that are for general use, including those placed on the table or on or
behind the counter. (Emphasis added.) As revised, Sec.
101.11(b)(1)(ii) includes condiments placed ``on'' the counter in
accordance with section 403(q)(5)(H)(vii)(I)(aa) of the FD&C Act and in
order to take into account varying business practices.
    We disagree that the exemption for condiments should include only
those self-serve items that are calorie free or that have a Nutrition
Facts label. The exemptions under Sec.  101.11(b)(1)(ii) are based on
the language of section 403(q)(5)(H)(vii) of the FD&C Act. Section
403(q)(5)(H)(vii) of the FD&C Act generally provides that the nutrition
labeling requirements of section 403(q)(5)(H) of the FD&C Act do not
apply to certain foods, including certain condiments. Section
403(q)(5)(H)(vii) of the FD&C Act does not qualify such exemptions
based on the caloric content of the food or the fact that some food
would be available in packaged form that provides a Nutrition Facts
label.

However, we note that under Sec.  101.11(b)(2)(iii)(C), a covered
establishment would not be required to provide the written nutrition
information required by section 403(q)(5)(H)(ii)(III) of the FD&C Act
and Sec.  101.11(b)(2)(ii) for a self-service food or food on display
that is a packaged food insofar as it bears nutrition labeling
information required by and in accordance with Sec.  101.11(b)(2)(ii)
and the packaged food, including its label, can be examined by a
consumer before purchasing the food.
    We also note that spices and seasonings (such as crushed dried
peppers) are considered condiments that are exempt from the
requirements of section 403(q)(5)(H) of the FD&C Act under section
403(q)(5)(H)(vii)(I)(aa) of the FD&C Act, provided that they are for
general use by customers regardless of their particular order
selection.

D. Daily Specials, Temporary Menu Items, Custom Orders, and Food That
Is Part of a Customary Market Test

    (Comment 61) Several comments agreed with the proposed exemption
for daily specials. One comment disagreed with the proposed exemption
because the burden to calculate the calories and other nutrition
information is not so great for daily specials to justify this
exemption. The comment maintained that consumers often buy what is on
sale and that excluding daily specials from the requirements of section
403(q)(5)(H) of the FD&C Act would undermine the purpose of the
statute.
    One comment opposed the proposed exemption for temporary menu items
because temporary menu items represent a large portion of what is
ordered on a single day at some establishments.
    Several comments agreed with the proposed exemption for food that
is part of a customary market test. One comment opposed the proposed
exemption because chain restaurants test market their menu items
carefully before they mass market menu items and the determination of
the nutrient content should be part of that process. The comment
asserted that disclosing the calorie content of the food may impact the
consumer's decision to purchase the food and may impact the
establishment's decision whether to include that food on the regular
menu.
    (Response 61) We are retaining in Sec.  101.11(b)(1)(ii) the
exemptions for daily specials, temporary menu items, custom orders, and
food that is part of a customary market test. Section 403(q)(5)(H)(vii)
of the FD&C Act specifically exempts such items from the requirements
of section 403(q)(5)(H) of the FD&C Act regardless of the factors
identified by the comments, such as how the burden to calculate
calories for these items compares to the burden to calculate calories
for standard menu items; the tendency of consumers to buy what is on
sale; and whether a chain restaurant could determine nutrition
information.
    Section 403(q)(5)(H)(vii) of the FD&C Act generally provides that
the nutrition labeling requirements of section 403(q)(5)(H) of the FD&C
Act do not apply to certain foods, including daily specials, temporary
menu items appearing on the menu for less than 60 days per calendar
year, custom orders, and food that is part of a customary market test
appearing on the menu for less than 90 days under terms and conditions
established by FDA. Accordingly, Sec.  101.11(b)(1)(ii) provides that
the labeling requirements of Sec.  101.11(b) do not apply to such foods
and Sec.  101.11(a) defines the terms for such foods. We note that, as
discussed in Response 62, self-service food and food on display that
are temporary menu items or part of a customary market test, but do not
appear on a menu, are also exempt from the requirements of section
403(q)(5)(H) of the FD&C Act because these foods are not standard menu
items.
    However, neither section 403(q)(5)(H) of the FD&C Act nor this rule
would prevent a covered establishment from voluntarily declaring
calories or providing written nutrition information for condiments,
daily specials, temporary menu items, or food that is part of a
customary market test.
    Regarding daily specials, we note that we would not consider an
item that is offered every week on a particular day (e.g., the Monday
special) to be a ``daily special'' because it is being routinely
offered for sale (i.e., every Monday). In addition, we would not
consider a standard menu item, as defined in this rule, to be a ``daily
special'' if it is offered at a discounted price on a particular day
(e.g., a turkey club sandwich that is a standard menu item and normally
costs 5 dollars, but is specially advertised as costing only 4 dollars
on Fridays).
    (Comment 62) In the proposed rule (76 FR 19192 at 19205), we noted
that self-service food and food on display that do not appear on menus
or menu boards would not be considered temporary menu items or food
that is part of a customary market test. Therefore, even if a self-
service food or food on display that does not appear on a menu or menu
board is only offered by a covered establishment for a limited time,
such as a pumpkin spice muffin available only in November, we
tentatively concluded that the nutrition information declaration
requirements in section 403(q)(5)(H) of the FD&C Act would still apply.
    Several comments that addressed the exemption in proposed Sec.
101.11(b)(1)(ii) for temporary menu items and food that is part of a
customary market test considered that this exemption should apply to
self-service food and food on display even though such foods may not
``appear[ ] on a menu'' as described in section 403(q)(5)(H)(vii) of
the FD&C Act. These comments said that Congress excluded temporary menu
items and customary market test items from the nutrition labeling
requirements of section 403(q)(5)(H) of the FD&C Act because it
recognized that restaurants should be able to test products (many of
which fail and are discontinued quickly) without incurring the
significant costs associated with changing their menu and compiling
nutritional information. The comments considered that this same
reasoning applies to temporary menu items and customary market test
items offered in self-service restaurants (whether the restaurant
displays items on a menu, menu board, or individual signs). The
comments asserted that for buffet-type restaurants, there would be
significant costs in attempting to improve and change their menus for
temporary menu items and food that is being market tested and that
these costs would not be incurred by other kinds of non-buffet-type
restaurants.
    (Response 62) We agree with these comments that the statutory
exemptions for temporary menu items appearing on the menu for less than
60 days per calendar year and customary market test items appearing on
the menu for less than 90 days apply to self-service foods and foods on
display that fall into those categories, as defined in Sec.  101.11(a).
We also agree that a self-service food and food on display that does
not appear on a menu or menu board but otherwise meets the definition
for temporary menu items or food that is part of a customary market, in
that the food is offered for sale in a covered establishment for less
than a total of 60 days per calendar year or fewer than 90 consecutive
days in order to test consumer acceptance, should not be required to
comply with the requirements of section 403(q)(5)(H) of the FD&C Act
and Sec.  101.11. The requirements of section 403(q)(5)(H) of the FD&C
Act and Sec.  101.11 apply to foods that are standard menu items.
However, self-service foods and foods on display that do not appear on
a menu or menu board, but otherwise meet the definitions for temporary
menu items or

food that is part of customary market test, along with the foods
described in section 403(q)(5)(H)(vii) of the FD&C Act, do not meet the
definition for a standard menu item in Sec.  101.11(a) because such
self-service foods and foods on display are neither ``routinely
included on a menu or menu board'' nor ``routinely offered as a self-
service food or food on display.'' Like temporary menu items or food
that is part of a customary market test appearing on a menu or menu
board, as described in section 403(q)(5)(H)(vii) of the FD&C Act, self-
service foods and foods on display that do not appear on a menu or menu
board but otherwise meet the definitions for temporary menu items or
food that is part of a customary market are offered for a limited time
and are subject to variation and discontinuation depending on the
seasonality and consumer response. Thus, these foods, like the foods
described in section 403(q)(5)(H)(vii) of the FD&C Act, are not
standard menu items and the requirements of this rule do not apply to
such foods.
    For these reasons, we are modifying Sec.  101.11(b)(1)(ii)(A).
First, we are specifying in Sec.  101.11(b)(1)(ii)(A) that the labeling
requirements in paragraph (b) do not apply to foods that are not
standard menu items. Second, we are specifying in Sec.
101.11(b)(1)(ii)(A)(1) that such foods that are not standard menu items
include items such as condiments that are for general use, including
those placed on the table or on or behind the counter; daily specials;
temporary menu items; custom orders; and food that is part of a
customary market test. Third, we are specifying in Sec.
101.11(b)(1)(ii)(A)(2) that such foods that are not standard menu items
also include self-service food and food on display that is offered for
sale for less than a total of 60 days per calendar year or fewer than
90 consecutive days in order to test consumer acceptance.

E. Additional Comments on Food That Is Part of a Customary Market Test

    (Comment 63) Some comments asked us to clarify that if a food is
tested in more than one location, the 90-day period is applied to each
location. These comments maintained that it is common for restaurants
and similar retail food establishments to conduct iterative tests to
evaluate the performance of a menu item and change the menu in light of
test results. For example, the results of iterative tests may lead to
``changes in product makeup, including size, shape, taste profile, and
preparation,'' with accompanying changes to the underlying nutrient
content. The comment asked us to clarify that a food that changes in
such a manner during a market test is a new food, and the 90-day period
would begin again. One comment asked us to confirm that a market test
may be conducted in multiple locations and that the 90-day period
starts when the testing begins in a particular location.
    (Response 63) As we discussed in the proposed rule (76 FR 19192 at
19205) and as suggested by the comments, in some cases, a chain of
restaurants and similar retail food establishments may test a new
product in different locations within the chain and in more than one
region of the country at different times. We conclude that a
``customary market test,'' for the purposes of Sec.  101.11, refers to
a test in a single covered establishment. Therefore, we agree with the
comments that the 90-day period for the food that is part of a
customary market test applies to each covered establishment that offers
for sale food that is part of a customary market test.
    Further, we recognize that restaurants and similar retail food
establishments may change the foods that they are market testing in an
iterative process. Therefore, we agree that if a food changes in ways
such as those noted in the comments (e.g., changes in product makeup,
including size, shape, taste profile, and preparation), it would be a
new food and the 90-day period would begin again. We would consider the
food to be a new food if it is not made with the same general recipe or
same ingredients or otherwise has a significant change in the nutrient
profile during the market test. For example, we would consider a soup
prepared without meat, and a soup prepared with added sausage, to be
different foods and would expect differences between the nutrient
profiles of these different foods.

XI. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(i)(A)(1)
to (b)(2)(i)(A)(3)--General Requirements for Calorie Declaration on
Menus and Menu Boards

    Proposed Sec.  101.11(b)(2)(i)(A)(1) to (b)(2)(i)(A)(3) would
require that covered establishments declare the number of calories
contained in each standard menu item listed on the menu or menu board,
as usually prepared and offered for sale in the following manner:
     The number of calories must be listed adjacent to the name
or the price of the associated standard menu item, in a type size no
smaller than the name or the price of the associated standard menu
item, whichever is smaller, in the same color, or a color at least as
conspicuous as the name of the associated standard menu item, and with
the same contrasting background as the name of the associated standard
menu item (proposed Sec.  101.11(b)(2)(i)(A)(1)).
     The calories must be declared to the nearest 5-calorie
increment up to and including 50 calories and to the nearest 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero (proposed Sec.  101.11(b)(2)(i)(A)(2)).
     The term ``Calories'' or ``Cal'' must appear as a heading
above a column listing the number of calories for each standard menu
item or adjacent to the number of calories for each standard menu item.
If the term ``Calories'' or ``Cal'' appears as a heading above a column
of calorie declarations, the term must be in a type size no smaller
than the smallest type size of the name or price of any menu item on
that menu or menu board in the same color or a color at least as
conspicuous as that name or price and in the same contrasting
background as that name or price. If the term ``Calories'' or ``Cal''
appears adjacent to the number of calories for the standard menu item,
the term ``Calories'' or ``Cal'' must appear in the same type size and
in the same color and contrasting background as the number of calories
(proposed Sec.  101.11(b)(2)(i)(A)(3)).
    In the following paragraphs, we discuss comments on these proposed
provisions. After considering the comments, we are:
     Revising Sec.  101.11(b)(2)(i)(A) to specify that in the
case of multiple-serving standard menu items, the calorie declaration
must be for the whole menu item as listed on the menu or menu board, as
usually prepared and offered for sale (e.g., ``pizza pie: 1600
calories''), or per discrete serving unit as long as the discrete
serving unit (e.g., pizza slice) and total number of discrete serving
units are declared on the menu or menu board, and the menu item is
usually prepared and offered for sale divided in discrete serving units
(e.g., ``pizza pie: 200 cal/slice, 8 slices'').
     Revising Sec.  101.11(b)(2)(i)(A)(1) to provide additional
flexibility for the contrasting background used for the calorie
declaration;
     Making a conforming editorial change to the requirement
for the color used for the calorie declaration for grammatical
consistency; and
     Making an editorial correction for clarity to insert ``the
type size of'' between ``no smaller than'' and ``the name or the
price'' in Sec.  101.11(b)(2)(i)(A)(1).
    (Comment 64) Many comments regarding the proposed requirement that
the number of calories contained in each standard menu item listed on
the

menu or menu board be declared as usually prepared and offered for sale
addressed the discussion in the proposed rule regarding how the calorie
labeling requirements on menus and menu boards would apply to multiple-
serving foods that are standard menu items (76 FR 19192 at 19203-
19204). Many comments agreed with the view we expressed in the proposed
rule that section 403(q)(5)(H) of the FD&C Act requires that calories
be declared for standard menu items regardless of how many servings are
included in the item (76 FR 19192 at 19203). The comments asserted that
servings vary by product and by portions taken by consumers. One
comment considered that if a menu item is to be shared, it would be
easier for consumers to determine how many people will share the item
and divide the calories accordingly than for the restaurant to choose
how many servings are in a menu item. The comment said that we should
not allow restaurants to choose how many servings are in a menu item.
    Many other comments opposed listing the calories for the entire
standard menu item and instead supported the listing of calories per
serving. Some comments asserted that listing calories per serving would
be less confusing, would be consistent with calorie declarations on
packaged food, and would not require consumers to do a calculation. One
comment agreed with our determination that a multiple-serving food is a
standard menu item but disagreed with our tentative conclusion that the
calorie declaration should be for the entire multiple-serving food
because providing calories for the entire multiple-serving food would
not be helpful and would be detrimental for those who need the
information per serving (e.g., diabetics). A few comments asked us to
provide an option to permit either the declaration of calories for the
entire multiple-serving menu item, or the declaration of the number of
servings and the calories per serving. As an example, one comment
suggested that a restaurant selling a four-serving family-style platter
of pasta could comply either by disclosing that the whole menu item
contains 2,000 calories, or by disclosing that the menu item consists
of 4 servings, 500 calories per serving.
    One comment pointed out that if we required calorie declaration for
an entire multiple-serving food, nutrition information would be
inconsistent in some instances. For example, a cheesecake from a
display case would have different nutrition information than the same
cheesecake in prepackaged form, because the first would list calories
for the entire item whereas the second would list calories per serving.
One comment suggested that, for foods that are not appetizers or
desserts that are intended to serve more than one person, calorie
disclosure should include the number of persons intended to be served
and the calorie content per serving.
    A few comments recommended that calories for pizza be listed per
slice. One comment reported that it received complaints when it
provided calorie information for the entire listed pizza. The comment
provided a report of consumer research showing that 60 percent of
consumers preferred calorie information per slice. The report of this
survey was submitted with the comment (Ref. 32). Some comments referred
to our previous statements that nutrition information should be
declared per serving. For example, in our proposed rule on ``Food
Labeling: Serving Sizes,'' we stated that for ``[f]oods in large
discrete units,'' ``the household measure most meaningful for these
products is a fraction of the whole unit.'' (56 FR 60394 at 60410,
November 27, 1991). Another comment referred to statements in our 2008
``Guidance for Industry: A Labeling Guide for Restaurants and Other
Retail Establishments Selling Away-From-Home Foods (the 2008 restaurant
labeling guide) (Ref. 10) that generally the nutrition information
should be presented on a per serving basis. For example, the 2008
restaurant labeling guide states that ``[i]t is especially important
that the basis be declared when a food is available in more than one
size serving (e.g., pizza that is available whole and by slice). . . .
The restaurant may provide additional information, such as `8 slices
per medium 16-inch pizza, 1 slice contains . . .' to help consumers put
nutrition information in context.''
    Other comments urged us to clarify that a covered establishment can
voluntarily provide nutrition information per serving. These comments
suggested that we revise the rule to indicate that fact. These comments
suggested adding the following to Sec.  101.11(b)(2)(i)(A): ``(5) For
items that could serve more than one person, such as a large pizza or a
bucket of chicken, calories must be listed per standard menu item as
offered for sale and listed on the menu or menu board or as placed on
display. In addition, restaurants and similar retail food
establishments may also voluntarily provide nutrition information per
serving.''
    (Response 64) Listing calories for multiple-serving standard menu
items as usually prepared and offered for sale by a covered
establishment is consistent with section 403(q)(5)(H) of the FD&C Act.
As discussed in the proposed rule, section 403(q)(5)(H) of the FD&C Act
requires covered establishments to disclose calorie information for
standard menu items as usually prepared and offered for sale,
regardless of how many servings are included in the menu item (76 FR
19192 at 19203).
    Based on the comments that supported calorie declarations for
multiple-serving standard menu items ``per serving,'' the complexity of
consumer eating habits and preferences described by the comments, and
the variety of ways that covered establishments may choose to usually
prepare and offer their foods for sale, we have revised the rule's
calorie declaration requirements for multiple-serving standard menu
items on menus and menu boards.
    Where a multiple-serving standard menu item is usually prepared and
offered for sale divided in discrete serving units (e.g., slices of
pizza), we are allowing covered establishments to provide the calorie
declaration per discrete serving unit, subject to some additional
requirements. If a covered establishment declares calories for a
multiple-serving standard menu item per discrete serving unit, the
establishment must also declare the discrete serving unit and the total
number of discrete serving units in the menu item on the menu or menu
board so that the consumer can make a fully-informed decision before
selecting the item.
    We are allowing calorie declarations per discrete serving unit for
multiple-serving standard menu items that are usually prepared and
offered for sale divided in discrete serving units because such
division will likely enable consumers to easily identify the discrete
serving unit (e.g., pizza slice) and therefore keep track of the number
of serving units consumed. Pizza slices that come in a pie, or
breadsticks that come in a bunch (e.g., ``pizza pie: 200 cal/slice, 8
slices;'' ``breadsticks: 150 cal/stick, 5 sticks'') are examples of
multiple-serving standard menu items that are usually prepared and
offered for sale divided in discrete serving units. If consumers share
such a menu item, the discrete serving units provide a distinct
division along which portions can be divided, thereby allowing
consumers to keep track of calories consumed by either adding or
multiplying the per discrete serving unit calorie declaration based on
the number of serving units consumed. Providing the number of calories
per discrete serving unit and the total number of discrete serving unit
contained in the menu item for

multiple-serving standard menu items that are usually prepared and
offered for sale divided in discrete units enables consumers to
determine the number of calories they may actually consume and
therefore enables consumer to make informed dietary choices.
    However, where a multiple-serving standard menu item is not usually
prepared and offered for sale divided in discrete serving units,
covered establishments must declare calories for the entire menu item
listed on the menu or menu board, as usually prepared and offered for
sale. We disagree with the comment that said a calorie declaration for
a whole multiple-serving standard menu item would be unhelpful or
detrimental. If consumers decide to share a multiple-serving standard
menu item, they can divide the total number of calories by the number
of individuals sharing it. We clarify--as one comment suggested--that
for multiple-serving standard menu items that are not usually prepared
and offered for sale divided in discrete serving units, we would not
object if a covered establishment decided to voluntarily declare
calories per serving, in addition to the calories for the entire
standard menu item.
    (Comment 65) A few comments recommended that calories be declared
per reference amount customarily consumed (RACC) or by household
measure. A RACC represents the amount of food customarily consumed at
one eating occasion (Sec.  101.12 (21 CFR 101.12)). A few comments
considered that listing calories per serving based on the RACC would be
consistent with the labeling of packaged food. One comment noted that
customers are used to seeing information per serving even though actual
consumption may not be aligned with the RACC.
    (Response 65) We assume that ``household measure'' refers to
measures such as ``cups'' or ``tablespoons.'' RACCs represent the
amount of food customarily consumed at one eating occasion and are
calculated for a variety of foods purchased by consumers in
establishments such as grocery stores (see Sec.  101.12). RACCs are
based on data set forth in national food consumption surveys and other
sources of information on serving sizes of food, including serving
sizes used in dietary guidance recommendations or recommended by other
authoritative systems or organizations, serving sizes used by
manufacturers and grocers, and serving sizes used by other countries
(Sec.  101.12(a)). We developed RACCs as the basis for determining
serving sizes for specific products for the purpose of declaration of
nutrition information on product labels.
    We disagree that calories for standard menu items should be
declared per RACC or by household measure. Section 403(q)(5)(H) of the
FD&C Act requires covered establishments to disclose the number of
calories contained in a standard menu item ``as usually prepared and
offered for sale.'' Although many standard menu items may have an
associated RACC, others may not. Even if some standard menu items have
an associated RACC, each covered establishment is free to choose the
amount of food offered for sale in its standard menu items, and section
403(q)(5)(H) of the FD&C Act does not require covered establishments to
prepare and offer standard menu items in particular amounts, such as
RACCs.
    (Comment 66) Some comments considered that calories should be
declared for each size of a menu item (such as ``upgrades'' or
``upsized options'' and ``downsized options'') offered on menus and
menu boards. Some comments linked the requirement to declare calories
for different sizes to different prices--e.g., by considering that
calories must be declared for any size option that has a distinct price
on the menu or menu board. Some comments specifically addressed fixed
combination meals and considered that calories should be declared for
fixed combination meals available in multiple sizes.
    One comment asked us to allow the restaurant to list calories for a
6-inch version of a sandwich and provide a statement on the menus and
menu boards that the 12-inch sandwich is double that amount.
    (Response 66) The calorie labeling requirements of Sec.
101.11(b)(2)(i)(A) apply to each standard menu item listed on the menu
or menu board, as usually prepared and offered for sale. Thus, if a
standard menu item (such as fries or onion rings) is listed on the menu
or menu board in more than one size (such as ``small'' and ``large''),
the menu or menu board must provide calories for each size, following
the format requirements of Sec.  101.11(b)(2)(i)(A)(1),
(b)(2)(i)(A)(2), and (b)(2)(i)(A)(3). Likewise, if a fixed combination
meal (i.e., a meal consisting of components that are not subject to a
consumer's selection, such as a burger and fries) is listed on the menu
or menu board in more than one size (e.g., a hamburger with small fries
or large fries), the menu or menu board must provide calories for each
size of the fixed combination meal, also following the format
requirements of Sec.  101.11(b)(2)(i)(A)(1), (b)(2)(i)(A)(2), and
(b)(2)(i)(A)(3).
    If a 6-inch sandwich and a 12-inch sandwich are both standard menu
items listed on a menu or menu board, or are on display in a covered
establishment, the establishment must disclose the number of calories
for each sandwich size, following the format requirements of Sec.
101.11(b)(2)(i)(A)(1), (b)(2)(i)(A)(2), and (b)(2)(i)(A)(3) or Sec.
101.11(b)(2)(iii) as applicable, unless the sandwich is exempt from the
nutrition labeling requirements under section 403(q)(5)(H)(vii) of the
FD&C Act.
    (Comment 67) One comment interpreted the phrase ``as usually
prepared'' within ``as usually prepared and offered for sale'' in
proposed Sec.  101.11(b)(2)(i)(A) to be a ``standard formula,''
``recommended formula,'' ``standard build,'' or any other term that
means a predetermined method of preparation designed to ensure that all
menu offerings are nutritionally consistent and uniform throughout all
covered establishments in a chain.
    One comment agreed that the number of calories for a standard menu
item should be measured based on how the standard menu item is usually
prepared and offered for sale, but expressed concern about build-as-
you-go menu items. The comment explained that, a covered establishment
might post the number of calories for a build-as-you-go menu item as an
``undressed'' sandwich (the comment did not define this term), giving
the false impression that the sandwich has fewer calories than it may
actually contain as prepared by the covered restaurant and then
consumed by a customer. This comment contended that this type of
sandwich should be considered a variable menu item with calories posted
as a range (i.e., in accordance with proposed Sec.
101.11(b)(2)(i)(A)(4)) that includes the undressed sandwich and the
fully built one, because there is standardization with respect to the
specific amount of each particular food item or condiment that
consumers can add to the build-as-you-go menu item. As evidence for
this view, the comment referred to the standard extra charge for items
such as an extra scoop of guacamole.
    (Response 67) We agree that ``standard build'' or ``recommended
formula'' is consistent with the term ``as usually prepared and offered
for sale.'' However, it is the build that is standard to any given
covered establishment, rather than recommendations or standards by or
from the chain as a whole, that dictates the nutrition information that
would be required to be declared for standard menu items in a
particular covered establishment.
    Regarding the comment expressing concern about build-as-you-go menu

items, we first note that a build-as-you-go menu item, such as a
sandwich with the option of adding different fixings, that is a
standard menu item, likely would be considered a variable menu item. As
discussed previously in this document (see sections VIII.B and VIII.D),
Sec.  101.11(a) defines the terms, ``standard menu item'' and
``variable menu item.'' A variable menu item is defined in Sec.
101.11(a) as a standard menu item that comes in different flavors,
varieties, or combinations, and is listed as a single menu item. A
variable menu item is one type of standard menu item. In the proposed
rule, we provided examples of ``standard menu items''--e.g., a
hamburger, a combination meal, a specific type of pizza (e.g., deluxe
pizza), potato salad that is routinely offered at a salad bar, pancakes
that are routinely offered at a buffet, and pudding that is routinely
offered at a cafeteria line (76 FR 19192 at 19203). We also provided
examples of variable menu items--i.e., foods that may have flavoring
options (e.g., a milkshake that is available in vanilla, chocolate, or
strawberry flavors) or topping options (e.g., pizza prepared with a
selection of toppings) (76 FR 19192 at 19204). In the following
paragraphs, we provide additional examples relevant to build-as-you-go
menu items and explain how the calorie labeling requirements of Sec.
101.11(b)(2)(i)(A) would apply.
    A standard menu item that is listed on a menu or menu board that is
not a variable menu item, in that it does not come in different
flavors, varieties, or combinations that are listed as a single menu
item, (e.g., a turkey and Swiss cheese sandwich on whole wheat bread
with mustard), would be subject to the calorie declaration format
requirements of Sec.  101.11(b)(2)(i)(A)(1) to (b)(2)(i)(A)(3), but
would not be subject to the additional format requirements for variable
menu items (proposed Sec.  101.11(b)(2)(i)(A)(4)), established in this
rule as Sec.  101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8); see the
discussion of the additional format requirements for variable menu
items in section XII). However, a standard menu item that comes in
different flavors, varieties, or combinations, and is listed as a
single menu item on a menu or menu board (e.g., a ``turkey and cheese
sandwich,'' with different options for the type of bread (e.g., whole
wheat or white), cheese (e.g., Swiss, provolone, cheddar), fixings
(e.g., onions, lettuce, tomato), and condiments (mustard, ketchup,
mayonnaise)) would be a variable menu item subject to both the general
calorie declaration format requirements of Sec.  101.11(b)(2)(i)(A)(1)
to (b)(2)(i)(A)(3) for all standard menu items and the additional
format requirements for variable menu items as applicable in Sec.
101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8).
    (Comment 68) Several comments agreed with proposed Sec.
101.11(b)(2)(i)(A)(2) and the flexibility in proposed Sec.
101.11(b)(2)(i)(A)(3) to permit the abbreviation ``Cal'' for calories.
    Several comments addressed the placement provisions for the calorie
declarations in proposed Sec.  101.11(b)(2)(i)(A)(1) and
(b)(2)(i)(A)(3). A few comments agreed that the number of calories be
posted next to the name or price of the menu item (proposed Sec.
101.11(b)(2)(i)(A)(1)) and that the term ``Calories'' or ``Cal'' be
next to the number of calories (proposed Sec.  101.11(b)(2)(i)(A)(3)).
One comment found that customers in its restaurants confused calorie
declarations with price declarations and noted that declaring calories
in the same font, size, and contrast as the price would create
confusion, even if the color is different.
    Another comment from a chain restaurant found that consumers in its
restaurants were confused when calories were posted next to the name of
the menu item and thought the number of calories was the order number;
to address this confusion, the restaurant put the number of calories
after the price and in a different color, font, and size. This comment
emphasized its 3 years of experience with posting calorie declarations
and provided examples of its menu boards to demonstrate how it
communicates calorie information about its menu offerings. This comment
agreed that calorie information should be listed in a manner that
allows the customer to easily identify the calories associated with a
particular menu item, but disagreed that listing calories adjacent to a
menu item is the only way (or even the best way) for customers to
understand the information associated with their menu choice. This
comment asserted that it had specifically learned from practical
application and guest feedback that this generally is not the most
useful method of providing caloric information. This comment suggested
that the rule require a logical and clear association between the menu
item and calorie declaration, but provide flexibility for how that
logical and clear association occurs.
    (Response 68) We appreciate receiving the sample menu boards from
the comment as a means of sharing experience with us. However, we are
retaining in Sec.  101.11(b)(2)(i)(A)(1) the requirement that the
number of calories be listed adjacent to the name or the price of the
associated standard menu item. This requirement is consistent with
section 403(q)(5)(H)(ii)(I)(aa) of the FD&C Act, which requires that
the calorie declaration be ``adjacent to the name of the standard menu
item, so as to be clearly associated with the standard menu item.''
Placing calorie declarations adjacent to the names of standard menu
items provides a clear and logical association between the standard
menu item and the calorie declaration and helps to ensure that
consumers are able to see the declarations. In addition, Sec.
101.11(b)(2)(i)(A)(3) provides that the term ``Calories'' or ``Cal''
must appear as a heading above a column listing the number of calories
for each standard menu item or adjacent to the number of calories for
each standard menu item. As such, Sec.  101.11(b)(2)(i)(A)(3) helps to
further ensure that the calorie declaration is clearly associated with
a particular standard menu item, and the required use of the term
``Calories'' or ``Cal'' will help inform consumers that the number
listed refers to calories. Section 101.11(b)(2)(i)(A)(1) also provides
flexibility by requiring a covered establishment to declare calories
adjacent to either the name or the price of the standard menu item.
This flexibility is consistent with what one comment described doing in
a restaurant. As finalized, Sec.  101.11(b)(2)(i)(A)(1) also provides
sufficient flexibility to accommodate different types of menus and menu
boards and the various ways that standard menu items may be listed on
menus and menu boards. Specifically, in this rule Sec.
101.11(b)(2)(i)(A)(1):
     Provides flexibility to use a color ``at least as
conspicuous'' as that of the name of the associated standard menu item
and, thus, allows for the use of a different color;
     Provides flexibility to use a contrasting background ``at
least as conspicuous'' as that used for the name of the associated
standard menu item and, thus, allows for the use of a different
contrasting background (see Response 73);
     Provides flexibility to use a type size ``no smaller than
the type size of the name or price'' of the associated standard menu
item and, thus, allows for the use of a different type size; and
     Does not restrict the font style.
    We also note that the sample menu boards of the chain restaurant
provided in the comment generally followed the provisions of the
proposed rule in terms of type size and placement of calorie
declarations. For example, the menu boards listed calorie declarations

adjacent to the names of standard menu items in a type size no smaller
than the name or the price of the associated standard menu item,
whichever is smaller, in a column with a heading ``Calories.''
Therefore, while the comment opposed the requirement that calorie
declarations be placed adjacent to the names of standard menu items on
menus and menu boards, the menu boards of the chain restaurant,
nevertheless, generally used the same method of calorie declaration on
menus and menu boards as required by this rule.
    (Comment 69) In the proposed rule, we tentatively concluded that
some packaged foods offered for sale in covered establishments are
covered by the menu labeling requirements (see 76 FR 19192 at 19217,
proposed Sec.  101.11(b)(2)(iii)(C)). For example, a covered
establishment may list ``chips'' on its menu board, referring to
packaged bags of chips that are available as self-service foods or
foods on display within the establishment. In this situation, the
establishment would be required to disclose on the menu board calorie
information for the packaged chips. In addition, if a covered
establishment lists on its menu or menu board a combination meal that
includes a packaged food, the establishment would be required to
disclose the total calorie information for the combination meal,
including the packaged food.
    One comment agreed with requiring the total calorie information of
a combination meal that includes a packaged food to include the
calories for the packaged food. Another comment disagreed that calories
should be declared on a menu or menu board for packaged foods,
particularly packaged soft drinks.
    (Response 69) As required by section 403(q)(5)(H) of the FD&C Act,
covered establishments must provide calorie information for all
standard menu items, including foods that are packaged. In addition,
sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C Act requires
that covered establishments disclose the number of calories contained
in a standard menu item, ``as usually prepared and offered for sale.''
As such, we agree that a covered establishment that lists on its menu
or menu board a combination meal that includes a packaged food must
disclose the total number of calories in the combination meal,
including the calories for the packaged food.
    (Comment 70) One comment stated that the total calorie declaration
for a standard menu item must include all ingredients of a standard
menu item, as it is usually prepared and offered for sale, e.g., for a
teaspoon of sugar added to oatmeal and salad dressings served on or
with salad.
    (Response 70) We agree that the total calorie declaration for a
standard menu item must include all ingredients of the standard menu
item, as it is usually prepared and offered for sale, e.g., for a
teaspoon of sugar added to oatmeal and salad dressings served on or
with salad. As with the scenario discussed in Response 69 for a
combination meal that includes a packaged food, doing so is required by
section 403(q)(5)(H) of the FD&C Act and by sections
403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C Act.
    (Comment 71) One comment suggested that we require that covered
establishments provide the Reference Daily Intakes (RDIs) of calories,
fat, cholesterol, and ``salt'' on menus and menu boards. The comment
acknowledged that there is no RDI for sugar, but requested that it
nonetheless be included on menus and menu boards. The comment also
recommended that menus and menu boards only list percent Daily Value
(DV) of calories, fat, cholesterol, sugar, and ``salt'' and not list
vitamins and minerals because ``too many details may lead to
information overload and defeat the purpose.''
    (Response 71) We disagree with the comment's suggestions, and we
are not requiring covered establishments to include RDIs or percent DVs
for certain nutrients on menus and menu boards. On menus and menu
boards, we are requiring the number of calories contained in standard
menu items, as usually prepared and offered for sale, and a succinct
statement concerning suggested daily caloric intake, as required by
sections 403(q)(5)(H)(ii)(I) and (II) of the FD&C Act. The succinct
statement will adequately enable the public to understand, in the
context of a total daily diet, the significance of the caloric
information provided on menus or menu boards. We further note that
percent DVs cannot be expressed for sugar or calories because Daily
Reference Values (DRVs) have not been established for these nutrients.
(See Sec.  101.9(c)(9), which lists DRVs for fat, cholesterol, sodium,
and other food components.) The term Reference Daily Intake (RDI)
applies to a vitamin or mineral but does not apply to calories, fat,
cholesterol, sugar, or salt. (See Sec.  101.9(c)(8)(iv), which lists
the RDIs for vitamins and minerals that are essential for human
nutrition.) For the Nutrition Facts Label, the amount of a nutrient is
calculated as a percentage of the RDI or DRV, as appropriate, and
expressed using the same term--i.e., percent DV. Because ``salt'' can
be either a general term applicable to substances such as calcium
chloride or potassium chloride, or a synonym for the specific food
substance ``sodium chloride,'' and because nutrition information
generally is directed to information about the sodium content of food,
we considered the request of the comment to be directed to the
declaration of percent DV for ``sodium'' rather than to ``salt.''
    (Comment 72) A few comments agreed with the proposed requirement
(in proposed Sec.  101.11(b)(2)(i)(A)(1)) that the type size for the
calorie disclosure be no smaller than the name or the price of the
associated standard menu item, whichever is smaller. Other comments
considered that the proposed type size requirements are too
prescriptive and recommended that we require only that the type size be
``clear and conspicuous.'' One comment stated that restaurants located
in one State have already complied with a clear and conspicuous
standard; therefore, to move to a type size no smaller than the smaller
of the name or price of the menu item would require changes. Another
comment asked us to provide guidance that if the calorie declaration is
as large as the name, price, or description of the menu item, whichever
is smaller, it is presumptively clear and conspicuous and complies with
section 4205 of the ACA, rather than require a specific font size
relative to the price or name; as an alternative, the type size of the
calorie declaration could be the same size as the description of the
menu item (rather than the name of the menu item) (emphasis added). One
comment recommended that any required minimum type size for the calorie
declaration be half the size of the name or price, whichever is
smaller. Another recommended that the calorie declaration be the same
size and font as either the name or price.
    A few comments recommended that we require that the calorie
declaration be at least as large as (or no smaller than) the name or
price, whichever is larger. One comment recommended that the type size
of the calorie declaration be no less than 10 point font on menus and
no less than 22 point font on menu boards or a type size equal to the
type size of the food listed.
    (Response 72) We are retaining the type size requirements for the
calorie declaration without change. We disagree that the requirements
for the type size of the calorie declaration are too prescriptive. Some
type size requirements suggested in the comments would be more
restrictive than what we proposed. This would be true for those
comments specifying a

type size at least as large as (or no smaller than) the name or price,
whichever is larger; a type size the same as the type size of the name
or price; a type size the same size as the description of the menu
item; or a specific type size. Such type size requirements would not
take into consideration the various types and sizes of menus and menu
boards that may be used in covered establishments. We have concerns
that a type size that is half the size of the name or price, whichever
is smaller, would result in a calorie declaration that is not clear and
conspicuous and, therefore, not compliant with sections
403(q)(5)(H)(ii)(I) and (II) and 403(f) of the FD&C Act. Sections
403(q)(5)(H)(ii)(I) and (II) of the FD&C Act require, in relevant part,
that calorie declarations required on menus and menu boards be clear
and conspicuous and clearly associated with the corresponding standard
menu item. Further, section 403(f) of the FD&C Act provides that a food
shall be deemed misbranded ``if 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.'' The calorie declaration specified in
Sec.  101.11(b)(2)(i)(A)(1) is tied to the name and price of the
standard menu item, which typically are included on menus and menu
boards and are two primary features of a menu or menu board typically
used by consumers to make order selections. The type size requirements
for calorie declarations balance the statutory requirements of sections
403(q)(5)(H)(ii)(I) and (II) and 403(f) of the FD&C Act that calorie
declarations be clear and conspicuous with the mandate in section
403(q)(5)(H)(x)(II)(aa) of the FD&C Act to consider space on menus and
menu boards and, thus, provide flexibility for different covered
establishments.
    (Comment 73) A few comments discussed the proposed requirements (in
proposed Sec.  101.11(b)(2)(i)(A)(1)) for the color and contrasting
background of the calorie declaration. Some comments suggested changes
to the proposed requirements for color and contrasting background. One
comment emphasized that some menus and menu boards may have different
contrasting background colors and provided two suggestions to
accommodate such menus and menu boards. One suggestion was that we
require that the calorie declaration have the same contrasting
background, or a background at least as contrasting as the background
used for the name of the associated standard menu item on the menu or
menu board. As an alternative, the comment suggested that we could
require that the calorie declaration have a background at least as
contrasting as that used for the price and that menus using the same
contrasting background as the price of the standard menu item will be
presumed to comply.
    One comment asserted that the color and contrast requirements are
too restrictive and maintained that many menu boards have a variety of
colors to enhance customer experiences. One comment suggested that the
color of the calorie declaration should not be fainter or less obvious
than that of the other items on the menu. Another comment asked us to
permit the calorie declaration to be in the same color as the subtext
that lists ingredients. One comment that opposed the proposed
requirement for color asserted that ``the eye becomes overwhelmed''
when all copy is the same size and color, and the consumer misses the
information or gives up looking for the information. This comment
requested flexibility in color and ``weight of calorie information'' (a
term the comment did not define). This comment also asked us to clarify
whether ``type'' is limited to font type (e.g., Arial) or whether it
also includes text effects (e.g., bold, italics, color).
    One comment stated that the proposal was written with menu boards
in mind and noted that some restaurants use translites (lighted boxes)
where the name and price are in ``oversized type'' for marketing
purposes. It asked us to permit the use of ``reverse type'' (which is
white or light colored type printed on a dark background) and varied
backgrounds if translites are used.
    (Response 73) We have revised the contrasting background portion of
Sec.  101.11(b)(2)(i)(A)(1) to require that the number of calories be
in the same contrasting background, or a background at least as
contrasting as that used for the name of the associated standard menu
item. We agree that this revision provides additional flexibility
related to the prominence requirements to take into account that there
may be different backgrounds on a single menu or menu board.
    We disagree that the color requirements of the calorie declarations
should be revised. Section 403(q)(5)(H)(ii) of the FD&C Act requires
that the calories be disclosed in a clear and conspicuous manner and
clearly associated with the standard menu item. Further, section 403(f)
of the FD&C Act provides that a food shall be deemed misbranded ``if
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.''
Requiring the calorie declaration to be in the same color, or in a
color at least as conspicuous as the color of the name of the
associated standard menu item helps ensure that the calorie
declarations are clear and conspicuous, prominently placed on the menu
or menu board with such conspicuousness as compared to other words on
the menu or menu board and likely to be read and understood by the
ordinary individual under customary conditions of purchase and use, and
clearly associated with the standard menu item. However, to match the
grammatical construction of the revised requirement for the contrasting
background used for the calorie declaration, we are making a conforming
editorial change to require that the color used for the calorie
declaration be in the same color, or a color at least as conspicuous as
that used for the name of the associated standard menu item (emphasis
added).
    In addition, we are not requiring calorie declarations to be in a
specific font or to include particular text effects because we
recognize that menus and menu boards come in a variety of sizes and
include different fonts and type sizes. We are providing flexibility by
taking into consideration the space on menus and menu boards (see
section 403(q)(5)(H)(x)(II)(aa) of the FD&C Act), along with the fonts
and type sizes already in use by the covered establishments, while also
establishing requirements that help ensure calorie declarations are
disclosed in a manner that is clear and conspicuous and that otherwise
satisfies the requirements of applicable sections of the FD&C Act.
    We would not object to reverse type and varied backgrounds on
translites, provided that the calorie declarations are clear and
conspicuous and satisfy the requirements of applicable sections of the
FD&C Act and Sec.  101.11. Calorie declarations on translites would be
subject to the same general requirements as disclosures on other types
of menu boards, as specified in Sec.  101.11(b)(2)(i)(A).

    (Comment 74) Some comments asked us to require a comma for
declaring more than 1,000 calories because consumers are accustomed to
seeing a comma in numbers of one thousand or greater. The comments
suggested that we revise proposed Sec.  101.11(b)(2)(i)(A) to include a
new subparagraph to state ``(4) Calorie numbers over 1,000 must include
a comma after the thousands place.''
    (Response 74) We would not object to the voluntary use of a comma
for calorie declarations of 1,000 or more, but decline to revise the
rule to require a comma. The requirements we have established in Sec.
101.11(b)(2)(i)(A) adequately ensure that calorie declarations are
disclosed in a clear and conspicuous manner, as required by section
403(q)(5)(H) of the FD&C Act, and render the calorie declarations
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use, as required by section 403(f)
of the FD&C Act. A covered establishment may choose to declare numbers
over 1,000 with or without a comma.
    (Comment 75) One comment suggested that we accommodate vision-
impaired consumers by providing for alternate menus and availability of
other nutrition information. This comment asserted that vision-impaired
consumers suffer more from hypertension, heart problems, and diabetes.
    (Response 75) We recognize that vision-impaired consumers should
have access to nutrition information for standard menu items in covered
establishments. However, we are only implementing the nutrition
labeling requirements specified in section 403(q)(5)(H) of the FD&C
Act, at this time. Covered establishments may voluntarily provide
visually impaired individuals with nutrition information for standard
menu items in a way that is accessible to them. For example, we would
not object to a covered establishment providing nutrition information
for standard menu items through a Braille menu or a menu that gives
information about menu items orally, in addition to providing nutrition
information in accordance with Sec.  101.11.

XII. Additional Format Requirements That Apply When Declaring Calories
on Menus and Menu Boards for Variable Menu Items, Combination Meals,
and Toppings (Final Sec.  101.11(b)(2)(i)(A)(4) Through
(b)(2)(i)(A)(8))

A. Proposed Format for Declaring Calories for Variable Menu Items

    Section 403(q)(5)(H)(v) of the FD&C Act requires FDA to establish
by regulation standards for determining and disclosing the nutrient
content for variable standard menu items that are listed as a single
menu item ``through means determined by the Secretary, including
ranges, averages, or other methods.'' (See the discussion of the
definition of the term ``variable menu item'' in section VIII.D) In the
proposed rule, we considered five options for implementing this
statutory provision, and selected Option 2 (76 FR 19192 at 19207-
19209). Consistent with Option 2, proposed Sec.  101.11(b)(2)(i)(A)(4)
would require, in relevant part, that for variable menu items, the
calories must be declared as a range, in the format ``xx-yy'' where
``xx'' is the caloric content of the lowest calorie variety, flavor, or
combination, and ``yy'' is the caloric content of the highest calorie
variety, flavor, or combination. The other options we considered were
as follows:
     Option 1. Single value; either in the form of an average
(obtained by summing up the calorie content of all options and then
dividing by the number of options) or a median of all options (obtained
by determining the ``middle'' number of calories from the list of
options).
     Option 3. Hybrid combining averages and ranges;
declaration of a single average value for variable menu items whose
calorie ranges fall within specified bounds and declaration of a range
for variable menu items whose calorie ranges fall outside those bounds.
     Option 4. If only 2 options are available for an item
(e.g., a sandwich with fries or with fruit), provide both numbers with
a forward slash between (e.g., 450/350). If three or more options are
available, provide the range in calories.
     Option 5. If only 2 options are available for an item
(e.g., a sandwich with fries or with fruit), provide both numbers with
a forward slash between (e.g., 450/350). If three or more options are
available, use one of the hybrid approaches outlined in Option 3.
    We also proposed specific requirements that would apply when a
variable menu item appears on the menu or menu board and is a self-
service food or food on display, and there is no clearly identifiable
upper bound to the range, e.g., all-you-can-eat buffet. In the
following paragraphs, we discuss comments on these proposed provisions.
After considering these comments, we have revised the provisions to:
     Require Option 4 instead of Option 2;
     Specify additional format requirements that apply when
declaring calories on menus and menu boards for variable menu items,
combination meals, and toppings (Sec.  101.11(b)(2)(i)(A)(4) through
(b)(2)(i)(A)(7)); and
     Redesignate the requirements that apply to a variable menu
item when there is no clearly identifiable upper bound to the range of
calories to Sec.  101.11(b)(2)(i)(A)(8) and clarify that such item is
otherwise exempt from the requirements of Sec.  101.11(b)(2)(i)(A) for
what must be provided on menus and menu boards.

B. Decision To Require Option 4

    (Comment 76) Several comments supported our proposal to require
Option 2 because they considered that ranges provide more detailed
information. Several comments addressed one or more of the other four
options we described. One comment stated that the use of ranges does
not require customers to make calculations as would be the case for
medians and means. This comment asserted that declaring calories in
mixed options and hybrids would be confusing because consumers would
need to understand why and when a single value (e.g., mean) is used
rather than a range. One comment asserted that if single calorie values
for each flavor and size were used rather than ranges, the menu board
would be unreadable and consumers would be confused by too much
information or would ignore the information. Another comment asserted
that without a range, a single value calorie declaration for a variable
menu item would be false.
    Other comments supported the use of hybrid approaches (such as in
Options 3 and 5) that would provide calorie information in both ranges
and averages. One comment recommended that Sec.  101.11(b)(2)(i)(A)(4)
be revised to include specific exceptions that would limit the use of
ranges--i.e., (1) very low or no calorie beverages should be listed
separately from other beverages; (2) the mean must be used for menu
items that come in different flavors, varieties, or combination meals
if all options are within 40 calories of each other and all of the
options contain fewer than 400 calories, or if all options are within
80

calories of each other and one or more options contain more than 400
calories; and (3) if there is a fixed or default option for a
combination meal, calories should be posted for that option. This
comment explained that it suggested the 40-calorie range because 40
calories is used as the basis for low calorie claims, and that it
suggested a cut-off of 400 calories because 400 is 20 percent of a
2,000 calorie diet and is high according to our labeling principles.
    One comment recommended that a covered establishment be able to
declare one range for a variable menu item that comes in different
sizes only if the difference between the upper and lower limits is less
than 5 percent. This comment did not explain the basis for its
recommendation to use 5 percent to limit the use of ranges.
    One comment stated a preference for Option 4, but also requested
that we limit the use of calorie ranges, within the constraints of
Option 4. This comment considered that ranges are not particularly
useful to customers in putting their choices into context. Several
other comments opposed Option 4 because they considered that it would
be confusing.
    (Response 76) After considering all five options in light of the
totality of the comments and the advantages and disadvantages of each
option as described in the proposed rule (76 FR 19192 at 19207 through
19209), we are requiring Option 4, rather than Option 2, as the format
for declaring calories for variable menu items on menus and menu
boards.
    Option 4 is similar to proposed Sec.  101.11(b)(2)(i)(A)(4) in that
it continues to provide for the declaration of calories using a range,
which some comments supported. However, Option 4 also provides for the
use of a different communication tool--i.e., a slash (e.g., 110/230)--
that is more tailored to a situation in which there are only two
options available for a variable menu item. Using a slash instead of a
dash (e.g., 110-230) better reflects the fact that there are only two
options for a variable menu item available (see the discussion in 76 FR
19192 at 19209), and more accurately informs consumers about the
calories for each of the two options, whereas using a range represented
by a dash is more appropriate when there are more than two options. As
we discussed in the proposed rule, we recognize that in some instances,
a calorie range may be so wide that a consumer may still need the
calorie information for the particular menu item before he or she can
make a fully informed purchase decision (76 FR 19192 at 19209). For
example, the potential calorie range for a variable menu item that is
offered for sale with the option of adding toppings (e.g., pizza) may
be very wide. We are establishing specific requirements for such
variable menu items when the toppings are listed on a menu or menu
board in Sec.  101.11(b)(2)(i)(A)(5), in part to address the
potentially large variation in calories and to provide more specific
calorie information to consumers regarding their order selections.
    In general, however, we agree with the comments that use of a range
is less confusing than hybrids and single values where consumers may
not understand how a single value is derived if a median or mean is
used. Requiring a range for variable menu items where three or more
options are available gives consumers a consistent format across such
variable menu items and may allow covered establishments to save some
space on menus and menu boards.
    We disagree that we should limit the use of ranges to calorie
declarations for variable menu items where the difference between the
upper and lower limits is less than 5 percent. While this approach may
provide for smaller range variations, such limitations likely would
require additional calorie declarations on menus and menu boards and
significant redesigns of menus and menu boards. Taking into
consideration the space on menus and menu boards and the fact that
calorie declarations for individual variable menu items will be
included in the written nutrition information required under section
403(q)(5)(H)(ii)(III) of the FD&C Act and Sec.  101.11(b)(2)(ii), we
are not requiring limits on the use of ranges where the difference
between the upper and lower limits is less than 5 percent, at this
time. Further, the comment provided no basis to use 5 percent to limit
the use of ranges.
    For these reasons, we have revised Sec.  101.11(b)(2)(i)(A)(4) to
require Option 4 for the declaration of calories on the menu or menu
board for variable menu items. Requiring the declaration of calories of
each option for a variable menu by using a slash where only two options
are available will reduce or limit the number of times that calories
are declared as a range, as requested by some comments, while also
providing specific calorie information about each option. If there are
three or more options available, the calories must be provided in a
range in the format ``xx-yy,'' where ``xx'' is the caloric content of
the lowest calorie variety, flavor, or combination, and ``yy'' is the
caloric content of the highest calorie variety, flavor, or combination.
The use of a slash to declare calories for each option for a variable
menu item where only two options are available and the use of a range
where three or more options are available satisfy the requirements of
section 403(q)(5)(H)(v) of the FD&C Act.
    We have revised Sec.  101.11(b)(2)(i)(A)(4) to specify, in
subparagraphs (b)(2)(i)(A)(4) through (b)(2)(i)(A)(7):
     Specific requirements that apply to individual variable
menu items (Sec.  101.11(b)(2)(i)(A)(4));
     Specific requirements that apply to a variable menu item
that is offered for sale with the option of adding toppings listed on
the menu or menu board (Sec.  101.11(b)(2)(i)(A)(5));
     Specific requirements that apply to a combination meal
(Sec.  101.11(b)(2)(i)(A)(6)); and
     Specific format requirements for declaring calories for an
individual variable menu item, a combination meal, and toppings as a
range, if applicable (Sec.  101.11(b)(2)(i)(A)(7)).
    We discuss these specific requirements in sections XII.C through
XII.F.
    We note that variable menu items that are self-service food or food
on display are subject to the calorie declaration requirements, in
Sec.  101.11(b)(2)(iii), for food that is self-service or on display,
as discussed in section XVII.B.

C. Requirements That Apply to Individual Variable Menu Items (Final
Sec.  101.11(b)(2)(i)(A)(4))

    (Comment 77) One comment stated that the proposed rule suggests
that a calorie range is only appropriate when a general term such as
``soda'' is used for a set of beverages, but not when specific flavors
or brands are also named. The comment considered that the proposed rule
therefore would require a calorie declaration for each specific size or
each specific brand of a beverage listed on the menu. The comment
referred to a discussion in the proposed rule (76 FR 19192 at 19216)
where we compared individually listed beverages to individually listed
flavors of ice cream and indicated that calorie declarations must be
provided on menus and menu boards for the individually listed flavors.
The comment contended that there is not enough space to list the
calorie content for each size of each beverage offered for sale in the
required type size. The comment also stated that this requirement will
force covered establishments to refrain from listing the beverage
options.
    (Response 77) We are establishing in Sec.  101.11(b)(2)(i)(A)(4)(i)
through (b)(2)(i)(A)(4)(iii) requirements for

declaring calories on the menu or menu board for individual variable
menu items. First, we are establishing in Sec.
101.11(b)(2)(i)(A)(4)(i) the principle, discussed in the proposed rule,
that calorie declarations must be provided on menus and menu boards for
the individually listed flavors (76 FR 19192 at 19216). Section
403(q)(5)(H)(v) of the FD&C Act provides, in relevant part, that FDA
shall establish by regulation standards for disclosing the nutrient
content for standard menu items that come in different flavors,
varieties, or combinations, but which are listed as a single menu item
through means determined by FDA, including ranges, averages, or other
methods. Accordingly, Sec.  101.11(b)(2)(i)(A)(4)(i) specifies that
when the menu or menu board lists flavors or varieties of an entire
individual variable menu item (such as soft drinks, ice cream,
doughnuts, dips, and chicken that can be grilled or fried), the
calories must be declared separately on the menu or menu board for each
listed flavor or variety.
    We acknowledge the comment's concern about space on menus and menu
boards. However, a covered establishment could group together varieties
or flavors that have the same number of calories (after rounding in
accordance with Sec.  101.11(b)(2)(i)(A)(2)) and declare the calories
for that group as a single calorie declaration, specifying that the
calorie declaration represents the calorie amount for each individual
flavor or variety (e.g., ``Diet Lemon Lime or Diet Cola (0 cal); Cola
or Lemon Lime (150 cal)''). We have revised Sec.
101.11(b)(2)(i)(A)(4)(i) to include this option for grouping flavors
and varieties that have the same calorie amounts. We discuss in more
detail the specific requirements for calorie declarations for self-
service beverages in section XVII.E.3.
    Flavors or varieties of variable menu items such as soft drinks,
ice cream, doughnuts, dips, and chicken are not always listed on the
menu or menu board. When the menu or menu board does not list flavors
or varieties for an entire individual variable menu item, and only
includes a general description of the variable menu item (e.g. ``soft
drinks''), Sec.  101.11(b)(2)(i)(A)(4)(ii) specifies that the calories
must be declared for each option with a slash between the two calorie
declarations where only two options are available (e.g., ``150/250
calories'') or as a range in accordance with the requirements of Sec.
101.11(b)(2)(i)(A)(7) where more than two options are available (e.g.,
``100-250 calories''). As discussed in section XII.F, Sec.
101.11(b)(2)(i)(A)(7) specifies the format requirements for declaring
calories as a range.
    Some menus or menu boards describe flavors or varieties for only
part of an individual variable menu item (such as different types of
cheese offered in a sandwich). To address these types of variable menu
items, Sec.  101.11(b)(2)(i)(A)(4)(iii) specifies that when the menu or
menu board describes flavors or varieties for only part of an
individual variable menu item (such as different types of cheese
offered in a grilled cheese sandwich (e.g., ``Grilled Cheese (Cheddar
or Swiss)'')), the calories must be declared for each option with a
slash between the two calorie declarations where only two options are
available (e.g., ``450/500 calories'') or as a range in accordance with
the requirements of Sec.  101.11(b)(2)(i)(A)(7) where more than two
options are available (e.g., ``450-550 calories'').

D. Requirements That Apply to a Variable Menu Item That Is Offered for
Sale With the Option of Adding Toppings Listed on the Menu or Menu
Board (Final Sec.  101.11(b)(2)(i)(A)(5))

    (Comment 78) A few comments recommended that the calories either be
declared as a range as proposed or be declared for the basic
preparation of the item together with a separate calorie declaration
for each topping. These comments supported separate calorie
declarations for sauces and dressings served on the side.
    One comment appeared to believe that covered establishments must
list a range providing calories for pizzas with no toppings and pizzas
with everything on them. The comment asserted that this calorie range
would be too wide and ``useless.'' The comment also asserted that
measuring toppings is not an ``exact science.'' The comment recommended
that calories be disclosed on menus and menu boards for the standard
build pizzas but not for toppings, because the nutrient information for
the toppings would be required in the written nutrition information.
However, the comment suggested that a single calorie listing for all
toppings as a range from lowest to highest would be appropriate if we
require calorie disclosures for pizza toppings on menus and menu
boards.
    One comment recommended that ranges not be the only option for
pizza. The comment asserted that pizzas can have up to 34 million
combinations with a range as wide as 1,610 calories. The entity
submitting the comment said it had received complaints from consumers
in one jurisdiction where calorie information for pizza is provided by
a range and found that the customers questioned the usefulness of a
wide range of calories for a whole pizza. This comment stated that some
jurisdictions have attempted to address this problem by requiring that
the covered establishments list calories per each component or topping.
The comment asserted that listing calories for each component or
topping would not be useful for pizza because each topping has a
different portioning based on the size of the pizza and the total
number of toppings on the pizza. The comment explained that the amount
of an individual topping selection (e.g., pepperoni, sausage,
mushrooms, green peppers) added to a pizza is reduced based on the
total number of individual toppings selections ordered. For example, a
one-topping medium pizza where ham is the topping may have 10 grams of
ham per slice (adding 10 calories from the ham per slice) whereas a
medium pizza with ham as a topping and three other toppings may have 6
grams of ham per slice (adding 5 calories from the ham per slice).
Therefore, the comment contended that individual labeling of toppings
would lead to large calorie ranges that would not be useful information
for the consumer. This comment stated that under one State law, pizza
is a custom order and nutrition information is not required for
toppings. The comment maintained that the best way to make calorie
declarations for pizza is to declare calorie information for the
standard build and provide calorie information for other customizations
in a brochure or an online calculator.
    One comment noted that, in the proposed rule, we discussed the
possibility of listing calories for both the standard preparation of
pizza and for each topping (76 FR 19192 at 19207) but did not codify
this as we did for the written nutrition information. One comment asked
us to clarify that calories should be listed for each separate pizza
topping. Another comment recommended that calories for items such as
pizzas and sundaes be posted for the standard preparation only if
calories for each topping or option are also listed.
    (Response 78) In Sec.  101.11(b)(2)(i)(A)(5)(i) through
(b)(2)(i)(A)(5)(iv), we are specifying format requirements that apply
to a variable menu item that is offered for sale with the option of
adding toppings listed on the menu or menu board. Doing so is
consistent with section 403(q)(5)(H)(v) of the FD&C Act, responds to
the comments making specific suggestions for how to declare calories
for toppings such as those used

on pizza and sundaes, and acknowledges some of the unique
characteristics of such toppings (e.g., that the amount of each topping
added to a menu item such as pizza may decrease with the total number
of toppings ordered).
    As noted by the comments, the proposed rule acknowledged that some
comments received in response to the 2010 docket notice recommended
that the calorie information for items such as pizza be displayed for
the standard preparation of the item, with the standard preparation of
the item clearly noted on the menu, menu board, or food tag or next to
the food on display. The calorie content for each additional food
component would then be displayed on the menu, menu board, food tag, or
next to the food on display for each food component (76 FR 19192 at
19207). In light of these comments to the 2010 docket notice and the
comments received to the proposed rule, Sec.  101.11(b)(2)(i)(A)(5)(i)
specifies that when the menu or menu board lists toppings that can be
added to a menu item (such as pizza or ice cream), the calories must be
declared for the basic preparation of the menu item as listed (e.g.,
``small pizza pie,'' or ``single scoop ice cream''). Section
101.11(b)(2)(i)(A)(5)(ii) specifies that the calories must be
separately declared for each topping listed on the menu or menu board
(e.g., pepperoni, sausage, green peppers, onions on pizza; fudge,
almonds, sprinkles on ice cream), and the menu or menu board must
specify that the calories are added to the calories contained in the
basic preparation of the menu item. For example:

                        Ice Cream Scoop: 300 cal
------------------------------------------------------------------------
                        Toppings                             Added cal
------------------------------------------------------------------------
Almonds.................................................              25
Fudge...................................................              50
------------------------------------------------------------------------

    Furthermore, a covered establishment could group toppings that have
the same calorie amounts (after rounding in accordance with Sec.
101.11(b)(2)(i)(A)(2)), and declare the calories for such toppings as a
single calorie declaration adjacent to the toppings, specifying that
the calorie declaration represents the calorie amount for each
individual topping (e.g., ``Red Peppers or sweet onions (adds 10
cal);'' ``Red peppers, sweet onions (adds 10 cal per topping)''). We
have revised Sec.  101.11(b)(2)(i)(A)(5)(ii) to include this option for
grouping toppings that have the same calorie amounts.
    We note that if the general term, ``toppings'' is used on a menu or
menu board, but the individual toppings are not listed, then the format
requirements of Sec.  101.11(b)(2)(i)(A)(4)(ii) would apply (i.e., the
calories must be declared for each option with a slash between the two
calorie declarations where only two options are available (e.g., ``150/
250 calories'') or as a range where more than two options are available
(e.g., ``100-250 calories'').
    Foods such as pizza and ice cream are often offered for sale in
different sizes (e.g., a small, medium, or large pizza pie, and ice
cream dishes that contain one, two, or three scoops of ice cream). As
mentioned by a comment, the amount of a topping added to a variable
menu item may vary based on the size of the variable menu item ordered
by a consumer. The calorie content of each topping will likely vary
accordingly, depending on the size of the variable menu item ordered.
To account for the potential variability in calorie content of each
topping based on the size of the variable menu item ordered, Sec.
101.11(b)(2)(i)(A)(5)(iii) specifies that the calories for the basic
preparation of the menu item must be declared for each size of the menu
item, and the calories for each topping listed on the menu or menu
board must either be declared separately for each size of the menu
item, or declared using a slash between the two calorie declarations
for each topping where only two sizes of the menu item are available
(e.g., ``adds 150/250 cal'') or as a range for each topping in
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of the
rule where more than two sizes of the menu item are available (e.g.,
``adds 100-250 cal''). If a slash between two calorie declarations or a
range of calorie declarations is used, the menu or menu board must
indicate that the variation in calories for each topping arises from
the size of the menu item to which the toppings are added. For example:

  Plain Pizza Pie: Small (12'') 500 cal * Medium (14'') 750 cal * Large
                             (16'') 1000 cal
------------------------------------------------------------------------
                                                      Added cal
                 Toppings                  -----------------------------
                                              Small      Med      Large
------------------------------------------------------------------------
Pepperoni.................................       200       300       400
Sausage...................................       250       350       450
Green Peppers.............................        15        20        25
------------------------------------------------------------------------

or

  Plain Pizza Pie: Small (12'') 500 cal * Medium (14'') 750 cal * Large
                             (16'') 1000 cal
------------------------------------------------------------------------
                                                          Added cal (S/M/
                        Toppings                              L pie)
------------------------------------------------------------------------
Pepperoni...............................................         200-400
Sausage.................................................         250-450
Green Peppers...........................................           15-25
------------------------------------------------------------------------

    In the proposed rule, we requested comment on complexities that may
be raised by certain variable menu items, such as those offered for
sale with the option of adding toppings (such as pizza or ice cream)
(76 FR 19192 at 19209). As mentioned by the comments, the amount of a
topping added to a variable menu item, and therefore the calorie
content of each topping, may vary not only based on the size of the
menu item, but also based on the total number of toppings ordered by a
consumer. Specifically, the amount of each topping added to a variable
menu item may decrease as the total number of toppings ordered by a
consumer increases.
    Therefore, to address this complexity, we have established a
specific calorie declaration requirement in Sec.
101.11(b)(2)(i)(A)(5)(iv) for variable menu items offered for sale with
the option of adding toppings listed on the menu or menu board, where
the amount of the topping included on the basic preparation of the menu
item decreases based on the total number of toppings ordered (such as
sometimes is the case with pizza toppings). In such situation, the
calories for each topping listed on the menu or menu board must be
declared as single values representing the calories for each topping
when added to a one-topping menu item, and the menu or menu board must
specify that the calorie declaration is for the topping when added to a
one-topping menu item. The following table provides an example of
calorie declarations that would satisfy the requirements of Sec.
101.11(b)(2)(i)(A)(5)(i) through (iv):

  Plain Pizza Pie: Small (12'') 500 cal * Medium (14'') 750 cal * Large
                             (16'') 1000 cal
------------------------------------------------------------------------
                                                             Added cal
                                                              (single
                        Toppings                           topping S/M/L
                                                               pie)
------------------------------------------------------------------------
Pepperoni...............................................         200-400
Sausage.................................................         250-450
Green peppers...........................................           15-25
------------------------------------------------------------------------

    Structuring the requirement in this way helps ensure that consumers
are given accurate and consistent information about the calories of
each

topping that are added to the calories contained in the basic
preparation of the menu item. We would not object if a covered
establishment voluntarily includes a statement on the menu or menu
board explaining how the calories per topping might fluctuate if
ordering multiple toppings; for example, for a pizza pie, the statement
might say, ``Calories per topping may decrease as the number of
toppings per pizza increases.''
    In Sec.  101.11(b)(2)(i)(A)(5)(i) through (b)(2)(i)(A)(5)(iv), we
are establishing requirements for declaring calorie information for
variable menu items with toppings listed on a menu or menu board, and
specifying the format and manner of such declarations, as required by
sections 403(q)(5)(H)(v) and (x)(II)(bb) of the FD&C Act. Because the
requirements in Sec.  101.11 (b)(2)(i)(A)(5)(iii) and
(b)(2)(i)(A)(5)(iv) address the potential variability in calorie
content of each topping based on the size of the menu item, and the
total number of toppings ordered, the required calorie declarations
will provide accurate calorie information to consumers regarding the
calorie content of each topping they order. In addition, the
requirement in Sec.  101.11(b)(2)(i)(A)(5)(iii) for toppings added to
menu items that come in different sizes provides covered establishments
with flexibility to choose one of two options that best fits their
establishments and menus and menu boards. Allowing covered
establishments to use a range for each topping to represent the added
calories across various sizes of the menu item may save some space on
menus and menu boards while still providing the necessary calorie
information for consumers to make informed dietary choices.
    We disagree that pizza with toppings generally would be a custom
order for the purposes of this rule and that nutrition information is
not required for such foods for a number of reasons. First, the
requirements of section 403(q)(5)(H) of the FD&C Act and this rule
apply to standard menu items. This rule defines a standard menu item as
restaurant-type food that is routinely included on a menu or menu board
or routinely offered as a self-service food or food on display. To the
extent a pizza with toppings meets the definition of a standard menu
item, the requirements of section 403(q)(5)(H) of the FD&C Act and
Sec.  101.11(b) would apply to such pizza.
    Second, while section 403(q)(5)(H)(vii) of the FD&C Act exempts
from the nutrition labeling requirements of section 403(q)(5)(H) of the
FD&C Act items that are custom orders, a pizza with toppings that meets
the definition of a standard menu item would not be a custom order
within the meaning of Sec.  101.11. Under the definition of ``custom
order'' in Sec.  101.11(a), a custom order is a food order that is
prepared in a specific manner based on an individual consumer's
request, which requires the covered establishment to deviate from its
usual preparation of a menu item. For example, if a covered
establishment offers a ``Meat Lovers'' pizza containing ground meat and
sausage as a standard menu item, and a customer orders a ``Meat
Lover's'' pizza without sausage, that order could be considered a
custom order. In contrast, a pizza with toppings routinely listed on
the menu or menu board of a covered establishment would meet the
definition of a standard menu item, and toppings can be added to a
pizza as part of the establishment's usual preparation of the menu
item.
    Third, pizza is explicitly identified in section 403(q)(5)(H)(v) of
the FD&C Act as a variable menu item for which the nutrition
information must be disclosed. If Congress had meant for pizza,
including pizza with toppings, not to be covered by the requirements of
section 403(q)(5)(H) of the FD&C Act, it would not have had reason to
specifically include pizza as an example of the foods described in
section 403(q)(5)(H)(v) of the FD&C Act.
    We also disagree that calorie declarations for different toppings
should not be required on menus or menu boards because these calorie
declarations will be provided in the written nutrition information or
can be provided in a brochure. When toppings are listed on a menu or
menu board, consumers can use such information to make order
selections. Accordingly, when toppings are listed on a menu or menu
board, a covered establishment must declare calories for each topping
on the menu or menu board in accordance with Sec.
101.11(b)(2)(i)(A)(5)(ii) through (b)(2)(i)(A)(5)(iv). Requiring
calorie declarations for toppings when they are listed on the menu or
menu board helps to inform consumers' decisions by providing the
calorie content of menu items before consumers make their order
selections. Further, providing such information will enable consumers
to make informed and healthful dietary choices.

E. Requirements That Apply to a Combination Meal (Final Sec.
101.11(b)(2)(i)(A)(6))

    (Comment 79) Some comments recommended that, when practicable,
calorie amounts for all components of a variable menu item that is a
combination meal be listed on the menu or menu board. One comment
provided an example of a variable menu item for a pancake combination
meal with a choice of bacon strips or pork sausages to accompany
pancakes, eggs, and hash browns. In the comment's example, the calories
for the two options ranged from 1,200 to 1,420 calories, and the
comment stated that the covered establishment could list the calories
as ``Two pancakes (600 calories) served with two eggs (200 calories),
hash browns (300 calories) and your choice of 2 bacon strips (100
calories) or 2 pork sausages (320 calories).''
    A few comments acknowledged that ranges are a better mechanism for
presenting calorie information about variable menu items that are
combination meals than are medians or means, but also pointed out that
ranges have a disadvantage in that they do not sufficiently convey the
necessary information to the consumer. One comment maintained that its
consumer research shows that calorie ranges are confusing and not
informative for variable menu items. Another comment recommended that
if calorie ranges are used, the calories for the menu options that are
included in that range must be disclosed, either on the menu, through
signs for foods on display, or through the device used to provide the
other written nutrition information required in section
403(q)(5)(H)(ii)(III) of the FD&C Act.
    Another comment provided sample menu boards that offered for sale
menu items in a meal described as ``You Pick 2'' (YP2), such as a meal
consisting of a half sandwich and a half salad. For each menu item, the
sample menu boards declared the number of calories in the menu item
when ordered by a consumer individually and when ordered as one of the
components of the ``You Pick 2'' meal, if available as a ``You Pick 2''
component (e.g., ``Chicken Caesar Salad, YP2 360, Whole 720''). The
comment asserted that declaring calories for each menu item
individually, rather than declaring the calories for all possible
combinations of its ``You Pick 2'' menu items in a range, was the best
way to ensure that consumers have the necessary information to make
choices about their calorie consumption.
    (Response 79) We disagree that we should require calories to be
listed on a menu or menu board for each component of a variable menu
item that is a combination meal. In many cases, one or more components
of a variable menu item (such as the pancakes, eggs,

hash browns, bacon, and pork sausages in the comment's example) are
also included on a menu or menu board as standard menu items, and the
calories for such components would already be on the menu or menu board
when this is the case. However, we would not object if a covered
establishment voluntarily lists the calories for each component of a
variable menu item that is a combination meal, provided that the
covered establishment also complies with the format requirements for
declaring calories for variable menu items on menus and menu boards in
Sec.  101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(7).
    Section 403(q)(5)(H)(v) of the FD&C Act provides, in relevant part,
that FDA shall establish standards for disclosing the nutrient content
for standard menu items that come in different flavors, varieties, or
combinations, but which are listed as a single menu item through means
determined by FDA, including ranges, averages, or other methods.
Accordingly, Sec.  101.11(b)(2)(i)(A)(6)(i) through
(b)(2)(i)(A)(6)(iii) require calorie declarations for combination
meals. Consistent with our selection of Option 4 for declaring calories
for variable menu items generally (see discussion in section XII.B),
Sec.  101.11(b)(2)(i)(A)(6)(i) specifies that when the menu or menu
board lists two options for menu items in a combination meal (e.g., a
sandwich with a side salad or chips), the calories must be declared for
each option with a slash between the two calorie declarations (e.g.,
``350/450 calories''). Section 101.11(b)(2)(i)(A)(6)(ii) specifies that
when the menu or menu board lists three or more options for menu items
in a combination meal (e.g., a sandwich with chips, a side salad, or
fruit), the calories must be declared as a range in accordance with the
requirements of Sec.  101.11(b)(2)(i)(A)(7) (e.g., ``350-500
calories'').
    As such, the requirements for calorie declarations for combinations
meals in Sec.  101.11(b)(2)(i)(A)(6)(i) through (b)(2)(i)(A)(6)(iii)
are consistent with the view of comments asserting that ranges are a
better mechanism for presenting calorie information than are medians or
means. The requirements in Sec.  101.11(b)(2)(i)(A)(6)(i)
through(b)(2)(i)(A)(6)(iii) also address the concerns of other comments
that ranges do not sufficiently convey the necessary information to the
consumer by limiting the use of a range to combination meals with three
or more options, and providing specific calorie information about each
option of a combination meal where only two options are available. In
addition, we find that the small sample size (n = 127) of the consumer
research submitted with one comment limits it as support for the
comment's assertion that calorie ranges are confusing and not
informative for variable menu items (Ref. 33). Further, although this
small study suggests possible consumer preference among different
declaration formats, it does not provide evidence about how consumers
understand and use the formats (Ref. 33).
    Immediately following, in Response 80, we discuss the third
provision we are establishing in Sec.  101.11(b)(2)(i)(A)(6) regarding
the format of declaring calories on the menu or menu board for
combination meals--i.e., for ``upsize'' and ``downsize'' options for
combination meals.
    Regarding the ``You Pick 2'' meal described by one comment, we note
that the sample menu board provided by the comment had a separate
section describing an opportunity for a consumer to combine standard
menu items for a special price, such as by combining any half sandwich
with any half salad. The comment's sample menu board declared the
number of calories for each standard menu item available for consumers
to combine for a special price (e.g., ``Chicken Caesar Salad, YP2 360,
Whole 720''). Generally, the calories for a combination meal must be
declared as a range in accordance with Sec.  101.11(b)(2)(i)(A)(7) as
required by Sec.  101.11(b)(2)(i)(A)(6)(ii) if the menu or menu board
lists three or more options for the menu items in the combination meal.
However, in the sample menu boards provided by the comment, the section
describing an opportunity for a consumer to combine standard menu items
merely informed consumers of a special price when standard menu items
separately listed on the menu board, each with declared calories, are
combined in a ``mix and match'' situation. In this type of ``mix and
match'' situation, as displayed in the sample menu board provided by
the comment, a consumer would have the calorie information for each
standard menu item available for the consumer to combine before he or
she selects one or more standard menu items. Because the covered
establishment would be providing calorie declarations for each standard
menu item available for the consumer to combine on the menu or menu
board that would be visible to consumers when making order selections,
and taking into consideration space on menus and menu boards, we agree
with the comment that requiring the disclosure of additional calorie
ranges in such a situation, particularly where there are a large number
of combinations available, likely would not be necessary. For these
reasons, in this type of ``mix and match'' situation, where the menu or
menu board describes an opportunity for a consumer to combine standard
menu items for a special price (e.g., ``Combine Any Sandwich with Any
Soup or Any Salad for $8.99''), and the calories for each standard menu
item, including each size option as described in Sec.
101.11(b)(2)(i)(A)(6)(iii) if applicable, available for the consumer to
combine are declared elsewhere on the menu or menu board, we would not
require a covered establishment to also declare the calories for the
combination in a range. To make this clear, Sec.
101.11(b)(2)(i)(A)(6)(iv) of the final rule specifies that where the
menu or menu board describes an opportunity for a consumer to combine
standard menu items for a special price (e.g., ``Combine Any Sandwich
with Any Soup or Any Salad for $8.99''), and the calories for each
standard menu item, including each size option as described in Sec.
101.11(b)(2)(i)(A)(6)(iii) if applicable, available for the consumer to
combine are declared elsewhere on the menu or menu board, the
requirements of Sec.  101.11(b)(2)(i)(A)(6)(i), (ii), and
(b)(2)(i)(A)(6)(iii) do not apply.
    In establishing Sec.  101.11(b)(2)(i)(A)(6)(iv), we have considered
space on menus and menu boards and how to minimize the burden on
covered establishments to comply with this rule while ensuring that the
requirements of section 403(q)(5)(H) of the FD&C Act and other
applicable sections of the FD&C Act are satisfied and nutrition
information for standard menu items is made available to consumers in a
direct and accessible manner. Further, our approach to this ``mix and
match'' situation is similar to our approach to a situation where a
covered establishment includes packaged food (such as chips) as part of
a combination meal. As discussed later in this document (see section
XVII.H), a packaged food that is a food on display that bears Nutrition
Facts information, including the nutrition information specified in
section 403(q)(5)(H)(ii)(III) of the FD&C Act and Sec.
101.11(b)(2)(ii) satisfies the calorie disclosure requirement for self-
service food or food on display in section 403(q)(5)(H)(iii) of the
FD&C Act and Sec.  101.11(b)(2)(iii), so long as a consumer is able to
examine the calorie information on the label prior to purchase.
    (Comment 80) As another example of complexities that may be raised
by certain variable menu items, we noted in the proposed rule that some
menus with combination meals list an option to increase the size of
components of those

meals for a discounted additional price (76 FR 19192 at 19209). ``Add
25 cents to Upgrade to Large Fries & Large Drink'' is an example of
such an option. We stated that we were considering whether those
listings should be labeled with the number or range of calories they
add to the standard combination meal, and requested comment on this
issue.
    Several comments responded to this request for comment. In general,
these comments considered that calories should be declared for each
size of a menu item (such as ``upgrades'' or ``upsized options'' and
``downsized options'') offered on menus and menu boards. Some comments
linked the requirement to declare calories for different sizes to
different prices--e.g., by considering that calories must be declared
for any size option that has a distinct price on the menu or menu
board. Some comments addressed combination meals, including fixed
combination meals and combination meals that are variable menu items
and considered that calories should be declared for fixed or variable
combination meals available in multiple sizes.
    (Response 80) We previously addressed comments directed to standard
menu items other than variable menu items when the menu or menu board
lists an option to change the size of the standard menu item (see
Response 66). Here, we focus on calorie declarations for ``upsized
options'' and ``downsized options'' for combination meals that are
variable menu items. Consistent with our selection of Option 4 (see
discussion in section XII.B), Sec.  101.11(b)(2)(i)(A)(6)(iii)
specifies that when the menu or menu board includes a choice to
increase or decrease the size of a combination meal, the calorie
difference must be declared for the increased or decreased size with a
slash between two calorie declarations (e.g., ``Adds 100/150
calories,'' ``Subtracts 100/150 calories'') if the menu or menu board
lists two options for menu items in the combination meal, or as a range
in accordance with the requirements of Sec.  101.11(b)(2)(i)(A)(7)
(e.g., ``Adds 100-250 calories,'' ``Subtracts 100-250 calories'') if
the menu or menu board lists three or more options for menu items in
the combination meal.
    For example, if a covered establishment offers for sale a
combination meal that is a variable menu item consisting of a sandwich
with fries or with onion rings, and the menu or menu board includes a
choice to increase the size of the fries or the onion rings, the number
of calories added by the larger size must be declared using a slash
(e.g., ``Adds 250/300 calories'') since there are only two options for
menu items in the combination meal (e.g., fries or onion rings).
    As another example, if a covered establishment offers for sale a
combination meal that is a variable menu item consisting of a sandwich
with fries, onion rings, or tater tots, and the menu or menu board
includes an option to increase the size of the fries, onion rings, or
tater tots, the number of calories added by the larger size must be
declared as a range in accordance with the requirements of Sec.
101.11(b)(2)(i)(A)(7) (e.g., ``Adds 250-450 calories''), because there
are three options for menu items in the combination meal (e.g., fries,
onion rings, or tater tots).
    (Comment 81) A few comments requested flexibility and recommended
that the rule allow a covered establishment to choose the option for
declaring calories for variable menu items that best fits its business
and menu, and display calories for variable menu items in the best way,
as determined by the establishment, that allows consumers to choose
healthier options. One comment presented a series of specific
recommendations for disclosing calories, including specific
recommendations that did not fit squarely within any of the five
options for disclosing calories for variable menu items discussed in
the proposed rule. This comment recommended that calories for variable
menu items be disclosed by (1) providing an average or range, for each
size or price of the variable menu item accompanied by the term ``Avg.
Cal''; (2) declaring calories for the flavors, components, or toppings
that make up that variable menu item elsewhere on the primary writing;
or (3) displaying the calorie amount for one preset ``build'' of the
variable menu item. Under the comment's third option, the ``build''
would be representative of a finished version of the typical order and
could not be a rarely ordered base product to which additional fixings
are added. The comment also recommended that a covered establishment
declare the calories for the additional options available for the
variable menu item in a separate writing (such as an electronic kiosk,
a nutrition brochure, a menu addendum, a nutrition poster, or an online
nutrition application) available before or at the point of sale.
    For combination meals that are fixed, this comment recommended that
calories be disclosed by (1) providing total calories for the fixed
combination meal or (2) providing calories for each item or component
of the fixed combination meal elsewhere on the primary writing. For
combination meals that contain variable menu items, the comment
recommended that calories be disclosed by (1) providing calories as a
range reflecting the lowest and highest total meal calorie content
among the variations available; (2) providing a median or average
accompanied by the term ``Avg. Cal'' if the calories for all variations
within a variable combination meal are within 20 percent of the median
calorie value; (3) providing calorie information for each item of the
variable combination meal elsewhere on the primary writing; or (4)
providing the calories for one specified variation of the variable
combination meal. A covered establishment that elects to provide
calories for one specified variation of the combination meal would
identify the items in the variation specified, and disclose calories
for the other variations of the variable combination meal in a separate
writing available at the point of sale.
    (Response 81) We decline the requests of these comments to allow a
covered establishment to determine the method for declaring calories
for variable menu items based on factors determined by the
establishment. While this rule provides flexibility where appropriate,
taking into account different business practices, standard menu items,
and menus and menu boards, it also provides for uniform nutrition
labeling requirements to be applied in covered establishments. Such
consistency was one of the primary purposes of section 4205 of the ACA
(see e.g., section 4205(c)). Further, section 403(q)(5)(H)(v) of the
FD&C Act specifically directs FDA to establish by regulation
requirements for disclosing nutrition information for variable menu
items through means determined by FDA. In addition, section
403(q)(5)(H)(x)(II)(bb) of the FD&C Act directs FDA to issue
regulations specifying the format and manner of the nutrition
information disclosure requirements of section 403(q)(5)(H) of the FD&C
Act. This rule establishes requirements for disclosing the nutrition
information required under section 403(q)(5)(H) of the FD&C Act while
also providing flexibility. For example, we are establishing specific
format requirements for calorie declarations for individual variable
menu items, toppings listed on a menu or menu board, and combination
meals (Sec.  101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(7)), and we
also are providing an exemption from the requirements for calorie
declarations for combination meals in Sec.  101.11(b)(2)(i)(A)(6)(i)
through

(b)(2)(i)(A)(6)(iii) under the circumstances described in Sec.
101.11(b)(2)(i)(A)(6)(iv). In addition, Sec.  101.11(b)(2)(i)(A)(3)
provides flexibility on where to place the term ``Calories'' or ``Cal''
on a menu or menu board, and Sec.  101.11(b)(2)(i)(A)(1) provides
flexibility for the color and contrasting background of calorie
declarations. The calorie declaration requirements for variable menu
items in this rule help ensure that consumers get consistent
information when ordering from different covered establishments and
even when ordering within a single covered establishment. For example,
the approach suggested by the comments could lead to an inconsistent
presentation on the same menu or menu board within a single
establishment if a covered establishment determined that one approach
worked best for some of its menu items and another approach worked best
for other menu items.
    (Comment 82) A few comments recommended that calories for
combination meals be declared for the standard, ``default,'' or most
popular build. As an example, one comment recommended that calories
declared for a combination meal include the calories for fries if the
meal is depicted on a menu board as including fries. As another
example, the comment recommended that calories declared for a
combination meal include the calories in a full-calorie drink if more
than 50 percent of a covered establishment's combination meals are sold
with a full-calorie drink. One comment considered that the standard or
default is the meal depicted that accounts for more than a majority (51
percent) of the sales for that meal.
    (Response 82) We disagree with the comments in part. A combination
meal, including those described by the comments, could be listed on a
menu or menu board as a variable menu item, meaning that it could be
listed as a single menu item that comes in different flavors,
varieties, or combinations. Where a combination meal is listed on a
menu or menu board as a variable menu item, the meal would not have a
typical ``default build'' because some components that make up the meal
(e.g., hamburger, fries or onion rings, soft drink) come in different
flavors, varieties, or combinations that consumers are able to select.
Section 403(q)(5)(H)(v) of the FD&C Act requires, in relevant part,
that FDA establish by regulation standards for disclosing the nutrient
content for variable menu items, through means determined by FDA,
including ranges, averages, or other methods. Accordingly, we have
established the requirements for calorie declarations for variable menu
items that are combination meals in Sec.  101.11(b)(2)(i)(A)(6)(i)
through (b)(2)(i)(A)(6)(iii). These calorie declaration requirements
communicate the variability of calorie content in the combination meal
to consumers by providing the calorie information for each option when
there are only two options available or in a range when there are three
or more options available. In contrast, the methods for declaring
calories for combination meals that are variable menu items suggested
by the comments would not inform consumers that the calorie content of
their order selection may vary based on the options selected in the
combination meal.
    Where a combination meal is not listed on a menu or menu board as a
variable menu item, but is instead listed as a menu item that comes in
only one flavor, variety, or combination, the combination meal would
have a ``default build.'' As with a combination meal that comes in
different sizes, in this situation, Sec.  101.11(b)(2)(i)(A) requires a
covered establishment to provide the number of calories contained in
the combination meal listed on the menu or menu board, as usually
prepared and offered for sale. (See discussion about fixed combination
meals offered for sale in different sizes in Response 66.)

F. Format Requirements for Declaring Calories for an Individual
Variable Menu Item, a Combination Meal, and Toppings as a Range, if
Applicable (Final Sec.  101.11(b)(2)(i)(A)(7))

    As discussed previously in this document (see section XII.B), we
are revising Sec.  101.11(b)(2)(i)(A)(4) to require Option 4. One such
revision (established in Sec.  101.11(b)(2)(i)(A)(7)) specifies the
format requirements that must be followed when declaring calories as a
range. Under Sec.  101.11(b)(2)(i)(A)(7), calories that are declared as
a range must be in the format ``xx-yy,'' where ``xx'' is the caloric
content of the lowest calorie variety, flavor, or combination, and
``yy'' is the caloric content of the highest calorie variety, flavor,
or combination. We are establishing these specific format requirements
as a separate subparagraph so that the rule does not need to include
this format information each time the rule requires use of a range.

G. Exception for a Variable Menu Item When There Is No Clearly
Identifiable Upper Bound to the Range of Calories (Final Sec.
101.11(b)(2)(i)(A)(8))

    Proposed Sec.  101.11(b)(2)(i)(A)(4) would require, in relevant
part, that if a variable menu item appears on the menu or menu board
and is a self-service food or food on display, and there is no clearly
identifiable upper bound to the range, e.g., all-you-can-eat buffet,
then the menu or menu board must include a statement, adjacent to the
name or price of the item, referring customers to the self-service
facility for calorie information, e.g., ``See buffet for calorie
declarations.'' This statement must appear in a type size no smaller
than the name or price of the variable menu item, whichever is smaller,
and in the same color or a color at least as conspicuous as that name
or price, with the same contrasting background as that name or price.
    Comments that addressed this proposed provision supported it.
Therefore, we are finalizing it without change, except to:
     Redesignate it as Sec.  101.11(b)(2)(i)(A)(8) and clarify
that it is an ``exception'' to the requirements of Sec.
101.11(b)(2)(i)(A) for calorie declarations that must be provided on
menus and menu boards;
     Make a conforming change to Sec.  101.11(b)(2)(i)(A) to
acknowledge the exception in Sec.  101.11(b)(2)(i)(A)(8);
     Provide the same flexibility for the contrasting
background used for the statement referring customers to the self-
service facility for calorie declarations as for the calorie
declaration in Sec.  101.11(b)(2)(i)(A)(1);
     Make the same conforming editorial change to the
requirement directed to the color of this statement as for the calorie
declaration in Sec.  101.11(b)(2)(i)(A)(1);
     Make an editorial correction for clarity to insert ``the
type size of'' between ``no smaller than'' and ``the name or price.''
    Characterizing the provisions of Sec.  101.11(b)(2)(i)(A)(8) as an
``exception'' will clarify that the requirements of Sec.
101.11(b)(2)(i)(A)(1) through (b)(2)(i)(A)(7) do not apply when a
variable menu item appears on the menu or menu board and is a self-
service food or food on display, and there is no clearly identifiable
upper bound to the range of calories. Providing the same flexibility
for the contrasting background as for the contrasting backgrounds for
calorie declarations in Sec.  101.11(b)(2)(i)(A)(1) will provide a
consistent approach to background requirements on menus and menu

boards. Making the conforming editorial change to the requirement
directed to the color will promote consistency in terminology in the
rule.
    With these changes, Sec.  101.11(b)(2)(i)(A)(8) specifies that if a
variable menu item appears on the menu or menu board and is a self-
service food or food on display, and there is no clearly identifiable
upper bound to the range, e.g., all-you-can-eat buffet, the menu or
menu board must include a statement, adjacent to the name or price of
the item, referring customers to the self-service facility for calorie
information, e.g., ``See buffet for calorie declarations.'' This
statement must appear in a type size no smaller than the type size of
the name or price of the variable menu item, whichever is smaller, and
in the same color or a color at least as conspicuous as that used for
that name or price, with the same contrasting background or a
background at least as contrasting as that used for that name or price.

H. Declaring Calories Using Interactive Menus or New Technology

    (Comment 83) In the proposed rule, we recognized that the Internet
may allow for the use of different methods for disclosing calories,
such as by providing a calorie tracker in the ordering frame to tally
calories as customers make order selections (76 FR 19192 at 19209). We
requested comment on whether different methods should be used for
nutrient content declarations for interactive Internet menus in general
(76 FR 19192 at 19209). One comment asked that we acknowledge the
potential for advances in technology and establish a petition process
to request alternative methods of nutrition information disclosure via
technological innovations, e.g., via smart phone applications. The
comment also asked us to establish a process to approve methods that
reflect technological advances that we did not anticipate but that
comply with the statute.
    (Response 83) We are not establishing a petition process to approve
future methods for calorie declarations at this time. As suggested by
the comment, we specifically acknowledged that potential technological
advances may allow for the use of different methods in disclosing
calories in covered establishments and requested comments on such
methods. To the extent that the technological advances described by the
comment provide methods for declaring calorie information in accordance
with section 403(q)(5)(H) of the FD&C Act and Sec.  101.11, such
methods would be permissible. We will continue to consider whether
specific advances in technology may result in alternative methods for
nutrient content declarations under section 403(q)(5)(H) of the FD&C
Act.
    Later in this document (see Comment 113 and Response 113 in section
XVI.E), we address a similar comment from the perspective of new
technologies for providing written nutrition information.

XIII. Additional Requirements That Apply to Beverages That Are Not
Self-Service or on Display (Final Sec.  101.11(b)(2)(i)(A)(9))

    (Comment 84) One comment noted that the proposed rule did not
address the issue of ice fill for the declaration of calories for
beverages. The comment asked us to permit covered establishments to
calculate calories based on their standard ice fill as long as the
level of ice fill is disclosed to consumers. The comment recommended
that we expressly permit, regardless of whether there is a standard ice
fill, the following statement regarding ice fill: ``Calorie content may
vary based on the amount of ice used.''
    (Response 84) For beverages that are standard menu items and are
dispensed by an employee of a covered establishment (and, thus, are not
self-service), we acknowledge that some of the beverage would be
displaced by any ice added by the covered establishment. In addition,
the amount of beverage displaced may vary based on the amount and type
of added ice (e.g., crushed, cubed, shaved). Whereas some covered
establishments may dispense a standard beverage fill (i.e., a fixed
amount that is less than the full volume of the cup per cup size),
others may not. Likewise, whereas some covered establishments may have
a standard ice fill (i.e., a fixed amount of ice per cup size), others
may not. Accordingly, Sec.  101.11(b)(2)(i)(A)(9) of the final rule
requires that, for beverages that are not self-service, calories must
be declared based on the full volume of the cup served without ice,
unless the covered establishment ordinarily dispenses and offers for
sale a standard beverage fill (i.e., a fixed amount that is less than
the full volume of the cup per cup size) or dispenses a standard ice
fill (i.e., a fixed amount of ice per cup size). If the covered
establishment usually prepares and offers for sale a beverage using a
standard beverage fill or dispenses a standard ice fill, the covered
establishment must declare calories based on such standard beverage
fill or standard ice fill. Section 101.11(b)(2)(i)(A)(9) of the final
rule does not require a covered establishment to set a standard
beverage fill or standard ice fill. Instead, Sec.
101.11(b)(2)(i)(A)(9) requires the covered establishment to disclose
the number of calories contained in a beverage with a standard beverage
fill or ice fill ``as usually prepared and offered for sale,'' as
required by section 403(q)(5)(H)(ii) of the FD&C Act. The rule also
does not specify how a covered establishment should dispense a standard
beverage fill or standard ice fill. A covered establishment may choose
a method that is suited to its establishment--e.g., by using equipment
that automatically dispenses a volume specified by the establishment,
by using cups that have markings that enable an employee to manually
add a certain volume of beverage or ice, or by using a particular ice
scoop.
    Section 101.11(b)(2)(i)(A)(9) is consistent with section
403(q)(5)(H)(ii) of the FD&C Act, which requires covered establishments
to declare on menus and menu boards the number of calories contained in
standard menu items listed on such menus and menu boards, as usually
prepared and offered for sale. In establishing Sec.
101.11(b)(2)(i)(A)(9), we considered among other things, reasonable
variations in serving sizes used by covered establishments, and
therefore are allowing covered establishments to disclose calories
based on the full volume of the cup served without ice, unless the
covered establishment ordinarily dispenses and offers for sale a
standard beverage fill or dispenses a standard ice fill. We do not
expect that a statement that the calorie content of the beverage may
vary based on the amount of ice used, such as the one suggested by the
comment, will be necessary in light of the requirements of Sec.
101.11(b)(2)(i)(A)(9).
    In section XVII.D, we discuss ice fill for self-service beverages.

XIV. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(i)(B)--
Succinct Statement That Must Be on Menus and Menu Boards To Provide
Context About Calories in a Daily Diet

A. The Proposed Requirements

    Proposed Sec.  101.11(b)(2)(i)(B) would require the following
statement designed to enable consumers to understand, in the context of
a total daily diet, the significance of the calorie information
provided on menus and menu boards: A 2,000 calorie daily diet is used
as the basis for general nutrition advice; however, individual calorie
needs may vary.
    In the proposed rule, we referred to the statement in this
provision as the ``succinct statement'' and discussed principles that
should be met to help

ensure that the succinct statement is designed to enable consumers to
understand, in the context of a total daily diet, the significance of
the calorie information provided on menus and menu boards (76 FR 19192
at 19210). These principles are:
     The succinct statement should be succinct;
     The succinct statement should be in plain language that
consumers can understand;
     The total caloric value should be framed appropriately so
that it is not viewed as a recommendation for daily intake for every
consumer;
     The succinct statement should give consumers a means to
compare the calorie declaration for a menu item to total calories; and
     The succinct statement should inform consumers that
individual needs vary.
    In the following paragraphs, we discuss comments on this proposed
provision. After considering these comments, we are:
     Revising the succinct statement; and
     Providing for an optional succinct statement (which this
document refers to as the ``children's succinct statement'') for use on
menus and menu boards targeted to children as a substitute for, or in
addition to, the succinct statement.

B. Principles for Establishing the Succinct Statement

    (Comment 85) Several comments supported the principles we discussed
in the proposed rule for establishing the succinct statement.
    (Response 85) We acknowledge these comments.

C. Wording of the Succinct Statement

    (Comment 86) In the proposed rule, we signaled an intent to conduct
consumer research to evaluate consumer response to the proposed
succinct statement as well as to alternative succinct statements (which
we discussed in the proposal) (76 FR 19192 at 19210). One comment
supported such research, but suggested that more research should be
done to assess if there is a permanent behavioral change.
    (Response 86) Although the proposed rule contemplated consumer
research to guide the design of the succinct statement, we are
foregoing such research at this time in light of the number of comments
providing useful insight regarding the proposed succinct statement,
related principles, and whether we should provide a succinct statement
for children.
    (Comment 87) Several comments supported the proposed wording of the
succinct statement. Other comments opposed the proposed wording of the
succinct statement. Some comments considered that the information that
calorie needs vary should not be included because it is obvious, it
will clutter menus and menu boards, and there is no such phrase on
packaged food. Another comment expressed concern about the use of 2,000
calories in the succinct statement and recommended that the succinct
statement be better phrased to emphasize ``individual needs may vary,''
e.g., by including information that many adults need fewer than 2,000
calories. This comment opposed adding phrases about the amount of
exercise needed to burn a particular number of calories. One comment
asserted that the proposed succinct statement is not specific enough
and recommended that it focus on suggested calorie intake rather than
on a typical caloric intake.
    (Response 87) We are retaining the use of 2,000 calories as an
appropriate reference value to include in the succinct statement. As
discussed in the proposed rule, the Nutrition Facts on packaged foods
uses 2,000 calories as a reference amount on which to base recommended
intake for some nutrients for individuals 4 years of age and older, and