fatty acids in their diets (Ref. 6). The 2010 DGA recommends limiting
the consumption of saturated fatty acids accompanied with replacing
them with polyunsaturated and monounsaturated fatty acids (Ref. 6).
However, as discussed in this document, the IOM did not set DRIs for
total polyunsaturated fatty acids, but rather provided AIs and AMDRs
each for two specific fatty acids, linoleic acid (an n-6
polyunsaturated fatty acid) and [alpha]-linolenic acid (an n-3
polyunsaturated fatty acid) based on median intakes of each fatty acid
using NHANES data (Ref. 49).
    We acknowledge that certain polyunsaturated fatty acids are
essential and understand the interest expressed by some comments that
there is a need to provide information on beneficial fats. However, the
essentiality of a nutrient is not a factor considered for the mandatory
or voluntary labeling of non-statutory nutrients, other than essential
vitamins and minerals (see section I.C). Although certain
polyunsaturated fatty acids are essential, an essential fatty acid
deficiency is basically nonexistent in the United States and,
therefore, is not of public health significance (Ref. 49).
    A quantitative intake recommendation is not available from relevant
U.S. consensus reports (see discussion in this document), but there is
well-established evidence to indicate that replacing saturated fatty
acids with polyunsaturated and monounsaturated fatty acids reduces
blood LDL cholesterol levels and, therefore, the risk of CVD (Ref. 30).
The prevalence of CVD in the U.S. population is substantial (Ref. 30).
We are not proposing any changes to the requirement for mandatory
declaration of saturated fat (see section II.B.2.). Because
polyunsaturated fat has public health significance when it replaces
saturated fat, consistent with the factors for voluntary declaration
discussed in section I.C., we are proposing to continue to permit
voluntary declaration of polyunsaturated fat, as provided in Sec.
101.9(c)(2)(iii). We request comment about whether there is an
appropriate alternative analysis to the application of the factors in
section I.C. regarding the voluntary declaration of polyunsaturated
fat.
    b. DRV--FDA regulations do not provide a DRV for polyunsaturated
fat. The IOM did not set a DRI or AMDR for polyunsaturated fat, but
provided AIs and AMDRs for two specific essential fatty acids, linoleic
acid (an n-6 polyunsaturated fatty acid) and [alpha]-linolenic acid (an
n-3 polyunsaturated fatty acid) based on median intakes of each fatty
acid using NHANES data (Ref. 49). The AIs for linoleic acid and
[alpha]-linolenic acid are 17 and 1.6 micrograms (mcg)/d, respectively.
The AMDRs for linoleic acid and [alpha]-linoleic acid are 5 to 10
percent of calories and 0.6 to 1.2 percent of calories, respectively.
In the 2007 ANPRM, we asked: (1) Whether a DRV for total
polyunsaturated fat should be derived based upon AIs for linoleic acid
plus [alpha]-linolenic acid; and (2) whether a DRV for total
polyunsaturated fat should be established using the AMDRs for n-6 and
n-3 polyunsaturated fatty acids and, if so, should a midpoint be used.
We received comments in response to these questions (Ref. 47).
    We are not able to set an appropriate DRV for polyunsaturated fat
at this time given the lack of established DRIs for total
polyunsaturated fatty acids. We do not consider that the AMDRs or AIs
for linoleic acid and [alpha]-linolenic acid provide a sufficient basis
on which a DRV for polyunsaturated fat could be derived. The AIs for
linoleic and [alpha]-linolenic acid were set based on U.S. median
intake levels because there were insufficient experimental data to set
an RDA (Ref. 49). Similarly, the AMDRs for linoleic acid and [alpha]-
linolenic acid were based on the percent of calories needed to meet the
AI for each fatty acid (lower range) and the percent of calories
representing the highest intake level of each fatty acid (upper range).
As such,

neither of these values provides an adequate basis on which to
determine a DRV. For these reasons, we disagree with comments that
supported using the sum of AIs or AMDRs to establish a DRV for total
polyunsaturated fat.
    Therefore, we tentatively conclude that there is no appropriate
quantitative intake recommendation to form a basis for setting a DRV
for polyunsaturated fat. Accordingly, we are not proposing a DRV for
polyunsaturated fat.
    c. Declaration of Individual Polyunsaturated Fatty Acids--The
declaration of individual polyunsaturated fatty acids on the Nutrition
Facts label is not permitted. The IOM did not set DRIs for total n-6
and n-3 polyunsaturated fatty acids, but established AIs and AMDRs for
two specific fatty acids, linoleic acid (an n-6 polyunsaturated fatty
acid) and [alpha]-linolenic acid (an n-3 polyunsaturated fatty acid)
(Ref. 49). The 2007 ANPRM asked for public comment on whether separate
DRVs for linoleic acid and [alpha]-linolenic acid should be established
and, if so, whether the declaration of these nutrients should be
voluntary or made mandatory. We received comments in response to these
questions (Ref. 47).
    Linoleic and [alpha]-linolenic acids are essential fatty acids that
differ physiologically and compete metabolically. Based on a review of
relevant scientific research, in 2004, FDA concluded in its qualified
health claim review that there is supportive, but not conclusive,
research to suggest that n-3 polyunsaturated fatty acids (EPA and DHA)
reduce the risk of CHD (Ref. 59). Results of one clinical trial on the
effects of EPA published since 2004 fail to demonstrate a significant
reduction in the hazard ratio for the primary prevention of major
coronary events (Ref. 60).
    More recently, the 2010 DGAC concluded that moderate evidence shows
that the consumption of two servings of seafood per week, which
provides an average of 250 mg/d of long-chain n-3 polyunsaturated fatty
acids (i.e., EPA and DHA), is associated with reduced cardiac mortality
from CHD or sudden deaths, both in persons with and without CVD (Ref.
30). The DGAC also concluded that the evidence for plant-derived n-3
polyunsaturated fatty acids (i.e., [alpha]-linolenic acid) in reducing
mortality among persons with existing CVD is limited (Ref. 30).
Similarly, there is no conclusive evidence for an independent role of
n-6 polyunsaturated fatty acids in reducing blood cholesterol levels
and, consequently, the risk of CHD. Evidence suggests that the benefit
of n-6 polyunsaturated fatty acids is observed only as a result of a
reduction in saturated fatty acid intake (Refs. 6 and 59). The IOM
noted that the evidence for a role of EPA and DHA in CHD risk is
growing (Ref. 49), but set AIs and AMDRs for [alpha]-linolenic acid,
not for EPA or DHA.
    While a ``healthy'' n-6:n-3 ratio may be important in human health,
such a ratio has not been defined and much of the available evidence is
based on studies conducted in animals, infants, and patients on total
parenteral nutrition and much of the evidence in adults has come from
observational studies (Ref. 49).
    Because of the lack of well-established evidence for a role of n-3
or n-6 polyunsaturated fatty acids in chronic disease risk and the lack
of a quantitative intake recommendation, and consistent with the
factors discussed in section I.C., we tentatively conclude that the
declarations of n-3 and n-6 polyunsaturated fatty acids are not
necessary to assist consumers to maintain healthy dietary practices.
Accordingly, we are not proposing to provide for the individual
declaration of either n-3 or n-6 polyunsaturated fatty acids on the
Nutrition Facts label. Similarly, because of the lack of well-
established evidence for a role of EPA and DHA in chronic disease risk
and the lack of a quantitative intake recommendation, consistent with
the factors discussed in section I.C., we tentatively conclude that the
declarations of EPA and DHA are not necessary to assist consumers to
maintain healthy dietary practices. Accordingly, we are not proposing
to provide for the mandatory or voluntary declaration of EPA or DHA on
the Nutrition Facts label. We request comment about whether there is an
appropriate alternative analysis to the application of the factors in
section I.C. regarding the individual declaration of n-3 or n-6
polyunsaturated fatty acids, as well as EPA or DHA.
5. Monounsaturated Fat
    a. Voluntary Declaration--FDA regulations currently permit, but do
not require, the declaration of monounsaturated fat (defined as cis-
monounsaturated fatty acids (e.g., oleic acid)) on the Nutrition Facts
label (Sec.  101.9(c)(2)(iii)). To determine whether any changes are
needed to the provision for voluntary declaration, we considered
recommendations in current consensus reports as well as comments
received in response to the 2007 ANPRM (Ref. 47), in which we requested
comment on whether declaration of monounsaturated fat should remain
voluntary or be made mandatory.
    In 2002, the IOM noted that there was no known independent role of
monounsaturated fatty acids in preventing chronic disease (Ref. 49).
The lack of an independent effect of monounsaturated fatty acids on
heart disease risk was also substantiated in a 2004 FDA review of a
qualified health claim regarding monounsaturated fatty acids from olive
oil and CHD (Ref. 61). Upon review of data related to this qualified
health claim, we concluded that there was no evidence to indicate that
monounsaturated fatty acids from olive oil, independent of saturated
fatty acid displacement, lower serum total and LDL cholesterol levels.
Most recently, the 2010 DGAC (Ref. 30) noted that there was strong
evidence indicating that monounsaturated fatty acids are associated
with improved blood lipids related to CVD when they replace saturated
fatty acids. Consequently, the 2010 DGA recommends that most fats
should be consumed as polyunsaturated and monounsaturated fatty acids
(Ref. 6). Current dietary recommendations advise consumers to increase
intakes of monounsaturated fatty acids to replace saturated fatty acids
in their diets.
    We acknowledge that monounsaturated fatty acids are not essential
in the diet (Ref. 49). However, a lack of essentiality is not a basis
for determining whether a nutrient should be required to be declared
(see section I.C.). Indeed, nonessential nutrients trans fat, saturated
fat, and cholesterol are required to be declared on the label because
of their public health significance. Scientific evidence points to the
positive effects of increased monounsaturated fatty acid intake as a
result of reduced intake of saturated fatty acids.
    While a quantitative intake recommendation is not available from
relevant U.S. consensus reports, there is well-established evidence to
indicate that replacing saturated fatty acids with polyunsaturated and
monounsaturated fatty acids reduces blood LDL cholesterol levels and,
therefore, the risk of CVD, and that the prevalence of CVD is
substantial in the United States (Ref. 30). We are not proposing any
changes to the current requirement for mandatory declaration of
saturated fat (see section II.B.2.). Because monounsaturated fat has
public health significance when it replaces saturated fat, consistent
with the factors we consider for voluntary declaration discussed in
section I.C., we are proposing to continue to allow for voluntary
declaration of

monounsaturated fat, as provided in Sec.  101.9(c)(2)(iii). We request
comment about whether there is an appropriate alternative analysis to
the application of the factors in section I.C. regarding the voluntary
declaration of monounsaturated fat.
    b. DRV--FDA regulations do not provide a DRV for monounsaturated
fat. Current consensus reports do not provide specific quantitative
intake recommendations for monounsaturated fatty acids. The IOM did not
set a DRI for monounsaturated fatty acids because these fatty acids are
not essential in the diet and have no known independent role in
preventing chronic diseases (Ref. 49). Therefore, we tentatively
conclude that there is no scientific basis on which we can rely to set
a DRV for monounsaturated fat and, therefore, we are not proposing to
set a DRV for monounsaturated fat.

C. Cholesterol

1. Mandatory Declaration
    Section 403(q)(1)(D) of the FD&C Act requires the declaration of
the amount of cholesterol on food labels, and cholesterol content must
be declared on the Nutrition Facts label in accordance with Sec.
101.9(c)(3). 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 (Ref. 6). In addition, the 2010 DGA provided a
quantitative intake recommendation for cholesterol (Ref. 6) (see
discussion in this document). Furthermore, FDA authorized a health
claim for dietary saturated fat and cholesterol and risk of CHD, for
which we evaluated the scientific evidence on the association between
dietary cholesterol and serum cholesterol levels (Sec.  101.75).
    We are unaware of evidence that would support a change to the
requirement for mandatory declaration of cholesterol on the Nutrition
Facts label in Sec.  101.9(c)(3) and, therefore, we are not proposing
any changes to the current requirement for mandatory declaration.
2. DRV
    FDA regulations provide a DRV for cholesterol of 300 mg (Sec.
101.9(c)(9)). The IOM Labeling Committee recommended, based on the IOM
DRIs, that the DV for cholesterol (along with saturated fat and trans
fat) should be set at a level that is as low as possible in keeping
with an achievable health-promoting diet (Ref. 25). The IOM Labeling
Committee suggested that FDA use food composition data, menu modeling,
and data from dietary surveys to estimate minimum intakes that are
consistent with nutritionally adequate and health-promoting diets for
diverse populations (Ref. 25). Acknowledging these IOM recommendations,
in the 2007 ANPRM, we asked for public comment on (1) whether the
current DRV for cholesterol of 300 mg should be retained; and (2)
whether food composition data, menu modeling, and data from dietary
surveys should be used to establish a DRV for cholesterol that is as
low as possible while consuming a nutritionally adequate diet. We
considered recommendations in current consensus reports as well as
comments received (Ref. 47).
    The 2010 DGA recommends consuming less than 300 mg/d of cholesterol
to help maintain normal blood cholesterol levels and reducing intake to
less than 200 mg/d for individuals at high risk of CVD (Ref. 6). The
IOM also reported a relationship between increased cholesterol intake
and increase in serum cholesterol, a surrogate endpoint for CHD risk
(Ref. 62). The IOM macronutrient report recommended that cholesterol
intakes should be as low as possible while consuming a nutritionally
adequate diet, but did not set ULs for cholesterol (Ref. 62). Based on
the reasons set forth previously, we disagree with the comments
suggesting that a DRV of 300 mg is too low or that there is no strong
association between cholesterol intake and CHD risk, or that current
science justifies eliminating the percent DV declaration.
    We do not agree with the IOM recommendation that food composition
data, menu modeling, and data from dietary surveys offer a suitable
approach for determining DRVs. Limitations inherent to menu modeling
and food composition and dietary survey data sources are discussed in
sections II.B.2.c. and II.B.3.c. We established the current DRV for
cholesterol based on quantitative intake recommendations that
considered specific effects on health outcomes (e.g., CHD) (58 FR 2206
at 2217). Use of menu modeling to determine a quantitative intake
recommendation for cholesterol is inconsistent with this approach and
may result in a reference intake level that is not based on scientific
evidence related to actual public health outcomes.
    Although the 2010 DGA recommends that cholesterol intake levels
should be less than 200 mg/d for individuals at high risk of CVD, we
consider the DGA recommendation of 300 mg/d 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. Therefore, we are not
proposing any changes to the DRV for cholesterol of 300 mg specified in
Sec.  101.9(c)(9).

D. Carbohydrate

    In this section, we discuss our consideration of provisions related
to definitions, declarations, DRVs, and analytical methods for total
carbohydrate, total sugars, added sugars, dietary fiber, soluble and
insoluble fiber, sugar alcohols, and other carbohydrates.
1. Total Carbohydrate
    a. Calculation of Total Carbohydrate--For the purposes of the
Nutrition Facts label, total carbohydrate content is calculated by
subtracting the sum of protein, total fat, moisture, and ash from the
total weight of the food (Sec.  101.9(c)(6)). 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. 63). Total carbohydrate includes
starch, sugars, sugar alcohols, and dietary fiber.
    On July 8, 2004, the National Starch and Chemical Company (National
Starch) submitted a citizen petition requesting that dietary fiber
content be excluded from the calculation of total carbohydrate that is
declared on the Nutrition Facts label (Docket No. FDA-2004-P-0094)
(http://www.regulations.gov/# !docketDetail;D=FDA-2004-P-0094). The
petition noted that consumers wishing to reduce their intake of
carbohydrate may also be inadvertently decreasing their consumption of
high fiber foods, such as whole grains, because dietary fiber is
included in the definition of ``Total Carbohydrate.'' National Starch,
therefore, requested an amendment to the second sentence in Sec.
101.9(c)(6) to read as follows: ``Total carbohydrate content shall be
calculated by subtraction of the sum of the crude protein, total fat,
moisture, ash, and dietary fiber from the total weight of the food.''
The petition noted that excluding dietary fiber from the definition
would be consistent with the way the IOM DRI report and Codex
guidelines refer to carbohydrates and would be a more accurate
representation of the amount of calories contributed by carbohydrates.
To support this request, the petition presented study findings reported
in the New York Times in 2004 and from research conducted on the
Internet. In

addition, the petition discussed the use of the term ``net carbs'' in
labeling and discussed inconsistencies in the way different
manufacturers define the term ``net carbs.'' According to the petition,
some manufacturers define ``net carbs'' as the amount of total
carbohydrate excluding the amount of dietary fiber and sugar alcohols
while others exclude sugar alcohols and ``other carbohydrates,'' as
specified in Sec.  101.9(c)(6)(iv), or sugar alcohols and ``certain
other carbohydrates.'' The petition suggested that the varied
approaches to describing carbohydrates have led to consumer confusion.
    In the 2007 ANPRM, we asked for comment on whether the approach for
calculating total carbohydrate by difference should be retained and, if
not, which specific components should be included or excluded from the
calculation of total carbohydrate. In addition, acknowledging the 2005
DGA recommendation to consume fiber-rich foods, we asked for comment on
whether separating dietary fiber from the amount of total carbohydrate
would affect consumer understanding and use of the information,
particularly with respect to fiber consumption. We received several
comments (Ref. 47).
    We reviewed scientific evidence and considered the petition's
requests and comments received. As explained in this document, we
decline to change to the current method for calculating total
carbohydrate by difference.
    Under FDA regulations, compliance with certain nutrition labeling
requirements may be achieved by the use of an FDA-approved database
(Sec.  101.9(g)(8)). Nutrient databases include carbohydrate values
that are determined by difference. Changing the way carbohydrate is
calculated would either necessitate an analogous change to the way
carbohydrate is calculated in major nutrient databases, such as the
USDA National Nutrient Database for Standard Reference, or would
substantially decrease the usefulness of these databases in assisting
manufacturers in making nutrient content declarations.
    We also considered an alternative approach of calculating total
carbohydrates by summing individual carbohydrate measurements rather
than calculating by difference, as suggested by a comment. There is
variability and error that are introduced with each analytical test
that is performed (Ref. 64). When summing the values from the various
tests, the amount of variability and error would multiply and such an
approach is likely to result in greater variability and error. As
discussed in the documentation for USDA's National Nutrient Database
for Standard Reference, Release 23, when the analyses of starch,
sugars, sugar alcohol, and dietary fiber are performed separately, the
result reflects the analytical variability inherent to each of those
measurement processes (Ref. 65). Thus, such an approach does not
provide any distinct advantage over measuring carbohydrate by
difference.
    With respect to removal of dietary fiber from the calculation of
total carbohydrate, we agree that the IOM provided separate DRIs for
carbohydrate (i.e., starch and sugars) and dietary fiber. However, the
IOM DRI Report does not provide recommendations for nutrition labeling.
Furthermore, the report defines dietary fiber as ``non-digestible
carbohydrates and lignin that are intrinsic and intact in plants''
(Ref. 66). Thus, the report acknowledges that dietary fibers, with the
exception of lignin, are carbohydrates. As discussed in section
II.D.5., the definition of dietary fiber adopted by Codex in 2010
specifies that dietary fibers are carbohydrate polymers (Ref. 67). The
Codex Guidelines on Nutrition Labeling, however, indicate that the
nutrient declaration for carbohydrate should be ``available
carbohydrate,'' which is the amount of dietary carbohydrate, excluding
dietary fiber (Ref. 67).
    The petition states that the inclusion of dietary fibers in the
calculation of total carbohydrate is not fully aligned with the Codex
Guidelines on Nutrition Labeling. Our rationale for including dietary
fiber in the calculation of total carbohydrate is based on what is
considered to be a carbohydrate. To the extent the petition is
requesting the removal of dietary fiber from the total carbohydrate
calculation due to its physiological effects, we consider in greater
detail in this document the classification and declaration of
carbohydrates based on their chemical definition or their physiological
effects. As discussed in greater detail in this document, we find that
inclusion of dietary fiber in the determination of the label
declaration of total carbohydrate is scientifically sound based on our
chemical definition of total carbohydrate and the analytical methods
used to determine carbohydrate content, as well as being consistent
with the way subcategories of other macronutrients, such as fat, are
listed on the Nutrition Facts label. Dietary fiber is a subset of
carbohydrates. All dietary fibers, with the exception of lignin, are
carbohydrate polymers. Although lignin is not a carbohydrate, it is
tightly bound to other dietary fibers and cannot be easily isolated
using AOAC or equivalent methods. It is, therefore, included in the
calculation of total carbohydrate.
    Further, dietary fiber is a mandatory separate listing on the
Nutrition Facts label. Therefore, for consumers who wish to know the
carbohydrate content of a food that excludes dietary fiber, this
information can be deduced by subtracting the declared amount of
dietary fiber from the declared amount of total carbohydrate on the
Nutrition Facts label.
    In addition, a calculation based on eliminating dietary fiber
content from the declared value of total carbohydrate would necessitate
calculating total carbohydrate by difference using the current method
and then subtracting from that number the amount of dietary fiber
obtained from separate analysis. This option presents a challenge with
respect to the use of existing databases in the United States, which
include dietary fiber in the calculation of total carbohydrate.
    Moreover, the petition provided no references to (and we could not
locate) the studies identified in the petition. We have no data or
information at this time to indicate that removal of dietary fiber from
the declaration of total carbohydrate would promote consumption of
dietary fiber due to lower amounts of carbohydrate contents declared in
nutrition labeling. Finally, to the extent that the petition seeks to
define the term ``net carbs,'' such a request is outside the scope of
this rulemaking. In this proposed rule, we are considering whether to
propose a change in how ``total carbohydrate'' is calculated.
Therefore, to the extent the petitioner is requesting to remove
``dietary fiber'' from the total carbohydrate calculation to prevent
consumer confusion from the term ``net carb,'' we decline to change the
calculation of total carbohydrate by difference on that basis. We
consider the calculation and declaration of ``net carbs'' and the total
carbohydrate calculation and declaration on the label as separate and
distinct. The declaration of total carbohydrate is required under
section 403(q)(1)(D) of the FD&C Act.
    For these reasons, we decline to change the method for calculating
total carbohydrate by difference and, therefore, we are not proposing
any changes to the method for calculating total carbohydrate by
difference specified in Sec.  101.9(c)(6).
    b. Classification of Carbohydrates Based on a Chemical Definition
or Physiological Effect--In the 2007 ANPRM, we asked for comment on
whether carbohydrates should be classified and declared in nutrition
labeling based on their chemical

definition (current method) or on their physiological effect (e.g.,
attenuation of blood sugar or laxation if dietary fiber were to be
included in the total carbohydrate declaration), and whether additional
types of carbohydrates (e.g., starch) should be listed separately on
the Nutrition Facts label. We received several comments (Ref. 47) in
response to these questions.
    We considered this issue in light of the comments received. We
agree with the comments that stated that classification of
carbohydrates based on validated analytical techniques, which isolate
and measure the individual carbohydrates based on their chemical
structure rather than based on their physiological effects, is
necessary for determining the accuracy of values declared on the label.
Carbohydrates include starch, sugars, sugar alcohols, and dietary
fibers. Different types of carbohydrates have different physiological
effects. The effects of some carbohydrates are not fully understood and
are the subject of debate in the scientific community. 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 disagree that a definition based on ``physiological
effects'' would be a better approach than a chemical definition for
total carbohydrate declaration. The use of a chemical definition is
also consistent with the classification and declaration of fat on the
Nutrition Facts label. Different types of fats identified in nutrition
labeling are not classified based on their physiological effect but
rather on their chemical definition.
    Therefore, we are not proposing to use physiological effects of
carbohydrates as a basis for classifying or declaring total
carbohydrate. Accordingly, we are not proposing to change our
provisions for the classification or declaration of carbohydrates
specified in Sec.  101.9(c)(6).
    c. Separate Declaration of Additional Individual Types of
Carbohydrates--In the 2007 ANPRM, we asked whether additional types of
carbohydrates (e.g., starch) should be listed separately on the
Nutrition Facts label. We considered comments received (Ref. 47),
which, taken together, did not support declaration of additional types
of carbohydrates. Some comments stated that such additional information
could distract consumers from information that is important, such as
dietary fiber. A few comments that supported the declaration of starch
provided no evidence to support their assertions regarding the benefit
of this declaration for diabetics. Moreover, there is no strong
scientific evidence for us to consider related to the role of starch in
human health. Therefore, we are not proposing to require the separate
declaration of additional types of individual carbohydrates such as
starch on the Nutrition Facts label.
    d. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of total carbohydrate. Correspondingly,
regulations require the declaration of the amount of total carbohydrate
on the Nutrition Facts label (Sec.  101.9(c)(6)). 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 (Ref. 68). We have no basis on which to reconsider
the requirement for mandatory declaration of the amount of total
carbohydrate on the Nutrition Facts label and comments in response to
the 2007 ANPRM also supported this mandatory declaration. We
tentatively conclude that the declaration of carbohydrates on the
Nutrition Facts label continues to be necessary to assist consumers in
maintaining healthy dietary practices. Therefore, we are not proposing
any changes to the current requirement for mandatory declaration of
total carbohydrate, as specified in Sec.  101.9(c)(6).
    e. DRV--The DRV for total carbohydrate is 300 g (Sec.
101.9(c)(9)). The IOM established an AMDR for carbohydrate intake of 45
to 65 percent of energy for adults and an EAR of 100 g/d for adults and
children (Ref. 69). In the IOM report, ``carbohydrate'' only included
starch and sugars, not sugar alcohols or dietary fiber. The IOM also
set the RDA for ``carbohydrate'' (i.e., starch and sugars) at 130 g/d
for adults and children based on the average minimum amount of glucose
utilized by the brain in adults, which was extrapolated to children
ages 1 through 18 years. Subsequently, the IOM Labeling Committee
recommended that, as in the case of protein and total fat, the AMDRs
should be the basis for DVs for total carbohydrate (Ref. 25).
Considering that AMDRs vary with age, the IOM Labeling Committee
recommended a population-weighted midpoint of the AMDR. Under this
approach, using a population-weighted mid-point of the AMDR for adults
and children, i.e., 45 to 65 percent, the DV for total carbohydrate
would amount to 55 percent or, based on a 2,000 calorie reference
calorie intake, 275 g of carbohydrate.
    However, as we noted in the 2007 ANPRM, the IOM's AMDR, EAR, and
RDA values for carbohydrate do not include sugar alcohols or dietary
fiber. In contrast, our calculation of total carbohydrates for the
purposes of nutrition labeling accounts for all types of carbohydrates,
including sugar alcohols and dietary fiber. Therefore, applying the IOM
Labeling Committee's approach, in which a DV is derived from the AMDR,
would result in a reference value based on recommendations specifically
for sugars and starches, whereas the absolute gram amount of
carbohydrates declared on the label includes all carbohydrates.
Consequently, 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. We did not ask any questions about
the DRV for total carbohydrate in the 2007 ANPRM nor did we receive any
comments on this issue. Consistent with calculating total carbohydrate
``by difference'' (discussed previously), we are proposing no changes
to the approach to calculate the percent DV for carbohydrate ``by
difference'' as well. In addition, we are not proposing to change the
DRVs for fat or protein (see sections II.B. and II.E.), which are used
to derive the DRV for total carbohydrate. Therefore, we are not
proposing any changes to the DRV for total carbohydrate of 300 g/d. We
note that the RDA for carbohydrate for men and women 19 years of age
and older is 130 g/d. Therefore, the DRV should not be viewed as an
intake requirement, but as a reference amount.
    f. Calculation of Calories From Carbohydrate--FDA regulations
require that the calories from total carbohydrate be calculated by
using the general factor of 4 calories/g of carbohydrate less the
amount of insoluble dietary fiber (Sec.  101.9(c)(1)(i)(C)). We are
proposing a new definition of dietary fiber (see section II.D.5.a.i.)
that only allows for the declaration of dietary fibers that we have
determined to have a physiological effect that is beneficial to human
health, as ``dietary fiber'' on the Nutrition Facts label. Therefore,
the new definition of dietary fiber would exclude both soluble and
insoluble non-digestible carbohydrates that do not meet the proposed
definition. For the purposes of

calculating calories from carbohydrate, 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 are
proposing 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.
As discussed in section II.D.5.b.v., a value of 2 calories/g of soluble
non-digestible carbohydrates is then added to the calculation.
2. Sugars
    a. Definition--Sugars are defined in Sec.  101.9(c)(6)(ii) as a
statement of the number of g of sugars in a serving. They are the sum
of all free mono and disaccharides (e.g., glucose, fructose, lactose,
and sucrose). We received a citizen petition on the term ``sugars''
and, as explained in this document, we are not proposing any changes to
the term or its definition for the purpose of nutrition labeling.
    b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of sugars. FDA regulations require the
declaration of sugars on the Nutrition Facts label (Sec.
101.9(c)(6)(ii)).
    The Sugar Association submitted a citizen petition on August 16,
2005 (Docket No. FDA-2005-P-0373) requesting among other things that we
eliminate ``sugars'' as a mandatory nutrient that is declared on the
Nutrition Facts label or, alternatively, rename ``sugars'' as ``sugars/
syrup'' and require the mandatory declaration of polyol and artificial
sweeteners on the Nutrition Facts label, as well as the mandatory
labeling of each specific polyol and artificial sweetener ingredient
and its amount on the food label (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373). The petition asserted that consumers
understand ``sugars'' to mean sucrose. The petition stated that an
increasing number of manufacturers are using artificially produced
(alternative) sweeteners, such as high fructose corn syrup, instead of
sucrose products such as table sugar. The petition also asserted that,
under current regulations, information on sugar content is presented in
a manner that is misleading to consumers because it does not reflect
the caloric content of artificially produced sweeteners and does not
identify the specific sweeteners used in food products. The petition
also expressed concern about the potential caloric and health effects
of alternative sweeteners and asserted that the current labeling of
sugar and lack of labeling for artificially produced sweeteners on the
Nutrition Facts label did not provide consumers with relevant
information about alternative sweeteners. However, the petitioner did
not include any data to specifically support these assertions and
concerns.
    In the 2007 ANPRM, we requested comment on whether ``sugars''
should continue to be included on the Nutrition Facts label. We
received several comments which were in favor of continuing to require
mandatory labeling of sugars on the Nutrition Facts label (Ref. 47).
    We considered the petition and comments received in light of
scientific evidence. There is strong and consistent evidence based on
valid endpoints that consumption of sugars is associated with an
increased risk of dental caries (Refs. 6 and 68). We authorized a
health claim for dietary non-cariogenic carbohydrate sweeteners and
dental caries (Sec.  101.80). The IOM macronutrient report noted that
dental caries is a condition of public health concern that is
associated with consumption of sugars (Ref. 68). Therefore, we
tentatively conclude that the declaration of sugars continues to be
necessary to assist consumers in maintaining healthy dietary practices,
and we are not proposing to change the current requirement for
mandatory declaration of sugars.
    Moreover, we decline the petition's request to rename ``sugars'' as
``sugars/syrups'' on the Nutrition Facts label. The petition requested
that we rename the ``sugars'' category to prevent consumers from being
misled with regard to the ingredients that are permitted to be
considered sugars under the current regulation (monosaccharides plus
disaccharides such as high fructose corn syrup). The petition, however,
did not provide data or information to support the assertion that
consumers are misled by the term ``sugars'' on products containing
sweeteners that are a combination of mono and disaccharides, as defined
in Sec.  101.9(c)(6)(ii). We are considering using the term ``total
sugars'' in lieu of ``sugars'' on the Nutrition Facts label if ``added
sugars' declaration is finalized, as proposed. FDA plans to conduct
consumer testing of the terms ``total sugars'' and ``sugars'' on the
Nutrition Facts label (FR 2013-12824) to determine if use of the term
``total sugars'' aids consumers in understanding that added sugars are
part of the total amount of sugars in product.
    We also decline the petition's request to require manufacturers to
declare the specific type of artificial sweetener used on the Nutrition
Facts label so that consumers can be made aware of the degree of
substitution, when artificial sweeteners are substituted for sugars,
and the overall level of the artificial sweeteners in the food. Under
FDA regulations, artificial sweeteners that are added to a food are
required to be declared in the ingredient statement of the label. The
petition did not provide any justification that additional information
about artificial sweeteners in nutrition labeling is warranted and we
have no data to suggest that a declaration of artificial sweeteners is
necessary to assist consumers in maintaining healthy dietary practices.
    Therefore, we are not proposing any change to the current
requirement for mandatory declaration of sugars on the Nutrition Facts
label, as specified in Sec.  101.9(c)(6)(ii). We are also not proposing
to rename the ``sugars'' category as ``sugars/syrups'' or require the
mandatory declaration of specific sugar alcohols or other artificial
sweeteners.
    c. DRV--FDA regulations do not specify a DRV for sugars. Current
consensus reports have not set dietary reference values based on which
we could derive an appropriate DRV for total sugars. While the IOM
found an association between sugar consumption and risk of dental
caries, due to the various factors that contribute to dental caries,
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 (Ref. 68). We did not ask
any questions related to the DRV for sugars in the 2007 ANPRM nor did
we receive any comments recommending the establishment of a DRV for
total sugars. For these reasons, we are not proposing to establish a
DRV for total sugars.
3. Added Sugars
    a. Declaration--FDA regulations neither define the term ``added
sugars'' nor require or permit its declaration on the Nutrition Facts
label. We are reconsidering the declaration of added sugars taking into
account new data and information, including U.S. consensus reports and
recommendations related to the consumption of added sugars, a citizen
petition submitted by the CSPI, and public comments. For the purposes
of the discussion in this document, added sugars refer to sugars and
syrups that are added to foods during processing or preparation (Ref.
6).

    i. Consensus Reports. The IOM DRI Report on Macronutrients stated
that ``although added sugars are not chemically different from
naturally occurring sugars, many foods and beverages that are major
sources of added sugars have lower micronutrient densities compared to
foods and beverages that are major sources of naturally occurring
sugars'' (Ref. 68). Although an upper level was not set for total or
added sugars, a maximal intake level of 25 percent or less of energy
from added sugars was suggested based on data that demonstrated
decreased intakes of some micronutrients among American subpopulations
whose intake of added sugars exceeded this level.
    In addition, the 2010 DGA (Ref. 6) noted that the primary
prevention of obesity, especially in childhood, is an important
strategy for combating and reversing the obesity epidemic. Over the
last few decades, the prevalence of overweight and obese individuals in
the United States dramatically increased among children, adolescents
and adults. Many factors contribute to weight gain and obesity but
maintaining an appropriate calorie balance and increasing physical
activity and reducing sedentary behaviors are key recommendations to
help combat the problem. The 2010 Dietary Guidelines Advisory Committee
(DGAC) concluded that strong evidence shows that children who consume
more sugar-sweetened beverages have greater adiposity (body fat)
compared to those with a lower intake. The sole source of calories in
many sugar-sweetened beverages (e.g., soda) is added sugars. The 2010
DGA specifically suggest that reducing the intake of sugar-sweetened
beverages may help individuals control their total calorie intake and
manage their body weight. The report stated that Americans consume too
many calories from solid fats (fats containing a high percentage of
saturated and trans fatty acids and are solid at room temperature) and
added sugars and these foods replace nutrient-dense foods and beverages
and make it difficult for people to achieve the recommended nutrient
intake while controlling their calorie intake. Together, solid fats and
added sugars contribute a substantial portion of Americans' calories,
35 percent on average (16 percent total on average from added sugar)
without contributing to the overall nutrient adequacy of the diet and
thus have implications for weight management. Thus, to meet nutrient
needs within an individual's calorie limits, a key recommendation of
the 2010 DGA is to reduce the intake of calories from solid fats and
added sugars.
    The report recognized that foods containing solid fats and added
sugars are no more likely to contribute to weight gain than any other
source of calories in an eating pattern that is within calorie limits.
However, reducing the consumption of calories from solid fats and added
sugars allows for increased intake of nutrient-dense foods without
exceeding overall calorie needs. The report recommended several ways to
reduce the consumption of solid fats and added sugars including eating
the most nutrient-dense forms of foods from all food groups, limiting
the amount of solid fats and added sugars when cooking or eating, and
consuming fewer and smaller portions of foods and beverages that
contain solid fats and added sugars. Specifically, the 2010 DGA noted
that, for most people, no more than about 5 to 15 percent of calories
from solid fats and added sugars can be reasonably accommodated in the
USDA Food Patterns, which are designed to meet nutrient needs within
calorie limits. The 2010 DGA also outlined common elements of healthy
eating patterns and stated that reducing the intake of added sugars is
one component.
    Although the subject of front-of-package labeling (FOP) is outside
the scope of this proposed rule, we reviewed the IOM Front-of-package
Nutrition Rating Systems and Symbols Committee's final report for their
conclusions on scientific evidence related to the effect of added
sugars on human health. This Committee cited the 2010 DGA
recommendations related to added sugars and noted that while there is a
lack of scientific agreement on the effects of added sugars on health
outcomes independent of the effects of total sugar, there is adequate
evidence that added sugars (whether a solid or liquid) contribute extra
calories to a diet, which could in turn lead to weight gain and obesity
(Ref. 28).
    ii. CSPI Petitions. We received a petition from CSPI on August 3,
1999 (hereafter referred to as ``the 1999 CSPI petition'') requesting
that we require the Nutrition Facts label to disclose the quantity of
added sugars present in packaged foods and to set a DRV for refined
sugars added to foods (Docket No. FDA-1999-P-0158) (http://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158). The petition
stated that the DRV for added sugars should be 40 g based on USDA's
``Food Guide Pyramid'' recommendations that Americans should limit
their daily intake of added sugars to about ten teaspoons (40 g) for a
2,000 calorie healthful diet. The petition cited USDA Economic Research
Service's data that show that the per capita consumption of added
sugars rose by 28 percent from 1983 to 1999 (Ref. 70). The petition
also referred to evidence that added sugars may contribute to obesity
and heart disease, and argued that it is impossible for consumers to
determine how much sugar has been added to foods or how much added
sugars are reasonable to consume because the Nutrition Facts label does
not currently provide this information. Although the petition also
requested that we amend our regulations to prescribe nutrient content
claims and health claims related to ``added sugars,'' those requests
are not considered within the scope of this proposed rule. We received
another petition from CSPI on February 13, 2013 (hereafter referred to
as ``the 2013 CSPI petition''), requesting that we revise the
``sugars'' line of the Nutrition Facts label to address ``added
sugars.'' (Docket No. FDA-2013-P-0217) (http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217). CSPI described ``added sugars'' as
``various caloric sweeteners,'' including sucrose, high-fructose corn
syrup, corn sugar, invert sugar, corn syrup ``and others.'' We address
CSPI's request for an ``added sugar'' declaration in this proposed
rulemaking. The data and information provided by the 2013 CSPI petition
in regards to added sugar declaration does not change our current
considerations or rationale for mandating added sugars on the label
that are addressed in this document. Although CSPI included other
requests in its petition, which generally relate to lowering levels of
added sugars in foods, we do not address those requests in the context
of this proposed rule because they are outside the scope of this
proposed rule.
    iii. Public Comments. On June 26, 2000, we published a notice of
availability of the 1999 CSPI petition in the Federal Register and
requested comment (65 FR 39414). We received more than 2,700 comments
from individuals, industry, academic institutions, advocacy groups, and
health care groups. Several comments stated that added sugar
declaration should be voluntary and not mandatory (Ref. 47). We did not
ask any questions on added sugars in the 2007 ANPRM. However, we
received comments that supported and others that opposed the
declaration of added sugars on the Nutrition Facts label (Ref. 47).
    iv. FDA's Considerations and Proposal. A key recommendation of the
2010 DGA is to reduce the intake of

calories from solid fats and added sugars. A high intake of calories
from excess solid fat and added sugars can decrease the intake of
nutrient-rich foods in the diet and can increase the overall caloric
intake which could lead to weight management issues. As such, this key
recommendation feeds into two overarching concepts of the intent of the
Dietary Guidelines of maintaining calorie balance over time to achieve
and sustain a healthy weight as well as supporting consumption of
nutrient-dense foods (Ref. 6). As discussed in this document, a
declaration of added sugars on the Nutrition Facts label would assist
consumers in maintaining healthy dietary practices by providing them
with information necessary to meet the key recommendations to construct
diets containing nutrient-dense foods and reduce calorie intake from
added sugars by reducing consumption of added sugars.
    The Nutrition Facts label includes the mandatory declaration of the
fatty acids that are contained in solid fats from the DGA
recommendation, in that saturated fatty acids and trans fatty acids are
required to be declared on the Nutrition Facts label. Solid fats are
solid at room temperature and contain a mixture of saturated and
unsaturated fatty acids but tend to contain a high percentage of
saturated or trans fatty acids. The disclosure of saturated fat and
trans fat on the label not only provides information to consumers for
managing their effects on CVD (see sections II.B. and II.C.) but also
could provide a marker for foods that contain solid fats that are
abundant in the diets of Americans and contribute significantly to
excess calorie intake (Ref. 6). However, similar information about
added sugars is not currently available on the Nutrition Facts label.
Thus, we are proposing to require the declaration of added sugars on
the Nutrition Facts label to provide consumers with information that is
necessary to meet the dietary recommendation to reduce caloric intake
from solid fats and added sugars.
    Added sugars contribute an average of 16 percent of the total
calories in American diets (Ref. 6). According to NHANES, the major
sources of added sugars in the diet in descending order are soda,
energy and sports drinks, grain based desserts, sugar-sweetened fruit
drinks, dairy-based desserts and candy. Most of these foods are not
nutrient-dense and may add calories to the diet without providing
dietary fiber or essential vitamins and minerals (Ref. 6). The
consumption levels of added sugars alone exceed the discretionary
calorie recommendations of 5 to 15 percent of calories from both solid
fats and added sugars discussed in the 2010 DGA. Although foods
containing solid fats and added sugars do not contribute to weight gain
any more than another calorie source, they make up a significant
percentage of the American diet and are a source of excess calories.
The 2010 DGAC concluded that strong evidence shows that children who
consume sugar-sweetened beverages have increased adiposity (increased
body fat). The 2010 DGAC also concluded that there is a moderate body
of evidence suggesting that greater consumption of sugar-sweetened
beverages is associated with increased body weight in adults and that
under isocaloric controlled conditions, added sugars, including sugar-
sweetened beverages, are no more likely to cause weight gain in adults
than any other source of energy. While the IOM FOP report did not
review scientific data on added sugars, based on the 2010 DGA
recommendation to reduce intake of calories from added sugars, it
concluded that added sugars should be included in an FOP labeling
system. In addition the IOM FOP committee recommended that the FOP
symbol system should be integrated with the Nutrition Facts label so
that the two are mutually reinforcing. The IOM DRI Macronutrient Report
noted the difficulty, among some populations, of consuming adequate
amounts of certain micronutrients when excessive amounts of added
sugars are consumed.
    As the CSPI petition pointed out, other groups such as the American
Heart Association (AHA), American Academy of Pediatrics, and World
Health Organization (WHO) have recommended limiting added sugars
consumption. None of these recommendations was based on an increased
risk of obesity or heart disease. Both the AHA and American Academy of
Pediatrics recommendations point out that added sugars intake is
associated with a greater intake of calories and a lower intake of
essential nutrients, whereas the 1990 WHO recommendation for decreasing
added sugars is based on dental caries and that excessive consumption
of these sugars can displace nutrient-containing foods in the diet
(Refs. 71 to 73). While these groups are not recognized as U.S.
consensus groups by FDA, these recommendations support our proposal to
require the mandatory declaration of added sugars so that consumers can
achieve a dietary pattern that is nutrient-dense and that does not
exceed caloric needs from added sugars, consistent with the 2010 DGA
recommendations.
    Further, we consider it necessary to require a declaration of added
sugars for all foods for which a Nutrition Facts label is required.
Using the current label, consumers cannot identify or compare the
amounts of added sugars to enable them to follow the recommendation of
the 2010 DGA. We are proposing mandatory declaration of added sugars on
all foods because of (1) the variability in ingredients used, (2) the
need for consumers to have a consistent basis on which to compare
products, (3) the need for consumers to identify the presence or
absence of added sugars, and (4) when added sugars are present, the
need for consumers to identify the amount of added sugars added to the
food. The mandatory declaration of added sugars may also prompt product
reformulation of foods high in added sugars like what was seen when
trans fat labeling was mandated (Ref. 58).
    We understand that our rationale to support an added sugars
mandatory declaration in labeling is different from our rationale to
support other mandatory nutrients to date which, consistent with the
factors we describe in section I.C., generally relate to the intake of
a nutrient and risk of chronic disease, a health-related condition, or
a physiological endpoint. U.S. consensus reports have determined that
inadequate evidence exists to support the direct contribution of added
sugars to obesity or heart disease. Specifically, although it is
recognized that sugar-sweetened beverages increase adiposity (body fat)
in children (Ref. 30), neither the 2010 DGA nor the IOM macronutrient
report concluded that added sugars consumption from all dietary
sources, in itself, increases obesity. In fact, the 2010 DGA states
that added sugars do not contribute to weight gain more than any other
source of calories. The evidence submitted by CSPI supporting the
contribution of added sugars to heart disease failed to show a direct
association between added sugars consumption and heart disease risk.
Rather, the evidence shows that the consumption of total carbohydrates
(not added sugars, per se) is associated with an increase in serum
triglyceride levels. Moreover, serum triglyceride level is not an
endpoint that we recognize as a validated surrogate marker for CHD risk
in our evidence-based review system for health claims (Ref. 74).
Nevertheless, for the reasons explained previously that include
providing consumers with the information necessary to follow the 2010
DGA recommendations to reduce the intake of calories from added sugars,

we tentatively conclude that the declaration of added sugars is
required to assist consumers in maintaining healthy dietary practices.
    Additionally, in the absence of uniform added sugars declaration on
the Nutrition Facts label, consumers would not be able to compare the
added sugars content of foods, particularly those that contain both
naturally occurring sugars and added sugars (e.g., yogurt and dairy-
based desserts). Contrary to what one comment stated, the added sugars
declaration in the ingredient statement of a food label may not provide
sufficient or quantitative information for consumers to be able to
formulate diets consistent with the dietary recommendations. Sugars may
be added to foods in the form of various ingredients, such as fruit
juice concentrates, fructose, maltose, sucrose, and honey, and
consumers may not realize that these ingredients are, in fact, forms of
added sugars and would not be able to determine the quantities added.
Thus, as pointed out in some comments, calorie declaration and
ingredient listing do not provide enough information for consumers to
determine the amount of calories derived from added sugars in the food.
We acknowledge that some products may contain only added sugars and no
naturally occurring sugars (e.g., soda) and that the amount shown in
the total ``sugars'' declaration on the Nutrition Facts label for such
products would be the amount of added sugars. In this case, however,
some consumers may still not be able to determine the amount of added
sugars because the term would not appear on the label at all. At this
point in time, we cannot be certain that most consumers would
understand that, in the absence of added sugars declaration, all sugars
in these products are added sugars. Therefore, without the added sugars
declaration, some consumers may perceive the amount of added sugars in
the product differently and some perceived amounts may differ from the
actual amount in the product. Food formulations may vary and
consistency in the mandatory declaration of added sugars is important
so that consumers are not confused.
    We recognize that small amounts of added sugars can increase the
palatability of nutrient-dense foods, as suggested by a comment. The
disclosure of added sugars on the label may allow consumers to plan and
construct their diets to include small amounts of added sugars and
still consume adequate amounts of necessary nutrients. Consumers may
select from a variety of such nutrient-dense foods as part of their
overall dietary pattern in a way to reduce or minimize the caloric
contribution of added sugars from such sources. The IOM FOP report
noted that small amounts of added sugars would be appropriate for foods
to earn FOP points in their recommended labeling scheme, which suggests
that small amounts would be appropriate in a balanced diet (Ref. 29).
    We acknowledge that, if finalized, a requirement for declaration of
added sugars on the Nutrition Facts label will need to be accompanied
by consumer education on the role of added sugars, along with solid
fats, and the use of the new information on the label in overall
dietary planning. We will be conducting consumer studies that include
questions regarding including added sugars on the Nutrition Facts
label. We plan to use the results of these studies to help inform our
future actions on this issue.
    We understand that there are currently no analytical methods that
are able to distinguish between naturally occurring sugars and those
sugars added to a food. However, we do not agree with comments that
analytical limitations should preclude mandatory declaration of added
sugars because there is an alternative method to assess compliance. The
amount of added sugars declared on the label could be verified through
means other than chemical analysis, such as through maintenance and
review of records. The reliance on records for compliance purposes is
not unique to added sugars as we have previously required that
manufacturers provide records under certain circumstances to support
statements made on food labels (for example, with respect to aeration
to reduce fat and caloric content of foods (58 FR 2229 at 2271) and
caloric content of new products with reduced digestibility (58 FR 2079
at 2111)). In addition, in sections II.D.5., II.J.2., and II.J.3., we
are proposing to use records to determine compliance with declared
values of dietary fiber, folate, and vitamin E, under certain specified
circumstances.
    We continue to recognize the lack of a physiological distinction
between added and naturally occurring sugars. While comments expressed
concerns that declaration of added sugars could significantly under-
represent the sugars content of many foods with a large quantity of
naturally occurring sugars, we are not proposing to remove the total
sugars declaration (see section II.D.2.) because there continues to be
strong scientific evidence linking total sugars intake with dental
caries. Therefore, the sugar content of foods with naturally occurring
sugars would not be under-reported.
    We also considered the appropriateness of voluntary declaration of
added sugars, an approach supported by several comments. However, we
are concerned that voluntary declaration of added sugars may not ensure
that consumers have the information that will allow them to follow the
current dietary recommendations. Added sugars declared voluntarily by
manufacturers on some products, but not on others, either within a
given product category or across different product categories, could be
confusing to consumers, and would not provide consumers with the
information they need to plan their dietary pattern to reduce
consumption of calories from added sugars.
    In light of current dietary recommendations that advise Americans
to reduce their intake of calories from added sugars, we consider that
an added sugars declaration will help individuals identify foods that
are nutrient-dense within calorie limits and aid in reducing excess
discretionary calorie intake from added sugars. We tentatively conclude
that the declaration of added sugars on the Nutrition Facts label is
necessary to assist consumers to formulate diets consistent with
current dietary recommendations and, thus, maintain healthy dietary
practices. Therefore, proposed Sec.  101.9(c)(6)(iii) would require the
mandatory declaration of added sugars as an indented line item
underneath the declaration of total sugars on the Nutrition Facts
label. We invite comment on this issue. We also invite comment,
including the submission of research on whether calories from added
sugars should be declared on the Nutrition Facts label in lieu of a
gram declaration of added sugars to aid consumers in maintaining
healthy dietary practices.
    FDA regulations require that the statement ``Not a significant
source of ----'' for calories from fat, saturated fat, trans fat,
cholesterol, dietary fiber, sugars, and protein must be placed at the
bottom of the table of nutrient values in the same type size, under the
specific circumstances described for each nutrient in Sec.  101.9(c).
For sugars, the phrase ``Not a significant source of sugars'' must be
placed at the bottom of the table of nutrient values if a statement of
the sugars content is not required and, as a result, not declared. A
statement of sugars content is not required for products that contain
less than 1 gram of sugars in a serving if no claims are made about
sweeteners, sugars, or sugar alcohol content (Sec.  101.9(c)(6)(ii)).
Similar information on added sugars could also be useful to consumers
who are trying to limit their

intake of added sugars. Therefore, proposed Sec.  101.9(c)(6)(iii)
would 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. We are also proposing 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 (proposed Sec.
101.9(c)(6)(iii)).
    In addition, for total carbohydrate, dietary fiber, soluble fiber,
insoluble fiber, sugars, and sugar alcohol, when a serving of the food
contains less than 1 gram of the nutrient, FDA regulations in Sec.
101.9 permit the use the alternative statements ``Contains less than 1
gram'' or ``less than 1 gram,'' and if a serving of the food contains
less than 0.5 grams of the nutrient, the content may be expressed as
zero. Proposed Sec.  101.9(c)(6)(iii) would provide for similar use of
alternative statements, ``Contains less than 1 gram'' and ``less than 1
gram'' for added sugars. In addition, if the serving contains less than
0.5 g of added sugars, we are proposing to permit the content to be
expressed as zero (proposed Sec.  101.9(c)(6)(iii)).
    b. Proposed Definition--The term ``added sugars'' is not defined in
FDA regulations. Given our tentative conclusion to require mandatory
declaration of ``added sugars'' on the Nutrition Facts label, we are
proposing to define added sugars. In proposed Sec.  101.9(c)(6)(iii),
we are proposing to define ``added sugars'' as sugars that are either
added during the processing of foods, or are packaged as such, and
include sugars (free, mono- and disaccharides), syrups, naturally
occurring sugars that are isolated from a whole food and concentrated
so that sugar is the primary component (e.g., fruit juice
concentrates), and other caloric sweeteners. This would include single
ingredient foods such as individually packaged table sugar. Sugar
alcohols are not considered to be added sugars. Names for added sugars
include: Brown sugar, corn sweetener, corn syrup, dextrose, fructose,
fruit juice concentrates, glucose, high-fructose corn syrup, honey,
invert sugar, lactose, maltose, malt sugar, molasses, raw sugar,
turbinado, sugar, trehalose, and sucrose. This proposed definition of
added sugars includes what CSPI described as ``added sugars'' in the
2013 CSPI petition.
    c. Daily Value--Given our proposal to require the declaration of
added sugars, we also considered establishing a DRV for added sugars.
In its 1999 petition as well as in a published report (Ref. 75), CSPI
recommended that FDA base a DV for ``added sugars'' on suggested limits
of added sugars published in the 1992 USDA's Food Guide Pyramid (Ref.
76). CSPI determined that a DRV for added sugars based on a 2,000
calorie diet would be 10 teaspoons or 40 g of added sugars. Overall,
comments submitted in response to CSPI's 1999 petition were in favor of
this approach to setting a DRV for added sugars. Comments in response
to the 2007 ANPRM also recommended establishing a DV for added sugars
(Ref. 47).
    We reviewed scientific evidence and recommendations of consensus
reports, and disagree with the petitioner and comments that there is
currently a sound scientific basis for the establishment of a
quantitative intake recommendation upon which a DRV could be derived.
The IOM did not set a DRI, such as a UL, for added sugars (Ref. 68).
The IOM suggested that no more than 25 percent of energy should be
consumed from added sugars, but noted that a defined intake level at
which inadequate micronutrient intakes occur could not be identified.
The 2010 DGA did not provide a quantitative intake recommendation for
added sugars intake but did provide a maximum intake level for solid
fats and added sugars at 13 percent of calories for a 2,000 calorie
diet based on food pattern modeling of the USDA Food Patterns and also
described the ``DASH'' (Dietary Approaches to Stop Hypertension) eating
plan which recommends 5 servings or less per week of sweets and added
sugars for a 2,000 calorie diet (Ref. 6). The USDA Food Patterns, which
provide recommended amounts of foods from each food group that
individuals should consume in order to meet their nutrient needs within
a specific calorie level, specify that the maximum amount of calories
from solid fats and added sugars that can be consumed at the 2,000
calorie level while staying within calorie limits is 258 calories (Ref.
6). The solid fats and added sugars limit at each calorie level in the
USDA Food Patterns is determined by calculation through food pattern
modeling rather than on any biomarker of risk of disease or other
public health endpoint. However, an exact amount of calories for added
sugars is not detailed in either the USDA Food Patterns or ``DASH''
eating plans, as they represent templates that translate and integrate
dietary recommendations, rather than specific quantitative intake
recommendations (Ref. 6). Thus, we have no scientifically supported
quantitative intake recommendation for added sugars on which a DRV for
added sugars can be derived. Therefore, we are not proposing a DRV for
added sugars. Accordingly, the proposed rule, if finalized, would
declare added sugars on the Nutrition Facts label only in absolute
amounts (in g), similar to the declaration of total sugars.
    d. Compliance--As expressed in the preamble to the 1993 RDI/DRV
final rule, we are not aware of an analytical method that is capable of
distinguishing between added and intrinsically occurring sugars in a
food product (58 FR 2206 at 2222). Thus, it is not technologically
feasible for us to rely on an analytical method to determine compliance
with the declaration of added sugars in foods that contain both added
sugars and naturally occurring sugars. We recognize that enforcement of
the mandatory declaration of added sugars content will require an
alternative means of verifying compliance and are proposing in Sec.
101.9(g)(10) to include records requirements related to the added
sugars declaration in food. Similarly, in the other cases where there
are not reliable and appropriate analytical methods that will allow us
to verify the amount of a given nutrient in a food (dietary fiber,
vitamin E (tocopherol), and folate), we are also proposing to require
manufacturers make and keep certain records necessary to verify the
amount of these nutrients present in a food (see proposed Sec.
101.9(g)(10)). In the case of added sugars that are not subject to
fermentation, when a mixture of naturally occurring and added sugars is
present in the food, we are proposing that a manufacturer must make and
keep written records of the amount of added sugars added to the food
during the processing of the food, and if packaged as a separate
ingredient, as packaged (whether as part of a package containing one or
more ingredients or packaged as a single ingredient) to verify the
amount of added sugars present in the food (Sec.  101.9(g)(10)(iv)).
(See section II.N for more details about this requirement.)
    i. Reactions during processing. Sugars in some foods may undergo
chemical changes mediated by chemical reactions from non-enzymatic
browning (i.e., Maillard reactions and caramelization) and fermentation
during food processing. During these reactions, some sugars are
metabolized or otherwise transformed and converted into compounds that
are no longer recognizable or detectable as sugars through conventional
analytical methods (Ref. 77). We expect that the

amount of added sugars transformed during non-enzymatic browning
reactions is insignificant relative to the initial levels of sugars
(Ref. 78).
    Unlike browning reactions, fermentation is a process that typically
involves the action of desirable microorganisms (e.g., yeasts and
lactic acid bacteria) and enzymes to convert organic compounds,
especially sugars and other carbohydrates, to simpler compounds such as
carbon dioxide, lactic acid, and ethyl alcohol (Refs. 52 and 79).
Typical foods that are subject to fermentation during manufacturing are
breads, cheese, yogurt, vinegar, vegetables, meats, beer and wine. Some
foods, such as sweetened, yeast-leavened breads and wines that are
processed through a fermentation step contain added sugars which will
likely be consumed by the microorganisms during fermentation; other
foods processed through a fermentation step contain added sugars that
will likely not be consumed to a large extent, if at all, during
fermentation, for example, yogurt sweetened with sucrose. In addition,
many products processed through a fermentation step, such as cheese, do
not contain added sugars to aid in fermentation or improve taste (Ref.
78). Therefore, we tentatively conclude that the amount of added sugars
present in foods prior to undergoing fermentation, with the exception
of yeast-leavened bakery products, wines with less than 7 percent
alcohol by volume, and beers that do not meet the definition of a
``malt beverage'' as defined by the Federal Alcohol Administration Act
(27 U.S.C. 211(a)(7)) with sugars added during the fermentation
process, will not be significantly affected by virtue of the food
having undergone fermentation. We do not have adequate information to
assess the degradation of added sugars during fermentation for yeast-
leavened bakery products, wine with less than 7 percent alcohol by
volume, and beers that do not meet the definition of a malt beverage
with sugars added before or during the fermentation process. (Ref. 78).
    We request comments, including available data and information, on
our tentative conclusions with respect to added sugars in products that
are subjected to non-enzymatic browning reactions and fermentation. We
specifically request data on the amount of variability that occurs
among various types of products where added sugars are transformed into
other compounds as a result of chemical reactions during food
processing.
    ii. Records required to assess compliance. For yeast-leavened
bakery products, wines with less than 7 percent alcohol by volume, and
beers that do not meet the definition of a malt beverage with sugars
added before and during the fermentation process, it is unclear to us
whether, as with most fermented foods, the reduction in the amount of
added sugars would be insignificant. In addition to the records we
propose to require for added sugars in foods generally, under proposed
Sec.  101.9(g)(10), we recognize that there is a need to consider other
types of records related to added sugars content for a yeast-leavened
bakery product, wine with less than 7 percent alcohol by volume, or a
beer that does not meet the definition of a malt beverage when sugars
are added to the food before or during the fermentation process (e.g.
the added sugars are present during fermentation and the amount may be
reduced by the fermentation process). Because of the unique issues that
may be associated with a yeast-leavened bakery product, wine with less
than 7 percent alcohol by volume, or a beer that does not meet the
definition of a malt beverage when added sugars are present during the
fermentation process (Ref. 78), we are proposing a new subparagraph
(Sec.  101.9(g)(10)(v)) to specifically address records requirements
for these products.
    Some manufacturers of yeast-leavened bakery products, wine with
less than 7 percent alcohol by volume, and beers that do not meet the
definition of a malt beverage where sugar is added before or during the
fermentation process would likely have more detailed information about
the reduction in added sugars from the process for the products they
manufacture. Thus, we anticipate that manufacturers of some of these
foods that undergo fermentation would be able to determine the amount
of added sugars in the finished food product. For example,
manufacturers could choose to determine through laboratory analysis the
amount of added sugars as well as naturally occurring sugars consumed
in their product during the fermentation process. Other manufacturers
that are unable to conduct additional laboratory analyses of their
product may rely on a scientific document (e.g., journal article or
reference book) showing the amount of added sugars typically consumed
during fermentation in a specific food product (see proposed Sec.
101.9(g)(10)(v)(A)). Manufacturers may use information gathered through
additional analyses or from scientific references to adjust the amount
of sugars added in processing to achieve the desired taste and
organoleptic properties in the finished food product.
    We also recognize that some manufacturers of these foods may not be
able to use scientific data and information to verify the amount of
added sugars in the finished food product. We tentatively conclude that
it is appropriate to include, as an alternative to the use of
scientific data and information for such verification, proposed record
requirements for the amount of added sugars added to these products
before and during fermentation for the verification of the declaration
of added sugars content (see proposed Sec.  101.9(g)(10)(v)(B)). As
with other products containing added sugars, the amount of sugars added
before or during fermentation could be determined through information
such as databases, recipes, formulations, or batch records.
    Therefore, we are proposing, in Sec.  101.9(g)(10)(v), to require a
manufacturer of yeast-leavened bakery products, wines with less than 7
percent alcohol by volume, and beers that do not meet the definition of
a malt beverage with sugars added before and during the fermentation
process to make and keep records of added sugars necessary to determine
the amount of added sugars present in the finished food in one of two
ways. The first would require the manufacturer to make and keep records
of all relevant scientific data and information relied upon by the
manufacturer that demonstrates the amount of added sugars in the food
after fermentation and a narrative explaining why the data and
information are sufficient to demonstrate the amount of added sugars
declared in the finished food. When the manufacturer is relying upon
scientific data and information from reference documents to determine
the amount of added sugars in these finished food products, the
information used must be specific to the type of fermented food
manufactured. For example, if a manufacturer produces raisin bread, the
reference that the manufacturer is relying upon would need to show the
amount of sugars typically consumed in raisin bread that undergoes
fermentation. The second would require the manufacturer to make and
keep records of the amount of added sugars added to the food before and
during the processing of the food, and, if packaged as a separate
ingredient, as packaged (whether as part of a package containing one or
more ingredients or packaged as a single ingredient). The records would
need to be made available to FDA consistent with the proposed
requirements in Sec.  101.9(g)(11).
    It is likely that the actual amount of added sugars remaining in
yeast-leavened breads, wines with less than 7

percent alcohol by volume, and beers that do not meet the definition of
a malt beverage after they undergo fermentation will be less than the
amount added before processing. We are proposing in section II.N to
allow for reasonable deficiencies of added sugars under labeled amounts
that are acceptable within current good manufacturing practice in Sec.
101.9(g)(6). Because the consumer is not generally harmed if the amount
declared on the nutrition label is a reasonable overage of the actual
amount as indicated by Sec.  101.9(g)(6), when the manufacturer
chooses, as the declaration, the amount of sugars added to these
specific foods before fermentation, the we consider the actual amount
of added sugars in the finished food product to be a reasonable
deficiency under Sec.  101.9(g)(6). In some cases of these specific
fermented foods, when the amount of sugar added to a product before
fermentation is declared, it will exceed the amount of total sugars in
the finished food product determined through laboratory analysis. This
is due to the fact that the amount of added sugars consumed during the
fermentation process is not reflected in the declared amount. In such
cases, the we tentatively conclude that it may be confusing to the
consumer if the amount of added sugars declared exceeds the amount of
total sugars declared on the Nutrition Facts label. Therefore, we are
proposing in Sec.  101.9(g)(10)(v)(B) that the amount of added sugars
declared shall not exceed the amount of total sugars declared on the
label.
4. Sugar Alcohols
    FDA regulations define sugar alcohols, in part, as the sum of
saccharide derivatives in which a hydroxyl group replaces a ketone or
aldehyde group (e.g., mannitol or sorbitol) (Sec.  101.9(c)(6)(iii)).
    a. Voluntary Declaration--FDA regulations permit the voluntary
declaration of sugar alcohols on the Nutrition Facts label (Sec.
101.9(c)(6)(iii)). In 2005, we received a citizen petition from the
Sugar Association (Docket No. 2005-P-0373) requesting, among other
requests, mandatory declaration of sugar alcohols on the Nutrition
Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-
0373). The petition stated that, without this information, consumers
would be misinformed about important modifications to foods and cannot
make informed decisions about their particular sensitivity to the
potential effects of sugar alcohols on the body. In the 2007 ANPRM, we
asked whether the declaration of sugar alcohols should continue to be
voluntary or made mandatory. We considered comments received (Ref. 47)
as well as arguments presented by the petition.
    We tentatively conclude that declaration of sugar alcohols should
continue to be voluntary. Although a quantitative intake recommendation
for sugar alcohols is not available from relevant U.S. consensus
reports, sugar alcohols have positive health effects when they replace
sugars in the diet. For example, there is well-established evidence to
indicate that replacing sugars in the diet with sugar alcohols reduces
the risk of dental caries, including the evidence used to support the
health claims authorized by FDA on sugar alcohols and dental caries (72
FR 52783 at 52785; Sec.  101.80). Therefore, we tentatively conclude
that sugar alcohols have public health significance and, in the absence
of a quantitative intake recommendation, voluntary declaration is
consistent with the factors we consider for when voluntary declaration
is appropriate (section I.C.). Accordingly, we are proposing to
continue to provide for the voluntary declaration of sugar alcohols (in
Sec.  101.9(c)(6)(iii) redesignated as Sec.  101.9(c)(6)(iv)).
    We disagree with the petition that mandatory declaration of sugar
alcohols is necessary to ensure that consumers are not misinformed
about modifications to foods. Sugar alcohols that are added to food
must be listed in the ingredients list on food labels and, therefore,
consumers will be informed of their use in a product. We also disagree
with the comment that supported mandatory declaration when there is at
least 1 gram of sugar alcohols per serving due to gastrointestinal
problems at such a level. As warranted, FDA regulations require
specific labeling statements to accompany the use of certain sugar
alcohols to provide information to consumers about any gastrointestinal
effects. For example, in the case of mannitol and sorbitol, the
statement ``Excessive consumption may have a laxative effect,'' is
required on the label and labeling of a food whose reasonably
foreseeable consumption may result in a daily ingestion of 20 g for
mannitol (21 CFR 180.25) and 50 g for sorbitol (Sec.  184.1835 (21 CFR
184.1835)).
    b. Use of the Term ``Sugar Alcohol''--In 1995, we received a
citizen petition submitted by the Calorie Control Council requesting
the use of the term ``polyols'' in lieu of ``sugar alcohols'' (Docket
No. FDA-1995-P-0142) (http://www.regulations.gov/#!docketDetail;D=FDA-
1995-P-0142). The petition stated that ``polyol'' is a regulatory term
used in other countries, such as Canada and New Zealand. In addition,
the petition cited a survey that showed that 78 percent of consumers
surveyed thought that products with sugar alcohol contained some sugar
even when labeled ``sugar free'' and 69 percent thought that the
product contained some alcohol. We considered the petition as well as
comments in response to the 2007 ANPRM (Ref. 80).
    We previously considered the use of ``polyol'' (a contraction of
``polyalcohol'') and determined that it could be potentially more
confusing to consumers than the term ``sugar alcohol.'' However, we
acknowledge that consumers also may not be familiar with the term
``sugar alcohol.'' Therefore, in Sec.  101.9(c)(6)(iii), we allow for
the use of the name of the specific sugar alcohol in lieu of ``sugar
alcohols,'' provided that only one sugar alcohol is present in the
food, since many of the sugar alcohols are listed as ingredients (e.g.,
sorbitol, mannitol, xylitol) and hence may be more recognizable for
consumers (58 FR 2079 at 2100).
    We continue to support the term ``sugar alcohols'' rather than
``polyols,'' because ``sugar alcohols'' more accurately describes the
group of substances encompassed in the definition in Sec.
101.9(c)(6)(iii). ``Polyols'' includes non-carbohydrate polyalcohols,
such as polyesters, whereas ``sugar alcohols,'' as defined by FDA,
includes only carbohydrates. Accordingly, we are not proposing to
change the term ``sugar alcohols'' when used on the Nutrition Facts
label, as specified in Sec.  101.9(c)(6)(iii) redesignated as Sec.
101.9(c)(6)(iv).
    c. DRV--FDA regulations do not provide a DRV for total sugar
alcohols or for individual sugar alcohols. A quantitative reference
intake recommendation for sugar alcohols is not available from current
consensus reports and we have no basis on which to consider setting an
appropriate DRV. Therefore, we are not proposing to set a DRV for sugar
alcohols.
    d. Caloric Value--The caloric value for carbohydrates, other than
insoluble fiber, is 4 kcal/g (Sec.  101.9(c)(1)(i)(C)). Sugar alcohols
have been shown to have a caloric value lower than 4 kcal/g (Refs. 81
and 82). The 2007 ANPRM asked for comment on (1) how the energy
contribution of sugar alcohols should be represented on the label since
energy values vary, and (2) what analytical methods could be used to
determine the energy contribution of sugar alcohols. We considered
comments received (Ref. 47). We also considered relevant caloric values
recommended by the Life Sciences Research Office (LSRO) that

were determined by various methods, including studies conducted in
animals and human subjects, and based on the amount of energy
metabolized or net energy values (Refs. 81 and 82). LSRO expert panel
reports provided the following caloric values for individual sugar
alcohols: Isomalt (2.0 kcal/g), lactitol (2.0 kcal/g), xylitol (2.4
kcal/g), maltitol (2.1 kcal/g), sorbitol (2.6 kcal/g), hydrogenated
starch hydrolysates (3.0 kcal/g), and mannitol (1.6 kcal/g).
    We support the use of the LSRO caloric values for individual sugar
alcohols. The LSRO reports used appropriate methods and study design
criteria for measuring caloric value, and noted that human data were
preferred and that animal data should be viewed as supplemental
information. We do not have any data that would question the caloric
values determined by the LSRO reports for the specified sugar alcohols.
We did not identify any human studies published since the release of
the LSRO reports that demonstrate that a different caloric value for
any of these sugar alcohols would be more appropriate. Therefore, we
are proposing to amend Sec.  101.9(c)(1)(i)(F) to establish the
following general factors for caloric values of sugar alcohols, using
the values recommended by LSRO: Isomalt--2.0 kcal/g, lactitol--2.0
kcal/g, xylitol--2.4 kcal/g, maltitol--2.1 kcal/g, sorbitol--2.6 kcal/
g, hydrogenated starch hydrolysates--3.0 kcal/g, and mannitol--1.6
kcal/g. Accordingly, we are also proposing to amend Sec.
101.9(c)(1)(i)(C) such that the 4 kcal/g is not applied to sugar
alcohols.
5. Dietary Fiber
a. Dietary Fiber
    i. Definition. FDA regulations do not establish a definition for
dietary fiber. There is no specific chemical definition for dietary
fiber. Because of the difficulties in accurately isolating the set of
fibers relevant to health, in 2001, the IOM established a panel to
develop a new definition of dietary fiber (IOM Panel on the Definition
of Dietary Fiber or IOM Panel). Subsequently, the IOM then issued a
report defining ``total fiber'' as the sum of ``dietary fiber'' and
``added fiber,'' where ``dietary fiber'' consists of non-digestible
carbohydrates and lignin that are intrinsic and intact in plants, and
``added fiber'' (referred to as ``functional fiber'' in the IOM
Macronutrient Report) consists of isolated, non-digestible
carbohydrates that have beneficial physiological effects in humans
(Ref. 24). The IOM's definitions of ``dietary fiber'' and ``total
fiber'' only include those fibers that are considered to have health
benefits. The 2007 ANPRM asked for public comment on whether the IOM
dietary or functional fiber definitions should become the FDA
definition for dietary fiber. We also asked whether it should develop
criteria for identifying fibers that demonstrate a physiological
benefit, and, if so, what those criteria should be. We received several
comments (Ref. 47).
    We considered IOM recommendations, comments received, and relevant
international guidelines. The Codex Alimentarius Commission adopted the
following definition of dietary fiber in 2010 (Ref. 67):
    ``Dietary fibre means carbohydrate polymers \1\ with ten or more
monomeric units,\2\ which are not hydrolysed by the endogenous enzymes
in the small intestine of humans and belong to the following
categories:
---------------------------------------------------------------------------

    \1\ ``When derived from a plant origin, dietary fibre may
include fractions of lignin and/or other compounds associated with
polysaccharides in the plant cell walls. These compounds also may be
measured by certain analytical method(s) for dietary fibre. However,
such compounds are not included in the definition of dietary fibre
if extracted and re-introduced into a food.'' (Ref. 67).
    \2\ ``Decision on whether to include carbohydrates from 3 to 9
monomeric units should be left to national authorities.'' (Ref. 67).
---------------------------------------------------------------------------

     Edible carbohydrate polymers naturally occurring in the
food as consumed,
     Carbohydrate polymers, which have been obtained from food
raw material by physical, enzymatic or chemical means and which have
been shown to have a physiological effect of benefit to health as
demonstrated by generally accepted scientific evidence to competent
authorities, and
     Synthetic carbohydrate polymers which have been shown to
have a physiological effect of benefit to health as demonstrated by
generally accepted scientific evidence to competent authorities.
    As with the IOM definition of ``total fiber,'' the 2010 Codex
definition for ``dietary fiber'' includes naturally occurring fibers
and only those non-digestible carbohydrates added to food that have a
physiological effect that is beneficial to human health.
    Dietary fiber represents a heterogeneous group of compounds that
vary in their carbohydrate composition, linkages between carbohydrates,
and molecular weight. As stated previously, there is no specific
chemical definition for dietary fiber. Therefore, considering the IOM
and Codex definitions and comments received, as well as the role of the
dietary fiber declaration on the Nutrition Facts label, we tentatively
conclude that a regulatory definition for dietary fiber should be one
that emphasizes its physiological effect that is beneficial to human
health. The declaration of dietary fiber that accurately reflects the
amount of fiber that provides a physiological effect that is beneficial
to human health would assist consumers in maintaining healthy dietary
practices.
    We are proposing a single definition for dietary fiber that is
equivalent to the IOM's definition for ``total fiber,'' rather than
IOM's separate definitions of ``dietary fiber'' and ``functional
fiber.'' Because both ``dietary fiber'' and ``functional fiber'' as
defined by IOM are considered to have beneficial health effects, we
tentatively conclude that there is little benefit for consumers in
distinguishing between these two types of fiber on the Nutrition Facts
label. In addition, the IOM itself recognized analytical limitations in
distinguishing between ``dietary fiber'' and ``functional fiber'' and
noted that the labeling of ``total fiber'' would be more practical than
labeling ``dietary fiber'' and ``functional fiber'' separately (Ref.
24).
    The Codex definition includes a minimum degree of polymerization
(DP) for a carbohydrate of 10, and it also provides that the inclusion
of non-digestible carbohydrates with 3 to 9 monomeric units should be
left to national authorities. The IOM's definition for ``total fiber''
includes those non-digestible carbohydrates of 3 to 9 DP (Ref. 24).
    Because we seek to include in our definition non-digestible
carbohydrates with physiological effects that are beneficial to human
health, regardless of size, we are proposing to adopt a definition for
total fiber that includes a DP of >= 3, consistent with the IOM's
definition.
    Therefore, we are proposing to amend Sec.  101.9(c)(6)(i) to
include the following definition for dietary fiber: (1) Non-digestible
soluble and insoluble carbohydrates (with 3 or more monomeric units)
and lignin that are intrinsic and intact in plants; (2) isolated and
synthetic non-digestible carbohydrates (with 3 or more monomeric units)
that FDA has granted be included in the definition of dietary fiber, in
response to a petition submitted to FDA under Sec.  10.30 (21 CFR
10.30) demonstrating that such carbohydrates have a physiological
effect(s) that is beneficial to human health; or (3) isolated and
synthetic non-digestible carbohydrates (with 3 or more monomeric units)
that are the subject of an authorized health claim. We invite comment
on the proposed definition of dietary fiber.
    As proposed, under provisions 2 and 3, manufacturers would be
required to provide evidence to FDA to demonstrate

the physiological effects that are beneficial to human health, of
isolated and synthetic non-digestible carbohydrates added to food, and
FDA would have to grant a petition or authorize a health claim before
they can be considered as ``dietary fiber'' for declaration on the
Nutrition Facts label. Manufacturers would use the citizen petition
process in Sec.  10.30 or, in case of a related health claim, the
health claims petition process in Sec.  101.70. We intend to issue
guidance to industry on submissions to demonstrate physiological
effects that are beneficial to human health.
    Under these proposed provisions, both [beta]-glucan soluble fiber
(Sec.  101.81(c)(2)(ii)(A)) and barley [beta]-fiber (Sec.
101.81(c)(2)(ii)(A)(6)) that are added to foods would meet the
definition of dietary fiber and, therefore, would be included in the
amount of dietary fiber declared on the Nutrition Facts label. We are
proposing to list isolated and synthetic non-digestible carbohydrates
that have been determined by FDA to have a physiological effect that is
beneficial to human health, in Sec.  101.9(c)(6)(i). Accordingly, we
are proposing to amend Sec.  101.9(c)(6)(i) to list [beta]-glucan
soluble fiber and barley [beta]-fiber (as these substances are
described in Sec.  101.81(c)(2)(ii)(A) and (c)(2)(ii)(A)(6),
respectively) as isolated and synthetic non-digestible carbohydrates
that have been determined by FDA to have a physiological effect that is
beneficial to human health and, therefore, must be included in the
declaration of dietary fiber. Under this process, we would amend Sec.
101.9(c)(6)(i) to list any additional isolated and synthetic non-
digestible carbohydrates that FDA determines have a physiological
effect that is beneficial to human health, through either the citizen
petition process or the health claims petition process.
    ii. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act
specifies, in part, that for each serving size or other unit of measure
of a food, the amount of dietary fiber must be provided. Accordingly,
FDA regulations require the declaration of dietary fiber on the
Nutrition Facts label, as provided in Sec.  101.9(c)(6)(i).
    We did not ask any questions about the mandatory labeling of
dietary fiber in the 2007 ANPRM, and we received no comments on this
subject. Dietary fiber is not an essential nutrient. However, it has
physiological effects that are beneficial to human health, such as
attenuation of postprandial blood glucose concentrations, attenuation
of blood cholesterol concentrations, and improved laxation (Ref. 66).
The IOM DRI report noted that consumption of certain dietary fibers,
particularly those that are poorly fermented (i.e., insoluble fiber),
improve fecal bulk and laxation and ameliorate constipation (Ref. 66).
In addition, soluble fiber plays a beneficial role in reducing the risk
of heart disease (Ref. 66). ``Dietary fiber'' is identified as a
nutrient of public health concern in the 2010 DGA. The 2010 DGA also
emphasized the consumption of whole grains, in part, because they are a
source of dietary fiber, noting that choosing whole grains that are
higher in dietary fiber has health benefits in addition to meeting
nutrient needs (Ref. 6).
    Given the health benefits of dietary fiber, we have no basis to
conclude that the declaration of dietary fiber is no longer necessary
to assist consumers in maintaining healthy dietary practices.
Therefore, we are not proposing to change our current requirement for
the mandatory declaration of dietary fiber in Sec.  101.9(6)(i).
    With respect to the term used to declare dietary fiber content on
the Nutrition Facts label, we considered comments received in response
to the 2007 ANPRM (Ref. 47). The term ``dietary fiber'' has been listed
on the Nutrition Facts label since 1993. One survey pointed out by
comments suggests that both ``fiber'' and ``dietary fiber'' are
similarly acceptable by consumers (Ref. 47). Alternative terms such as
``natural fiber'' or ``isolated fiber'' would not be appropriate to
declare all dietary fiber given that we are proposing a definition of
dietary fiber that includes both natural fiber and fiber that is added
to food. Although the IOM used the term ``total fiber,'' there is no
evidence to suggest that this term is preferable to the term ``dietary
fiber.'' Therefore, we are not proposing to change the current
requirement to declare dietary fiber using the term ``dietary fiber,''
as specified in Sec.  101.9(f). However, we request comment on this
issue, including consumer understanding of the term ``dietary fiber''
relative to other relevant terms.
    iii. Analytical methods. Per FDA regulations, compliance with the
requirement for declaration of dietary fiber is determined using
appropriate AOAC analytical methods (58 FR 2079 at 2113; Sec.
101.9(g)(2)). In the 2007 ANPRM, we noted the IOM Panel's consideration
of analytical issues related to dietary fiber, and asked whether we
should continue to use the AOAC International methods to determine the
amount of dietary fiber and, if not, what other or additional methods
should be used.
    We reviewed comments (Ref. 47) received as well as current AOAC
methods for dietary fiber and the various analytes measured by these
methods in light of our proposed definition for dietary fiber. AOAC
methods, such as AOAC 985.29, 991.43 and 994.13, measure soluble and
insoluble polysaccharides, lignin, higher molecular weight non-
digestible oligosaccharides (DP > 12), and some resistant starch,
inulin and low molecular weight non-digestible oligosaccharides (DP <
10). These methods do not measure all non-digestible carbohydrates with
a DP < 10. In contrast, newer methods (AOAC 2009.01 and AOAC 2011.25)
measure all low molecular weight non-digestible carbohydrates (i.e.,
non-digestible oligosaccharides) in addition to the higher molecular
weight non-digestible carbohydrates (Ref. 83). Thus, these newer, more
inclusive AOAC methods would be more consistent with our proposed
definition. However, there is no analytical method that can distinguish
non-digestible carbohydrates that have a beneficial physiological
effect from those that do not.
    We are proposing to amend Sec.  101.9(c)(6)(i) to indicate that
dietary fiber content may be determined by subtracting the amount of
non-digestible carbohydrates added during processing that do not meet
the definition of dietary fiber (in proposed Sec.  101.9(c)(6)(i)) from
the value obtained using AOAC 2009.01, AOAC 2011.25 or an equivalent
AOAC method of analysis as given in the ``Official Methods of Analysis
of the AOAC International'' 19th Edition. If a product contains only
non-digestible carbohydrates that meet the proposed definition of
dietary fiber, using AOAC 2009.01, AOAC 2011.25, or an equivalent
method would be sufficient to quantify the dietary fiber content of a
food. However, if the product contains both dietary fiber that is
included in the proposed definition (e.g., naturally occurring fibers)
and non-digestible carbohydrates not included in the definition (e.g.,
synthetic fibers without a physiological effect that is beneficial to
human health), neither AOAC 2009.01 or AOAC 2011.25 nor an equivalent
AOAC method would accurately quantify the dietary fiber that could be
declared on the Nutrition Facts label, because the determination of
fiber by these methods would include the non-digestible carbohydrates
that do not meet the proposed definition of dietary fiber.
    To verify that the quantity of dietary fiber declared on the
Nutrition Facts label includes only those fibers that

meet the regulatory definition of dietary fiber, when a food contains a
mixture of non-digestible carbohydrates that meet the proposed dietary
fiber definition and those that do not, we are proposing in Sec.
101.9(c)(6) and (g)(10) to require manufacturers to make and keep
written records to verify the amount of added non-digestible
carbohydrates that do not meet the proposed definition of dietary
fiber. See discussion in section II.N. Such records would provide
information to verify that the amount of dietary fiber declared meets
the proposed definition. The amount of non-digestible carbohydrate
measured by AOAC 2009.01 or AOAC 2011.25 (or an equivalent AOAC method)
minus the amount of added non-digestible carbohydrate that has not been
determined by FDA to have a physiological effect that is beneficial to
human health would reflect the amount of dietary fiber lawfully
declared on the label.
    iv. DRV. The DRV for dietary fiber is 25g (Sec.  101.9(c)(9)). We
did not ask specific questions in the 2007 ANPRM and received no
comments on the DRV for dietary fiber. In 2002, the IOM set an AI of 14
g/1,000 kcal for ``total fiber'' (Ref. 66). The AI was primarily based
on the intake level that was associated with the greatest reduction in
the risk of CHD. We are proposing to define dietary fiber to include
those fibers that have a physiological effect that is beneficial to
human health (see section II.D.5.) and, as such, the AI for ``total
fiber'' provides an appropriate basis for setting a DRV for dietary
fiber declared on the Nutrition Facts label.
    Therefore, we are proposing to use 14 g/1,000 kcal as the basis for
a DRV for dietary fiber. Using a reference calorie intake of 2,000
calories (see section II.A.3.), we are proposing to amend Sec.
101.9(c)(9) to set a DRV of 28 g (14g/1,000 kcal x 2,000 kcal/d) for
dietary fiber.
    b. Soluble and Insoluble Fiber--Dietary fibers can be classified as
being soluble or insoluble. Soluble fibers, such as pectin and gums,
dissolve in water and are digested by the bacteria in the large
intestine. Insoluble fibers, such as cellulose and lignin, do not
dissolve in water and are not digested by bacteria in the large
intestine, adding bulk to the stool for improved laxation.
    i. Definition. Like dietary fiber, FDA regulations do not establish
definitions for soluble or insoluble fiber. The 2007 ANPRM did not ask
questions about definitions for soluble and insoluble fiber and we did
not receive any comments about them. Because soluble and insoluble
fibers are components of dietary fiber, we tentatively conclude that
soluble and insoluble fibers must meet the proposed definition of
dietary fiber. Therefore, we are proposing in Sec.  101.9(c)(6)(i)(A)
and (c)(6)(i)(B) that soluble fiber and insoluble fiber, respectively,
must meet the definition of dietary fiber in paragraph 101.9(c)(6)(i).
    ii. Voluntary declaration. FDA regulations permit, but do not
require, the declaration of soluble fiber (Sec.  101.9(c)(6)(i)(A)) and
insoluble fiber (Sec.  101.9(c)(6)(i)(B)) on the Nutrition Facts label.
In the 2007 ANPRM, FDA asked whether the declaration of soluble and
insoluble fiber should continue to be voluntary or made mandatory. We
considered comments received (Ref. 47).
    While a quantitative intake recommendation is not available from
relevant U.S. consensus reports, there is well-established evidence
showing that soluble and insoluble fibers have distinct physiological
effects that are beneficial to human health. For example, the IOM noted
that the body of evidence indicates that non-fermentable fiber sources
(often isolated as insoluble fiber) promote laxation, and improved
laxation is an established physiological effect that is beneficial to
human health (Ref. 66). Therefore, we tentatively conclude that soluble
and insoluble fibers that meet the definition of dietary fiber have
public health significance and, in the absence of quantitative intake
recommendations, are consistent with the considerations for voluntary
declaration explained in section I.C. Accordingly, we are proposing to
continue to provide for the voluntary declaration of soluble and
insoluble fibers, as specified in Sec.  101.9(c)(6)(i)(A) and (B).
    With respect to the term used to declare dietary fiber content on
the Nutrition Facts label, in 2001, the IOM Panel recommended that the
terms ``soluble'' and ``insoluble'' fiber be phased out and replaced
with relevant descriptors of the physicochemical properties of
particular fibers (e.g., ``viscous'' or ``fermentable'' fiber to
replace ``soluble'' fiber), as the characterization of the properties
of various fibers becomes standardized (Ref. 24). In the 2007 ANPRM, we
noted this recommendation and asked for public comment on whether the
terms ``soluble fiber'' and ``insoluble fiber'' should be changed to
``viscous'' and ``nonviscous'' fiber.
    We considered the IOM recommendations as well as comments received
(Ref. 47), and tentatively conclude that the terms ``soluble fiber''
and ``insoluble fiber'' are most appropriate for reasons discussed in
this document. While the IOM recommended replacing ``soluble fiber''
and ``insoluble fiber'' with appropriate physicochemical terms as the
characterization of the properties of various fibers becomes
standardized, such standardization has not yet occurred. In addition,
as the comments stated, viscosity does not predict fermentability (Ref.
47), which the IOM recognized is a physicochemical property that is
linked to health benefits, and it is not known at what level of
viscosity a fiber begins to have a physiological effect (Ref. 66).
Moreover, there are no currently available scientifically valid methods
that FDA could use to measure the amount of various fibers defined by
their physicochemical properties in various food matrices, whereas
scientifically valid methods to measure soluble and insoluble fiber are
currently available. Therefore, we are not proposing any changes to the
use of terms ``soluble fiber'' and ``insoluble fiber'' in the Nutrition
Facts label.
    iii. Analytical methods. Per FDA regulations, compliance with any
declaration of soluble or insoluble fibers is determined using
appropriate AOAC analytical methods (Sec.  101.9(g)(2)). While there
are a number of traditional AOAC methods available for measuring
soluble fiber (e.g., AOAC 991.43 and 993.19) and insoluble fiber (e.g.,
AOAC 991.42 and 991.43), as is the case with dietary fiber, these
methods cannot measure all non-digestible carbohydrates with a DP < 10.
A newer method, AOAC 2011.25 (Ref. 83), can measure low molecular
weight non-digestible carbohydrates, as well as separately measure
soluble and insoluble non-digestible carbohydrates. However, as in the
case of AOAC 2009.01, AOAC 2011.25 (Ref. 83) cannot distinguish soluble
and insoluble non-digestible carbohydrates that have a physiological
effect that is beneficial to human health from those that do not.
    We are proposing to amend Sec.  101.9(c)(6)(i)(A) and (c)(6)(i)(B)
to indicate that the soluble and insoluble non-digestible carbohydrate
content may be calculated by first using AOAC 2011.25, or an equivalent
AOAC method of analysis. If a food contains only non-digestible
carbohydrates that meet the proposed definition of dietary fiber (e.g.,
contains naturally occurring fiber only), then AOAC 2011.25 or an
equivalent AOAC method would measure the amount of soluble or insoluble
fiber that can be declared on the Nutrition Facts label. If a food
contains a mixture of non-digestible carbohydrates that do and do not
meet the proposed dietary fiber definition, and the label of the food
declares soluble or insoluble fiber content, we are proposing to amend
Sec.  101.9(c)(6)(i)(A) and (c)(6)(i)(B) to

require manufacturers to make and keep records to verify the amount of
soluble or insoluble non-digestible carbohydrates that do not meet the
proposed definition of dietary fiber that have been added to the food
product during processing. (See discussion in section II.N.)
    iv. DRV. FDA regulations do not establish DRVs for soluble fiber or
insoluble fiber. No DRIs were established for soluble or insoluble
fiber during the IOM's evaluation of a DRI for dietary fiber (Ref. 66),
and we have no basis on which to derive an appropriate DRV. Therefore,
we are not proposing to set a DRV for either soluble fiber or insoluble
fiber.
    v. Caloric value. Per FDA regulations, the caloric content of a
food may be calculated by, among other methods, using the general
factors of 4, 4, and 9 kcal/g for protein, total carbohydrate less the
amount of insoluble dietary fiber, and total fat, respectively (Sec.
101.9(c)(1)(i)(C)). Accordingly, soluble fiber, which is encompassed
within ``total carbohydrate,'' is assigned a general factor of 4 kcal/
g. We did not ask questions about the caloric value of dietary fibers
in the 2007 ANPRM, but received a few comments on the caloric value of
soluble fiber, including that 4 kcal/g for soluble fiber was too high
and that we should consider 2 kcal/g, which is the caloric value
identified by the United Nations Food and Agriculture Organization. We
also received a citizen petition from the Calorie Control Council
requesting that the caloric value of soluble fiber be no more than 2
kcal/g (Docket No. FDA-1997-P-0232), based on the caloric contribution
of energy yielding short chain fatty acids that are produced as a
result of colonic fermentation of soluble fiber (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232).
    We agree with the comments and the petition supporting a caloric
value of 2 kcal/g for soluble fiber. The anaerobic fermentation of
soluble fibers in the colon has been shown to yield less energy than
the 4 kcal/g obtained from aerobic metabolism of carbohydrates (Ref.
66). In addition, the absorption of energy yielding short chain fatty
acids that are produced as a result of colonic fermentation of soluble
fiber can vary, and data indicate that the average energy yield from
soluble fibers is 1.5 to 2.5 kcal/g (Ref. 66). Therefore, we
tentatively conclude that 2 kcal/g is a reasonable estimate of the
caloric value of soluble non-digestible carbohydrates. Accordingly, we
are proposing to amend Sec.  101.9(c)(1)(i)(C) to establish a general
factor of 2 kcal/g as the caloric value of soluble non-digestible
carbohydrates. Insoluble non-digestible carbohydrates are not included
in the caloric calculation.
    We are also proposing a corresponding change to the introductory
text in Sec.  101.9(c)(1)(i)(C) to exclude non-digestible carbohydrate
from total carbohydrate. FDA regulations require that the calories from
total carbohydrate be calculated by using the general factor of 4 kcal/
g of carbohydrate less the amount of insoluble dietary fiber (Sec.
101.9(c)(1)(i)(C)). We are proposing a new definition of dietary fiber
(see section II.D.5.a.i.) that only allows for the declaration of
dietary fibers that are added to foods that we have determined to have
a physiological effect that is beneficial to human health, as ``dietary
fiber'' on the Nutrition Facts label. Therefore, the proposed new
definition of dietary fiber would exclude soluble and insoluble non-
digestible carbohydrates that do not meet the proposed definition of
dietary fiber. For the purposes of calculating calories from soluble
non-digestible carbohydrate, the proposed factor of 2 kcal/g should
apply to those soluble non-digestible carbohydrates that both do and do
not meet the proposed definition of dietary fiber. To ensure that
soluble non-digestible carbohydrates that do and do not meet the
proposed definition of dietary fiber are excluded from total
carbohydrate, such that a general factor of 2 kcal/g is applied to
these non-digestible carbohydrates, we are proposing to amend Sec.
101.9(c)(1)(i)(C) to require that calories from carbohydrate be
calculated using a general factor of 4 kcal/g of total carbohydrate
less the amount of non-digestible carbohydrates, which includes soluble
and insoluble non-digestible carbohydrates that do and do not meet the
definition of dietary fiber (see also section II.D.1.f.).
6. Other Carbohydrate
    FDA 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)).
Examples of ``other carbohydrate'' include starch and oligosaccharides.
A statement of the amount of ``other carbohydrate'' may be voluntarily
declared on the Nutrition Facts label (Sec.  101.9(c)(6)(iv)). We did
not ask questions about the labeling of ``other carbohydrate'' in the
2007 ANPRM, and we received no comments on this issue. However, we
reconsidered the provision for voluntary declaration of ``Other
carbohydrate'' on the Nutrition Facts label based on the factors we
consider for the mandatory and voluntary declaration discussed in
section I.C.
    ``Other carbohydrate'' represents different types of carbohydrate,
and, unlike sugars and dietary fiber, carbohydrates covered under this
heterogeneous category have no shared physiological effects. Moreover,
there is no well-established evidence to support the role of particular
types of carbohydrate that fall within the ``other carbohydrate''
category, such as starch and oligosaccharides, in human health that is
based on reliable and valid physiological or clinical endpoints. In
addition, a quantitative intake recommendation for ``Other
carbohydrate'' is not available from relevant consensus reports. Given
the lack of public health significance or a quantitative intake
recommendation for ``other carbohydrate'' as a category, consistent
with the factors discussed in section I.C., we tentatively conclude
that ``Other carbohydrate'' should no longer be permitted to be
declared on the Nutrition Facts label.
    Therefore, we are proposing to remove current Sec.  101.9(c)(6)(iv)
to remove the provision that allows for the voluntary declaration of
``Other carbohydrate'' on the Nutrition Facts label. We are also
proposing to make a corresponding revision to Sec.  101.9(g)(4) and
(g)(6) to remove references to ``Other carbohydrates.'' We invite
comment on this issue, including any other data or factual information
that we should consider in making a final determination.

E. Protein

1. Mandatory and Voluntary Declaration
    Section 403(q)(1)(D) of the FD&C Act requires food labeling to bear
nutrition information about protein. FDA regulations require the
declaration of the amount of protein by weight, and provide for
voluntary declaration of the percent DV for protein on the Nutrition
Facts label (Sec.  101.9(c)(7)(i)). In response to the 2007 ANPRM, one
comment supported the current approach, whereas another comment
recommended that FDA require the labeling of the percent DV for
protein.
    We considered current scientific evidence and comments received
(Ref. 47). There is strong evidence based on valid physiological and
clinical endpoints that protein is an essential nutrient that is
necessary for human health and growth (Refs. 6 and 84). Therefore, we
tentatively conclude that the declaration of protein content

remains necessary to assist consumers in maintaining healthy dietary
practices. In addition, because protein intake in the U.S. population
continues to be adequate when compared to the EAR absent a mandatory
percent DV declaration (Ref. 85), we tentatively conclude that the
declaration of protein as a percent DV should remain voluntary.
Accordingly, we are not proposing any changes to the requirement for
declaration of the quantitative amount of protein and the voluntary
declaration of this amount as a percent DV on the Nutrition Facts
label.
2. Analytical Methods
    Under Sec.  101.9(c)(7), protein may be calculated on the basis of
6.25 times the nitrogen content of the food determined by the
appropriate method of analysis as given in the Official Methods of
Analysis of AOAC International, 15th ed. (1990), except when the
official procedure for a specific food requires another factor. On
December 21, 2000, we received a citizen petition from Protein
Technologies International, Inc. (FDA-2000-P-0569), requesting that FDA
amend the reference to the method used to calculate protein content
found in Sec.  101.9(c)(7) to read ``the appropriate method of analysis
as given in the Official Methods of Analysis of the AOAC International,
17th ed. (2000)'' (http://www.regulations.gov/#!docketDetail;D=FDA-
2000-P-0569). The petition explained that the only approved method for
use in human food in the 15th edition of the AOAC Official Methods of
Analysis was the Kjeldahl method, which the petition stated involves
the use of a mercury catalyst and, therefore, can be potentially
harmful to humans and the environment. The petition asserted that the
17th edition of the AOAC Official Methods of Analysis recognized an
alternative method, the Combustion method, also known as the Dumas
method, to measure protein levels in some human foods and that we
should permit its use for measuring protein content.
    We note that not all Kjeldahl methods included in the Official
Methods of Analysis of the AOAC contain a mercury catalyst.
Furthermore, the Kjeldahl method is a well-recognized, standard method
for determination of protein content. In fact, it is the method cited
for use in determination of protein digestibility in the ``Protein
Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on
Protein Quality Evaluation'' (Ref. 86) that is incorporated by
reference in Sec.  101.9(c)(7)(ii).
    As discussed in section II.N.2., we see a need to update the
version of the Official Methods of Analysis of the AOAC International
that we use for compliance purposes because newer, and sometimes
better, analytical methods for many nutrients are included in versions
of the methods that have been published since the 15th edition. We are,
therefore, proposing to amend Sec.  101.9(c)(7) to incorporate by
reference the Official Methods of Analysis of the AOAC International,
19th ed. (2012) by removing ``15th Ed. (1990)'' and adding in its place
``19th Ed. (2012).'' The 19th edition is the most recent edition of the
published AOAC methods, and includes both the Kjeldahl and the
Combustion/Dumas methods. While the petition requested that the Agency
amend Sec.  101.9(c)(7) to incorporate the 17th edition of the AOAC
methods, the 19th edition includes all of the methods for protein that
were available in the 17th edition. Thus, the proposed action is
consistent with the petition's request. If a newer version of the
Official Methods of Analysis of the AOAC International is published
before publication of the final rule (assuming that this rulemaking
does result in a final rule), we will consider, as appropriate, using
the most recent version of the official AOAC methods in the final rule.
To the extent that the methods for protein determination in the newer
version differ from those provided in the 19th edition of the Official
Methods of Analysis of the AOAC International, we will consider the
need to seek additional public comment on the version of the AOAC
Methods of Analysis of the AOAC International that is incorporated by
reference in Sec.  101.9(c)(7).
3. DRV
    The DRV for protein is 50 g (Sec.  101.9(c)(9)) and represents 10
percent of the 2,000 reference calorie intake level. The IOM Labeling
Committee considered the IOM's AMDR for protein (10 to 35 percent of
energy intake for adults) and the AMDRs for fat and carbohydrates, and
recommended setting the DV for protein based on the difference between
total energy intake and the combined DVs for fat and carbohydrate
(i.e., 100 percent of energy - (DVfat +
DVcarbohydrate). The 2007 ANPRM requested comment on whether
the DV for protein should be based on (1) the approach recommended in
the IOM Labeling Report; (2) the midpoint of the AMDR for protein
(i.e., 22.5 percent); or (3) the EAR or RDA for protein. We received
comments on each of these approaches (Ref. 47). Overall, comments
supported the approach recommended in the IOM Labeling Report and
maintaining the DV of 50 g/d.
    We considered current scientific recommendations and agree with the
comments that supported the continued use of the current approach.
First, as explained in sections II.B. and II.D., we are not proposing
to change the DRVs for fat (30 percent of calories from fat or 65 g) or
carbohydrate (60 percent of calories from carbohydrate or 300 g).
Applying the IOM Labeling Committee's recommended approach, given our
tentative conclusions on DRVs for fat and carbohydrates, that approach
would result in no change to the DRV for protein, i.e., 10 percent (100
- (60 + 30)) of calories from protein.
    Second, at 10 percent of caloric intake and using a reference
energy intake of 2,000 calories, the DRV for protein is set at 50 g,
which is relatively close to the IOM's RDAs for men and women. The
RDAs, which represent values that meet the needs of almost all (97 to
98 percent) individuals in a group, are set at 0.80 g/kg for men and
women who are 19 years and older, 0.85 g/kg for boys and girls 14 to 18
years of age, and 0.95 g/kg for boys and girls 4 to 13 years of age.
Using reference weights established for age and gender groups, the
resulting values are 56 g/d for males and 46 g/d for females who are 19
years of age or older (not including pregnant and lactating women), 52
g/d for males and 46 g/d for females between the ages of 14 through 18
years of age, 34 g/d for males and females between the ages of 9 and 13
years, and 19 g/d for males and females between the ages of 4 through 8
years. Thus, the DRV of 50 g for protein falls within the range of the
RDAs calculated using reference weights.
    We do not consider the midpoint of the AMDR of 22.5 percent of
energy intake to provide the most appropriate basis for a DRV for
protein. We have no data to show that protein intakes are inadequate or
that setting a higher DRV that is based on the midpoint of the AMDR is
needed to prevent chronic diseases such as cardiovascular disease,
obesity, and sarcopenia, as asserted by some comments (Ref. 47). The
AMDR is a range of intakes for a particular energy source that is
associated with reduced risk of chronic diseases while providing
adequate intakes of essential nutrients (Ref. 20). The DRV of 10
percent of calories from protein falls within the AMDR. Thus, the DRV
for protein falls within a range of protein consumption that is
associated with a reduced risk of chronic disease while providing
essential nutrients.

    Finally, we consider the use of the population-weighted EAR to be
inappropriate. First, as the comments pointed out (Ref. 47), using the
population-weighted EAR could lead to inadequate consumption in some
subpopulations, such as males 19 years and older. In addition, the EARs
for protein are expressed in terms of g/kg of body weight and based on
consumption of good quality or ``complete'' protein. In order to
calculate a DRV from the population-weighted EAR for the purposes of
nutrition labeling, a reference body weight would have to be selected.
Although we could use the EER predictive equations included in the
IOM's DRI macronutrient report (Ref. 50) to determine a reference body