100 mg/day) in dietary cholesterol (Refs. 55-57).
    (Response) We agree that saturated fat has a larger impact on
raising blood cholesterol levels. We disagree that there is not enough
evidence or that the evidence for the cholesterol-raising effects of
dietary cholesterol is weak or does not exist. Numerous clinical
studies have reported a cholesterol-raising effect of dietary
cholesterol (Ref. 53). Using such studies, the IOM illustrated a
curvilinear relationship between change in dietary cholesterol and
change in serum total cholesterol levels ranging from 0 to 4,500 mg/
day, with the greatest change (increase) in serum cholesterol occurring
with an increased cholesterol intake of up to 50 mg/day.
    The comments about EFSA support mandatory listing of both
cholesterol and saturated fat because EFSA recognizes that intake of
both nutrients have a positive association with blood cholesterol
levels.
    The final rule, therefore, does not change the pre-existing
requirement for mandatory declaration of cholesterol.
    (Comment 111) Some comments opposed to mandatory declaration of
cholesterol noted that the NHLBI Lifestyle Evidence Review (Ref. 17)
states that there is insufficient evidence to determine whether
lowering dietary cholesterol reduced LDL cholesterol in the blood.
    (Response) While we recognize the conclusion of the NHLBI Lifestyle
Evidence Review in addition to blood LDL cholesterol being a surrogate
endpoint for CHD risk, blood total cholesterol is also considered a
valid predictor of CHD risk as approximately 80 percent of total
cholesterol is LDL cholesterol (Ref. 29). The NHLBI Lifestyle Evidence
Review did not review the findings for blood total cholesterol. Much of
the evidence, as was analyzed and reported by the IOM (2002),
demonstrated a positive association between cholesterol intake and
total cholesterol in the blood. While the 2015 DGAC concluded that
there was no appreciable relationship between the consumption of
dietary cholesterol and serum cholesterol, the only information the
DGAC considered was that in the NHLBI Lifestyle Evidence Review, which
was specific to studies that measured LDL cholesterol.
    (Comment 112) One comment opposed to mandatory declaration of
cholesterol stated that clinical trials have identified individuals
across all ages who have very limited or no increase in plasma
cholesterol as a result of additional dietary cholesterol. The comments
said that, even among hyper-responders (high response in blood
cholesterol to dietary cholesterol), the response is an increase in
both LDL and HDL cholesterol levels, such that the LDL/HDL ratio, a key
marker of CHD risk, does not change (Refs. 58-61). Furthermore, the
comments said, the amounts of cholesterol provided in clinical trials
are well in excess of normal consumption.
    (Response) We agree that individual's blood cholesterol levels
respond differently to dietary cholesterol; this difference in
individual response is true for most nutrients when they are associated
with chronic disease risk. We disagree that differences in individual
response is a basis for not considering the numerous studies showing
that cholesterol intake raises average blood cholesterol levels. The
reported findings on blood cholesterol levels from clinical trials
usually represent the averages of these blood levels of the study
subjects, including those who respond and those who do not respond.
Assessment of the average findings from clinical studies is more
relevant because the Nutrition Facts label is intended for the general
U.S. population.
    We also disagree that the ratio of LDL cholesterol to HDL
cholesterol is a key marker of CHD risk. We do not consider HDL
cholesterol, and therefore the LDL:HDL cholesterol ratio, to be a key
marker (i.e., surrogate endpoint) of CHD risk. Blood HDL cholesterol
has not been qualified as being a strong predictor of CHD risk.
Therefore, the evidence on LDL cholesterol outweighs any evidence on
the LDL:HDL cholesterol ratio with respect to evaluating the role of
cholesterol in CHD risk.
    (Comment 113) Some comments opposed to the mandatory declaration of
cholesterol said that the 2010 DGA stated that an egg a day does not
increase blood cholesterol levels, that eggs are not associated with
greater risk of CVD, and that eggs are nutrient-dense. Other comments
cited a number

of studies and meta-analyses (Refs. 62-66) concluding that there was
not an association between egg consumption and CVD or CHD risk.
    (Response) We recognize that the 2010 DGA noted that evidence
suggests that one egg (i.e., egg yolk) per day does not result in
increased blood cholesterol levels, nor does it increase the risk of
cardiovascular disease in healthy people. The 2010 DGAC, however, noted
that, while eggs are a major source of cholesterol in the American
diet, eggs and egg mixed dishes provide 25 percent of total cholesterol
intake. Therefore, we do not consider studies involving only eggs to be
sufficient to understand the role of total cholesterol intake on CVD
risk.
    As for the comments stating that eggs are nutrient-dense, the
mandatory declaration of cholesterol relates to the relationship
between cholesterol intake from consumption of all food sources, as
part of the total daily dietary intake, and risk of CHD. Therefore, the
comment does not change our conclusion about the scientific basis for
the mandatory declaration of cholesterol. As we stated in the preamble
to the proposed rule (79 FR 11879 at 11899), current dietary
recommendations continue to recognize the well-established relationship
between consumption of cholesterol and its effect on blood cholesterol
levels, which are a surrogate endpoint for CHD risk. We continue to
believe that information regarding cholesterol is necessary to assist
consumers in maintaining healthy dietary practices.
    As for the studies cited in the comments, the studies do not imply
that total cholesterol intake (from all dietary sources) does not
contribute to CHD risk. Consequently, rather than view eggs and
cholesterol content in eggs in isolation, our Nutrition Facts label
provides information to help the consumer understand the ``relative
significance'' of eggs and their cholesterol content in the context of
a ``total daily diet'' (see section 2(b)(1)(A) of the NLEA).
    (Comment 114) Some comments opposed to mandatory declaration of
cholesterol stated that dietary cholesterol has been proven to be
unrelated to CVD and CVD mortality. The comments cited review articles
(Refs. 67-68) to assert such studies do not support a connection
between dietary cholesterol and CHD events. The review articles
summarized observational studies, as well as some clinical trials, that
questioned an association between cholesterol intake and risk of CHD.
    (Response) We agree that some observational studies have failed to
support an association between dietary cholesterol and CHD events.
However, we put greater reliance on clinical trials when substantiating
nutrient and disease relationships. Observational studies measure
associations between foods/nutrients and diseases without demonstrating
that the food or nutrient caused, in part, the change in risk of a
chronic disease. The IOM (2002) (Ref. 29) noted that the lack of
consistency in observational studies on dietary cholesterol may be due
to many factors, including inaccuracies of dietary intake data, and to
the limited ability to distinguish the effects of dietary cholesterol,
independent of energy intake and other dietary variables that may be
positively (e.g., saturated fat) or negatively (e.g., dietary fiber
intake) associated with dietary cholesterol and heart disease risk.
Individual studies, as well as an analysis of a number of these studies
(Ref. 29), have demonstrated a positive association between cholesterol
intake and total cholesterol, which is a risk factor of CHD. Therefore,
we rely on the best available data and use clinical trial data more
heavily than observational data when they are available for evaluating
the role of dietary cholesterol in CHD risk. These two review articles
(Refs. 67-68) also cited clinical trial data and noted that, while
dietary cholesterol raises LDL cholesterol, it also raises HDL
cholesterol and therefore does not change the LDL:HDL ratio. While LDL
cholesterol is considered a surrogate endpoint for CHD risk, HDL is
not. Therefore, the LDL:HDL ratio is not relied on for evaluating CHD
risk.
    (Comment 115) One comment opposed to the mandatory declaration of
cholesterol stated that the evidence is questionable for an association
between cholesterol intake and risk of type 2 diabetes.
    (Response) Whether or not the evidence supporting cholesterol's
role in type 2 diabetes risk may be questionable, the basis for
mandatory declaration of cholesterol on the label is because of its
role in CHD risk.
    (Comment 116) One comment opposed to the mandatory declaration of
cholesterol said that overconsumption of cholesterol is not a concern
in the United States. The comment said that the average dietary
cholesterol intake reported by CDC is 307 mg/day for men and 225 mg/day
for women and that, among men, the average consumption exceeds 300 mg/
day by only 2 percent while, among women, the average consumption is 25
percent below 300 mg/day (NHANES 1999-2000).
    (Response) We disagree with the comment. Data from NHANES (2007-
2010) show that, for all individuals over 1 year of age, 32 percent
consume cholesterol in excess of 300 mg/day. For men and women 19 years
of age and older, 59 percent and 17 percent consume in excess of 300
mg/day of cholesterol, respectively. These findings are indicative that
a significant portion of the U.S. population consumes amounts of
cholesterol in excess of the DRV of 300 mg. Therefore, we decline to
make changes in response to this comment.
    (Comment 117) Other comments opposed the mandatory declaration of
cholesterol for several reasons. The comments said that:
     Consumers who want to take care of their blood cholesterol
levels may orient their food choices only towards foods that contain
low amounts of cholesterol, regardless of their saturated fat content.
A focus on saturated fat may lead to better results in terms of public
health.
     Listing cholesterol could have a negative impact on
protein intake. According to the comments, because most meat and other
protein rich foods also contain cholesterol, cholesterol declaration
will likely dissuade consumers from eating protein-rich foods. The
result will be an increase in the consumption of carbohydrate-rich
foods, causing delayed satiety and contributing to increased caloric
consumption.
    (Response) We require declaration of cholesterol on the Nutrition
Facts label pursuant to section 403(q) of the FD&C Act. Cholesterol
intake is related to the risk of CHD. The comments did not provide
information on the impact of the mandatory declaration of cholesterol
on the consumer's intake of saturated fat, protein or carbohydrate-rich
foods. We are not aware of information indicating that mandatory
listing of cholesterol over the past 20 years has resulted in more
focus on cholesterol, less focus on saturated fat, and reduced intake
of protein-rich foods. We consider the declaration of cholesterol is
necessary to assist consumers maintain healthy dietary practices and
are making no changes in response to this comment.
    (Comment 118) One comment said that mandatory declaration of
cholesterol was not necessary because cholesterol consumption has not
been a concern for a long time in treating patients with high
cholesterol levels.
    (Response) The Nutrition Facts label is intended for the general
U.S. population, and nutrient declarations and percent DVs on the label
are to help consumers make more informed choices to consume a healthy
diet and there is a strong relationship between dietary cholesterol
intake and total serum

cholesterol which is a marker of CVD risk (see 79 FR 11879 at 11887 and
part II.C.).
    (Comment 119) One comment opposed to the mandatory declaration of
cholesterol said that the U.S. government's advice to reduce
cholesterol intake is unusual compared to other countries in focusing
on dietary cholesterol. The comment said that dietary recommendations
in other countries, such as Canada, do not have an upper limit for
cholesterol intake and, instead, focus on saturated and trans fat.
    (Response) There is a strong relationship between dietary
cholesterol intake and total serum cholesterol which is a marker of CVD
risk. Section 403(q)(2)(B) of the FD&C Act authorizes us to remove, by
regulation and under certain circumstances, nutrient information. We
would need a scientific basis about the relationship between total
cholesterol intake and CVD risk to no longer require the mandatory
declaration of cholesterol. While other countries may not require the
listing of cholesterol on their food labels, section 403(q)(1)(D) of
the FD&C Act requires the declaration of the amount of cholesterol on
the food label. The fact that other countries lack cholesterol
recommendations is, alone, an insufficient reason for us to no longer
require the mandatory listing of cholesterol.
2. DRV
    Our preexisting regulations, at Sec.  101.9(c)(9), provide a DRV
for cholesterol of 300 mg. In the preamble to the proposed rule (79 FR
11879 at 11899), we discussed how the IOM Labeling Committee had
recommended that the DV for cholesterol (along with saturated fat and
trans fat) be set at a level that is as low as possible in keeping with
an achievable health-promoting diet and how, in the 2007 ANPRM, we
asked for public comment on whether the current DRV for cholesterol of
300 mg should be retained. We also noted that, although the 2010 DGA
recommended that cholesterol intake levels should be less than 200 mg/
day for individuals at high risk of CVD, we considered the DGA
recommendation of 300 mg/day for maintaining normal blood cholesterol
levels as an appropriate basis for setting a DRV because it represents
the maximum intake level that covers the general U.S. population 4
years of age and older (id.). Consequently, we did not propose changes
to the DRV for cholesterol of 300 mg specified in Sec.  101.9(c)(9).
    (Comment 120) One comment did not support a DRV for cholesterol
because cholesterol is made in the body.
    (Response) We agree that cholesterol is made in the body and is
therefore not essential in the diet. However, the basis for the DRV is
an intake level not to exceed to reduce the risk of CHD, rather than an
intake level to achieve (e.g., a DV for essential vitamins and
minerals). Therefore, we decline to revise Sec.  101.9(c)(9) insofar as
a DRV for cholesterol is concerned.

H. Carbohydrate

1. Total Carbohydrate
    a. Calculation of total carbohydrate. Under our preexisting
regulations, at Sec.  101.9(c)(6), total carbohydrate content is
calculated by subtracting the sum of protein, total fat, moisture, and
ash from the total weight of the food. This calculation method is
called ``carbohydrate by difference'' and is described in A.L. Merrill
and B.K. Watt, ``Energy Value of Foods--Basis and Derivation,'' in the
USDA Handbook No. 74 (Ref. 69). Total carbohydrate includes starch,
sugars, sugar alcohols, and dietary fiber.
    We did not propose to change the method for calculating
carbohydrate content.
    (Comment 121) While some comments agreed with our decision to
retain the calculation method for total carbohydrate content, other
comments suggested that dietary fiber should not be included in the
declaration of total carbohydrate. The comments stated that a
significant number of consumers, especially individuals who have
diabetes, want to know the amount of carbohydrates excluding dietary
fiber (also known as ``net carbs'') because it is helpful to know when
trying to control blood glucose. One comment recommended that
carbohydrate should be calculated by difference, but that moisture,
fat, protein, dietary fiber, and ash should be excluded from the
declaration of carbohydrate. The comment suggested that the benefits of
such an approach include easy comparison of carbohydrates between food
choices that do or do not contain dietary fiber, easy calculation of
calories from carbohydrates with a value of 4 calories per gram, and
easy calculation of calories from dietary fiber with a value of
approximately 2 calories per gram. In addition, the comment stated that
such an approach would encourage manufacturers to increase the dietary
fiber content of their product without increasing the carbohydrate
content of their product and that it would simplify consumer education
and understanding. The comment further stated that nutrient databases
can easily exclude dietary fiber from the calculation of carbohydrate
because analytical laboratories are easily able to determine total
carbohydrate by excluding protein, total fat, moisture, dietary fiber,
and ash from the total weight of the food and nutrient composition
tables will continue to change on a regular basis to provide new and
updated data.
    (Response) We decline to change the current method of calculating
carbohydrate by difference. Total carbohydrate is one of the
macronutrients and includes starch, sugars, sugar alcohols, and fiber.
As discussed in the preamble to the proposed rule (79 FR 11879 at
11900), dietary fibers, with the exception of lignin, are considered
carbohydrates and are listed as a subset of total carbohydrate on the
label. Individuals who are interested in knowing the amount of
carbohydrate in a serving of a product less the amount of dietary fiber
may determine this information based on what is currently declared on
the label. Because dietary fibers are a type of carbohydrate, to
maintain consistency with how components of macronutrients are declared
on the label, we decline to remove dietary fiber from the calculation
of total carbohydrate, as suggested by the comments.
    With respect to comments suggesting that dietary fiber should be
excluded from the calculation of total carbohydrate because such a
change would be helpful to diabetics when managing their blood sugar
levels, we disagree that this should be a reason to remove dietary
fiber from the declaration of carbohydrate. The information found in
the Nutrition Facts and Supplement Facts labels is not targeted to
individuals with acute or chronic diseases, such as diabetics (see part
II.B.2; 79 FR 11879 at 11887).
    We also disagree that removal of dietary fiber from the declaration
of total carbohydrate would allow consumers to compare products that do
and do not contain dietary fiber more easily. It is not clear how the
comparison would be made easier by removal of dietary fiber from the
total carbohydrate declaration because, if the consumer is interested
in knowing how much dietary fiber is in a product, the consumer can
take that information into consideration by looking for the declaration
of the amount of dietary fiber on the label.
    Calories from total carbohydrate may be declared voluntarily on the
label. We discuss calculation of calories from total carbohydrate in
greater detail later in

this part. We agree that additional steps are necessary to calculate
calories from total carbohydrates when dietary fiber is included in the
declaration. However, we did not receive any comments that the
calculation of total carbohydrate when dietary fiber is included in the
declaration would be unnecessarily burdensome or difficult for
manufacturers to perform. The calculation would not require additional
laboratory analysis or expense.
    We disagree that exclusion of dietary fiber from the declaration of
total carbohydrate would encourage manufacturers to raise dietary fiber
values independent from raising carbohydrate values. So long as the
dietary fiber added to a product meets our definition of dietary fiber,
the additional fiber added by the manufacturer would be reflected in
the dietary fiber declaration. Consumers who are interested in
consuming more dietary fiber may use the dietary fiber declaration to
determine which products they purchase. Therefore, it is not clear how
removing dietary fiber from the declaration of carbohydrate on the
label would encourage manufacturers to add dietary fiber to their
products.
    With respect to the assertion that exclusion of dietary fiber from
the calculation of total carbohydrate simplifies the education process
and understanding for consumers, absent additional information, we are
unable to judge whether such a change would lead to better
understanding of the total carbohydrate and/or dietary fiber
declaration on the label, and thus, whether consumers would benefit
from such a change in how carbohydrate is calculated.
    With respect to the comment asserting that nutrient databases can
easily exclude dietary fiber from the calculation of carbohydrate, we
disagree that this is a reason to exclude dietary fiber from the
calculation of total carbohydrate. Although nutrient databases may be
updated, we decline to exclude dietary fiber from the calculation of
total carbohydrate because dietary fiber is a carbohydrate and should
be declared as such to maintain consistency with how other
macronutrients are determined and declared on the label.
    (Comment 122) One comment encouraged us to conduct consumer studies
to examine if the separation of dietary fiber from total carbohydrate
on the label would benefit the overall use of the Nutrition Facts label
as a tool for nutrition literacy and education.
    (Response) We are always interested in understanding how consumers
interpret and use information on the label. However, we are not aware
of a specific need, and the comment did not specify how this
information could aid consumers. Therefore, we decline to conduct these
studies. We will consider conducting such studies if we have
information showing that there is a need for these studies and we have
the resources available to conduct such studies.
    b. Classification of carbohydrates based on a chemical definition
or physiological effect. The preamble to the proposed rule (79 FR 11879
at 11900 through 11901) discussed how the 2007 ANPRM invited comment on
whether carbohydrates should be classified and declared in nutrition
labeling based on their chemical definition (which is the current
method) or on their physiological effect (e.g., attenuation of blood
sugar or laxation), and whether additional types of carbohydrates
(e.g., starch) should be listed separately on the Nutrition Facts
label. We explained that carbohydrates include starch, sugars, sugar
alcohols, and dietary fibers and that different carbohydrates have
different physiological effects (id. at 11901). Within the different
types of carbohydrate (i.e., starch, sugars, sugar alcohols, and
dietary fibers), too, specific carbohydrates may have different
physiological effects (e.g., different types of dietary fibers) making
it difficult to apply a definition that is based on physiological
effects across a category of carbohydrates. Furthermore, analytical
methods for measuring different types of carbohydrates are based on
chemical structure rather than physiological effect. Given the various
components of total carbohydrate and different types of physiological
effects of each, we decided not to change our provisions for the
classification or declaration of carbohydrates specified in Sec.
101.9(c)(6).
    (Comment 123) One comment recommended that complex carbohydrates
should be listed separately under total carbohydrate on the label. The
comment stated that people do not understand that they have to subtract
in order to get an idea of how much good carbohydrates are in a food
product.
    (Response) We decline to list complex carbohydrates separately on
the label. The comment did not provide any information to explain what
is considered to be a ``complex'' or ``good carbohydrate,'' and it did
not explain what subtraction method can be used to calculate ``good''
or ``complex'' carbohydrates from information found on the label.
    We have allowed for voluntary declaration of ``other carbohydrate''
on the Nutrition Facts label (Sec.  101.9(c)(6)(iv)). Our regulations
define ``other carbohydrate'' as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared, ``other carbohydrate'' is
defined as the difference between total carbohydrate and the sum of
dietary fiber and sugars (Sec.  101.9(c)(6)(iv)). Thus, the category of
``other carbohydrate'' includes what are typically considered to be
complex carbohydrates. As discussed in part II.H.6, the final rule does
not permit the category of ``other carbohydrate'' to be declared on the
label.
    c. Separate declaration of additional individual types of
carbohydrates. In the preamble to the proposed rule (79 FR 11879 at
11901), we discussed how the 2007 ANPRM asked whether additional types
of carbohydrates (e.g., starch) should be listed separately on the
Nutrition Facts label. We stated that the comments we received in
response to the 2007 ANPRM did not support the declaration of
additional types of carbohydrates (e.g., starch). Thus, the proposed
rule would not require the separate declaration of additional types of
individual carbohydrates, such as starch, on the Nutrition Facts label.
    (Comment 124) Several comments discussed Allulose. Allulose (also
known as psicose) is a monosaccharide that is derived from fructose.
According to the comments, Allulose is approximately 70 percent as
sweet as sucrose, but contributes less than 0.2 calories/gram to the
diet. The comments said that Allulose is added to foods and beverages
as a partial replacement for sugars and/or high-fructose corn syrup
because of its low, near zero, calorie content and other organoleptic
properties (e.g. mouthfeel, texture, etc.).
    One comment said we should not include Allulose in the declaration
for total carbohydrate and added sugar. In contrast, another comment
said Allulose should be included in the declaration of ``total
carbohydrate'' for nutrition labeling purposes, but should not be
included in the declaration of ``sugars'' or ``added sugars.'' The
comments suggested that Allulose does not have the metabolic properties
of fructose or other sugars and does not contribute calories or raise
blood sugar levels like other sugars do. The comments said that, upon
ingestion, approximately 70 percent of Allulose is unabsorbed in the
small intestine, passes into the bloodstream and is then excreted in
the urine, without significant metabolism; the other 30 percent that is
not absorbed

is transported to the large intestine where it is not fermented.
Allulose is then excreted without being absorbed (Refs. 70-71).
    One comment stated that, when Allulose is used in food, there
should be a reduction in the amount of calories declared of 4 calories/
gram.
    (Response) On April 10, 2015, we received a citizen petition from
Tate & Lyle Ingredients Americas LLC (Docket Number FDA-2015-P-1201)
requesting that Allulose be exempt from being included as a
carbohydrate, sugars, or added sugar in the Nutrition Facts label on
foods and beverages. The petition provided data and other information
suggesting that Allulose is different from other sugars in that it is
not metabolized by the human body, has negligible calories (0.2
calories per gram or less), does not contribute to increases in blood
glucose or insulin levels, and, if included as carbohydrates and sugars
(added sugars) on the Nutrition Facts label, would lead to consumer
confusion, particularly consumers with diabetes or consumers otherwise
concerned with accurately monitoring blood glucose. The petition, which
was submitted after the comment period for the proposed rule had ended,
provided new evidence that was not previously submitted in comments to
the proposed rule. We need additional time to fully consider the
information provided in the comments and the citizen petition.
Therefore, the final rule does not reach a decision as to whether
Allulose should be excluded from the labeling of carbohydrate, sugars
and/or added sugars, and Allulose, as a monosaccharide, must be
included in the declaration of each pending any future rulemaking that
would otherwise exclude this substance from the declaration.
    d. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act
requires the declaration of total carbohydrate, and our preexisting
regulations, at Sec.  101.9(c)(6), require the declaration of the
amount of total carbohydrate on the Nutrition Facts label. In the
preamble to the proposed rule (79 FR 11879 at 11901), we said that
carbohydrates are an essential part of the diet because they provide
energy to the cells in the body, especially the brain, which is
dependent on carbohydrate for proper functioning, and we tentatively
concluded that the declaration of carbohydrates on the Nutrition Facts
label continues to be necessary to assist consumers in maintaining
healthy dietary practices.
    (Comment 125) Many comments supported the continued mandatory
declaration of total carbohydrates; some comments stated that the
reason that total carbohydrates should continue to be declared on the
label is because the information is used by individuals who have
diabetes to ``count carbs.''
    (Response) While we agree that total carbohydrates should continue
to be declared on the label, we disagree with the comments' rationale
for the continued mandatory labeling of total carbohydrates. As
discussed in part II.B.2, the information on the label is intended for
the general healthy population rather than individuals with chronic
diseases such as diabetes. In the preamble to the proposed rule (79 FR
11879 at 11901), we explained that carbohydrates are an essential part
of the diet because they provide energy to the cells in the body,
especially the brain, which is dependent on carbohydrate for proper
functioning. Thus, the declaration of carbohydrates on the Nutrition
Facts label continues to be necessary to assist consumers in
maintaining healthy dietary practices, and so the final rule does not
change the requirement in Sec.  101.9(c)(7) for mandatory labeling of
total carbohydrate.
    e. DRV. The DRV for total carbohydrate is 300 grams (Sec.
101.9(c)(9)). Consistent with calculating total carbohydrate ``by
difference,'' the proposed rule would not change the approach to
calculate the percent DV for carbohydrate ``by difference'' as well. In
addition, the proposed rule would not change the DRVs for fat or
protein (see parts II.F.1.c, II.F.2.c, II.F.3.c, II.F.4.b, and II.I.3),
which are used to derive the DRV for total carbohydrate. The DRV for
total carbohydrate would remain at 300 grams/day. We note that the RDA
for carbohydrate for men and women 19 years of age and older is 130
grams/day. Therefore, the DRV should not be viewed as an intake
requirement, but as a reference amount.
    (Comment 126) One comment said we should no longer require a
percent DV declaration for total carbohydrate because consumption of
some carbohydrates, such as naturally occurring sugars from fruit and
milk, are not a public health concern.
    (Response) We disagree with the comment that the percent DV
declaration for total carbohydrate should no longer be required. Total
carbohydrate is one of the three major macronutrients in the diet. It
provides basic information about a food's nutrient profile. The percent
DV declaration for total carbohydrate helps consumers put the amount of
total carbohydrate in a serving of a food into the context of their
total daily diet.
    (Comment 127) One comment supported maintaining the current DRV for
total carbohydrate of 300 grams. The comment stated that it falls
within the AMDR range. In addition, the comment said, although there is
an EAR and RDA for total carbohydrate, neither is appropriate or needed
to serve as the basis for the DRV because relevant public health
concerns are the ratio of carbohydrate to total fat and the source and
type of carbohydrate in the diet.
    Other comments suggested that the DRV of 300 grams is too high and
that we should take a different approach to setting the DRV for total
carbohydrate. One comment stated that, even though the DRV should not
be viewed as an intake requirement, but rather as a reference amount,
consumers often perceive it as recommended amount. The comment
recommended using the population-weighted mid-point of the AMDR for
adults and children of 275 grams to encourage reduction in carbohydrate
consumption. The comment suggested that the current DRV of 300 grams is
excessive given that the RDA for carbohydrate for adults 19 years of
age and older is 130 grams/day, and that excessive carbohydrate intake
is a central cause of the American obesity epidemic.
    Another comment recommended reducing the DRV for total carbohydrate
because the American population is sedentary and prone to metabolic
syndrome. The comment also referred to the current DRV of 300 grams as
a recommended intake level for a daily energy intake of 2,000 calories.
    (Response) We agree with the comments recommending a reduction in
the DRV for total carbohydrate, but for different reasons. We disagree
with the comment that recommended decreasing the DRV for total
carbohydrate because the American population is sedentary and prone to
metabolic syndrome. It is unclear, based on the comment, what the
comment is suggesting regarding the relationship between consumption of
carbohydrates and a sedentary lifestyle or risk of metabolic syndrome.
Furthermore, we disagree with the comment that the current DRV is a
recommended intake level. As stated in the preamble to the proposed
rule (79 FR 11879 at 11901), the DRV should not be viewed as an intake
requirement, but as a reference amount.
    We agree that neither the EAR or RDA values for total carbohydrate
are appropriate to serve as the basis for a DRV, but we agree for
different reasons than those stated in the comment. As discussed in the
preamble to the proposed rule (79 FR 11879 at 11901), the EAR and RDA
values set by the IOM

do not include sugar alcohols or dietary fiber. Our calculation of
total carbohydrate, for the purposes of nutrition labeling, accounts
for all types of carbohydrates, including sugar alcohols and dietary
fiber. Therefore, using the EAR and RDA to set a DRV for total
carbohydrate would result in a reference value that is based on
recommendations specifically for sugars and starches. As we stated in
the preamble to the proposed rule (id.), if the midpoint of the AMDR
range is used as the basis for the DRV, there would be a discrepancy in
what carbohydrates are encompassed in the information provided on the
label for the absolute gram amount versus the percent DV.
    The current DRV for total carbohydrate of 300 grams is calculated
based on 60 percent of a 2,000 calorie diet ((0.60 x 2,000 calories)/4
calories per gram of carbohydrate = 300 grams). The percentage of
calories contributed by total fat, total carbohydrate, and protein add
up to 100 percent on the label. The DRV for carbohydrate of 60 percent
of a 2,000 calorie diet is determined by the difference of what is left
over by the DRVs for total fat and protein and 100 percent. As
discussed in part II.F.1, we are increasing the DRV for total fat from
30 to 35 percent. Therefore, in order for the percentages of calories
contributed by total fat, total carbohydrate, and protein to add up to
100 percent, either the percentage of calories contributed by the DRV
for total carbohydrate or protein needs to decrease. Some comments
suggested that the DRV for total carbohydrates be decreased, and the
DRV for total carbohydrate is significantly greater than the RDA for
carbohydrate for adults 19 years of age and older of 130 grams/day.
Reducing the DRV for protein to 5 percent of calories to account for
the 5 percent increase in the DRV for fat would result in a DRV value
of 25 grams of protein, which is below the RDA for protein for children
and adults 9 years and older. Therefore, we conclude that the DRV for
total carbohydrate should be decreased from 60 percent of calories to
55 percent of calories for a DRV of 275 grams.
    f. How total carbohydrates appears on the label.
    (Comment 128) Several comments discussed the placement of
carbohydrates on the label itself. One comment said that consumers need
to be made aware of the fact that carbohydrates are sugars chemically
because, according to the comment, most consumers believe that
carbohydrates and sugars are two distinct nutrients. The comment would
place the word ``sugars'' in parentheses next to ``Total Carbs'' or
place ``Total Carbs'' in parentheses next to ``Total Sugars.''
    (Response) We disagree that carbohydrates are chemically sugars.
Although the body converts carbohydrates to sugars, the chemical
structure of some carbohydrates (e.g., starches) differs from the
chemical structure of sugars. Sugars are a subset of carbohydrates and
are declared as such on the label. Some examples of carbohydrates
include sugars, such as sucrose and lactose, and polysaccharides, such
as cellulose, glycogen, and starch. Therefore, we decline to change the
label's format as suggested by the comment.
    (Comment 129) Some comments would move ``Total Carbohydrates'' to
the top of the list of declared nutrients on the label. The comments
cited the significant rise in diabetes and the need to make the
declared amount of total carbohydrates more prominent on the label.
    (Response) We disagree that the increase in diabetes in the United
States is a reason to move total carbohydrates to the top of list of
declared nutrients on the label. As stated in part II.B.2, the intended
purpose of information on the Nutrition Facts label is to assist the
general healthy population in maintaining healthy dietary practices.
    (Comment 130) One comment recommended listing the amount of total
carbohydrate in a product in teaspoons rather than grams. The comment
said that people do not understand what gram of carbohydrate would look
like and providing the information in teaspoons would be more helpful
for consumers.
    (Response) We decline to revise the rule as suggested by the
comment. We address arguments regarding the use of household measures,
rather than in gram amounts on the label, in part II.B.3.
    g. Calculation of calories from carbohydrate. Our preexisting
regulations, at Sec.  101.9(c)(1)(i)(C), require that the calories from
total carbohydrate be calculated by using the general factor of 4
calories/gram of carbohydrate less the amount of insoluble dietary
fiber. The proposed rule also would revise the definition of dietary
fiber so that only those dietary fibers that we have determined to have
a physiological effect that is beneficial to human health would be
considered to be ``dietary fiber'' on the Nutrition Facts label. For
the purposes of calculating calories from carbohydrate, when it is
voluntarily declared, all soluble and insoluble non-digestible
carbohydrates should be excluded from the calculation, not just those
known to meet the definition of dietary fiber. To ensure that all
soluble and insoluble non-digestible carbohydrates are excluded from
the calculation of calories from carbohydrate, we proposed to amend
Sec.  101.9(c)(1)(i)(C) to require that calories from carbohydrate be
calculated using a general factor of 4 calories/g of total carbohydrate
less the amount of non-digestible carbohydrates and sugar alcohols, and
the caloric value of each (the non-digestible carbohydrates and sugar
alcohols) is then added to the sum of the carbohydrates.
    We did not receive any comments on this proposed amendment, and so
we have finalized the rule without change.
2. Sugars
    a. Definition. Our preexisting regulations, at Sec.
101.9(c)(6)(ii), define sugars as a statement of the number of grams of
sugars in a serving. They are the sum of all free mono and
disaccharides (e.g., glucose, fructose, lactose, and sucrose). We
considered whether we should continue to require mandatory declaration
of sugars on the label in the proposed rule, but tentatively concluded
that the declaration of sugars continues to be necessary to assist
consumers in maintaining healthy dietary practices, and thus did not
propose to change the current requirement for mandatory declaration of
sugars (79 FR 11879 at 11902).
    As discussed in the total carbohydrates section at part II.H.1,
some comments and a citizen petition said we should exclude Allulose
from the declaration of sugars. We discuss those comments in part
II.H.1 (see comment 124).
    b. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act
requires the declaration of sugars, and our preexisting regulations, at
Sec.  101.9(c)(6)(ii), require the declaration of sugars on the
Nutrition Facts label. We did not propose to change this requirement.
    (Comment 131) Several comments supported the continued mandatory
declaration of sugars. One comment stated that sugars should continue
to be labeled as part of total carbohydrate because they are a type of
carbohydrate. The comment added that the amount of declared sugar is
possible to quantify, easy to verify using analytical methods, and is
information that is easily understood by consumers, nutritionists, and
health professionals.
    In contrast, other comments asked us to remove sugars from the
label or replace it with a declaration of added sugars or ``fruit &
milk sugars.'' The

comments recommending replacement of sugars with added sugars said that
consumers, including individuals who have diabetes, focus on the sugars
instead of the total carbohydrate amount declared on the label. One
comment suggested that, when registered dietitians provide Medical
Nutrition Therapy for diabetics, the sugars line is not valuable and
contributes to information overload. The comment also stated that the
sugars declaration makes consumers reluctant to eat foods, such as
fruit and milk, which contain sugars as their source of carbohydrates.
    One comment would replace sugars with fruit and milk sugars and
place the new heading directly under dietary fiber; the comment said
this change would clearly distinguish added sugars from naturally
occurring sugars in whole fruit and from sugars from dairy ingredients
and also eliminate the need for a double indentation (for declaration
of added sugars) under the ``Total Carbs'' heading. The comment cited
data from an online survey of 500 participants showing that, when
``Sugars'' is replaced with ``Fruit & Milk Sugars'' on the Nutrition
Facts label, significantly more individuals were able to correctly
identify the amount of naturally occurring sugars in one serving of the
food (Ref. 72).
    (Response) We decline to remove the declaration of sugars from the
label because consumption of sugars continues to be associated with an
increased risk of dental caries; thus, the information continues to be
necessary to assist consumers in maintaining healthy dietary practices.
We agree that sugars should continue to be labeled as part of total
carbohydrate and that the amount of total sugars can be quantified
using existing analytical methods.
    Similarly, we disagree with the comments suggesting that the total
sugars declaration should be removed from the label because consumers,
especially individuals with diabetes, focus on the sugars declaration
rather than the total carbohydrate declaration and may be overwhelmed
by the information. The comments did not provide data or other
evidence, nor are we aware of such data or evidence, to support this
assertion. The total carbohydrate and sugars declaration has been on
the label for over 20 years. Furthermore, as noted in part II.B.2, the
information on the label is intended for the general healthy population
and not for individuals with chronic diseases, such as diabetes.
    Likewise, we are unable to evaluate whether the sugars declaration
results in a reluctance to consume foods, such as fruit or milk, which
are natural sources of sugars because the comment did not provide data
or information, and we are not aware of such data or information, to
support this assertion.
    We disagree with the comment which would replace ``Sugars'' with
``Fruit & Milk Sugars'' on the Nutrition Facts label. Total sugars
continue to be associated with risk of dental caries. Furthermore, our
definition of added sugars includes (see part II.H.3.n) some fruit and
milk sugars, such as sugars found in concentrated fruit juice that is
not reconstituted to 100 percent fruit juice.
    c. Changing ``Sugars'' to ``Total Sugars''. In the preamble to the
proposed rule (79 FR 11879 at 11902), we said that we were considering
whether to use the term ``Total Sugars'' instead of ``Sugars'' on the
label if we finalize a declaration of added sugars. We also said that
we planned to conduct consumer research that would include, among other
things, questions regarding the declaration of added sugars on the
Nutrition Facts label in order to help or enhance our understanding of
how consumers would comprehend and use this new information, and to
inform education efforts (id.). In the supplemental proposed rule (80
FR 44303 at 44306, 44308), we discussed the results of our consumer
research which showed that when an ``Added Sugars'' declaration was
indented below a ``Total Sugars'' declaration on the label,
participants appeared to be better able to comprehend the total amount
of sugars in a food than if an ``Added Sugars'' declaration was
indented below a ``Sugars'' declaration. In the supplemental proposed
rule (id. at 44304), we asked for comment on whether the term ``Total
Sugars'' should be declared on the label instead of ``Sugars.''
    The final rule uses the term ``Total Sugars'' to replace the
declaration of ``Sugars.'' We explain our rationale and respond to
comments on this change in part II.H.3.
    d. DRV. Our preexisting regulations do not specify a DRV for
sugars. In the preamble to the proposed rule (79 FR 11879 at 11902), we
explained that consensus reports did not set dietary reference values
based on which we could derive an appropriate DRV for total sugars.
Therefore, we did not propose to establish a DRV for total sugars.
    (Comment 132) Some comments submitted in response to the proposed
rule agreed that there is insufficient information to establish a DRV
for sugars. However, others comments recommended establishing a DRV and
requiring mandatory declaration of a percent DV for sugars. One comment
stated that such information would help consumers choose food and
beverages that are low in sugar. Another comment said that, with
``skyrocketing'' overweight, obesity, and their co-morbidities, a
percent DV for sugar would be a useful tool for informing consumers of
sugar content and would help consumers make better choices. The comment
said that the declaration could help consumers to visually understand
approximately how much sugar they should be getting each day and how
much sugar they are actually consuming. One comment suggested that a
declaration of a percent DV for sugars would allow consumers to compare
products more easily.
    Other comments said that a DRV for sugars could be based on
recommendations from the World Health Organization or the American
Heart Association. One comment said that the National Institutes of
Health should ask the IOM to set a suggested limit on how much sugar
one should consume on a daily basis.
    (Response) We decline to set a DRV for sugars or to require the
declaration of a percent DV for sugars. We are not aware of data or
information related to a quantitative intake recommendation for sugars
that we could use as the basis for a DRV for total sugars.
    With respect to the comments suggesting that the World Health
Organization (WHO) or the American Heart Association (AHA) could give
us a basis to establish a DRV, we acknowledge that the WHO recently
released guidelines for sugars intake for adults and children (Ref.
73). The WHO recommends reducing the intake of free sugars to less than
10 percent of total energy intake in both children and adults. It also
provided a conditional recommendation which suggested further reduction
of the intake of free sugars to below 5 percent of total energy intake.
The WHO defines ``free sugars'' as monosaccharides and disaccharides
added to foods and beverages by the manufacturer, cook, or consumer,
and sugars naturally present in honey, syrups, fruit juices and fruit
juice concentrates (Ref. 73). The WHO definition of ``free sugars'' is
not consistent with our definition of ``sugars'' because the WHO
definition does not include all free mono and disaccharides. It
excludes some naturally occurring sugars, such as lactose. Therefore,
we disagree that the WHO's recommendations could be used to establish a
DRV for sugars. The AHA recommended limits for intake of added sugars
and not total sugars (Ref. 74). Therefore, it would not be appropriate

to use the AHA recommendations to establish a DRV for total sugars.
    As for the comment suggesting that the IOM could set a maximum
intake recommendation, the IOM reviewed the evidence on this topic in
the Macronutrient report (Ref. 75). As discussed in the preamble to the
proposed rule (79 FR 11879 at 11902), the IOM found an association
between sugar consumption and risk of dental caries, but, due to the
various factors that contribute to dental caries, the IOM could not
determine an intake level of sugars that is associated with increased
risk of dental caries and, therefore, did not have sufficient evidence
to set a UL for sugars.
    e. Seasonal variation in sugars content.
    (Comment 133) One comment noted that, depending on the time of
year, the sugar content of fruit changes, which could impact the sugar
content of products to which fruit is added. The comment questioned
whether the product labels have to change throughout the year to
reflect the seasonal variation in sugar content of the fruit or fruit
juice in a product. The comment also questioned if the seasonal
variation in the sweetness of fruit is compensated for by adjusting the
amount of sugar alcohols in the product and whether a label change
would be required. Another comment suggested that sugars may be added
to fruits and vegetables to achieve a standard flavor profile and said
that the amount of sugars added to the food may change throughout the
year.
    (Response) Our compliance requirements in Sec.  101.9(g)(5) state
that a food with a label declaration of calories, sugars, total fat,
saturated fat, trans fat, cholesterol, or sodium shall be deemed to be
misbranded under section 403(a) of the FD&C Act if the nutrient content
of the composite is greater than 20 percent in excess of the value for
that nutrient declared on the label. However, no regulatory action will
be based on a determination of a nutrient value that falls above this
level by a factor less than the variability generally recognized for
the analytical method used in that food at the level involved. This
approach takes into account seasonal variability as well as variability
due to the analytical method used. Therefore, so long as the
variability in the sugars content of the fruit does not cause the total
sugars comment to be greater than 20 percent in excess of the declared
value, the manufacturer of a product containing fruit would not be in
violation of the regulation. The manufacturer is in the best position
to determine if and when a label change is needed based on the total
sugar content and the amount of sugars or sugar alcohols added to
standardize the flavor profile of the food.
    The declaration of the amount of sugar alcohols on the Nutrition
Facts label is voluntary, so if a manufacturer uses sugar alcohols to
account for the variation in the sugar content of the product, the
label would only need to change if the amount of sugar alcohol is
voluntarily declared on the label. However, if a food product does not
typically contain a certain sugar alcohol which is added to adjust for
the sugars content of fruit, that sugar alcohol would need to be
declared in the ingredient list.
3. Added Sugars
    In the preamble to the proposed rule, we explained that current
regulations neither define the term ``added sugars'' nor require or
permit the declaration of added sugars on the label. We considered
requiring the declaration of added sugars taking into account new
information. We tentatively concluded that the declaration of added
sugars on the label is necessary to assist consumers to maintain
healthy dietary practices, and we proposed to require the declaration
of the amount of added sugars in a serving of a product (79 FR 11879 at
11905). We are finalizing the requirement for mandatory labeling of
added sugars in Sec.  101.9(c)(6)(iii), and our rationale for doing so
is discussed in this section below.
    We have requirements for label statements that must be made if a
product contains an insignificant amount of many nutrients on the label
such as carbohydrate, sugars, and dietary fiber. We also have
requirements for when the nutrient content can be expressed as zero. We
proposed that a statement of added sugars content would not be required
for products that contain less than 1 gram of added sugars in a serving
if no claims are made about sweeteners, sugars, or sugar alcohol
content and we are finalizing this requirement, as proposed, in Sec.
101.9(c)(6)(iii). We proposed to require that the phrase ``Not a
significant source of added sugars'' be placed at the bottom of the
table of nutrient values if a statement of the added sugars content is
not required, and as a result, is not declared. Alternatively, we
proposed to permit the use of the alternative statements ``Contains
less than 1 g'' and ``less than 1 g'' to be declared. We also proposed
to permit the added sugars content to be expressed as zero if a serving
of food contains less than 0.5 grams of added sugars. We are finalizing
the requirements for when label statements if a product contains an
insignificant amount of added sugars and for when the added sugars
content may be expressed as zero, as proposed, in Sec.  101.9(c)(6).
    Because our preexisting regulations do not define ``added sugars,''
the proposed rule would define ``added sugars'' as sugars that are
added during the processing of foods, or are packaged as such, and
include sugars (free, mono- and disaccharides), syrups, naturally
occurring sugars that are isolated from a whole food and concentrated
so that sugar is the primary component (e.g. fruit juice concentrates),
and other caloric sweeteners. A summary of the comments regarding our
proposed definition of added sugars, and our responses to those
comments, can be found in part II.H.3.a.
    In February 2015, the 2015 DGAC submitted the 2015 DGAC Report to
the Secretaries of the U.S. Department of Health and Human Services and
the U.S. Department of Agriculture. The 2015 DGAC reaffirmed
recommendations in the 2010 DGA, which included recommending the
reduction of added sugars intake. For the first time, the 2015 DGAC
conducted a systematic review of the evidence related to dietary
patterns and health outcomes, including cardiovascular disease (CVD),
body weight and type 2 diabetes, cancer, congenital abnormalities,
neurological and psychological illness, and bone health. The 2015 DGAC
concluded that there is strong and consistent evidence that healthy
dietary patterns characterized, in part, by lower intakes of sugar-
sweetened foods and beverages relative to less healthy patterns, are
associated with a reduced risk of CVD. We considered the evidence that
the 2015 DGAC relied upon in making its determinations, and tentatively
concluded, in the preamble to the supplemental proposed rule (80 FR
44303), that this information provides further support for our proposal
to require the mandatory declaration of the amount of added sugars in a
serving of a product on the label.
    The proposed rule would not establish a DRV for added sugars. We
explained, in the preamble to the proposed rule (79 FR 11879 at 11906),
that the USDA Food Patterns specify the maximum amount of calories from
solid fats and added sugars that can be consumed at each calorie level,
while staying within calorie limits. A 2,000 calorie diet could contain
approximately 260 calories from solid fats and added sugars (id.). The
limit of 260 calories served as a reference to ensure the selection of
a nutrient dense

diet without excess discretionary calories from added sugars and solid
fats. These limits established for calories from solid fats and added
sugars in the USDA Food Patterns are based on food pattern modeling.
Because the limits are not based on any biomarker of risk of disease
from an independent relationship between a nutrient and chronic disease
risk we stated that we did not have a quantitative intake
recommendation upon which a DRV for added sugars could be derived. The
statement was not intended to suggest a limitation for when we can
mandate a nutrient declaration in the nutrition label, as some comments
seem to suggest. The 2015 DGAC further evaluated limits for added
sugars in the diet based, in part, on food pattern modeling and
recommended that Americans limit their intake of added sugars to a
maximum of 10 percent of total daily caloric intake. The 2015 DGAC said
that its recommendation was supported by a food pattern modeling
analysis conducted by the 2015 DGAC and the scientific evidence review
on added sugars and chronic disease risk. In the preamble to the
supplemental proposed rule (80 FR 44303 at 44308), we reconsidered our
tentative conclusion that a DRV for added sugars could not be
established and proposed to establish a DRV for added sugars of 10
percent of total energy intake from added sugars and to require the
declaration of the percent DV for added sugars on the label.
    Thus, we have scientific evidence to support a limit for added
sugars that can serve as the basis for a DRV for added sugars. The
limit for calories from added sugars to less than 10 percent of
calories is a reference value that is appropriate for use as a DRV for
added sugars. The DRV is used to calculate the percent DV, and a
percent DV provides information that Americans can use to determine how
the amount of added sugars in a serving of food contributes to his or
her individual total daily diet. The food pattern modeling used to
support a limit in the intake of added sugars to less than 10 percent
of calories was used to create the USDA Food Patterns. The USDA Food
Patterns provide suggested amounts of food to consume from the basic
food groups, subgroups, and oils to meet recommended nutrient intakes
at 12 different calorie levels. They can be used by Americans to
construct a healthful dietary pattern that is consistent with current
recommendations. We have concluded that evidence on dietary patterns
and health outcomes showing that healthy dietary patterns
characterized, in part, by lower amounts of sugar-sweetened foods and
beverages are associated with a reduced risk of CVD supports a
mandatory declaration of added sugars. Both the USDA Food Patterns and
the dietary patterns and health outcomes analysis that were discussed
in the 2015 DGAC Report provide information about healthy dietary
patterns. Therefore, the DRV of 10 percent of calories and the
mandatory declaration of the amount of added sugars in a serving of
food are related to providing information that will assist consumers in
constructing a healthy dietary pattern.
    On January 7, 2016, the Secretaries of the U.S. Department of
Health and Human Services and the U.S. Department of Agriculture
released the 2015-2020 DGA (Ref. 28). The 2015-2020 DGA focuses on
eating patterns in addition to nutrients and foods because healthy
dietary patterns may be more predictive of overall health status and
disease risk than individual foods or nutrients. A key recommendation
of the 2015-2020 DGA is to limit calories from added sugars and
saturated fats and reduce sodium intake. In order to achieve this
recommendation, the 2015-2020 DGA says that Americans should consume an
eating pattern that is low in added sugars. Another key recommendation
of the 2015-2020 DGA is to consume less than 10 percent of calories per
day from added sugars. The 2015-2020 DGA is consistent with the
recommendations and the science presented in the 2015 DGAC Report. We
considered the scientific evidence in the 2015 DGAC Report related to
dietary patterns, as well as evidence related to limiting calories from
added sugars that served as our basis for proposing a DRV for added
sugars of 10 percent of total calories.
    Throughout this part, we refer to the underlying scientific
evidence that we have reviewed and considered which supports our basis
for the mandatory declaration of the amount of added sugars in a
serving of a product, the DRV, and the declaration of the percent DV
for added sugars. The need for a mandatory declaration of added sugar
is supported by strong and consistent evidence that dietary patterns
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 relative to less healthy dietary
patterns; regular consumption of nuts and legumes; moderate consumption
of alcohol; lower in saturated fat, cholesterol, and sodium and richer
in fiber, potassium, and unsaturated fats are associated with a
decreased risk of CVD. The scientific evidence from the 2010 DGA
supporting that consumption of excess calories from added sugars can
lead to a less nutrient-dense diet, current consumption data showing
that Americans are consuming too many calories from added sugars, and
the strong evidence that greater intake of sugar-sweetened beverages is
associated with increased adiposity in children also support mandatory
declaration of added sugars.
    We reviewed and considered the evidence that the 2015 DGAC relied
upon for its conclusion that healthy dietary patterns characterized, in
part, by lower intakes of sugar-sweetened foods and beverages are
associated with a decreased risk of CVD relative to less healthy
dietary patterns, which included an existing review from the NEL
Dietary Patterns Systematic Review Project as well as the NHLBI
Lifestyle Evidence Review and the associated Lifestyle Management
Report (Refs. 17-18). We have concluded that it is appropriate to rely
on evidence that considered not only added sugars but also sugar-
sweetened foods and beverages to support the mandatory declaration of
added sugars on the label because sugars are added to sugar-sweetened
foods and beverages and provide extra calories in those foods. When
those foods are consumed in excess, they are not consistent with
healthy dietary patterns. We also note that the strong and consistent
association with CVD risk was seen when healthy dietary patterns were
compared with less healthy dietary patterns. As discussed in the 2015
DGAC Report, dietary patterns of the American public are suboptimal and
are causally related to poor individual and population health and
higher chronic disease rates. On average, the U.S. diet is low in
vegetables, fruits, and whole grains, and high in sodium, calories,
saturated fat, refined grains, and added sugars. Underconsumption of
the essential nutrients vitamin D, calcium, potassium, and fiber are
public health concerns for the majority of the U.S. population, and
iron intake is of concern among adolescents and premenopausal females
(Ref. 19).
    There were many statements made in the 2010 DGA related to
consuming a dietary pattern that is nutrient dense. Those statements
included the concepts that added sugars displace other nutrient-dense
foods in the diet and that as the amount of solid fats and added sugars
increase in the diet, it becomes more difficult to also eat foods with
sufficient dietary fiber and essential vitamins and minerals, and still
stay

within calorie limits. The 2010 DGA relied on food pattern modeling
done for the USDA Food Patterns to support statements in the 2010 DGA
related to nutrient density. We considered these statements and
evidence from the IOM macronutrient report (Ref. 75) showing that
decreased intake of some micronutrients occurs when individuals consume
in excess of 25 percent of calories from added sugars.
    The 2015 DGAC said that current intake of added sugars remains high
at 268 calories, or 13.4 percent of total calories per day among the
total population ages 1 year and older (Ref. 19). Intake data from the
What We Eat In America, 2007-2010 (Ref. 76), the dietary component of
NHANES was used by the 2015 DGAC to answer questions related to current
intake of added sugars. We also considered how this current intake data
relates to recommendations from the 2015 DGAC when concluding that
Americans are consuming too many calories from added sugars.
    We considered the scientific evidence in the 2010 DGAC Report
supporting the conclusion related to consumption of sugar-sweetened
beverages and adiposity in children when determining that the evidence
supports the mandatory declaration of added sugars. The 2010 DGAC
conducted a full NEL search to evaluate the association between sugar-
sweetened beverages and adiposity in children. Results of this review,
covering 2004-2009 were supplemented by the findings of prospective
studies included in an earlier evidence review conducted by the
American Dietetic Association (ADA) (1982-2004). Although we have
concluded that this body of evidence provides further support for a
mandatory declaration of added sugars on the label, it is limited to
children. Therefore, we refer to the general population, which includes
both children and adults, when we discuss the evidence on dietary
patterns characterized, in part, by lower intakes of sugar-sweetened
foods and beverages and decreased risk of CVD because the healthy
dietary pattern components described in the literature for adults are
reaffirmed with the USDA Food Patterns, which aim to meet nutrient
needs across the lifespan, including children 2 years of age and older.
a. Declaration
(i) Comments on the Rationale for Requiring Mandatory Declaration of
Added Sugars
    In the preamble to the proposed rule, we identified the factors
that we considered when determining which non-statutory (those that are
not explicitly required by the FD&C Act) nutrients should be declared
on a mandatory and voluntary basis on the label (79 FR 11879 at 11889).
We considered whether a quantitative intake recommendation existed and
whether there is public health significance when determining which
nutrients should be declared on the label. We considered mandatory
declaration to be appropriate when there is public health significance
and a quantitative intake recommendation that can be used for setting a
DV for a nutrient (79 FR 11879 at 11890). For nutrients that are not
essential vitamins and minerals, we considered voluntary declaration to
be appropriate when the nutrient either has a quantitative intake
recommendation but does not have public health significance, or does
not have a quantitative intake recommendation available for setting a
DRV but has public health significance (79 FR 11879 at 11891). We also
considered the scientific evidence from the 2010 DGA related to the
intake of added sugars in the diet and the role of such information in
assisting consumers to maintain healthy dietary practices. We noted
that our review for added sugars was not based on the factors we have
traditionally considered for mandatory declaration that are related to
an independent relationship between the particular nutrient and a risk
of chronic disease, health-related condition, or health-related
physiological endpoint.
    (Comment 134) Many comments addressed our rationale for requiring
the declaration of added sugars on the label in relation to the risk of
chronic disease. One comment recognized that our rationale for
proposing to require the mandatory declaration of added sugars is
atypical and is not based on a traditional nutrient health-outcome
linkage. In contrast, other comments suggested that we not require the
declaration of added sugars on the label because they do not meet the
factors outlined in our criteria for mandatory labeling. One comment
also objected to voluntary declaration of added sugars because,
according to the comment, it does not meet either of our proposed
factors. Another comment said that we have not shown that a public
health significance exists for added sugars labeling through well-
established scientific evidence. The comments also noted that our
rationale for requiring the declaration of added sugars differs from
our rationale for declaring other nutrients on the label.
    (Response) Our determination under section 403(a)(2)(A) of the FD&C
Act of whether a nutrient is necessary to assist consumers in
maintaining healthy dietary practices is not limited to the factors we
have used when assessing nutrients for which there is an independent
relationship between the nutrient and risk of disease, a health-related
condition, or a physiological endpoint (see our response to comment
45). Our rationale for requiring the mandatory declaration of added
sugars is different from that of nutrients for which such an
independent relationship exists. Rather than basing a declaration of
added sugars on an association with risk of chronic disease, a health-
related condition, or a physiological endpoint, for the purposes of the
general population (see part II.H.3), we are considering a declaration
of added sugars in the context of how it can assist consumers in
maintaining healthy dietary practices by providing information to help
them limit consumption of added sugars, and to consume a healthy
dietary pattern. Instead of considering an association with risk of
chronic disease, for the purposes of the general population, our review
for the proposed rule was based on information which supported the need
for further information about added sugars on the label to assist
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). We relied on multi-faceted evidence
showing that added sugars consumption in the United States is a public
health concern. We cited information from the 2010 DGA indicating that
a high intake of calories from excess solid fats and added sugars can
decrease the intake of nutrient-dense foods in the diet and can
increase the overall caloric intake, which could lead to weight
management issues (79 FR 11879 at 11904). We considered evidence
related to excess consumption of calories from added sugars. For many
years, added sugars have contributed a significant amount of calories
to the American diet. The 2010 DGA cited intake data showing that
Americans consumed approximately 16 percent of calories from added
sugars (Ref. 77). More recent data shows that consumption of added
sugars has decreased to approximately 13.4 percent of calories in
recent years; however, the intake still remains high and exceeds 10
percent of total calorie intake. In the preamble to the proposed rule,
we also

cited to the strong evidence reviewed by the 2010 DGAC that shows that
children who consume sugar-sweetened beverages have increased adiposity
(increased body fat) (79 FR 11879 at 11904).
    The evidence we considered when determining that the amount of
added sugars in a serving of a product must be declared on the label
includes the scientific evidence from the 2010 DGA and the 2015 DGAC
Report related to limiting calories from added sugars. The 2015-2020
DGA also includes this scientific evidence.
    A recommendation to limit the intake of added sugars has been long-
standing in the various editions of the DGA, although the terminology
and specificity of the guidance has evolved over time. In fact, we
considered requiring the declaration of added sugars on the label in
the January 6, 1993 final rule for the Mandatory Status of Nutrition
Labeling and Nutrient Content Revision, Format for Nutrition Label (58
FR 2079 at 2098). The comments that we received to a 1990 proposed rule
recommended mandating the declaration of added sugars only, rather than
total sugars, because dietary recommendations urged the use of sugar in
moderation, while at the same time recommending increased consumption
of fruits, which are sources of naturally occurring sugars. Though the
terminology ``added sugars'' was not introduced into the DGA until
2005, when Americans were advised to ``choose and prepare foods and
beverages with little added sugars or caloric sweeteners, such as
amounts suggested by the USDA Food Guide and the DASH eating plan,''
the DGA has included key recommendations advising Americans to limit
their intake of ``sugar'' since the first report in 1980 (Refs. 30, 78-
83). Even in the 1980 DGA, Americans were advised to ``avoid excessive
sugars'' by using less of all sugars, including white sugar, brown
sugar, raw sugar, honey, and syrups. Consumers were also advised to
reduce their consumption of foods containing these sugars such as
candy, soft drinks, ice cream, cakes, and cookies. All of the
ingredients that consumers were advised to limit in their diet in the
1980 DGA would meet our current definition of an added sugars, and the
foods that Americans were advised to limit are some of the largest
contributors to added sugars intake today.
    Over the past century the health profile of Americans has changed.
Deficiencies of essential nutrients have dramatically decreased, and
chronic diseases that are related to poor quality dietary patterns and
physical inactivity, such as obesity, CVD, type 2 diabetes, and diet-
related cancers, have become much more prevalent in the population
(Ref. 19). Dietary patterns and their food and nutrient characteristics
were at the core of the conceptual model that guided the 2015 DGAC's
work and resulted in scientific evidence supporting the recommendations
from both the 2015 DGAC Report and the 2015-2020 DGA related to healthy
dietary patterns (Refs. 19, 28). For the first time, the 2015 DGAC
completed a systematic review to examine the relationship between
dietary patterns and health outcomes. The data related to dietary
patterns and health outcomes, which was reviewed by the 2015 DGAC,
focused on specific health outcomes including: CVD, measures of body
weight or obesity, type 2 diabetes, cancer, congenital anomalies,
neurological and psychological illnesses, and bone health. The 2015
DGAC concluded that the overall body of evidence examined by the 2015
DGAC identifies that a healthy dietary pattern is higher in vegetables,
fruits, whole grains, low- or non-fat dairy, seafood, legumes, and
nuts; and moderate in alcohol (Ref. 19). The 2015 DGAC also concluded
that dietary patterns characterized, in part, by lower consumption of
sugar-sweetened foods and beverages relative to less healthy dietary
patterns were strongly and consistently associated with a reduced risk
of CVD (Ref. 19). Evidence for dietary patterns and the other health
outcomes that were included in the analysis was moderate or limited.
The new evidence from the systematic review examining the relationship
between dietary patterns and health outcomes provide further support
for a mandatory declaration of added sugars because consumers need to
know how much added sugars are in their foods in order for them to
construct an overall healthy dietary pattern and to limit consumption
of added sugars. The scientific evidence also was included in the 2015-
2020 DGA. Furthermore, consumers need to know how much added sugars are
in a serving of a product so that they can avoid consuming excess
calories from added sugars, at the expense of calories from other
components as part of a healthy dietary pattern within calorie limits,
such as fruits, vegetables, fat-free and low-fat dairy, grains, protein
foods, and oils.
    We disagree with the comment that added sugars should not be
required on the label because we have not shown that a public health
significance exists for added sugars labeling through well-established
scientific evidence. The comment is considering the guidance we have
given related to determining public health significance in our proposed
factors for mandatory and voluntary labeling, which are focused on
nutrients for which there is a relationship with a risk of a chronic
disease, a health-related condition, or a physiological endpoint.
However, we are using a different paradigm for the labeling of added
sugars for the general population (see part II.H.3) than has been used
traditionally. We have established that there is public health
significance of added sugars through other evidence and recommendations
related to a healthy dietary pattern low in sugar-sweetened foods and
beverages that is associated with reduced risk of CVD, through
consumption data showing that Americans are consuming too many calories
from added sugars, through evidence showing that it is difficult to
meet nutrient needs within calorie limits if one consumes too many
added sugars, and through evidence showing that increased intake of
sugar-sweetened beverages is associated with greater adiposity in
children.
    We disagree with the comments that suggested that added sugars
should not be required to be declared on the label because they do not
meet the factors we consider for mandatory labeling of nutrients for
which there is an independent relationship between the nutrient and a
risk of chronic disease, a health-related condition, or a physiological
endpoint. We must evaluate the current nutrition science and determine
whether a nutrient will assist consumers in maintaining healthy dietary
practices. We are not bound by certain factors when determining if any
and all nutrients should be declared on the label now or in the future
(see part II.C.3).
    The final rule, therefore, at Sec.  101.9(c)(6)(iii), requires the
mandatory declaration of added sugars.
    (Comment 135) Many comments said we should not require the
declaration of added sugars on the label because they do not have a
unique role in causing weight gain or increasing the risk of chronic
disease when compared to other macronutrients. Many comments cited the
2010 DGA's conclusion that added sugars are no more likely to
contribute to weight gain or obesity than any other source of calories
(Ref. 30). Some comments also cited the conclusion in the IOM DRI
report for macronutrients that there is no clear and consistent
association between increased intake of added sugars and BMI (Ref. 75).
The comments noted that studies have shown that with respect to weight
loss, reducing total caloric intake is more

important than the source of calories. The comments asserted that
excess energy in any form will promote body fat accumulation.
    (Response) We agree that excess calories from any source can
contribute to weight gain. However, Americans are consuming too many
calories from added sugars, and those calories typically are not
accompanied by other beneficial nutrients. The comments are considering
the evidence that we have used to support a declaration of added sugars
against our proposed factors for mandatory and voluntary declaration of
non-statutory nutrients for which there is an independent relationship
between the nutrient and a risk of chronic disease, a health-related
condition, or a physiological endpoint. Rather than considering a
direct relationship between consumption of added sugars and risk of a
chronic disease, health-related condition, or physiological endpoint,
for the purposes of the general population (see part II.H.3), we have
focused on how added sugars found in sugar-sweetened foods and
beverages contribute to a dietary pattern, and how the contribution of
added sugars to the total diet impacts health. The evidence points to
the need for consumers to know how much added sugars are in a serving
of a product to assist them in achieving a healthy dietary pattern and
maintaining healthy dietary practices.
(ii) Evidence on Added Sugars and Risk of Chronic Disease
    (Comment 136) Many comments suggested that, if we are using the
traditional relationship between a nutrient and risk of chronic
disease, a health-related condition, or a physiological endpoint when
determining if added sugars should be declared on the label, there is
specific scientific evidence on added sugars and risk of disease that
we should consider. Many comments suggested that a declaration of added
sugars is necessary because consumption of added sugars is associated
with an increased risk of chronic disease or markers for chronic
disease. Some comments provided evidence that increased consumption of
sugar-sweetened beverages, which are the primary source of added sugars
in the American diet, is associated with increased body weight, an
increase in body mass index (BMI), adiposity (body fat), increased
blood pressure leading to increased incidence of hypertension, and in
increased risk of metabolic syndrome, type 2 diabetes, and gout. Other
comments provided evidence that high intakes of fructose-containing
sugars can raise levels of triglycerides, visceral fat, liver fat,
blood glucose, insulin, and LDL cholesterol. The comments suggested
that the findings indicate that diets high in fructose increase markers
or risk factors for heart disease, diabetes, non-alcoholic fatty liver
disease, and metabolic syndrome. The comments noted that randomized,
controlled clinical trials to test the hypothesis that added sugars
increase disease risk would violate ethical standards, and therefore,
are impossible to conduct.
    In contrast, many comments argued that there is no association
between consumption of added sugars and risk of chronic disease, and
therefore, there is a lack of a scientific basis to require the
mandatory declaration of added sugars on the label. One comment stated
that evidence available since the 2010 DGA is conflicting and
inconclusive. In reference to the evidence showing that all sugars
contribute to dental caries, one comment suggested that there are many
factors that can contribute to dental caries, including oral bacteria,
salivary flow, oral hygiene behavior, and susceptibility of the tooth.
The comment stated that it was not aware of any evidence showing that
added sugars presents a unique risk for causing dental caries.
    Some comments criticized studies on added sugars and risk of
disease. The comments suggested that scientific consensus groups have
found difficulty in determining any relationship between added sugars
intake and health outcomes due to a variety of complex reasons. The
reasons cited included lack of harmonization within the scientific
literature of the definition and inclusion of ingredients considered to
be added sugars, difficulty comparing studies where the primary health
outcomes measured are not consistent across studies, systematic reviews
draw conclusions across multiple studies with various inclusion
criteria and designs, excess energy intake may not be controlled for in
the analysis, much of the information about added sugar content of
products is proprietary, and methodological problems with observational
studies which have suggested detrimental associations of added sugars
intake with health outcomes. The comments also noted that sugar-
sweetened beverages are often inappropriately used as a proxy or
surrogate for total added sugars intake.
    (Response) Added sugar in the diet is an area that is of particular
interest in the nutrition community. A substantial amount of research
has been conducted on the association between consumption of sugar-
sweetened beverages and risk of chronic disease, as noted in the
comments. The 2010 DGAC concluded that an increased intake of sugar-
sweetened beverages is associated with greater adiposity in children.
Since 2010, additional evidence on sugar-sweetened beverages and their
association with risk of disease has emerged. The 2015 DGAC concluded
that there is strong and consistent evidence that intake of added
sugars from foods and/or beverages is associated with excess body
weight in children and adults (Ref. 19). We note that the majority of
the evidence that the 2015 DGAC relied on for this conclusion was from
studies on the relationship between intake of sugar-sweetened beverages
and body weight. Although the evidence on sugar-sweetened beverages and
body weight/adiposity is strong and consistent, sugar-sweetened
beverages represent only 39 percent of food sources of added sugars. As
noted in the comments, sugar-sweetened beverages may not be an
appropriate proxy or surrogate for total added sugars intake.
    Research on the health effects of total added sugars continues to
emerge. One difficulty that researchers face when designing studies on
added sugars from all food sources is that there are many ingredients
containing added sugars by different names, and no single definition of
added sugars has been adopted by the scientific community. In Sec.
101.9(c)(6)(iii) of the final rule, we are establishing a regulatory
definition of added sugars. We expect that, by requiring the
declaration of the amount of added sugars in a serving of a product on
the label, and by establishing a definition of added sugars, additional
research on the health effects of added sugars from food and beverages
will be conducted in the future that will further clarify the direct
relationship of added sugars with risk of chronic diseases, health-
related conditions, and physiological endpoints.
    Although we are not basing a mandatory declaration of added sugars
for the general population on an independent relationship between added
sugars and risk of chronic disease, we are, instead, basing an added
sugars declaration on the need to provide consumers with information to
construct a healthy dietary pattern that is low in added sugars. We
intend to monitor the evidence in this area and will consider how any
new evidence may impact our regulations in the future.
    (Comment 137) In the preamble to the proposed rule (79 FR 11879 at
11904), we suggested that the disclosure of saturated fat and trans fat
on the label not only provides information to consumers for managing
their risk of

CVD, but the declaration of these nutrients also could provide a marker
for foods that contain solid fats (fats which are solid at room
temperature and contain a mixture of saturated and unsaturated fatty
acids but tend to contain a high percentage of saturated and trans
fats). We suggested that there is not currently information on the
label that could serve as a marker for added sugars.
    Some comments took issue with comparisons made between fats and
sugars in the proposed rule. The comments noted that there are
significant health differences between fats in general and solid fats.
The comments asserted that those differences provide a defensible basis
for delineating the types of fats on the label, and there are no
similar functional health differences between sugars and added sugars.
Therefore, the comments said we do not have a basis for requiring a
separate declaration for added sugars on the label.
    (Response) Our basis for requiring the declaration of added sugars
for the general population (see part II.H.3) is not related to an
independent relationship between added sugars and a risk of chronic
disease, but rather on the contribution of added sugars to an overall
dietary pattern. Added sugars consumption among the general U.S.
population exceeds what can reasonably be consumed within calorie
limits and can have a negative impact on health. The declaration of
added sugars will assist consumers in maintaining healthy dietary
practices. In the preamble to the proposed rule, we were not making a
comparison between the level of evidence related to an independent
relationship between the intake of fats and sugars and chronic disease
risk. Instead, we were describing whether information on the label for
certain fats and sugars would allow the consumer to use the label to
reduce their consumption of calories from solid fats and added sugars.
    (Comment 138) Some comments likened the public interest in added
sugars to that in total fat in previous years and suggested that we
consider the unintended consequences associated with a single nutrient-
type approach.
    (Response) We disagree with the comment's suggestion that we are
taking a single nutrient-type approach to the labeling of added sugars.
We are considering how added sugars interact with other components in
the diet and make it difficult for individuals to meet nutrient needs
within calorie limits and to construct a healthful dietary pattern. As
noted in the 2015 DGAC Report, added sugars are not intended to be
reduced in isolation; in fact, sodium and saturated fats are also
recommended to be reduced in order to achieve a healthy dietary pattern
that is balanced, as appropriate, in calories (Ref. 19). These
considerations have led us to conclude that consumers need information
on the amount of added sugars in a serving of a product as well as a
percent DV declaration to help them maintain healthy practices and
determine how a serving of a product fits into the context of their
total daily diet. Furthermore, the declaration of added sugars will be
included with other nutrient declarations on the label. This is one of
many pieces of nutrition information that consumers should use when
making food choices.
(iii) New Evidence Presented in the 2015 DGAC Report
    After publication of the 2010 DGA, the USDA NEL completed a
systematic review project examining the relationships between dietary
patterns and several health outcomes, including CVD, body weight, type
2 diabetes, and dental caries. In addition, the DGAC reviewed the NHLBI
Lifestyle Evidence Review and the Lifestyle Management Report. Based on
the information provided in the NEL report, the 2015 DGAC made
conclusions about the association of healthy dietary patterns and the
risk of the named health outcomes. In particular, the 2015 DGAC
concluded that strong and consistent evidence demonstrates that dietary
patterns 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 relative to less healthy patterns;
regular consumption of nuts and legumes; moderate consumption of
alcohol; lower in saturated fat, cholesterol, and sodium, and richer in
fiber, potassium, and unsaturated fats is associated with a decreased
risk of CVD. We reviewed and considered the evidence that the DGAC
relied on for making this conclusion, and determined that it supports
our basis for requiring the mandatory declaration of the gram amount of
added sugars on the label. We requested comment on this new information
in the supplemental proposed rule.
    (Comment 139) Some comments supporting our inclusion of the new
information on dietary patterns and CVD risk in our rationale for the
declaration of added sugars said that the U.S. population should be
encouraged and guided to consume dietary patterns that are rich in
vegetables, fruit, whole grains, seafood, legumes, and nuts; moderate
in low- and non-fat dairy products and alcohol (among adults); lower in
red and processed meat; and low in sugar-sweetened foods and beverages
and refined grains. One comment noted that the dietary patterns that
are now recommended for CVD reduction by the American Heart Association
and the American College of Cardiology and the new part 2
recommendations of the National Lipid Association all refer to a
dietary pattern low in sweets and sugar-sweetened beverages.
    Many comments supported the 2015 DGAC's recommendation that
Americans reduce their intake of added sugars and said that the
recommendation is consistent with the American Cancer Society's
nutrition and physical activity guidelines, the recent guidelines from
the World Health Organization on added sugars intake, and recent
lifestyle guidelines from the American Heart Association and the
American College of Cardiology.
    (Response) We have reviewed and considered the data and information
underlying the 2015 DGAC's recommendations and have concluded that the
declaration of added sugars is necessary to assist consumers in
maintaining healthy dietary practices. The declaration would enable
consumers to limit added sugars as part of a healthy dietary pattern.
    (Comment 140) Although we did not propose to rely on the analysis
conducted by the 2015 DGAC (Ref. 84) on the relationship between the
intake of added sugars and CVD, body weight/obesity, type 2 diabetes,
and dental caries, some comments addressed the analysis and whether it
supports a mandatory declaration of added sugars.
    Some comments said that it is appropriate for us to rely on
information from the 2015 DGAC Report as well as the robust science
upon which that report is based regarding the health risks of added
sugars. The comments said that the DGAC comprehensively reviewed the
current scientific literature and concluded that added sugars increase
the risk of multiple health outcomes, including excess body weight,
type 2 diabetes, CVD and dental caries. According to the comments, the
evidence, which was graded either as ``strong'' or ``moderate'' by the
DGAC, further supports the mandatory declaration of added sugars on the
label and supports the addition of a percent DV declaration on the
label. The comments cited additional scientific evidence supporting an
association between consumption of added sugars and/or sugar-sweetened
beverages and

the risk of the health outcomes named in the 2015 DGAC Report or
endpoints such as serum triglycerides, LDL cholesterol, and blood
pressure.
    Other comments suggested that the existing evidence related to
consumption of added sugars and the risk of various chronic diseases
and health-related conditions is limited and does not demonstrate a
clear, causative relationship or direct contribution of added sugars to
obesity, heart disease, or other diseases or conditions.
    Some comments questioned why we are relying on evidence related to
dietary patterns and risk of disease to support a mandatory declaration
of added sugars when a review was done by the DGAC that specifically
looked at consumption of added sugars and risk of CVD and the DGAC
concluded that the evidence was moderate rather than strong. The
comments noted that the evidence reviewed by the DGAC in chapter 6
(clinical trials and observational studies on sources of added sugars
and CVD risk) provides a more direct and specific evaluation on added
sugars and CVD risk than from data on dietary patterns and CVD risk.
    (Response) As discussed in part II.H.3.a, we are requiring an added
sugars declaration so that consumers can limit calories from added
sugars as part of a healthy dietary pattern lower in sugar-sweetened
foods and beverages which is associated with a reduced risk of chronic
disease and can meet nutrient needs within calorie limits. We do not
need to limit our review of the science to the moderate evidence
related to an independent relationship between added sugars and risk of
chronic disease; instead, we can include in our review the strong and
consistent association between the healthy dietary pattern with lower
amounts of sugar-sweetened foods and beverages, compared to less
healthy dietary patterns, and reduced risk of CVD (see added sugars
introduction). Although the 2015 DGAC concluded that strong and
consistent evidence shows that intake of added sugars from food and/or
sugar-sweetened beverages are associated with excess body weight in
children and adults, the evidence reviewed by the 2015 DGAC was
primarily on sugar-sweetened beverages, which only represent 39 percent
of food sources of added sugars. The consumption of added sugars and
their impact on health continues to be an area of great interest to the
scientific community and to consumers. We intend to monitor future
research that may impact the labeling of added sugars.
    (Comment 141) Some comments suggested that our review is
inconsistent and selective. The comments said that the particular
dietary pattern related to CVD was singled out from the DGAC Report of
dietary patterns and other chronic diseases (e.g. cancer, type 2
diabetes) in the supplemental proposed rule because it was the only
chronic disease for which the evidence was considered to be strong and,
as such, we consider strong evidence to be necessary for requiring
added sugars on nutrients in the proposed rule.
    (Response) We have strong and consistent evidence that dietary
patterns associated with a decreased risk of CVD are characterized by
higher consumption of fruits, vegetables, whole grains, low-fat dairy,
and seafood, and lower consumption of red and processed meats, and
lower intakes of refined grains and sugar-sweetened foods and beverages
relative to less healthy dietary patterns. The dietary pattern approach
focuses on components of the diet and how they contribute to an overall
healthy dietary pattern that is associated with a decreased risk of
disease. Although this is the first time that the 2015 DGAC has
conducted a systematic review of the evidence related to dietary
patterns and health outcomes, analysis of diet quality using scoring
indices is an accepted scientific method that has been used for years
to assess diet quality. The evidence that the 2015 DGAC considered
related to dietary patterns and CVD risk adds to information that we
provided in the proposed rule to support an added sugars declaration
and is not the only evidence that we are relying on to support the
declaration. Evidence related to an independent association between
consumption of added sugars and risk of chronic disease continues to
emerge. Although science related to the independent relationship
between total added sugars and risk of chronic disease is not
conclusive at this point, it does not mean that we cannot and should
not rely on the evidence that we currently have related to healthy
dietary patterns characterized, in part, by a reduced intake of sugar-
sweetened foods and beverages and reduced risk of CVD, which is strong
and consistent.
    (Comment 142) Some comments cited reasons why the type of analysis
which was conducted to examine the relationship between healthy dietary
patterns and health outcomes cannot be used to make conclusions
regarding single nutrients, food components, or foods. The comments
noted that we have stated that we do not accept this type of
extrapolation from an association of a complex mixture with disease
risk to determine the association between a single component of the
mixture to disease risk in our Guidance on Evidenced Based Review (Ref.
85). The comments said that the extrapolation does not establish a
public health endpoint to justify mandatory declaration added sugars.
Some comments also said that the evidence on dietary patterns is not
nutrient specific and a dietary pattern is defined as the quantities,
proportions, variety or combinations of different foods and beverages
in diets, and the frequency with which they are habitually consumed.
    (Response) This type of analysis that was conducted to examine the
relationship between healthy dietary patterns and health outcomes is
appropriate to answer questions about how dietary patterns, as a whole,
impact disease risk. This type of analysis also takes into account
relationships between components of a healthy dietary intake, which
cannot be determined when looking at specific associations with a
nutrient and risk of disease. Other analyses are more appropriate for
answering questions related to a direct cause and effect relationship
between a nutrient and the risk of a disease or health-related
endpoint.
    The evidence considered by the 2015 DGAC related to dietary
patterns and CVD risk provides us with information about the components
of a healthy dietary pattern and how those components, when taken in
combination, make up a dietary pattern that is associated with the
reduced risk of CVD. As noted by the 2015 DGAC, it is often not
possible to separate the effects of individual nutrients and foods. The
2015 DGAC Report says that the components of the eating pattern can
have interactive and potentially cumulative effects on health (Ref.
19). The 2015-2020 DGA also says that people do not eat food groups and
nutrients in isolation but rather in combination, and the totality of
the diet forms an overall eating pattern.
    The dietary pattern analysis as well as information from the USDA
food patterns showing how much added sugars individuals can reasonably
consume in their diet while meeting nutrient needs, and consumption
data showing that consumption of added sugars among Americans remains
high supports limiting consumption of added sugars. In order for
consumers to limit consumption of added sugars in the diet, it is
necessary for information to be provided on the label that allows
consumers to determine how much added sugars is in a serving of food,
so

they can determine whether and how that food fits into their total
daily diet. Therefore, information about what constitutes a healthy
dietary pattern that is associated with a decreased risk of disease
supports a label declaration of added sugars even though conclusions
about a nutrient-specific association with risk of disease cannot be
drawn from this type of evidence.
    (Comment 143) Some comments noted that the 2010 DGA said that
individuals can achieve a healthy diet in multiple ways and preferably
with a wide variety of foods and beverages. Optimal nutrition can be
attained by many different dietary patterns, and a single dietary
pattern approach or prescription is unnecessary. The comments said that
dietary patterns other than those evaluated in Chapter 2 of the 2015
DGAC Report might not have necessarily shown that reduced added sugars
intake was associated with increased risk of CVD.
    (Response) While individuals can follow a number of different
healthful dietary patterns, the NEL review on dietary patterns and CVD
risk did not specifically look at studies where individuals were placed
on a particular diet or were instructed to follow a specific diet. The
2015 DGAC did consider evidence from DASH trials where participants
were placed on the DASH diet. With the exception of the DASH trials,
the analyses included free-living individuals who were following many
dietary patterns. Certain scoring indices were then applied to intake
data to look at how closely the diets of study participants matched
certain types of healthy dietary patterns. Scores were then given based
on adherence to the dietary pattern of interest. The dietary quality
analyses included individuals that did not closely adhere to a
particular dietary pattern of interest. In looking at all reports,
which included an analysis of adherence to multiple types of healthy
dietary patterns, the 2015 DGAC concluded that closer adherence to the
healthy dietary patterns of interest, which tended to include less
sugar-sweetened foods and beverages, resulted in a decreased risk of
CVD. Therefore, the analysis included individuals who followed a wide
variety of dietary patterns, some of which were determined to be more
strongly associated with chronic disease risk than others. Although it
is possible that some dietary patterns including substantial amounts of
sugar-sweetened foods and beverages are associated with a decreased
risk of CVD, research conducted across cohorts using multiple dietary
pattern indices show that there is a high degree of correlation
(highest quintile of scores) across scoring indices, and that higher
diet quality is significantly and consistently associated with a
reduced risk of death due to all causes, CVD, and cancer compared to
the lowest quintile of scores (Ref. 86). Therefore, it is very unlikely
that the majority of the population can consume a high quality diet
that incorporates the proper amounts from food groups to meet nutrient
needs as well as a significant amount of added sugars and still stay
within calorie limits. The research suggests that there is a high level
of consistency between different scoring indices in what is considered
to be a healthy diet. Furthermore, as shown in the USDA Food Patterns
for three patterns of health eating (a Healthy U.S.-Style Eating
Pattern, a Healthy Mediterranean-Style Eating Pattern, and a Healthy
Vegetarian Eating Pattern (Ref. 19)), in order to eat a dietary pattern
that includes the amounts of other healthy dietary components, it is
not possible to consume large amounts of empty calories.
b. The 2015 DGAC Analysis of Dietary Patterns and Health Outcomes
    (Comment 144) In the analysis of dietary patterns and health
outcomes, dietary quality indices were used to evaluate adherence to
certain dietary patterns. An individual's score is derived by comparing
and quantifying their adherence to the criterion food and/or nutrient
component of the index and then summed over all components (Ref. 19). A
population's average mean and individual component scores can be
similarly determined. Some examples of the dietary quality scores used
for the analysis include: The Health Eating Index (HEI)-2005 and 2010,
the Alternate HEI (AHEI) and updated AHEI-2010, the Recommended Food
Score (RFS), the Mediterranean Diet Score (MDS), and the Alternate
Mediterranean Diet Score (aMed).
    Some comments took issue with the various scoring algorithms used
to evaluate adherence to certain dietary patterns as well as with the
studies included in the analysis. One criticism of the scoring
algorithms was that the majority of dietary pattern index studies cited
by the 2015 DGAC did not include an added sugars criterion. The
comments noted that the MDS, the aMed, the AHEI, and the RFS do not
include a ``sweets or sugar products'' component. The comments said the
HEI-2005 included sugar in a combined category of solid fats, alcoholic
beverages and added sugars, the AHEI-2010 included sugar-sweetened
beverages and fruit juice, and the Dietary Approaches to Stop
Hypertension adherence index included soda, sugar sweetened beverages
or a broader ``sweets'' category depending on the scoring method used.
The comments said that none of these indices specifically address added
sugars independently. One comment stated that not one of the
Mediterranean dietary pattern studies cited by the DGAC had a sugars or
added sugars criterion.
    Other comments singled out studies from the 55 that were included
in the NEL review based on whether they included a measure of added
sugars in the study. The comments suggested that studies with scoring
indices that did not include a measure of added sugars should be
excluded from our analysis. Some comments suggested that, when only the
studies in which dietary pattern scoring indices were used that
included a measure of added sugars are considered, the evidence related
to CVD risk is not strong and consistent. The comments noted that the
2015 DGAC Report says that ``certain scores also included added sugars
or sugar-sweetened beverages as negative components.''
    (Response) While a number of index studies did not include a direct
measure of added sugars or sugar-sweetened foods and/or beverages, the
scoring systems in the study were measuring adherence to an overall
dietary pattern, such as the Mediterranean diet, that is typically low
in added sugars. Furthermore, research shows that there is consistency
in scoring as well as association with health outcomes across dietary
quality indices, including two that do not typically include a sugar-
sweetened food and beverages component (i.e. aHEI and AMED) (Ref. 86).
    The Dietary Patterns Methods Project conducted standardized and
parallel analyses of the prospective association of select dietary
patterns characterized by dietary quality indices and mortality
outcomes in three large cohort studies conducted in the United States.
The investigators selected four commonly used dietary quality indices
including the HEI-2010, the AHEI-2010, the aMED, and the DASH (Ref.
86). The comments noted that the AHEI and aMED dietary quality indices
do not have a specific measure of added sugars. Liese et al. found that
the indices were highly correlated, which means that individuals with
the highest scores of adherence were likely to be scored similarly
across all of the four dietary quality indices. They also found that
higher diet quality (highest quintile of scores) was associated with
lower all-

cause, CVD, and cancer mortality when compared to lower diet quality
(lowest quintile of scores) across the diet quality indices. Similar
findings have been seen across dietary quality scoring indices and
large prospective cohort studies (Refs. 87-89). These results suggest
that dietary quality scoring indices consistently determine diet
quality, regardless of whether they include a component for sugar-
sweetened foods and/or beverages. The research also suggests that,
because the diet quality indices are so comparable in what they measure
as a high quality diet, it is very likely that the diets of individuals
with higher diet quality scores will have a lower intake of sugar-
sweetened foods and/or beverages. Furthermore, it is very unlikely that
participants with high diet quality scores across the various scoring
indices would be able to consume enough of the other components of a
healthy dietary pattern to receive a high score if they were consuming
large amounts of sugar-sweetened foods and beverages.
    We also note that the dietary pattern scoring indices were modified
by study investigators, so it is necessary to review each study to
determine whether the diet quality index used in a particular study
included a component that measured added sugars. Table 4-B-I-1 from the
2015 DGAC Report shows a comparison of the dietary components across
some of the major diet scoring indices (Ref. 19). The comment noting
that the MDS, the aMed, the AHEI, and the RFS do not include a ``sweets
or sugar products'' component was likely referring to the information
in Table 4-B-I-1. However, to determine if the scoring index used in a
particular index study included a measure of sugars-sweetened foods or
beverages, it is necessary to go to the study report because
investigators did include measures of types of sugar-sweetened foods
and/or beverages in most of the studies included in the analysis. For
example, Trichopoulou et al. evaluated adherence to a Mediterranean
diet by using the MDS, but included sweets as a component of the
scoring algorithm.
    (Comment 145) One comment noted that, if a company wanted to make a
voluntary claim that there is a strong association between diets low in
added sugars and a decreased risk of CVD, we would not consider the
underlying evidence that the DGAC relied upon as sufficient to support
such a claim, yet we are relying on this same level of evidence to
require that companies include a mandatory claim on their labels that
is potentially false and misleading for certain foods which undergo
chemical processes that reduce the amount of sugar in a product.
    (Response) To the extent that the comments are suggesting that it
is not appropriate for us to rely on evidence related to dietary
patterns and health outcomes to support a mandatory declaration of
added sugars, we disagree. The scientific evidence related to dietary
patterns and health outcomes that was presented in the 2015 DGAC
Report, and more specifically the evidence related to a healthy dietary
pattern that is associated with a decreased risk of CVD relative to
less healthy dietary patterns does show that there are certain
characteristics of a healthy dietary pattern that consumers need when
selecting foods to eat and when determining how much of those foods
they should eat. The information that we are relying upon related to
healthy dietary patterns characterized, in part, by lower amounts of
sugar-sweetened foods and beverages and CVD risk is directly related to
the need for consumers to have information on the label, which they do
not currently have in the case of added sugars, so that they can
construct a healthy dietary pattern that is associated with a decreased
risk of disease and maintain healthy dietary practices.
    In response to the comment's suggestion that an added sugars
declaration is potentially false and misleading for certain foods which
undergo chemical processes that reduce the amount of sugar in a
product, we have concluded that, generally, manufacturers of foods that
undergo non-enzymatic browning and fermentation are able to determine a
reasonable approximation of the amount of added sugars in a serving of
their finished product (see part II.H.3.k). Therefore, added sugars
declarations on foods that undergo non-enzymatic browning and
fermentation are not potentially false and misleading.
    (Comment 146) Some comments noted that the studies that did include
an assessment of sugar sweetened foods and/or beverages did not include
an assessment of everything that we would consider to be added sugars.
One comment said that some of the studies only assessed
sugars[hyphen]sweetened beverage intake, and some considered fruit
juices to be sugar-sweetened beverages. The studies included no
assessment of intake of sugar-containing foods.
    Other comments noted that the scoring algorithms used to evaluate
dietary pattern adherence may differ and may affect the results of
studies examining specific health outcomes. The comments said that this
factor may hamper cross-study comparisons and limit reproducibility.
    (Response) Some studies included only sugar-sweetened beverages,
while others included ``sugar'' or ``sweets.'' The scoring algorithms
also did vary from study to study. However, research shows that
different dietary quality indices are very comparable in what they
consider to be a high quality versus a low-quality diet (Ref. 86). The
different dietary quality indices also are very consistent in their
association with health outcomes (Ref. 86). Although the studies
included different types of added sugars as components of their
analysis, when taken as a whole, the data generally shows that healthy
dietary patterns that are associated with a decreased risk of CVD
relative to less healthy dietary patterns are characterized, in part,
by lower amounts of sugar-sweetened foods and beverages. Additionally,
it would be extremely difficult for individuals consuming large amounts
of empty calories from sugar-sweetened foods and beverages to be able
to consume enough of the other components of a healthy dietary pattern
to be able to receive a high diet quality score.
    We also recognize that the scoring algorithms used in the studies
included in the analysis differ from study to study. However, despite
having different ways to evaluate many different types of healthy
diets, a strong and consistent pattern emerged from the evidence. We
view the variety of scoring algorithms to be a strength of the review
because, despite the differences in scoring algorithms, there was
consistency in what constituted a diet that would receive a high
dietary quality score and there was consistency in the association
between higher dietary quality scores and CVD risk versus lower diet
quality scores.
    (Comment 147) Some comments noted that none of the definitions of
added sugars used in the studies included in the analysis of dietary
patterns and CVD risk are consistent with our proposed definition since
it was not released until 2014 and the studies were conducted prior to
that date. One comment suggested that many more sources of sugar are
included in our proposed definition than in the studies cited in the
2015 DGAC Report.
    (Response) The studies included in the analysis on dietary patterns
and CVD risk assessed the intake of foods that are part of an eating
pattern rather than intake of specific nutrients. Therefore, we would
not expect, nor would it be necessary for, our proposed definition of
added sugars to be consistent with how sugar-sweetened

foods and beverages were defined for the purposes of this type of
analysis. Furthermore, we would not anticipate that researchers would
have used our proposed definition as a guide when determining what
foods include added sugars because, at the time the studies were
conducted, we had not finalized the rule.
    (Comment 148) One comment cited several epidemiological studies
which evaluated the DASH dietary scoring pattern and CVD outcomes. The
comment said that, in one study included in the 2015 DGAC analysis
(Ref. 90), the range of sweetened beverage intake across the DASH score
quintile was narrow (0.3 servings per day in the lowest quintile and
0.2 servings per day in the highest quintile). The comment noted that
the authors of the study concluded that a diet that resembles the DASH
eating plan was significantly associated with lower risk of CHD and
stroke, but they made no mention of reduced consumption of sweetened
beverages as part of the diet. The comment also referred to a
subsequent study in the Women's Health Study cohort which evaluated the
relationship between adherence to a DASH dietary pattern score and risk
of CVD. In this study, an apparently strong association of adherence to
the DASH diet with incidence of CVD was attenuated upon control for
confounding variables. The comment noted that, Folsom et al. found that
adherence to the DASH diet, where sweets were evaluated as a broad
category, did not have an independent long-term association with
hypertension or CVD mortality after adjustment for confounding
variables in a cohort of women (Ref. 91).
    (Response) Although study authors may not have mentioned sweetened
beverages as part of the DASH eating plan, the DASH diet is typically
lower in the category of food called ``sweets.'' Therefore, it is
appropriate to rely on studies where a DASH scoring index was used
because the scoring algorithm is based on a diet that is low in sweets.
    We considered all 55 articles reviewed by the NEL, which summarized
evidence from 52 prospective cohort studies and 7 randomized-controlled
trials (RCTs), and the NHLBI Lifestyle Evidence Review and the
associated Lifestyle Management Report, which included primarily RCTs.
Although some studies where a DASH dietary quality scoring index was
used did not show an association with CVD risk, and some DASH dietary
quality scoring indices did not include a direct measure of sugar-
sweetened foods and beverages, as noted in the comments, when taken
together with other studies included in the analysis, the body of
evidence supports the conclusion that there is strong and consistent
evidence dietary patterns 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 relative to less
healthy patterns; regular consumption of nuts and legumes; moderate
consumption of alcohol; lower in saturated fat, cholesterol and sodium
and richer in fiber, potassium, and unsaturated fats are associated
with decreased CVD risk.
    (Comment 149) Some comments cited a number of studies where an
association with higher adherence scores and CVD risk, CHD risk, or
ischemic stroke was found, but when an analysis of sugar sweetened
foods and/or beverages was done in the same data set, an association
with the outcome of interest was not found. The comments referred to
component analyses that were conducted as part of some of the studies
included in the analysis of the evidence related to dietary patterns
and CVD risk. In these component analyses, the data for intake of
certain dietary components, such as fruits and vegetables, were looked
at more closely to see if they were associated with the outcome of
interest (CVD risk) when looked at in isolation. The comments said that
``added sugars'' intake was not a factor in the observed differences in
CVD risk in some of the studies where component analyses were
performed. Additionally, the comments said that sugars are only one of
many dietary factors included in the scoring indexes, and interplay
between multiple factors in the dietary patterns cannot be excluded.
Some comments said that the analysis is limited because not all of the
studies included in the NEL review included a component analysis. The
comments pointed to the statement in the 2015 DGAC Report which says
``although a large number of the studies assessed food group components
and their association with CVD outcomes, many did not, and more precise
determination of the benefits and risks of individual components (e.g.,
alcohol) would be helpful for policy recommendations. One comment noted
that the 2015 DGAC Report fails to mention all of the individual
components that were tested that had no effect on CVD (e.g., added
sugars). Another comment noted that throughout the studies, the impact
of dairy on the association between a dietary pattern and a health
outcome was inconsistent, which shows that the methodology used is
imprecise.
    (Response) For the first time, the 2015 DGAC conducted a systematic
review of the evidence related to dietary patterns and health outcomes.
The analysis was included because people do not eat nutrients or foods
in isolation. Rather than focusing on specific nutrients, the 2015 DGAC
and the 2015-2020 DGA focused on eating patterns and shifts that
Americans need to make in order to move towards a healthier diet that
is associated with a decreased risk of chronic disease. The 2015-2020
DGA said that the key recommendations for healthy eating patterns
should be applied in their entirety, given the interconnected
relationship that each dietary component can have with others (Ref.
28). The 2015 DGAC Report said, and we agree, that it is often not
possible to separate the effects of individual nutrients and foods and
that the totality of the diet-the combinations and quantities in which
foods and nutrients are consumed may have synergistic and cumulative
effects on health and disease (Ref. 19). It is with this information in
mind that we reviewed the evidence related to dietary patterns and
health outcomes presented in the 2015 DGAC Report.
    We disagree with the comments stating that studies that included a
component analysis for added sugars and CVD risk that did not show a
favorable association cannot be used to support an added sugars
declaration. Investigators use component analyses as an exploratory
measure to see if the result seen is mainly due to one component or
another. How these component analyses are conducted varies from study
to study because there is not consensus within the scientific community
yet on what methods should be used for component analyses. For example,
in some studies, the effects of individual components of the diet are
looked at separately without controlling for the effects of other
components of the diet, while in other studies investigators control
for other variables in the diet when looking at the effect of an
individual dietary component. Because the methodology related to
dietary pattern component analyses is still evolving and there is a
great deal of variability between studies in how the component analyses
are performed, we believe that it would not be appropriate to conclude
that sugar-sweetened beverages have no responsibility for the overall
relationship that is seen with CVD risk just because a component
analysis indicates that there is no

independent effect of sugar-sweetened beverage consumption on CVD risk
in the data set. Instead, we have considered the evidence related to
the totality of the dietary pattern. By considering the makeup of the
entire healthy dietary pattern, we can take into account connections
that foods and dietary components may have with one another.
    As noted in the 2015 DGAC Report, the analysis of dietary patterns
and health outcomes captures the relationship between the overall diet
and its constituent foods, beverages and nutrients in relationship to
outcomes of interest and quality, thereby overcoming the collinearity
(closely aligned relationship) among single foods and nutrients (Ref.
19). Therefore, we agree with the comment that said that interplay
between multiple factors in dietary patterns cannot be excluded. The
dietary pattern should be looked at as a whole rather than a sum of its
parts because there is interplay between the multiple factors. When
certain nutrients or foods are looked at individually without taking
into account the relationships that the nutrient or food component has
with other pieces of the dietary pattern, the effects of those
relationships are lost. Information that would allow consumers to
understand how a food fits into their overall dietary pattern is
therefore important to be declared on the label.
    In addition, investigators often analyze data using different
methods, depending on the research question, and not all articles
include a report of all of the study findings. Therefore, it is
possible that sugar-sweetened foods and beverages could have been
measured or that a component analysis was conducted for sugar-sweetened
foods and/or beverages, but the findings were not reported in a
particular published article.