the Nutrition Facts on packaged foods have been required for nearly 20
years. Moreover, a 2,000-calorie reference value is close to the
midpoint of the range of energy requirements for sedentary adults (76
FR 19192 at 19209).
    We also are retaining information that individual calorie needs may
vary, albeit in shortened form (calorie needs vary). As discussed in
the proposed rule and emphasized by the comments, although 2,000
calories is an appropriate reference value, not everyone should eat
2,000 calories per day (76 FR 19192 at 19210). As a result, a factor
that FDA considered in establishing a succinct statement was whether
the succinct statement should be framed appropriately so that it is not
viewed as a recommendation for daily intake for every consumer because
individual calorie needs vary. For these reasons, we conclude that the
succinct statement should inform consumers that calorie needs vary.
    (Comment 88) Several comments suggested specific revisions to the
succinct statement as follows:
     ``Most adults should eat less than 2,000 calories a day,
or less than 600 calories per meal.'' (A few comments cited New York
State Department of Health focus groups that showed participants
preferred per meal calorie messages over daily calorie messages. The
comments stated that consumers could not calculate the distribution of
a daily calorie budget between meals.)
     ``2,000 calories a day is an estimate of what adults need,
but individual needs vary.''
     ``Consumption of 2,000 calories each day is used as the
basis for general nutrition advice; however, individual daily calorie
needs may be higher or lower.''
     ``The recommended caloric intake for a day varies from
___-- to ___-- for adolescents and adults, from ___-- to ___-- for
school-age children, and from ___-- to ____-- for preschool children
above age 2 years, although diets may vary.''
     ``2,000 calories a day is used for general nutrition
advice, but calorie needs vary.''
     ``A 2,000 calorie daily diet is recommended for most
adults; however, individual needs vary depending on age, gender, and
physical activity.''
     ``To maintain a healthy diet, most adults need no more
than 2,000 calories per day. Caloric needs for most children and less
active adults range from 1,200 to 1,600 calories.'' One comment noted
that this statement reflects a separate range for children and
recommended that the statement with the range for children be on all
menus, not only children's menus.
    (Response 88) We have revised Sec.  101.11(b)(2)(i)(B) to require
that the following succinct statement be posted on menus and menu
boards: 2,000 calories a day is used for general nutrition advice, but
calorie needs vary. Most of the suggested alternatives were variations
of the succinct statement we proposed. The alternative we selected
captures the principles discussed in the proposed rule in a more
concise fashion than the succinct statement that we proposed.
    We disagree that the succinct statement should include the amount
of calories per meal because individuals can choose many different ways
to distribute their caloric intake throughout the day, and simply
dividing the total calories into three meals does not acknowledge this
variation or give consumers flexibility to distribute their own caloric
intake. In addition, section 403(q)(5)(H) of the FD&C Act applies to
standard menu items offered for sale in a variety of covered
establishments, including establishments that do not serve foods that
may constitute meals, such as chain ice cream shops and chain pretzel
vendors.
    We disagree that the succinct statement required on the menu or
menu board should include specific reference calorie intake values or
ranges for different ages or should specify the

types of factors (such as age, gender, and physical activity) that
impact the caloric needs of individuals. Such details are adequately
captured by the phrase ``calorie needs vary'' and would unnecessarily
increase the wordiness of the statement (i.e., make it less
``succinct''). Because the Nutrition Facts label on packaged foods has
been required for nearly 20 years, and the Nutrition Facts uses 2,000
calories as a reference amount, consumers are already familiar with
this single reference amount for daily calorie consumption for
individuals 4 years of age and older. However, as discussed later in
this document (see Comment 90 and Response 90), we are providing for
the optional use of a children's succinct statement on a menu or menu
board targeted to children as a substitute for, or in addition to, the
succinct statement.
    (Comment 89) One comment noted that ``a 2,000 calorie diet'' may be
misleading without the terms ``daily'' or ``per day.'' The comment also
recommended adding a message that calorie content alone is not the only
nutritional factor to consider when choosing a diet for optimal health,
because a focus on calories may incorrectly lead consumers to choose
options that are nutrient poor instead of nutrient rich.
    (Response 89) We agree that the succinct statement should provide
the context that 2,000 calories refers to a daily diet and the succinct
statement we are establishing in the final rule provides this context
by informing consumers that ``2,000 calories a day is used for general
nutrition advice.'' However, we disagree that the succinct statement
should state that calorie content alone is not the only nutritional
factor to consider. Sections 403(q)(5)(H)(ii)(I) and (II) of the FD&C
Act specifically require a covered establishment to disclose the number
of calories contained in standard menu items and post a ``succinct
statement concerning suggested daily caloric intake'' on menus or menu
boards. The succinct statement we are establishing in the final rule
adequately enables consumers to understand, in the context of a total
daily diet, the significance of the calorie information provided on the
menu or menu board, as required by sections 403(q)(5)(H)(ii)(I)(bb) and
(II)(bb) of the FD&C Act. By allowing consumers to compare the caloric
content of a standard menu item to the reference value of 2,000
calories a day, the succinct statement will enable consumers to make
informed and healthful dietary choices and highlight the potential
effects of additional calorie consumption throughout the day.
    Further, as required by sections 403(q)(5)(H)(ii)(III) and (IV) of
the FD&C Act, a covered establishment must also provide, in a written
form and upon consumer request, additional nutrition information, and
post on the menu or menu board a prominent, clear, and conspicuous
statement regarding the availability of this additional nutrition
information. Consumers therefore will have access to additional
nutrition information and are notified of the availability of this
information on the menu or menu board so that they are able to use the
information to make informed and healthful dietary choices.

D. Succinct Statement on Menus Targeted to Children

    (Comment 90) In the proposed rule, we requested comment on whether
we should require a different succinct statement on menus that are
targeted to children (76 FR 19192 at 19210). One comment opposed a
separate succinct statement for children and a few comments recommended
such a statement. One comment recommended a separate children's
succinct statement if there is a separate children's menu. Another
comment recommended a different succinct statement for children's menus
to inform consumers that calorie needs differ because of age, sex, or
activity (the comment stated that calorie needs are about 1,000 to
1,400 calories for 2- to 3-year old children, and can be up to 2,200 to
2,700 calories for 14- to 18-year old active boys).
    The comments suggested the following succinct statements for
children:
     ``Most children 4 to 8 years old need 1,500 calories a
day, or less than 500 calories a meal.''
     ``The daily calorie requirement for children 4 to 8 years
is about 1,500 calories, though individual needs vary.''
     ``Calorie needs for young children range from 1,000 to
2,000 calories per day and vary based on age and physical activity
levels.''
     ``Most children 4 to 8 years old need about 1,500 calories
a day including snacks, or fewer than 500 calories a meal.''
    One comment suggested that we conduct consumer research on the
following succinct statements:
     ``Most children 4 to 8 years old need 1,500 calories a
day, or less than 500 calories a meal. Most children 2 to 3 years old
need 1,200 calories a day, or less than 400 calories a meal.''
     ``Children need smaller food portions than adults. Calorie
needs vary by child. For information on healthy eating, go to
www.choosemyplate.gov.''
     ``Children's calorie needs vary by age and the individual
child's nutrition and health status. Please consult your child's
physician or health care professional.''
    (Response 90) We have revised Sec.  101.11(b)(2)(i)(B) to provide
for the optional use of either of the following children's succinct
statements on menus and menu boards targeted to children as a
substitute for, or in addition to, the succinct statement:
     1,200 to 1,400 calories a day is used for general
nutrition advice for children ages 4 to 8 years, but calorie needs
vary.
     1,200 to 1,400 calories a day is used for general
nutrition advice for children ages 4 to 8 years and 1,400 to 2,000
calories a day for children 9 to 13 years, but calorie needs vary.
    Under Sec.  101.11(b)(2)(i)(B), a covered establishment may use one
of these children's succinct statements on a menu or menu board
targeted to children (e.g., on a standalone children's menu or menu
board, or in the children's section of a general menu or menu board) as
a substitute for, or in addition to, the succinct statement required in
Sec.  101.11(b)(2)(i)(B). To ensure consistency, a covered
establishment that includes a children's succinct statement on a menu
or menu board may only use the children's succinct statements listed in
Sec.  101.11(b)(2)(i)(B). If the covered establishment chooses not to
use the children's succinct statements listed in Sec.
101.11(b)(2)(i)(B), it must use the succinct statement required in
Sec.  101.11(b)(2)(i)(B).
    We realize that many covered establishments offer food selections
that may only be purchased for children under a certain age specified
by the covered establishment (e.g., under 9 years). Some of these
children's food selections are offered on separate children's menus,
while others are included on the general menu or menu board along with
items for all consumers. We have concluded that covered establishments
should have the option of providing a succinct statement more relevant
to children on menus and menu boards that provide food selections
targeted to children. Childhood obesity is an important public health
concern, and a succinct statement specifically targeted to the calorie
needs of children may enable parents and children to make informed
dietary choices.
    We considered whether covered establishments should be required to
provide both the 2,000-calorie succinct statement and an additional
children's succinct statement on menus and menu boards. Sections
403(q)(5)(H)(ii)(I)(bb)

and (II)(bb) of the FD&C Act require that covered establishments post
on menus and menu boards ``a succinct statement concerning suggested
daily caloric intake . . . designed to enable the public to understand,
in the context of a total daily diet, the significance of the [calorie]
information'' provided on menus and menu boards. (Emphasis added.)
Therefore, it is reasonable to interpret these sections to only require
one succinct statement on menus and menu boards, and we are providing
for the optional use by a covered establishment of a children's
succinct statement on menus or menu boards targeted to children.
Accordingly, the rule does not require that a covered establishment
that includes a children's succinct statement on a menu or menu board
targeted to children also include the succinct statement required by
Sec.  101.11(b)(2)(i)(B) on that menu or menu board.
    To develop the children's succinct statement, we used the 2010
Dietary Guidelines as the reference for the estimated calorie needs of
children (Ref. 3). The 2010 Dietary Guidelines are based on the review
of scientific evidence by a committee of scientific experts. The 2010
Dietary Guidelines provide information and advice for choosing a
healthy eating pattern that focuses on nutrient-dense foods and
beverages, and that contributes to achieving and maintaining a healthy
weight. One goal of the 2010 Dietary Guidelines is to aid policymakers
in designing and carrying out nutrition-related programs. As such, the
2010 Dietary Guidelines are well suited to serve as the reference for
the estimated calorie needs of children for the purpose of this rule.
    As the comments noted, there is broad variability in the daily
caloric needs of children, and this variability is captured in table 2-
3 in the 2010 Dietary Guidelines. Table 2-3 reports the estimated
calorie needs per day by age, gender, and physical activity level. The
relevant data and information in table 2-3, which we used to develop
the children's succinct statement, covers four age groups (ages 2 to 3
years, 4 to 8 years, 9 to 13 years, and 14 to 18 years) and three
activity levels (sedentary, moderately active, and active). Male and
female children are grouped together in the group aged 2 to 3 years but
reported separately in the groups aged 4 to 8 years, 9 to 13 years, and
14 to 18 years. Although most comments suggesting specific wording for
the children's succinct statement focused on the calorie needs of
children ages 8 and younger, some covered establishments may offer food
selections targeted to somewhat older children--e.g., for ``kids under
12.'' Therefore, we focused on estimated caloric needs for children
aged 4 to 8 and children aged 9 to 13. We did not focus on the
estimated caloric needs for the youngest age group (aged 2 to 3 years)
and the oldest age group (aged 14 to 18 years). Although one comment
suggested that we include the youngest age group (aged 2 to 3 years),
we considered a number of factors and ultimately decided not to include
the youngest age group (aged 2 to 3 years) and the oldest age group
(aged 14 to 18 years). First, we considered space on menus and menu
boards, the types of standard menu items offered in covered
establishments, and different practices among covered establishments.
Second, we were concerned that a children's succinct statement with
four age groups would cross a reasonable threshold for one of the
principles governing the succinct statement--i.e., that it be succinct.
Third, we concluded that covered establishments might be deterred from
voluntarily posting a children's succinct statement on menus and menu
boards if such statement was not succinct. Fourth, children's menus are
typically not targeted to the youngest and the oldest age groups.
    In developing the specific language of the two options for the
children's succinct statement, we considered the principles that apply
to the succinct statement, the comments, data and information discussed
in the proposed rule, and the wording established in Sec.
101.11(b)(2)(i)(B) for the succinct statement. As with the succinct
statement, we concluded that the children's succinct statement should
be directed to an estimated daily caloric need rather than the amount
of calories per meal.
    In contrast to the succinct statement, which uses a single
reference value (2,000 calories) regardless of age group, we concluded
that the children's succinct statement needed to both reflect a range
of calories and link that range of calories to a specific age group to
adequately enable parents and possibly some children to understand the
significance of the calorie information in the context of their total
daily diet. We focused on estimated caloric needs for sedentary
children and did not focus on additional calories consumed by active
children. This is consistent with our approach to the succinct
statement, where the 2,000 calorie daily diet does not take into
account additional calories consumed by persons such as athletes or
persons with a regular fitness regime. As with the succinct statement,
the children's succinct statement addresses the differential caloric
consumption associated with activity and other factors by informing
consumers that ``calorie needs vary.''
    Table 2-3 in the 2010 Dietary Guidelines reports the same estimated
daily caloric needs for sedentary males and females aged 4 to 8 years
(i.e., 1,200 to 1,400 calories) and, thus, we selected 1,200 to 1,400
calories as the range to include for children aged 4 to 8 years in each
of the two options listed in Sec.  101.11(b)(2)(i)(B) for the
children's succinct statements. Table 2-3 in the 2010 Dietary
Guidelines reports different estimated daily caloric needs for
sedentary males aged 9 to 13 years (i.e., 1,600 to 2,000 calories) and
sedentary females aged 9 to 13 years (i.e., 1,400 to 1,600 calories).
For the option listed in Sec.  101.11(b)(2)(i)(B) for a children's
succinct statement that includes the estimated caloric needs of
children aged 9 to 13 years, we simply reported the range as the lowest
estimated caloric needs for sedentary males and females aged 9 to 13
years (i.e., 1,400 calories for females) and the highest estimated
caloric needs for sedentary males and females aged 9 to 13 years (i.e.,
2,000 calories for males). Thus, the listed option that includes the
group aged 9 to 13 years reports the range of estimated caloric needs
as 1,400 to 2,000 calories.
    (Comment 91) One comment suggested that children's menus may
benefit from a traffic light concept (e.g., green, yellow, and red
signage) that indicates which foods should be eaten more or less
frequently.
    (Response 91) Section 403(q)(5)(H) of the FD&C Act generally
requires covered establishments to provide calorie declarations for
standard menu items on menus, menu boards, and signs adjacent to self-
service food and food on display, and other nutrition information in a
written form. Section 403(q)(5)(H) also requires covered establishments
to post on menus and menu boards a succinct statement concerning daily
caloric intake and a statement regarding the availability of the
written nutrition information. FDA is establishing requirements to
implement only what is specified in section 403(q)(5)(H) of the FD&C
Act and information that is necessary for the efficient enforcement of
such requirements.

E. Requirements for the Succinct Statement To Be Prominent, Clear, and
Conspicuous

    Proposed Sec.  101.11(b)(i)(2)(B)(1) would require that the
succinct statement be posted prominently and in a clear and conspicuous
manner in a type size no

smaller than the smallest calorie declaration appearing on the same
menu or menu board and in the same color or in a color at least as
conspicuous as the calorie declarations and with the same contrasting
background as the calorie declarations. In the proposed rule, we
recognized that some restaurants and similar retail food establishments
may have menu boards that list very few items in very large font. We
asked for comment on whether the succinct statement and statement of
availability should be tied to the type size for some menus that have
few items and that may be listed in large type size (76 FR 19192 at
19211).
    In the following paragraphs, we discuss comments on this proposed
provision. After considering these comments, we are:
     Revising the proposed provision to provide additional
flexibility for the contrasting background of the succinct statement;
     Making a conforming editorial change to the requirement
for the color used for the succinct statement for grammatical
consistency; and
     Making an editorial correction for clarity to insert ``the
type size of'' between ``no smaller than'' and ``the smallest calorie
declaration.''
    (Comment 92) One comment suggested that the size of the succinct
statement be ``no smaller than the menu description or what any
ordinary person can read without any trouble.'' Due to space
limitations on menus, this comment considered that the succinct
statement should not be tied to the type size on menus that list
relatively few items that are listed in very large type size. One
comment asked us to permit a type size smaller than the smallest
calorie declaration appearing on the menu or menu board due to the
limited space on menu boards and the amount of text required to be
included in the statement. Another comment maintained that the succinct
statement takes up too much space and would force covered
establishments to decrease the type size used for calories. A few
comments suggested that we require the succinct statement to be no
smaller than the type size most frequently used throughout the menu and
in the same color and contrast, or in color and contrast at least as
conspicuous and contrasting as the color and contrast most frequently
used throughout the menu for the names of standard menu items.
    (Response 92) We agree, in part, and disagree, in part, with these
comments. As a practical matter, the type size of the succinct
statement would, as requested by the comments, likely be no smaller
than the menu description or what any ordinary person can read without
any trouble, because Sec.  101.11(b)(2)(i)(B)(1) requires that the type
size for the succinct statement be no smaller than the smallest type
size of any calorie declaration and, under Sec.  101.11(b)(2)(i)(A)(1),
the type size of the calorie declaration would be in a type size no
smaller than the type size of the name or the price of the associated
standard menu item, whichever is smaller. Because consumers typically
view the name and/or price of a standard menu item to place an order,
our decision to anchor the type size of the succinct statement to the
type size of information already on the menu or menu board acts, in
essence, as an objective and measurable performance standard and helps
ensure, among other things, that the succinct statement will be clear
and conspicuous to consumers and posted prominently, as required by
sections 403(q)(5)(H)(ii) and 403(f) of the FD&C Act.
    We disagree that the type size, color, and contrast should be tied
to the type size, color, and contrast most frequently used throughout
the menu. Section 101.11(b)(2)(i)(A)(1) provides flexibility for the
type size, color, and contrasting background used for the calorie
declaration (and, accordingly, Sec.  101.11(b)(2)(i)(B)(1) provides
flexibility for the type size, color, and contrasting background used
for the succinct statement), by anchoring these three parameters to the
name or price of standard menu items. The suggestion in this comment
would establish an additional burden for a covered establishment,
particularly when a covered establishment has more than one menu or
menu board, to determine the type size most frequently used. The
comment provided no basis, such as apparent benefit for either the
restaurant or the consumer, to justify this additional burden.
    However, we agree that we should provide additional flexibility for
the contrasting background of the succinct statement by permitting the
statement to be in a background at least as contrasting as that used
for the calorie declarations. Consequently, we have revised Sec.
101.11(b)(2)(i)(B)(1) to do so. We also are making a conforming
editorial change to the grammatical construction of the requirement for
the color used for the succinct statement to match the grammatical
construction of the revised requirement for the contrasting background
used for the succinct statement. With these changes, Sec.
101.11(b)(2)(i)(B)(1) requires that the succinct statement be posted
prominently and in a clear and conspicuous manner in a type size no
smaller than the smallest type size of any calorie declaration
appearing on the same menu or menu board and in the same color or in a
color at least as conspicuous as that used for the calorie
declarations, and with the same contrasting background or a background
at least as contrasting as that used for the calorie declarations
(emphasis added).

F. Placement of the Succinct Statement on Menus and Menu Boards

    For menus, proposed Sec.  101.11(b)(2)(i)(B)(2) would require that
the succinct statement appear on the bottom of each page of the menu.
On menu pages that also bear the statement regarding the availability
of the written nutrition information required in Sec.
101.11(b)(2)(i)(C), proposed Sec.  101.11(b)(2)(i)(B)(2) also would
require that the succinct statement appear directly above the statement
of availability required in Sec.  101.11(b)(2)(i)(C). For menu boards,
proposed Sec.  101.11(b)(2)(i)(B)(3) would require that the succinct
statement appear on the bottom of the menu board, immediately above the
statement of availability required in Sec.  101.11(b)(2)(i)(C).
    In the following paragraphs, we discuss comments on these proposed
provisions. After considering these comments, we have revised the
proposed provisions for placement of the succinct statement to provide
additional flexibility for the succinct statement to appear immediately
above, below, or beside the statement of availability of the written
nutrition information.
    (Comment 93) Several comments agreed with the proposed placement
requirements for the succinct statement. One comment recommended that
covered establishments be permitted to put the succinct statement on a
separate sign near the menu boards because of space constraints.
    (Response 93) We are not revising the rule to allow a covered
establishment to post the succinct statement on a separate sign near a
menu board as suggested by the comment. First, we are concerned that if
a covered establishment were to post the succinct statement on a
separate sign, the statement would not be posted prominently, and
therefore, consumers would not be able to use the statement to
understand, in the context of a total daily diet, the significance of
the calorie information that is provided on the menu board. Second,
this rule provides flexibility regarding posting calorie declarations
and other information on

menus and menu boards, including flexibility regarding the size of the
calorie declarations and placement of the statement of availability of
additional written nutrition information, such that covered
establishments have a number of ways to satisfy the requirements based
on their menus and menu boards and business operations. Lastly,
sections 403(q)(5)(H)(ii)(I)(bb) and (II)(bb) of the FD&C Act require
that covered establishments post the succinct statement on menus and
menu boards prominently and in a clear and conspicuous manner. The
comment's request would be inconsistent with the express requirements
of sections 403(q)(5)(H)(ii)(I)(bb) and (II)(bb) of the FD&C Act. Later
in this document, we discuss the requirements for placement of the
succinct statement on small signs for self-service food and food on
display that may meet the definition of a ``menu'' or ``menu board'' in
section 403(q)(5)(H)(xi) of the FD&C Act, in that such signs are the
primary writings of the establishment from which consumers make order
selections (see the discussion of Sec.  101.11(b)(2)(iii)(B) in section
XVII.G).
    (Comment 94) A few comments expressed concern about the space that
the succinct statement would take on menus and the proposed requirement
that the statement appear on every page, in light of other statements
on menus (such as the advisory statements in our Food Code, footnotes
regarding daily availability of various menu items, and footnotes
referencing ``net weight before cooking''). The comments asserted that
menus would become cluttered. One comment asserted that the message we
want to convey would ``get lost in the noise at the bottom of each
page.'' The comments agreed that the succinct statement should appear
at the bottom of menus and menu boards, but asked us to clarify that it
would appear only once on each menu or menu board and not on each page
or panel. The comments recommended that for menus, the succinct
statement must appear either on the first or last page. One comment
suggested that the succinct statement need only appear on one panel of
the main menu board that is visible at all times to consumers.
    One comment asserted that because space is finite, adding the
required succinct statement to multiple pages of a menu would lead to
removal of ``optional information,'' such as some menu offerings. This
comment expressed concern that menu items, such as seafood dishes, will
be dropped from menus to make room for this additional information to
appear on each page of the menu. The comment noted that the 2010
Dietary Guidelines have outlined the importance of including seafood in
a healthy diet, and that roughly 67 percent of the seafood consumed in
the United States is consumed away from the home.
    (Response 94) We disagree that the succinct statement needs to
appear only once on menus. In particular, we are concerned that for
large multi-paged menus, consumers may not read the entire menu and
instead may turn to a specific section of the menu (e.g., the section
for burgers and sandwiches). Unless the succinct statement is on the
page for that particular section, it is possible that consumers could
miss the succinct statement and therefore be unable to use the
statement ``to understand, in the context of a daily diet, the
significance of the caloric information that is provided on the menu,''
as specified by section 403(q)(5)(H)(I)(bb) of the FD&C Act. Therefore,
in Sec.  101.11(b)(2)(i)(B)(2), we are requiring the succinct statement
to appear on the bottom of each page of the menu.
    However, we agree that the succinct statement needs to appear only
once on a menu board, including a menu board consisting of more than
one panel in one physical location (a multi-paneled menu board). For
the purpose of this rule, we consider such a multi-paneled menu board
to be a single menu board, provided that the entire multi-paneled menu
board is visible to consumers when consumers are placing order
selections for the standard menu items listed on such menu board. A
multi-paneled menu board is different from a menu with multiple pages
because all panels are visible to consumers when they place an order,
regardless of the specific panel containing the menu item the consumer
selects. A succinct statement on a single panel of a multi-paneled
board is likely to be clear and conspicuous to the consumer and posted
prominently, provided that the type size, color, and background of the
succinct statement meet the applicable requirements in Sec.
101.11(b)(2)(i)(B)(1) and the entire multi-paneled menu board is
visible to consumers when consumers are placing order selections for
the standard menu items listed on such menu board.
    Regarding one comment's assertion that requiring the succinct
statement to appear on each page of a menu could lead to the removal
from a menu or menu board of information that a covered establishment
views as optional, we note that a decision to remove ``optional
information'' or to drop certain menu items from menus belongs to the
covered establishment. The succinct statement is necessary on the
bottom of each page of a menu that includes standard menu items and
calorie information because the succinct statement is designed to
enable consumers ``to understand, in the context of a total daily diet,
the significance of the caloric information that is provided on the
menu,'' as required by section 403(q)(5)(H)(I)(bb) of the FD&C Act.
However, we have also considered the space on menus and therefore
provided flexibility where appropriate. For example, in addressing
comments on the statement of availability of written nutrition
information, we concluded that this statement of availability need
appear only once on a menu or menu board. In reaching that conclusion,
we considered the goals of the succinct statement and the statement of
availability, which are different (see the discussion of Sec.
101.11(b)(2)(i)(C) in section XV.C).
    (Comment 95) A few comments maintained that the proposed order of
the succinct statement (i.e., in relation to the statement of
availability of additional written nutrition information) limits
flexibility. The comments asserted that both statements could be just
as clear and conspicuous if they were placed in some other way.
    (Response 95) We agree with the comments, and are providing
flexibility for the placement of the succinct statement in relation to
the statement of availability of the written nutrition information.
Consequently, we have revised Sec.  101.11(b)(2)(i)(B)(2) and
(b)(2)(i)(B)(3) to provide that on menu pages that also bear the
statement of availability and on menu boards, the succinct statement
must appear immediately above, below, or beside the statement of
availability. In addition, as an editorial change for consistency
throughout Sec.  101.11, we have revised the cross-references within
Sec.  101.11(b)(2)(i)(B)(2) and (b)(2)(i)(B)(3) referring to the
statement of availability to read ``the statement required by paragraph
(b)(2)(i)(C) of this section'' (i.e., Sec.  101.11(b)(2)(i)(C)). With
these changes, Sec.  101.11(b)(2)(i)(B)(2) requires that for menus, the
succinct statement must appear on the bottom of each page of the menu.
On menu pages that also bear the statement required by Sec.
101.11(b)(2)(i)(C), the succinct statement must appear immediately
above, below, or beside the statement required by Sec.
101.11(b)(2)(i)(C). In addition, with these changes Sec.
101.11(b)(2)(i)(B)(3) requires that for menu boards, the succinct
statement must appear on the bottom of the menu board, immediately
above, below, or

beside the statement required by Sec.  101.11(b)(2)(i)(C).

XV. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(i)(C)--
Statement That Must Be on Menus and Menu Boards About Availability of
Written Nutrition Information

A. Proposed Wording of the Statement of Availability

    Proposed Sec.  101.11(b)(2)(i)(C) would require the following
statement regarding the availability of the additional written
nutrition information required in Sec.  101.11(b)(3)(i) on all forms of
the menu or menu board: Additional nutrition information available upon
request. In a correction document, we corrected the regulatory
designation of the requirement for the statement of availability to be
Sec.  101.11(b)(2)(ii) rather than Sec.  101.11(b)(3)(i) (76 FR 30050
at 30051).
    One comment supported the wording of the statement of availability
and no comments opposed the wording. We are finalizing the proposed
wording of the statement of availability without change.

B. Requirements for the Statement of Availability To Be Prominent and
Conspicuous

    Proposed Sec.  101.11(b)(2)(i)(C)(1) would require that the
statement of availability be posted prominently and in a clear and
conspicuous manner in a type size no smaller than the smallest calorie
declaration appearing on the same menu or menu board and in the same
color or in a color at least as conspicuous as the caloric
declarations, and with the same contrasting background as the caloric
declarations.
    In the following paragraphs, we discuss comments on this proposed
provision. After considering these comments, we are:
     Revising the proposed provision to provide additional
flexibility for the contrasting background used for the statement of
availability;
     Making a conforming editorial change to the requirement
for the color used for the statement of availability for grammatical
consistency; and
     Making an editorial correction for clarity to insert
``type size of any'' between ``no smaller than the smallest'' and
``calorie declaration.''
    (Comment 96) One comment recommended that the type size of the
statement of availability ``be no smaller than the menu description or
what any ordinary person can read without any trouble.'' Some comments
recommended that we permit a smaller type size for the statement of
availability. A few comments suggested that we require the statement of
availability to be in a type size no smaller than the type size most
frequently used throughout the menu. Some comments suggested that the
statement of availability be in the same color or a color at least as
conspicuous as the color most frequently used throughout the menu for
the names of standard menu items and with the same contrasting
background or a contrasting background at least as contrasting as the
background most frequently used throughout the menu for the names of
standard menu items.
    (Response 96) These comments on the proposed requirements for type
size, color, and contrasting background of the statement of
availability are analogous to certain comments on the proposed
requirements for the succinct statement (see Comment 92), and our
response to these comments is analogous to our response to Comment 92
(see Response 92). Specifically, we disagree that a smaller type size
should be used for the statement of availability for the reasons
discussed in Response 92. We disagree that the type size, color, and
contrasting background of the statement of availability should be tied
to the type size, color, and contrasting background most frequently
used throughout the menu for the names of standard menu items for the
reasons discussed in Response 92. However, we agree that we should
provide additional flexibility for the contrasting background of the
statement of availability by permitting the statement to be in a
background at least as contrasting as that used for the calorie
declarations. Consequently, we have revised Sec.  101.11(b)(2)(i)(C)(1)
to do so. In addition, we are making a conforming editorial change to
the grammatical construction of the requirement used for the color of
the statement of availability to match the grammatical construction of
the revised requirement for the contrasting background used for the
statement of availability. We also are making an editorial correction
for clarity to insert ``type size of any'' between ``no smaller than
the smallest'' and ``calorie declaration.'' With these changes, Sec.
101.11(b)(2)(i)(C)(1) requires that the statement of availability be
posted prominently and in a clear and conspicuous manner in a type size
no smaller than the smallest type size of any calorie declaration
appearing on the same menu or menu board and in the same color or in a
color at least as conspicuous as that used for the caloric
declarations, and with the same contrasting background or a background
at least as contrasting as that used for the caloric declarations.
(Emphasis added.) We conclude that the type size, color, and
contrasting background requirements for the statement of availability
in Sec.  101.11(b)(2)(i)(C)(1) will help ensure that the statement of
availability is prominent, clear, and conspicuous, as required by
sections 403(q)(5)(H)(ii)(IV) and 403(f) of the FD&C Act.

C. Placement of the Statement of Availability

    For menus, proposed Sec.  101.11(b)(2)(i)(C)(2) would require that
the statement of availability appear on the bottom of the first page
with menu items. For menus with more than two pages, it would also
require that the statement of availability appear either at the bottom
of every page with menu items (proposed Sec.
101.11(b)(2)(i)(C)(2)(i)), or at the bottom of only the first page with
menu items, as long as a symbol (e.g., asterisk) clearly referring to
the required statement appearing on the first page of the menu follows
the term `Calories' or `Cal,' where the term first appears on each page
after the page with the statement (proposed Sec.
101.11(b)(2)(i)(C)(2)(ii)). For menu boards, proposed Sec.
101.11(b)(2)(i)(C)(3) would require that the statement of availability
appear on the bottom of the menu board immediately above or below the
succinct statement. In the following paragraphs, we discuss comments on
these proposed provisions. After considering these comments, we are:
     Revising proposed Sec.  101.11(b)(2)(i)(C)(2) to require
that the statement of availability appear on the first page of a menu
with menu items and to delete the proposed provisions that would have
required the statement of availability, or a symbol referring to the
statement of availability, on subsequent menu pages;
     Revising both proposed Sec.  101.11(b)(2)(i)(C)(2) and
(b)(2)(i)(C)(3) to provide that the statement of availability must
appear immediately above, below, or beside the succinct statement; and
     Making additional editorial changes for consistency.
    (Comment 97) Some comments supported the proposed requirements for
placement of the statement of availability. A few comments disagreed
with our proposal that a symbol (e.g., asterisk) can be used to refer
to the statement of availability on the first page, if the statement
does not appear on every page. These comments considered that requiring
the placement

of asterisks on each subsequent page in reference to a disclosure on
the first page with menu items would only confuse a reader who, upon
seeing an asterisk, has been trained since elementary school to look
for the associated footnote at the bottom of the page on which the
asterisk appears.
    A few comments expressed concern about the space that the statement
of availability would take in light of other statements on menus (such
as consumer advisories), and recommended that the statement of
availability appear only once on the menu, either on the first or last
page. The comments agreed that the statement of availability should
appear at the bottom of menus and menu boards, but recommended that we
require that the statement appear only once on menus and menu boards,
and not on each page or panel. One comment recommended that covered
establishments be able to put the statement of availability on a
separate sign near the menu boards.
    (Response 97) We are not revising the rule to allow a covered
establishment to post the statement of availability on a separate sign
near a menu board as suggested by the comment. This comment is
analogous to a comment on the proposed requirements for the placement
of the succinct statement (see Comment 93), and our response to this
comment is analogous to our response to Comment 93 (see Response 93).
Section 403(q)(5)(H)(ii)(IV) of the FD&C Act requires that covered
establishments post a prominent, clear, and conspicuous statement of
availability on menus and menu boards. The comment's request is
inconsistent with the express statutory direction. Later in this
document, we discuss the requirements for placement of the statement of
availability on small signs for self-service food and food on display
that may meet the definition of a ``menu'' or ``menu board'' in section
403(q)(5)(H)(xi) of the FD&C Act, in that such signs are the primary
writings of the establishment from which consumers make order
selections (see the discussion of Sec.  101.11(b)(2)(iii)(B) in section
XVII.G).
    We agree that an asterisk referring to a statement on the first
page of a menu may confuse consumers. We also agree that the statement
of availability only needs to appear on one page of a menu. Unlike the
succinct statement, which is designed to enable the public to
understand the significance of the caloric information in the context
of a total daily diet and is therefore needed on each page of a menu
that includes standard menu items and calorie information, the
statement of availability informs consumers that there is additional
written nutrition information available on the premises of the covered
establishment upon request. We believe that posting the statement of
availability on one page of a menu will be adequate to achieve that
goal. Consequently, we have revised Sec.  101.11(b)(2)(i)(C)(2) to
require that the statement of availability appear on the first page of
a menu with menu items and to delete the proposed provisions that would
have required the statement of availability, or an asterisk referring
to the statement of availability, on subsequent menu pages.
    (Comment 98) A few comments maintained that the proposed order of
the statement of availability in relation to the succinct statement
limits flexibility. The comments contended that both statements would
be just as clear and conspicuous if they were to appear in some other
position such as side by side or in some other place on the page.
    (Response 98) For menu boards, we note that there was an
inconsistency in the proposed rule between the preamble and the
codified regarding the proposed order of the statement of availability
in relation to the succinct statement. According to the preamble, the
statement of availability would have been required to appear
immediately below the succinct statement (76 FR 19192 at 19211), while
in the codified text, proposed Sec.  101.11(b)(2)(i)(C)(3) would
require that the statement of availability appear on the bottom of the
menu board immediately above or below the succinct statement. For both
menus and menu boards, we agree with the comments and are providing
additional flexibility for the placement of the statement of
availability of the written nutrition information in relation to the
succinct statement. We have revised proposed Sec.
101.11(b)(2)(i)(C)(2) and (b)(2)(i)(C)(3) to provide that for menus and
menu boards, the statement of availability must appear immediately
above, below, or beside the succinct statement. For clarity and
consistency, we are specifying the placement of the statement of
availability in Sec.  101.11(b)(2)(i)(C)(2) in relation to the succinct
statement even though proposed Sec.  101.11(b)(2)(i)(C)(2) did not do
so.

XVI. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(ii)--
Nutrition Information That Must Be Made Available in Written Form

A. Required Nutrients

    Proposed Sec.  101.11(b)(2)(ii) would require, in relevant part,
that:
     Certain nutrition information for a standard menu item be
available in written form on the premises of the restaurant or similar
retail food establishment and provided to the customer upon request;
     The nutrition information be presented in the order listed
and using the measurements listed, except as provided in Sec.
101.11(b)(2)(ii)(B);
     Rounding of these nutrients be in compliance with Sec.
101.9(c); and
     Covered establishments include the following nutrition
information in the written form, as specified in Sec.
101.11(b)(2)(ii)(A)(1) through (b)(2)(ii)(A)(11):
    1. Total number of calories derived from any source (cal)
    2. Total number of calories derived from the total fat (fat cal)
    3. Total fat (g)
    4. Saturated fat (g)
    5. Trans fat (g)
    6. Cholesterol (mg)
    7. Sodium (mg)
    8. Total carbohydrate (g)
    9. Dietary fiber (g)
    10. Sugars (g)
    11. Protein (g)
    In the following paragraphs, we discuss comments on this proposed
provision. After considering these comments, we have revised the
provision to:
     Replace the terms ``total number of calories derived from
any source'' and ``total number of calories derived from the total
fat'' with the terms ``total calories'' and ``calories from fat'';
     Provide that covered establishments may use the
abbreviations allowed for Nutrition Facts for certain packaged foods in
Sec.  101.9(j)(13)(ii)(B); and
     Clarify that the information must be provided on the
premises of the ``covered establishment'' rather than the ``restaurant
or similar retail food establishment'' (see the discussion in section
VI.I).
    (Comment 99) One comment suggested that we come up with a standard
list of abbreviations for the nutrients for consistency and consumer
understanding. This comment pointed out that we proposed ``Cal'' as an
abbreviation for calories but did not suggest abbreviations for the
other nutrients.
    (Response 99) We agree with this comment. Providing abbreviations
for the written nutrition information will improve the consistency of
the written nutrition information provided by different covered
establishments. Therefore, we have revised Sec.  101.11(b)(2)(ii) to
provide that covered establishments may use the abbreviations allowed
for Nutrition

Facts for certain packaged foods in Sec.  101.9(j)(13)(ii)(B) for the
nutrient information required to be disclosed in the written nutrition
information under section 403(q)(5)(H)(ii)(III) of the FD&C Act. For
example, a covered establishment may use ``sat fat'' for saturated fat
and ``cholest'' for cholesterol.
    (Comment 100) One comment suggested that ``total number of calories
derived from any source'' (required under section 403(q)(1)(C) of the
FD&C Act) be changed to ``total number of calories,'' which, according
to the comment, is clear and concise.
    (Response 100) We agree with the comment's suggestion that the term
``total number of calories derived from any source'' can be revised to
be more concise. Specifically, we are replacing the term ``total number
of calories derived from any source'' (which had been specified by
section 403(q)(1)(C) of the FD&C Act) with ``total calories.'' This
change is consistent with how the ``total number of calories derived
from any source'' is disclosed in the Nutrition Facts under Sec.
101.9. For consistency, we are making an analogous revision to replace
the term ``total number of calories derived from the total fat'' with
``calories from fat.'' This change is consistent with section
403(q)(1)(C) of the FD&C Act, and the declaration of ``total calories''
and ``calories from fat'' will be consistent with the terms used for
nutrition labeling for packaged food (see Sec.  101.9(c)).
    (Comment 101) Several comments supported the proposed nutrients
that must be listed in the written nutrition information. Some comments
suggested that the written nutrition information also include the
weight in grams of the standard menu item. These comments considered
that the weight of the standard menu item is an important indicator of
portion size and allows consumers to compare similar products more
easily, and that including the weight of the standard menu item would
be consistent with the Nutrition Facts for packaged foods.
    (Response 101) We disagree that we should require that the written
nutrition information include the weight in grams for each standard
menu item. Section 403(q)(5)(H)(ii)(III) of the FD&C Act specifically
requires covered establishments to provide in a written form, available
on the premises of the covered establishment and to the consumer upon
request, the nutrition information required under clauses (C) and (D)
of section 403(q)(1) of the FD&C Act. We are only requiring that
covered establishments provide in the written nutrition information the
nutrition information specified in section 403(q)(5)(H)(ii)(III) of the
FD&C Act, along with trans fat, for standard menu items as usually
prepared and offered for sale, or in the case of standard menu items
that are self-service food or food on display, by displayed food item
or per serving. Although the weight of a standard menu item may give
some indication of portion sizes, it does not necessarily correlate
with how many calories are contained in a food or with what nutrients
are in a food. For example, some foods may weigh less than other
similar foods but have more calories because of the source of the
calories. At this time, we conclude that the written nutrition
information required by Sec.  101.11(b)(2)(ii)(A) will allow consumers
to make comparisons between menu items and help inform their dietary
choices. A covered establishment may voluntarily provide the weight of
the standard menu item in the written nutrition information. We also
note that for some foods, the weight is already provided as part of the
name or description of the standard menu item on the menu or menu
board, e.g., a 10-ounce steak versus a 12-ounce steak.
    (Comment 102) One comment recommended that the written nutrition
information include calcium, potassium, and phosphorus because patients
with kidney disease may have diabetes, hypertension, or both. The
comment suggested that covered establishments give information on the
need to limit these nutrients and to limit sodium.
    (Response 102) We disagree with these comments. Section
403(q)(5)(H)(ii)(III) of the FD&C Act requires in relevant part that
covered establishments provide, in written form, the nutrition
information required under clauses (C) and (D) of section 403(q)(1) of
the FD&C Act. Sections 403(q)(1)(C) and (D) of the FD&C Act do not
require the disclosure of calcium, potassium, and phosphorus in food
labeling. Section 403(q)(5)(H)(vi) of the FD&C Act provides that ``[i]f
the Secretary determines that a nutrient, other than a nutrient
required under [section 403(q)(5)(H)(ii)(III) of the FD&C Act], should
be disclosed for the purpose of providing information to assist
consumers in maintaining healthy dietary practices, the Secretary may
require, by regulation, disclosure of such nutrient in the written form
required under [section 403(q)(5)(H)(ii)(III) of the FD&C Act].''
However, the comment did not provide any supporting information showing
that the disclosure of calcium, potassium, and phosphorus in the
written nutrition information will assist consumers in maintaining
healthy dietary practices. At this time, we conclude that the nutrition
information specified in section 403(q)(5)(H)(ii)(III) of the FD&C Act,
along with trans fat information, is sufficient to assist consumers in
maintaining healthy dietary practices within the context of section
403(q)(5)(H) of the FD&C Act. If we determine that other nutrient
information should be disclosed in the written form required under
section 403(q)(5)(H)(ii)(III) of the FD&C Act, we will make changes to
such requirements as appropriate. We note that consumers who have a
particular disease or health-related condition may be able to use the
written nutrition information to follow advice they have received from
a health care professional concerning dietary practices relevant to
their conditions.
    (Comment 103) One comment asked us to permit voluntary declaration
of micronutrients such as vitamins and minerals.
    (Response 103) We would not object to the voluntary declaration of
vitamins and minerals that may be declared on the Nutrition Facts Label
of a packaged food (see Sec.  101.9(c)(8)(ii)), provided that the
declaration is truthful and not misleading, as required by section
403(a)(1) of the FD&C Act.
    (Comment 104) One comment recommended that if future changes are
made to the Nutrition Facts of packaged foods, then the requirements
for the written nutrition information should be made consistent with
such changes.
    (Response 104) If future changes are made to the requirements
regarding the Nutrition Facts for packaged foods, we will consider
whether changes should also be made to the requirements regarding the
written nutrition information required by this rule.
    (Comment 105) One comment recommended that the nutrient values in
the written nutrition information be reviewed and updated yearly or
when changes are made.
    (Response 105) We agree, in part, and disagree, in part, with this
comment. Under Sec.  101.11(c), a covered establishment must have a
reasonable basis for its nutrient content declarations. Under section
403(a)(1) of the FD&C Act, covered establishments must also ensure that
their nutrient content declarations are truthful and not misleading. To
do so, a covered establishment would need to update the written
nutrition information when certain changes are made, e.g., as a result
of a recipe change that affects the nutrient content of a standard menu
item. However, we see no reason why nutrition information for a
standard

menu item must be updated on a recurring basis (such as yearly) when
there are no changes to the standard menu item or its method of
preparation.
    (Comment 106) One comment recommended that covered establishments
provide references for their nutrient values to consumers on request.
    (Response 106) We are not requiring a covered establishment to
provide supporting references for the nutrient values in its written
nutrition information to consumers upon request. Section 403(q)(5)(H)
of the FD&C Act generally requires covered establishments to provide
calorie and other nutrition information for standard menu items.
Further, as required by section 403(q)(5)(H)(iv) of the FD&C Act, a
covered establishment must have a reasonable basis for its nutrient
content disclosures. Covered establishments must also ensure that their
nutrient content disclosures are truthful and not misleading in
accordance with section 403(a)(1) of the FD&C Act. Section 403(q)(5)(H)
of the FD&C Act does not require that covered establishments provide
supporting references for their nutrient content disclosures to
consumers. However, we would not object if a covered establishment
provides this information voluntarily.
    (Comment 107) Several comments generally agreed that trans fat must
be included with the written nutrition information. Some comments
expressed the view that providing information about trans fat is
warranted because of concern with partially hydrogenated vegetable
oils.
    Comments that opposed including trans fat in the written nutrition
information generally focused on the distinction between ``industrial
trans fat'' (i.e., trans fat chemically manufactured from vegetable
oils) and trans fat naturally occurring in food such as ruminant
animals. Some comments expressed concern that listing such naturally
occurring trans fat in the written nutrition information, particularly
when it is present in small amounts, could lead to problems in States
and localities that have banned the use of trans fat in restaurants, or
could lead consumers to think that a covered establishment is breaking
State or local law. These comments stated that eliminating the
requirement to list trans fat in the written nutrition information, or
limiting the listing for trans fat to industrial trans fat, would
prevent such problems. Other comments expressed the view that the
health effects of naturally occurring trans fat from ruminants may be
different from the health effects of trans fat chemically manufactured
from vegetable oils. Some comments stated that, in Europe, scientists
and regulators have not singled out ruminant trans fat for pejorative
labeling. Some comments stated that naturally occurring trans fats
derived from high fat ruminant animal products (namely, beef and dairy
products) are converted to conjugated linoleic acid, which the comments
reported have been associated with health benefits. These comments
considered that industrial and naturally occurring trans fat should
therefore be distinguished on food nutrition labels and menus to give
consumers a more accurate assessment of nutritional quality.
    (Response 107) We disagree that we should require the declaration
of only ``industrial trans fat'' in the written nutrition information.
For purposes of the current Nutrition Facts label, our regulatory
definitions of nutrients (such as for trans fat, total fat, or
saturated fat) have traditionally been based on chemical definitions.
For example, under Sec.  101.9(c)(2)(ii), the declaration of nutrition
information on the label and in labeling of a food must contain a
statement of the number of grams of trans fat in a serving, defined as
the sum of all unsaturated fatty acids that contain one or more
isolated (i.e., nonconjugated) double bonds in a trans configuration.
Analytically, this definition captures all trans fatty acid isomers
that have isolated bonds, regardless of the origin of the trans fatty
acid. For example, vaccenic acid (one of the most abundant trans fatty
acids in ruminant fat) is included in the chemical definition of trans
fat. Therefore, listing the sum of all unsaturated fatty acids that
contain one or more isolated double bonds in a trans configuration
regardless of the source of such trans fat is consistent with the
requirements for declaring the amount of trans fat in a packaged food
on the label for such food (see Sec.  101.9(c)(2)(ii)). Further, in the
rulemaking to require the declaration of trans fat, we responded to
comments regarding functional or metabolic aspects of trans fatty acids
(e.g., their metabolic transformations to other types of fatty acids)
rather than on their actual chemical structures, including potential
differences between trans fat from industrial sources and trans fat
from ruminant sources. We concluded that we should define trans fat
based on its chemical definition rather than any functional attributes
(68 FR 41434 at 41461, July 11, 2003). The comments provided
insufficient information to overturn the conclusion we previously
reached about declaring trans fat on the label of packaged food.
    We also decline to require the declaration of ``industrial trans
fat'' in the written nutrition information because declaration of
ruminant trans fat may lead inspectors or consumers to believe that
covered establishments are violating State or local requirements in
jurisdictions that ban artificial trans fat. We recognize that, in the
United States, some jurisdictions, such as the State of California
(Ref. 34), New York City (Ref. 35), the City of Baltimore (Ref. 36),
and Montgomery County, Maryland (Ref. 37) have imposed restrictions on
the use of industrial trans fat ingredients in food service
establishments. However, a trans fat declaration of 0.5 grams or more
for a standard menu item in the written nutrition information of a
covered establishment does not necessarily mean that the covered
establishment is violating a State or local requirement that prohibits
industrial trans fat ingredients. So long as such standard menu item
does not contain the restricted trans fat ingredients and is otherwise
in compliance with the applicable State or local trans fat requirement,
a trans fat declaration of 0.5 grams or more for such standard menu
item could mean that the menu item contains a certain amount of
naturally occurring trans fat. States and localities would be able to
continue to enforce requirements restricting artificial trans fat
ingredients relying on the same measures they already use to determine
if establishments under their jurisdiction are using a prohibited
ingredient.
    We also note that we recently published a tentative determination
that partially hydrogenated oils, the source of industrially produced
trans fat, are not generally recognized as safe for any use in food
based on current scientific evidence establishing the health risks
associated with the consumption of trans fat (78 FR 67169, November 8,
2013). If this determination is finalized, we will consider whether the
trans fat requirements of this rule should be amended.

B. Manner of Presentation of the Written Nutrition Information

    Proposed Sec.  101.11(b)(2)(ii) would require, in relevant part,
that the written nutrition information be presented in a clear and
conspicuous manner. We received several comments on this proposed
provision. After considering these comments, we have revised the
provision to specify that the written nutrition information must be
``clear and conspicuous,'' including in a color, type size, and in a
contrasting

background that render the information likely to be read and understood
by the ordinary individual under customary conditions of purchase and
use.
    (Comment 108) One comment supported the proposed requirements that
the written nutrition information be clear and conspicuous. Some
comments asked us to give more guidance on format and on the standard
for the written nutrition information to be presented in a clear and
conspicuous manner--e.g., that it be easy to read, have a large enough
font, have a contrasting background, and not use all capital letters
for the names of standard menu items. One comment recommended that we
include specifications for font size.
    (Response 108) We disagree that we should specify the particular
type size and contrasting background that must be used in the written
nutrition information, and prohibit the use of all capital letters for
the names of standard menu items in the written nutrition information.
Section 403(q)(5)(H)(ii) of the FD&C Act requires covered
establishments to provide the written nutrition information required by
section 403(q)(5)(H)(ii)(III) of the FD&C Act in a clear and
conspicuous manner. As discussed later in this document (see the
discussion of Sec.  101.11(b)(2)(ii)(D) in section XVI.E), we are
providing covered establishments with the flexibility to use different
types of media (e.g., flyers, posters, booklets, kiosks) to provide the
written nutrition information. Whether the written nutrition
information is clear and conspicuous depends on the media through which
a covered establishment chooses to provide the written nutrition
information. For example, a specific type size and contrasting
background may result in written nutrition information that is clear
and conspicuous on a tray liner or brochure, but not on a poster that a
consumer may view from several feet away. Thus, we are not establishing
specific requirements for type size, contrasting background, or use of
capital letters for the written nutrition information so that covered
establishments have the flexibility to provide the written nutrition
information in a clear and conspicuous manner based on the particular
media through which the information is presented.
    However, we agree that some guidance is needed on the requirement
that the written nutrition information be provided in a clear and
conspicuous manner. Section 403(f) of the FD&C Act provides that a food
will be deemed to be misbranded ``[i]f any word, statement, or other
information required by or under authority of this Act to appear on the
label or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements, designs, or
devices, in the labeling) and in such terms as to render it likely to
be read and understood by the ordinary individual under customary
conditions of purchase and use.'' Accordingly, we conclude that in
order for the written nutrition information to be clear and
conspicuous, the information must be presented in a manner that renders
it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use. Specifically, we have revised
Sec.  101.11(b)(2)(ii) to require that the written nutrition
information be presented in a clear and conspicuous manner, including
using a color, type size, and contrasting background that render the
information likely to be read and understood by the ordinary individual
under customary conditions of purchase and use. We are also revising
Sec.  101.11(f) to state that a standard menu item offered for sale in
a covered establishment shall be deemed misbranded under sections
201(n), 403(a), 403(f), and/or 403(q) of the FD&C Act if its label or
labeling is not in conformity with paragraph (b) or (c) of the section.
    (Comment 109) One comment asked us to require that standard menu
items in the written nutrition information be listed in the same order
as they are on menus and menu boards.
    (Response 109) We disagree that we should require covered
establishments to list standard menu items in the written nutrition
information in the same order as on menus and menu boards. The comment
provided no basis for why this particular order of listing standard
menu items is the only order that would be useful to consumers. We are
providing flexibility for a covered establishment to list its standard
menu items in the written nutrition information in a manner that is
best suited to its menu offerings, and conclude that the written
nutrition information can enable consumers to make informed dietary
choices regardless of the order in which the standard menu items are
listed.
    (Comment 110) One comment responded to our request for comment on
whether to require that nutrients that are particularly important for
consumers with obesity and diabetes to monitor in order to maintain
healthy dietary practices (e.g., total calories, total fat, sodium,
sugar) be bolded or placed in a separate table of nutritional content
(76 FR 19192 at 19214-19215). This comment opposed such measures
because doing so would highlight the negative aspects of food even
though the food also has positive nutrients. Another comment supported
the bolding of nutrients of concern to consumers with obesity and
diabetes, such as saturated fat and sodium.
    (Response 110) We disagree that we should decide whether to require
measures for highlighting nutrient declarations important to maintain
healthy dietary practices for consumers with obesity and diabetes based
on a concern that doing so would highlight the ``negative'' aspects of
a menu item even though the menu item also has ``positive'' aspects.
However, we did not receive sufficient information in the comments to
warrant adding a requirement to emphasize certain nutrients, and we are
not requiring such a requirement in this rule. The requirements for the
written nutrition information in Sec.  101.11(b)(2)(ii) make nutrition
information available to consumers in a direct and accessible manner to
enable consumers to make informed and healthful dietary choices.

C. Nutrients in Insignificant Amounts

    Proposed Sec.  101.11(b)(2)(ii)(B) would provide that if a standard
menu item contains insignificant amounts of all the nutrients required
to be disclosed in Sec.  101.11(b)(2)(ii)(A), the establishment is not
required to include nutrition information regarding the standard menu
item in the written form. Proposed Sec.  101.11(b)(2)(ii)(B) would
explain, however, that if the covered establishment makes a nutrient
content claim or health claim, the establishment is required to provide
nutrition information on the nutrient that is the subject of the claim
in accordance with Sec.  101.10. Proposed Sec.  101.11(b)(2)(ii)(B)
would provide that covered establishments may present the written
nutrition information in a simplified format for standard menu items
that contain insignificant amounts of six or more of the required
nutrients and proposed Sec.  101.11(b)(2)(ii)(B)(1) would define what
is an insignificant amount.
    We note that there is an inconsistency regarding the nutrients that
must be included in the simplified format between the preamble
discussion and the regulatory text in proposed Sec.
101.11(b)(2)(ii)(B)(2). In the preamble discussion, we stated: ``In
addition, we are proposing that the simplified format must include
information on the nutrients required in Sec.  101.9(f)(2)(i) and (ii)
(i.e., total calories, total fat, total carbohydrate, protein, and
sodium).'' (76 FR 19192 at 19213). However, proposed Sec.
101.11(b)(2)(ii)(B)(2)

specified that the simplified format must include information on total
carbohydrates, total fat, protein, and sodium, calories from fat, and
any other nutrients identified in Sec.  101.11(b)(2)(ii)(A) that are
present in more than insignificant amounts. Proposed Sec.
101.11(b)(2)(ii)(B)(2) did not specify that the simplified format must
include information on total calories, as we intended. In addition,
proposed Sec.  101.11(b)(2)(ii)(B)(2) did not make it clear that the
simplified format must include calories from fat only if calories from
fat are present in more than insignificant amounts, as would be
consistent with Sec.  101.9(f)(2)(ii). We have revised and
redesignating Sec.  101.11(b)(2)(ii)(B)(2) so that it contains three
separate subparagraphs that more clearly communicate the requirements.
As revised, Sec.  101.11(b)(2)(ii)(B)(2) requires that the simplified
format must include information, in a column, list, or table, on the
nutrients specified in Sec.  101.11(b)(2)(ii)(B)(2)(i) and (ii).
Section 101.11(b)(2)(ii)(B)(2)(i) specifies that the simplified format
must include information on total calories, total fat, total
carbohydrates, protein, and sodium. Section 101.11(b)(2)(ii)(B)(2)(ii)
specifies that the simplified format must include calories from fat and
any other nutrients identified in Sec.  101.11(b)(2)(ii)(A) that are
present in more than insignificant amounts. Section
101.11(b)(2)(ii)(B)(3) specifies that if the simplified format is used,
the statement ``Not a significant source of ____--'' (with the blank
filled in with the names of the nutrients required to be declared in
the written nutrient information and calories from fat that are present
in insignificant amounts) must be included at the bottom of the list of
nutrients.
    In the following paragraphs, we discuss comments on proposed Sec.
101.11(b)(2)(ii)(B)(2). We are finalizing it without change other than
to revise Sec.  101.11(b)(2)(ii)(B)(2) to correct the discrepancy
between the description of the proposed requirement in the preamble and
the regulatory text and to clarify the requirements.
    (Comment 111) One comment recommended that the simplified format we
proposed in Sec.  101.11(b)(2)(ii)(B)(2), when a standard menu item
contains insignificant amounts of more than one-half of the nutrients
required to be declared in the written nutrition information, include
information on fiber. The comment contended that fiber is an important
element in considering the overall nutritional value of a certain food,
both in addressing obesity and diabetes. The comment stated that only
knowing information on the total carbohydrates without information on
the fiber will not allow consumers to make sufficiently healthy choices
or will undermine their intent to do so.
    (Response 111) If a standard menu item has an insignificant amount
of six or more of the required nutrients, the simplified format must
include information on total calories, total fat, total carbohydrates,
protein, and sodium (Sec.  101.11(b)(2)(ii)(B)(2)(i)) as well as
information on calories from fat and any other nutrient that is present
in the food in more than insignificant amounts (Sec.
101.11(b)(2)(ii)(B)(2)(ii)). Thus, if fiber is present in a standard
menu item at a level that is more than insignificant (i.e., one gram or
more), the amount of fiber must appear in the simplified format. On the
other hand, if an insignificant amount of fiber is present in a
standard menu item, the simplified format must disclose this
information through the statement, ``Not a significant source of ____--
'' (with the blank filled in with ``fiber'' since fiber is required to
be declared in the written nutrition information) (Sec.
101.11(b)(2)(ii)(B)(3)). Therefore, the simplified format for the
written nutrition information already must include information on
fiber, and there is no need to revise proposed Sec.
101.11(b)(2)(ii)(B) to include fiber as recommended by the comment.

D. Variable Menu Items

    Proposed Sec.  101.11(b)(2)(ii)(C) would require that, for variable
menu items, the nutrition information listed in Sec.
101.11(b)(2)(ii)(A) must be declared as follows for each size offered
for sale:
    (1) The nutrition information required in Sec.  101.11(b)(2)(ii)(A)
must be declared for the basic preparation of the item and, separately,
for each topping, flavor, or variable component.
    (2) If the calories and other nutrients are the same for different
flavors, varieties, and substitutable components of the combination
meal, each variety, flavor, and substitutable component of the
combination meal is not required to be listed separately. All items
that have the same nutrient levels could be listed together with the
nutrient levels listed only once.
    In the proposed rule, we considered the following options for
providing the nutrition information in the written form for a variable
menu item:
     Option 1. List the nutrition information for each nutrient
in the variable menu item as a range.
     Option 2. List the nutrition information for each
component in the variable menu item (the proposed requirement).
     Option 3. If a standard menu item only has two variations
(e.g. a sandwich with fruit or with fries), provide both numbers for
each nutrient in each option with a forward slash between (e.g., 450/
700). If three or more options are available, provide the range in
calories.
    In the proposed rule, we stated that option 2 provides the consumer
with all the required nutrient information for each flavor or variety
of a variable item, or each component of a combination meal in a format
that facilitates quick comparisons between different menu items (76 FR
19192 at 19213). In the following paragraphs, we discuss comments on
this proposed provision. We are making no changes in response to these
comments.
    However, similar to the specific format requirements we established
for declaring calories on a menu or menu board for toppings listed on a
menu or menu board, where the amount of the topping on the menu item
decreases based on the total number of toppings ordered, we are
establishing in Sec.  101.11(b)(2)(ii)(C)(2) specific format
requirements for providing the written nutrition information for
toppings if the amount of the topping included on the basic preparation
of the menu item decreases based on the total number of toppings
ordered for the menu item (such as is sometimes the case with pizza
toppings). Section 101.11(b)(2)(ii)(C)(2) of the final rule specifies
that if the amount of the topping included on the basic preparation of
the menu item decreases based on the total number of toppings ordered
for the menu item, the nutrients for each topping must be declared as
single values representing the nutrients for each topping when added to
a one-topping menu item, specifying that the nutrient declaration is
for the topping when added to a one-topping menu item. The nutrients
for each topping must also be declared for each size of the menu item
offered for sale, as required by Sec.  101.11(b)(2)(ii)(C). We are
establishing requirements for providing the written nutrition
information for variable menu items offered for sale with the option of
adding toppings, and specifying the format and manner of such nutrient
content disclosures, as required by sections 403(q)(5)(H)(v) and
(x)(II)(bb) of the FD&C Act. Section 101.11(b)(2)(ii)(C)(2) helps
ensure that consumers are given accurate and consistent information
about the nutrient of each topping on a menu item. We would not object
if a covered establishment voluntarily includes a statement on the
written nutrition information explaining how the nutrients per topping
might fluctuate if ordering multiple toppings; for example,

such a statement regarding a pizza pie might say, ``Nutrient values per
topping may decrease as the number of toppings per pizza increases.''
Section 101.11(b)(2)(ii)(C)(2) is therefore consistent with the
requirements for declaring calories for toppings listed on the menu or
menu board, where the amount of the topping on the menu item decreases
based on the total number of toppings ordered.
    Because we added this requirement in Sec.  101.11(b)(2)(ii)(C)(2)
to address the potential variation in nutrient content for each topping
based on the total number of toppings ordered, proposed Sec.
101.11(b)(2)(ii)(C)(2), which allows items that have the same nutrient
values to be listed together with the nutrient values listed only once,
is renumbered for the final rule as Sec.  101.11(b)(2)(ii)(C)(3). We
are replacing the phrase ``substitutable component'' in two places in
the first sentence of Sec.  101.11(b)(2)(ii)(C)(3) with ``variable
component.'' We are making this change for consistency with the term
used in Sec.  101.11(b)(2)(ii)(C)(1). We also are replacing the phrase
``nutrient levels'' in two places in the final sentence of Sec.
101.11(b)(2)(ii)(C)(3) with ``nutrient values.'' We are making this
change for consistency with Sec.  101.11(c), which we have revised to
consistently use the term ``values'' in the requirements for
determination of nutrient content.
    (Comment 112) A few comments supported option 2. Some comments
opposed the use of slashes for different flavors and considered that
slashes would be confusing and unclear because consumers are not used
to nutrition information in restaurants.
    (Response 112) We are retaining Option 2 in the rule for providing
the written nutrition information for variable menu items generally.
Option 2 does not specify the use of the slashes opposed by some
comments.

E. Form of the Written Nutrition Information

    Proposed Sec.  101.11(b)(2)(ii)(D) would permit the written
nutrition information required in Sec.  101.11(b)(2)(ii)(A) to be
provided on a counter card, sign, poster, handout, booklet, loose leaf
binder, or electronic device such as a computer, or in a menu, or in
any other form that similarly permits the written declaration of the
required nutrient content information for all standard menu items.
Proposed Sec.  101.11(b)(2)(ii)(D) would explain that if the written
information is not in a form that can be given to the customer upon
request, it must be readily available in a manner and location on the
premises that allows the customer/consumer to review the written
nutrition information upon request.
    In the proposed rule, we discussed the flexibility provided by
proposed Sec.  101.11(b)(2)(ii)(D) for the written nutrition
information and requested comment on whether we should be more
prescriptive in the format and manner of providing the written
nutrition information in order to ensure they are useful to consumers
(76 FR 19192 at 19214). We also stated that we would not object to the
use of tray liners or wrappers as a means to provide nutrition
information, as long as the tray liners or wrappers are available upon
request to the consumers, and the tray liner or wrapper contains
nutrition information for all standard menu items offered for sale at
the covered establishment (76 FR 19192 at 19214).
    In the following paragraphs, we discuss comments on this proposed
provision. We are finalizing it without change, except for an editorial
change from ``written information'' to ``written nutrition
information'' in the final sentence. With this editorial change, Sec.
101.11(b)(2)(ii)(D) will consistently use the same phrase (``written
nutrition information'').
    (Comment 113) One comment supported our proposal to permit
flexibility in how the written nutrition information would be provided
but questioned the use of wrappers, arguing that it is unlikely that
there would be enough room on a wrapper to list the nutrition
information for all standard menu items in a covered establishment and
to make the information easily readable. Another comment recommended
that Sec.  101.11(b)(2)(ii)(D) specify the media allowed for the
written nutrition information, with a petition and approval process for
alternate media, rather than include a ``catch-all phrase'' such as
``any other form that similarly permits the written declaration of the
required nutrient content information for all standard menu items,''
which was included in proposed Sec.  101.11(b)(2)(ii)(D). Another
comment recommended that we expressly recognize that Nutrition Facts
labels can be used to convey the written nutrition information.
    (Response 113) Section 101.11(b)(2)(ii) specifies that the written
nutrition information must be provided in a clear and conspicuous
manner, including using a color, type size, and contrasting background
that render the information likely to be read and understood by the
ordinary individual under customary conditions of purchase and use. A
covered establishment could use a wrapper if the written nutrition
information for all standard menu items offered for sale at the covered
establishment can be presented in a clear and conspicuous manner on the
wrapper, is available upon request to the consumers, in accordance with
Sec.  101.11(b)(2)(ii), and otherwise complies with the applicable
sections of the FD&C Act and Sec.  101.11(b)(2)(ii). For example, there
may be enough room on a wrapper to include the written nutrition
information for all standard menu items in a clear and conspicuous
manner when a covered establishment offers for sale a small number of
standard menu items.
    In addition, Sec.  101.11(b)(2)(ii) ensures that the written
nutrition information is presented in a clear and conspicuous manner
without prescribing a list of allowed media or the exact format of the
written nutrition information. If we amended Sec.  101.11(b)(2)(ii)(D)
to specify the particular types of media that can be used by covered
establishments to provide the required written nutrition information,
as recommended by one comment, Sec.  101.11(b)(2)(ii)(D) would limit
the types of media that can be used by covered establishments,
including those developed based on technological advancements. Further,
Sec.  101.11(b)(2)(ii) would need to amended every time a covered
establishment sought to use a type of media not specified. Rather than
specify the media allowed for the written nutrition information, we
conclude that the public health goal of this rule would be better
served by providing flexibility to covered establishments to use any
media to provide the written nutrition information in the way that is
best suited to their establishments, as long as the written nutrition
information is available on the premises of the covered establishment
and to the consumer upon request, is clear and conspicuous, and
otherwise complies with the requirements of the applicable sections of
the FD&C Act and Sec.  101.11(b)(2)(ii). Providing such flexibility
satisfies the requirements of section 403(q)(5)(H)(ii)(III) of the FD&C
Act while taking into consideration the varying practices at different
covered establishments. With this flexibility, the petition and
approval process suggested by the comment is unnecessary.
    We agree that Nutrition Facts labels can be used to provide the
written nutrition information required under Sec.  101.11(b)(2)(ii) for
packaged foods, and this rule provides flexibility to do so (see the
discussions of Sec.  101.11(b)(2)(iii)(C) in Response 133, and of Sec.
101.11(c)(1) in section XVIII).
    (Comment 114) Some comments stated that the written nutrition
information should not have to be

provided with carry out menus. The comments recommended that carry out
menus could contain a link to the covered establishment's Internet menu
where the written nutrition information may be found. Another comment
stated that the written nutrition information should be permitted on
Internet menus but not required.
    (Response 114) We agree with the comments stating that the written
nutrition information should not be required with carry out menus. We
are not requiring a specific manner for providing the written nutrition
information, as long as the written nutrition information is available
on the premises of the covered establishment and provided to the
consumer upon request, is disclosed in a clear and conspicuous manner,
and otherwise complies with the applicable sections of the FD&C Act and
Sec.  101.11(b)(2)(ii). If a consumer who orders from a menu such as a
carry out menu or an Internet menu requests the written nutrition
information, the covered establishment must provide the information to
the consumer. For example, if a covered establishment delivers a menu
item to a consumer, the covered establishment could deliver the written
nutrition information with the menu item if the consumer requests the
information. As another example, if a consumer orders from an Internet
menu, a covered establishment could provide the written nutrition
information on its Web site or include a link directing the consumer to
a Web site providing the written nutrition information. Similarly, as
suggested by the comments, a covered establishment could provide a link
on carry out menus that directs consumers to a Web site providing the
written nutrition information. We note that all menus, including carry
out menus, and menu boards must include a prominent, clear, and
conspicuous statement regarding the availability of the written
nutrition information, as required by section 403(q)(5)(H)(ii)(IV) of
the FD&C Act.
    (Comment 115) Some comments recommended that we require that the
written nutrition information be readily available upon request to
consumers before ordering. The comments also recommended that the
information be provided in a manner that allows consumers to compare
the information between different menu items before ordering and
without losing their place in line or having to leave the table. The
comments stated that if the written nutrition information is not in a
form that can be given to the consumer upon request, it must be readily
available in a manner and location on the premises that allows the
consumer to review the written nutrition information when ordering
(i.e., the consumer should be able to see and review both the menu or
menu board and the written nutrition information at the same time). One
comment recommended that the information be provided at the place where
consumers place their orders and not upon request. One comment
recommended that we ensure that all consumers have access to the
information. The comment maintained that information on a poster or on
a computer in a fixed location may not be accessible to the mobility
impaired.
    (Response 115) We decline to require that covered establishments
make the written nutrition information readily available to consumers
where consumers place their orders rather than providing such
information to consumers upon request. Section 403(q)(5)(H)(ii)(III) of
the FD&C Act specifically requires covered establishments to provide
the written nutrition information ``to the consumer upon request.'' In
addition, nothing in Sec.  101.11(b)(2)(ii) would preclude consumers
from requesting the written nutrition information before ordering. We
disagree that the rule must require a format and manner of providing
the written nutrition information that ensures that a consumer who
requests written nutrition information will avoid losing a place in an
ordering line or leaving a table. A covered establishment has
flexibility to use a format (e.g., a poster) that may be readily seen
by consumers even if they do not specifically ask to see it.
    We agree that covered establishments must make the written
nutrition information available to all consumers, including consumers
with mobility impairment, upon request, and must ensure that the
information is presented in a clear and conspicuous manner to all
consumers. Section 101.11(b)(2)(ii)(D) specifically identifies formats
such as on a counter card, sign, poster, handout, booklet, loose leaf
binder, or electronic device such as a computer, or in a menu through
which a covered establishment may provide the written nutrition
information.

XVII. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(iii)--
Requirements for Food That Is Self-Service or on Display

A. Applicability of Sec.  101.11(b)(2)(i) to Food That Is Self-Service
or on Display

    Under sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C
Act, we proposed to establish requirements for the declaration of
calories for standard menu items on menus and menu boards in proposed
Sec.  101.11(b)(2)(i). Under section 403(q)(5)(H)(iii), we proposed to
establish requirements for the declaration of calories for self-service
food and food on display in proposed Sec.  101.11(b)(2)(iii). In the
proposed rule, we tentatively concluded that when self-service foods
and food on display appear on menus or menu boards, the menus or menu
boards must bear the calorie declarations required by sections
403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C Act (76 FR 19192 at
19216). In other words, we tentatively concluded that self-service food
and food on display that appear on a menu or menu board are subject to
both requirements for the declaration of calories--i.e., the
requirements in Sec.  101.11(b)(2)(i) applicable to declaration on a
menu or menu board and the requirements in Sec.  101.11(b)(2)(iii)
applicable to self-service food and food on display.
    (Comment 116) One comment disagreed with our tentative conclusion
that the proposed requirements for calorie declaration of standard menu
items on menus and menu boards (Sec.  101.11(b)(2)(i)(A)) apply to food
on display and self-service food that is also listed on menus and menu
boards. The comment asserted that this tentative conclusion is against
the plain language of section 403(q)(5)(H) of the FD&C Act and that to
require covered establishments to label menu boards and display cases
is unnecessary. The comment asserted that only requiring calorie
labeling on signs adjacent to food on display and self-service food
would provide information at the point of ordering and therefore would
be more consistent with the requirement of section 403(q)(5)(H) of the
FD&C Act that calorie information be provided on menus and menu boards,
as defined in section 403(q)(5)(H)(xi) of the FD&C Act (``the primary
writing of the . . . establishment from which a consumer makes an order
selection'').
    (Response 116) We disagree with this comment. The plain language of
section 403(q)(5)(H)(i) of the FD&C Act provides that ``in the case of
food that is a standard menu item . . . [the covered] establishment
shall disclose the information described in subclauses (ii) and (iii)''
(emphasis added). As discussed in the proposed rule, the word ``and''
between the references to subclause (ii) and subclause (iii) indicates
that for each standard menu item, including self-service food and food
on display, covered establishments must follow the requirements in
section 403(q)(5)(H)(ii) of the FD&C Act as applicable and section
403(q)(5)(H)(iii) of the FD&C Act as applicable. Further,

if Congress had meant for section 403(q)(5)(H)(ii) of the FD&C Act not
to apply to self-service food and food on display, it could have
included an exception for such foods within that section, as it did for
foods described in section 403(q)(5)(H)(vii) of the FD&C Act, but it
did not include such an exception. See e.g., Russello v. U.S., 464 U.S.
16, 23 (1983) (``[W]here Congress includes particular language in one
section of a statute but omits it in another section of the same
[statute], it is generally presumed that Congress acts intentionally
and purposely in the disparate inclusion or exclusion.'') (internal
citations omitted). In addition, a consumer may make his or her order
selection by using information provided on a traditional menu or menu
board or on a sign adjacent to a self-service food or food on display.
Disclosing calorie information for self-service food and food on
display on traditional menus and menu boards, where such menus and menu
boards list self-service food and food on display, and on signs
adjacent to self-service food and food on display would help ensure
that consumers are able to see the calorie declarations before making
order selections and is consistent with the plain language of sections
403(q)(5)(H)(ii) and (iii) of the FD&C Act.
    Therefore, when a self-service food or food on display is listed on
a menu or menu board, the food is subject to both Sec.  101.11(b)(2)(i)
for declaration of calories on menus and menu boards and to Sec.
101.11(b)(2)(iii) for foods on display.

B. Placement of Calories for Self-Service Foods and Foods on Display

    Proposed Sec.  101.11(b)(2)(iii)(A) would require that when a self-
service food or food on display is already accompanied by an individual
sign, adjacent to the food, that provides the food's name, price, or
both, the calories per item or per serving must be provided on the
sign. When a self-service food or food on display is not already
accompanied by an individual sign, adjacent to the food, that provides
the food's name, price, or both, the covered establishment must place a
sign adjacent to each food with the number of calories per serving or
per item in a clear and conspicuous manner.
    In the following paragraphs, we discuss comments on this proposed
provision. After considering these comments, we have revised the
provision to provide more options for the declaration of calories for
self-service food and food on display and to require that if the
individual sign does not already include the serving, the amount of the
serving on which the calories are based must also be provided on the
sign, e.g., ``150 calories per scoop.''
    We also are correcting the introductory text in Sec.
101.11(b)(2)(iii) by inserting a hyphen between ``self'' and
``service.''
    (Comment 117) Several comments supported the requirements in
proposed Sec.  101.11(b)(2)(iii). Some comments recommended that foods
on display be labeled with calorie information regardless of whether
the food is served by the customer or employee. Some comments asked us
to clarify that a calorie declaration is also required for displayed
foods such as pastries and doughnuts at bakeries and ice cream behind a
glass case in an ice cream shop.
    (Response 117) The definition of ``self-service food'' includes
restaurant-type food that is served by the customers themselves, and
the definition of ``foods on display'' includes restaurant-type food
that is visible to the customer before the customer makes a selection.
In general, pastries, donuts, and ice cream on display, such as behind
a glass case, meet the definition of food on display. Under these
definitions, the requirements in proposed Sec.  101.11(b)(2)(iii) apply
to standard menu items that are foods served by the customers
themselves as well as to standard menu items that are foods such as
pastries, donuts, and ice cream that are behind a glass case or in an
ice cream shop and are served by an employee.
    (Comment 118) Some comments requested flexibility to determine the
placement of calorie information that works best for them. Some
comments recommended that the calorie declaration be permitted to be
placed on a single sign, or electronically via kiosks or touch screen
computers, and not on all individual signs. One comment asserted that,
for buffets, the layout and number of items make it difficult to
display signs for hundreds of items without cluttering the space or
obstructing the view. The comment also asserted that customers may
inadvertently move the signs, and therefore, the calorie declaration
should instead appear on counters or in display cases.
    Some comments stated that buffets are unique because foods vary and
change often. For example, according to one comment, a restaurant may
have as many as 175 different menu items in a meal period. One comment
stated that the foods are changed multiple times a day, the items may
change from day to day, and the rotation of foods would create
confusion if the food signs are not accurately changed with each new
menu item.
    One comment stated that the location and size of the food signs are
affected by health and safety regulations because the food signs could
lead to contamination of the food and because food signs adjacent to
heated areas or grills for food items cooked to order could create a
hazard. Moreover, the comment noted that multiple menu items may be
simultaneously prepared to order on open grills. This comment
recommended that these types of restaurants be permitted to place the
calorie information on individual signs adjacent to or in close
proximity to the food by using a variety of options (e.g., sneeze
guards; partition or placard; menu board or placard adjacent to the
buffet with all the items listed with nutrition content; pamphlet
adjacent to the buffet; written or electronically displayed information
using kiosks; tablet computers; or touch screen computers).
    (Response 118) We agree that placing individual signs adjacent to a
self-service food or food on display may pose a hazard in certain
circumstances, such as when there is an open heat source (such as a
grill) in close proximity to the sign that could create a fire hazard.
We also agree that more flexibility is needed for foods that are
constantly being replenished or changed. Therefore, to provide more
flexibility and reduce the potential for a sign used to declare
calories for self-service food or food on display to create a hazard,
we have revised Sec.  101.11(b)(2)(iii)(A) to allow covered
establishments to declare calories for standard menu items that are
self-service or on display, and the serving or unit used to determine
the calorie content (e.g., ``per scoop'' or ``per muffin''), using one
of the following options:
     On a sign, adjacent to and clearly associated with the
corresponding food item;
     On a sign attached to a sneeze guard with the calorie
declaration and the serving or unit used to determine the calorie
content above each specific menu item so that the consumer can clearly
associate the calorie declaration with the standard menu item. For
example, if a buffet has several menu items in the serving display case
including, in particular, a broccoli and cheese casserole, the sign
attached to the sneeze guard right above the broccoli and cheese
casserole may declare the calories, e.g., ``200 calories

per scoop.'' If it is not clear to which food the calorie declaration
and serving or unit refers, then the sign must also include the name of
the food, e.g., ``Broccoli and cheese casserole--200 calories per
scoop;'' or
     On a single sign or placard listing the calorie
declaration for several menu items along with the names of the menu
items, so long as the sign or placard is located where a consumer can
view the name, calorie declaration, and serving or unit of a particular
menu item while the consumer is selecting that item. The sign must list
the names of the menu items along with their corresponding calorie
declarations. For example, for a soup station, the sign or placard must
list all the soups that are available at that station along with each
calorie declaration, e.g., ``chicken noodle soup, 125 calories per
cup,'' ``minestrone soup, 100 calories per cup.'' This sign may be
placed on the wall behind the station, on a sign at the beginning or
end of the station, or at another location so long as the consumer can
read the name, calorie declaration, and serving or unit of a particular
menu item while selecting the menu item.
    Each option, when implemented appropriately, associates the calorie
declaration with the appropriate food on display or self-service food
to help ensure that consumers can see such declarations when making
their selections.
    (Comment 119) In the proposed rule, we stated that placing a
separate sign with calorie information adjacent to a food that is
already accompanied by a sign bearing its name, price, or both, could
make it more difficult for consumers to clearly associate the calorie
information with its corresponding self-service food or food on display
(76 FR 19192 at 19215). We requested comment on whether establishments
that already provide an individual sign identifying each food on
display or self-service food with its name, price, or both should have
the option of providing a separate individual sign for each food on
display or self-service food for the calorie declaration, so long as
the sign with the calorie declaration is adjacent to and clearly
associated with its corresponding food.
    One comment recommended that calories appear on the same sign as
the name or price of the food rather than on a separate sign, because
more than one sign could cause confusion.
    (Response 119) We acknowledge the comment's concern, which mirrored
a concern we raised in the proposed rule. However, in light of the
recommendations in the comments describing the need for more
flexibility in declaring calories for self-service foods and foods on
display, we have concluded that there are a number of ways in which a
covered establishment can comply with section 403(q)(5)(H)(iii) of the
FD&C Act to provide calorie declarations for self-service foods and
foods on display based on the establishment's particular operations,
including the use of a separate sign placed adjacent to a self-service
food or food on display that is clearly associated with the food (see
Comment 118 and Response 118). Therefore, we have revised Sec.
101.11(b)(2)(iii)(A) by removing the sentence requiring that when a
self-service food or food on display is already accompanied by an
individual sign, adjacent to the food, that provides the food's name,
price, or both, the calories per item or per serving must be provided
on the sign. In addition, we have revised Sec.  101.11(b)(2)(iii)(A) by
providing options for a covered establishment to provide calorie
declarations on signs for self-service food and food on display,
including the options described in Response 118. We are making these
changes based on the reasons discussed in Response 118 and because we
recognize that existing individual signs for these foods may be quite
small and either not have enough space for the calorie declaration, or
cause the sign to be so crowded that the calorie declaration may not be
easily read or clear and conspicuous enough for the consumer to read
the information. (See, e.g., the discussions in Comment 126 and
Response 126, and in Comment 127 and Response 127, about the
requirements for type size of the calorie declaration when a self-
service food or food on display is already accompanied by a sign with
the food's name, price, or both.)

C. Declaring Calories ``Per Item'' or ``Per Serving''

    Proposed Sec.  101.11(b)(2)(iii)(A)(1) would specify that for
purposes of Sec.  101.11(b)(2)(iii)(A), ``per item'' means per each
discrete unit offered for sale, for example, a bagel, a slice of pizza,
a muffin, or a multi-serving food such as a whole cake. Proposed Sec.
101.11(b)(2)(iii)(A)(2) would specify that for purposes of Sec.
101.10(b)(2)(iii)(A), ``per serving'' means: (1) Per each common
household measure, e.g., cup, scoop, tablespoon, offered for sale as
dispensed using a serving instrument such as a scoop, ladle, cup, or
measuring spoon; or (2) per unit of weight offered for sale, e.g., per
half pound or pound.
    In the following paragraphs, we discuss comments on these proposed
provisions. After considering these comments, we are:
     Deleting ``a multi-serving food such as a whole cake''
from the list of examples of what the rule means by ``per item.'' As
discussed in section VI.C, the definition of ``restaurant-type food''
established in the rule includes food that is usually eaten on the
premises, while walking away, or soon after arriving at another
location, and whole cakes that are self-service food or food on display
are not likely to meet this definition.
     Providing the options to declare calories ``per serving
instrument'' or ``per common household measure'' in separate
subparagraphs, rather than in the same subparagraph, to emphasize that
these are distinct alternatives for declaration of calories ``per
serving.''
     Revising the examples of what we mean by ``per unit of
weight offered for sale'' to be ``per quarter pound'' or ``per 4
ounces.'' We are making this change because examples of a quarter pound
or 4 ounces are more likely to reflect a serving of self-service food
or food on display.
     Changing Sec.  101.11(b)(2)(iii)(A)(1) and
(b)(2)(iii)(A)(2) to read ``paragraph (b)(2)(iii)(A) of this section''
rather than ``Sec.  101.11(b)(2)(iii)(A)'' to be more consistent with
FDA's general practice. We note that the proposed rule had identified
the cross-reference as ``Sec.  101.10(b)(2)(ii)(A).'' We revised this
to ``Sec.  101.11(b)(2)(iii)(A)'' in the correction document, but did
not identify the format change at that time.
    (Comment 120) One comment suggested that the portion of the
standard menu item used to calculate the calorie content also be
clearly displayed in the same font, color, and size as the item name
and be posted on or next to the available food on display or self-
service food.
    (Response 120) We agree that the serving or unit of a standard menu
item that is a self-service food or food on display used to determine
the calorie content for such food must be included in the calorie
declaration. Without information about the serving or unit of a self-
service food or food on display, the consumer would not be able to
ascertain the calorie content of the amount of food that would be
consumed. This would defeat the purpose of the calorie declaration.
Therefore, we have revised Sec.  101.11(b)(2)(iii)(A) to require that
the calorie declaration for foods on display and self-service food
include the serving or unit on which the calorie content is based. The
requirements in

Sec.  101.11(b)(2)(iii)(A)(3)(ii) for font size and color will apply to
the entire calorie declaration, including the serving or unit used to
determine calorie content. (See the discussion of Sec.
101.11(b)(2)(iii)(A)(3)(ii) in section XVII.E.2.)
    (Comment 121) One comment asked us to allow a covered establishment
to list nutrition information for standard menu items that are self-
service or on display per serving size and requested clarification on
how the RACC would be used in this case. The comment asked us to keep
in mind that many retailers would like to align their calorie
declarations for menu items with serving sizes for packaged food so as
not to have two different serving sizes.
    (Response 121) In Response 65 in section XI, we explained why a
calorie declaration for a multiple-serving standard menu item that is
not self-service or on display must declare ``the number of calories
contained in the standard menu item, as usually prepared and offered
for sale'' instead of per RACC (to the extent that there is a RACC for
such standard menu item). Similarly, we disagree that a calorie
declaration for a standard menu item that is a self-service food or
food on display should be declared per RACC or per serving size used on
packaged food, unless such RACC or serving size is the portion or
serving used by the covered establishment to display or otherwise offer
such standard menu item for sale. Self-service food and food on display
may be portioned differently than a RACC or serving size used on
packaged food. Section 403(q)(5)(H) of the FD&C Act does not require a
covered establishment to prepare and offer standard menu items in
particular sizes or amounts, such as RACCs or serving sizes used on
packaged foods. Instead, section 403(q)(5)(H)(iii) of the FD&C Act
expressly requires covered establishments to disclose the number of
calories for self-service foods and foods on display ``per displayed
food item or per serving.'' Accordingly, a covered establishment may
choose the portion or serving of the food that it offers for sale, and
must base the calorie declaration for a self-service food or food on
display per displayed item (e.g., ``per muffin'') or per serving (e.g.,
``per scoop'') as offered for sale.
    (Comment 122) A few comments expressed concern with portion sizes
and with declaring nutrient values for items that vary in size and
content (e.g., baked potato, chicken breast). Some comments asked for
guidance on serving sizes for calorie declarations pertaining to foods
on display. One comment asked us to clarify that the calories should be
declared per item or serving as offered for sale and not for a portion
of a food item that is smaller than the food offered for sale. For
example, a covered establishment that offers a large muffin for sale
should be required to declare calories per item (i.e., the large
muffin) and should not be permitted to declare calories per serving and
describe the large muffin as containing two servings.
    One comment maintained that calories of foods at salad bars should
be declared per cup and not per serving. Several comments asked us to
require that calories be based on serving utensil sizes where possible.
One comment recommended that we require the same serving size as for
packaged food if no utensil is used. The comment suggested that
calories be declared per cup if tongs are used for lettuce at a salad
bar. The comment suggested that the rule be revised to include:
    (iii) The following must be provided for food that is self-service
or on display.
    ``(1) Calories must be provided for each standard serving size
offered, e.g., each beverage cup size offered for a fountain beverage
dispenser or each container size available for a deli salad.
    (2) For purposes of Sec.  101.10(b)(2)(iii)(A), ``per item''' means
per each discrete unit offered for sale--for example, a bagel, a
muffin, a sandwich, or a multi-serving food, such as a whole cake.
    (3) If the item is not sold as a discrete unit, it can be labeled
per serving. For purposes of Sec.  101.10(b)(2)(iii)(A), ``per
serving''' means:
    (i) Per each scoop or container as dished up using the serving
instrument provided, such as a ladle, cup, or measuring spoon, or per
weight or container-size offered, such as a quarter pound of potato
salad or a container of soup.
    (ii) If the item is not served using a ladle or other measuring
instrument or per container size, the item must be labeled in the
common household measure closest to the Reference Amount Customarily
Consumed (RACC) for that item, e.g., per cup or tablespoon.''
    (Response 122) We agree that a calorie declaration for a self-
service food or food on display per displayed food item should be
declared for the entire item as offered for sale and not based on a
portion of the food item that is smaller than the food item offered for
sale. For example, if a covered establishment offered a muffin for sale
as a self-service food or food on display, the establishment should
declare calories for the entire muffin rather than just a portion of
the muffin (e.g., one-half or one-third of the muffin) because the
entire muffin is the standard menu item offered for sale by the
establishment.
    We also agree with the comment asserting that the rule should be
revised to require that when a self-service food or food on display is
offered for sale per displayed food item, meaning per a discrete unit
offered for sale, such as a bagel, a slice of pizza, or a muffin, the
calorie declaration for such food should be based on the discrete unit
offered for sale rather than another amount. In the proposed rule, we
tentatively concluded that for self-service food or food on display
that is displayed per item, where the item represents one serving, the
calorie declaration should be per item (76 FR 19215). We affirm this
conclusion.
    We also agree with the comment asserting that the rule should be
revised to require that when a self-service food or food on display is
not offered for sale per displayed food item, the calorie declaration
for such food should be based on the serving offered for sale. In the
proposed rule, we tentatively concluded that for self-service food or
food on display that is not displayed per item (e.g., potato salad at a
buffet or ice cream at an ice cream parlor), the calorie declaration
should be per serving (76 FR 19215). We affirm this conclusion.
    For these reasons, we have revised Sec.  101.11(b)(2)(iii)(A) to
further specify that a covered establishment must declare calories for
a self-service food or food on display per displayed food item, or if
the food is not sold in a discrete unit, per serving as offered for
sale. Under Sec.  101.11(b)(2)(iii)(A)(1), ``per displayed food item''
means per each discrete unit offered for sale, for example, a bagel, a
slice of pizza, or a muffin. Accordingly, if a covered establishment
offers a food that is self-service or on display for sale in a discrete
unit, such as a muffin, the establishment would have to declare
calories for the food per such discrete unit offered for sale, and not
based on a different amount.
    As discussed in Response 65 and Response 121, we disagree that the
rule should require that calories for self-service food and food on
display be declared per RACC and, therefore, we are not revising Sec.
101.11(b)(2)(iii)(A)(2) to require that an item that is not served
using a measuring instrument be labeled in the common household measure
closest to the RACC for that item. However, we agree that specifying
that calories for a self-service food or food on display be disclosed
per displayed food item, if applicable, and providing other options to
declare calories ``per serving

instrument'' and ``per common household measure'' in separate
subparagraphs, as suggested by this same commenter, would provide a
clearer framework regarding how calorie declarations must be provided
for self-service foods and foods on display. Therefore, in addition to
the revisions we made to Sec.  101.11(b)(2)(iii)(A)(1) as described
previously, we have revised Sec.  101.11(b)(2)(iii)(A)(2)(i) to specify
that, for the purposes of Sec.  101.11(b)(2)(iii)(A), ``per serving''
means (1) per serving instrument used to dispense the food offered for
sale, provided that the serving instrument dispenses a uniform amount
of the food (e.g., a scoop or ladle); or (2) if a serving instrument
that dispenses a uniform amount of food is not used to dispense the
food, per each common household measure (e.g., cup or tablespoon)
offered for sale or per unit of weight offered for sale (e.g., per
quarter pound or per 4 ounces). As revised, Sec. Sec.
101.11(b)(2)(iii)(A)(1), and (b)(2)(iii)(A)(2)(i) to
(b)(2)(iii)(A)(2)(ii) establish a logical hierarchy for determining how
to declare calories for a self-service food or food on display. For
example, if a covered establishment offered a self-service food for
sale in a discrete unit, such as a muffin, the establishment would have
to declare calories for the muffin as a whole. If the covered
establishment offered another self-service food for sale, but the food
was not offered for sale in a discrete unit, such as pasta salad, the
establishment would have to declare calories for the food ``per
serving'' as defined in Sec.  101.11(b)(2)(iii)(A)(2). Under Sec.
101.11(b)(2)(iii)(A)(2)(i), the covered establishment would have to
declare calories for the pasta salad per serving instrument used to
dispense the pasta salad if the serving instrument dispensed a uniform
amount of the food (e.g., per scoop or ladle). If the covered
establishment used a serving instrument that does not dispense a
uniform amount of the food, such as tongs, declaring calories per that
serving instrument used to dispense the food would not be appropriate
because the calorie declarations would not always be consistent with
the amount of food dispensed, and therefore the covered establishment
would look to the remaining options to declare calories, which include
declaring calories per common household measure or per unit of weight
offered for sale (in Sec.  101.11(b)(2)(iii)(A)(2)(ii)). If a covered
establishment offers food for sale per unit of weight, and the unit of
weight offered for sale is in ounces, then it would be required to
declare calories per ounce (or per some number of ounces)--i.e., using
the same unit of weight (ounces) as the unit of weight offered for
sale.
    We disagree that we should establish specific examples of portion
sizes in the rule or add details such as specifying that a ``container
of soup'' is an appropriate portion size for soup. A covered
establishment has flexibility to establish the portion sizes for
standard menu items offered for sale in such establishment.
    As discussed in section VI.C, the definition of ``restaurant-type
food'' generally covers food that usually is eaten on the premises,
while walking away, or soon after arriving at another location. Foods
(such as whole cakes and deli salads that are sold from a display case
rather than from a salad bar) that are grocery-type items that
consumers usually store for use at a later time or customarily further
prepare would not be included within the meaning of ``restaurant-type
food.'' Thus, we have deleted ``a multi-serving food such as a whole
cake'' from Sec.  101.11(b)(2)(iii)(A)(1). We decline to add ``deli
salad'' as an example in what we mean by ``per serving'' because doing
so could incorrectly imply that a deli salad sold at a deli counter as
a grocery-type item is likely to be covered by the rule. We are adding
Sec.  101.11(b)(2)(iii)(A)(2)(iii) to specify what we mean by ``per
serving'' for self-service beverages--i.e., per total number of fluid
ounces in the cup in which a self-service beverage is served and, if
applicable, the description of the cup size (e.g., ``140 calories per
12 fluid ounces (small)''). See Response 125 in the next section of
this document for an explanation of this new provision.
    (Comment 123) One comment noted that some foods on display are
offered in different flavors or varieties such as ice cream or
doughnuts. The comment asked us to clarify that a covered establishment
may disclose the nutrition information for such items by using a range
per serving (or one of the other options being considered for other
variable menu items).
    (Response 123) A standard menu item on display may meet the
definition for a variable menu item in Sec.  101.11(a) when it is
offered for sale in different flavors, varieties, or combinations, and
is listed on a menu or menu board as a single menu item. When this is
the case, the format requirements for variable menu items in Sec.
101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8) would apply to calories
declared on the menu or menu board. Accordingly, to the extent that
standard menu items on display offered for sale in different flavors or
varieties are listed as single menu items on menus or menu boards, a
covered establishment would be required to declare calories on such
menus and menu boards for such foods using the same methods applicable
to other variable menu items, including ranges, as specified in Sec.
101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8). However, when these
foods are on display, they would also be subject to the requirements of
section 403(q)(5)(H)(iii) of the FD&C Act and Sec.  101.11(b)(2)(iii).
For a standard menu item that is a self-service food or food on
display, section 403(q)(5)(H)(iii) of the FD&C Act requires the covered
establishment to ``place adjacent to each food offered a sign that
lists the calories per displayed food item or per serving'' (emphasis
added). Typically, a standard menu item that is on display is presented
to the consumer as a unique menu item, in that the food is made visible
to the consumer, and the consumer can see what other standard menu
items are available, including other standard menu items that come in
different flavors, varieties, or combinations, such as various muffins
or pastries in a display case. Because these standard menu items
typically are on display in a manner that allows consumers to see each
menu item individually, as well as the other menu items available,
including menu items offered in different flavors or varieties, the way
in which these items are offered for sale is not analogous to standard
menu items that come in different flavors or varieties but are listed
as a single menu item on a menu or menu board. For example, a covered
establishment may offer for sale different flavors of ice cream (e.g.,
vanilla, chocolate, strawberry) in individual containers in a display
case visible to consumers. In this situation, because the consumer can
see each flavor of ice cream offered for sale, the consumer should also
be able to see the number of calories contained for each flavor of ice
cream offered for sale. As a result, the covered establishment would be
required to place a sign adjacent to each flavor of ice cream in the
display case that lists the calories per each individual displayed food
item or per serving in accordance with Sec.  101.11(b)(iii).

D. Declaring Calories ``Per Serving'' for Self-Service Beverages

    In the proposed rule, we discussed the serving size of beverages
following our discussion of the declaration of calories for self-
service food and food on display ``per item'' and ``per serving'' (76
FR 19192 at 19216). We recognized that covered establishments may have
different sizes for beverages that are

listed on the menu as small, medium, and large and stated that we were
considering whether the amount of calories declared should be based on
the number of ounces. In the proposed rule, we anticipated that if we
adopt this view in the final rule, we would not object to the covered
establishment listing the number of ounces as part of the size
declaration, e.g., ``140 calories per 12 ounces (small).'' We requested
and received comment on this issue. After considering these comments,
we are establishing a new provision to specify that, for beverages that
are self-service or on display, ``per serving'' means per total number
of fluid ounces in the cup in which a self-service beverage is served
and, if applicable, the description of the cup size (e.g., ``140
calories per 12 fluid ounces (small)'') (Sec.
101.11(b)(2)(iii)(A)(2)(iv)). As an operational companion to new Sec.
101.11(b)(2)(iii)(A)(2)(iii), we also are establishing a new provision
(Sec.  101.11(b)(2)(iii)(A)(3)(iii)) to require that calorie
declarations for self-service beverages be accompanied by the term
``fluid ounces'' and, if applicable, the description of the cup size
(e.g., ``small,'' ``medium''). (See also Response 129 in section
XVII.E.3 of this document.)
    (Comment 124) One comment noted that the proposed rule did not
address the issue of ice fill for the declaration of calories for