at 29483). The DRVs were finalized in the 1993 Reference Daily Intakes
and Daily Reference Values final rule (58 FR 2206, Jan. 6, 1993).
    As new evidence emerges, we will consider whether we need to update
the DRV. In the future, there may be more information available that
would allow us to establish a DRV for added sugars that is based on a
linear relationship with the risk of disease. We intend to monitor the
evidence related to added sugars and consider whether changes need to
be made to the label based on the evidence in the future.
    (Comment 230) One comment referred to the DGA recommendation that
Americans consume fatty fish due to their omega-3 fatty acid content,
but noted that there is no reference value for omega-3 fatty acids. The
comment said that added sugars are no different than omega-3 fatty
acids and suggested that added sugars can be reduced in the diet, even
while there is not sufficient evidence to recommend that they be
limited to a particular intake level.
    (Response) We do not agree that omega-3 fatty acids are an
appropriate comparison to added sugars. For

example, we do not have scientific evidence to support a reference
value for omega-3 fatty acids. We include a reference value for added
sugars in the final rule to provide information that allows consumers
to put the amount of the nutrient into the context of the total daily
diet.
(iii) Food Pattern Modeling
    (Comment 231) Food pattern modeling was used to support the 2015
DGAC recommendation that Americans should limit added sugars to a
maximum of 10 percent of total caloric intake. For the 2015 DGAC, USDA
used a modeling process to develop new USDA Food Patterns based on
different types of evidence: The ``Healthy Vegetarian Pattern,'' which
takes into account food choices of self-identified vegetarians, and the
``Healthy Mediterranean-style Pattern,'' which takes into account food
group intakes from studies using a Mediterranean diet index to assess
dietary patterns. The USDA Food Patterns provide suggested amounts of
foods to consume from the basic food groups, subgroups, and oils to
meet recommended nutrient intakes at 12 different calorie levels. They
also show the number of calories from solid fats and added sugars that
can be accommodated within each calorie level, in addition to the
suggested amounts of nutrient-dense forms of foods in each food group.
    Many comments questioned the use of food pattern modeling to
establish a DRV for added sugars. The comments noted that, when we
considered establishing a DRV for trans fat using menu modeling, we
said that we continue to adhere to the approach of determining DRVs for
a nutrient based on the nutrient's association with a specific health
outcome (e.g., LDL cholesterol levels), yet we proposed to use food
pattern modeling to establish a DRV for added sugars rather than data
on an association with a health outcome. The comment noted that we
stated previously in the proposed rule, as well as in 1993, that we do
not consider the use of food composition data, menu modeling, or
dietary survey data as a suitable approach to determine DRVs. The
comments explained that menu modeling involves individual foods,
whereas food pattern modeling involves food group composites, but the
process for menu and food pattern modeling is similar. The comments
said that the issues that we raised for not using menu modeling for
setting a DV for trans or saturated fat are the same for a food pattern
modeling approach and would therefore apply to added sugars.
    (Response) Although we have stated in the past that use of food
composition data, menu modeling, or dietary survey data is not a
suitable approach to determine DRVs, these statements were made in the
context of establishing DRVs for nutrients where a causal relationship
between consumption of the nutrient and risk of disease exists. Added
sugars are different than trans fats in that there is a linear
relationship between consumption of trans fats and LDL cholesterol
whereas, for added sugars we do not have the type of direct association
with risk of disease, based on the evidence we are using to support a
mandatory declaration of added sugars for the general U.S. population,
that we do with trans fats. When a linear relationship with disease
risk is present, there are other, more appropriate, ways to establish a
DRV for the nutrient. Because the current evidence supports more of a
dietary pattern approach than a specific nutrient-disease approach, it
is appropriate to use methods for the development of a DRV for added
sugars that are based on constructing a healthy dietary pattern that is
low in added sugars. The food pattern modeling that was done when
developing the healthy U.S.-style, the healthy Mediterranean-style, and
healthy vegetarian patterns provides a model of what a healthy dietary
pattern should look like at different calorie levels. Therefore, the
use of food pattern modeling to support a DRV for added sugars is
closely aligned with our rationale for requiring the mandatory
declaration of added sugars for the general U.S. population on the
label.
    (Comment 232) Some comments noted that the 2010 DGA states that the
USDA Food Patterns are only one example of suggested eating patterns
and that the USDA Food Patterns have not been scientifically tested for
health benefits.
    (Response) We acknowledge that the USDA Food Patterns are only one
example of a healthy eating pattern and that it is possible for
individuals to consume other patterns that are associated with a
decreased risk of disease. However, analyses using diet quality index
scores show that there is a great deal of consistency in what is
considered a healthy dietary pattern that is associated with a
decreased risk of disease (Ref. 86). Although it is possible to eat
other healthy dietary patterns, it would be very difficult to meet
nutrient needs within calorie limits by consuming enough of the other
components of a healthy dietary pattern while consuming high levels of
added sugars.
    We also recognize that individuals may be able to accommodate more
or less than 10 percent of calories in their diet while meeting
nutrient needs within calorie limits. The purpose of a percent DV is to
provide context to consumers so that they can determine how a food fits
within their diet. The percent DV declaration can also allow for
consumers to determine if a product is relatively high or low in a
nutrient based on a reference amount. Therefore, a DRV of 10 percent of
total calories should not be viewed as a recommended consumption level,
but rather a reference amount that consumers can use as a guide.
    We disagree with the comment that the USDA Food Patterns have not
been scientifically tested for health benefits. Schroeder et al.
assessed the effects of a diet based on the USDA Food Patterns used in
the 2010 DGA, a Korean diet, and a typical American diet on blood lipid
(fat) levels and blood pressure in overweight, non-Asian individuals in
the United States with elevated LDL cholesterol (Ref. 101). They found
that total cholesterol and LDL cholesterol significantly decreased when
subjects were on fed a diet that is consistent with the USDA Food
Patterns. Although the USDA Food Patterns in the 2015 DGAC Report
differ slightly from those included in the 2010 DGA, they were designed
in a very similar manner with the goal of meeting nutrient needs within
calorie limits.
    (Comment 233) Some comments objected to the use of food pattern
modeling to establish a DRV for added sugars because, according to the
comments, it lacks a scientific basis. The comments said that the
reference value of 10 percent of total calories that the 2015 DGAC
produced using modeling is a mathematical calculation of empty calories
``left over'' after the recommendations for food groups and nutrients
in the different dietary patterns have been met. It does not signify a
level at which negative metabolic effects occur. The comments asserted
that the calories available for solid fats or added sugars in the
``empty calories'' category would completely change based on one
addition or deletion of a serving of food.
    The comments cited a number of limitations of food pattern
modeling, such as:
     It is not evidence-based or nutrient specific so
conclusions cannot be drawn with respect to health-related outcomes;
     It was designed to study the impact of an overall diet,
not to evaluate the effect of a single nutrient;
     The nutritional adequacy was derived from a limited number
of

representative foods, limiting the ability to extrapolate the
nutritional adequacy of the food patterns beyond these ``representative
foods;''
     Table sugar was used as a surrogate for added sugar in the
USDA Food Patterns. As such, the model only identifies how much pure
sugar can be consumed after achieving nutrient requirements, and not
how to incorporate foods with added sugars into a dietary pattern;
     The modeling is based on a misperception that added sugars
provide no additional nutritional value and are merely ``empty
calories.'' Sugars are added to many nutrient-dense foods;
     The contribution of the representative foods to total
daily added sugar intake was not considered or reported;
     It presents one modeling scenario with one set of
assumptions and presents no uncertainty around their assumptions.
Micronutrient requirements in the USDA Food Pattern are not always
based on established intakes i.e., the USDA Food Patterns calcium
intakes can range from 110 percent of the RDA at the lower calorie
range to 138 percent of the RDA at the highest, the RDA range for iron
is 110 to 265 percent. As caloric levels increase, there is a disregard
for the percent adequacy of micronutrients;
     The model did not test if nutritional adequacy could be
achieved at added sugar intake levels above 10 percent and was not
tested to assess efficacy or sensitivity;
     The USDA food modeling (with few exceptions) does not take
into consideration fortification in the food supply, which could
dramatically reduce the number of food servings in the USDA Food
Patterns and increase the calories designated as leftover; and
     Food formulations and food consumption is continually
changing. With continuing changes to food composition databases,
information derived from food pattern modeling could change frequently.
Using such changing information to update daily values could be costly
to manufacturers for frequent changes to labels especially when based
on an approach that has no public health relevance. The comment said
that we chose, in part, to not use similar type data (i.e., census
data) for using a population weighted approach for setting daily values
for vitamins and minerals.
    (Response) As previously noted in our response to comment 224, we
do not have the type of quantitative intake recommendation for added
sugars that we have for other nutrients that have an independent
association with the risk of chronic disease. However, we do have
evidence that added sugars are a public health concern, and that
consumers need information about of added sugars in a serving of food
to maintain healthy dietary practices. Consumers also need to know how
that amount of added sugars in a serving of food fits into the context
of their total daily diet. Although we do not have the same type of
reference amount for added sugars that we do for other nutrients that
are associated with chronic disease risk, the scientific evidence
supporting a limit in consumption of added sugars to a maximum of 10
percent of total calories provides a reference value that can be used
to give context to the gram declaration for added sugars. The DRV, in
general, should not be viewed as a precisely defined limit, but rather
a guide to help consumers when selecting foods and determining how much
of those foods they can eat within a healthful diet.
    We recognize that empty calories allotment in the USDA Food
Patterns represents an amount that is left over once all other
requirements of the diet are met. We also recognize that conclusions
related to health outcomes cannot be drawn from food pattern modeling.
However, the dietary patterns approach to setting a DRV is consistent
with the dietary pattern approach that we are taking to the evidence
that we have considered to support the mandatory declaration of added
sugar. Rather than basing the declaration on a nutrient-disease
relationship, we are considering how a dietary pattern that is lower in
added sugars is characterized, in part, by lower intakes of sugar-
sweetened foods and beverages.
    We disagree with the comment that said that the USDA Food Patterns
were designed to study the impact of an overall diet and not to
evaluate the effect of a single nutrient. The USDA Food Patterns were
not designed to study nutrient or diet/disease relationships. They
provide a conceptual framework for selecting the kinds and amounts of
foods of various types, which together, provides a nutritionally
satisfactory diet. The USDA Food Patterns assist Americans in meeting
their nutrient requirements based on different caloric needs. In
general, food patterns, such as the USDA food patterns, translate
recommendations on nutrient intake into recommendations on food intake
based on selective nutrient-dense foods.
    During the modeling of the USDA intake patterns, 292 representative
foods were chosen in order to provide healthy food intake patterns to
meet nutrient needs for various age/sex groups of Americans ages 2
years and older within their calorie limits. We disagree with the
comment stating that the contribution of the representative foods to
total daily added sugar intake was not considered or reported. About 7
percent of these representative foods contain some added sugars (Ref.
124). For all added sugars in the USDA food patterns, the nutrients in
granulated white sugar were used for the nutrient profile; however,
this does not limit the application of the information for use as a
DRV. While sugars are added to many nutrient-dense foods, and the
assumption is made for the purposes of the USDA Food Patterns that the
sugars do not come along with other nutrients, they provide a way to
identify how much added sugars one could consume in various forms in
the diet while meeting nutrient needs within calorie limits. The empty
calorie allotment in the USDA Food Patterns gives Americans a general
sense of how many calories from added sugars they can incorporate into
a nutrient-dense diet without exceeding calorie limits. It is up to
each individual to determine if he or she wants to consume those extra
calories in the form of a food that is nutrient dense (e.g., cereal,
yogurt, or dried fruit with sugar added to them) or whether to consume
it in a less nutrient-dense form such as a cola. The Nutrition Facts
label also provides factual information that consumers can use to make
choices about their diet.
    With respect to the suggestion that micronutrient requirements in
the USDA Food Patterns are not always based on established intakes, we
agree. Instead, they are based on nutrient requirements for specific
age and sex groups. However, the nutrient profiles of the food groups
and subgroups used to construct the USDA Food Patterns are calculated
and weighted by consumption of the U.S. population. It is not clear
what the comment meant when it said that, as caloric levels increase in
the USDA Food Patterns, there is a disregard for the percent adequacy
of micronutrients. To the extent that the comment is suggesting that at
higher calorie levels, the amounts of nutrients provided in the USDA
Food Patterns exceed nutrient recommendations, as long as the food
pattern does not exceed the UL for nutrients, it should not be a
concern if the USDA Food Patterns exceed nutrient recommendations.
    In developing the dietary intake patterns, USDA built nutrient
adequacy in its dietary pattern by selecting a nutrient-dense food to
represent each item cluster (Ref. 19). The selection of item clusters
is based on the

consumption amount of the U.S. population (more than 1 percent of the
weighted amount). A limited number of the representative foods for an
item cluster were fortified foods. These fortified representative foods
were selected when fortification of the food is mandatory, such as
folate in enriched cereal grains, the food is typically fortified, or
when the market leader for the food is fortified and its consumption in
the population was consistent over time. Most nutrients in the USDA
Food Patterns come from non-fortified food sources. It is possible
that, if other fortified foods are used as representative foods in the
model, the quantities of foods in the USDA Food Patterns may increase
or decrease thereby increasing or decreasing the empty calorie
allotment. The USDA Food Patterns are a theoretical model that is used
to help Americans put the dietary recommendations into practice. The
amount of added sugars that could be reasonably consumed while eating a
healthy dietary pattern may be slightly more or less depending on the
foods included when modeling the dietary patterns; however, they show
that, across calorie levels, it would be very difficult to consume
significantly more than 10 percent of calories as added sugars while
still consuming enough foods from the food groups to meet nutrient
needs within calorie limits.
    We agree that nutrient intake data can be affected due to factors
such as nutrient database changes, reformulation, or change of dietary
behaviors. This is a limitation with the use of all intake data, and
affects evidence that we rely on for other label declarations as well
(e.g., assessment of nutrient adequacy when determining what the
nutrients of public health concern are). The DRV of 10 percent of
calories from added sugars is based on the data that we have available
to us at this time. We plan to monitor intake data and other evidence
and information on added sugars and will consider whether and how it
affects both an added sugars declaration and a DRV for added sugars in
the future.
    (Comment 234) The 2015 DGAC Report explains that, for purposes of
the USDA Food Pattern Food Groups, the term solid fats and added sugars
is an analytic grouping, but the 2015 DGAC elected to use the term
``empty calories'' for the food grouping in the USDA Food Patterns
which includes solid fats and added sugars. The empty calorie allowance
in the USDA Food Patterns is 8 to 19 percent of calories, and, based on
current consumption patterns, 45 percent of empty calories were
allocated to limits for added sugars with the remainder (55 percent)
allocated to solid fats.
    Some comments opposed the assignment of 45 percent of empty
calories to added sugars based on current consumption data. The
comments said that consumption data changes, so the assignment of 45
percent of calories to added sugars could change. Furthermore, the
comments noted that Americans are consuming too many calories from
added sugars, so using current consumption data to set a limit for
added sugars consumption is inappropriate. One comment said that
current intake of solid fats and added sugars has no relevance to the
intended use of the USDA Food Patterns (e.g., nutrient density). The
intent is for these leftover calories to be used at the discretion of
the individual as to how they consume these calories all added sugars,
all solid fats, or a combination. The comments also said that the
assignment of 45 percent of calories to added sugars in the USDA Food
Patterns is not linked to a health-related outcome or a healthy diet.
    (Response) We agree that consumption data changes and the
designation of 45 percent of empty calories to added sugars could
change. Consumption of added sugars could change in the future, which
may prompt a change to the recommendations and the how empty calories
from solid fats and added sugars are divided in the USDA Food Patterns.
If changes are made to the USDA Food Patterns in the future related to
added sugars, we will consider whether and how those changes impact the
DRV for added sugars. We also acknowledge that Americans are currently
consuming too much added sugars, so the assignment of 45 percent of the
empty calories allotment could reflect overconsumption. However,
Americans also are consuming too many solid fats, so the relative
proportion of empty calories assigned to both solid fats and added
sugars reflects overconsumption of both components of the diet.
Although the empty calorie allotment is intended to be used by
Americans based on their discretion, using consumption data to provide
a percentage of empty calories from solid fats and added sugars can be
consumed within a healthy dietary pattern reflects how Americans
currently are using those left over calories. The modeling of dietary
patterns for the USDA Food Patterns is done for a different reason than
to evaluate a dietary pattern for health-related outcomes, so the
assignment of 45 percent of calories to added sugars is not expected to
be linked to a health-related outcome. However, we disagree that the
assignment of 45 percent of calories to added sugars is not associated
with a healthy diet. The purpose of the USDA Food Patterns is to assist
consumers in putting intake recommendations for nutrients, foods, and
food groups into practice so that they can construct a healthful diet.
After nutrient needs are met, the left over calories are empty calories
which Americans can choose to consume in the form of solid fats and/or
added sugars. Therefore, how the empty calorie allowance was derived
was based on getting adequate amounts of nutrients from a variety of
foods in the diets to make up a healthy diet.
    (Comment 235) One comment said that we should not base a DRV for
added sugars on the USDA Food Patterns because they have not been
validated. The comment noted that, although the 2015 DGAC Report states
that an extensive effort was made to validate the food patterns, the
DGAC did not actually test the patterns in a clinical study. Instead,
it plotted the USDA food groups against those found in published
hypothesis-based dietary pattern studies on a graph. The comment
questioned whether the data provided by USDA to support a validation of
the USDA food patterns is empirical evidence that the USDA food
patterns are evidence-based guides for food consumption because, the
comment said, the majority of food group intakes from the USDA Food
Patterns do not actually fall within the range of intakes in the
published dietary pattern study recommendations and because the
majority of dietary pattern index studies used for the exercise did not
included added sugars criteria.
    (Response) The comment is suggesting that the USDA Food Patterns
are not evidence based guides for food consumption and have not been
validated because it is comparing them to dietary pattern studies where
dietary quality indices are used to evaluate dietary patterns and
health outcomes. Comparing the USDA Food Patterns, which have been
developed through the process of menu modeling, to studies evaluating
certain dietary patterns and health outcomes is not an appropriate way
to assess the validity of the USDA Food Patterns. The USDA Food
Patterns have been developed to be used as an example of a
nutritionally adequate and balanced diet. Although the purpose is not
to provide an example of a diet that is associated with decreased risk
of disease, Schroeder et al. did assess the effects of the USDA Food
Patterns from the 2010 DGA and found that total and LDL cholesterol
were significantly lower in participants on the 2010 DGA diet

compared to typical American diet (Ref. 101). The proper assessment of
the USDA Food Patterns is to consider whether they meet current dietary
recommendations. The 2015 DGAC evaluated the Healthy U.S.-style,
Mediterranean-style, and Vegetarian-style Patterns and determined that
they meet nutritional goals without excess calories, and use a variety
of foods (Ref. 19).
    (Comment 236) In the preamble to the supplemental proposed rule (80
FR 44303 at 44307 through 44308), we noted that the 2015 DGAC based its
recommendation that Americans limit their added sugars intake to no
more than 10 percent of total energy intake, in part, on current
consumption data. For many of the same reasons that comments opposed
the use of current consumption data to allocate 45 percent of available
empty calories in the USDA Food Patterns to added sugars, some comments
generally opposed the use of current consumption data to support a DRV
of 10 percent of total calories. The comments noted that consumption of
added sugars has been declining in recent years although the prevalence
of overweight and obesity have increased. One comment said that intake
data do not support ``added sugars'' intake as a major source of
increased caloric intake. The comment said that, in the past 40 years,
U.S. per capita consumption of sugar/sucrose declined by 33 percent as
obesity and other serious diseases increased. The comment noted that a
recent analysis of U.S. National Health and Nutrition Examination
Survey (NHANES) data found that ``added sugars'' consumption has
declined to 14.6 percent of energy, which is a decrease of 19.3 percent
over a period of 8 years (2000 to 2008) and as the 2015 DGAC noted
intake continues to decrease and current intake is now 13.4 percent of
energy. The comment also said that, according to USDA data, Americans
are consuming 425 more calories per person per day than they did in
1970 and of these 425 calories only 38 calories are attributed to
``added sugars'' intake (2009).
    Other comments said that a maximum limit for added sugars should
not be based on consumption data but rather on science with meaningful
endpoints. While current intake of added sugars (13 percent of
calories) is above but near a maximum level of 10 percent of calories,
suggesting that this current intake makes 10 percent a reasonable goal
is also not a health-based approach for setting a maximum intake level.
The comments noted that current average intake of sodium is
approximately 3,400 mg/day, but that the IOM panel set the upper level
at 2,300 mg/day based on a public health outcome, even though they said
it is generally agreed this is not a reasonable intake level that can
be achieved in the near future. The comments said that current intakes
are used to estimate prevalence of overconsumption by comparing to a
maximum intake level tied to an adverse outcome rather using current
intake to set the maximum intake level.
    (Response) Americans are still consuming 13.4 percent of their
calories from added sugars, which is a significant proportion of
calories. Despite the fact that consumption of added sugars may have
declined in recent years, consumption among the U.S population remains
high. While current consumption data was a consideration in the 2015
DGAC's recommendation, it was used more to show that limiting calories
from added sugars is a reasonable goal for Americans to strive for than
it was to establish a precise limitation. Furthermore, current
consumption data was not the only information that was used by the 2015
DGAC to support a recommendation to limit added sugars to a maximum of
10 percent of total calories. Information from the USDA Food Patterns
showing that one can reasonably accommodate approximately 4 to 9
percent of calories in a diet that meets nutrient needs within calorie
limits as well as data information from a published meta-analysis, also
supported the 2015 DGAC's recommendation.
    We explain, in our response to other comments in part II.H.3.o,
that we are considering how added sugars interact with other components
of a healthy dietary pattern. When too many added sugars are consumed,
it makes it difficult to meet nutrient needs within calorie limits and
it also makes it difficult for one to consume the recommended amount of
other foods that make up a healthy dietary pattern that is associated
with a decreased risk of CVD. Because our basis for requiring the
mandatory declaration of added sugars on the label for the general U.S.
population is related to consumption of a healthy dietary pattern that
is low in added sugars, it is appropriate to establish a DRV that is
based, in part, on information derived from modeling of healthy dietary
patterns. The IOM has not set a UL for added sugars so we do not have a
maximum intake level tied to an adverse outcome to which we can compare
current intake levels. The USDA Food Patterns show that it would be
difficult for Americans to consume a nutritionally adequate diet within
calorie requirements if they are consuming more than 4 to 9 percent of
their calories from added sugars. Because Americans are consuming
approximately 13.4 percent of their calories, or even more in some
segments of the population, the evidence supports that Americans are
consuming too many calories from added sugars.
    (Comment 237) Some comments questioned our reliance on findings and
recommendations in the 2015 DGAC Report for establishing a DRV for
added sugars. The comments asked whether we took the conclusions and
recommendations from the 2015 DGAC at face value or whether we
conducted our own rigorous review of the scientific evidence. The
comments (which were submitted in response to the proposed rule before
the 2015 DGAC Report became available) said that the DGAC Report has
not yet been sanctioned by the Secretaries of Health and Human Service
and the U.S. Department of Agriculture, which are under Congressional
mandate to ensure that the general dietary guidance for the American
public in the DGA is based on the preponderance of scientific and
medical knowledge at the time of the report. The comments noted that
the Secretaries not only consider the recommendations in this advisory
report to ensure the Dietary Guidelines are based on the preponderance
of science and medical knowledge, but also take into consideration
public comment, a process that has not yet been completed. The comments
said that our reliance on information and conclusions from the DGAC
Report is setting a new precedent.
    Other comments said that the DGAC was not convened with the purpose
and intent of establishing specific reference values for labeling. The
comments noted that the 2015 DGAC did not include a carbohydrate and/or
``added sugars'' expert. The comments suggested that a robust review by
carbohydrate and sugars experts familiar with the entire body of high-
quality scientific literature is necessary for establishing a reference
value for added sugars. The comments said that the lack of ``added
sugars'' expertise on the DGAC not only calls into question the
legitimacy of the DGAC's ``added sugars'' upper daily intake limit
intake recommendation, but also disputes the validity of the 2015 DGAC
Report as a ``consensus report'' from which we can establish a DRV.
    One comment said that the IOM recommendations are based on thorough
and systematic reviews of the scientific literature; a process that
usually takes 2 to 3 years to complete by experts in the field of
investigation. The comment said that the DGAC did not conduct a

thorough review of the evidence to determine its recommendation to
limit consumption of added sugars to less than 10 percent of calories.
The comment said that the DGAC did not convene the Added Sugars Working
Group until a few months before the DGAC process concluded. The comment
suggested that, because the Added Sugars Working Group was not
established earlier on, the DGAC had only 90 days to collect, review,
synthesize and formulate conclusions on the extensive body of
literature on sugars, with no experts in carbohydrate metabolism on the
2015 DGAC.
    (Response) Since the publication of the supplemental proposed rule,
the Secretaries of the U.S. Department of Health and Human Services and
the U.S. Department of Agriculture released the 2015-2010 DGA (Ref.
28). During the process of developing the 2015-2020 DGA, government
officials considered the recommendations from the 2015 DGAC as well as
comments from the public. The scientific evidence in the 2015-2020 DGA
related to added sugars corroborates the scientific evidence in the
2015 DGAC. The scientific evidence supports limiting calories from
added sugars and saturated fats and reducing sodium intake. Americans
can achieve this by consuming an eating pattern low in added sugars,
saturated fats, and sodium as well as by cutting back on foods and
beverages higher in these components to amounts that fit within healthy
eating patterns. A healthy eating pattern accounts for all foods and
beverages within an appropriate calorie level and limits saturated fats
and trans fats, added sugars, and sodium. The scientific evidence, from
the 2015 DGAC (that is corroborated by the 2015-2020 DGA) supports the
recommendation from the 2015 DGAC for Americans to consume less than 10
percent of calories per day from added sugars. Therefore, because the
2015-2020 DGA is in agreement with the 2015 DGAC, the concern related
to us basing an added sugars declaration on the evidence from the 2015
DGAC have been addressed.
(iv) The Te Morenga et al. Meta-Analysis
    (Comment 238) The 2015 DGAC reported that its recommendation to
limit added sugars to a maximum of 10 percent of total daily caloric
intake is supported by scientific evidence on added sugars and chronic
disease risk conducted by the DGAC. The 2015 DGAC Report also says that
the data analyzed by Te Morenga et al. supports limiting added sugars
to no more than 10 percent of daily total energy intake based on lowest
versus highest intakes from prospective cohort studies (Ref. 125). The
Te Morenga et al. study is a systematic review and meta-analysis of
randomized controlled trials and prospective cohort studies that was
commissioned by the WHO to look at the relationship between dietary
sugars and body weight (Ref. 125). Several comments criticized the Te
Morenga paper, stating that:
     It is a meta-analysis commissioned by the WHO and not a
U.S. consensus report;
     Although Te Morenga et al concluded that among free living
people consuming ad libitum diets, intake of free sugars or sugar-
sweetened beverages is a determinant of body weight, the comments noted
that in the WHO report on sugars intake for adults and children, they
graded their own evidence for free sugars intake and body weight for
both adults and children to be of moderate quality at best;
     The Te Morenga et al. interpretation did not establish a
reference value for intake of free sugars and body weight;
     The definition of free sugars differs from our proposed
definition of added sugars. The WHO defines ``free sugars'' as all
monosaccharides and disaccharides added to foods by the manufacturer,
cook or consumer, plus the sugars that are naturally present in honey,
syrups and fruit juices. In particular, the definition of free sugars
includes natural sugars from fruit juices which are not included in our
proposed definition of added sugars;
     Te Morenga et al. investigates the relationship between
added sugars intake and body weight rather than CVD risk;
     The authors' conclusion that any role of sugars on body
weight results from alteration in energy balance rather than a
physiological or metabolic consequence of monosaccharides or
disaccharides. The paper further stated that ``the extent to which
population-based advice to reduce sugars might reduce risk of obesity
cannot be extrapolated from present findings'' because few studies
lasted longer than 10 weeks;
     Many studies in the meta-analysis fail to provide any
comparative associations between total sugar intakes and metrics of
obesity (i.e., BMI, adiposity measures) in comparison with their
analyses of free sugar intakes. The comments said that this may be a
source of bias for their conclusions that only ``free sugars''
contribute to weight gain and fatness;
     Of the 77 studies evaluated for full review, only 11
isoenergetic studies were identified and composite results from those
studies provided ``no evidence of difference in weight change as a
result of difference in sugar intakes when energy intakes were
equivalent.'' The comments concluded that it cannot be assumed that
``free sugars'' is linked to fatness when excess energy intake was not
taken into consideration in the meta-analysis for non-isoenergetic
studies;
     The authors noted significant heterogeneity (the studies
included in the meta-analysis were not undertaken in the same way using
the same experimental design) and potential bias in some of the trials
examined;
     The authors concluded that comparison of the lowest to
highest intakes in cohort studies was compatible (not supportive as the
2010 DGAC Report indicates) with a recommendation to restrict intake to
below 10 percent of total energy. However, there is no evidence of a
dose-response relationship, a key component of elucidating potential
mechanisms, was provided through the array of research studies
evaluated;
     The findings are consistent with the 2010 DGA advice that
states, ``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; and
     The research included in Te Morenga et al. is not current.
Less than 10 percent of the studies included in the report were
published after 2010, more than 50 percent of the studies are over 10
years old, more than 70 percent of the trials (in children and adults)
are over 10 years old, and 80 percent of the randomized trials on
adults are over 10 years old.
    Other comments questioned our reliance on the Te Morenga et al.
paper due to a number of factors and suggested that the results of this
study should not be extrapolated to nutrient-dense foods and beverages
with small amounts of added sugars.
    The comments questioned our reliance on a meta-analysis for the
proposed DRV of 10 percent of calories from added sugars and said that
a meta-analysis does not provide sufficient scientific support to make
an intake recommendation of 10 percent of energy.
    One comment noted that the Te Morenga et al. paper was published
and available to us at the time of the March 2014 proposed rule, but we
said, in the preamble to the proposed rule (79 FR 11879 at 11906), that
we reviewed scientific evidence and recommendations of consensus
reports

and concluded that we could not propose to establish a DRV for added
sugars. The comment questioned why we now have determined that the Te
Morenga et al. paper provides suitable evidence to establish a DRV, but
not when we developed the proposed rule.
    (Response) We are relying on information from the USDA Food
Patterns showing that it would be difficult for one to consume more
than 10 percent of their calories from added sugars and still be able
to consume enough of the other components of a healthy dietary pattern
to meet nutrient needs within calorie limits to support a DRV for added
sugars. We are also relying on consumption data showing that, on
average, Americans are consuming 13.4 percent of calories from added
sugars. Therefore, because we are not relying on the Te Morenga et al.
paper to support a DRV for added sugars, we need not address specific
comments on the merits of the Te Morenga et al. paper. We have
determined that, because we are focusing on a healthy dietary pattern,
the interactions that sugar-sweetened foods and beverages have with
other components of a healthy dietary pattern, and how that healthy
dietary pattern is associated with health outcomes, and basing a DRV
for added sugars on data that takes into consideration the whole of a
healthy dietary pattern, we do not need to rely on evidence related to
a direct association between added sugars and risk of disease for a
DRV. It also suggests that a DRV for added sugars of 10 percent of
total calories is not an unrealistic reference value. We note that the
2015-2020 DGA also bases the recommendation to limit intake of calories
from added sugars to less than 10 percent per day on food pattern
modeling and national intake data on intakes of calories from added
sugars that demonstrate the public health need to limit calories from
added sugars to meet food group and nutrient needs within calorie
limits. The 2015-2020 DGA states that, for most calorie levels in the
USDA Food Patterns, there are not enough calories available after
meeting food group needs to consume 10 percent of calories from added
sugars and 10 percent of calories from saturated fats and still stay
within calorie limits.
    (Comment 239) One comment said that our scientific justification
for proposing a DRV for added sugars of 10 percent of total energy is
not clear because it is based on menu-modeling and is not included in
the meta-analysis conducted by Te Morenga et al.
    (Response) We proposed to establish a DRV for added sugars of 10
percent of total calories (50 grams for children and adults 4 years of
age and older and 25 grams for children 1 through 3 years of age). We
said that the 2015 DGAC Report recommended that Americans keep added
sugars intake below 10 percent of total energy intake, and that
recommendation was based on modeling of dietary patterns, current
consumption data, and a published meta-analysis on sugars intake and
body weight (80 FR 44303 at 44308). We concluded that the scientific
information from the 2015 DGAC report provides a basis for FDA to
establish a DRV for added sugars. The 2015 DGAC relied on both food
pattern modeling information from the USDA Food Patterns as well as
information from the Te Morenga et al. paper for its recommendation to
limit added sugars to a maximum of 10 percent of total daily caloric
intake.
    After further consideration, we are establishing a DRV for added
sugars of 10 percent of total calories, and are relying on information
from the USDA Food Patterns as well as current consumption data for
this determination.
    (Comment 240) Some comments said it would be inappropriate to base
a DRV for added sugars on recommendations from the WHO. The comments
said that the WHO recommendation to limit intake of free sugars to 10
percent of energy intake was based on evidence for dental caries and
not body weight or CVD risk. In reference to the Te Morenga et al.
paper, the comments said that there was no effect of sugar and measures
of weight found in children based on the reviews of randomized
controlled trials and only a minor effect was found in cohort studies
with intake of sugar-sweetened beverages but no other sugar-containing
foods.
    Other comments referred to the new WHO conditional recommendation
to further reduce free sugars intake to 5 percent of total calories and
said that this recommendation appears to be based solely on data from
several studies that are more than 50 years old. The comments noted
that the findings of the evidence-based review are described by the
review authors as of ``very low quality'' (Ref. 126).
    (Response) Although the WHO commissioned a systematic literature
review to answer a series of questions relating to the effects of
sugars on excess adiposity that resulted in the Te Morenga et al.
paper, the 2015 DGAC considered the evidence discussed to the Te
Morenga et al. paper and concluded that the evidence reviewed by Te
Morenga et al., as well as food pattern modeling analysis conducted by
the 2015 DGAC and consumption data supported a recommendation to limit
added sugars to a maximum of 10 percent of total daily caloric intake.
We did not propose to establish a DRV based on recommendations from the
WHO, nor are we finalizing a DRV for added sugars based on
recommendations from the WHO.
(v) The Iom Suggested Maximum Intake Level of 25 Percent or Less of
Energy From Added Sugars
    (Comment 241) Some comments noted that the 2005 IOM Macronutrient
Committee concluded that ``based on the data available on dental
caries, behavior, cancer, risk of obesity, and risk of hyperlipidemia,
there is insufficient evidence to set a UL for total or added sugars.
Although a UL is not set for sugars, a maximum intake level of 25
percent or less of energy from added sugars is suggested based on the
decreased intake of some micronutrients of American subpopulations
exceeding this level'' (Ref. 75). The comments asked why we did not use
this 25 percent level as the basis for a DRV for added sugars because
it was determined using an evidence-based approach.
    (Response) We have concluded that using the IOM suggested maximum
intake level of 25 percent or less of energy from added sugars to set a
DRV for added sugars would be inappropriate. As noted in the IOM
macronutrient report, the IOM could not establish a UL for total or
added sugars based on the evidence, and the less than 25 percent of
total energy recommendation should not be viewed as a UL. Setting a DRV
for added sugars that is one quarter of a 2,000 calorie diet would
result in a DRV for added sugars of 125 grams (2,000 x 0.25 = 500
calories and 500 / 4 = 125 grams). Such a DRV for added sugars would be
greater than the DRV for protein and fat, and would be approximately 42
percent of the DRV for total carbohydrate. Although DRVs are reference
values rather than precise recommended intake levels, the percent DV
declaration, which is calculated based on the DRV, gives the consumer a
general idea of how much of a nutrient should be consumed (79 FR 11879
at 11926). A DRV of 25 percent of calories would indicate to consumers
that foods containing a significant amount of added sugars are
relatively low in added sugars. Such a DRV also would send the message
to the American public that consuming one fourth of one's calories in
the form of added sugars is appropriate. If a consumer chooses to eat
those added sugars in the form of foods that contain few or little
other nutrients, it would be very difficult, if

not impossible, to consume a healthful dietary pattern that includes
adequate amounts from food groups, meets nutrient needs, and is within
calorie limits. As such, a DRV for added sugars that is 25 percent of
total calories could have negative public health implications.
Therefore, we are not setting a DRV for added sugars based on the IOM
suggested maximum level of 25 percent of total calories.
(vi) DRV of 10 Percent of Total Calories
    Many comments to the supplemental proposed rule discussed whether a
DRV of 10 percent of total energy intake is appropriate or whether
another number should be chosen.
    (Comment 242) Many comments suggested that the DRV for added sugars
should be lower than 10 percent of calories. The comments referred to
the 2015 WHO Guideline for Sugars intake for adults and children which
recommends reducing the intake of free sugars to less than 10 percent
of total energy intake. In the report, the WHO also suggested a further
reduction of the intake of free sugars below 5 percent of total energy
intake as a ``conditional recommendation.'' The comments also
recommended that we follow the recommendation of the Scientific
Advisory Committee on Nutrition in the United Kingdom that added sugars
should account for no more than 5 percent of daily energy intake. The
comments said that the American Heart Association (AHA) also recommends
limiting added sugars consumption to no more than 5 percent of total
energy intake. The comments also said that a DRV of 5 percent of total
energy intake would align with AHA's recommendation that no more than
one-half of discretionary calories should come from added sugars. The
AHA recommends that most women consume no more than 100 calories (6
teaspoons) from added sugars per day and no more than 150 calories (9
teaspoons) per day for most men. The comments suggested that a DRV of 5
percent of total energy intake would be more appropriate than a DRV of
10 percent of total energy intake because the 2,000[hyphen]calorie
``Healthy U.S.[hyphen]Style,'' ``Healthy Mediterranean[hyphen]Style,''
and ``Healthy Vegetarian'' dietary patterns developed for the DGAC
Report included only 6 or 7 percent of calories from added sugars.
    (Response) We disagree that the DRV for added sugars should be
lower than 10 percent of calories or that there is adequate evidence at
this time to set a DRV for added sugars of less than 5 percent of
calories. While the WHO and other health organizations have recommended
that individuals should consume 5 percent or less of total calories
from added sugars, those recommendations are not consistent with those
of U.S. consensus reports. Furthermore, current consumption data shows
that Americans, on average, are consuming 13.4 percent of calories from
added sugars, and the USDA Food Patterns show that it is possible to
construct a healthful dietary pattern that includes more than 5 percent
of calories from added sugars. The USDA Food Patterns were developed
using representative foods with very little or no added sugars or solid
fats. Even with using representative foods with little or no added
sugars, the amount of calories left over that consumers can use to
incorporate added sugars into their diet was 5 percent or more for all
but two calorie levels (Ref. 19). A DRV of 10 percent of total calories
provides a value that is more realistic considering current consumption
of added sugars in the United States as well added sugars in the food
supply.
    (Comment 243) Several comments recommended lowering the added
sugars DRV for children. The comments said that a DRV of 50 grams of
added sugars for children 4 years of age and older which is based on
the 2,000 reference value is too high. The comments said that according
to USDA, 4 year olds should be consuming 1,400 calories per day,
assuming moderate activity. The comments said that under our proposal,
a 4 year old could consume more than 14 percent of calories from added
sugars and still be within the guidelines. The comments noted that this
disparity does not align with the 2015 DGAC's or WHO's recommendations
for added sugars accounting for no more than 10 percent of total
calories until age 11 for boys and age 12 for girls. The comments
suggested changing the DRV to 25 grams of added sugars for children
aged 1 to 11years, and no more than 50 grams of added sugars for
individuals 12 and older. The comments said that this change would
bring our recommendations more in line with the stated goal of
consuming less than 10 percent of total calories from added sugars. The
comments also said that for products marketed to children between the
ages of 1 to 11 years old, we should require the use of a DRV of 25
grams for added sugars. The comments suggested criteria that could be
used to identify products marketed to children.
    One comment noted that in the United Kingdom health authorities
further stratify recommendations for children to include no more than
19 grams for children ages 4 to 6 and no more than 24 grams for
children ages 7 to 10.
    (Response) We decline to revise the rule as suggested by the
comments. DRVs should be viewed as reference amounts that consumers can
use to determine how a serving of a food fits within their total daily
diet. A DRV for children between the ages of 4 through 11 or 7 through
10, as the comments suggested, could clutter the label, cause
confusion, and draw attention to the added sugars declaration because
more space would be required for two separate percent DV declarations
on the label. In addition, the approach we have taken for setting a DRV
for added sugars for children and adults 4 years of age and older is
consistent with that of total and saturated fat where the DRVs are
based on an amount not to exceed.
(vii) Education
    (Comment 244) Many comments discussed the need for consumer
education to help consumers understand the addition of an added sugars
disclosure to the Nutrition Facts label and to help consumers use this
information to make healthy food choices. Other comments suggested that
education should focus on total calories, total sugars, and the
ingredient list--information which can already be found on the current
Nutrition Facts label. One comment suggested that we educate consumers
about the fact that sugars are included in total carbohydrates, instead
of requiring an added sugars declaration on the label. Many comments
also said that Nutrition Facts labels that declare added sugars in
addition to total sugars will be confusing to consumers, suggest to
consumers that added sugars are more harmful than naturally occurring
sugars, or suggest that consumers should focus on added sugars more
than on other nutrients.
    One comment argued that consumer responses to added sugars
declarations could lead to unintended consequences, citing studies that
have found that ``low-fat'' labels may reduce consumers' experience of
guilt associated with excess consumption of foods bearing such labels
or may increase what consumers perceive to be an appropriate serving
size of such foods. Many comments said that requiring a new line for
added sugars could suggest to consumers that they should give increased
attention to added sugars whereas current U.S. dietary guidelines do
not support an overemphasis on added sugars. One comment said that an
added sugars declaration could call undue attention to added sugars as
a source of calories when it is no different from other caloric
sources. This

comment said that emphasis on reducing individual macronutrients, in
lieu of reducing total energy intake defeats the primary goals of our
Calories Count report (Ref. 127). Another comment said that the
addition of added sugars declarations to the label may lead consumers
to opt for foods of equal total sugar content but lesser nutrition, and
to overlook health benefits that some foods have to offer.
    In contrast, some comments said that listing added sugars on the
Nutrition Facts label would provide vital information on the amount of
added sugars in a food and help consumers eat less added sugars.
    Some comments also said that public education on the food sources
and health consequences of excessive added sugars intake is needed. One
comment suggested that we develop materials to explain that consuming
foods high in added sugars makes it difficult to meet nutritional needs
and stay within calorie limits. The comment also suggested that we
emphasize that naturally occurring sugars in fruits, vegetables, and
dairy products do not pose any health problem, and that people should
consume more fruits, vegetables, and low-fat dairy products.
    One comment said that an industry-sponsored reanalysis of FDA's
added sugars consumer study and a consumer study commissioned by a
group of national food and beverage associations showed that the ``%
DV/Added Sugars'' information will create consumer confusion that does
not exist today. The comment said that we would face education campaign
challenges such as confusion related to the concept of percent DV,
possible misinterpretation of the new term ``Added Sugars,'' and
``unintended effects'' of placing a percent DV next to ``Added Sugars''
and not ``Total Sugars.'' The comment also said that when
misperceptions of ``% DV/Added Sugars'' arise in the marketplace, it
will be difficult to correct those misperceptions, particularly given
that the new rule and label changes would be interpreted and defined by
many other communicators outside FDA. The comment cited examples of
other campaigns that faced similar obstacles, and concluded that any
campaign FDA undertook related to added sugars would not succeed. Some
comments said that some segments of the population may be more
susceptible to misunderstanding added sugars information than the
general population. Another comment suggested explaining ``daily
values'' better and to clarify that the daily value for added sugars
does not represent a suggested amount one should eat, but rather,
represents a ``conservative estimate'' of the highest amount one should
consume of added sugar. The comment also said that if subsequent
research were to show that the current daily value for added sugars is
too high or too low, the ``incorrect'' value may remain in the public
mind long after it has been proven to be incorrect.
    One comment included information from a consumer study that sampled
1,088 participants aged 18 years and older from an online respondent
panel. The comment described results including, but not limited to,
participants' understanding of the term ``Added Sugars'' as displayed
on Nutrition Facts labels used in the study. Respondents' answers
reflected a range of interpretations, including, but not limited to,
beliefs that added sugars refer to specific types of sugars (e.g.,
``white sugar'') or artificial sweeteners. The comment said that 30
percent of participants said they ``don't know'' what added sugars are
or provided no answer. The comment said that the study findings
indicated that there is confusion among consumers regarding what added
sugars are and that ``consistent, coordinated communication efforts''
will be needed to educate consumers about the Nutrition Facts label and
added sugars.
    (Response) Increased consumer education about nutrition and healthy
dietary practices would likely benefit a number of consumers in the
United States. The updated Nutrition Facts label promulgated by this
rule is an important foundational tool for that consumer education. As
noted in part II.B.1, we are committed to increasing understanding and
use of the Nutrition Facts label to improve healthy dietary patterns
through consumer education, in collaboration with key Federal partners
such as USDA and CDC, health professionals, and the broader public
health community, as well as with industry partners. One aspect of
those education and outreach activities will be increasing
understanding of new components to the label including added sugars
(e.g., definition, relationship to total sugars), considerations for
how to interpret the information on added sugars in the context of a
healthy diet, and how all of the information provided on the Nutrition
Facts label is important to consider when constructing a healthy
dietary pattern--not only information on added sugars, but the
nutrients declared, the percent Daily Value, and the importance of
being mindful of total caloric intake. Attention to calories is
highlighted by the substantially increased font size of the calorie
declaration per serving of a product discussed in part II.Q. Focusing
on the totality of nutrition information on the label in education
activities will enable consumers to identify foods that are nutrient
rich and may contain some added sugars, and reinforces the
recommendations of the 2015 DGAC Report and 2015-2020 DGA to increase
fruit and vegetable consumption, decrease saturated fat and sodium, and
to limit added sugar intake to less than 10 percent of total calories.
    With regard to the comment stating that no education initiative can
be successful in helping consumers understand added sugars, and
therefore implying that added sugars should not be on the Nutrition
Facts label, we disagree. The requirement to declare added sugars on
the label is important public health information based on the latest
science. Not requiring this important information to be declared would
be detrimental to public health and run counter to our mandate to
promote healthy dietary practices, even if not all consumers understand
and use the information immediately.
    With regard to the comments questioning the addition of added
sugars to the label, we have determined that there is a public health
need for this declaration and that it is necessary to assist consumers
in maintaining healthy dietary practices (see part II.H.3.a). We have
the legal authority to require this declaration (see part II.C.3).
Moreover, we are not aware of any data or information suggests that
consumers will focus undue attention on added sugars as a source of
calories any more than other nutrients on the label that are a source
of calories. Our determination that added sugars should be declared on
the label is consistent with the intent of our Calories Count report
because the information an assist consumers in limiting their total
energy intake.
    With regard to the comments questioning the confusion about a
percent DV relating to added sugars and not total sugars, we address
the need for a percent DV for added sugars and why it is not
appropriate for total sugars (see part II.H.3).
    Regarding the question about consumer confusion about the concept
of the percent DV, we have updated the footnote explaining the percent
DV (see part II.Q.11).
    With regard to the question about consumer confusion on the
relationship between total and added sugars, as described in our
response to comment 188, we have modified the format of the added
sugars declaration to appear indented under total sugars using the
phrasing: ``Includes X g Added Sugars.''

    p. Records. When a mixture of naturally occurring and added sugars
is present in a food, the proposed rule, at Sec.  101.9(g)(10)(iv),
would require manufacturers to 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. We also proposed specific recordkeeping requirements specific to
yeast-leavened bakery products, wines with less than 7 percent alcohol
by volume, or beer that does not meet the definition of a ``malt
beverage,'' as defined by the Federal Alcohol Administration Act (27
U.S.C. 211(a)(7)), if the amount of added sugars in those products is
reduced through the process of fermentation.
    Several comments addressed the proposed recordkeeping requirements
for added sugars. We discuss those comments in part II.R.3.
    As discussed in part II.H.3.n, we are requiring manufacturers of
products containing fruit and vegetable juice concentrates as an
ingredient that have not been reconstituted to 100 percent juice in the
finished food to provide documentation that shows how they determined
how much of the sugars provided by the juice concentrate should be
declared as added sugars.
    Also, as discussed in part II.H.3.k, when the amount of added
sugars in a product is reduced through non-enzymatic browning and/or
fermentation, we are requiring manufacturers to make and keep records
to demonstrate the amount of amount of added sugars after non-enzymatic
browning and/or fermentation, make and keep records of the amount of
sugars added to the food before and during the processing of the food,
or the submission of a citizen petition requesting an alternative means
of compliance if the manufacturer has reason to believe that the amount
of added sugars in the finished product is significantly less than the
amount added prior to non-enzymatic browning and fermentation but they
have no way to determine a reasonable approximation of the amount in
the finished food.
4. Sugar Alcohols
    Our preexisting regulations, at Sec.  101.9(c)(6)(iii), 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).
    a. Voluntary declaration. Our preexisting regulations, at Sec.
101.9(c)(6)(iii), permit the voluntary declaration of sugar alcohols on
the Nutrition Facts label. The preamble to the proposed rule (79 FR
11879 at 11908) discussed how, in reaction to a citizen petition and in
the 2007 ANPRM, we considered whether to make the declaration of sugar
alcohols on the Nutrition Facts label mandatory. We tentatively
concluded that the declaration of sugar alcohols should remain
voluntary, and so the proposed rule would not revise the requirement
but would, because of other changes, renumber the provision as Sec.
101.9(c)(6)(iv).
    We did not receive any comments regarding the voluntary declaration
of sugar alcohols, and so the final rule continues to provide for their
voluntary declaration.
    b. Use of the term ``sugar alcohols''. In the preamble to the
proposed rule (79 FR 11879 at 11908), we discussed our consideration of
a citizen petition and comments to the 2007 ANPRM regarding the use of
the term ``polyols'' (a contraction of the term ``polyalcohol'' instead
of ``sugar alcohols''). We determined that ``polyols'' could be
potentially more confusing to consumers than the term ``sugar
alcohol,'' but acknowledged that consumers also may not be familiar
with the term ``sugar alcohol.'' Nevertheless, we continued to support
the term ``sugar alcohols'' rather than ``polyols'' because we stated
that ``sugar alcohols'' more accurately describes the group of
substances encompassed in the definition in Sec.  101.9(c)(6)(iii) (79
FR 11879 at 11908). We explained that ``polyols'' includes non-
carbohydrate polyalcohols, such as polyesters, whereas ``sugar
alcohols,'' as defined by FDA, includes only carbohydrates, and so the
proposed rule would not change the term ``sugar alcohols'' when used on
the Nutrition Facts label.
    (Comment 245) Several comments supported using the term ``polyols''
instead of ``sugar alcohols.''
    Some comments said that sugars are mono- and disaccharides, whereas
most sugar alcohols are pentoses and hexoses. The comments said that
the chemical structures of sugars are rings, and the chemical structure
of sugar alcohols are chains. The comments also said that sugars and
sugar alcohols have different calorie contributions. Therefore, the
comments said that the term ``polyols'' is more appropriate in
reference to carbohydrate-based polyalcohols.
    (Response) We disagree with the comments. Both sugars and sugar
alcohols contain saccharides. Sugars are defined as mono- and
disaccharides (Sec.  101.9(c)(6)(ii)). Sugars alcohols are defined as
the ``sum of saccharide derivatives in which a hydroxyl group replaces
a ketone or aldehyde group'' (Sec.  101.9(c)(6)(iv)). The presence of
the hydroxyl group is the basis for these modified sugars being called
``sugar alcohols.'' The term ``sugar alcohols'' more accurately
reflects the chemical composition of these compounds than ``polyols.''
Because of the difference in chemical composition, they are metabolized
differently and have different caloric contributions. Analytical
methods are available to measure sugar alcohols based on their chemical
composition and structure (79 FR 11879 at 11901), and they are listed
separately in the Nutrition Facts label. ``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 (see 79 FR
11879 at 11908). Thus, we decline to revise Sec.  101.9(c)(6)(iii) to
use the term ``polyols.''
    (Comment 246) One comment supporting use of the term polyols noted
that our explanation in the preamble to the proposed rule, that polyols
only cover non-carbohydrate polymers while sugar alcohols include only
carbohydrates, is not supported. The comment said that polyols are low-
digestible carbohydrates and the only sugar alcohols used in foods are
also considered polyols.
    (Response) We disagree that polyols only pertain to non-digestible
carbohydrate polymers. We consider polyols to include low-digestible
carbohydrates (i.e., sugar alcohols) that are used in foods, as well as
non-carbohydrate polyalcohols (see 79 FR 11879 at 11908). Therefore,
``sugar alcohols'' is a more specific description of the listing of
these ingredients in the Nutrition Facts label.
    (Comment 247) One comment said that ``sugar alcohol'' may be
confusing to consumers and that ``polyols'' is less likely to cause
confusion. The comment said that ``sugar alcohol'' may mislead the
consumer regarding health effects, given the negative health
connotations of the terms ``sugar'' and ``alcohol'' separately. The
comment said that we, at the very least, should conduct consumer
testing of the term ``polyols'' and ``sugar alcohols.''
    Another comment cited a 1995 survey provided to FDA in a citizen
petition in 1995, stating that there is strong evidence that ``sugar
alcohols'' is a term widely misunderstood by consumers, with most
consumers mistakenly

believing that foods containing sugar alcohols contain both sugar and
alcohol. Another comment cited a 2012 survey, ``Adults Remain Confused
about `Sugar Alcohol'--and Whether It Contains Sugar and/or Alcohol,''
which observed that a majority of the 1,000 adults polled believed that
``sugar-free'' products containing ``sugar alcohols'' contained sugar
(74 percent) or alcohol (64 percent).
    (Response) We previously considered the use of the term ``polyol''
and determined that it could be potentially more confusing to consumers
than ``sugar alcohols.'' However, we acknowledge that consumers may not
be familiar with the term ``sugar alcohol'' (see 79 FR 11879 at 11908).
Therefore, we allow for the listing of the name of the specific sugar
alcohol instead of ``sugar alcohols,'' provided that only one sugar
alcohol is present in the food, because many sugar alcohols are listed
as ingredients (e.g., sorbitol, mannitol, and xylitol) and therefore
may be more recognizable to consumers.
    (Comment 248) One comment supporting use of the term ``polyols''
said that the EU has introduced optional declaration for ``polyols''
(Ref. 128) (``on the provision of food information to consumers'').
    (Response) We acknowledge that the EU provides for the option to
declare ``polyols'' which is defined as ``alcohols containing more than
two hydroxyl groups.'' The EU, however, does not allow for the optional
listing of specific sugar alcohols. ``Sugar alcohols'' more accurately
reflects the chemical composition of these ingredients than
``polyols.'' Furthermore, unlike the EU, we allow for the listing of
specific sugar alcohols because consumers may not be familiar with the
term ``sugar alcohol.''
    c. DRV. Our preexisting regulations do not provide a DRV for total
sugar alcohols or for individual sugar alcohols. The preamble to the
proposed rule (79 FR 11879 at 11908) explained that a quantitative
reference intake recommendation for sugar alcohols is not available
from current consensus reports, so we have no basis on which to
consider setting an appropriate DRV. Therefore, we did not propose to
set a DRV for sugar alcohols.
    (Comment 249) One comment agreed that there was no scientific basis
to establish a DRV for ``sugar alcohols.''
    (Response) Because we continue to lack a basis to set an
appropriate DRV for sugar alcohols, the final rule does not establish a
DRV for sugar alcohols.
    d. Caloric value. The caloric value for carbohydrates, other than
insoluble fiber, is 4 kcal/gram (Sec.  101.9(c)(1)(i)(C)). Sugar
alcohols have been shown to have a caloric value lower than 4 kcal/gram
(Refs. 129-130). In the preamble to the proposed rule (79 FR 11879 at
11908 through 11909), we explained that we considered revising the
energy contribution of sugar alcohols and also considered relevant
caloric values recommended by the Life Sciences Research Office (LSRO).
The LSRO expert panel reports provided the following caloric values for
individual sugar alcohols: Isomalt (2.0 kcal/gram), lactitol (2.0 kcal/
gram), xylitol (2.4 kcal/gram), maltitol (2.1 kcal/gram), sorbitol (2.6
kcal/gram), hydrogenated starch hydrolysates (3.0 kcal/gram), and
mannitol (1.6 kcal/gram). Consequently, we proposed 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/gram, lactitol--2.0 kcal/gram, xylitol--2.4 kcal/
gram, maltitol--2.1 kcal/gram, sorbitol--2.6 kcal/gram, hydrogenated
starch hydrolysates--3.0 kcal/gram, and mannitol--1.6 kcal/gram. We
also proposed to amend Sec.  101.9(c)(1)(i)(C) such that the 4 kcal/
gram value is not applied to sugar alcohols.
    (Comment 250) Several comments supported the proposed caloric
values. Some comments, however, noted that we did not identify a
caloric value for erythritol. Some comments noted that a caloric value
of 0.2 kcal/gram was consistent with the EU and Health Canada, while
other comments supported 0 kcal/gram as a value consisted with the EU.
One comment provided a review of the evidence, including a publication
by Livesey (1992) (Ref. 131) and more recent evidence from human (Ref.
132) and rat studies to support of a caloric value of 0 kcal/gram for
erythritol.
    (Response) We agree that a caloric value for erythritol should be
considered. We generally do not consider animal studies for determining
the caloric contribution of nutrients. Livesey (1992) determined that
the caloric value for erythritol was 0.2 kcal/gram in humans. Applying
the factors that Livesey (1992) used for determining the caloric value
for erythritol and considering the newer evidence using radiolabelled
erythritol in humans (Ref. 132), the review submitted as part of the
comment concluded that erythritol is a substrate that is readily
absorbed, and undergoes no metabolism, therefore providing 0 calories.
These methods are consistent with those used for establishing caloric
values for the other sugars alcohols determined by LSRO (79 FR 11879 at
11909). Therefore, the final rule provides a caloric value of 0 kcal/
gram for erythritol.
5. Dietary Fiber
    a. Dietary fiber.
(i) Definition
    Our preexisting regulations do not establish a definition for
dietary fiber. Dietary fiber represents a heterogeneous group of
compounds that vary in their carbohydrate composition, linkages between
carbohydrates, and molecular weight. Therefore, there is no specific
chemical definition for dietary fiber. The amount of dietary fiber that
is currently declared is based on analytical methods such as the AOAC
analytical methods.
    In the preamble to the proposed rule (79 FR 11879 at 11909), we
explained how the IOM had 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. We proposed to adopt a definition for
dietary fiber that is equivalent to the IOM's definition of ``total
fiber'' and therefore would include fibers that the IOM defines as
``dietary fiber'' and ``functional fiber.'' Both ``dietary fiber'' and
``functional fiber,'' as defined by the IOM, are considered to have
beneficial health effects, so there is little benefit for consumers in
distinguishing between these two types of fiber on the Nutrition Facts
label. In addition, the IOM 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 (79 FR
11879 at 11909). Specifically, the proposed rule would amend Sec.
101.9(c)(6)(i) to include the definition for dietary fiber. The
proposed definition would include: (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 we
have granted be included in the definition of dietary fiber, in
response to a citizen petition we received 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. Our

proposed definition for total fiber also would include a minimum degree
of polymerization (DP) greater or equal to 3 monomeric units.
    In the preamble to the proposed rule (79 FR 11879 at 11909 through
11910), we proposed to list isolated and synthetic non-digestible
carbohydrates with beneficial physiological effect(s) in the definition
of dietary fiber. In the proposed codified language, we identified two
ways the list of dietary fibers could be amended to include new fibers
in the definition. Specifically, we identified the existing citizen
petition process in Sec.  10.30 that a manufacturer could use to
request an amendment to the definition of dietary fiber and the
petition process for the authorization of a health claim (21 CFR
101.70) where a fiber that is the subject of an authorized claim would
be considered a dietary fiber that we could add to the list of fibers
in the definition. We would consider an isolated or synthetic non-
digestible carbohydrate that meets the significant scientific agreement
standard in section 403(r)(3) of the FD&C Act, for which a health claim
is authorized, to be a dietary fiber with a beneficial physiological
effect to human health. Two dietary fibers, for which an authorized
health claim exists, i.e., [beta]-glucan soluble fiber and barley
[beta]-fiber, were included in the proposed definition. The two types
dietary fibers, for which an authorized health claim exists (i.e.,
[beta]-glucan soluble fiber and psyllium husk), are included in the
codified definition for dietary fiber in this final rule.
    (Comment 251) Some comments stated that it would be a burden to us
to maintain and update an approved list of dietary fibers.
    (Response) We consider a listing of dietary fibers that provide a
beneficial physiological effect to be an efficient way to ensure the
use of a common definition on which all manufacturers can rely to
evaluate the fiber content of their products for purposes of the
dietary fiber declaration and that we can use to evaluate compliance.
Therefore, we decline to revise the rule in response to this comment.
    (Comment 252) Some comments expressed concern about using the
citizen petition process in Sec.  10.30 to amend the listing of
isolated and synthetic non-digestible carbohydrates in the definition
of dietary fiber. Some comments considered this aspect of the
definition as creating an approval process for dietary fiber and stated
that we did not have legal authority for such a process. The comments
said our pre-approval authority is limited to the premarket review of
food additives, color additives, and health and nutrient/content claims
and that section 403(q) of the FD&C Act does not provide a legal basis
to support premarket approval. The comments also asserted that, under
the Administrative Procedure Act, our actions must be consistent with
the authority given to us under the FD&C Act and cannot be arbitrary or
capricious.
    (Response) We disagree that defining the term ``dietary fiber'' to
include the identification of specific isolated and synthetic non-
digestible carbohydrates is a pre-approval process for dietary fibers
like that for food additives, color additives, and health or nutrient
content claims. First, the listing of isolated and synthetic dietary
fibers in the definition of dietary fiber does not constitute a pre-
approval process related to the safety of the food as an ingredient. We
are defining dietary fiber under our authorities in sections 403(q),
403(a), 201(n) and 701(a) of the FD&C Act and not under the food
additive approval provisions in section 409 of the FD&C Act (21 U.S.C.
348). Moreover, the definition of dietary fiber does not prevent the
use of an isolated or synthetic non-digestible carbohydrate to be used
as an ingredient in the manufacture of a food. The use of such an added
fiber as an ingredient must be lawful under the relevant provisions in
the FD&C Act. Second, our definition of dietary fiber for a label
declaration does not constitute a health claim or a nutrient content
claim under the provisions to authorize such claims in section 403(r)
of the FD&C Act. By defining the term dietary fiber, based on
beneficial physiological effects in human health rather than by
chemical definition, we will ensure that the dietary fiber declared
amount will assist consumers to maintain healthy dietary practices,
consistent with our labeling authorities under section 403(q) the FD&C
Act.
    To avoid confusion in the final rule about the citizen petition
process at Sec.  10.30, we removed the language that referred to
dietary fibers ``that FDA has granted be included in the definition of
dietary fiber, in response to a petition submitted to FDA under Sec.
10.30 demonstrating that such carbohydrates have a physiological effect
that is beneficial to health.'' The language is not necessary. Any
interested person may seek to amend the listing of added fibers through
the existing citizen petition process in Sec.  10.30. We do not need to
cite to that process within the codified definition of dietary fiber
for that process to be available or used to amend the definition of
dietary fiber.
    (Comment 253) Some comments expressed concern about the citizen
petition process with respect to the time for FDA to respond and about
the priority of review. Several comments said that, if we did not
respond to a citizen petition after 180 days, the dietary fiber should
be considered to be officially recognized. One comment would change the
deadline for responding to a petition to 30 days or to 90 days.
    (Response) Under Sec.  10.30(e)(2), the Commissioner is to provide
a response to a petitioner within 180 days of receipt of the petition
to approve the petition, deny the petition, or provide a tentative
response. In addition, under Sec.  10.30(e)(3), the Commissioner may
grant such other relief or take other action as the petition warrants.
The comment that requests a shorter time period for review under Sec.
10.30 would require a substantive amendment to the existing regulation
in Sec.  10.30 and is outside the scope of this rule. Therefore, we
decline to revise the rule in response to this comment.
    (Comment 254) Several comments asked how we would handle more than
one petition on the same added non-digestible carbohydrate. For
example, if two petitions were submitted on the same added non-
digestible carbohydrate, but for different endpoints, and the added
non-digestible carbohydrate meets the dietary fiber definition based on
one endpoint, but not the other endpoint, would the added non-
digestible carbohydrate meet the dietary fiber definition? Another
comment stated that it is unlikely that a single dietary fiber source
will produce all of the potential health outcomes anticipated for
dietary fiber consumption. Some comments questioned whether all
manufacturers would have to submit a citizen petition for the same
fiber.
    (Response) We recognize that different isolated or synthetic non-
digestible carbohydrates can have different beneficial physiological
effects. An isolated or synthetic non-digestible carbohydrate only
needs to demonstrate one beneficial physiological effect. Therefore,
for example, if the non-digestible carbohydrate attenuates blood
glucose levels, but not blood cholesterol levels, it would meet the
definition of dietary fiber. As long as one of the petitions provided
sufficient evidence for a beneficial physiological effect, we could add
the dietary fiber to the regulation. After an isolated or synthetic
non-digestible carbohydrate is included in the list of such fibers in
the definition of dietary fiber in Sec.  101.9(c)(6)(i), all
manufacturers must list the dietary fiber

as part of the total dietary fiber declaration if it is present in
their product. Manufacturers would not have to individually submit a
citizen petition for the same fiber already listed before being subject
to the mandatory declaration for that fiber.
    (Comment 255) One comment said we should authorize only specific
formulations of an isolated or synthetic non-digestible carbohydrate.
The comment said that generic approval of many added fibers would be
inappropriate because companies produce a wide variety of each fiber.
    (Response) We recognize that companies may produce a wide variety
of specific formulations of isolated or synthetic non-digestible
carbohydrates, and we would, as appropriate, provide the needed
specificity in a list of isolated or synthetic non-digestible
carbohydrates in the definition, including their source and chemical
structure to ensure clarity in what fibers must be declared as
``dietary fiber'' if present as an ingredient in food. We intend to
issue a guidance document on the information we recommend be provided
to us for scientific review, the approach we intend to use to evaluate
the studies, including the approach for our evaluation of the strength
of the scientific evidence, if a company petitions us to amend the
definition of dietary fiber to include an additional fiber in the
definition.
    (Comment 256) One comment suggested that we use a voluntary pre-
notification process, such as that used for FDAMA health claims, to
substantiate an added non-digestible carbohydrate. Other comments
suggested the use of a voluntary GRAS notification process that
involves submitting a detailed summary of a determination for safety
or, for companies that have self-determined their ingredient as GRAS,
their self-determination process. Other comments said that added non-
digestible carbohydrates that are GRAS should meet the dietary fiber
definition. Many comments suggested that we use a pre-market
notification process, such as that used for structure/functions claims,
where the evidence is on file and the evidence is publically available.
    (Response) We decline to revise the rule as suggested by the
comments. A voluntary process, such as the GRAS notification program,
is not consistent with ensuring that there is a singular definition of
dietary fiber for purposes of the declaration in the Nutrition Facts
label. Furthermore, the GRAS review system evaluates ingredients for
their safety, rather than beneficial physiological effects. A dietary
fiber that is GRAS does not necessarily meet the definition of dietary
fiber for purposes of a nutrient declaration. A non-digestible
carbohydrate that is added to a food by a manufacturer must be approved
as a food additive under section 409 of the FD&C Act or be GRAS under
the conditions of its intended use (see sections 201(s) and 409 of the
FD&C Act). The lawfulness of the use of various fibers added to food is
outside the scope of this rule.
    Moreover, a process whereby a firm retains the evidence that its
fiber meets the definition of dietary fiber would not ensure that there
is a singular definition of dietary fiber for purposes of the
declaration in the Nutrition Facts label. By including a list of all
isolated or synthetic dietary fibers that meet the definition of
dietary fiber, manufacturers will know that, when they use those fibers
as an ingredient in their product, they must include the fibers in the
declaration of dietary fiber. Consumers will have a consistent basis on
which the declared values for dietary fiber are derived and can use
that information in making healthy dietary choices and for comparing
products. We are establishing a definition for dietary fiber that
includes isolated or synthetic non-digestible carbohydrates that have a
beneficial physiological effect to human health and are to be included
in the declaration for dietary fibers on the Nutrition Facts label.
Without a consistent regulatory definition, we would not be able to
determine the veracity of a dietary fiber declaration on the Nutrition
Facts label for purposes of compliance, and consumers would not be
assured that the fibers declared as dietary fiber on the label are
those that will assist them in maintaining healthy dietary practices.
    Furthermore, although we consider an isolated or synthetic fiber
that is the subject of an authorized health claim to meet the
definition of dietary fiber, we are not able to make the same
determination for such a fiber if subject of a health claim
notification submitted under section 403(r)(3)(C) of the FD&C Act. (We
refer to this health claim as a ``FDAMA health claim'' based on the
statutory language enacted as part of the Food and Drug Administration
Modernization Act of 1997, Pub. L. 105-115, 111 Stat. 2296 (1997).) A
FDAMA health claim relates to an authoritative statement made by a
scientific body of the U.S. Government with official responsibility for
public health protection or research directly relating to human
nutrition (section 343(r)(3)(C)(i)) of the FD&C Act). A FDAMA health
claim may be used on food in the market within 120 days of a
submission; however, there are certain circumstances under which we may
object to the content of the submission. For FDAMA health claims in
use, for which the 120-day period has passed, we must issue a
regulation to prohibit or modify the claim or make other findings to
prevent the use of the claim (section 343(r)(3)(D) of the FD&C Act).
There are a number of factors we must evaluate during the 120-day
period of review that could raise questions about the use of the claim.
For example, we may have questions about the source of the statement
and whether the statement is a health claim, whether the notification
contains a balanced representation of the scientific literature about
the health claim and whether the claim is misleading. Thus, unlike the
540-day period available to publish a final rule to authorize a health
claim (section 403(r)(4)(A)(i) of the FD&C Act), we may not have
adequate time during a FDAMA health claim review period to address
additional questions about the fiber as it relates to our authority in
section 403(q) of the FD&C Act for purposes of nutrient declaration.
Therefore, we plan to consider, on a case-by-case basis, whether the
scientific evidence for a fiber that is the subject of a FDAMA health
claim notification is sufficient to amend the list of dietary fibers in
the dietary fiber definition for nutrient declaration.
    (Comment 257) One comment asked us to clarify that, when a company
makes a structure/function claim (e.g., fiber helps maintain healthy
digestive function), the substantiation for that claim would need to be
based on a physiological effect. The comment said that companies
already must substantiate all claims on the label and said we could
issue a guidance document to clarify how substantiation of a claim
should be done.
    (Response) Structure or function claims are outside the scope of
this rule. Therefore, we are making no clarifying statements with
respect to structure or function claims in this final rule.
    (Comment 258) One comment that objected to the proposed rule's
mention of citizen petitions stated that the evidence for meeting the
dietary fiber definition should meet the significant scientific
agreement (SSA) standard for health claims and that small, short-term
studies of varying quality with conflicting results would not suffice.
The comment also said that a health claim authorization would require
us to consider whether levels of an added non-digestible carbohydrate
in foods are sufficient to cause the physiological effect. Other
comments said we should only require evidence needed to

demonstrate the physiological effect of the added non-digestible
carbohydrate, regardless of the amount in the finished food.
    Another comment said that we should not expect the evidence to be
equivalent to the significant scientific agreement (SSA) standard
required for an authorized health claim. Instead, the comment said the
evidence considered could include animal and in vitro studies or else
the evidentiary standard would be the same as for structure function
and health claims. The comment said we should provide the evidentiary
standard in the final rule.
    (Response) The comments express concern about the level and
sufficiency of the scientific evidence necessary to demonstrate a fiber
provides a beneficial physiological benefit to health and whether a
certain level of such a fiber in food is needed in order to be
considered a ``dietary fiber'' for purposes of a Nutrition Facts label
declaration. A health claim and a nutrient declaration are distinct
from each other. A health claim is a statement about the relationship
between a food or a food component and risk of chronic disease or a
health-related condition. A nutrient declaration on a food label is a
statement of the amount of the nutrient in a serving of a food that is
necessary to assist consumers to maintain healthy dietary practices. A
beneficial physiological effect to human health for purposes of
nutrition labeling may be based on a relationship between the nutrient
(e.g., dietary fiber) and a risk of chronic disease or a health-related
condition, but that is not a prerequisite. Not all beneficial
physiological effects are specific to chronic disease risk (e.g.,
attenuation of postprandial blood glucose, improved bowel function).
Thus, for purposes of the Nutrition Facts label, the evidence to
support a beneficial physiological effect on human health may differ
from that required for a health claim that relates to a relationship
between an isolated or synthetic non-digestible carbohydrate and a risk
of chronic disease. As part of the factors for mandatory declaration,
the evidence for a relationship between the nutrient and a health-
related physiological endpoint should be ``well-established'' which
includes conclusive or strong evidence (79 FR 11879 at 11890). For
evidence submitted as part of a citizen petition, we consider that the
strength of the total evidence should demonstrate a specific beneficial
physiological effect and that the beneficial effect should be
replicated (Ref. 133), consistent with generally accepted scientific
evidence to competent authorities in the Codex definition of dietary
fiber in 2010 (79 FR 11879 at 11909). Accordingly, we do not consider
animal or in vitro data to be sufficient. The physiology of animals is
different than that of humans. In vitro studies are conducted in an
artificial environment and cannot account for a multitude of normal
physiological processes such as digestion, absorption, distribution,
and metabolism that affect how humans respond to the consumption of
foods and dietary substances (Ref. 134). Animal and in vitro studies
can be used to generate hypotheses, investigate biological plausibility
of hypotheses, or explore a mechanism of action of a specific food
component through controlled animal diets; however, these studies do
not provide information from which scientific conclusions can be drawn
regarding the beneficial physiological effects of a food component,
such as added non-digestible carbohydrates.
    If a dietary fiber is the subject of an authorized health claim, we
would consider the relationship between the fiber and the chronic
disease risk or health-related condition, to provide a beneficial
physiological benefit to health. In fact, we proposed, and include in
this final rule, two dietary fibers in the definition of dietary fiber
that are the subject of an authorized health claim. Prospectively, if
we issue a final rule authorizing a health claim for a dietary fiber,
we intend to modify the dietary fiber definition accordingly.
    Moreover, we are not including a requirement that an isolated or
synthetic non-digestible carbohydrate that has beneficial physiological
benefit be included at or above a certain level in food in order to be
declared as dietary fiber on the Nutrition Facts label. The dietary
fiber declaration is not a health claim. We do not consider it
necessary to titrate an amount of a dietary fiber in a food with the
beneficial physiological effect of the fiber for purposes of a nutrient
declaration. We recognize that dose-response relationships may exist
between certain isolated or synthetic non-digestible carbohydrates and
a beneficial physiological endpoint. We also recognize that the amount
of an isolated or synthetic non-digestible carbohydrate will vary in
similar and different marketed food products. The scientific evidence
from a clinical study to support a beneficial physiological effect
should provide an amount of the fiber that is a reasonable level to be
expected in a food and relevant based on typical consumption of dietary
fiber.
    (Comment 259) Several comments said we should accept functional
fibers (i.e., isolated or synthetic non-digestible carbohydrates)
identified in the IOM macronutrient report (Ref. 5) that summarizes the
scientific evidence and where sufficient data documents their
beneficial physiological effect. The comments said that the 2002 IOM
report already included inulin and oligofructose as dietary fibers in
table 7-1 and pages 345 through 346.
    (Response) We disagree with the comments. The IOM (Ref. 5) did not
consider whether the scientific evidence is sufficient to support a
beneficial physiological effect to human health for specific isolated
or synthetic non-digestible carbohydrates, but rather identified or
classified which non-digestible carbohydrates would be considered to be
a functional fiber and, therefore, would need to demonstrate a
beneficial physiological effect to fall within the dietary fiber
definition. For example, the IOM report states that inulin,
oligofructose, and fructooligosaccharides ``could be classified as
functional fibers where there are sufficient data to show positive
physiological effects in humans'' (Ref. 135). Table 7-1 of the IOM
report simply provides the general characteristics of what could
qualify as a dietary fiber. The IOM did not evaluate the beneficial
physiological effects of the individual non-digestible carbohydrates
for the purpose of identifying those that meet the dietary fiber
definition. Instead, the IOM provided a brief science review rather
than an indepth review for the various physiological endpoints. The IOM
stated that it is important to note that the discussions on the
potential benefits of what might eventually be classified as functional
fibers should not be construed as endorsements of those fibers.
    (Comment 260) One comment said our consideration of physiological
effects was arbitrarily limited to three endpoints. Many comments said
we should use and incorporate into a guidance document the endpoints
identified at the Vahouny Fiber Symposium, besides the three endpoints
listed in the IOM report (and the proposed rule).
    (Response) We disagree that we limited the physiological effects to
three endpoints. In the preamble to the proposed rule (79 FR 11879 at
11910), we identified examples of physiological effects that are
beneficial to human health, such as attenuation of postprandial blood
glucose concentrations, attenuation of blood cholesterol
concentrations, and improved laxation. The terms ``such as'' indicate
that the subsequent list of items is merely an illustration rather than
an exhaustive list.

    As for the comments' reference to Vahouny endpoints, at the 9th
Vahouny Fiber Symposium, nine physiological health effects were
identified: (1) Total/LDL cholesterol; (2) post-prandial glucose and
insulin; (3) increased fecal bulk and laxation; (4) colonic transit
time; (5) blood pressure; (6) colonic fermentation and short chain
fatty acid production; (7) modulation of the colonic microflora; (8)
weight loss, weight maintenance, and reduction in satiety; and (9)
increased satiety (Ref. 136). We agree that lowering total/LDL levels,
lowering post-prandial glucose levels, reducing gut transit time and
improving laxation (fecal output), reduced blood pressure, and
increased satiety associated with reduced energy intake and with
possible associated outcomes on body weight are beneficial to human
health. We consider colonic fermentation and short chain fatty acid
production and modulation of the colonic microflora to be processes
that may be associated with a physiological endpoint, rather than
physiological endpoints themselves.
    (Comment 261) One comment said that requiring added non-digestible
carbohydrates to have a beneficial physiological effect will require
research, and funds to support such research, to demonstrate such an
effect. The comment said this would be a burden to firms who seek to
develop new fibers. Another comment said we should accept the existing
body of evidence as an appropriate demonstration of benefit, in many
cases, without requiring new substantiation for a beneficial ingredient
already in common use.
    (Response) The final rule does not require a firm to demonstrate
that there is a beneficial physiological effect before it can add an
isolated or synthetic non-digestible carbohydrate to a food and declare
it as part of the Total Carbohydrate declaration. We recognize that
firms may develop new fibers and that we may not be aware of all of the
added fibers that a manufacturer may be using as an ingredient in its
products. For example, there may be some fibers that a manufacturer has
self-determined to be GRAS for which we did not receive a GRAS
notification. In addition, isolated or synthetic added fibers may be
approved for use as a food additive. Moreover, even if a manufacturer
self-determines that a fiber is GRAS, or there is a food additive
approval for the fiber, whether the fiber has a beneficial
physiological effect to health is a separate question. Therefore, given
the potential uncertainties and possible inconsistencies in what fibers
may be declared as dietary fiber, we define dietary fiber to include a
listing of isolated or synthetic non-digestible carbohydrate that will
provide a beneficial physiological effect. In this way, there is
transparency in what added fibers are included in the definition that
will assist consumers in maintaining healthy dietary practices and
certainty in what must be declared for compliance purposes.
    Numerous studies have already been conducted on many different
types of isolated or synthetic non-digestible carbohydrates. We
reviewed the publically available studies for various non-digestible
carbohydrates. Based on our review, we found that a number of isolated
or synthetic fibers have a demonstrated beneficial physiological effect
to health (Ref. 137), and we include such fibers in the definition for
dietary fiber (Sec.  101.9(c)(6)(i)). We consider the totality of the
evidence when evaluating the beneficial physiological effect(s) of an
isolated or synthetic non-digestible carbohydrate. We reviewed several
non-digestible carbohydrates for which the publically available
scientific evidence indicated mixed results, or appears to be
insufficient. It is not clear whether there may be additional data or
information concerning the beneficial health effects of these non-
digestible carbohydrates that interested persons have and are not yet
publically available. Therefore, we decline to make a determination on
whether these non-digestible carbohydrates meet the definition of
``dietary fiber'' without first providing an opportunity for comment on
the available scientific evidence for these non-digestible
carbohydrates. We intend to publish a separate notice to seek comment
on the available scientific data on these non-digestible carbohydrates
to determine if we should consider additional non-digestible
carbohydrates to be added to the list of dietary fibers. We also intend
to publish a guidance document on the type of evidence we recommend be
provided and the approach we plan to use to evaluate the beneficial
physiological effect of a non-digestible carbohydrate.
    If a manufacturer wants to add an isolated or synthetic non-
digestible carbohydrate to the listing of fibers in the dietary fiber
definition, it can petition us to amend the definition to include that
fiber in the dietary fiber listing for these types of carbohydrates.
Under Sec.  10.30(b), the citizen petition must include all relevant
information and views on which the petitioner relies, as well as
representative information known to the petitioner which is unfavorable
to the petitioner's position. Thus, any petition to request an
amendment to the definition to include an additional dietary fiber
should include all publically available evidence relevant to the review
about a beneficial effect of the isolated or synthetic added non-
digestible carbohydrate.
    (Comment 262) The proposed definition of dietary fiber would
mention citizen petitions submitted to us pursuant to Sec.  10.30. One
comment said that requiring a citizen petition to seek approval of
currently used fibers will cause disruption in the food supply. The
comment said there could be a backlog of petitions.
    Several comments raised concerns that a review of new fibers that
manufacturers want to include as part of a listing of fibers within the
definition of dietary fiber will result in lag time resulting in
manufacturers dropping the extrinsic fiber they use in products. With a
label compliance period of 2 years, the comments questioned whether we
could review and respond to citizen petitions within this time period
and allow manufacturers to design and secure new packaging. Some
comments said that, once we begin implementing the final rule, the time
for review of subsequent petitions may be unreasonable and that some
added non-digestible carbohydrates that are currently declared as
dietary fiber may have to come off the Nutrition Facts label. The
comments said that a lengthy petition process undermines the overall
purpose to promote the healthful consumption of dietary fibers and that
industry would have to make the other label changes in response to the
final rule without knowing the amount of dietary fiber to declare and
could lose dietary fiber health claims. Some comments said that
premarket review should only apply to those fibers that we did not
identify as dietary fiber. One comment said that we should issue the
guidance document along with the listing of the dietary fibers,
including the commonly used added non-digestible carbohydrates that we
have determined to have a beneficial effect without submission of
formal petitions.
    (Response) We recognize that there may be uncertainty about whether
certain isolated or synthetic non-digestible carbohydrates, currently
in use by manufacturers and declared as dietary fiber, meet the dietary
fiber definition. We proposed to list isolated or synthetic non-
digestible carbohydrates that we have been determined to have a
physiological effect that is beneficial to human health in Sec.
101.9(c)(6)(i), and the final rule includes additional dietary fibers
in the definition based on the review of

publically available evidence (Ref. 137). These reviews identify a
number of isolated or synthetic non-digestible carbohydrates for which
the publically available scientific evidence supports a beneficial
physiological effect to human health.
    With respect to the concern about a possible backlog in petitions,
we did not receive any comment about numbers of specific isolated or
synthetic fibers used as an ingredient in food that would not otherwise
have been included in our review of publically available evidence. Our
review was necessarily limited to the publically available evidence on
such fibers. Therefore, to the extent there are uses of isolated or
synthetic fibers that are specific to a particular manufacturer, we
will need to consider those case-by-case in the context of petition
submitted under Sec.  10.30 and consider the resources needed to
evaluate such requests as we receive them.
    (Comment 263) Several comments said that certain added non-
digestible carbohydrates meet the dietary fiber definition. Some
comments would add psyllium husk to the list of approved fibers and
said that there is a wealth of clinical trial data on inulin which met
the dietary fiber definition based on the 2002 IOM report and that
there were data to support galactooligosaccharides (GOS) as a dietary
fiber.
    Other comments supported the inclusion of bamboo fiber, soy fiber,
pea fiber, wheat fiber, cellulose, cotton seed fiber, sugar cane fiber,
sugar beet fiber, and oat fiber. One comment said that cellulose is
GRAS under a ``prior sanctioned category.''
    (Response) We agree that psyllium husk meets the dietary fiber
definition (Sec.  101.81(c)(2)(B)) and have revised the definition
accordingly. We have reviewed the publicly available scientific
evidence for some of the isolated or synthetic non-digestible
carbohydrates, including cellulose (Ref. 137). Based on our review, we
determined that the scientific evidence supports a showing of a
beneficial physiological effect to human health from the following
fibers: Cellulose, guar gum, pectin, locust bean gum, and
hydroxypropylmethylcellulose. Cellulose was determined to improve bowel
function. Guar gum, pectin, locust bean gum and
hydroxypropylmethylcellulose were determined to lower blood total and/
or LDL cholesterol levels. Therefore, we include these isolated or
synthetic dietary fibers in the final rule's definition of dietary
fiber.
    As for the other carbohydrates mentioned in the comments, the
comments did not provide data on beneficial physiological effects, so
we are unable to conduct a scientific review. However, we intend to
publish a separate notice to seek comment on the available scientific
data on non-digestible carbohydrates to assist us in the review of the
scientific evidence. Publically available clinical trial data will be
identified and summarized for non-digestible carbohydrates, including
inulin, bamboo fiber, soy fiber, pea fiber, wheat fiber, cotton seed
fiber, sugar cane fiber, sugar beet fiber, and oat fiber.
    (Comment 264) Several comments stated that we should provide
guidance to industry on submissions to demonstrate physiological
effects that are beneficial to humans before we issue the final rule so
that meaningful comments can be provided on the process. The comments
said that our failure to provide notice and an opportunity to comment
on a guidance document would violate the Administrative Procedure Act.
Other comments stated that, once we have identified the dietary fibers,
we should reopen the dietary fiber section of the proposed rule for
public comment, including the requirements for defining dietary fiber.
    (Response) We intend to issue guidance concerning the evidence to
submit and our approach to reviewing the science in a request to amend
the dietary fiber definition to support a fiber's beneficial
physiological effect to human health. We do not consider it necessary
to publish the draft guidance before the final rule is published. There
will be an opportunity to submit comments to the guidance, consistent
with our good guidance practices regulation at 21 CFR 10.115.
    To the extent the comment asserts a failure to receive comment on
the draft guidance before the publication of the final rule violates
the Administrative Procedure Act (APA), we disagree. The publication of
a draft guidance document is not a general notice of proposed
rulemaking to which the APA requirements under 5 U.S.C. 553 would
otherwise apply. Furthermore, we provided adequate notice and
opportunity to comment on our proposed definition of dietary fiber and
provided the Codex definition that includes isolated or synthetic non-
digestible carbohydrates that have been shown to have a beneficial
physiological effect to health as demonstrated by generally accepted
scientific evidence to competent authorities (79 FR 11879 at 11909). We
provided examples of beneficial physiological effects (e.g.,
attenuation of blood glucose and cholesterol levels and improved
laxation) and the reference to the IOM reports (Ref. 138) (id.). We
also asked for comment on the IOM definition of dietary and functional
fibers dating back to the 2007 ANPRM (id.). Therefore, we decline to
delay issuance of the final rule as suggested by the comments.
Furthermore, the administrative process for submitting a request to
amend the definition of dietary fiber is in Sec.  10.30. We have not
proposed changes to that regulation in the context of this rulemaking,
and, therefore, comments to Sec.  10.30 are outside the scope of this
rule.
    (Comment 265) Many comments supported the proposed definition of
dietary fiber, but for different reasons. Some comments supported the
proposed definition because, according to the comments, dietary fibers
should show a physiological benefit, and the proposed definition would
facilitate the development of healthier products. Other comments said
the proposed definition aligns with the IOM and Codex definitions for
dietary fiber.
    Several comments, however, asked us for clarification. Some
comments asked us to clarify what we meant by ``intact and intrinsic in
plants'' and ``isolated and synthetic.''
    (Response) Consistent with the IOM fiber report (Ref. 138), we
consider ``intact'' as having no relevant component removed or
destroyed and ``intrinsic'' as originating and included wholly within a
food. Intact and intrinsic fibers are naturally present such that they
are integrated within the plant matrix and contain other nutrients
naturally present in proportions that exist in the plant cell. For
example, brans, which are obtained by grinding, are anatomical layers
of the grain consisting of intact cells and substantial amounts of
starch, protein and other nutrients. Non-digestible carbohydrates that
are created during normal food processing (e.g., cooking, rolling, or
milling) are intrinsic and intact (e.g., non-digestible (resistant)
starch in flaked corn cereal). However, a resistant starch that has
been extracted and isolated from the flaked corn cereal, such that it
is no longer part of the food matrix (intrinsic) and no longer consists
of relevant food components (intact), often with an increased
concentration of non-digestible carbohydrates, would be considered an
isolated non-digestible carbohydrate. The term ``isolated'' is used to
describe isolated non-digestible carbohydrates that are isolated from
plant sources such that they are no longer intrinsic or intact. Some of
these isolated fibers can be further modified. The term ``synthetic''
is used to describe

synthetic non-digestible carbohydrates that are not isolated from plant
sources, but rather chemically synthesized.
    We note that the distinction between ``intrinsic and intact'' and
``isolated or synthetic'' is important because foods that contain
intrinsic and intact fibers include naturally occurring dietary fibers
that contain other nutrients normally found in foods that may be
associated with beneficial physiological effects. Such beneficial
physiological effects, associated with natural dietary fibers, cannot
be assumed to exist when non-digestible carbohydrates are isolated from
foods, and especially when synthesized. We note that the IOM (2002)
cited an earlier IOM report (Ref. 139), which stated that, while
dietary fiber intake is associated with decreased risk or improvements
in several chronic diseases, there is no conclusive evidence that
dietary fiber, rather than the other components of vegetables, fruits,
and cereal products, reduces the risk of those diseases. Furthermore,
the IOM stated that there are many constituents of whole grains, in
addition to dietary fiber, that may reduce the risk of CHD. These
statements emphasize the inherent benefits of intact and intrinsic non-
digestible carbohydrates.
    (Comment 266) Several comments would change ``intact and intrinsic
in plants'' to ``intact or intrinsic.'' The comments said that, without
this change, the definition would exclude almost all fiber ingredients.
    (Response) We disagree with the comment. These two terms
collectively require that the non-digestible carbohydrate is naturally
present such that it is integrated within the plant matrix and contains
other nutrients naturally present in proportions that exist in the
plant cell. These conditions (integration in the plant matrix and
providing proportional nutrients that are present naturally in the
plant cell) are considered to be inherent in the health benefits
associated with naturally occurring dietary fibers. The definition of
dietary fiber includes these intact and intrinsic fibers in addition to
isolated or synthetic fibers that have a beneficial physiological
effect. Therefore, we disagree that the definition of dietary fiber
would ``exclude almost all fiber ingredients'' if we retained
``intrinsic and intact in plants'' in the definition. We decline to
revise the definition as suggested by the comment.
    (Comment 267) One comment suggested changing ``isolated and
synthetic'' to ``isolated or synthetic.''
    (Response) We agree with the comment. Non-digestible carbohydrates
that are added to foods are either isolated from foods or synthesized,
and so we have revised the rule as suggested by the comment.
    (Comment 268) One comment stated that brans, obtained by mechanical
action (grinding), are a layer of grains and therefore should be a
dietary fiber.
    (Response) We agree that brans that are obtained by mechanical
actions are unique and, unlike other fibers subject to mechanical
actions, are intact and intrinsic and therefore meet the dietary fiber
definition. Bran is the hard outer layer of cereal grain and is
obtained by mechanical processing. Bran is rich in dietary fiber, as
well as other nutrients including starch, protein, vitamins, and
minerals. Furthermore, naturally occurring dietary fiber is part of the
matrix in bran. Therefore, dietary fiber in bran is intact and
intrinsic.
    (Comment 269) One comment opposed to the proposed definition of
dietary fiber stated that, as is the case for most dietary components,
the health benefits of dietary fiber have only been studied in clinical
trials in isolated forms rather than in their intrinsic and intact
forms. The comment said it is nearly impossible to separate out any
associated health outcome from other bioactive components within the
food matrix.
    (Response) We agree that the health benefits of non-digestible
carbohydrates have been studied in numerous clinical trials in isolated
forms. These clinical trials have been used to identify those added
non-digestible carbohydrates that meet the dietary fiber definition
(Ref. 137). Fiber-containing fruits, vegetable, and grain products have
been shown to have beneficial health effects via such clinical trials,
as well as observational studies on chronic disease risk (e.g., CHD).
The collective information from such studies has been used to
substantiate the evidence for the relationship between soluble fibers
and CHD risk (e.g., Sec. Sec.  101.77 and 101.81), as well as the
establishment of an AI for dietary fiber (Ref. 36). Thus, the health
benefits of foods that contain naturally occurring dietary fibers have
already been substantiated.
    (Comment 270) Several comments asked us to clarify the meaning of a
``physiological effect that is beneficial to human health.''
    (Response) In the preamble of the proposed rule (79 FR 11879 at
11909), we explained that a regulatory definition for dietary fiber,
such as those consistent with the IOM and Codex, should be one that
emphasizes its physiological effect that is beneficial to human health
to assist consumers in maintaining healthy dietary practices. We also
identified, in the preamble to the proposed rule (id. at 11910),
physiological effects that are beneficial, such as attenuation of blood
glucose and cholesterol levels (i.e., total or LDL). We also would
consider the lowering of blood pressure to be a beneficial
physiological effect. The attenuation/lowering of these biomarkers
(lowering of blood glucose and cholesterol levels and lowering of blood
pressure) are associated with reduced risk of type 2 diabetes or CVD.
Another outcome we consider a beneficial physiological effect is
increased satiety, where an isolated or synthetic non-digestible
carbohydrate is associated with a reduced energy intake. A reduced
energy intake can reduce the risk of being overweight or obese. In
addition, improved laxation and bowel function is a beneficial
physiological effect where an isolated or synthetic non-digestible
carbohydrate shows a reduced intestinal transit time or an increase in
the passage of stools. These outcomes result in an increased rate of
defecation to improve bowel function. Increased absorption of minerals,
such as calcium, are considered to provide beneficial physiological
effects because increased absorption of calcium is associated with
increased bone mineral density which may reduce osteoporosis. For the
purposes of Nutrition Facts labeling, we do not consider processes and
mechanisms (e.g., fermentation) per se as beneficial physiological
effects for determining whether an isolated or synthetic non-digestible
carbohydrate meets the definition of dietary fiber. Fermentation is not
a physiological benefit; rather, it is a process associated with the
digestion of the non-digestible carbohydrate itself. Unless there is
information to support a beneficial physiological effect, such non-
digestible carbohydrates would not assist consumers in maintaining
healthy dietary practices. As stated in the IOM Diet and Health report
(Ref. 139), while dietary fiber intake is associated with decreased
risk or improvements in several chronic diseases, there is no
conclusive evidence that it is dietary fiber, rather than the other
components of vegetables, fruits, and cereal products, that reduces the
risk of those diseases. There are many constituents in whole grains, in
addition to dietary fiber, that may reduce the risk of CHD. Therefore,
unlike the inherent benefits of intact non-digestible carbohydrates,
isolated or synthetic non-digestible carbohydrates must be
independently shown to have physiological health benefits, and not all
such fibers have these types of benefits. One example of a process that
is not considered to be a

beneficial physiological effect is fermentation. Another example is
changes in the microbiota in the large intestine as a result of the
consumption of non-digestible carbohydrates. Physiological effects that
are beneficial (e.g., satiety) may be an outcome of a process, such as
fermentation and changes in the colonic microbiota.
    (Comment 271) One comment said that the food industry will be able
to demonstrate at least one physiological effect for each type of
isolated or synthetic non-digestible carbohydrate and those effects may
be less significant than the benefits from intact fiber. For example,
the comment said, referring to EFSA, reduced post-prandial glycemic
response would apply for all isolated or synthetic non-digestible
carbohydrates (compared to sugar). The comment also said that the
evidence showing that isolated or synthetic non-digestible
carbohydrates are beneficial is often inconsistent and based on poorly
established biomarkers. Thus, according to the comment, added fiber may
have less benefit than its intact counterpart.
    (Response) Without reviewing the evidence on the beneficial
physiological effects of non-digestible carbohydrates, it is premature
for us to state whether or not at least one physiological effect for
each type of isolated or synthetic non-digestible carbohydrate can be
demonstrated. We disagree with the comment, referring to EFSA, that
reduced post-prandial glycemic response would apply for all isolated or
synthetic non-digestible carbohydrates. As an example, EFSA concluded
that a relationship has not been established between acacia gum and
reduced postprandial glycemic response (Ref. 140). While some studies
may have used poorly established biomarkers, our science reviews have
included endpoints that are reliable measurements of physiological
effects (e.g., total and LDL cholesterol levels, and intestinal transit
time and frequency of bowel movements as a measure of laxation) (Ref.
137).
    (Comment 272) One comment said there is an insufficient
understanding of the complex interactions among and between gut
microbiota and the human host. The comment said these interactions are
affected by total fiber intake, but the effects of specific fiber
components can be difficult to define. Another comment said that we
should indicate that the list of beneficial physiological effects is
not exhaustive and is evolving.
    (Response) We agree that scientific knowledge of beneficial
physiological effects to human health is evolving. The physiological
endpoints that we have considered in our science reviews include those
that are supported by the current scientific evidence (Ref. 137). We
recognize that, as the science evolves, the list of dietary fibers in
the definition may change. Thus, our list is not exhaustive.
    (Comment 273) One comment presumed that, based on the proposed
factor of 2 kcal/gram, ``non-digestible carbohydrates'' includes
partially and totally digested carbohydrates. The comment said that,
for this reason, we should define ``non-digestible carbohydrate'' to
mean ``carbohydrates that are partially or totally fermentable by
colonic microflora.''
    (Response) As provided in the IOM fiber report (Ref. 138), ``non-
digestible'' is an adjective that implies a substance is not broken
down to simpler chemical compounds in the living body chiefly through
the action of secretion-containing enzymes such as the saliva and the
gastric, pancreatic, and intestinal juices in the alimentary canal.
Thus, non-digestible carbohydrates are not digested by human enzymes
and pass into the colon where they may or not be fermented by colonic