One comment pointed out that menu items in chain restaurants and
similar retail food establishments vary between States and within
States to accommodate local tastes, even if the menu items have the
same name. The comment cited chili as an example, stating that in
Cincinnati it is common for chili to be made with cocoa and cinnamon
thinned out with finely ground meat over spaghetti, whereas in Texas,
chili is made with large chunks of meat, often with beans, served alone
in a bowl.
    One comment stated that some food service contractors provide
clients with menus that may change daily, weekly, or monthly and with
rotating cycle menus that can use up to several hundred recipes with
cycle menus that vary from 3, 4, or 5 week cycles and from 5, 6, or 7
day service weeks. Due to the variability in menus in locations that
rely on contract food services, the comment recommended that the
definition of ``offering for sale substantially the same menu item'' be
changed to ``establishments in a chain that offer standard menus
comprised of menu items that use the same general recipes and are
prepared in substantially the same ways with substantially the same
food components, even if the name of the menu item varies.''
    (Response 31) We decline to name a proportion or percentage of menu
items that must be shared between establishments. Restaurants and
similar retail food establishments regularly offer new and reformulated
menu items in their establishments. It would be burdensome and
impractical for establishments and inspectors to continually evaluate
all of the establishments in the chain to count the numbers of standard
menu items in common in order to determine whether a given
establishment is covered. In addition, some establishments that are
part of a large chain may not offer for sale all of the standard menu
items offered in other locations of that chain. For example, some
chains have a handful of locations in airports or other venues notated
by the term ``Express'' added to the name, that sell a subset of the
foods that are carried by the larger establishments in the chain.
Finally, as the comments point out, some restaurants that are part of
large chains have some unique or regional items or may vary recipes in
a unique way. These types of minor variations should not exclude
establishments from the requirements of this rule.
    Based on the comments and on the considerations discussed
previously in this document, we are not finalizing a specific
proportion or percentage of menu items that covered establishments
within a chain must share. However, we understand from the comments
that our definition should speak to the number of menu items that must
be shared more clearly. Therefore, we are adding a qualitative, not
quantitative, description of the number of menu items that must be
shared in order for the criterion of ``offering for sale substantially
the same menu items'' to be met. Given the statutory language, along
with the practicalities of and variations within the industry, we are
adding ``offering for sale a significant proportion of menu items'' to
the definition of ``offering for sale substantially the same menu
items.'' For example, if establishments only share one or two menu
items, those establishments would not meet the criterion of ``offering
for sale substantially the same menu items.''
    We recognize that some establishments in a chain may have some menu
items with ingredients that vary based on regional taste or source.
Some menu items may be designed or prepared to meet certain dietary
practices (e.g., Kosher or Halal) or contain a ``secret ingredient.''
This is why our definition of ``offering for sale substantially the
same menu items'' includes the criteria ``us[ing] the same general
recipe, prepared in substantially the same way, with substantially the
same food components.'' By ``the same general recipe,'' we mean that
the establishments share a recipe, even if one establishment
subsequently tweaks that recipe due to regional tastes or dietary
practices. By ``prepared in substantially the same way,'' we mean to
include slight deviations from the recipe, because of, for example,
food service worker variability. By ``with substantially the same food
components,'' we mean to include situations where ingredients may vary
based on local availability or sourcing, including those used to
conform to certain dietary practices (e.g., Kosher meat).
    We also agree with comments that having the same name may indicate
that the menu items are substantially the same, but it does not always
do so. As comments pointed out, menu items that reflect regional
differences may be so different that the name of the menu item sheds
little light on whether the menu items use the same general recipe and
are prepared in substantially the same way with substantially the same
food components. For example, in some regions of the United States a
menu item named ``barbecue'' may refer to a food prepared from pulled
pork, whereas in other regions a menu item named ``barbecue'' may refer
to a food prepared from beef ribs. Therefore, we have revised the
definition to add a new sentence stating that having the same name may
indicate, but does not necessarily guarantee, that menu items are
substantially the same.
    The definition for ``substantially the same menu items'' would also
apply to establishments relying on food contractors. If such an
arrangement caused menu rotations, the relevant question would still be
whether those establishments are offering for sale substantially the
same menu items, including whether they are selling a significant
proportion of menu items that use the same general recipe and are
prepared in substantially the same way with substantially the same food
components, even if not necessarily at the same time. In other words,
the focus is on whether the menu items are substantially the same, not
on whether the menus or menu boards are substantially the same. We
decline to accept the suggestion from the comment to revise the
definition to include ``establishments in a chain that offer standard
menus comprised of menu items that . . .'' because it reflects a
misunderstanding that an establishment needs to have a menu, or a
``standard menu'' more specifically, to be covered by the new law.
    (Comment 32) One comment maintained that convenience stores in a
chain do not have identical business plans and the same food; the food
varies per establishment and is not prepared to corporate policy as it
is in restaurants.
    (Response 32) As explained previously in this document,
establishments can be ``offering for sale substantially the same menu
items'' even if not all of their menu items are exactly the same.
Depending on the extent to which the menu items vary, a convenience
store may or may not meet the criterion of offering for sale

substantially the same menu items as defined in the rule.
    (Comment 33) One comment described itself as a family-owned
restaurant operator with 25 restaurants located entirely within a
single State. Two of its restaurants also contain sushi operations,
each under a different name and with entirely different menus than the
larger establishment. The comment asked us to confirm that the rule
would not apply to these sushi operations.
    (Response 33) Based on the information in the comment, the two
sushi operations do not appear to be covered by the rule because they
are neither doing business under the same name (see section VI.E) nor
offering for sale substantially the same menu items as 18 other
establishments.

G. Authorized Official of a Restaurant or Similar Retail Food
Establishment

    Proposed Sec.  101.11(a) would define ``Authorized official of a
restaurant or similar retail food establishment'' as the owner,
operator, agent in charge, or other person authorized by the owner,
operator, or agent in charge to register the restaurant or similar
retail food establishment, which is not otherwise subject to section
403(q)(5)(H) of the FD&C Act, with FDA for the purposes of Sec.
101.11(d). (Section 101.11(d) pertains to voluntary registration to
become subject to the requirements of section 403(q)(5)(H) of the FD&C
Act.)
    We received no comments on the proposed definition and are
finalizing it without change.

H. Covered Establishment

    As already noted in section VI.A, proposed Sec.  101.11(a) would
define ``covered establishment'' as a restaurant or similar retail food
establishment that is a part of a chain with 20 or more locations doing
business under the same name (regardless of the type of ownership,
e.g., individual franchises) and offering for sale substantially the
same menu items, as well as a restaurant or similar retail food
establishment that is registered to be covered under section
403(q)(5)(H)(ix) of the FD&C Act. (Emphasis added).
    In the following paragraphs, we discuss general comments on this
proposed definition. We are finalizing the definition of ``covered
establishment'' without change, except to refer to Sec.  101.11(d)
instead of section 403(q)(5)(H)(ix) of the FD&C Act. However, as
already discussed (see sections VI.B, VI.C, VI.D, VI.E, and VI.F),
changes we are making to other terms (i.e., adding a definition of
``location,'' revising the definition of ``restaurant or similar retail
food establishment,'' revising the definition of ``restaurant-type
food,'' revising the definition of ``doing business under the same
name,'' and revising the definition of ``offering for sale
substantially the same menu items'') affect the overall set of covered
establishments.
1. General Comments on the Definition of Covered Establishment
    (Comment 34) One comment considered that our proposed definition
would make it conceivable for the requirements to apply to a single,
completely unique ``restaurant concept'' that is owned by a chain with
20 or more other restaurants. The comment described a ``restaurant
concept'' as separate and distinct operations by virtue of the
individual restaurant's menu offerings or recipes, name, decor, and
other distinguishing characteristics such as different dining
experiences with higher quality food and different menu items that may
be unrecognizable to the average diner as being operated by the larger
chain. This comment also considered that applying the menu labeling
requirements to these individual ``restaurant concepts'' would not be
consistent with the statute or intent of Congress. Another comment
expressed concern that a person who operates more than 20 chain retail
food establishments and wants to start a ``new concept'' would be
required to provide nutrition information if this ``new concept'' is
only in one location.
    (Response 34) We disagree that we need to revise the definition of
a covered establishment to prevent a misinterpretation that a single,
completely unique ``restaurant concept'' that is owned by a chain with
20 or more other restaurants generally would be covered by the rule. An
establishment that is ``single'' and a ``completely unique restaurant
concept'' is unlikely to have ``20 or more locations'' and be
``offering for sale substantially the same menu items'' as 20 or more
other restaurants. Thus, such an establishment is unlikely to satisfy
the criteria in the proposed definition to be a ``covered
establishment'' as it is currently written. Likewise, if a person
operates more than 20 chain retail food establishments and starts a
``new concept,'' that ``new concept'' establishment would not be a
covered establishment unless it is part of a chain with 20 or more
locations doing business under the same name and offering for sale
substantially the same menu items. We are retaining our definition,
which, as we described in the proposed rule, is derived from sections
403(q)(5)(H)(i) and (xi)(I) of the FD&C Act (76 FR 19192 at 19195).
    (Comment 35) One comment recommended that we revise the definition
of covered establishment to use the following language from its State's
regulation: ``A food establishment that: (1) Is engaged in the business
of preparing and selling food items for immediate human consumption on
the premises or off the premises, . . . and (2) offers for sale
substantially the same menu items, utilizing menus, menu boards or food
item tags, in servings that are standardized for portion size and
content, and (3) is one of a group of . . . food establishments . . .
that (a) operates under common ownership or control, or (b) operates as
franchised outlets of a parent business, or (c) does business under the
same name.'' The comment cited only those portions of its regulation
relevant to the questions raised by the definition of covered
establishment in our proposed rule, and used ellipses to indicate text
that was in the State regulation but not being offered as part of the
definition of ``covered establishment'' in this rule.
    (Response 35) We disagree with this comment and are not revising
the definition of ``covered establishment'' to incorporate its
suggestions. Our definition of covered establishment is derived from
the Federal statutory language. The only basis offered by the comment
was that the suggestions are used in a State law; the comment did not
state why these changes were necessary from a policy perspective or
legally justified under the Federal law.
    (Comment 36) One comment recommended that the rule apply to most
restaurants, and not just those with more than 20 locations, possibly
excluding only establishments with a very small seating capacity. The
comment contended that consumers already know that fast food is ``bad
for you'' and they need to know the nutrition information about the
food in other restaurants.
    (Response 36) This rule implements section 4205 of the ACA, which,
in general, covers only restaurants and similar retail food
establishments that are part of a chain with 20 or more locations.
Section 4205 of the ACA allows other restaurants and similar retail
food establishments to register with FDA to become subject to the
Federal requirements, but it does not require them to do so.
    (Comment 37) One comment asked us to clarify whether the rule would
apply to foreign establishments of a particular chain that has 20 or
more establishments in the United States, and also has an establishment
located in a foreign location, such as Italy.

    (Response 37) The rule applies to locations in the United States,
including any State or Territory of the United States, the District of
Columbia, and the Commonwealth of Puerto Rico. This geographic scope is
consistent with the definitions of ``State'' and ``Territory'' in
section 201(a) of the FD&C Act.
    (Comment 38) A few comments asked us to clarify that contractors
and managed food service operations would be covered if they offer for
sale substantially the same menu items.
    (Response 38) Whether any other specific contractor or managed food
service would be subject to the rule would depend on whether it
satisfied all criteria established within the definition of ``covered
establishment.'' Thus, to be a covered establishment, an establishment
operated by a contractor or managed food service must be a restaurant
or similar retail food establishment that is a part of a chain with 20
or more locations doing business under the same name and offering for
sale substantially the same menu items. We expect that some
establishments operated by contractors and managed food services will
satisfy all of these criteria.
2. Cooperatives
    (Comment 39) Some comments addressed cooperatives and discussed
multiple aspects related to the definition of ``covered
establishment,'' including ``part of a chain,'' ``doing business under
the same name,'' and ``offering for sale substantially the same menu
items.'' One comment considered that cooperatives should not be exempt
because the law expressly states ``regardless of . . . ownership.'' One
comment considered that the type of ownership of grocery stores, such
as a cooperative, is irrelevant to whether a store is part of a chain.
This comment maintained that the law clearly requires chains operating
under the same name to disclose calories, regardless of the type of
ownership. This comment also maintained that grocery store cooperatives
face a similar situation as that faced by independent franchise owners
of chain restaurants.
    Other comments generally expressed the view that cooperatives
should not be covered by the rule. One comment asserted that
establishments associated with the same wholesaler or cooperative
should not be considered ``part of a chain'' regardless of whether they
operate under the same ``banner'' or under a different ``banner.'' The
comment considered that cooperatives are the opposite of chains because
they are owned by individual members, operate independently, and are
not bound by franchise agreements, whereas chains are centrally
controlled with little say or choice by participants. The comment asked
us to recognize that independent grocers are not part of a chain of 20,
doing business under same name and selling the same items, even if we
believe cooperatives are similar retail food establishments.
    A few comments maintained that the definition for ``doing business
under the same name'' does not apply to cooperatives because they are
independent and exercise their independence more than franchised
restaurants. According to one comment, independent retailers own,
control, and operate their stores independently as customers of
voluntary wholesalers and members of cooperatives. The comment
explained that the food distribution system allows independent
retailers to take advantage of economies of scale when procuring goods
and services, as well as marketing and advertising, thus helping
independent operators effectively compete with large national chain
stores. The comment also explained that these entities are
independently owned and operated businesses that often compete with
other stores under the same banner name, and that menu items can have
different general recipes and be prepared in substantially different
ways with substantially different food components.
    One comment asked us to recognize that members of cooperatives are
not ``doing business under the same name.'' For example, the comment
considered that ``Fred's Thriftway'' is not the same as ``Bob's
Thriftway.'' The comment considered that ``Thriftway'' signals that
these establishments are part of a cooperative but maintained that they
are two different stores.
    One comment contended that the term ``offering for sale
substantially the same menu items'' may not apply to some foods, such
as brownies or potato salad, made in grocery store cooperatives,
although those foods may be offered for sale under the same name in
those stores. According to the comment, ``Bob's Thriftway'' and
``Mike's Thriftway'' may both sell brownies made from the same general
recipe, (e.g., flour, sugar, eggs, chocolate and butter); however,
because independent grocers compete with each other, each is likely to
include a secret ingredient, and as a result, the brownies are not the
same.
    (Response 39) We agree with some comments that the type of
ownership of an establishment is not relevant to whether it is covered.
To be subject to the rule, a cooperative must satisfy all the criteria
in the definition of ``covered establishment.'' In other words, to be
subject to the rule a cooperative must be a restaurant or similar
retail food establishment that sells restaurant-type food and is a part
of a chain with 20 or more locations doing business under the same name
(regardless of the type of ownership, e.g., individual franchises) and
offering for sale substantially the same menu items. As we explain in
section VI.D., we are not defining the term ``chain'' in this
rulemaking. In addition, for the reasons we provide in section VI.E.,
we continue to define doing business under the same name to include
names that are slight variations of each other. Independent businesses
that are cooperatives, even those that are similarly named, are not
covered establishments if, for example, they are only connected insofar
as they take advantage of economies of scale when procuring goods and
services, or for marketing and advertising purposes, but are not
``offering for sale substantially the same menu items.''
    However, given the way cooperatives generally are structured, we do
not expect that two cooperatives would be offering for sale
substantially the same menu items. Unless a food such as a brownie
offered for sale in Bob's Thriftway has the same general recipe,
prepared in substantially the same way, with substantially the same
food components as a brownie offered for sale in Mike's Thriftway, the
two cooperatives' brownies would not be ``substantially the same.''
However, if Bob's Thriftway and Mike's Thriftway share a recipe such as
a brownie recipe, and the only difference between the two brownie
recipes is that Mike's Thriftway has added a ``secret ingredient,'' the
brownies could be considered substantially the same menu item,
depending on the importance of that ingredient. Note that even in this
circumstance, Bob's Thriftway and Mike's Thriftway would not be
``offering for sale substantially the same menu items'' if the brownie
is the only menu item that the two cooperatives share.
    In addition, we note that a cooperative that is a restaurant or
similar retail food establishment and does not satisfy all of the
criteria to be a covered establishment, but voluntarily registers to be
covered in accordance with Sec.  101.11(d), would be subject to the
rule.

I. Revisions to Several Provisions To Clarify the Applicability of the
Rule to Those Restaurants and Similar Retail Food Establishments That
Are Covered Establishments

    This rule applies to restaurants and similar retail food
establishments that satisfy the definition of ``covered establishment''
in this rule. Several provisions of the proposed rule that would apply
to ``covered establishments'' used the term ``restaurant or similar
retail food establishment'' rather than ``covered establishment.'' To
make clear that those provisions only apply to those restaurants and
similar retail food establishments that satisfy the definition of
``covered establishment,'' we are replacing the term ``restaurant or
similar retail food establishment'' with ``covered establishment'' in
those provisions. The affected provisions are:
     The definition of ``custom order'' (Sec.  101.11(a));
     The definition of ``menu or menu board'' (Sec.
101.11(a));
     The introductory text of Sec.  101.11(b)(2)(ii) regarding
nutrition information for a standard menu item that must be available
in written form;
     The introductory paragraph of proposed Sec.  101.11(c)(6)
(which we are establishing in Sec.  101.11(c)(3)) regarding information
that must be provided to FDA substantiating nutrient information; and
     A subparagraph of proposed Sec.  101.11(c)(6) regarding
specific substantiation documentation (i.e., proposed paragraph
(c)(6)(ii)(D), which we are establishing as paragraph (c)(3)(ii)(D)).
    We note these changes in our discussion of each of these specific
provisions.

VII. Comments and FDA Response on the Proposed Definition of Menu or
Menu Board (Proposed Sec.  101.11(a))

    Proposed Sec.  101.11(a) would define ``menu or menu board'' as the
primary writing of the restaurant or similar retail food establishment
from which a customer makes an order selection, including, but not
limited to, breakfast, lunch, and dinner menus; dessert menus; beverage
menus; children's menus; other specialty menus; electronic menus; and
menus on the Internet. The proposed definition would also provide that
menus may be in different forms, e.g., booklets, pamphlets, or single
sheets of paper and that menu boards include those inside a restaurant
or similar retail food establishment as well as drive-through menu
boards at restaurants or similar retail food establishments.
    In the proposed rule, we stated that given the importance for all
consumers to have access to nutrition information when making order
selections, ``primary writing'' should be interpreted from a consumer's
vantage point (76 FR 19192 at 19202). For example, while a printed menu
may be the ``primary writing'' of a restaurant used by a customer
ordering food while dining inside the restaurant itself, a menu mailed
as a flyer to another customer's home could be the ``primary writing''
of the restaurant used by that customer ordering take-out or delivery
from the same restaurant. Both the printed menu and the menu flyer
would meet the definition of ``menu'' or ``menu board'' under proposed
Sec.  101.11(a).
    In the following paragraphs, we discuss comments on this proposed
definition. We have revised the definition by replacing the term
``restaurant or similar retail food establishment'' with ``covered
establishment'' in three locations in the definitions for clarity (see
explanation in section VI.I). We are also including factors used to
determine whether a writing is or is part of the primary writing from
which a consumer makes an order selection.
    (Comment 40) Many comments supported the proposed definition and
agreed that ``primary writing'' should be interpreted from the
perspective of consumers, so that each writing of the establishment
that is the primary writing used by consumers in making order
selections would be considered a menu or menu board. Several comments
asserted that consumers need to see calorie information when making
order selections in order for the information to be useful to them. One
comment noted that Congress did not intend for covered establishments
to only provide calorie declarations on a single medium in each
establishment, as evidenced by the fact that section 4205 of the ACA
requires calorie declarations on drive-through menu boards and menus
and menu boards located inside establishments. Another comment
suggested that we emphasize that any list or display of a standard menu
item that is primary to the consumer placing an order would constitute
a menu or menu board.
    One comment considered that a single store that has multiple menus
or menu boards should be able to select the menu on which the calories
must be disclosed. For example, a single store might have more than one
menu board--with one such board being handwritten and highlighting
specific special options. As long as every food offered for sale in the
establishment is listed on one menu board and that menu board includes
the necessary information, the comment considered that requiring
calories on that one menu board should be sufficient. Alternatively,
the comment suggested that the calorie declaration be required on the
``menu board of prominence,'' which the comment considered to be the
menu board from which the order is placed.
    Another comment similarly asserted that covered establishments must
post the required information on the menu used most often rather than
on all menus. Alternatively, the comment suggested that we provide an
exemption for menus not commonly used by customers. In support of its
suggestion, the comment pointed out that the statute uses the singular
term ``writing'' and not a plural term. The comment stated that 90
percent of pizza customers order over the phone or the Internet or may
order from memory. The comment asserted that to require nutrient
information on every menu, menu board, Internet menu, or other writing
is expensive, time consuming, and burdensome. The comment stated that
it already uses in-store brochures to provide nutrition information to
the small percentage of in-store customers. Although each franchisee in
the applicable chain is required to carry certain menu items, the
comment considered that each franchisee has the latitude to add items
to the menu. Because the franchisee can add menu items to its menu, the
comment asserted that it would be costly to a franchisee to change menu
boards, because the franchisee will be required to order new menu
boards and request calorie information for the new menu items.
    One comment referred to an ``industry proposal'' for posting
calories only on menus and menu boards that have the highest percentage
of sales for that particular establishment, e.g., Web sites used for
Internet ordering and paper menus for phone ordering. This comment was
opposed to any such proposal. The comment asserted that this approach
would be an unfair business advantage for certain restaurants because
it would allow some restaurants to provide calorie declarations on less
expensive menus such as paper take-out menus or Internet Web sites
while others would have to provide calorie declarations for more
expensive in-restaurant menus and menu boards. The comment also
expressed concern that any requirement for a covered establishment to
declare calories on only the menus that listed substantially all menu
items would exclude children's menus and dessert menus.

    (Response 40) We agree with the comments in support of the proposed
definition. We disagree that the required information should only be
posted on the menu or menu board most often used by consumers in a
covered establishment, the ``menu board of prominence,'' or only on the
menus and menu boards that have the highest percentage of sales for a
particular covered establishment. The critical factor is whether
written material is or is part of the primary writing of a covered
establishment from which a customer makes an order selection. It is not
a matter of physical prominence of a menu, or the proportion of
customers who order from a menu. Some consumers may want to select from
a subset of standard menu items sold in the covered establishment. For
example, if a consumer wanted to order only a dessert, he or she may
ask for a dessert menu. As raised by one comment, if calorie
information is listed only on the dinner menu, the consumer would not
have access to the calorie information for the desserts if he or she is
ordering from the dessert menu. As we stated in the proposed rule,
given the importance for all consumers to have access to nutrition
information when making order selections, we believe that the term
``primary writing'' should be interpreted from a consumer's vantage
point (76 FR 19192 at 19202).
    In addition, in the proposed rule, we tentatively concluded that a
``menu'' or ``menu board'' includes any writing of the covered
establishment that is the primary writing from which a consumer makes
an order selection (76 FR 19192 at 19201). We affirm this conclusion.
The ``primary writing'' of an establishment can include more than one
form of written material, such as a paper menu, a delivery menu, and a
menu board; the critical factor is whether the written material is or
is part of the primary writing of a covered establishment from which a
customer makes an order selection. Further, we clarify that determining
whether a writing is or is part of the primary writing from which a
consumer makes an order selection depends on a number of factors,
including whether the writing, such as a paper menu, delivery menu, or
sign, lists the name of a standard menu item (or an image depicting the
standard menu item) and the price of the standard menu item, and
whether the writing can be used by a consumer to make an order
selection at the time the consumer is viewing the writing (e.g., the
writing is posted at the cash register in a covered establishment, or
the writing lists the phone number or email address of a covered
establishment for purposes of placing an order).
    Accordingly, a writing of a covered establishment that contains the
name (or image) and price of a standard menu item, and that can be used
by a consumer to make an order selection from the establishment at the
time the consumer is viewing the writing would be a menu or menu board
regardless of whether, for example, the writing is not the menu used
most often by consumers. Another writing, such as a poster on a
storefront, a banner or billboard located along a road or highway, or a
tray-liner or table-tent at a quick-service restaurant, could be
considered a ``secondary'' writing within this context and would not
meet the definition of a ``menu or menu board,'' provided that such
writing does not contain the name (or image) and price of a standard
menu item, and cannot be used by a consumer to make an order selection
at the time the consumer is viewing the writing.
    We interpret the comment asserting that section 403(q)(5)(H)(xi) of
the FD&C Act uses the singular term ``writing'' in defining the term
``menu or menu board'' as raising the question of what Congress
intended ``primary writing'' to mean within the context of section
403(q)(5)(H)(xi) of the FD&C Act. In construing section
403(q)(5)(H)(xi) of the FD&C Act, FDA is confronted with two questions.
First, has Congress directly spoken to the precise question presented
(Chevron step one)? (Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837,
842 (1984).) If the ``intent of Congress is clear,'' an Agency ``must
give effect to the unambiguously expressed intent of Congress.'' (Id.
at 843.) However, if ``Congress has not directly addressed the precise
question at issue,'' and the statute is ``silent or ambiguous with
respect to the specific issue,'' then our interpretation of the term
``primary writing'' will be upheld as long as it is based on a
``permissible construction of the statute (Chevron step two). (Chevron,
467 U.S. at 842-43; FDA v. Brown & Williamson Tobacco Corp, 529 U.S.
120, 132 (2000).) To find no ambiguity, Congress must have clearly
manifested its intention with respect to the particular issue. (See
e.g., Young v. Community Nutrition Institute, 476 U.S. 974, 980
(1986).)
    We have determined that, in enacting section 403(q)(5)(H)(xi) of
the FD&C Act, Congress did not speak directly and precisely to the
meaning of ``primary writing'' within the definition of ``menu or menu
board.'' In conducting the Chevron step one analysis, we began with the
language of section 403(q)(5)(H)(xi) of the FD&C Act. (See e.g., Touche
Ross & Co. v. Redington, 442 U.S. 560, 568 (``[A]s with any case
involving the interpretation of a statute, our analysis must begin with
the language of the statute itself.'').) The term ``primary writing''
is not defined in section 403(q)(5)(H) of the FD&C Act or elsewhere in
the FD&C Act. In general, a term that is undefined in a statute carries
its ordinary meaning. (See e.g., Perrin v. United States, 444 U.S. 37,
42 (1979) (``A fundamental canon of statutory construction is that,
unless otherwise defined, words will be interpreted as taking their
ordinary contemporary, common meaning.'').) One common definition of
the term ``writing'' is ``something written, especially (a) meaningful
letters or characters that constitute readable matter . . . (b) a
written work, especially a literary composition'' (Ref. 20). Similarly,
another common definition of the term ``writing'' is ``something
written: As (a) letters or characters that serve as visible signs of
ideas, words, or symbols; (b) a letter, note, or notice used to
communicate or record; (c) a written composition.'' (Ref. 21; see also
Ref. 22).
    One common definition of the term ``primary'' is ``first or highest
in rank or importance; principal'' (Ref. 23; see also Refs. 24 and 25).
Another common definition of the term ``primary'' is ``functioning or
transmitting without intermediary: Direct'' (Ref. 25; see also Ref.
24).
    Where, as here, the statutory language on its face does not clearly
establish Congressional intent, it is appropriate to also consider
other traditional tools of statutory construction, including other
language in the section, the language, design, and purpose of the
statute as whole, and legislative history. (See e.g., Pharmaceutical
Research & Manufacturers of America v. Thompson, 251 F.3d 219, 224
(D.C. Cir. 2001); Davis v. Michigan Department of Treasury, 489 U.S.
803, 809 (1989); Martini v. Federal National Mortgage Association, 178
F.3d 1336, 1345 (D.C. Cir. 1999).) The other language in section
403(q)(5)(H)(xi) of the FD&C Act indicates that the writing at issue is
writing of the establishment ``from which a consumer makes an order
selection.'' Further, other provisions within section 403(q)(5)(H) of
the FD&C Act indicate that requirements apply to more than one form of
writing within a covered establishment. (See sections
403(q)(5)(H)(ii)(I) and (II) of the FD&C Act.) In addition, a general
purpose of section 4205 of the ACA is to make calorie and other
nutrition information available to consumers in a direct and

accessible manner to enable consumers to make informed and healthful
dietary choices. Lastly, the legislative history does not suggest that
Congress intended to limit the term to only one writing of the
establishment.
    Having determined that the meaning of ``primary writing'' in
section 403(q)(5)(H)(xi) of the FD&C Act is ambiguous, we have
determined that the final rule's interpretation of ``primary writing''
is a permissible construction of the statute (Chevron step two). In
conducting the Chevron step two analysis, the same tools of statutory
construction are available as those for the step one analysis.
    First, the interpretation in the final rule is consistent with the
plain meaning of the statute (Ref. 26). (See also Perrin v. United
States, 444 U.S. 37, 42 (1979).) Under the final rule, a ``primary
writing'' is ``something written,'' such as letters or characters on a
sign or board. Further, determining whether the ``writing'' is
``primary,'' meaning of the most relevance or importance within this
context or functioning without intermediary, or direct, depends on a
number of factors, including whether the writing lists the name of a
standard menu item (or an image depicting the standard menu item) and
the price of the standard menu item, and whether the writing can be
used by a consumer to make an order selection at the time the consumer
is viewing the writing. In developing these factors, we considered
other language in section 403(q)(5)(H)(xi) of the FD&C Act,
specifically that the writing of the establishment is one ``from which
a consumer makes an order selection.'' We also considered other
language within section 403(q)(5)(H) of the FD&C Act, including
sections 403(q)(5)(H)(i) and (ii)(I) and (II) of the FD&C Act, which
together require a covered establishment to post calorie and other
information on a menu and menu board. Further, in considering the
general purpose of the section 4205 of the ACA, we determined that
construing the term ``primary writing'' within the meaning of section
403(q)(5)(H)(xi) of the FD&C Act so as to include more than one form of
writing, dependent on specific factors, would better serve the purposes
of section 4205.
    For all of these reasons, Sec.  101.11(a) continues to specify that
a menu or menu board is defined as the primary writing of the
restaurant or similar retail food establishment from which a consumer
makes an order selection.
    In response to the comment regarding costs related to adding new
menu items to a menu or menu board, we first note that section
403(q)(5)(H)(ii) of the FD&C Act requires covered establishments to
declare calories on menus and menu boards for standard menu items
listed on such menu and menu boards. Therefore, to the extent a covered
establishment adds a new standard menu item to the establishment's menu
or menu board, the establishment would be required to declare calories
on the menu or menu board for the new standard menu item. Further, a
covered establishment that decides to add a new menu item to a menu or
menu board has already decided to incur the cost of redesigning or
replacing the menu or menu board for such change--i.e., to display the
new standard menu item. In this situation, the additional cost to the
establishment is the cost for determining the calorie information that
must be declared for the new standard menu item.
    Regarding costs related to determining nutrition information for
standard menu items, we note that this rule also provides flexibility
in order to minimize such costs. As discussed in section XVIII, section
403(q)(5)(H)(iv) of the FD&C Act provides that a restaurant or similar
retail food establishment must have a reasonable basis for its nutrient
content disclosures. As also discussed in section XVIII, this rule
provides that a covered establishment can satisfy the requirements of
403(q)(5)(H)(iv) of the FD&C Act by various means, including use of
nutrient databases, cookbooks, laboratory methods, and other reasonable
means, including the use of Nutrition Facts on labels on packaged foods
that comply with the nutrition labeling requirements of section
403(q)(1) of the FD&C Act and Sec.  101.9, FDA nutrient values for raw
fruits and vegetables in Appendix C of part 101 (21 CFR part 101), or
FDA nutrient values for cooked fish in Appendix D of part 101 (see
Sec.  101.11(c)(1)). In addition, this rule provides that a covered
establishment can satisfy the requirements of 403(q)(5)(H)(iv) of the
FD&C Act by relying on nutrition information for a standard menu item
determined by the establishment's corporate headquarters or parent
entity (see Sec.  101.11(c)(3)(i)(F), (c)(3)(iii)(D), and
(c)(3)(iv)(D)). In some cases, a corporate headquarters or parent
entity could decide to maintain a nutrient database and use it to
determine nutrition information for specialty standard menu items
offered for sale by one or a few individual establishments in the
chain. Therefore, this rule provides flexibility for covered
establishments in order to minimize costs while also helping to ensure
that calorie and other nutrition information is made available to
consumers in a direct and accessible manner to enable consumers to make
informed and healthful dietary choices.
    (Comment 41) A few comments appeared to believe that the proposed
rule would require covered establishments to post or otherwise have
menu boards for disclosing calorie information. These comments asked
for other options for disclosing calories. One comment suggested that
large menu boards should not be required because they will obscure the
consumers' view of the preparation of their food and thereby create a
food safety issue. One comment suggested that we consider
``technological solutions'' instead of menu boards, e.g., use of a
kiosk near the point of sale. The comment also suggested that we
provide flexibility to cover alternative sources such as a daily
feature board.
    One comment asked us to provide flexibility for facilities that
operate in locations too small to display a menu board by allowing
establishments to choose among several different options for display
methods. As one alternative to the traditional menu board, the comment
asked us to permit the use of a display terminal to provide nutrition
information for menu items or allow ``menu identifiers'' (a term the
comment did not define) at the point of selection, and to permit
nutrition information to be displayed adjacent to the food item in
cafeteria and buffet type settings.
    (Response 41) Some comments may have misinterpreted the proposed
rule. We did not propose to require that covered establishments post or
otherwise have menu boards. Rather, within this context, we proposed to
define the terms ``menu'' and ``menu board,'' based on the statutory
definition at section 403(q)(5)(H)(xi) of the FD&C Act, and to provide
direction regarding what information must be disclosed on menus and
menu boards for covered establishments that have menus and menu boards.
That proposed definition relies on the concept of a primary writing. If
an electronic display is the primary writing of the covered
establishment from which a customer makes an order selection, it would
satisfy our definition of a menu or menu board. As such, electronic
menus may be used by covered establishments, and we have retained
electronic menus as an example of menus in the definition of menu or
menu board in Sec.  101.11(a).
    Standard menu items offered for sale in covered establishments with
cafeteria- and buffet-type settings are most likely foods on display or
self-service foods. As discussed in section XVII.B, for a food on
display or a self-

service food, section 403(q)(5)(H)(iii) of the FD&C Act and Sec.
101.11(b)(2)(iii) require covered establishments to place a sign
adjacent to the food listing calories per displayed food item or per
serving. This rule provides flexibility for covered establishments by
providing a number of options for meeting the requirements of section
403(q)(5)(H)(iii) of the FD&C Act and Sec.  101.11(b)(2)(iii). For
example, covered establishments are permitted to declare calories for a
food on display or a self-service food by posting calorie declarations
on signs adjacent to the food, on a sign attached to a sneeze guard, or
on a single sign or placard (Sec.  101.11(b)(2)(iii)(A)). Therefore,
this rule provides flexibility, as requested by some comments, for
covered establishments to choose among several options for declaring
calorie information for standard menu items, including self-service
foods or foods on display in cafeteria and buffet-type settings.
    (Comment 42) In the proposed rule, we noted that many consumers
order restaurant-type food from restaurants or similar retail food
establishments over the phone or Internet. We tentatively concluded
that if consumers can order from a covered establishment online, over
the phone, or by fax, using a writing of the covered establishment on
the Internet as the primary writing from which he or she makes his or
her order selection, then the writing on the Internet is a menu for the
purposes of section 403(q)(5)(H) of the FD&C Act (76 FR 19192 at
19202). Some comments asked us to keep in mind the need to keep up with
technology and not have a rigid standard.
    (Response 42) The definition of ``menu or menu board'' clearly
specifies that menus may be in different forms and does not establish a
standard for the technology used on a menu or menu board. The
definition lists a number of examples of primary writings that may be
menus or menu boards, including electronic menus and menus on the
Internet, that are not meant to be all-inclusive, as indicated by use
of the terms ``including, but not limited to'' before the examples.
Because a menu or menu board is defined as the primary writing of the
covered establishment from which a customer makes an order selection,
the definition is adequate to capture methods and media other than
those specifically listed in that definition, so long as such methods
and media otherwise satisfy the criteria in the definition.
    (Comment 43) Several comments noted that some local zoning laws do
not permit restaurants with drive-through windows to build larger menu
boards. These comments expressed concern about how to comply with the
new requirements for menu boards in light of State or local size
restrictions. One comment asked us to provide more flexibility for
compliance, including permitting the use of a pamphlet next to the
drive-through menu board. Some comments suggested that we allow
nutrition information on a large poster adjacent to the menu board.
    A few comments supported the use of stanchions (i.e., free-standing
boards that are not connected to the menu board and are often placed
near drive-through menu boards) to post calorie information. One
comment maintained that restaurants and similar retail food
establishments have a vested interest in customer satisfaction in the
context of drive-through windows and have concluded that clear and
organized space, presented within the framework of a known brand, is
the most critical success factor in presenting information to consumers
on menu boards. This comment considered that stanchions adjacent or
close to menu boards are ``complete thoughts'' if the information is
relevant, well organized, and clearly marked, and that such stanchions
will help consumers with their menu choices. The comment considered
that in many cases information on stanchions is more clear and
conspicuous than on menu boards. The comment noted that calorie
information is provided on stanchions in some jurisdictions that
require nutrition labeling on menus and menu boards, including
Montgomery County (Maryland), New York City, Philadelphia, and certain
counties in New York. The comment maintained that the current use of
stanchions in some jurisdictions is evidence of its effectiveness, and
noted that some States and localities permit stanchions because
information is hard to read on already crowded drive-through menu
boards.
    A comment from a quick-service restaurant chain asserted that
stanchions are less costly to update and replace than menu boards. The
chain had conducted a consumer survey of customers who purchased food
from the chain's drive-through windows in 13 of the chain's restaurants
that use stanchions, as permitted in King County, Washington, and
submitted a report of this survey to the docket for this rule (Ref.
27). For the 128 customers surveyed, the comment reported that 92
percent felt it was easy to find calories, 98 percent felt calories
were easy to understand, 95 percent thought the stanchion location was
clearly visible to consumers, 95 percent noted nothing blocked view of
stanchion, and 76 percent felt they had adequate time to review before
ordering.
    One comment considered that while ``the statute'' refers to menus
and menu boards, it also gives us authority to define those terms. (We
assume this comment is referring to section 4205 of the ACA.) The
comment stated that we could include stanchions as a method to
communicate calorie information that is clear and conspicuous.
    Several comments agreed with our tentative conclusion that
stanchions inadequately convey calorie information. The comments
asserted that it is challenging for consumers to read different
information in different locations at a drive-through window especially
when trying to read the information from a car, where consumers have
limited mobility and a limited field of vision. The comments also
asserted that, even with different zoning laws, drive-through menu
boards have enough room for calories, although photos and other
marketing information may need altering. One comment pointed out that
separate stanchions would not comply with section 403(q)(5)(H)(ii) of
the FD&C Act, which requires that calories be on the menu board itself.
    (Response 43) We disagree that the rule should provide for
declaration of calorie information in pamphlets or on posters or
stanchions, rather than on the menu board at a drive-through in a
covered establishment. In the proposed rule, we tentatively concluded
that stanchions inadequately convey calorie information because a
situation in which customers need to look to one board (the menu board)
for important food-selection information, such as price, and another
(the stanchion) for calories, is likely to be more difficult for
customers attempting to use the declared calorie information at the
point of selection (76 FR 19192 at 19206). We also tentatively
concluded that this is particularly true in the drive-through context,
where customers have a restricted field of vision from their car
windows, and may have a relatively short time to consider the menu
board prior to ordering, because customers often cannot view the full
menu while waiting in line. As discussed further in the following
paragraphs, the comments provide insufficient basis for us to conclude
otherwise, and as a result, we affirm our conclusion from the proposed
rule.
    In addition, section 403(q)(5)(H)(ii)(II)(aa) of the FD&C Act
requires the number of calories contained in standard menu items to be
disclosed on the menu board itself.

Section 403(q)(5)(H)(xi) of the FD&C Act defines ``menu'' or ``menu
board'' as ``the primary writing of the restaurant or similar retail
food establishment from which a customer makes an order selection.''
Because a stanchion is a free-standing board that is not connected to a
drive-through menu board and therefore typically is not used by
consumers to make order selections, we do not consider it to meet the
definition of ``menu'' or ``menu board'' as defined in this rule and
section 403(q)(5)(H)(xi) of the FD&C Act. Accordingly, we concluded
that a stanchion cannot be the means by which a covered establishment
discloses calorie declarations on menus and menu boards as required
under section 403(q)(5)(H)(ii) of the FD&C Act and this rule.
    We considered the consumer survey results provided with one comment
and did not find the information adequate to overcome the concerns we
raised in the proposed rule regarding the use of stanchions (Ref. 28).
Although the participants expressed favorable impressions of the
stanchions, the survey data:
     Did not provide a comparison with other calorie displays,
including calorie declarations on drive-through menu boards without
stanchions;
     Did not show whether participants would have more or less
favorable impressions of calorie declarations on drive-through menu
boards without stanchions.
     Only showed that the participants liked the display and
not whether the display was useful for them in making their order
selections; and
     Did not assess the use of stanchions in situations where
the consumer needs to make quick decisions because other consumers are
in the drive-through line behind them.
    For all of the reasons discussed in response to this comment, this
rule does not provide for declaration of calories in a pamphlet or on a
stanchion at a drive-through of a covered establishment as a means of
satisfying the requirement that the number of calories contained in a
standard menu item be disclosed on the menu and the menu board, as
required by section 403(q)(5)(H)(ii) of the FD&C Act and Sec.
101.11(b)(2)(i).
    (Comment 44) Some comments asserted that the proposed rule allows
the Secretary to amend the nutrition information that must be disclosed
and that this will further burden restaurants to replace drive-through
and interior menu boards multiple times.
    (Response 44) We interpret the comments as referring to section
403(q)(5)(H)(vi) of the FD&C Act. Under section 403(q)(5)(H)(vi) of the
FD&C Act, the Secretary (and, by delegation, FDA) may, by regulation,
require the disclosure of a nutrient, other than a nutrient required
under section 403(q)(5)(H)(ii)(III) of the FD&C Act, in the written
nutrition information that is available to consumers upon request if
FDA determines that the nutrient information should be disclosed for
the purpose of providing information to assist consumers in maintaining
healthy dietary practices. If this is indeed what the comments mean,
the comments appear to have confused section 403(q)(5)(H)(vi) of the
FD&C Act with the requirements in section 403(q)(5)(H)(ii)(I)(aa)
related to the disclosure of calories on a menu or menu board. The
statutory authority in section 403(q)(5)(H)(vi) of the FD&C Act for FDA
to require disclosure in the written nutrition information of a
nutrient other than one required under section 403(q)(5)(H)(ii)(III) of
the FD&C Act does not address the calories declarations that must be on
a menu or menu board.
    (Comment 45) In the proposed rule, we stated that we recognize that
some establishments may send menus as a form of advertising. We
tentatively concluded that advertisements for food fall outside the
scope of section 4205 of the ACA. However, take-out and delivery menus,
which include all or a significant portion of items offered for sale
and serve as the primary writing from which consumers make their order
selections, would be menus under the proposed rule (76 FR 19192 at
19201).
    Several comments considered that the proposal did not adequately
distinguish between menus and menu boards and advertisements or
promotional material. One comment considered that it is not appropriate
to require calorie disclosure in advertising, such as a postcard
announcing a new restaurant that has pictures of a few sample dishes.
However, the comment also considered that when the advertising is the
menu itself and can be used as the ``primary writing'' a customer uses
to make an order, calorie disclosure should be required. The comment
recommended that the test be whether customers can use the menu as a
primary writing for making their selection, not the way in which the
menu is presented or delivered to the customers by the restaurant or
similar retail food establishment. One comment asked us to clarify that
calorie disclosure should be on any menu regardless of whether the menu
also serves as a marketing tool. One comment stated that any list of
covered food items that is the primary vehicle from which a customer
places his or her order constitutes a menu. The comment noted that in
some instances, an in-store sign that looks like an advertisement
(e.g., promotional poster) for a menu item is the primary vehicle from
which the customer orders the menu item when the menu item is not
included on the menu but is included only on that sign. This comment
asked us to make clear that a sign listing a menu item that is only
listed on that sign makes it a menu board.
    One comment asked us to make clear that covered menus include
individualized order sheets used at certain restaurants. Another
comment asked us to make clear that take-out menus are included and
suggested that a take-out menu be added as an example to the definition
in the regulation.
    Some comments asked us to make a clear statement that
advertisements and promotional material such as table top stands,
newspaper advertisements and flyers, tray liners and point of purchase
marketing materials are not menus, even if they list some names and
prices. One comment noted that, in the proposed rule, we tentatively
concluded that ``advertisements for food fall outside the scope of
section 4205'' but did not include this statement in the proposed
definition. The comment asserted that we hinted at potential grounds
for excluding some menus from coverage, when we stated that ``take-out
and delivery menus, which include all or a significant portion of items
offered for sale and serve as the primary writing from which consumers
make their order selections, would be menus under the proposed rule''
(76 FR 19192 at 19202; emphasis added by comment). The comment
expressed concern that, without specific language in the final
regulation that advertisements are not menus and thus fall outside the
scope of section 4205 of the ACA, the terms ``menu'' or ``menu board''
could be construed to encompass materials that list menu items but that
are in fact used as advertisements. The comment maintained that this
clarity is needed to ensure consistent enforcement. The comment also
recommended that we expand on our statement that such promotional
materials are menus subject to the menu labeling requirements if they
``include all or a significant portion of items offered for sale.'' The
comment asserted that limiting labeling requirements, for example, to
only menus listing more than a certain percentage of standard menu
items sold by the restaurant would have the practical effect of
limiting the number of pieces covered, excluding many promotional items
(such as door hangers and pizza box tops) and creating an

objective standard that could guide both restaurant behavior and
enforcement. The comment considered that requiring calorie disclosures
on promotional material is especially burdensome for some of the
franchises who pay for this promotional material.
    One comment stated that circular advertisements should not be
menus. Another comment recommended that grocery store signs that
highlight the attributes of a food in the store not be considered a
menu or menu board. One comment supported including nutrition
information on any food advertisement that makes a health claim.
    (Response 45) As discussed previously in this document, the term
``menu'' or ``menu board'' includes any writing of the covered
establishment that is the primary writing from which a consumer makes
an order selection. As discussed in Response 40, determining whether a
writing is or is part of the primary writing from which a consumer
makes an order selection depends on a number of factors, including
whether the writing, such as a take-out menu, sign, or poster, lists
the name of a standard menu item (or an image depicting the standard
menu item) and the price of the standard menu item, and whether the
writing can be used by a consumer to make an order selection at the
time the consumer is viewing the writing (e.g., the writing is posted
at the cash register in a covered establishment, or the writing lists
the phone number or email address of a covered establishment for
purposes of placing an order). Accordingly, a writing of a covered
establishment that contains the name (or image) and price of a standard
menu item, and that can be used by a consumer to make an order
selection from the establishment at the time the consumer is viewing
the writing would be a menu or menu board regardless of whether, for
example, the writing is mailed to a consumer's home or is posted inside
a covered establishment. In contrast, written material of an
establishment that does not satisfy this criteria, such as a poster on
a storefront, a coupon or other promotional material, banners, tray
liners, billboards, and stanchions, could be considered a ``secondary
writing'' of an establishment.
    We recognize that, in the proposed rule, we tentatively concluded
that take-out and delivery menus would be considered menus within the
meaning of section 403(q)(5)(H)(xi) of the FD&C Act to the extent that
such menus include all or a significant portion of items offered for
sale (76 FR 19192 at 19201). However, we are not affirming this
conclusion for a number of reasons. First, we agree with the comment
asserting that the critical factor should be whether the take-out or
delivery menu is or is part of the primary writing from which a
consumer makes an order selection, not the way in which the menu is
presented or delivered to consumers.
    Second, as discussed previously in this document, in this rule we
clarified the factors to be considered in determining whether a writing
is or is part of the primary writing from which a consumer makes an
order selection, and these factors help clarify whether a writing
constitutes a menu or menu board or an advertisement or promotional
material, as requested by several comments. Further, in light of these
factors, if we were to conclude that delivery or take-out menus would
only be considered menus if they included all or a significant portion
of items offered for sale, that conclusion would be inconsistent with
how we will be determining whether other written material constitutes a
primary writing of an establishment from which a consumer makes an
order selection, particularly since consumers can use take-out and
delivery menus to make order selections in generally the same way as
they would use dine-in menus.
    In addition, menus vary in size and selection. A covered
establishment that has a single menu for daily use, including menu
offerings for breakfast, lunch, and dinner, may nonetheless have
separate take-out menus directed only to breakfast, lunch, or dinner.
We see no reason to treat a take-out menu that only includes menu
offering for breakfast any differently than we would treat a breakfast
menu used by consumers to order and consume breakfast while seated at
the establishment.
    For these reasons, in this rule we are not affirming the proposed
rule's tentative conclusion that take-out and delivery menus would be
considered menus within the meaning of section 403(q)(5)(H)(xi) of the
FD&C Act to the extent that such menus include all or a significant
portion of items offered for sale. Instead, in this document we
identify factors we would use to determine whether a writing is the
primary writing from which a consumer makes an order selection--i.e.,
the name (or image) and price of the standard menu item food and a
means to make an order selection at the time the consumer is viewing
the writing. Accordingly, determining whether a writing is a menu or
menu board does not depend on how many items are listed. If a writing
constitutes a menu or menu board within the meaning of section
403(q)(5)(H)(xi) of the FD&C Act and Sec.  101.11(a), it must contain
the information required under section 403(q)(5)(H) of the FD&C Act and
Sec.  101.11(b), regardless of the number of items on that menu or menu
board.
    Any written material that is or is part of the primary writing from
which a consumer makes an order selection, whether it is an
individualized order sheet or a take-out menu, would be a menu for
purposes of this rule if it includes the name (or image) and price of a
standard menu item and a means by which a consumer can make an order
selection from the establishment at the time the consumer is viewing
the writing. Providing calorie and other required information on menus
and menu boards will make such information available to consumers in a
direct and accessible manner to enable consumers to make informed and
healthful dietary choices.
    Using these factors, other writings of a covered establishment,
such as newspaper ads, circular advertisements, banners, or postcards
that announce a new restaurant and provide pictures of sample dishes
generally would not be menus or menu boards. Although it is possible
that such writings could include the name (or image) and price of
standard menu items, they generally would not provide a means by which
a consumer can make an order selection at the time the consumer is
viewing the writing and therefore such a writing would not constitute a
primary writing from which a consumer makes an order selection within
the meaning of section 403(q)(5)(H)(xi) of the FD&C Act. Likewise, a
sign in a grocery store that highlights attributes of a standard menu
item (e.g., by the name or image of the menu item), without including
the price, would not be a menu or menu board.
    While a writing may constitute a menu or menu board, not all of the
menu items listed on such writing would require calorie declarations.
For example, if the requirements of section 4205 of the ACA do not
apply to a food (e.g., as a daily special, temporary menu item, or
customary market test item), a covered establishment would not be
required to declare calories or other nutrition information for such
food under this rule, meaning that a writing listing a daily special or
temporary menu item would not be required to bear a calorie declaration
for such item. Further, as discussed later in this document (see
Response 79), for certain ``mix and match'' situations, 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 if applicable, available for the consumer to combine are
declared elsewhere on the menu or menu board, a covered establishment
would not be required to declare the calories for such item (see Sec.
101.11(b)(2)(i)(A)(6)(iv)).
    The comment supporting nutrition information on any food
advertisement that makes a health claim is outside the scope of this
rule, which establishes requirements for declaring nutrition
information for standard menu items offered for sale in establishments
covered by the requirements of section 4205 of the ACA. We note,
however, that material that constitutes food labeling within the
meaning of section 201(m) of the FD&C Act would be subject to the
requirements in Sec.  101.10. Under section 201(m) of the FD&C Act, the
term ``labeling'' means all labels and other written, printed, or
graphic matter (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article.
    (Comment 46) One comment recommended that menu labeling
requirements apply to airline magazines that include menus.
    (Response 46) In the proposed rule, we tentatively concluded that
most airplanes would not satisfy the definition of ``restaurant or
similar retail food establishment'' because, in general, they do not
present themselves to the public as restaurants, nor are they likely to
meet the floor space (or revenue) threshold. As discussed in section
VI.D, under the definition of ``covered establishment'' established in
this rule airplanes are not covered establishments that must comply
with the rule. Therefore, the nutrition labeling requirements of this
rule do not apply to airline magazines that include menus.

VIII. Comments and FDA Response on the Proposed Definition of Terms
Related to Foods Covered by the Rule (Proposed Sec.  101.11(a))

A. Restaurant Food and Restaurant-Type Food

    As discussed in section VI.C, after considering comments, we are
deleting the proposed definition of ``restaurant food'' and
establishing a revised definition of ``restaurant-type food'' that
better reflects the food most like the food offered for sale in
restaurants. We discussed these changes to two terms related to foods
covered by the rule within section VI because the definition of
``restaurant-type food'' established in this rule is one of several
terms related to the scope of establishments covered by the rule.

B. Standard Menu Item

    Proposed Sec.  101.11(a) would define ``standard menu item'' as a
restaurant or 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. In the following paragraphs, we discuss comments on this
proposed definition. We are finalizing it without change, except to
revise ``restaurant or restaurant-type food'' to ``restaurant-type
food'' to conform with our deletion of the term ``restaurant food''
throughout the rule (see section VI.C).
    (Comment 47) Several comments supported the proposed definition.
One comment opposed the proposed definition because it is
``incomplete'' and misunderstands the meaning of ``standard'' within
the context of a chain of 20 or more restaurants and similar retail
food establishments doing business under the same name and offering for
sale substantially the same menu items. The comment argued that it is
not the regularity with which a menu item is sold at a given restaurant
that renders the item ``standard'' within the context of a restaurant
chain; rather, it is the fact that the menu item is offered across many
establishments in the chain, in substantially the same form, and is
prepared according to the same recipe and using the same ingredients.
The comment maintained that when foods are standardized, nutrition
information can be derived. On the other hand, according to the
comment, if foods do not have a common recipe, nutrition information
would be determined case-by-case, which is impractical and cost
prohibitive. The comment suggested the following definition: ``A menu
item that appears on the menus of substantially all restaurants in a
chain that uses the same general recipe and that is prepared in
substantially the same way with substantially the same food components,
even if the name of the menu item varies.''
    The comment also recommended that, for a chain that prints a single
standardized menu for all its restaurants or establishments or for
those in a given region, the term ``standard menu item'' be interpreted
to refer to menu items that appear on those centrally printed and
distributed menus. The comment maintained that adopting this definition
would harmonize the terms ``standard menu item'' and ``covered
establishment'' and ensure that the requirements apply to the foods
that are subject to the type of standardization that would allow them
to be consistently prepared. The comment also requested that a covered
establishment be allowed but not required to provide the nutrition
information in writing at the point of sale for menu items offered for
sale in only some establishments in a chain if we decide to include
such menu items within the definition of standard menu item in the
final rule. Otherwise, the comment considered that a chain retail food
establishment would have to include, in nutrition brochures,
information on many menu items that are sold in a small percentage of
stores, which could be confusing and costly.
    (Response 47) We disagree that the definition of ``standard menu
item'' should be based on whether the menu item is offered across
substantially all of the establishments within the chain, in
substantially the same form, and is prepared according to the same
recipe and using the same ingredients. Section 403(q)(5)(H)(i) of the
FD&C Act provides, in relevant part, that ``in the case of food that is
a standard menu item that is offered for sale in a restaurant or
similar retail food establishment that is part of a chain with 20 or
more locations doing business under the same name . . . and offering
for sale substantially the same menu items, the restaurant or similar
retail food establishment shall disclose the [required] information. .
. .''. The statutory language does not indicate that a menu item must
be offered for sale in all of the restaurants or similar retail food
establishments within a chain in order for it to be a ``standard menu
item'' at a particular covered establishment. Indeed, it would be
burdensome and impractical for establishments and inspectors to
continually evaluate all of the menu items offered by a chain to
determine which items are offered by all establishments in the chain in
order to determine whether a given menu item is a standard menu item
subject to requirements of this rule. In addition, we have no evidence
that it would be impractical and cost prohibitive to require covered
establishment to provide the nutrition required by this rule for menu
items that they routinely offer. We continue to believe that it is
reasonable to interpret ``standard menu item'' to mean a restaurant-
type food routinely included on a menu or menu board or routinely
offered as a self-service food or food on display in a given covered
establishment.
    We would not object to central printing of a single, standardized
menu for use by all covered establishments within a chain, provided
that the

centrally printed menu complies with the requirements of this rule and
applicable provisions of the FD&C Act. However, if an individual
covered establishment offers for sale an additional standard menu item
that is not offered by every establishment in the chain and, therefore,
is not included on the centrally printed menu, that establishment still
must comply with all applicable requirements of this rule for that
standard menu item, including where and how the nutrition information
must be disclosed.
    We disagree that a covered establishment would have to include, in
nutrition brochures, information on many menu items that are sold in a
small percentage of stores. A covered establishment need only provide
the required information for the standard menu items it offers for
sale.
    (Comment 48) A few comments stated that grocery stores use items
from other departments within the grocery store (e.g., meat department,
produce department) to make its prepared food items. The ingredients
for a given prepared food can vary significantly depending on the
availability of items in the store. These comments argued that labeling
and determining calorie information for these items would be difficult.
    (Response 48) If a prepared food item varies significantly
depending on what ingredients a covered establishment happens to have
available, the item may not meet the definition of standard menu item.
For example, if a grocery store with a hot soup bar offers a different
vegetable soup every day based on whatever vegetables the store happens
to have in surplus (e.g., cabbage and tomatoes soup one day, carrots
and leeks the next, spinach and squash on a third day), and if none of
these vegetable soups is offered for sale routinely, then none of the
vegetable soups would meet the definition of standard menu item. Even
if the grocery store names each version of the soup as ``vegetable
soup,'' the item would not be considered a standard menu item, because
the soup's ingredients significantly differ daily.

C. Combination Meal

    Proposed Sec.  101.11(a) would define ``combination meal'' as a
standard menu item that consists of more than one food item, for
example a meal that includes a sandwich, a side dish, and a drink. The
proposed definition would further provide that a combination meal may
be represented on the menu or menu board in narrative form,
numerically, or pictorially. Some combination meals may include a
variable menu item (or be a variable menu item as defined in Sec.
101.11(a)) where the components may vary. For example, the side dish
may vary among several options (e.g., fries, salad, or onion rings) or
the drinks may vary (e.g., soft drinks, milk, or juice) and the
customer selects which of these items will be included in the meal.
    Comments that addressed the proposed definition agreed with it.
Therefore, we are finalizing it without change, except to correct a
typographical error by removing an open parenthesis mark between ``may
include a variable menu item'' and ``or be a variable menu item . . .''

D. Variable Menu Item

    Proposed Sec.  101.11(a) would define ``variable menu item'' as a
standard menu item that comes in different flavors, varieties, or
combinations, and is listed as a single menu item. In the following
paragraphs, we discuss comments on this proposed definition. We are
finalizing it without change.
    (Comment 49) Several comments considered that the term ``variable
menu item'' does not include items listed on a menu that can be
assembled in varying combinations, such as pizza. These comments
suggested that the definition of variable menu item be revised to ``a
standard menu item that comes in different flavors, varieties, or
combinations, and is listed as a single menu item. It does not include
foods, beverages, or meals that are listed as separate menu items but
could be combined in a variety of combinations or that are different
sizes of the same menu item.''
    Several comments asked that we clarify that the definition for
``variable menu item'' does not mean different sizes. They maintained
that each size should be accompanied by a calorie declaration. In
contrast, one comment opposed the posting of calories for different
sizes, maintaining that providing calorie information for each size
would take too much space and might force the reduction in font size.
This comment asked us to permit covered establishments to provide a
range of calories to reflect the calorie content range from the
smallest to the largest size for beverages offered as standard menu
items. This comment considered that the statute provides us discretion
to allow covered establishments to provide calorie information for
different sized beverages using ranges, as long as the calorie
information is clear and conspicuous.
    (Response 49) We disagree that variable menu items do not include
foods such as pizza. Our proposed definition is consistent with section
403(q)(5)(H)(v) of the FD&C Act, which expressly includes pizza as an
example of a standard menu item that comes in different flavors,
varieties, or combinations, but is listed as a single menu item. For
example, a menu or menu board can list a pizza with a particular price
and up to four toppings. This is an example of a food that comes in
different varieties because the consumer has the choice of various
toppings.
    We agree with the comments asserting that different sizes of a
standard menu item are not variable menu items, but disagree with the
comment opposing the posting of calories for different sizes. 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 single menu items.
When a standard menu item, including a beverage, is listed on a menu or
menu board by name with different sizes, or each size has its own
price, each size would constitute a standard menu item rather than a
different flavor, variety, or combination, and each standard menu item
must include a calorie declaration.

E. Food on Display

Proposed Sec.  101.11(a) would define food on display as restaurant or
restaurant-type food that is visible to the customer before the
customer makes a selection, so long as there is not an ordinary
expectation of further preparation by the consumer before consumption.
In the following paragraphs, we discuss comments on this proposed
definition. After considering comments, we are finalizing the
definition without changes, except to revise ``restaurant or
restaurant-type food'' to ``restaurant-type food'' to conform with our
deletion of the term ``restaurant food'' throughout the rule (see
section VI.C).
    (Comment 50) A few comments agreed with the proposed definition.
Other comments suggested modifications to the definition. Some comments
recommended that the definition clarify that the food can be self-serve
or served by the restaurant staff and that the food could be in the
open or behind glass. The comments suggested that the following
language be added to the proposed definition: ``It includes food that
is served by restaurant staff or self-served by customers and foods
with Nutrition Facts labels that customers cannot examine without
assistance. Food on display can be behind glass or other

material or in an open display accessible to consumers.''
    (Response 50) We decline the requests to revise the proposed
definition. The definition applies regardless of whether the food is
self-serve or served by the restaurant staff, whether it is in the open
or behind glass, or whether it has a Nutrition Facts label that can be
examined by a consumer without assistance. In addition, we do not want
to appear to limit the definition to only those foods described in the
language suggested by the comment.
    (Comment 51) One comment asserted that food on display, such as
deli meats and cheeses, should be covered even if there is an
expectation that there will be further preparation before consuming. A
few comments asked that we clarify that foods on display and self-
service food do not include fresh breads, cheese wheels, bulk olives,
bulk sauces, condiments, and salads sold by the pound like ``tuna
salad, egg salad, chicken salad, etc.'' One comment recommended that
grocery stores provide calories for bakery items, prepared deli foods
such as salads and sandwiches, prepared meals and side dishes, freshly
cooked pizza, fountain drinks, salad bars, and other foods sold for
immediate consumption. One comment requested an exemption for certain
food items prepared for home consumption, such as fruit slices, fruit
cups, fruit salads, containers of fresh-cut fruit, fresh squeezed
juices, bulk or packaged nuts, seeds, or dried fruit, and similar items
that are packaged (or in the case of bulk products, are sold in
containers that are available for self-packaging).
    (Response 51) As discussed in section VI.C, we are establishing a
revised definition of ``restaurant-type food'' that better reflects the
food most like the food offered for sale in restaurants (see Comment 24
and Response 24). Because restaurants typically sell food that is fully
prepared, deli meats and cheese generally will not meet the definition
of ``restaurant-type food,'' and therefore generally will not be
covered. However, certain foods offered for sale in grocery stores that
are visible to the consumer before the consumer makes a selection, such
as prepared sandwiches, freshly cooked pizza, and salad and hot food
bars would meet the definition of restaurant type food and do not have
an ordinary expectation of further preparation by the consumer before
consumption. These foods meet the definition of foods on display. Other
foods commonly offered for sale by grocery stores are not within the
definition of ``restaurant-type food'' and would not be subject to the
nutrition disclosure requirements of this rule (e.g., foods such as
dried fruit and nuts bought from bulk bins or cases; foods such as
loaves of bread, bags or boxes of dinner rolls, whole cakes, bags or
boxes of candy or cookies to be eaten over several eating occasions or
stored for later use; foods such as deli salads sold by unit of weight
that are not self-serve and are not intended solely for individual
consumption, either prepacked or packed upon consumer request).

F. Self-Service Food

    Proposed Sec.  101.11(a) would define ``self-service food'' as
restaurant or restaurant-type food that is available at a salad bar,
buffet line, cafeteria line, or similar self-service facility and that
is served by the customers themselves. Self-service food also includes
self-service beverages. Comments that addressed the proposed definition
supported it. We are finalizing it without changes, except to revise
``restaurant or restaurant-type food'' to ``restaurant-type food'' to
conform with our deletion of the term ``restaurant food'' throughout
the rule (see section VI.C).

G. Custom Order

    Proposed Sec.  101.11(a) would define ``custom order'' as a food
order that is prepared in a specific manner based on an individual
customer's request, which requires the restaurant or similar retail
food establishment to deviate from its usual preparation of a menu
item, e.g., a club sandwich without the bacon if the establishment
usually includes bacon in its club sandwich. In the following
paragraphs, we discuss comments on this proposed definition. We are
finalizing it without change, except for two clarifications. First, we
are clarifying that the deviation is from the usual preparation of a
standard menu item (emphasis added). Second, we are replacing the term
``restaurant or similar retail food establishment'' with ``covered
establishment'' to clarify the applicability of the definition (see the
discussion in section VI.I).
    (Comment 52) Several comments agreed with the proposed definition.
Some comments considered that the custom order exemption should apply
to custom birthday cakes and sandwiches made to order, because they
have no standard preparation from which to deviate.
    One comment maintained that supermarkets often preprint labels or
previously affix them to packaging (e.g., a paper bag for a sandwich or
bread) to improve efficiency or to save costs. Because consumers may
request that toppings be added or removed from a food item that is sold
in the prelabeled packaging, the comment considered that this would be
a custom order that would be exempt from the menu labeling
requirements. The comment asked us to clarify that the product would
not be misbranded if the packaging contained nutrition information
based on the standard preparation.
    (Response 52) If a custom birthday cake that is made to order is
not routinely included on a menu or menu board or routinely offered as
a self-service food or food on display, it would not be covered by the
rule, because it is not a standard menu item.
    We agree that a sandwich that is made to order can be a custom
order if the sandwich is prepared in a specific manner based on an
individual customer's request, which requires the covered establishment
to deviate from its usual preparation of a standard menu item. However,
some sandwiches that are made to order can be variable menu items,
depending on how the food is depicted on a menu or menu board or
otherwise offered for sale. We discuss the definition of variable menu
item in section VIII.D.
    We also agree that if a customer asks that toppings be changed or
removed from a standard menu item, and the standard menu item normally
includes certain toppings, the customer's order is a custom order. In
response to the question regarding the use of a preprinted label on a
food product, which is subject to modification, we first note that a
food order that is prepared in a specific manner based on an individual
customer's request, which requires a covered establishment to deviate
from its usual preparation of a standard menu item, is a custom order
and is not subject to the requirements of section 403(q)(5)(H) of the
FD&C Act and this rule. Nevertheless, food labeling, including
nutrition labeling, for a food must be truthful and not misleading
(section 403(a)(1) of the FD&C Act). If a label on a food bears
nutrition information for such food that is false or is otherwise
misleading, the food would be misbranded under section 403(a)(1) of the
FD&C Act. Accordingly, if a custom order, such as a club sandwich
without the bacon if the establishment usually includes bacon in its
club sandwich, bears nutrition information in a preprinted label that
is false or is otherwise misleading, such food could be misbranded
under the FD&C Act. We recommend that covered establishments refrain
from affixing preprinted labels on custom orders unless the information

included on such labels is truthful and not misleading.

H. Daily Special

    Proposed Sec.  101.11(a) would define ``daily special'' as a menu
item that is prepared and offered for sale on a particular day, that is
not routinely listed on a menu or offered by the covered establishment,
and that is promoted by the covered establishment as a special menu
item for that particular day.
    Comments that addressed the proposed definition agreed with it.
Therefore, we are finalizing it without change, except to add ``or menu
board'' after ``not routinely listed on a menu.'' We inadvertently
omitted ``or menu board'' in the proposed definition.

I. Food That Is Part of a Customary Market Test

    Proposed Sec.  101.11(a) would define ``food that is part of a
customary market test'' as food that is marketed in a covered
establishment for fewer than 90 consecutive days in order to test
consumer acceptance of the product. Comments that addressed the
proposed definition agreed with it. Therefore, we are finalizing it
without change, except for changes to clarify that food that is part of
a customary market test is food ``that appears on a menu or menu board
for less than 90 consecutive days'' rather than food ``that is marketed
in a covered establishment for fewer than 90 consecutive days.'' These
changes are consistent with section 403(q)(5)(H)(vii)(I)(cc) of the
FD&C Act, our description of ``food that is part of a customary market
test'' in the proposed rule (76 FR 19192 at 19205), and with the
definition for ``temporary menu item'' in Sec.  101.11(a).

J. Temporary Menu Item

    Proposed Sec.  101.11(a) would define ``temporary menu item'' as a
food that appears on a menu or menu board for less than a total of 60
days per calendar year. Proposed Sec.  101.11(a) would explain that the
60 days includes the total of consecutive and non-consecutive days the
item appears on the menu. In the following paragraphs, we discuss
comments on this proposed definition. We are finalizing it without
change.
    (Comment 53) Several comments agreed with the proposed definition.
One comment agreed that the 60 days need not be consecutive, but
considered that seasonal items (such as the pumpkin-flavored latte
example we included in the proposed rule (76 FR 19192 at 19205)) should
not be exempt if they are routinely offered each year.
    One comment recommended that we change the definition for temporary
menu item to shorten the time period from 60 to 45 days, to discourage
restaurants from continuously changing menus to avoid calorie
disclosure.
    (Response 53) The proposed definition for ``temporary menu item''
focused on the explicit statutory language in section 403(q)(5)(H)(vii)
of the FD&C Act, which provides in relevant part that the requirements
of section 403(q)(5)(H)(i) through (vi) of the FD&C Act do not apply to
``temporary menu items appearing on the menu for less than 60 days per
calendar year.'' Accordingly, we decline to shorten the 60-day time
period for temporary menu items to 45 days, as suggested by the
comment, because doing so would not be consistent with section
403(q)(5)(H)(vii) of the FD&C Act. We did not propose to go beyond the
language of section 403(q)(5)(H)(vii) of the FD&C Act by developing a
new category of foods called ``seasonal items.'' We disagree that
seasonal items should not be exempt if they are routinely offered each
year. Whether a ``seasonal item'' would be exempt would be determined
by whether the seasonal item satisfied the definition of a ``temporary
menu item'' as determined by the total number of consecutive and non-
consecutive days per calendar year that the menu item appears on the
menu or menu board.

IX. Comments and FDA Response on Proposed Sec.  101.11(b)(1)(i)--Food
Subject to the Labeling Requirements

    Proposed Sec.  101.11(b) would establish requirements for nutrition
labeling of food sold in covered establishments. Proposed Sec.
101.11(b)(1)(i) would provide that the labeling requirement would apply
to standard menu items offered for sale in covered establishments. We
are finalizing it without change.
    Most comments we received about how the nutrition labeling
requirements of the rule apply to standard menu items addressed
specific labeling requirements (e.g., the provisions of Sec.
101.11(b)(2)(i) for what must be provided on menus and menu boards),
and we discuss these comments as they relate to such specific
requirements. Immediately following, we discuss one comment more
generally directed to the applicability of the labeling requirements of
this rule.
    (Comment 54) One comment recommended that foods that are preordered
and picked up at a later date, such as birthday cakes, boxed lunches,
deli trays, and sandwich platters, not be covered by the menu labeling
requirements because they are not foods on display, standard menu
items, restaurant-type foods, or ordered from a menu or menu board. The
comment asserted that restaurant foods are ordered for consumption
within a proximate time from when they are ordered, and the person
ordering the food intends to eat a portion of the food, whereas catered
foods are ordered on behalf of a larger group of people and further
ahead of time.
    (Response 54) The rule applies to standard menu items offered for
sale in covered establishments. The rule defines 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 (see
Sec.  101.11(a)). The definition of ``restaurant-type food'' in Sec.
101.11(a) captures the time when the food will be eaten relative to
when it is purchased or picked up (i.e., usually eaten on the premises,
while walking away, or soon after arriving at another location) but
when the food is ordered in relation to when it is picked up, and how
many people will share the food, have no bearing on the applicability
of the rule.

X. Comments and FDA Response on Proposed Sec.  101.11(b)(1)(ii)--Food
Not Subject to the Labeling Requirements

A. The Proposed Requirements

    Proposed Sec.  101.11(b)(1)(ii) would provide that the labeling
requirements would not apply to alcohol beverages; items such as
condiments that are placed on the table for general use; daily
specials; temporary menu items; custom orders; and food that is part of
a customary market test. In sections X.B through X.E of this document,
we discuss comments on this proposed provision. After considering
comments, we are:
     Narrowing the proposed exemption of alcohol beverages from
all of the new requirements for nutrition labeling;
     Clarifying that the exemption applies to condiments that
are for general use, including those placed on the table or on or
behind the counter; and
     Clarifying that the labeling requirements of paragraph (b)
do not apply to 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.

B. Alcohol

1. Alcoholic Beverages
    (Comment 55) Some comments agreed with our proposal that alcoholic

beverages should not be covered. Some comments stated that alcoholic
beverages should not be considered food within the context of menu
labeling. Some comments supporting FDA's proposal to exclude alcoholic
beverages referenced Alcohol and Tobacco Tax and Trade Bureau's (TTB's)
oversight of alcoholic beverage labels, which includes premarket
approval. One comment referred to the district court decision cited in
FDA's proposed rule (76 FR 19192 at 19203), Brown-Forman Distillers
Corp. v. Mathews, 435 F. Supp. 5 (W.D.Ky. 1976), as evidence that TTB
has jurisdiction over the labeling of alcoholic beverages under the
Federal Alcohol Administration Act (FAA Act). Another comment argued
that requiring calorie declarations for alcoholic beverages will not
affect obesity, because obesity is the result of years of poor diet and
lack of exercise. Another comment mentioned a 2011 survey of adult
consumers and stated that it showed that most consumers do not want to
see calorie counts on drink menus and want to order what they want. The
comment did not include or provide a reference for the survey.
    In contrast, many comments argued that alcoholic beverages should
be covered in the final rule. Some comments asserted that it was not
the intent of Congress to exclude alcoholic beverages from the menu
labeling requirements. According to these comments, Congress excluded
some foods from menu labeling, but did not exclude alcoholic beverages.
One comment, referring to a press release of two Senators (Ref. 29),
contended that Congress rejected lobbyists who wanted to exclude
alcoholic beverages.
    Several comments argued that FDA has jurisdiction to require menu
labeling for alcoholic beverages and not TTB. According to these
comments, Congress directed FDA to require menu labeling for all food,
including alcoholic beverages. Some comments maintained that FDA
currently has exclusive authority to regulate labeling of certain
alcoholic beverages (such as wines containing less than 7 percent
alcohol by volume and some beers), and another comment stated that FDA
had asserted its authority over alcoholic beverages when FDA and the
Federal Trade Commission took action on caffeinated alcohol drinks. One
comment maintained that in the absence of a specific prohibition or
direct conflict, each Agency can regulate alcoholic beverages in line
with its mandate. Another comment stated that the U.S. Supreme Court
has noted, ``The courts are not at liberty to pick and choose among
congressional enactments, and when two statutes are capable of
coexistence, it is the duty of the courts, absent a clearly expressed
congressional intention to the contrary, to regard each as effective,''
citing Morton v. Mancari, 417 U.S. 535, 551 (1974). Thus, this comment
asserted that there is no need to pick and choose between the FAA Act
and section 4205 of the ACA because these statutes are capable of
coexistence in that they apply to different groups and different
practices.
    Several comments questioned the applicability of the Brown-Forman
Distillers v. Matthews case to section 4205 of the ACA and contended
that Brown-Forman addressed the FAA Act and FDA's authority to impose
ingredient labeling on alcoholic beverage labels, not nutrition
labeling on menus.
    Some comments also argued that FDA's proposed position with regard
to alcoholic beverage menu labeling contrasts markedly with its
position on meat and poultry menu items, the labels for which are
regulated by the USDA. One comment remarked that alcohol used in non-
beverage foods, such as bananas foster, would be covered under the
proposed rule, so not covering alcohol in foods that are beverages
would not be consistent.
    Comments supported covering alcoholic beverages on public health
grounds. Some comments argued that excluding alcoholic beverages is
problematic because it may give the false impression that alcoholic
drinks do not contribute to the overall caloric consumption of
consumers, working against the underlying goal of section 4205 of the
ACA. Other comments remarked that alcoholic beverages contribute a
substantial portion of average total calories consumed by Americans,
representing the fifth leading source of calories in American adults'
diets. One comment stated that alcoholic beverages provide more
calories per day on average than many of the food items required to be
labeled under this law including pizza, hamburgers, and fried potatoes.
Another comment argued that calories in alcoholic beverages count
toward overweight and obesity just like calories in foods and other
beverages.
    According to some comments, if some drinks are labeled and some are
not, consumers might be confused, and they would not have the
information to compare beverage options and make informed choices.
Comments also stated that the calorie content of alcoholic beverages
can vary widely and cited studies indicating that consumers are likely
to have difficulty identifying lower calorie options. Comments argued
that failing to provide consumers with calorie information for
alcoholic beverages will make it more difficult for them to follow the
2010 Dietary Guidelines' advice to control total calorie intake to
manage body weight.
    (Response 55) The final rule does not provide a general exemption
for alcoholic beverages. As we stated in the proposed rule, alcoholic
beverages are ``food'' under the FD&C Act. Section 201 of the FD&C Act
defines ``food'' to include ``articles used for . . . drink for man,''
``for the purposes of this Act.'' The nutrition labeling requirements
of section 403(q)(5)(H) of the FD&C Act apply to ``food that is a
standard menu item.'' In addition, as some comments indicated, section
403(q)(5)(H)(vii) of the FD&C Act deems the requirements of section
403(q)(5)(H) of the FD&C Act inapplicable to certain foods, and
alcoholic beverages are not one of them.
    While section 4205 of the ACA amends section 403(q) of the FD&C
Act, which generally provides nutrition labeling requirements for
certain foods, the nutrition labeling requirements in section 4205 are
directed specifically toward standard menu items sold in covered
restaurants or similar retail food establishments. Within this context,
providing nutrition information for an alcoholic beverage for which
other labeling is also regulated by TTB provides the same public health
benefit as providing the information for other foods. The provisions of
section 4205 of the ACA do not apply to and have no effect on the
labels of food products sold in packaged form, including alcoholic
beverages regulated by TTB.
    Thus, we conclude that the nutrient content disclosure requirements
in amended section 403(q)(5) of the FD&C Act for standard menu items
offered for sale in covered establishments apply to alcoholic
beverages, even though the labeling of alcoholic beverage containers
under the FAA Act is regulated by TTB.
    FDA's decision to include alcoholic beverages in the menu labeling
regulations is not inconsistent with the Brown-Forman decision, which
addressed the labeling of containers of distilled spirits, wines, and
malt beverages subject to the requirements of the FAA Act. This
conclusion will not subject the regulated alcohol beverage industry
``to `duplication and inconsistent standards,' '' a key basis for the
Brown-Forman decision. (Brown-Forman at 14, citing United States v.
National Ass'n of Securities Dealers, 422 U.S. 694, 735 (1975)). The
requirements we are finalizing here do not directly conflict with any
TTB requirements. As comments pointed out, the nutrition labeling
requirements

of section 4205 of the ACA do not apply to and have no effect on the
labels of alcoholic beverage containers. In addition, this final rule
applies to covered establishments, while the FAA Act's labeling and
advertising regulations generally apply to distillers, brewers,
rectifiers, blenders, producers, importers, wholesalers, bottlers, and
warehousemen of alcoholic beverages (see 27 U.S.C. 205). In short, the
two regulatory schemes address different labeling and different actors;
they are ``capable of coexistence.'' (See Manconi, cited previously in
this document.)
    We also recognize that applying this final rule to alcoholic
beverages also regulated by TTB is more consistent with the inclusion
of meat, poultry, and egg products that are also regulated by USDA.
    From a public health perspective, we agree that requiring nutrition
labeling of alcoholic beverages that are standard menu items is more
likely to enable consumers to compare beverage options and make
informed order selections in covered establishments. In addition, while
obesity may be related to poor diet generally and a lack of exercise,
calories in alcoholic beverages contribute to obesity and overweight
just like calories in other foods. Alcoholic beverages contribute a
substantial portion of average total calories consumed by American
adults (Ref. 3). Table 2-2 in the 2010 Dietary Guidelines for Americans
(``2010 Dietary Guidelines''), jointly developed and issued by HHS and
the USDA, reports that alcoholic beverages rank sixth in a list of the
top 25 food sources of calories among Americans ages 2 years and older,
and fifth in a list of the top 25 food sources of calories among adult
Americans ages 19 years and older (Ref. 3). The 2010 Dietary Guidelines
also discuss alcohol in Chapter Three, entitled ``Foods and Food
Components to Reduce'' (Ref. 3).
    As to the 2011 survey mentioned in one comment, FDA is unable to
draw regulatory conclusions from such a survey without being able to
evaluate the survey itself.
    (Comment 56) Several comments argued that providing calorie and
other nutrition labeling for alcoholic beverages on menus is feasible,
and one comment provided an example of a menu which included nutrient
content disclosures for alcoholic beverages.
    (Response 56) We agree with these comments. We see no basis for why
providing calorie and other nutrient content information for alcoholic
beverages on menus would be less feasible for covered establishments
than providing that same information for most other standard menu
items.
    (Comment 57) Some comments noted that TTB and FDA currently work
together through a Memorandum of Understanding (MOU) and asserted that
under this MOU, TTB ensures adequate and non-misleading labeling, and
FDA ensures safety. One comment that mentioned this MOU indicated that
FDA should not begin to regulate the labeling of alcoholic beverages,
while another comment that mentioned the MOU indicated that FDA's
coverage of alcoholic beverages would not be inconsistent with the
specific language of the MOU.
    (Response 57) We agree that FDA's coverage of alcoholic beverages
in this context does not affect the delineation of responsibilities
between FDA and TTB articulated in the MOU. FDA and TTB continue to
work together under the MOU, and FDA has consulted with TTB during this
rulemaking.
    (Comment 58) A few comments maintained that establishing menu
labeling requirements for alcoholic beverages could lead to
inconsistencies with TTB requirements. One comment pointed out that TTB
has rulemaking underway for ``serving facts'' on alcoholic beverage
labels and asserted that, if FDA establishes menu labeling requirements
for alcoholic beverages, there could be inconsistencies between
nutrition information on labels and menus.
    At the time that the proposed rule was issued, alcoholic beverages
subject to the labeling regulations under the FAA Act were required to
include a statement of average analysis if the label or advertisement
made a claim with regard to the calorie or carbohydrate content of the
product, and were allowed to include a statement of average analysis
for any product. The statement of average analysis listed the number of
calories and the number of grams of carbohydrates, fat, and protein per
serving (see TTB Ruling 2004-1). In the Federal Register of July 31,
2007 (72 FR 41860), TTB published a proposed rule to amend its
regulations to require a Serving Facts statement, which would include a
statement of calories, carbohydrates, fat, and protein per serving, on
alcohol beverage labels. As of December 1, 2014, the TTB proposed rule
has not been finalized. On May 28, 2013, TTB issued a ruling (TTB
Ruling 2013-2) (Ref. 30) that allows alcohol beverage industry members
to provide consumers with nutritional information on alcoholic beverage
container labels by using the format of a statement of average analysis
or a Serving Facts statement.
    The comment stated that TTB's rulemaking should be completed before
FDA takes further action or FDA should exclude alcoholic beverages from
the menu labeling requirements permanently. According to another
comment, the labels currently approved by TTB with a statement of
average analysis apply to a small portion of the total volume of beers
produced by small brewers. The comment stated that the format is not
consistent with FDA's proposed rule, because TTB only requires the
disclosure of calories, carbohydrates, protein, and fat, while FDA's
proposed rule would require disclosure of additional nutrients. Without
agreement on formats, the comment asserted, compliance with FDA
proposed menu labeling could contradict TTB guidance. This comment also
stated that without a final rule from TTB, beer sold in bottles and
cans on display in covered establishments will not be required to bear
nutrition information. Comments stated that if FDA decides to cover
alcoholic beverages in its menu labeling rule, FDA should coordinate
with TTB to ensure consistency.
    Some comments that were against including alcoholic beverages
maintained that the cost of laboratory analysis for alcoholic
beverages, which they assumed would fall on the alcoholic beverage
manufacturers, would be significant, especially for alcoholic beverage
manufacturers that are small businesses. One comment asserted that the
number of brands and styles of beer produced by small brewers varies
dramatically in comparison to large brewers, and without in-house
laboratories, which the comment believed large breweries would have,
covering alcoholic beverages would have a disproportionate effect on
small brewers. Several comments argued that sufficiently accurate
calorie values for various types of alcohol are readily available from
easily accessible databases, such as the USDA's National Nutrient
Database for Standard Reference. One comment suggested allowing covered
establishments to list estimated or approximate calorie values by
category on wine lists rather than by each brand, recognizing that some
types of alcoholic beverages, like red or white wines, contain
substantially the same calories regardless of variety.
    (Response 58) We agree with some comments and disagree with others.
As previously mentioned, the nutrition labeling requirements finalized
here do not apply to and have no effect on the labels of alcoholic
beverage containers. In addition, the new requirements apply

to covered establishments, not to alcoholic beverage manufacturers. In
contrast, TTB's ``Serving Facts'' rulemaking would establish new
requirements for disclosures on alcoholic beverage labels and would
apply to alcoholic beverage bottlers and importers.
    Under this final rule, covered establishments have significant
flexibility in choosing a reasonable basis for their nutrient content
disclosures, which can include a database such as the USDA's National
Nutrient Database for Standard Reference (see Sec.  101.11(c) and the
discussion in sections XVIII and XIX). The USDA's National Nutrient
Database for Standard Reference includes the categories, ``alcoholic
beverage, wine, table, red,'' ``alcoholic beverage, wine, table,
white,'' among several other general categories for alcoholic
beverages. Consistent with our treatment of other standard menu items
(see section XVIII of this document), we will allow covered
establishments to use these entries as the bases for their nutrient
content disclosures for alcoholic beverages that are standard menu
items.
    In addition, we recognize that statements of average analysis and
nutrient content disclosures under current TTB guidance include four
nutrients, and our final rule requires that covered establishments make
additional nutrient content disclosures for most standard menu items.
However, we do not see these differences as conflicts. Nutrient content
information on alcoholic beverage labels that is required by or
consistent with TTB regulations or guidance could be a reasonable basis
for a covered establishment's corresponding nutrient content
disclosures. In addition, many alcoholic beverages will be eligible for
the simplified format (see discussion re: Sec.
101.11(b)(2)(ii)(B)(2)). As provided in Sec.  101.11(c)(1), covered
establishments may also choose to use a database such as the USDA
National Nutrient Database for Standard Reference as the reasonable
basis for making their nutrient content disclosures, including
disclosures for nutrients that do not currently appear on alcoholic
beverage labels. This should address the comment's concerns about malt
beverages or other alcoholic beverages that do not currently include
nutrient information. FDA has consulted with TTB on this rulemaking and
intends to continue to consult with TTB in the future.
    (Comment 59) Some comments recommended that drinks that are ordered
by customers at the bar and that are not listed on the menu should be
exempt from this rule.
    (Response 59) We agree with these comments. The final rule covers
alcoholic beverages that are standard menu items that are listed on a
menu or menu board. However, we are finalizing the proposed exemption
for a subset of alcoholic beverages that are not listed on a menu or
menu board. Specifically, Sec.  101.11(b)(1)(ii)(B) of the final rule
provides that the labeling requirements of Sec.  101.11(b)(2)(iii) do
not apply to those alcoholic beverages that are food on display. Our
reasons follow. Because these reasons do not apply equally to alcoholic
beverages that are self-service foods, Sec.  101.11(b)(1)(ii)(B) of the
final rule clarifies that alcoholic beverages that are self-service
foods are covered.
    First, it is unclear whether covered establishments could provide
nutrient content disclosures for alcoholic beverages on display behind
a bar that would assist consumers in making informed and healthful
order selections. Covered establishments often serve such beverages in
mixed drinks, and the amount of each alcoholic beverage and other
mixers they serve to consumers may vary depending on the drink ordered.
Section 403(q)(5)(H)(iii) of the FD&C Act requires that calories for
self-service food and food on display be declared per serving or per
item. Examples of other food on display include: Burrito fillings
behind a counter at a burrito restaurant where burritos are made to
order and salad ingredients behind a counter at a quick-service salad
restaurant where salads are made to order. An employee generally adds a
standard serving of each burrito filling or salad ingredient when asked
by the customer, e.g., a standard measured weight of meat or a standard
spoonful of beans. Nutrient content declarations based on those
standardized servings are directly applicable to consumers' order
selections.
    Even for some foods on display that have servings that vary, e.g.,
ice cream (where a customer can order one, two, or three scoops) or
burrito fillings (where a customer can order extra cheese), the amount
the customer receives is generally a simple multiple of a base serving.
Ice cream would likely be labeled per scoop and cheese would likely be
labeled per standard portion, with extra cheese being double the
standard portion.
    In contrast, covered establishments with bottles of alcoholic
beverages on display behind a bar generally serve varying amounts of
alcohol and mixers depending on the establishment's recipes for the
various beverages ordered. For example, at a given covered
establishment, a martini recipe might have 2 ounces (oz.) of gin and
0.5 oz. vermouth; a cosmopolitan recipe might have 3.5 oz. vodka, a
dash of triple sec, a dash of cranberry juice, 1 tsp of sugar, and 1
oz. of lime juice; and a grasshopper recipe might have 1 oz. white
cr[egrave]me de cacao, 1 oz. green cr[egrave]me de menthe, and milk or
cream to fill the glass (Ref. 31). As a result, the covered
establishment does not have a standard serving on which to base a
nutrient content declaration for each ingredient that will be directly
applicable to all routinely ordered mixed drinks. In addition, recipes
for even well-known drinks, like margaritas, may differ from one chain
of restaurants to another, and consumers are unlikely to know a
particular establishment's recipe while ordering (Ref. 31). It is
difficult to see how a consumer would use an establishment's nutrient
content disclosure on a bottle of alcohol behind a bar in choosing
which mixed drink to order.
    Section 403(q)(5)(H)(x)(II)(aa) of the FD&C Act requires FDA to
``consider standardization of recipes and methods of preparation'' and
``variations in ingredients'' in issuing these regulations. Therefore,
in finalizing the exemption for alcoholic beverages that do not appear
on menus or menu boards, we considered that recipes and methods of
preparation for alcoholic mixed drinks are not standardized throughout
the industry. In addition, we considered the variations of the amounts
of alcoholic beverages and other mixers served in mixed drinks in a
given covered establishment.
    Alcoholic beverages that are on display differ from other food on
display in additional relevant ways. Alcoholic beverages that are on
display, particularly bottles of alcohol that are behind a bar, often
appear to be on display primarily for decoration or storage, not to aid
consumers in selecting among food options. This contrasts with most
food that is on display, which is on display in order to aid consumers
in selecting among food options (e.g., food choices at a salad bar,
cookie varieties at a mall cookie counter). Once covered establishments
comply with these new regulations, consumers in covered establishments
who look at food on display to decide which displayed food they would
like to consume will be able to consider calorie information on signs
adjacent to the food and adjust their selection if they choose.
    In contrast, bottles of alcoholic beverages often are displayed
very close together, layered on top of each other, staged in low
lighting or back lighting, or placed very high. In other words,

they are displayed in a manner that does not enable consumers to easily
identify the particular alcoholic beverages available to assist them in
making their selections. In addition, bartenders often use bottles of
alcoholic beverages under the bar--that are not on display--to mix
alcoholic drinks. Finally, at many covered establishments that serve
alcoholic beverages, mixed drinks and other alcoholic beverages that
are not on menus or menu boards are ordered by customers sitting at
tables, from which the bar could be completely out of sight.
    Based on the above considerations, we are exempting alcoholic
beverages that are food on display and are not self-service food.
Because these considerations do not apply readily to self-service
alcoholic beverages (e.g., bottles of beer in a cooler near the
register at a quick service restaurant), self-service alcoholic
beverages are covered by the final rule. Therefore, Sec.
101.11(b)(1)(ii)(B) of the final rule provides that the labeling
requirements of Sec.  101.11(b)(2)(iii) for standard menu items that
are self-service or on display do not apply to alcoholic beverages that
are foods on display and are not self-service foods.

C. Condiments

    (Comment 60) Several comments recommended that covered
establishments provide calorie information for all condiments. Other
comments maintained that calorie information should be provided for
condiments if they are part of the standard menu item. One comment
recommended that the following be added to the provision: ``Condiments
and sauces included as an ingredient or standard accompaniment to a
menu item must be included in the nutrition information calculated for
that item.''
    Another comment asked us to clarify that if condiments are provided
for optional use, they should not be included in the calorie
declaration. As an example, if a container of ketchup is provided on
the side with a hamburger and the consumer can decide whether to use
it, the container of ketchup should be treated the same as a bottle on
the table and be exempted from calorie declaration. Another comment
asked that the words ``on the table'' be removed from the provision and
that the statute be interpreted to encompass condiments and other items
kept behind the counter for general use. This comment explained that
its establishment does not typically have tables as most of the
business is take-out, and the condiments are kept behind the counter
and available to the consumer upon request.
    One comment suggested that the exemption for condiments include
only those self-serve items that are calorie free or that have a
Nutrition Facts label. Another comment recommended that self-serve
restaurants have the flexibility to determine which items can
reasonably be considered condiments for general use, noting that many
of its restaurants have an extensive ``spice bar'' that contains dozens
of different spices, seasonings, and other condiments that any customer
can use, regardless of that customer's order or food selections. The
comment maintained that the regulation should be clear that all spices
and seasonings fall in this exempt category.
    (Response 60) We are clarifying the exemption for condiments.
Section 403(q)(5)(H)(vii)(I)(aa) of the FD&C Act provides that the
requirements of section 403(q)(5)(H) of the FD&C Act do not apply to
``items that are not listed on a menu or menu board (such as condiments
and other items placed on the table or counter for general use).'' We
affirm our tentative conclusion in the proposed rule that, given the
phrase ``for general use,'' it is reasonable to interpret section
403(q)(5)(H)(vii)(I)(aa) of the FD&C Act to apply to foods, such as
many condiments, that are available for use by any customer in the
covered establishment, regardless of the customer's particular order or
food selection (76 FR 19192 at 19205). For example, it is reasonable to
apply section 403(q)(5)(H)(vii)(I)(aa) of the FD&C Act to maple syrup
that is provided in a bulk container or bottles of ketchup that are
available for any customer to add to his or her food.
    However, we agree that the calorie declaration for a standard menu
item must include the number of calories in the condiment if the
condiment is used as a component in the standard menu item, as usually
prepared and offered for sale. In such situation, the nutrient
declarations for the standard menu item in 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) must also include the nutrient amounts from
the condiment because the condiment is used as a component in the
standard menu item. The exemption in section 403(q)(5)(H)(vii)(I)(aa)
of the FD&C Act does not apply to condiments that are part of a
standard menu item, as the standard menu item is usually prepared and
offered for sale. For example, if a covered establishment ordinarily
offers for sale burgers containing ketchup and mayonnaise added by the
establishment, the ketchup and mayonnaise would be part of the standard
menu item as usually prepared and offered for sale, and the calorie
declaration for the standard menu item would include the calories in
the ketchup and mayonnaise. Likewise, if a covered establishment
ordinarily provides each customer who orders pancakes with a single
serving container of maple syrup, the maple syrup would be part of the
standard menu item as usually prepared and offered for sale, and the
calorie declaration for the standard menu item would include the
calories in the single serving container of maple syrup. Similarly, as
noted previously in this document, in these situations, the nutrient
declarations for the standard menu item in 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) must also include the nutrient amounts from
the condiment because the condiment is used as a component in the
standard menu item.
    We see no difference between a condiment brought to the table for
general use and a condiment kept behind the counter for general use
(and then provided to a customer who requests it), provided that such
condiments are not listed on the menu or menu board separately or as
part of a standard menu item. Therefore, we agree that condiments that
are behind the counter for general use are exempt from the nutrition
labeling 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. For clarity, we have
revised Sec.  101.11(b)(1)(ii) to explicitly provide that the labeling
requirements in paragraph (b) do not apply to items such as condiments