has been the only option, which results in complex
standards with detailed exemptions for foods with naturally occurring
sugars, such as fruit and dairy.
    In contrast, many other comments opposed to the mandatory
declaration of added sugars on the label argued that a label
declaration of the amount of added sugars is not necessary because it
does not convey information that consumers cannot already obtain from
total sugars and calorie declarations or from the ingredient list. One
comment said that we are already addressing how to help consumers
maintain appropriate caloric

balance through increasing the prominence of calories on the Nutrition
Facts label, and the DGAs are already providing consumers with
recommended food choices to increase consumption of nutrient dense
foods. Other comments stated that we did not show how an added sugars
declaration would provide consumers with any additional information to
help consumers maintain healthy dietary practices or enhance the
information that the Nutrition Facts label already provides, and
therefore, the added sugars declaration fails to assist consumers in
maintaining healthy dietary practices. One comment suggested that an
added sugars declaration will not help consumers select a nutrient-
dense diet because information on total calories and nutrient content
already allows for the identification of other nutrient-dense foods.
Other comments noted that foods that are major sources of added sugars
are products for which all or virtually all sugar is added and the
current sugars declaration already reflects the amount of added sugars.
    (Response) The calorie declaration, the total sugars declaration,
and the ingredient list do not provide the consumer with the amount of
added sugars in a serving of a product. An added sugars declaration is
necessary to provide consumers with a measure to assess the relative
contribution of the added sugars from a serving of food as part of a
healthy dietary pattern and enable consumers to avoid a dietary pattern
containing excess calories from added sugars. In some foods that are
high in added sugars, such as sugar-sweetened beverages, virtually all
sugars in the products are added sugars. In these types of foods, it
would be possible for the consumer to determine the amount of added
sugars in the product by looking at the (total) sugars declaration.
However, many other foods contain a mixture of naturally occurring and
added sugars. Based on information that is currently declared on the
label, the consumer is unable to determine what portion of the total
sugars declaration is naturally occurring and what portion of the total
sugars declaration is added sugars. Small amounts of added sugars found
in many different foods and ingredients can add up throughout the day
and can contribute empty calories in the diet at levels that exceed
what would otherwise be reasonable within recommended calorie limits.
Therefore, an added sugars declaration allows consumers to better
compare products and assess whether a particular product fits into a
healthy diet. Furthermore, the calorie declaration reflects calories
from all macronutrients, and the total sugars declaration would only be
a reflection of the amount of added sugars in a product if all of the
sugars are added rather than naturally occurring.
    Consumers would not be able to determine the relative amount of
added sugars in a serving of a product from the ingredient list for
several reasons. There are many different types and forms of sugar that
may be added to a food during processing and preparation. Consumers
also may not recognize the names of some types of sugars to be a sugar
(e.g. trehelose). Finally, consumers may also not know that the
ingredients are listed in order of predominance by weight, and no
quantitative information is provided in the ingredient list.
    Although the DGA already provides information on recommended food
choices to increase consumption of nutrient dense foods, the DGA does
not provide the amount of added sugars in a serving of food that
nutritional labeling provides. While some added sugars can be part of a
healthy dietary pattern, without a label declaration for added sugars,
consumers will not have the information they need to limit added sugars
to less than 10 percent of calories. Information about the amount of
added sugars in a serving of food and how to put that amount of added
sugars into the context of the total daily diet can further assist
consumers in reducing their intake of calories from added sugars.
    With respect to the comments that suggested we did not show how
added sugars would provide consumers with any additional information to
help them maintain healthy dietary practices or enhance what the
Nutrition Facts label already provides, we are not required to show
that consumers will use new information on the label to change their
behaviors or dietary practices before requiring the declaration of
information on the label. Furthermore, our consumer research shows that
without an added sugars declaration, consumers are unable to determine
the amount of added sugars in a serving of a product (Ref. 14).
Further, the current label provides only information on total
carbohydrates and total sugars. A declaration of added sugars on the
label would provide the needed information about the added sugars
content of a food.
    A declaration of the amount of added sugars in a serving of a
product will provide more specific quantitative information about the
amount of all added sugars found in a serving of a product that is not
currently available on the label. We anticipate that providing a
declaration of the amount of added sugars in a serving of a product
would assist government programs, schools, and other institutions in
limiting the amount of added sugars in foods they provide.
    (Comment 162) Some comments suggested that added sugars should be
declared on the label because this is information that consumers have
the right to know.
    (Response) While we appreciate consumers' interests, the statutory
framework for the declaration of a nutrient under section 403(q)(2) of
the FD&C Act is whether the declaration will provide information that
will assist consumers in maintaining healthy dietary practices, not
whether consumers want access to the information. Furthermore, consumer
interest or demand alone does not constitute a material fact under
section 201(n) of the FD&C Act and is not a sufficient basis upon which
we can require additional labeling for foods (see, e.g., Stauber v.
Shalala, 895 F. Supp. 1178, 1193 (W.D. Wisc. 1995) and Alliance for
BioIntegrity v. Shalala, 116 F. Supp. 2d 166, 179 (D.D.C. 2000)).
    Although consumer interest alone is not sufficient to require
mandatory labeling, we have discussed in part II.C that the amount of
added sugars in a serving of food is a declaration that meets the
statutory framework in section 403(q)(2) of the FD&C Act and,
furthermore, it is a material fact because added sugars is a public
health concern and knowing the amount of added sugars in a serving of
food will assist consumers in maintaining healthy dietary practices.
    (Comment 163) In our Preliminary Regulatory Impact Analysis (PRIA),
we extrapolated from the welfare effects estimated in a retrospective
study on the impact of the Nutrition Labeling and Education Act of 1990
(Ref. 99) to quantify benefits of the proposed rule. Some comments
suggested that it was inappropriate for us to rely on a paper written
by a graduate student, which was not peer-reviewed, as the basis for
our proposal to require the mandatory declaration of added sugars.
Another comment argued that we provided no basis to require the
mandatory declaration of added sugars on the label other than the
Abaluck paper.
    (Response) We note that we did not rely on the information provided
in the Abaluck paper as the basis for our proposal to require the
mandatory declaration of added sugars on the label. The information in
the Abaluck paper was used to estimate economic benefits

of our proposal for the PRIA. We are relying on information related to
overconsumption of added sugars, the reduction of the nutrient density
of the diet when substantial amounts of added sugars are present,
evidence showing the consumption of sugar-sweetened beverages is
associated with increased body weight and adiposity, and evidence
showing that consumption of health dietary patterns characterized, in
part, by lower consumption of sugar-sweetened foods and beverages is
associated with a decreased risk of CVD.
    (Comment 164) One comment noted that the FD&C Act only gives us the
authority to add nutrients to the Nutrition Facts label to help
consumers maintain healthy dietary practices, but our definition of
``healthy'' excludes any consideration of sugars content.
    (Response) The comment is referring to our regulation for implied
nutrient content claims (Sec.  101.65). Section 101.65(d)(1)(ii)(2)
provides requirements for the use of the term ``healthy'' or related
terms on the label or in the labeling of foods. The regulation requires
that a food must meet requirements for fat, saturated fat, cholesterol,
and other nutrients, but does not include limitations on the amount of
total or added sugars that a food may have if it bears an implied
``healthy'' nutrient content claim. Our authority in section 403(r) of
the FD&C Act to define a term, by regulation, to characterize the level
of a nutrient in the label or labeling is distinct from our authority
in section 403(q) of the FD&C Act to require the declaration of a
nutrient in nutrition labeling. As previously discussed in part II.B.4,
we intend to revisit our other regulations for nutrient content claims
at a later date to determine if changes are necessary.
    (Comment 165) One comment said that sources of sugar contribute the
same number of calories per gram weight of food, and calories should be
the principal nutrient of concern of a population striving to achieve
desired weight and control obesity. The comment suggested that giving
consumers a false impression that reducing added sugars without
reducing calories may actually delay finding a real solution to the
problem.
    (Response) We have increased the prominence of calories on the
label because of its importance for consumers to consider for the
purposes of weight management. We are not suggesting that consumers
should ignore or consider information about the amount of calories in a
serving of a food to be secondary to the amount of added sugars in a
serving of food. Instead, we are requiring the declaration of added
sugars on the label to provide one additional piece of information to
consumers to assist them in selecting foods that contribute to a
healthy dietary pattern. Therefore, we do not agree that an added
sugars declaration is unnecessary because the total amount of calories
in a serving of a food is already displayed on the label.
    (Comment 166) One comment stated that by mandating declaration of
both total sugars and added sugars, we are creating an arbitrary
distinction between two types of sugars which will not lead to any
nutritional differences for consumers.
    (Response) We do not agree with the comment that the distinction
between total and added sugars is arbitrary and will not lead to any
nutritional differences in the foods that consumers select. The
addition of added sugars to foods provides additional calories which
can make it difficult for consumers to meet nutrient needs within
calorie limits and can lead to issues with weight management. Sugars,
added in excess, do not provide any health benefits. In addition, foods
high in added sugars tend to be lower in beneficial nutrients. By
providing a declaration of added sugars on the label, consumers will
have additional information about a product that can assist them in
determining how much sugars have been added to a food. Moreover, the
intake of added sugars from sugar-sweetened foods and beverages needs
to be reduced as part of a healthy dietary pattern. A healthy dietary
pattern, when compared to less healthy dietary patterns, such as the
dietary pattern of the current U.S. general population, is strongly
associated with a reduced risk of CVD. The intake of foods with
naturally occurring sugars, such as fresh fruits and vegetables, is
encouraged as part of a healthy dietary pattern and not recommended to
be reduced.
(C) Comments on a Lack of a Chemical or Physiological Distinction
Between Naturally Occurring and Added Sugars
    (Comment 167) In the preamble to the proposed rule (79 FR 11879 at
11905), we recognized a lack of a chemical or physiological distinction
between added and naturally occurring sugars. Many comments agreed that
naturally occurring and added sugars are the same and argued that,
because there is no chemical or physiological distinction, we should
not require the mandatory labeling of added sugars. One comment cited a
paper by Murphy and Johnson (2003) that discusses added sugars in the
context of the 2000 DGA and suggested that it would be challenging to
require a declaration of added sugars on the label because they are not
chemically or physiologically distinct from naturally occurring sugars
(Ref. 100).
    However, other comments suggested that there is evidence that not
all sugars are chemically the same. The comments suggested that
different sugars are metabolized differently in the body. One comment
stated that naturally occurring sugars have more nutritional value than
those added to foods. Another comment stated that sugars that are found
naturally in foods are consumed in combination with all other
ingredients and nutrients in that food and that the body reacts to
inherent sugars in such combinations. The comment noted that emerging
studies suggest that inherent sugars in combination with plant
nutrients, for example, behave differently in the body than added
sugars without such accompanying nutrients. These comments indicated
that it is important for consumers to know how much added sugars are in
their products because they are inherently different from naturally
occurring sugars.
    (Response) A physiological or chemical distinction between added
and naturally occurring sugars is not a prerequisite to mandatory
declaration under section 403(q)(2)(A) of the FD&C Act. We explained in
the preamble to the proposed rule that our scientific basis for the
added sugars declaration, in fact, differed from our rationale to
support other mandatory nutrients related to the intake of a nutrient
and risk of chronic disease, a health-related condition, or a
physiological endpoint (see 79 FR 11879 at 11904). Rather than relying
on a causal relationship between added sugars to obesity or heart
disease, we considered, in the preamble to the proposed rule (79 FR
11879 at 11902 through 11908) and the preamble to the supplemental
proposed rule (80 FR 44303 at 44307 through 44309), the contribution of
added sugars as part of healthy dietary patterns and the impact to
public health from such patterns for the purposes of the general
population. Thus, the comments did not focus on added sugars as a
component of sugar-sweetened foods and beverages that have been found
to have health implications as part of a dietary pattern, or as a
nutrient that provides a source of empty calories consumed by the U.S.
population in excess, which make it difficult for consumers to meet
nutrient needs within calorie limits. Providing consumers with
information about the amount of added sugars in a serving of a product
will assist consumers in

planning a healthy diet. We have concluded that the consumption of
added sugars is related to health for a number of reasons, and
consumers will benefit from information about the added sugars content
of a food on the label.
    (Comment 168) Many comments did not support an added sugars
declaration because added sugars are not chemically or physiologically
distinct from naturally occurring sugars, and a separate declaration of
added sugars implies that there is a distinction. The comments
suggested that an added sugars declaration would arguably be false and
misleading because it would convey to the reasonable consumer that
added sugars are chemically different than naturally occurring sugars
and/or that added sugars has different health effects than naturally
occurring sugars. One comment further asserted that implying
superiority of one source of a nutrient versus another, when they are
not materially different and are chemically, nutritionally, and
functionally equivalent, is inherently misleading. Another comment
suggested that a separate declaration for added sugars could cause
consumers to believe that naturally occurring sugars are more
beneficial.
    (Response) As we explained in our response to comment 167, a
physiological or chemical distinction between added and naturally
occurring sugars is not a prerequisite to mandatory declaration under
section 403(q)(2)(A) of the FD&C Act. In fact, some nutrients currently
declared on separate lines in the Nutrition Facts label may be related
to the same chronic disease risk or physiological endpoint (e.g.,
saturated fat and trans fat and risk of CVD). Therefore, we disagree
that a separate declaration necessarily implies a chemical or
physiological distinction. Furthermore, the comments may not have
considered the basis for why the declaration of added sugars is
necessary to assist consumers in maintaining healthy dietary practices.
A dietary pattern characterized, in part, by larger amounts of sugar-
sweetened foods and beverages is associated with greater risk of CVD
than a healthy dietary pattern that includes less sugar-sweetened foods
and beverages. Moreover, added sugars provide excess calories in the
U.S. diet (see our responses to comment 29 and comment 177), and these
additional empty calories make it difficult for consumers to meet
nutrient needs within their calorie limits and can lead to issues with
weight management. Therefore, the intake of added sugars in the current
U.S. dietary pattern is a public health concern. The declaration of
added sugars provides factual, accurate information about the amount of
added sugars in a serving of food, and we are requiring the declaration
consistent with our authority in section 403(q) of the FD&C Act. The
added sugars declaration is not inherently misleading as the comments
suggest, as is addressed further in part II.C.3.
    (Comment 169) Some comments suggested that we are being
inconsistent in our treatment of the evidence for nutrients because we
are considering whether certain dietary fibers have a beneficial
physiological effect, but we are not considering whether added sugars
have a separate and distinct physiological effect in our determination
that added sugars should be declared on the label.
    (Response) In the case of dietary fiber, we are requiring that a
dietary fiber have a beneficial physiological effect to human health
for the purposes of declaration because there are dietary fibers
currently present in foods that are being declared on the label
indicating to consumers that they have the same beneficial
physiological effects to human health as other fibers, when in fact,
they do not. We previously have discussed in this section that added
sugars, independent of sugars naturally present in foods, can have a
negative impact on health. A decision to not require a separate
declaration of added sugars on the label would not allow consumers to
determine the additional sugars which have been added above and beyond
what is naturally present in a food which are contributing extra
calories to their diet and could also contribute to a dietary pattern
that is associated with disease risk.
    (Comment 170) One comment stated that the Nutrition Facts label
must remain a source of information about nutrients that are chemically
distinct based on analysis. The comment asserted that we have not
provided a reasonable basis for defining added sugars based on source
rather than chemical composition.
    (Response) We disagree with the comment that a chemical distinction
must be a requirement for declaration of a nutrient on the label.
Section 403(q)(2)(A) of the FD&C Act provides discretion to the
Secretary, and by delegation, to FDA, to determine whether providing
nutrition information regarding a nutrient will assist consumers in
maintaining healthy dietary practices and when to require information
relating to such additional nutrient be included in the label or
labeling of the food. This section does not include limitations on
chemical distinctions.
(D) Comments Questioning our Reliance on Conclusions and Information
From the 2010 DGA and the 2015 DGAC
    (Comment 171) Many comments questioned our reliance on conclusions
and information in the 2010 DGAC Report and 2010 DGA. One comment
asserted that it is a gross expansion of the law governing the DGA to
use selective dietary guidance from a single edition to promulgate food
labeling regulations. Some comments suggested that the evidence cited
by the 2010 DGAC and 2010 DGA was not strong enough to support a
declaration of added sugars. One comment stated that neither the 2010
DGA nor the 2010 DGAC Report provided a preponderance of scientific
information or conclusive, documented, or strong scientific evidence to
support these suppositions. The comments asserted that we did not
address the strength of the evidence that the 2010 DGAC reviewed as the
basis for their recommendations. One comment also noted that the 2010
DGAC addressed few or limited questions related to impact of added
sugars on health due to lack of available evidence. The comment stated
that what evidence there was at the time that the 2015 DGAC Report was
published was not conclusive.
    (Response) We note that we did not specifically rely on conclusions
or recommendations made by the 2010 DGAC Report or in the 2010 DGA. We
considered the information and underlying data presented in the 2010
DGAC Report and 2010 DGA that was used as the basis for their
conclusions and recommendations and determined that, for the purposes
of nutrition labeling, the evidence in the 2010 DGAC and 2010 DGA,
along with other data and information we considered, supports the
declaration of added sugars on the Nutrition and Supplement Facts
labels (79 FR 11879 at 11902 through 11908). The DGAs have recommended
that Americans reduce their intake of what we are defining to be added
sugars since the early 1980s, so the recommendation to limit
consumption of added sugars is not new. Since publication of the 2010
DGA and 2010 DGAC Report, new evidence has become available on added
sugars and dietary patterns that we have considered. We have determined
that this evidence further supports a declaration of added sugars on
the label.
    The comment suggesting that the evidence on added sugars is not
conclusive, documented, or strong is referring to the factors that we
considered for mandatory declaration of nutrients on the label for
which there is

an independent relationship between the nutrient and chronic risk of
disease. Our determination that added sugars should be declared on the
label for the general population (see part II.H.3) was not based on the
factors used to determine mandatory or voluntary declaration for these
other non-statutory nutrients that have an independent relationship
related to a chronic disease, a health-related condition, or health-
related physiological endpoint. Instead, our review is based on the
need for the declaration of nutrient information on the labels to
assist consumers in limiting their consumption of calories from added
sugars found in sugar-sweetened foods and beverages and consuming a
healthy dietary pattern that is associated with a reduce risk of CVD.
    (Comment 172) Many comments took issue with the 2010 DGA's use of
food pattern modeling to support the recommendation to reduce the
intake of calories from added sugars. One comment stated that the
amount of solid fats and added sugars in the USDA food patterns is the
outcome of using the remaining calories in that pattern rather than the
evidence-based research. Other comments said that the USDA Food
Patterns lack the scientific underpinning on which to base official
recommendations.
    Some comments said that the same issues that prevent FDA from using
food consumption data, menu modeling, and dietary survey data to
determine DRVs are also applicable when considering the mandatory
declaration of non-statutory nutrients. One comment noted that we have
concluded that menu modeling is not related to disease risk and is not
suitable for determining recommended intakes.
    Some comments also noted that the 2010 DGA clearly states that the
USDA Food Patterns are only one example of suggested eating patterns
and that the USDA Food Patterns have not been specifically tested for
health benefits. Another comment said that the extremely low suggested
intakes of 6 to 12 teaspoons of added sugars in the USDA Food Patterns
have no historical basis and lack context.
    (Response) We disagree with comments that questioned the use of
evidence based on food pattern modeling to support the added sugars
declaration so that consumers can use the information to reduce
calories from solid fats and added sugars. While the food pattern
modeling used to create the USDA Food Patterns was used to compare
current consumption data with recommended intakes from the USDA Food
Patterns, the 2010 DGA also considered information about the impact of
added sugars on nutrient density and on their implications for weight
management (Ref. 77). Furthermore, the fact that the USDA food patterns
were not studied for health effects until recently, does not lessen our
reliance on the information as part of our basis for a mandatory
declaration of added sugars. Since publication of the proposed rule,
the USDA Food Patterns have been studied for their association with
disease risk (Ref. 101). We also have evidence that dietary patterns
characterized, in part, by lower intakes of sugar-sweetened foods and
beverages are associated with a reduced risk of CVD that further
supports a mandatory declaration of added sugars on the label for the
general U.S. population. It is not clear what is meant by the comment
which stated that the extremely low suggested intakes of 6 to 12
teaspoons of added sugars in the USDA Food Patterns have no historical
basis and lack context. To the extent the comment disagrees with the
suggested intakes of 6-12 teaspoons of added sugars, we note that there
is evidence showing that Americans are consuming too many calories from
added sugars as well as evidence that it is difficult to meet nutrient
needs within calorie limits when excessive amounts of added sugars are
consumed.
    (Comment 173) In the preamble to the proposed rule (79 FR 11879 at
11890), we discussed the factors that we considered for mandatory and
voluntary declaration of non-statutory nutrients. We considered the
scientific evidence from other U.S. consensus reports or DGA policy
reports (79 FR 11879 at 11890). We also listed the DGA policy reports
among other reports that we would consider to be U.S. consensus
reports.
    One comment questioned whether the DGA is a consensus report
because it is a report that is issued jointly every 5 years by the USDA
and HHS. The comment said that the DGAC Report is an advisory report,
and the Secretaries of USDA and HHS have sole responsibility and
discretion as to the final content of the DGA. The comment also noted
that the DGAC Report does not undergo independent external review.
    (Response) In the preamble to the proposed rule (79 FR 11879 at
11885 through 11887), we listed new dietary recommendations, consensus
reports, and national survey data as sources of information that we
considered when developing the proposed amendments to the regulations.
Furthermore, our review of the scientific evidence in the 2010 DGA
relates to the intake of added sugars and the role of such information
in assisting consumers to maintain healthy dietary practices and the
need for consumers to be able to readily observe and comprehend the
information and to understand its relative significance in the context
of a total daily diet (79 FR 11879 at 11891). Therefore, whether the
2015 DGAC Report is or is not a consensus report is not relevant for
the added sugars declaration. Furthermore, we considered the underlying
evidence related to added sugars that supported the recommendation to
limit consumption of calories from solid fats and added sugars and did
propose to require a declaration of the amount of added sugars in a
serving of a product on the label because of the 2010 DGA
recommendation related to calories from solid fats and added sugars. We
considered the evidence in the 2010 DGAC Report and 2010 DGA, along
with other data and information in the proposed rule to support a
declaration of added sugars on the Nutrition Facts and Supplement Facts
labels (79 FR 11879 at 11902 through 11908).
    (Comment 174) One comment said that the proposed rule incorrectly
assumes that reduced consumption of added sugars will reduce the
problem of obesity, but noted that we acknowledged in the proposed rule
that solid fats and added sugars do not contribute to weight gain any
more than another source of calories.
    (Response) We have not changed our position with regard to the
effect of calories from solid fats and added sugars on weight gain.
However, as noted in the 2010 and 2015-2020 DGAs, consumption of excess
solid fats and added sugars make it difficult to meet nutrient needs
within calorie limits (Refs. 28, 30). Because sugars added to foods
during processing increase the calorie content of the food without
increasing other nutrients in the food, added sugars as an ingredient
could conceivably lead to weight gain if a consumer striving to meet
their nutrient needs does so by consuming foods containing too many
added sugars. Further, we stated in the proposed rule that we know that
foods containing solid fats and added sugars make up a significant
percentage of the American diet and are a source of excess calories (79
FR 11879 at 11904).
    (Comment 175) Some comments said that we are not being consistent
with the dietary recommendations we use for requiring nutrients on the
label because the 2010 DGA also recommended replacing saturated fats
with mono and polyunsaturated fats, yet the labeling of mono and
polyunsaturated fats is voluntary on the label.

    (Response) We do not rely on the 2010 DGA recommendation to reduce
calories from solid fats and added sugars. Instead, we examined the
underlying evidence and concluded that added sugars should be declared
on the label. Furthermore, the 2010 DGA recommendations related to mono
and polyunsaturated fats are about replacing saturated fats with the
mono and polyunsaturated fats, because reduction of saturated fats is
associated with reductions in blood LDL cholesterol and, therefore, the
risk of CVD. The 2015 DGA corroborates this finding. Saturated fats are
already declared on the label, so consumers have the information they
need to reduce their intake of saturated fat. In addition, current
evidence does not show that there is an inherent benefit to consumption
of mono and polyunsaturated fats by themselves. The benefit comes from
reduction of saturated fats in the diets by way of replacement.
Furthermore, the scientific evidence supports consuming a healthy
dietary pattern that is low in saturated fats. A healthy eating pattern
limits saturated fats, and the scientific evidence supports consumption
of added sugars to to less than 10 percent of calories per day from
saturated fats (Ref. 19). Therefore, Americans currently have the
information on the label which will allow them to limit saturated fats
in their diet.
d. Nutrient Density
    (Comment 176) Many comments suggested that including a declaration
of the amount of added sugars in a serving of a product can help
consumers select foods that contribute to a more nutrient-dense diet.
The comments noted that the 2010 DGA suggested that reduced intake of
added sugars allows for increased intake of nutrient-dense foods which
may help individuals to control their total caloric intake and better
manage their weight. The comments also said that sugars intrinsic to
foods are accompanied by nutrients, whereas added sugars are not. The
comments referred to the discussion in the proposed rule related to
intake of added sugars and its association with a lower intake of
essential nutrients (79 FR 11879 at 11903) and suggested that most
major sources of added sugars are high in calories and fats, but lack
meaningful amounts of dietary fiber, essential vitamins or minerals.
The comments said that, when added sugars intake is 10 to 15 percent of
calories, the median intakes of nine nutrients (vitamin A, vitamin E,
vitamin C, folate, magnesium, potassium, vitamin K, fiber, and total
choline) are significantly lower than the median intakes of those
nutrients for someone consuming 0 to 5 percent of their calories from
added sugars (Ref. 102). Another comment noted that IOM recommends that
the intake of added sugars not exceed 25 percent of energy to ensure
adequate intake of essential micronutrients that are typically not
present in foods high in added sugars (Ref. 75). One comment said that
consumers who eat less added sugars consume fewer calories and more
foods rich in essential nutrients.
    In contrast, many comments said that a declaration of added sugars
on the label will not assist consumers in constructing a more nutrient
dense diet. The comments said that there is a lack of science to
support the contention that added sugars intake displaces nutrients or
causes a decrease in the intake of nutrient-rich foods in the diet of
the general population, at current intake levels. One comment cited the
2010 DGA conclusion that added sugars replace nutrient-dense foods and
beverages and make it difficult for people to achieve the recommended
nutrient intake while controlling their calorie intake, but noted that
no evidence-based review was conducted on this topic, and no
conclusive, documented, or strong evidence was cited to support that
added sugars intake causes nutrient displacement, or decreased
consumption of nutrient-rich foods. Another comment noted that although
a recent analysis of NHANES data (Ref. 102) reaffirmed the conclusion
of the 2002 IOM report (Ref. 75), individuals with intakes of greater
than 25 percent of calories from added sugars appear to be at greater
risk for nutrient inadequacy based on comparison with the DRIs. The
comment said that the authors of the study also clarify the real-world
impact from these higher intake amounts, and stated ``However, high
levels of added sugars intake occur among only a small proportion of
the population and cannot explain the existing problem of poor nutrient
intake in the U.S. population as a whole.''
    (Response) We agree that a declaration of the amount of added
sugars can assist consumers in selecting foods that contribute to a
more nutrient dense diet. The IOM did not establish a UL for sugars or
added sugars, however they did conclude that increased consumption of
added sugars can result in decreased intakes of certain micronutrients
based on their review of the evidence available at the time that the
IOM Dietary Reference Intakes for energy, carbohydrate, fiber, fat,
fatty acids, cholesterol, protein, and amino acids were published (Ref.
103). As noted in comments, additional evidence has become available
since the IOM DRI reports were published, which supports their
conclusion (Ref. 102). Therefore, although the 2010 DGAC did not
conduct an evidence-based review on this topic, there is documented
evidence that increased consumption of added sugars can make it
difficult for individuals to meet nutrient needs.
    We disagree with the suggestion added sugars consumption is not
contributing to poor nutrient intake in the U.S. population as a whole
and thus should not be required on the label because only a small
proportion of the population is consuming large amounts of added
sugars. The 2015 DGAC found that the general U.S. population is
consuming 13.4 percent of its calories from added sugars. As the
comments noted, Marriott et al. found that median nutrient intakes were
lower when added sugars intake was 10 to 15 percent of calories (Ref.
102). Therefore, even at intake levels below 25 percent of calories,
nutrient intake can be negatively impacted by increased consumption of
added sugars. Furthermore, based on NHANES data from 2007 to 2010,
males aged 9 to 50 are consuming more than 300 calories per day from
added sugars, and females aged 9 to 30 are consuming more than 250
calories per day from added sugars (Ref. 104). Males between the ages
of 14 to 18 years old consumed almost 400 calories per day from added
sugars (Ref. 104). Although these subpopulations may not make up a
majority of the population, these groups include children and young
adults who are growing and need nutrients for proper growth. Therefore,
the impact of added sugars consumption on nutrient density in these
specific populations is an important consideration for the declaration
of added sugars.
    As for the comment which said that consumers who eat less added
sugars consume fewer calories and more foods rich in essential
nutrients, the comment did not provide evidence to support this
statement. Therefore, we are unable to determine if this information
adds to other evidence we have, which suggests that added sugars can
decrease the nutrient density of the diet.
    (Comment 177) Many comments suggested that the added sugars
declaration does not assist consumers in constructing a nutrient dense
diet because there are nutrient dense foods which contain added sugars,
and the declaration may obscure the fact that some foods with added
sugars may actually be good sources of beneficial nutrients. One
comment argued that the added sugars declaration does not meet

the proposed rule's stated goal to convey information necessary to meet
recommendations to construct diets containing nutrient-dense foods
because the declaration does not provide consumers with any means to
differentiate between foods that will contribute phytonutrients to
their diet from foods with empty calories. The comments provided
examples of nutrient-dense foods, such as yogurt, cranberries, tart
cherries, and cereal, which contain added sugars.
    Some comments from the cranberry industry asked that we make an
exception to added sugars labeling for cranberries, which require
sweetening for palatability. The comments noted that cranberries are a
nutrient-dense fruit with many known health benefits. Unlike other
fruits, cranberries have little natural sugar and, therefore, have a
uniquely tart taste. The comments expressed concern that cranberry
products would be considered ``unhealthy'' based solely on their added
sugars content. The comments said that the evidence shows that
cranberries are rich in polyphenols, specifically flavonoids, and have
a positive impact on urinary health. The comments also cited evidence
that the addition of sugar to cranberry products does not decrease the
polyphenol content. Furthermore, according to the comments, the calorie
content of each serving of dried cranberries is similar to that of
other dried fruits, and cranberry juice cocktail (27 percent juice) is
the standard equivalent to other 100 percent juices with similar total
calorie and sugar levels. The comments also noted that they contribute
to recommended fruit intake amounts in the DGA.
    The comments said that requiring the declaration of added sugars on
cranberry products may mislead consumers to believe that nutrient-dense
foods, such as cranberries, with their proven health benefits, are
somehow less nutritious than foods with the same amount of naturally
occurring sugar, or even those with more total sugars. The comments
expressed concern that a focus on added sugars may have the unintended
consequence of driving consumers away from nutrient dense products with
moderate amounts of sugar.
    Many comments said that a mandatory declaration of added sugars
could be damaging for the cranberry industry or for the tart cherry
industry. One comment noted that the drying operation used by the tart
cherry industry reduces the moisture content while simultaneously
increasing the percentage of sugar. The use of sugar as a natural
preservative combats the threat of mold and yeast contamination.
    Several comments noted that USDA grants an exemption, which is
similar to that which the comments requested for the labeling of added
sugars on cranberry products, for cranberry products offered for sale
in our nation's schools. One comment noted that the IOM, in its report
titled ``Nutrition Standards for Foods in Schools: Leading the Way
Toward Healthier Youth,'' made recommendations for nutrition standards
for competitive foods offered in schools, and has made an exception for
yogurt from its recommended general sugar standard of 35 percent or
less of calories from total sugars.
    One comment suggested that the added sugars declaration will not
help consumers select foods that contribute to a nutrient dense diet
because information on total calories and nutrient content (e.g. fiber
plus vitamins and minerals) already allows for the identification of
nutrient-dense foods.
    (Response) Consumers now have access to nutrient information
provided on the nutrition label that they can use to plan a nutrient
dense diet. We have required those nutrients that are of the greatest
public health significance be declared in nutrition labeling (58 FR
2079, 2107). An added sugars declaration is an important piece of
information because consumers need to ensure their diet does not
contain excess calories from added sugars which can make it difficult
for consumers to meet nutrient needs within calorie limits and can lead
to issues with weight management.
    As mentioned in the 2010 DGA, many foods that contain added sugars
often supply calories, but few or no essential nutrients, and no
dietary fiber (Ref. 77). However, there are some foods, such as dried
fruits, yogurt, and cereal, that contain significant amounts of
beneficial nutrients as well as added sugars. The declaration of added
sugars will enable consumers to understand the relative significance of
the added sugars content in a serving of dried fruit, yogurt, cereal,
and other foods that may contribute beneficial nutrients to the diet
and determine how to incorporate those foods into a healthy dietary
pattern and meet their nutrient needs within calorie limits. As
discussed in the 2015 DGAC report, there is room for Americans to
include limited amounts of added sugars in their eating patterns,
including to improve the palatability of some nutrient-dense foods,
such as fruits and vegetables that are naturally tart (e.g. cranberries
and rhubarb). Healthy eating patterns can also accommodate other
nutrient dense foods with small amounts of added sugars, such as whole-
grain breakfast cereals or fat-free yogurt, as long as the calories
from added sugars do not exceed 10 percent per day, total carbohydrate
intake remains within the AMDR, and total calorie intake remains within
limits (Ref. 19).
    The added sugars declaration is just one piece of information that
consumers can use to help them construct a healthful dietary pattern
that may include some added sugars. We acknowledge that some consumers
may focus in on the amount of added sugars in a product and may judge
it to be a less nutritious product even though it contains beneficial
nutrients. The added sugars declaration on the label is new information
that consumers will not have seen before. In collaboration with Federal
and other partners, we plan to engage in educational and outreach
activities for consumers and health professionals about the use of
information on the Nutrition Facts and Supplement Facts labels. Part of
that education will include information about added sugars. A key
message related to added sugars will be that consumers should consider
all of the information on the label when constructing a healthful
dietary pattern and not focus in on one specific nutrient, such as
added sugars. The message related to consumption of added sugars is not
to eliminate added sugars or foods high in added sugars from the diet;
instead, the message is to limit overall consumption of added sugars in
the diet to less than 10 percent of total calorie intake. Therefore, if
consumers choose to eat foods with sugars added to them for
palatability, such as cranberries, they may do so in moderation, and
cut back on added sugars elsewhere in the diet.
    We decline to exempt certain nutrient dense foods containing added
sugars from the requirement to declare the amount of added sugars in a
serving of a product on the label. If such products are exempt from
added sugars labeling, consumers may assume incorrectly that they
contain no added sugars. Providing added sugars information on the
label for all foods allows consumers to compare foods and make informed
choices. It allows them to also make trade-offs in their diet to
achieve an overall healthy dietary pattern that contains less than 10
percent of total calories from added sugars. As part of our education
and outreach activities, we plan to educate consumers that the amount
of added sugars in a serving of a product should be considered along
with other information on the label

when constructing a healthy dietary pattern.
    While other government programs and consensus bodies have excluded
cranberries and yogurt from their programs or recommended limits on
sugars, the purpose of those programs and reports are different than
the purpose of the information on the Nutrition and Supplement Facts
labels. The purpose of the Nutrition and Supplement Facts labels is to
provide nutrition information to consumers to allow them to make
informed choices about the foods that they eat. Therefore, although
some nutrient-dense foods containing added sugars have been excluded
from government programs or recommendations, the same approach does not
apply to the Nutrition and Supplement Facts labels.
    With regard to the comment that said that the drying operation used
by the tart cherry industry reduces the moisture content while
simultaneously increasing the percentage of sugar, we would not
consider sugars that naturally exist in the tart cherries prior to the
drying process to be added sugars. Only sugars that have been added to
the fruit would be required to be declared as added sugars on the
label.
e. Reformulation
    (Comment 178) While some comments said that an added sugars
declaration will be an incentive for food manufacturers to reformulate,
other comments said that reformulation of products to reduce the added
sugars content may not result in products that are healthier. Some
comments said that an added sugars declaration may lead to
reformulation or changes in consumer behavior that would not improve
overall nutritional profile or nutrient density of the diet and may
result in overconsumption of other macronutrient sources (e.g. fat)
without a reduction of calories. The comments said that added sugars
could be replaced with bulking agents, which provide calories and
carbohydrate. Another comment said that reformulation of products
containing added sugars could result in an increased use of artificial
sweeteners (i.e. low calorie sweeteners), which could be bad for
health. Other comments noted that consumers have many food and beverage
choices that are reduced in total and added sugars.
    (Response) Absent data, we do not know whether manufacturers will
reformulate their products if we require the declaration of added
sugars on the label. Likewise, absent data, we do not know whether
consumers will select reformulated products that may be higher in fat,
calories, or low-calorie sweeteners. In our efforts to educate
consumers and health professionals about the use of the label, we
intend to encourage consumers to consider all of the information on the
label when making decisions about what foods to eat and how much rather
than focusing on one specific nutrient, such as added sugars. If
consumers take all label information into consideration when making
dietary choices, they will recognize when a product is low in added
sugars, but still contains a significant amount of calories and
carbohydrate or fat per serving. They can also see if low-calorie
sweeteners have been added to a product by looking at the ingredient
list.
    With respect to the comment which suggested that low-calorie
sweeteners may be harmful to health, as noted in our Overview of Food
Ingredients, Additives & Colors, there is no convincing evidence of a
cause and effect relationship between these sweeteners and negative
health effects in humans. We have monitored consumer complaints of
possible adverse reactions for more than 15 years (Ref. 105).
    (Comment 179) One comment asked what studies we used to suggest
that declaring added sugars on the label will result in firms reducing
the amount of added sugars in products and result in an overall
reduction of sugar consumption.
    (Response) In the preamble to the proposed rule (79 FR 11879 at
11904), we said that the mandatory declaration of added sugars may
prompt product reformulation of foods high in added sugars like what
was seen when trans fat labeling was mandated. We do not know whether
or how manufacturers will reformulate their foods as the result of a
mandatory added sugars declaration.
f. Calories From Solid Fats and Added Sugars
    (Comment 180) The 2010 DGA provided a key recommendation that
Americans should reduce their intake of calories from solid fats and
added sugars (SoFAS). In the preamble to the proposed rule (79 FR 11879
at 11904), we concluded that the disclosure of saturated fat and trans
fat on the label not only provides information to consumers which can
be used to reduce their intake of these nutrients, and thus reduce
their risk of CVD, but the declaration of saturated and trans fats on
the label could also provide a marker for foods that contain solid fats
that are abundant in the diets of Americans and contribute
significantly to excess calorie intake. We stated that similar
information is not available on the label for calories from added
sugars (id.).
    Several comments disagreed that the declared amounts of saturated
and trans fats can be used as markers for solid fats in the diet. The
comments stated that the calculation of calories from SoFAS is not
feasible based on the information that is proposed for the label, and
the nature of the calculation that consumers would need to perform
would not be consistent with our objectives to make the label more
usable and understandable for consumers. The comments noted that it is
not feasible to determine the amount of solid fats from the saturated
and trans fat declarations alone because the label does not provide the
quantity of solid fat that USDA used in its menu modeling analysis. The
comments further stated that, while saturated fat and trans fat may be
components of solid fats, those values alone cannot be used to
determine the solid fat content of a food because it is not known what
portion of these declarations would be identified in the menu modeling
program used by USDA.
    One comment said that the declaration of saturated and trans fat
declarations are for the purposes of lowering risk of CVD and not for
estimating the SoFAS content of a food. The identification of SoFAS is
for the purposes of developing the USDA Food Patterns and is not a
suitable approach for mandating an added sugars declaration.
    Another comment suggested that the sugars declaration on the label
can serve as a marker for added sugars in the same way that saturated
fats serves as a marker for solid fats. The comment also suggested that
saturated fats in certain foods are not solid fats (such as in nuts) in
the same way that sugars in certain foods are not added sugars (such as
fruit juice and milk).
    (Response) We used the term ``marker'' in the preamble to the
proposed rule to mean that the amount of saturated and trans fats on
the label would give consumers a very good idea or a reasonable
estimate of the quantity of solid fats in a serving of a food. Although
many fat containing foods have a mixture of fats, such as nuts and oils
that may contain some solid fats and some unsaturated fats, the
saturated fat and trans fat declarations would account for these
differences. In addition, even though one would need more information
on how saturated fats were quantified for the development of the USDA
Food Patterns to determine the exact amount of calories from solid
fats, such specificity would not be needed to obtain a reasonable
estimate of solid fats using the declared value of

saturated fat and trans fat combined. Furthermore, unlike solid fats,
there is no information currently on the label that could give
consumers an estimate of the amount of added sugars in a serving of
food when the food contains both naturally occurring and added sugars.
In such a case, the amount of total carbohydrate or total sugars in a
serving of a food cannot be used as a reasonable estimate of the amount
of added sugars in a serving of the food.
    We disagree with the comment suggesting that the total sugars
declaration can serve as a marker of added sugars in the same way that
the saturated fat and trans fat declaration can serve as a marker for
solid fat. When both naturally occurring and added sugars are present
in a food, the consumer has no way of knowing from the total sugars
declaration what portion of that total sugars declaration represents
the amount of added sugars in a serving of the food.
    Since the publication of the proposed rule, the 2015 DGAC Report
became available. In that report, the solid fats and added sugars were
divided within the ``empty calories'' category with 45 percent of the
empty calorie allowance allocated to added sugars and 55 percent of the
empty calorie allowance allocated to solid fats. Furthermore, the
scientific evidence in the 2015 DGAC Report for limiting calories from
added sugars is separate from that for limiting saturated fats, which
are a key contributor of solid fats to the diet. There is adequate
information available to consumers on the label to assist them in
meeting the key recommendation to limit calories from saturated fats to
less than 10 percent of total calories; however, there is no such
information on the label to help consumers limit their consumption of
added sugars to no more than 10 percent of total calories. Whether
there is adequate information on the label to assist consumers in
limiting solid fats is not related to an added sugars declaration.
    (Comment 181) The comments were divided on whether calories from
added sugars should be declared on the label. One comment said that, if
added sugars are declared on the label, we should require the
declaration of calories from added sugars. Another comment stated that
concerns about the scientific evidence on the health effects of added
sugars and the usefulness of a declaration to improve food choices
apply to whether the declaration of added sugars is in gram units or
declared as calories from added sugars. Other comments suggested that a
declaration of calories from added sugars is unnecessary and not
beneficial. The comments noted that the total number of calories in a
serving of food is prominently displayed in the proposed format. The
comments said that a declaration of calories from added sugars could
cause consumer confusion, particularly for consumers who are unable to
readily understand the distinction between a gram value and calories
from added sugars. The comments noted that consumers are already
familiar with the gram unit from the total sugars declaration. The
comments said there is no evidence from consumer research that a
declaration of calories from added sugars in lieu of grams would lead
consumers to greater reductions in intake of added sugars.
    (Response) Evidence shows that heathy dietary patterns associated
with a decreased risk of chronic disease are lower in sugar-sweetened
foods and beverages. Consumption of too much added sugars can impact
the nutrient density of the diet, and consumption of sugar-sweetened
beverages are associated with increased adiposity in children. Thus,
the added sugars declaration is information that is necessary for
consumers to construct a healthy dietary pattern lower in added sugars
and that is less than 10 percent of calories from added sugars. The
information on the label includes the gram amount of added sugars in a
serving of a food product and the percent DV declaration for added
sugars. There is no need for consumers to be able to determine the
amount of calories from added sugars in a serving of a food because we
are establishing a DV that is based on 10 percent of total calories (50
grams in children and adults 4 years of age and older and 25 grams for
foods purported to be for children 1 through 3 years of age). Consumers
can use the percent DV declaration to determine what percentage of
total calories a serving of a food contributes. They can also use the
gram declaration of added sugars to construct a diet that is low in
added sugars by comparing the amount of added sugars between products
and by using trade-offs in the diet if they choose to include certain
foods which have a large amount of added sugars.
g. Consumer Research and Consumer Use of Added Sugars Declaration
    (Comment 182) One comment said that research does not substantiate
a causal effect between including added sugars information on the
Nutrition Facts label and decreased added sugars intake. The comment
cited a study in which data from the 1994-96 Continuing Survey of Food
Intakes by Individuals (CSFII) was used to model total consumption of
added sugars and the Diet and Health Knowledge Survey conducted by the
USDA was used to determine usage of labeling information on total
sugars (Ref. 106).
    (Response) Although the results of the study showed that regular
use of sugar information on nutrition labels is associated with a
significantly lower density of added sugar in the diet, the results of
this study cannot be used to determine whether there is a causal effect
between including added sugars information on the Nutrition Facts label
and decreased added sugars intake. The study did not assess use of
labeling information on added sugars, but rather use of information on
total sugars.
    (Comment 183) One comment noted that the use of the ``no added
sugars'' or ``without added sugars'' nutrient content claim focuses on
ingredients used in a product (Sec.  101.60(c)). The comment said that
manufacturers must put a disclaimer on the label of their product if
the food is not low or reduced in calories so that consumers are not
misled about the calories associated with such products. The comment
suggested that consumers could potentially be misled because when the
amount of added sugars in a serving of a product is declared on the
label, manufacturers who are currently using a ``no added sugars'' or
``without added sugars'' claim would be less likely to use the claim
because the amount of added sugars is stated on the label, and thus, a
disclaimer with regard to the calorie content of a product would not be
declared.
    (Response) We do not have data or information about whether
manufacturers may elect to use a voluntary nutrient content claim once
they are required to declare the amount of added sugars in a serving of
their product. Consequently, we also cannot determine whether consumers
might be misled, so we decline to revise the rule in response to this
comment.
    (Comment 184) Several comments addressed additional consumer
research on Nutrition Facts labels that include added sugars
declarations. One comment included two reports that described methods
and results of two studies, including one controlled experiment and one
cross-sectional survey study, both on cranberry and other fruit
products. Both studies included, among other formats of the Nutrition
Facts labels, Nutrition Facts labels with declarations of the gram
amount of added sugars in a serving of the product and the percent
Daily Value for added sugars displayed below a ``Total Sugars''
declaration. Regarding

the experiment on cranberry and other fruit products, the comment
described an online study conducted in a sample of 1,448 adults age 18
or older in the United States At the start of the study, participants
were shown a set of five statements, including two statements that
referred to added sugars: ``Americans should reduce consumption of
sodium, saturated fat, refined grains and added sugars;'' and ``Too
much added sugar in a person's diet can be bad for them and their total
added sugar intake should not exceed 10 percent of their total calorie
intake.''
    The comment described selected results including, but not limited
to, findings related to study participants who viewed a single
Nutrition Facts label, in FDA's proposed format, either for cranberry
juice cocktail or 100 percent grape juice. The cranberry juice cocktail
label showed 110 calories, 28 grams of total sugars, and 25 grams (50
percent DV) of added sugars. The 100 percent grape juice label showed
140 calories, 36 grams of total sugars, and 0 grams (0 percent DV) of
added sugars. The comment noted that when both groups of participants
were asked to describe ``the amount of sugar'' that the product
contains on a scale of 1 to 10, where 10 equaled ``extremely high,''
the average rating of the sugar content for the cranberry juice
cocktail was statistically significantly higher than the average rating
of the sugar content for the grape juice. The comment also described
findings from a group of participants who viewed a single Nutrition
Facts label, in FDA's proposed format, for dried cranberries, and
another group of participants who viewed a single nutrition label, in
FDA's proposed format, for raisins. The dried cranberries label
showed130 calories, 3 grams (12 percent DV) of dietary fiber, 29 grams
of total sugars, 26 grams (52 percent DV) of added sugars; 0 percent DV
of vitamin D, calcium, and iron; and 1 percent DV of potassium in a
serving of the product. The raisins label showed 130 calories, 2 grams
(8 percent DV) of dietary fiber, 29 grams of total sugars, 0 grams (0
percent DV) of added sugars, 0 percent DV of vitamin D, 2 percent DV of
calcium, 6 percent DV of iron, and 9 percent DV of potassium. The
comment said that when both groups of participants were asked to
describe ``the amount of sugar'' and ``the amount of calories'' that
the product contains by rating each item on a scale of 1 to 10, where
10 equaled ``extremely high,'' the average ratings of the sugar and
calorie content for the dried cranberries were statistically
significantly higher than the average ratings of the sugar and calorie
content for the raisins. In the same study, a subset of participants
also completed a ``forced choice task'' in which they were shown
Nutrition Facts labels for two products presented, displayed in FDA's
proposed label format, side-by-side, and were asked to choose which of
the two products was ``better described'' by eight different phrases.
Some participants were shown a Nutrition Facts label for dried
cranberries plus a Nutrition Facts label for raisins, both in FDA's
proposed format. The report submitted in the comment said that among
those who completed this task, statistically significantly more
participants selected the dried cranberries as being ``better
described'' as containing ``more sugar'' and ``more calories,'' whereas
statistically significantly more participants selected the raisins as
being ``better described'' as ``healthy.''
    The same comment described selected results from a cross-sectional
survey study on cranberry products. The survey was conducted online in
September 2015 and included 1,000 adults of 18 and over in the United
States. The study participants were asked how likely they are to
consume or purchase cranberry juice cocktail, apple juice, and grape
juice for their household on a regular basis. Participants were then
asked how strongly they agreed or disagreed with four statements: (1)
``Too much added sugar in a person's diet can lead to obesity and risk
of chronic health problems;'' (2) ``Many Americans do not meet dietary
recommendations for servings of fruit;'' (3) ``One should reduce
consumption of sodium, saturated fat, refined grains and added sugar;''
and (4) ``Dried fruits and fruit juices can form a nutritious part of a
well-balanced diet and help provide nutrients and servings of fruit.''
Participants were then shown nutrition information for three juice
products, displayed in FDA's proposed label format, in a rotating
order. One product was cranberry juice cocktail of which label showed
110 calories, 28 grams of total sugars, and 25 grams (50 percent DV) of
added sugars. One product was grape juice of which the label showed 140
calories, 36 grams of total sugars, and 0 grams (0 percent DV) of added
sugars. One product was apple juice of which the label showed 120
calories, 24 grams of total sugars, and 0 grams (0 percent DV) of added
sugars. As each product label was shown, participants were asked, ``How
does the information on this label affect your likelihood to consume or
purchase [name of juice] for your household?'' The comment said that 39
percent of participants were less likely to consume or purchase the
cranberry juice cocktail after viewing the FDA-proposed nutrition
label, versus 29 percent for the grape juice and 18 percent for the
apple juice. Participants were also asked to identify ``how many grams
of sugar'' were in each juice. The comment said that 30 percent of
participants could not answer the question correctly when viewing the
label for cranberry juice cocktail, versus 7 percent for the grape
juice and 7 percent for the apple juice. After answering questions
about the grams of sugar in each juice, participants who indicated that
they would be less likely to consume or purchase cranberry juice
cocktail were asked, ``Why do you say that?'' The comment said that the
``main reason'' for most of the participants who answered this question
was ``sugar content.'' The comment reported similar research findings
for participants who viewed Nutrition Facts labels, in our proposed
format, for dried cranberries versus raisins.
    Based on the research findings from the two cranberry studies, the
comment said that consumers misunderstood the sugar content of
cranberry juice cocktail and dried cranberries, and believed that
cranberry products contain more calories and more sugars and are less
healthy than competitive products, when presented with FDA-proposed
labels for each, both alone and as compared to competitive products.
Therefore, the comment said that requiring a naturally unpalatable
fruit product that has been sweetened to label the gram amount and
percent DV for added sugars, in comparison with naturally sweetened
fruit products labeled as having zero grams and zero percent DV for
added sugars, is misleading because it implies that a sweetened
unpalatable fruit with the same or fewer total calories and sugars as
the naturally sweetened fruit product is less nutritious and
``generally unhealthy.''
    Both cranberry studies also tested an alternative label format in
which the declaration of the grams and percent DV for added sugars was
replaced by a double asterisk symbol on the declaration of ``Total
Sugars,'' (instead of ``Sugars''), and a footnote placed at the bottom
of the label that stated, ``** Total sugars include sugars added for
fruit palatability.'' The comment said that the alternative label
format alleviated the confusion regarding the sugar content of
cranberry juice cocktail compared to grape juice and the confusion
regarding the sugar content of dried cranberries compared to raisins.
    Another comment described a separate, online experiment that tested

Nutrition Facts labels for fictitious products without any product
identities. The study, co-sponsored by five trade associations, was
conducted in October, 2015, among a sample of 2,014 U.S. adult
consumers aged 18 years or older. Half of the sample saw ``Control
labels'' that included only gram amounts of ``Sugars.'' The other half
of the sample saw ``Added Sugars labels'' that featured gram amounts of
added sugars and the percent Daily Value for added sugars displayed
below a ``Total Sugars'' declaration. All participants performed two
product comparison tasks. In the first product comparison task,
participants who saw the ``Control labels'' were shown two labels side-
by-side that displayed identical nutrition profiles, whereas
participants who saw ``Added Sugars labels'' saw two labels side-by-
side which were almost nutritionally identical, except that one
declared 4 grams of added sugars whereas the other declared 0 grams of
added sugars. All participants were asked to indicate which of the two
products was: (1) The ``healthier'' choice and (2) the ``best choice
for maintaining weight.'' The comment said that the results showed that
compared to those who saw two ``Control labels'' side-by-side,
participants who saw two ``Added Sugars labels'' side-by-side were less
likely to say that the product declaring 4 grams of added sugars was
equally healthy to, or equally helpful in maintaining a healthy weight
as, an identical product that declared 0 grams of added sugars. In the
second product comparison task, participants were shown two labels
side-by-side that displayed different nutrition profiles. One product
contained 190 calories, 2 grams (3 percent DV) of total fat, 37 grams
(12 percent DV) of total carbohydrates, 7 grams (28 percent DV) of
dietary fiber, 16 grams of total sugars, and, in the ``Added Sugars
labels'' but not the ``Control labels,'' 0 grams (0 percent DV) of
added sugars. The other product contained 190 calories, 3 grams (5
percent DV) of total fat, 35 grams (12 percent DV) of total
carbohydrates, 10 grams (40 percent DV) of dietary fiber, 8 grams of
total sugars, and, in the ``Added Sugars labels'' but not the ``Control
labels,'' 8 grams (16 percent DV) of added sugars. All other nutrients
were declared in identical amounts for both products. In this case, the
comment said that of the participants who saw ``Control labels,'' 56
percent selected the product with 10 grams (40 percent DV) of dietary
fiber and 8 grams of total sugars as the healthier choice, versus 32
percent of participants who saw the ``Added Sugars labels.''
    Many comments referenced a study that was initially submitted as a
comment and report to the proposed rule and subsequently published in
2015 (Ref. 107). The report provided qualitative and quantitative
results of a study conducted with 1,088 U.S. adults recruited from an
online consumer panel. The report said that study participants
generally did not understand the term ``added sugars'' and had
difficulty correctly identifying the amount of ``sugars'' on the label
when ``added sugars'' were declared. Some study participants perceived
that products with an ``Added Sugars'' declaration had a higher sugar
content than was actually present. The published paper of the study
also said that participants were shown three Nutrition Facts labels,
side-by-side, for three products that were nutritionally identical,
except that two of the three labels included ``Added Sugars''
declarations whereas one of the three included only a ``Sugars''
declaration. The paper said that, when participants were asked to rank
in order of descending preference which product they would buy based on
the label information, 76 percent of the participants gave the highest
preference to the label that included only a ``Sugars'' declaration.
    (Response) The findings from the research submitted in the comments
and from our own added sugars study suggest more limited conclusions
than the comments assert. Regarding the findings that some study
participants appeared to have overestimated the sugar content of the
products included in the study as a result of summing total and added
sugar amounts, we address this issue in our response to comment 188.
Regarding the comments' assertions that the study findings demonstrate
that our proposed label declaration of the percent Daily Value and
grams of added sugars would ``mislead'' consumers based on study
participants' responses to questions posed (which reflect participant
perceptions), we disagree that the results support such a conclusion
(see our response to comment 35).
    Our consumer study on added sugars was conducted to help inform our
consumer education. In particular, we were interested in better
understanding how the inclusion of added sugars declarations on the
Nutrition Facts label might influence consumer perceptions of various
products and comprehension of the label. A consumer's belief, opinion,
or previous exposure to information about added sugars and the impact
added sugars may have on health may affect how a consumer may view a
label with an added sugars declaration, whether the belief, opinion, or
information is grounded in scientific evidence or not. These factors
can influence how a consumer perceives information on a label and may
result in some consumer confusion and misunderstanding, e.g., when a
consumer thinks a food, which can be part of a healthy dietary pattern
for the day, is not ``healthful'' simply because it has a certain
amount of added sugars. We want to ensure, through our consumer
education, that consumers understand how to include a variety of foods
in their diet as part of a healthy dietary pattern and focus on
providing consumers the tools they need to understand how to include
added sugars in their diets and where calories from added sugars can be
included within calorie limits. FDA's consumer research on added sugars
suggests that in comparison to participants who saw the current label
without any added sugars declarations, some study participants'
perceptions of the healthfulness of a given product varied when added
sugars declarations were included on the Nutrition Facts label.
Specifically, the study showed that when participants compared two
products that declared added sugars, and the more nutritious product
had more added sugars, some participants had difficulty assessing the
relative healthfulness of the more nutritious product. This variation
in healthfulness perceptions suggests that, when presented with
Nutrition Facts labels that included added sugars declarations, some
FDA study participants may have applied their own understanding of
added sugars in deciding how to evaluate this new information, relative
to other, more familiar nutrients shown on the label, which may have,
in turn, affected these participants' perceptions about the
healthfulness of a given food. A variety of factors may account for
some of the product perceptions (e.g., healthfulness of a product)
found in our research, including but not necessarily limited to: (1)
Dietary advice disseminated since 1980 about limiting ``sugar'' intake,
particularly from sources of added sugars; (2) preexisting perceptions
and knowledge (both correct and incorrect) about ``sugars'' and ``added
sugars;'' and (3) potential confusion among some consumers about the
fact that the existing ``Sugars'' declarations on the current Nutrition
Facts label refers to the components of ``sugars,'' which include both
naturally occurring and added sugars.
    The information on the Nutrition Facts label provides consumers
with

information they need to maintain healthy dietary practices. Our
consumer research on added sugars was informative with respect to the
need for information about the amount of added sugars in a serving of
food to enable consumers to incorporate added sugars into a healthy
eating pattern. Our consumer research on added sugars demonstrated
that, without the added sugars declaration, consumers will not have
information they need to construct a dietary pattern that is low in
added sugars. Not all consumers understand the distinction between
``Sugars'' and ``Added Sugars,'' and, therefore, some consumers do not
understand that added sugars, along with naturally occurring sugars,
are components of ``Sugars.'' We found that some study participants
think a food with added sugars is less ``healthful,'' even though the
food could be included as part of a healthy dietary pattern.
    Without the factual information about the amount of added sugars in
a serving of food and percent DV declaration, consumers would not be
able to choose from a variety of foods for a healthy dietary pattern
and would not be provided with information about appropriate limits on
calories from added sugars in their diet. It is important to provide
consumers with the information on the amount of added sugars in a
serving of food so they can better manage their daily intake of added
sugars, rather than having consumers avoid foods with added sugars in
the ingredient list or conversely consume excess amounts of added
sugars because they are uninformed about the contribution of added
sugars in a serving of food. Information about added sugars on the
nutrition label will provide material information to the consumer to
better enable them to construct a healthy dietary pattern from a
variety of foods.
    In addition to our consumer study on added sugars, the comments
provided consumer research on added sugars related to consumer
perceptions. The research provided in the comments was designed to show
differences in how people view added sugars on the label, but did not
discuss the need for the added sugars declaration and its importance in
enabling consumers to construct healthy dietary patterns. If we do not
include added sugars on the label, based on how consumers may
misperceive added sugars or be confused about how to include it as part
of a healthy dietary pattern on intake, consumers could be harmed by
not having critical information needed to maintain healthy dietary
practices.
    The studies submitted in comments demonstrate the same issue we
have noted with respect to some consumers adding total and added sugar
declarations together, which led to our revisions to the final
declaration of added sugars to clarify that added sugars is a
subcomponent of total sugars (``included'' in total sugars).
Furthermore, due to a number of deficiencies in the information
provided about the cranberry studies as well as in the described study
methodologies, we are not able to assess the merits of any conclusions
described in the comments related to cranberry products. For example,
in the cranberry experiment, one dietary statement that participants
were shown at the beginning of the study about added sugars said: ``Too
much added sugar in a person's diet can be bad for them and their total
added sugar intake should not exceed 10 percent of their total calorie
intake.'' A DRV for added sugars of less than 10 percent calories
suggests that some added sugars can be part of a healthy diet. In fact,
the food pattern modeling that was part of the basis for establishing
the DRV for added sugars included 4 to 9 percent of calories from added
sugars. Therefore, some study findings in the cranberry experiment may
be attributable to participants having seen the negative dietary
statement before evaluating the label formats tested in the study.
    Additionally, it is not clear whether the cranberry experiment
tested how participants would have evaluated the cranberry juice
cocktail versus grape juice, or dried cranberries versus raisins when
using the current Nutrition Facts label and, more importantly, the
proposed Nutrition Facts label without the proposed declaration of
added sugars. Without such test results, it is not possible to
ascertain whether the reported results could be attributed, as the
comment asserted, to the added sugars declaration or were influenced by
other label elements. Moreover, although the comment said that the
cranberry experiment reduced confusion with an alternative label in
which the declaration of the grams and percent DV for added sugars was
replaced by a footnote that stated, ``** Total sugars include sugars
added for fruit palatability,'' based on findings from eye-tracking
studies (Refs. 15, 108), we suspect that the reduced confusion is
related more to participants overlooking the information in the
footnote, which is located at the bottom of the label. Regardless of
the findings described in the comment, the alternative label format
included in the cranberry experiment would not provide consumers with
essential information about the quantity of added sugars in a food or
what that amount of added sugars contributes to a daily diet. Without
this information, consumers will not be able to consume less added
sugars or put the added sugars declaration in the context of their
daily diet. Finally, although we acknowledge that the cranberry
experiment showed that statistically significantly more participants
selected raisins as being ``better described'' as ``healthy'' in
comparison to the dried cranberries, we note that there were other
differences between the dried cranberries and the raisins besides the
amount of added sugars. For example, the raisins contained more
protein, iron, potassium and calcium than cranberries. It is unclear
from the study results if the participants solely chose raisins based
on their lack of added sugars or if the increased levels of these other
nutrients may have impacted the participant's choice for the
``healthy'' product.
    In the cranberry survey study, selective reporting of the verbatim
results that were used to identify the reported reasons for the
decreases in purchase or consumption intentions, the absence of a
baseline assessment of how participants would respond to the study
questions using the current Nutrition Facts label, and the sequence and
nature of the questions described preclude a determination of the
extent to which the findings produced in the study are attributable to
the FDA-proposed label or to added sugars declarations. For example,
the cranberry survey study first asked participants to express
agreement or disagreement with a statement, ``Too much added sugar in a
person's diet can lead to obesity and risk of chronic health
problems.'' Given that 91 percent of the study sample said that they
strongly or somewhat agreed with this statement, it is reasonable to
infer that the study participants' preconceived beliefs and/or
heightened attention on added sugars may account for many of the
cranberry survey study findings reported in the comment, rather than
the declaration of added sugars. Given that study participants have
various preconceived perceptions about added sugars, it is not
surprising that participants have different purchase intentions or
perceptions. Furthermore, because the cranberry survey study led
participants through a sequence of questions where they answered
questions about grams of sugar in the products before viewing an
alternative label that was advocated by the authors of the comment, the
study methods

deliberately led participants to focus on information that they may not
have naturally focused on in other circumstances, therefore calling
into question whether the alternative label would produce less
confusion while also producing better comprehension about the added
sugars content of the tested foods if a different set or sequence of
questions had been employed.
    In the experiment that was co-sponsored by five trade associations,
we are unable to conclude that added sugars declarations were the
reason for the findings in the second product comparison task because
the experimental conditions included variations in total fat and
dietary fiber values, in addition to varying added sugars. For example,
in the second product comparison task, in which respondents viewed
``nutritionally different'' products, 50 percent of participants who
selected the product that declared 0 grams of added sugars as ``better
for maintaining healthy weight'' indicated ``it was low in fat'' as a
reason for their selection; in addition, our analysis of the raw data
submitted by the commenter shows that, 36 percent indicated ``has no
grams of added sugars'' as a reason for their selection. On the other
hand, our analysis of the raw data shows that among participants who
selected the product that declared 8 grams of added sugars as ``better
for maintaining healthy weight,'' 55 percent indicated ``is higher in
fiber'' as a reason for their selection, and 39 percent indicated
``contains less sugar'' as a reason. As for the findings from the first
comparison task, in which participants viewed two labels that were
almost nutritionally identical, we do not agree that participants
``misjudged'' the healthfulness or weight-related attributes of the
foods in the presence of added sugars information, because the
difference in added sugars content between the foods meant that the two
foods were, in fact, nutritionally different. Without added sugars
declarations, participants were unable to discern that such a
difference existed. Similarly, in the paper by Laquatra et al.,
participants who expressed a purchase preference for the label that
included only a ``Sugars'' declaration may not have understood that the
food contained added sugars and may have based their preference on that
mistaken understanding.
    Some research referenced different approaches for the labeling of
added sugars for certain nutrient-dense fruit products that are high in
acid. The proposed alternative approach to added sugars labeling for
dried unpalatable fruit and juices made with at least 27 percent juice
of an unpalatable fruit includes a proposed definition for an
unpalatable fruit. We note that there are other fruits, such as lemons
and limes, which contain nutrients, but have a low Brix value. When the
juices of such fruits are consumed, they typically have sugar added to
them for palatability. It is not clear what the impact of this approach
suggested in the comment, which includes a definition of dried
unpalatable fruit as well as use of a Brix-to-acid ratio that is not
defined by regulation, would have on other dried fruit products or
products made from juices of other fruits that typically have sugars
added to them. An alternative approach provided in comments includes
the use of a footnote in the Nutrition Facts box to explain that added
sugars are added to increase the palatability of the food. However, we
are concerned about the use of the Nutrition Facts label to convey this
type of information and the precedent such an approach may set for
other possible statements related to a nutrient declared on the label,
such as the purpose for its addition, and information related to the
characteristics or use of the nutrient. We consider it important to
maintain the consistency of the information contained within the
Nutrition Facts label, which provides factual information about the
amount of a nutrient in a serving of food. This ensures that consumers
can continue to readily use the Nutrition Facts label to make
comparisons across all packaged foods. Manufacturers who are interested
in communicating, through labeling, how products made from fruits that
have sugars added to them in order for the product to be acceptable to
consumers are free to make a statement elsewhere on the label or in
labeling, outside of the Nutrition Facts box, to explain the purpose
for which the sugars has been added, provided the information is
consistent with other labeling requirements, e.g., is truthful and not
misleading. Thus, for example, manufacturers could include a truthful
and not misleading statement explaining that total sugars include
sugars added for fruit palatability.
    (Comment 185) One comment described a reanalysis of the raw data
from our added sugars study, the availability of which we announced in
the Federal Register of September 10, 2015 (80 FR 54446). The
reanalysis confirmed some of the findings reported in an FDA memo (see
part II.H.3.g), but also found that participant perceptions of the
products in the study were inconsistent depending on race, education
level, or both. Based on the findings from the reanalysis and prior
published research that has examined how nutrition label use varies
with education level and ethnic minority status, the comment said that
the presence of added sugars information on the label produced
misperceptions and confusion, and that low-education consumers and
ethnic minorities seemed especially prone to ``unintended
consequences'' when added sugars was displayed on the label. The
comment said that more research is needed to thoroughly understand how
the provision of added sugars on the Nutrition Facts label would affect
``at-risk segments'' of the population.
    (Response) We agree that some findings suggest the potential for
consumer responses to labels vary depending on race, ethnicity, and
education level; this type of variation has been shown in prior
published research. On the other hand, because the reanalysis ventured
beyond the primary objectives of what the study was designed to explore
and because some findings reported in the comment were based on fewer
than five participants, many findings of the reanalysis are unreliable.
We also disagree with the comment's basis for asserting a need for
additional research as discussed in our response to comment 40. Due to
the limitations of the sample, limitations which the comment
acknowledged, we view the reanalysis as exploratory and inconclusive,
although potentially informative for future education efforts.
Furthermore, as addressed in our responses to comments 1 and 244, we
have considered, and will continue to consider, a variety of
educational efforts to assist consumers in comprehending and using the
Nutrition Facts label to maintain healthy dietary practices.
    h. Voluntary labeling. In the preamble to the proposed rule (79 FR
11879 at 11905), we considered the appropriateness of the voluntary
declaration of added sugars. However, we said that we were concerned
that voluntary declaration of added sugars may not ensure that
consumers have the information that will allow them to follow the
current dietary recommendations (id.). We also said that added sugars
declared voluntarily by manufacturers could be confusing to consumers
and would not provide consumers with the information they need to plan
their dietary pattern to reduce consumption of calories from added
sugars (id.).
    (Comment 186) Several comments disagreed with our tentative
conclusion that the labeling of added sugars should be mandatory and
provided a number of

reasons why the declaration of added sugars should be voluntary rather
than mandatory. Most comments suggested that labeling of added sugars
should be voluntary rather than mandatory for the same reasons that
they opposed mandatory labeling of added sugars. The comments, and our
responses to the comments, are provided in part II.H.3.a. Other
comments, which recommended that if we determine that added sugars
should be declared on the label, the label declaration should be
voluntary rather than mandatory, provided the following reasons:
     One comment referred to our discussion of voluntary
labeling of added sugars in the proposed rule (79 FR 11879 at 11905),
and said that whether declaration of a nutrient on the Nutrition Facts
label is mandatory or voluntary does not correspond to its bearing on
maintaining healthy dietary practices;
     The sole macronutrient made mandatory by regulation is
trans fat due to its established relationship to risk of chronic
diseases and health-related conditions;
     Other voluntary nutrients, such as polyunsaturated fat,
monounsaturated fat, potassium, soluble fiber, and sugar alcohol, are
the subject of authorized health claims;
     Executive Order 13563 requires us to consider less
burdensome alternatives;
     Consumers' understanding of the differences between added
and naturally present sugars should be determined before becoming
mandatory;
     Voluntary labeling would be consistent with the labeling
of added sugars in the United Kingdom, Canada, Australia, and New
Zealand, and would not run afoul of the World Trade Organization's
Agreement on Technical Barriers to Trade (``TBT Agreement''); and
     Manufacturers of foods containing a significant amount of
added sugars would likely be disinclined to declare added sugars if
labeling is voluntary, however manufacturers of foods containing an
insignificant amount of added sugars would likely use the added sugars
declaration to highlight the added sugars content by juxtaposing sugars
and added sugars declarations on the label.
    (Response) Since the publication of the proposed rule, additional
evidence has become available that further supports the need for a
mandatory declaration of added sugars. The scientific evidence supports
Americans limiting their calories from added sugars by consuming an
eating pattern low in added sugars. We explained that consumers need to
know how much added sugars is in a serving of a product in order to
consume a healthy dietary pattern that is low in added sugars because
we have evidence that healthy dietary patterns characterized, in part,
by lower intakes of sugar-sweetened foods and beverages when compared
to less healthy dietary patterns are associated with a decreased risk
of CVD. We have the authority to require the declaration of a nutrient
on the label if we determine the declaration will assist consumers in
maintaining healthy dietary practices. Our discretion includes whether
to permit the voluntary declaration or require the mandatory
declaration of a nutrient (56 FR 60366, November 27, 1991).
    With respect to the comment which noted that the only nutrient
which has been added to the label by regulation is trans fat, which was
based on its relationship to CVD risk, our basis for requiring the
declaration of added sugars for the general population is not its
independent association with the risk of chronic disease, a health-
related condition, or a physiological endpoint. Instead, we are
requiring the mandatory declaration of added sugars because evidence
shows that heathy dietary patterns associated with a decreased risk of
chronic disease are lower in added sugars, consumption of too much
added sugars can impact the nutrient density of the diet, and
consumption of sugar-sweetened beverages are associated with increased
adiposity in children.
    With respect to the comment that suggested that a declaration of
added sugars should be voluntary because it is not the subject of an
authorized health claim, our authority to add additional nutrients to
the label under section 403(q) of the FD&C Act is distinct from our
authority to authorize health claims.
    With respect to the comment suggesting that we should consider less
burdensome alternatives as directed by Executive Order 13563, we did
consider voluntary labeling of added sugars in the preamble to the
proposed rule (79 FR 11879 at 11905) and determined that a voluntary
declaration would not provide the information consumers need to
understand the relative contribution of added sugars from all food in
the context of a total daily diet and achieve a healthy dietary pattern
that is associated with a reduced risk of chronic disease. The 2015 DGA
provides further support for this conclusion.
    With respect to the comment that consumers' understanding of the
differences between added and naturally present sugars should be
determined before we can require the declaration of added sugars, that
is not consistent with our authority for when we can require a nutrient
declaration, as discussed in our response to comment 156.
    Concerning the comments raised with the TBT Agreement, the comments
have not explained why we would be acting inconsistently with our WTO
obligations if we require the declaration of added sugars, as compared
to other countries that allow for the voluntary declaration of added
sugars on their labels. As we have explained, our objectives will not
be fulfilled by voluntary labeling. Rather, the scientific evidence
supports the mandatory disclosure of the amount of added sugars in the
nutritional labeling of food. The dietary pattern of the general United
States population contains excessive calories from solid fats and added
sugars. The consumption of excess calories above calorie needs can lead
to overweight and obesity. There is public health need to reduce excess
calories from solid fats and added sugars to ensure that nutrient needs
are met within calorie limits. Moreover, a healthy dietary pattern that
is characterized, in part, by lower intakes of sugar-sweetened foods
and beverages relative to less healthy dietary patterns is associated
with a reduced risk of CVD. Thus, we have determined that there is a
public health need for Americans to be able to determine the amount of
added sugars in a serving of foods and to be able to put that amount
into the context of their total daily diet so that they can consume a
healthy dietary pattern that is lower in added sugars. We have a
legitimate regulatory objective to provide nutrition information to
consumers that includes the added sugars content in a serving of food
to protect the health of United States consumers. The scientific
evidence indicates that requiring disclosure of added sugar content is
necessary to achieving this objective. We address comments related to
international trade in part II.H.3.m.
    We have considered the comment about the possible inclination of
manufacturers to declare added sugars on their labels as a basis for
determining whether to require or permit the declaration of added
sugars on the label and consider the required declaration of added
sugars to be necessary to assist consumers in maintaining healthy
dietary practices. If consumers do not have information on the amount
of added sugars in foods available in the marketplace, they will not be
able to compare products so that they can avoid excess calories from
added sugars and