[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Proposed Rules]
[Pages 19192-19236]
[FR Doc No: 2011-7940]

Vol. 76

Wednesday,

No. 66

April 6, 2011

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 11 and 101

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants
and Similar Retail Food Establishments; Proposed Rule

Federal Register / Vol. 76 , No. 66 / Wednesday, April 6, 2011 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]
RIN 0910-AG57

Food Labeling; Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: To implement the menu labeling provisions of the Patient
Protection and Affordable Care Act of 2010 (Affordable Care Act), the
Food and Drug Administration (FDA) is proposing requirements for
providing certain nutrition information for standard menu items in
certain chain restaurants and similar retail food establishments. The
Affordable Care Act, in part, amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act), among other things, to require restaurants and
similar retail food establishments that are part of a chain with 20 or
more locations doing business under the same name and offering for sale
substantially the same menu items to provide calorie and other
nutrition information for standard menu items, including food on
display and self-service food. Under provisions of the Affordable Care
Act, restaurants and similar retail food establishments not otherwise
covered by the law may elect to become subject to the Federal
requirements by registering every other year with the FDA. Providing
calorie and other nutrition information in restaurants and similar
retail food establishments would assist consumers in making healthier
dietary choices.

DATES: Submit either electronic or written comments on the proposed
rule by June 6, 2011. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by May 6, 2011 (see the
``Paperwork Reduction Act of 1995'' section of this document). See
section III.G of this document for the proposed effective date of any
rule that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
F-0172 and/or RIN 0910-AG57, by any of the following methods, except
that comments on information collection issues under the Paperwork
Reduction Act of 1995 must be submitted to the Office of Regulatory
Affairs, Office of Management and Budget (OMB) (see the ``Paperwork
Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket No. FDA-2011-F-0172, and RIN 0910-AG57 for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Office of Foods,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm.
3234, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Public Health Impacts of Overconsumption of Calories and Poor
Nutrition

    The U.S. Centers for Disease Control and Prevention (CDC)
identifies as overweight an adult whose body-mass index, or BMI,
(defined as weight in kilograms divided by the height in meters
squared) is between 25 and 29.9. CDC defines an obese adult as a person
20 years of age or older whose BMI is 30 or above (Ref. 1). Data
published by CDC indicate that 68 percent of the adult U.S. population
is overweight or obese under this definition, including 34 percent who
are considered obese (Ref. 1). For adults, being overweight or obese
increases the risk for a number of chronic diseases, including coronary
heart disease, type 2 diabetes, stroke, hypertension, arthritis, and
certain types of cancer (Refs. 1 and 2). A BMI over 35 is associated
with excess mortality, primarily from cardiovascular disease, diabetes,
and certain types of cancer (Refs. 1, 3-5). Cardiovascular disease,
cancer and diabetes are the leading causes of death and disability in
the US, accounting for 70 percent of all deaths in the U.S. (Ref. 6).
In 2005, 133 million Americans (almost one out of every two adults) had
at least one chronic illness (Ref. 6). As noted previously, overweight
and obesity are important contributors to the morbidity and mortality
associated with these diseases.
    CDC defines obesity in children as a BMI at or above the 95th
percentile plotted on CDC BMI-for-age and sex growth charts. Overweight
in children is defined as BMI-for-age from the 85th up to the 95th
percentile (Ref. 7). Using this definition, CDC data indicate that
about 32 percent of children and adolescents, aged 2 to 19, are
overweight or obese (Ref. 8). Overweight and obesity in childhood is
associated with a risk for obesity in adulthood, with the associated
health risks. In addition, children with high BMI face health problems
even in childhood, including elevated lipid concentrations and blood
pressure (Ref. 8).
    The primary risk factors for overweight and obesity in the general
population are overconsumption of calories (i.e., eating more calories
than are needed to maintain body weight) and physical inactivity (i.e.,
getting an amount of exercise below the amount required to burn excess
calories consumed over the amount needed to maintain body weight) (Ref.
9 at pp. 1, 8, 9). Americans now consume an estimated one-third of
their total calories on foods prepared outside the home (Ref. 10) and
now spend almost half of their annual food dollars on foods prepared
outside the home (Refs. 11 and 12.). Consumers are generally unaware
of, or inaccurately estimate, the number of calories in restaurant
foods (Ref. 13). In one survey of 193 adults, the participants
underestimated the calorie content in foods prepared outside of the
home they perceived to be ``healthier'' food choices by nearly half, an
average of almost 650 calories per item (Ref. 14).

B. Nutrition Labeling Requirements That Currently Apply to Packaged
Foods

    The Nutrition Labeling and Education Act of 1990 (NLEA) amended the
FD&C

Act, in part, by adding section 403(q), which specifies, in pertinent
part and with certain exceptions, that a food is considered to be
misbranded unless its label or labeling bears nutrition information.
See 21 U.S.C. 343(q)(1)). In general, when a food is in package form,
the required nutrition labeling information (Nutrition Facts) must
appear on the label of the food. (Title 21 of the Code of Federal
Regulations (CFR) Sec.  101.9 (21 CFR 101.9). FDA's final regulations
establishing nutrition labeling requirements were published in 1993 (58
FR 2079, January 6, 1993) and are found at Sec.  101.9. Regulations
implementing the NLEA require nutrition information for a food product
intended for human consumption and offered for sale unless an exemption
is provided for the product (Sec.  101.9(a)). The declaration of
nutrition information on the label and labeling of food must include
information about the levels of the following nutrients: total
calories, calories from fat (unless the product contains less than 0.5
g of fat), total fat, saturated fat, trans fat, cholesterol, sodium,
total carbohydrate, dietary fiber, sugars, protein, vitamins, and
minerals. Research conducted by FDA and others shows that many
consumers use the Nutrition Facts to make their food choices (Ref. 15).
However, this nutrition information is generally not available for
foods sold in restaurants and similar retail food establishments, which
make up an increasing proportion of the American diet.

C. The Exemption From Federal Nutrition Labeling Requirements for Food
Sold in Restaurants and Other Retail Food Establishments Under NLEA

    The NLEA amendments to the FD&C Act included an exemption for
nutrition labeling for food that is ``served in restaurants or other
establishments in which food is served for immediate human
consumption'' or ``sold for sale or use in such establishments''
(403(q)(5)(A)(i)) (21 U.S.C. 343(q)(5)(A)(i)). The NLEA amendments to
the FD&C Act also included an exemption for food of the type described
in section 403(q)(5)(A)(i) that is primarily processed and prepared in
a retail establishment, ready for human consumption, ``offered for sale
to consumers but not for immediate human consumption in such
establishment and which is not offered for sale outside such
establishment'' (21 U.S.C. 343(q)(5)(A)(ii)). However, these exemptions
were contingent on there being no nutrient content claims or health
claims made on the label or labeling, or in the advertising, for the
food. Current provisions in Sec.  101.10 require restaurants and other
establishments in which food is offered for human consumption that make
either a nutrient content claim (defined in Sec.  101.13) or health
claim (defined in Sec.  101.14) to provide certain nutrition
information upon request. For example, if a menu lists an entr[eacute]e
as being low in fat, information about the amount of fat in the
entr[eacute]e must be available upon request. FDA notes that this
requirement is and will still be in place if this proposed rule is
finalized.
    FDA provided examples of restaurants or other establishments in
which food is offered for human consumption, in which food sold
generally was exempted from nutrition labeling requirements under NLEA,
in Sec.  101.9(j)(2). The agency also provided in Sec.  101.9(j)(3)
examples of food sold in establishments in which food is processed and
prepared, ready for human consumption, offered for sale to consumers
but not for immediate consumption, and not offered for sale outside of
the establishments. These regulations are further discussed in section
III.A of this document.
    In recent years, there has been growing support among public health
experts for providing calorie and other nutrition information on
restaurant menus in order to help consumers make more informed food
choices. (Refs. 13, 16-18) There is also evidence of consumer
preference for calorie information on menus. For example, more than 70
percent of respondents to a national telephone survey of 580 adults
supported the idea of listing calorie information on restaurant menus
(Ref. 19). In a subset of 150 individuals from an experimental study in
Minneapolis-St. Paul, MN about the influence of nutritional labeling on
fast-food meal choices, 79 percent of respondents said they would use
calorie information if it was provided (Ref. 20).
    Some State and local jurisdictions have enacted laws or regulations
requiring calorie declaration for food offered for sale at restaurants
and other establishments. However, the requirements of these laws
differed among the States and local jurisdictions. For example, some
laws applied to retail food establishments with 15 or more locations,
while others applied to retail food establishments with 20 or more
locations. Some jurisdictions required only calories on menus and menu
boards while others required additional nutrient declarations (e.g.,
variations of the following: total grams of trans fat, grams of
saturated fat, grams of carbohydrates, and milligrams of sodium). Some
State and local laws required a statement on menus and menu boards
regarding daily intake amounts for calories and other nutrients and
other laws did not require such a statement. The wording of those
required statements varied (Refs. 21 and 22).

D. Requirements of Section 4205 of the Patient Protection and
Affordable Care Act

    On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was
signed into law. Section 4205 of the Affordable Care Act (``section
4205'') amends section 403(q) of the FD&C Act, which governs nutrition
labeling requirements, and section 403A of the FD&C Act, which governs
Federal preemption of State and local food labeling requirements. As
amended, section 403(q) requires restaurants and similar retail food
establishments that are part of a chain with 20 or more locations doing
business under the same name and offering for sale substantially the
same menu items (``chain retail food establishments'') to provide
calorie information for standard menu items, including food on display
and self-service food, and to provide, upon consumer request,
additional written nutrition information for standard menu items. Such
food is deemed to be misbranded if these requirements are not met. More
specifically, the following information must be provided for standard
menu items that are sold in chain retail food establishments:
     The number of calories contained in each standard menu
item as usually prepared and offered for sale on a menu or menu board
(the calorie declaration must be ``adjacent to'' the name of the
standard menu item, so as to be ``clearly associated with'' the item);
     A succinct statement concerning suggested daily caloric
intake posted prominently on the menu or menu board designed to enable
the public to understand in the context of a total daily diet, the
significance of the calorie information provided on menus and menu
boards;
     Additional nutrition information for standard menu items
in a written form (``written nutrition information''), available on the
premises, which must be made available to consumers upon request;
     A ``prominent, clear, and conspicuous'' statement on the
menu or menu board regarding the availability of the written nutrition
information; and
     The number of calories (per item or per serving) on a sign
adjacent to self-service food and food on display. This food includes
food sold at salad bars, buffet lines, cafeteria lines or similar self-
service facilities, and self-service

beverages and food on display that is visible to consumers.
    Section 4205 of the Affordable Care Act became effective on the
date the law was signed, March 23, 2010; however, some provisions
depend on FDA to issue rules before they can be required. With respect
to chain retail food establishments, the provisions that became
requirements upon enactment are:
     Disclosing the number of calories contained in each
standard menu item as usually prepared and offered for sale on menus
and menu boards;
     Providing written nutrition information to consumers upon
request;
     Providing a ``prominent, clear, and conspicuous''
statement on menus and menu boards about the availability of the
written nutrition information; and
     Providing calorie information (per serving or per food
item) for self-service items and food on display, on a sign adjacent to
each food item.
    The law also specifies that FDA must issue regulations that:
     Establish requirements for a succinct statement concerning
daily caloric intake, posted prominently on the menu or menu board,
designed to enable the public to understand in the context of a total
daily diet, the significance of the calorie information provided on
menus and menu boards;
     Establish standards for determining and disclosing the
nutrient content for standard menu items that come in different
flavors, varieties, or combinations, but which are listed as a single
menu item; and
     Specify how an authorized official of any restaurant or
similar retail food establishment not subject to the requirements of
section 403(q)(5)(H) may elect to be subject to the requirements by
registering biannually the name and address of such restaurant or
similar retail food establishment with FDA.
    Although these provisions became requirements at the time the law
was signed, FDA has previously announced that we intend to exercise our
enforcement discretion until the final rule is published and in effect.
See 76 FR 4360 (Jan. 25, 2011). FDA believes that this approach to
implementing section 4205 will minimize uncertainty and confusion among
all interested persons. The agency also believes that expeditious
completion of the rulemaking process will most rapidly lead to full and
consistent availability of the newly required nutrition information for
consumers.
    Given that FDA does not intend to enforce the self-executing
provisions at this time, we encourage our State and local partners to
proceed in a similar way. We do, however, encourage establishments that
already have calorie and nutrition information available to continue to
provide that information to consumers.
    Section 403(q)(5)(H)(x) requires that FDA propose implementing
regulations no later than one year after enactment of the ACA (21
U.S.C. 343(q)(5)(H)(x)). In addition, section 4205 authorizes FDA to
require, by regulation, chain retail food establishments to disclose
information about a nutrient, not explicitly required to be disclosed
by section 4205, in the written nutrition information, if FDA
determines that such information should be disclosed for the purpose of
providing information to assist consumers in maintaining healthy
dietary practices (21 U.S.C. 343(q)(5)(H)(vi)).
    Section 403(q)(5)(H)(viii)(I) establishes calorie disclosure
requirements for certain articles of food sold from a vending machine
that is operated by a person who is engaged in the business of owning
or operating 20 or more vending machines (21 U.S.C.
343(q)(5)(H)(viii)(I)). Elsewhere in this issue of the Federal
Register, FDA is publishing a proposal related to calorie declaration
for food sold in vending machines.
    Section 4205 required FDA to publish a notice in the Federal
Register specifying the terms and conditions under which restaurants or
similar retail food establishments and vending machine operators not
subject to the requirements of section 4205 could elect to be subject
to requirements by registering with FDA (21 U.S.C. 343(q)(5)(H)(ix)).
FDA has published this notice. See 75 FR 43182, July 23, 2010.
Voluntary registration is discussed in section III.C. of this document.

E. FDA Activities Related to Implementation of Section 4205

    On July 7, 2010, FDA published a notice in the Federal Register
entitled ``Disclosure of Nutrient Content Information for Standard Menu
Items Offered for Sale at Chain Restaurants or Similar Retail Food
Establishments and for Articles of Food Sold From Vending Machines''
(``docket notice'') (75 FR 39026 (July 7, 2010)), to solicit comments
and suggestions on the new law. Comments to the docket were due
September 7, 2010. In response to this docket notice, FDA received
approximately 875 responses, each containing one or more comments. Many
of these comments, in general, supported the nutrient disclosure
requirements in chain retail food establishments and for food sold from
vending machines, whereas some comments opposed such requirements.
    On July 23, 2010, FDA published a Federal Register notice entitled,
``Voluntary Registration by Authorized Officials of Non-Covered Retail
Food Establishments and Vending Machine Operators Electing to Be
Subject to the Menu and Vending Machine Labeling Requirements
Established by Section 4205 of the Patient Protection and Affordable
Care Act of 2010'' (``registration notice'') (75 FR 43182 (July 23,
2010)). In response to this notice, FDA received seven responses, none
of which addressed registration.
    On August 25, 2010, FDA published a ``Guidance for Industry:
Questions and Answers Regarding the Effect of Section 4205 of the
Patient Protection and Affordable Care Act of 2010 on State and Local
Menu and Vending Machine Labeling Laws'' (``preemption guidance'') (75
FR 52427 (August 25, 2010)). The preemption guidance discusses the
preemptive effect of section 4205 and identifies the provisions of
amended section 403(q) that became requirements upon enactment. Our
current thinking on the preemptive effect of section 4205 is set out in
section IX. of this document.
    Also on August 25, 2010, FDA published a ``Draft Guidance for
Industry: Questions and Answers Regarding Implementation of the Menu
Labeling Provisions of Section 4205 of the Patient Protection and
Affordable Care Act of 2010'' (``draft implementation guidance'') (75
FR 52426, August 25, 2010). The draft implementation guidance described
which provisions became requirements upon enactment of the law and
which provisions FDA would implement through rulemaking. FDA received
approximately 80 responses to this draft implementation guidance, each
containing one or more comments. On January 25, 2011, FDA published in
the Federal Register a notice withdrawing the draft implementation
guidance (76 FR 4360 January 25, 2011)). FDA now intends to complete
the notice and comment rulemaking process for section 4205 before
initiating enforcement activities. In the course of developing this
proposed rule, we have considered the comments received on the draft
guidance.
    We describe in more detail and respond to the comments to the
notices and guidance documents, including the withdrawn draft
implementation guidance, in this proposal. Some of the comments to the
notices and guidances are duplicative. Therefore, in this document,
when responding to

comments from the docket notice, the registration notice, or the draft
implementation guidance, we will generally refer to them simply as
``comments'' without identifying to which document these were
submitted. Comments that are outside the proposed scope of this
rulemaking, such as those concerning labeling of ingredients, allergen
labeling, and labeling of genetically engineered foods, will not be
discussed.

II. Legal Authority

    As stated in section I.D. of this document, on March 23, 2010, the
Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205
amended section 403(q)(5) of the FD&C Act (21 U.S.C. 343(q)(5)) by
amending section 403(q)(5)(A) and by creating new clause (H), which
requires, in relevant part, covered establishments to provide certain
nutrient declarations for standard menu items. Under section 403(a)(1)
of the FD&C Act (21 U.S.C. 343(a)(1)), such declarations must be
truthful and nonmisleading. Because food that is not in compliance with
section 403 is deemed misbranded, food to which these requirements
apply is deemed misbranded if these requirements are not met. In
addition, under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), the
labeling of a food is misleading if it fails to reveal facts that are
material in light of representations actually made in the labeling.
Section 403(q)(5)(H)(x) requires that the Secretary of Health and Human
Services (Secretary) issue proposed regulations no later than one year
after enactment. Section 701(a) (21 U.S.C. 371(a)) vests the Secretary
with the authority to issue regulations for the efficient enforcement
of the FD&C Act. Thus, FDA has the authority to issue this proposed
rule under sections 201(n), 403(a)(1), 403(q)(5)(H), and 701(a) of the
FD&C Act.
    FDA is proposing requirements that covered establishments provide
calorie and other nutrition information for standard menu items,
including food on display and self-service food. Also, FDA is proposing
the terms and conditions for voluntary registration by establishments
that are not automatically subject to the requirements of section 4205
that elect to become subject to the requirements. FDA is proposing to
set out these provisions in new Sec.  101.11.

III. The Proposal

A. Summary

    This proposal would add a new section 101.11 to 21 CFR and make
additional changes to FDA's regulations as needed to conform existing
regulations to the new statutory requirements. In this section, we
explain the provisions of the new proposed section 101.11, beginning
with the definitions of several key terms in the proposal.

B. Definitions

    The menu labeling requirements of section 4205 apply to standard
menu items offered for sale in ``covered establishments'':
    1. ``Restaurants or similar retail food establishments'' that are
     Part of a chain with 20 or more locations,
     ``doing business under the same name'', and
     ``offering for sale substantially the same menu items'';
and
    2. Other restaurants or similar retail food establishments that
have been voluntarily registered to be subject to the Federal
requirements by an ``authorized official''.
    Covered establishments must provide calorie information on
``menus'' and ``menu boards,'' and other nutrition information upon
request, for ``standard menu items,'' including ``combination meals,''
``food on display,'' ``self-service food,'' and ``variable menu
items.'' The new nutrition labeling requirements do not apply to
``custom orders,'' ``daily specials,'' ``food that is part of a
customary market test,'' and ``temporary menu items.''
    To establish the scope of establishments, labeling, and food
covered by section 4205, FDA must define these and other key terms.
Therefore, we are proposing in the introductory paragraph of Sec.
101.11(a) that the definitions of terms in section 201 of the FD&C Act
(21 U.S.C. 321) are applicable to these terms when used in proposed
Sec.  101.11. Additional terms are defined alphabetically in the
proposed codified. Here, they are discussed in the order they are
mentioned in the outline above, organized into three categories: (1)
Terms related to the scope of establishments covered, (2) the terms
menu and menu board, and (3) terms related to foods covered.
1. Scope of Establishments Covered
    The menu labeling requirements in section 4205 of the Affordable
Care Act apply to foods ``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 (regardless of the type of
ownership of the locations) and offering substantially the same menu
items.'' They also apply to restaurants or similar retail food
establishments that voluntarily register to become subject to the
Federal requirements. Some of the questions related to the scope of
establishments covered are very complex, and FDA offers several
alternatives for public comment.
Covered Establishment
    We are proposing in Sec.  101.11(a) that the term ``covered
establishment'' means 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 of the
locations) and offering for sale substantially the same menu items, as
well as restaurants or similar retail food establishments that
voluntarily register to become subject to the Federal requirements. FDA
derived this proposed definition from the criteria in sections
403(q)(H)(i) and (ix)(I) of the FD&C Act. Section 403(q)(H)(i)
describes which restaurants and similar retail food establishments must
meet the new requirements: Restaurants and similar retail food
establishments that are part of a chain with 20 or more locations doing
business under the same name (regardless of the type of ownership of
the locations) and offering for sale substantially the same menu items.
Section 403(q)(H)(ix)(I) allows restaurants or similar retail food
establishments not otherwise subject to the requirements in section
403(q)(H) to register voluntarily to be subject to them (see section
III.C below). Both restaurants and similar retail food establishments
described in section 403(q)(H)(i) and those that register under section
403(q)(ix)(I) are subject to, or ``covered'' by, the nutrition labeling
requirements of section 4205.
    Terms within the definition of ``covered establishment'' are
discussed below. We note that we have not proposed a definition for the
statutory criterion, ``part of a chain with 20 or more locations.'' For
the purposes of this proposal, FDA is assuming the common meanings of
the words in that phrase. However, FDA requests comment on whether the
phrase should be defined in the final rule. In particular, we request
comment on the terms ``chain'' and ``location'' in the context of the
various types of corporate or other business arrangements or structures
that might be relevant, including contracting arrangements.
Restaurant and Similar Retail Food Establishment
    While the core coverage may seem clear, the relevant statutory term

(``restaurants and similar retail food establishments'') is ambiguous.
It is possible to imagine a range of interpretations, calling for
relatively narrow coverage (including only restaurants and those
establishments that are closely analogous to restaurants) or relatively
broad coverage (including a range of establishments that sell food
retail). FDA offers here a proposed interpretation alongside several
alternatives for public comment. Under the proposed interpretation,
explained in detail below, a retail food establishment is ``similar''
to a restaurant, and hence, covered, if it offers for sale restaurant
or restaurant-type food and its primary business activity is the sale
of food to consumers. FDA gives examples of included and excluded
establishments below.
    Statutory context. As a starting point for developing a regulatory
definition, we look to statutory context. As noted earlier, the 1990
NLEA amendments exempted two categories of food relevant for this
discussion: (1) Food ``which is served in restaurants or other
establishments in which food is served for immediate human consumption
or which is sold for sale or used in such establishments,'' and (2)
food ``which is processed and prepared primarily in a retail
establishment, which is ready for human consumption, which is the type
described in [(1)] and which is offered for sale to consumers but not
for immediate human consumption in such establishment and which is not
offered for sale outside such establishment.'' 21 U.S.C.
343(q)(5)(A)(i) and (ii). These are referred to in this document as
``restaurant food'' and ``restaurant-type food,'' respectively.
    When promulgating regulations in 1993 to implement NLEA, FDA
interpreted the categories of restaurant and restaurant-type food
broadly. The agency provided the following examples of restaurant food:
Food sold in institutional food service establishments, transportation
carriers, delicatessens and retail confectionery stores where there are
facilities for immediate consumption on the premises, food service
vendors such as mall cookie counters, and sidewalk carts where foods
are generally consumed immediately where purchased or while the
consumer is walking away, including similar foods sold from convenience
stores; and food delivery systems or establishments where ready-to-eat
foods are delivered to homes or offices. 21 CFR 101.9(j)(2)(ii). The
agency included the following examples of restaurant-type food: Ready-
to-eat foods that processed and prepared on-site and sold by
independent delicatessens, bakeries, or retail confectionary stores
where there are no facilities for immediate consumption; by in-store
delicatessen, bakery, or candy departments; or at self-service food
bars such as salad bars. FDA also issued guidance on the labeling of
foods sold in restaurants and other retail establishments selling
restaurant or restaurant-type foods (Ref. 23).
    Section 4205 amended the statutory exemption from Federal nutrition
labeling requirements for restaurant and restaurant-type food. In
determining the scope of section 4205, FDA considered which restaurant
and restaurant-type foods should remain exempt from the Federal
nutrition labeling requirements and which should be covered by the new
Federal nutrition labeling requirements of section 4205.
    Public comments. In response to the docket notice and other Federal
Register notices published in 2010, described in section I.E. above,
FDA received numerous comments on the types of establishments that
should be covered under section 4205. Some comments that were submitted
to FDA supported the inclusion of a broad list of establishments such
as those that had been exempted from nutrition labeling in FDA's
implementing regulations of the NLEA. Some of these comments stated
that concession stands at bowling alleys, amusement parks, stadiums,
casinos, miniature golf courses, and other entertainment venues should
be covered as well. These comments asserted that such establishments
should be covered because consumers need to have access to calorie and
other nutrition information for foods sold from such concession stands,
and requiring nutrition information in all of these establishments
provides a level playing field. A few of these comments maintained that
establishments such as grocery stores and convenience stores contain
facilities such as bakeries or cafes that are indistinguishable from
their stand-alone counterparts and, therefore, should be covered by
section 4205.
    Other comments opposed the inclusion of concession stands at
entertainment venues such as movie theaters, and restaurants at hotels,
stating that the primary purpose of going to these establishments is
not to buy food, but instead for entertainment or lodging. A few
comments suggested that FDA adopt a definition that excludes
establishments whose sale of prepared food (excluding pre-packaged
snacks that already list nutritional information) is less than 35
percent of gross revenue. One comment suggested that FDA examine the
percentage of sales derived at a particular retail location from food
served for immediate consumption on the premises, and that, if more
than 25 percent of total sales at a retail location are derived from
the sale of food served for immediate consumption on the premises, the
retail outlet is similar to a restaurant and should fall within the
scope of Sec.  4205.
    Some comments opposed the inclusion of convenience stores and some
grocery stores. The comments stated that not all chain convenience
stores have menus or sell the same food items at all locations. The
comments asserted that food in convenience stores is not standardized
and that the foods differ depending on the techniques and preferences
of the store employees preparing the foods. By contrast, according to
the comments, food sold in restaurant chains is typically standardized
and prepared in a homogeneous manner as dictated by corporate policy.
The comments stated that some grocery stores have cafes, food courts,
or otherwise sell restaurant food directly to consumers. Some comments
contended that only grocery stores with seating areas should be
covered. Other comments stated that FDA does not have authority under
section 4205 to regulate individual departments or operations within a
retail food establishment unless that establishment as a whole is
similar to a restaurant.
    FDA received a few comments regarding the possible inclusion of
food-service contractors, which the comments described as companies
that provide managed food and facility services to a variety of
institutions, including hospitals, schools, stadiums/arenas and
businesses, as covered establishments. Some of these comments stated
that menus at establishments operated by food service contractors can
vary from day-to-day and month-to-month. However, if food-service
contractors have quick-service restaurants, the comments support
calorie labeling in these establishments.
    We considered these comments, in addition to the language and
purpose of the statute, when deliberating on how to define restaurants
and similar retail food establishments for purposes of this rulemaking.
We also noted the existence of hybrid establishments, such as chain
coffee vendors operating in retail bookstores and soup and sandwich
counters, cafes, and food courts in grocery or convenience stores. For
example, a grocery store may have a salad bar from which consumers
select various foods that are ready for human consumption, processed
and prepared primarily in the grocery store, and not offered for sale
outside of the grocery

store. In addition, many establishments, such as certain coffee shops
in bookstores, operate in or consist of multipurpose businesses, where
entertainment, restaurant food and other goods and services are offered
together or in close proximity.
    Proposed definition. FDA tentatively concludes that a retail food
establishment is an establishment whose primary business activity is
the sale of food to consumers. FDA also tentatively concludes that in
order for a retail food establishment to be ``similar'' to a
restaurant, it must offer for sale restaurant or restaurant-type food.
Although there are many types of establishments where consumers come
into contact with food for purchase, FDA notes that the statutory text
focuses explicitly on restaurants and retail food establishments that
are ``similar'' to restaurants, rather than on all establishments where
food is sold (often incidentally to or quite separately from the
establishment's primary purpose). In light of the statutory language,
FDA is proposing in 101.11(a) that the term ``restaurant or similar
retail food establishment'' means a retail establishment that offers
for sale restaurant or restaurant-type food, where the sale of food is
the primary business activity of that establishment. FDA acknowledges
that the statutory language is not entirely clear, and invites comments
on various alternatives, but currently believes that the proposed
definition fits best with the natural meaning of the language and its
proper scope.
    The sale of food would be considered to be a retail establishment's
primary business activity if either (1) the establishment presents or
has presented itself publicly as a restaurant (e.g., through consumer-,
industry- or investor-oriented materials) or (2) greater than 50
percent of a retail establishment's gross floor area is used for the
preparation, purchase, service, consumption, or storage of food.
Examples of when an establishment is presenting itself as a restaurant
could include calling itself a restaurant on a consumer-oriented Web
site, listing itself under ``Restaurants'' in the phone book, and using
the term ``restaurant'' in its signage. Note that if a portion of the
establishment were to present itself publicly as a restaurant (e.g., a
``caf[eacute] car'' on a train), the first criterion would not
necessarily be satisfied; the question would be how the establishment
as a whole presents or has presented itself. See the discussion of
facilities within establishments below. For the second criterion, gross
floor area would include all floor space, wall to wall, including areas
under built-in counters, cooking equipment, seating, and similar
furniture. Multi-purpose seating areas used substantially for
activities other than food consumption, such as seating in
entertainment venues (e.g., shows, sport stadiums), would not be
counted in the share of floor space devoted to the sale of food. FDA
notes that some establishments may have seating outside for the
consumption of food (e.g., outdoor cafes). We seek comment on whether
this space should be considered in determining gross floor area.
    As an alternative to using percentage of gross floor area as an
indicator of the primary business activity of an establishment, FDA is
seeking comment on an approach based on the percent revenue of the
business. Under this alternative approach, the sale of food would be
considered to be a retail establishment's primary business activity if
either (1) the establishment presents or has presented itself publicly
as a restaurant or (2) more than 50 percent of the establishment's
revenues are generated by the sale of food. FDA requests comment on
this alternative means of determining an establishment's primary
business activity. We specifically seek comment on whether 50 percent
is the appropriate threshold or whether it should be higher or lower.
We also welcome comment on other suggested alternative criteria for
identifying the primary business activity of an establishment.
    Under the proposal that includes gross floor space, restaurants and
similar retail food establishments would likely include table service
and quick-service (or fast food) dining establishments, cafeterias,\1\
pastry and retail confectionary stores, coffee shops, snack bars, and
ice cream parlors, as well as grocery stores and convenience stores
that sell restaurant or restaurant-type food. In addition, multi-
purpose establishments that offer restaurant or restaurant-type food
and include areas for entertainment (e.g., games or children's shows)
would be restaurants or similar retail food establishments if they
present themselves or have presented themselves publicly as
restaurants, regardless of whether the amount of floor space dedicated
to the sale of food is greater than 50 percent of the venue's gross
floor space.
---------------------------------------------------------------------------

    \1\ Many cafeterias located within other establishments, e.g.,
most school and hospital cafeterias, would be considered part of
larger establishments they are situated within and would not be
covered by the proposed rule. See the discussion of facilities
located within larger establishments below.
---------------------------------------------------------------------------

    Correspondingly, establishments that do not sell restaurant or
restaurant-type food or whose primary business activity is not the sale
of food would not be considered restaurants or similar retail food
establishments and would not have to comply with the menu labeling
provisions of 403(q)(5)(H). For example, where a multi-purpose
establishment has never presented itself publicly as a restaurant and
the percentage of the establishment's gross floor area devoted to the
sale of food is less than 50 percent, the establishment would not be a
restaurant or similar retail food establishment under this proposal.
FDA expects that most movie theaters, amusement parks, general
merchandise stores with in-house concession stands, hotels, and
transportation carriers such as trains and airplanes will not be
considered restaurants or similar retail food establishments under this
proposal, 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.
    The following table provides examples of establishments that FDA
expects would be considered restaurants or similar retail food
establishments under the proposal and those that would not. Note that
whether a specific establishment would be considered a restaurant or
similar retail food establishment would depend on whether that specific
establishment met the proposed regulatory criteria. In addition, a
restaurant or similar retail food establishment is covered by the new
menu labeling requirements if 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, or it voluntarily registers with
FDA.

    Table 1--Are the Following Establishments ``Restaurants or Similar Retail Food Establishments'' Under the
                                                 Proposed Rule?
----------------------------------------------------------------------------------------------------------------
                       Generally yes                                            Generally no
----------------------------------------------------------------------------------------------------------------
Table service dining establishments                         Movie theaters
Quick service (fast food) establishments                    Amusement parks
Cafeterias                                                  General merchandise stores
Pastry and retail confectionary stores                      Hotels
Coffee shops                                                Trains
Snack bars                                                  Planes
Ice cream parlors
Multi-purpose establishments that have presented
 themselves publicly as restaurants
Establishments within larger establishments that are part
 of a chain with locations outside of the larger
 establishment's chain (e.g., chain coffee shop in a
 bookstore; see discussion below)
Grocery stores
Convenience stores
----------------------------------------------------------------------------------------------------------------
Note: While the appropriate categorization will often be straightforward, the word ``generally,'' used in the
  headings, is an important qualification. For example, some grocery and convenience stores may meet the
  definition of ``restaurants or similar retail food establishments'' under this proposed rule, while others may
  not.

    Many facilities that sell restaurant or restaurant-type food are
located within larger retail establishments, such as a coffee shop in a
bookstore, a hot dog stand in a stadium, a quick-service counter in an
establishment selling a range of packaged foods and household products
(``Superstore XYZ''), or a concession stand in an entertainment venue.
Some of these facilities would be considered separate retail
establishments, while others would be considered part of their larger
retail establishments.
    If a facility selling restaurant or restaurant-type food is part of
a chain with locations outside of the chain of the larger retail
establishment, the facility would be considered a separate retail
establishment. For example, if a coffee shop in a bookstore is part of
a chain of coffee shops with locations outside of the chain of
bookstores, the coffee shop would be considered a separate retail
establishment. When determining the primary business activity of the
coffee shop, only the representations of the coffee shop itself and the
coffee shop's floor area would be considered. The coffee shop in the
bookstore would most likely meet the proposed definition of a
restaurant or similar retail food establishment.
    If, by contrast, a facility selling restaurant or restaurant-type
food is not part of a chain with locations outside of the chain of the
larger retail establishment, the facility would be considered part of
the larger retail establishment. For example, if Superstore XYZ has a
caf[eacute] that appears only in other locations of the Superstore XYZ
chain, the caf[eacute] would be considered part of Superstore XYZ. When
determining the primary business activity of Superstore XYZ, the agency
would ask whether the superstore as a whole presents or has presented
itself as a restaurant and what percentage of the gross floor area of
the superstore as a whole, including the caf[eacute], is dedicated to
the sale of food. Because the caf[eacute] would not be considered an
``establishment,'' it would not be eligible for being a ``restaurant or
similar retail food establishment'' under this proposal. As a result,
whether the cafe independently presents itself as a restaurant (e.g.,
by listing itself in the phone book under ``Restaurants'') or has
greater than 50% of its floor space devoted to the sale of food would
be irrelevant.
    As another example, a movie theater concession stand that appears
only in other movie theaters in that particular chain of movie theaters
would not be considered a separate establishment for the purposes of
this proposed rule. Because movie theaters usually do not present
themselves as restaurants and do not dedicate more than 50 percent of
their gross floor area to the sale of food, they generally would not
fall within the definition of restaurant or similar retail food
establishment in this proposed rule.
    FDA requests comment on whether such facilities within larger
establishments should be included within the definition of restaurants
and similar retail food establishments in the final rule. FDA
particularly requests comment on this approach with respect to movie
theaters, other entertainment-type venues, and Superstores that offer
restaurant or restaurant-type food.
    An alternative. One alternative to our proposed definition is to
define ``restaurant or similar retail food establishment'' to mean a
retail establishment where the sale of restaurant or restaurant-type
food--as opposed to food in general--is the primary business activity
of that establishment. Restaurant or restaurant-type food here would
not include packaged food that is required to bear Nutrition Facts.
Under this alternative, the agency would consider the sale of
restaurant or restaurant-type food to be a retail establishment's
primary business activity if either (1) the establishment presents
itself or has presented itself publicly as a restaurant, or (2) a total
of more than 50 percent of a retail establishment's gross floor area is
used for the preparation, purchase, service, consumption, or storage of
restaurant or restaurant-type food or its ingredients. As with the
proposed definition, multi-purpose seating areas used substantially for
activities other than food consumption, such as seating in
entertainment venues (e.g., shows, sport stadiums) would not be counted
in the share of floor space devoted to the sale of restaurant or
restaurant-type food. Under this alternative, FDA solicits comment on
whether a percent revenue approach to determining an establishment's
primary business activity is the sale of restaurant or restaurant-type
foods.
    Under this alternative, ``restaurant or similar retail food
establishment'' would include table service and quick-service (or fast
food) dining establishments, cafeterias, pastry and retail
confectionary stores, coffee shops, snack bars, and ice cream parlors.
Establishments where the primary business activity is not the sale of
restaurant or restaurant-type food would not be considered restaurants
or similar retail food establishments. In contrast with the proposed
definition, establishments that are unlikely to be considered
restaurants or similar retail food establishments under this
alternative include grocery and convenience stores, in addition to
hotels and transportation carriers such as trains and airplanes. The
option would

not cover grocery and convenience stores because it would not count the
floor space used to sell food that is not restaurant or restaurant-type
food (e.g., packaged food) in determining the primary business
activity.
    The following table provides examples of establishments that FDA
expects would be considered restaurants or similar retail food
establishments under the alternative and those that would not. Note
that whether a specific establishment would be considered a restaurant
or similar retail food establishment would depend on whether that
establishment met the alternative regulatory criteria. In addition, a
restaurant or similar retail food establishment is only covered by the
new menu labeling requirements if 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.

   Table 2--Are the Following Eestablishments ``Restaurants or Similar Retail Food Establishments'' Under the
                                     Alternative to the Proposed Definition?
----------------------------------------------------------------------------------------------------------------
                       Generally yes                                            Generally no
----------------------------------------------------------------------------------------------------------------
Table service dining establishment                          Movie theaters
Quick service (fast food) establishments                    Amusement parks
Cafeterias                                                  General merchandise stores
Pastry and retail confectionary stores                      Hotels
Coffee shops                                                Trains
Snack bars                                                  Planes
Ice cream parlors                                           Grocery stores
Multi-purpose establishments that have presented            Convenience stores
 themselves publicly as restaurants
Establishments within larger establishments that are part
 of a chain with locations outside of the larger
 establishment's chain (e.g., chain coffee shop in a
 bookstore; see discussion below)
----------------------------------------------------------------------------------------------------------------
Note: While the appropriate categorization will usually be straightforward, the word ``generally,'' used in the
  headings, is an important qualification. For example, some grocery and convenience stores will qualify as
  similar retail food establishments under the rule, while others may not. The answer depends on the definition
  proposed in this section.

    Requests for comment. We request comment on the proposed definition
and on the alternatives. We are also interested in comments on whether
we should use ``primary business activity,'' or a different test, as a
basis for determining whether an establishment is a restaurant or
similar retail food establishment. We also request comment on whether
we should choose a different number for the cutoff for the percent of
gross floor area for determining the primary business activity of the
retail establishment or whether we should choose the percent revenue
approach discussed above or different criteria for determining primary
business activity, such as whether the consumer pays for admission to
the establishment.
    As we have noted, some comments have urged a broader test on public
health grounds. Any such test must explain how it is consistent with
statutory language. For example, if FDA adopted a percentage revenue
threshold test for determining primary business activity and set the
threshold at 25%, as some comments suggested, would chain movie theater
concessions be included? If so, would this test be appropriate, given
the statutory language? We are also interested in comments on the
impact of the proposed definition and alternatives on the sale of
restaurant or restaurant-type food by large chain ``Superstores'' or by
contractors servicing similar food outlets in 20 or more locations. FDA
notes that one food contractor commented that it offers quick service
or fast food concepts in some of its locations. The comment further
stated that menus in these locations are highly standardized and
consistent across locations. The comment supported calorie labeling on
menus and menu boards and the availability of additional written
nutrition information for these types of locations. Comments supporting
or opposing the possible definitions discussed here should include a
rationale and should explain the impact of the recommendation on the
implementation of section 4205.
Doing Business Under the Same Name
    The menu labeling requirements apply to restaurants and similar
retail food establishments that are part of a chain with 20 or more
locations ``doing business under the same name.'' We are proposing in
Sec.  101.11(a) that the term ``doing business under the same name''
means sharing the same name, where the term ``same name'' includes
names that are either exactly the same, or are slight variations on
each other due, for example, to the region, location or size.
    In some cases, a chain retail food establishment's name may vary
slightly from the names of other establishments in the same chain,
often reflecting the location or size of the establishment. For
example, a quick-service restaurant, ``Joe's Burgers New York Ave.,''
located on New York Avenue, might have another location on Pennsylvania
Avenue called ``Joe's Burgers Pennsylvania Ave.'' As another example, a
dine-in restaurant with the name ``ABC'' might have an outlet in an
airport called ``ABC Express'' that offers take-out. FDA is proposing
that the term ``same name'' includes names that are slight variations
on each other, for example, based on region, location or size (e.g.,
``Joe's Burgers New York Ave.'' and ``Joe's Burgers Pennsylvania Ave.''
or ``ABC'' and ``ABC Express''). FDA requests comment on this
definition. Specifically, we request comment on whether the relevant
term should be understood instead to refer to the underlying name of
ownership, such as the name of a parent company, or the name of the
entity conducting corporate business on behalf of the establishment,
such as the name of a contractor operating an establishment, regardless
of the public name used by individual establishments.
Offering for Sale Substantially the Same Menu Items
    We are proposing in Sec.  101.11(a) that the term ``offering for
sale substantially the same menu items'' means offering for sale menu
items that use the same general recipe and are prepared in
substantially the same way with substantially the same food components,
even if the name of the menu item varies. For example, a chain
restaurant may make a sandwich and call it ``Bay View Crab Cake,''
whereas another restaurant in that chain that makes the same sandwich
prepared the same way and with the same ingredients may call it ``Ocean
View Crab Cake.'' These two restaurants would be offering for sale the
same menu item. In addition, restaurants and similar retail

food establishments that are part of a chain can still be offering for
sale substantially the same menu items if the availability of some menu
items varies within the chain. For example, a covered restaurant in a
chain may have a limited menu and not carry all the standard menu items
as another restaurant in the chain. However, if most of the standard
menu items in the restaurant with the limited menu are sold in the
restaurant with the more extensive menu, these two restaurants would be
offering for sale substantially the same menu items. As another
example, a chain retail food establishment might offer standard menu
items that are mostly the same, except for a few that are unique to
that chain retail food establishment. That chain retail food
establishment would still be offering for sale substantially the same
menu items as the other establishments in the chain. In this proposed
definition, the term ``menu items'' refers to food items that are
offered for sale in a restaurant or similar retail food establishment.
Authorized Official
    Restaurants and similar retail food establishments that are not
automatically covered by the new menu labeling requirements can
voluntarily register to be subject to them. Section 403(q)(5)(H)(ix)
provides that ``[a]n authorized official of any restaurant or retail
food establishment * * * not subject to the requirements of this clause
may elect to be subject to the requirements of such clause, by
registering biannually the name and address of such restaurant or
similar retail food establishment * * * with the Secretary, as
specified by the Secretary by regulation.'' We are proposing in Sec.
101.11(a) that the term ``authorized official of a restaurant or
similar retail food establishment'' means the owner, operator, agent in
charge, or any other person authorized by the owner, operator, or agent
in charge of a restaurant or similar retail food establishment not
subject to the requirements of section 4205 to voluntarily register the
establishment with FDA to become subject to the requirements of section
4205. FDA tentatively concludes that it is appropriate for the owners,
operators, or agents in charge to be able to authorize other persons to
register on their behalf.
Summary of Proposed Scope of Covered Establishments
    When is an entity an establishment? If an entity is free-standing,
it would be an establishment. If an entity is inside an establishment,
then the entity could be considered a separate establishment or it
could be considered part of the establishment in which it is situated.
If the entity is part of a chain with locations outside of the chain of
the larger establishment, then the entity would be a separate
establishment. If not, the entity would be considered part of the
larger establishment.

              Table 3--When Is an Entity an Establishment?
------------------------------------------------------------------------
                                         Is the entity an establishment?
------------------------------------------------------------------------
The entity is free-standing............  Yes.
The entity is inside an establishment
 and:
     It only appears in          No.
     locations of the larger
     establishment's chain (e.g.,
     Superstore XYZ Caf[eacute] in
     Superstore XYZ).
     It is part of a chain with  Yes.
     locations outside of the larger
     establishment's chain (e.g.,
     coffee shop in a bookstore that is
     part of a chain of coffee shops
     with locations that are free-
     standing).
------------------------------------------------------------------------

    When is an establishment a restaurant or similar retail food
establishment? To be a restaurant or similar retail food establishment,
an establishment must sell restaurant or restaurant-type food. In
addition, the sale of food in general must be the establishment's
primary purpose. The sale of food is an establishment's primary purpose
if (1) the establishment publicly presents itself or has publicly
presented itself as a restaurant, or (2) the establishment dedicates
more than 50% of its floor space to the sale of food. This is
demonstrated in following flow chart:

[GRAPHIC] [TIFF OMITTED] TP06AP11.010

    When is a restaurant or similar retail food establishment a covered
establishment? A restaurant or similar retail food establishment is a
``covered establishment'' if (1) 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, or (2) it has voluntarily registered
with FDA to be subject to the Federal requirements. FDA refers to the
first category as ``chain retail food establishments.''

    Table 4--Statutory Criteria for Chain Retail Food Establishments:
------------------------------------------------------------------------
        Statutory criteria                 Proposed interpretation
------------------------------------------------------------------------
Part of a chain with 20 or more     The restaurant or similar retail
 locations.                          food establishment is part of a
                                     chain with at least 19 other
                                     establishments.
Doing business under the same name  Establishments in the chain share
                                     the same name or have names that
                                     are slight variations on each
                                     other, due to, for example, region
                                     or size (e.g., ABC and ABC Express,
                                     Joe's Burgers New York Ave. and
                                     Joe's Burgers Pennsylvania Ave).
Offering for sale substantially     Establishments in the chain offer
 the same menu items.                for sale 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.
                                     Establishments can be offering for
                                     sale substantially the same menu
                                     items even if the availability of
                                     some menu items varies within the
                                     chain.
------------------------------------------------------------------------

    Voluntary registration. If a restaurant or similar retail food
establishment is not 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 establishment may voluntarily elect to be subject
to the new Federal requirements by registering with FDA.
2. Menu and Menu Board
    Covered establishments are required to post calories and other
information on menus and menu boards. Section 403(q)(5)(H)(xi) provides
that ``the term `menu' or `menu board' means the primary writing of the
restaurant or other similar retail food establishment from which a
consumer makes an order selection.'' We are proposing in Sec.
101.11(a) to essentially codify this definition. The proposed
regulatory definition also clarifies that menus include breakfast,
lunch and dinner menus; dessert menus; beverage menus; children's
menus; other specialty menus; electronic menus; and menus on the
Internet. Menus may be in different forms, e.g., booklets, pamphlets,
or single sheets of paper. Menu boards include drive-through menu
boards as well as display boards above ordering counters.
    In developing this proposed definition, FDA considered comments
expressing various opinions on what constituted a menu or menu board.
According to several comments, FDA should allow electronic devices,
such as Internet-enabled smart phones, text messaging, and kiosks, to
serve as primary writings. One comment requested that FDA clarify
whether a writing posted on the Internet would only be considered a
menu if a consumer may place an order online. Several comments asserted
that marketing materials (e.g., banners, table tents) should not be
considered menus.
    FDA tentatively concludes that ``menu'' or ``menu board'' includes
any writing of the covered establishment that is the primary writing
from which a consumer makes an order selection.

FDA considered whether ``primary'' should be from the perspective of
the establishment or the consumer. If covered establishments were only
required to label the writing they consider to be their primary writing
from which consumers make order selections, only one writing would be
required to be labeled. For example, at a quick service restaurant that
has two menu boards, one above a counter inside and one outside at a
drive-through, the one the restaurant considers its ``primary writing''
would be labeled, but the other might not. Given the importance for all
consumers to have access to nutrition information when making order
selections, FDA proposes that ``primary writing'' should be interpreted
from a consumer's vantage point. 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 mailed 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). We recognize that some establishments may
send menus as a form of advertising. FDA tentatively concludes
advertisements for food fall outside the scope of section 4205.
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. FDA requests comment on these tentative
conclusions.
    FDA notes that many consumers order restaurant or restaurant-type
food from restaurants or similar retail food establishments over the
phone or Internet. FDA tentatively concludes 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).
3. Food Covered
    Section 4205 requires covered establishments to provide calorie and
other nutrition information for ``food that is a standard menu item,''
including combination meals, variable menu items, self-service food,
and food on display. The new requirements do not apply to custom
orders, daily specials, food that is part of a customary market test,
and temporary menu items.
Food
    The term ``food'' is defined in section 201(f) of the FD&C Act, in
relevant part, as ``articles used for food or drink for man * * *
chewing gum, and articles used for components of any such article.'' 21
U.S.C. 321(f). Under section 201 of the FD&C Act, this definition
applies ``for purposes of this Act.'' Therefore, articles of food that
are offered for sale in covered establishments as standard menu items,
including food on display and self-service foods would generally be
subject to section 403(q)(5)(H). The term ``food'' includes foods that
are also regulated by other U.S. Government agencies, such as meat,
poultry, and processed egg products, which are also regulated by the
United States Department of Agriculture (USDA), and alcoholic beverages
regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB) within
the United States Department of the Treasury.\2\ Comments submitted to
FDA supported the position that meat, poultry, processed egg products,
and alcoholic beverages are considered ``articles of food'' subject to
the requirements of amended section 403(q) because they are foods as
defined in the FD&C Act and they provide a significant amount of
calories.
---------------------------------------------------------------------------

    \2\ FDA exclusively regulates the labeling of alcoholic
beverages that are not under TTB's jurisdiction, including beers
that do not meet the definition of a ``malt beverage'' under the
Federal Alcohol Administration Act (FAA Act) (27 U.S.C. 201 et seq.)
and wine beverages containing less than 7 percent alcohol by volume.
See, e.g., FDA, ``Guidance for Industry: Labeling of Certain Beers
Subject to the Labeling Jurisdiction of the Food and Drug
Administration; Draft Guidance.'' August 2009. Available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm166239.htm. Malt beverage
is defined in section 117(a)(7) of the FAA Act (27 U.S.C. 211(a)(7))
and TTB regulations at 27 CFR 7.10.
---------------------------------------------------------------------------

    Other comments stated that TTB, which regulates the labeling of
certain alcohol beverages pursuant to the provisions of the Federal
Alcohol Administration Act (FAA Act) (27 U.S.C. 201 et seq.), does not
currently require nutrition labeling for the alcoholic beverages it
regulates, as required for packaged food regulated by FDA. The comments
stated further that while TTB requires a statement of average analysis
on labels that make calorie or carbohydrate claims, this statement
includes only calories, carbohydrates, protein, and fat. See TTB Ruling
2004-1. http://www.ttb.gov/rulings/2004-1.pdf. The comments noted that
TTB does not require the declaration of sugar, fiber, sodium, or
cholesterol content on a beer label. As a result, these comments stated
that beer brewers would have to undertake a substantial testing program
to be able to provide that nutrition information for consumers. In
addition, one comment expressed concern with obtaining nutrition
information, stating that beers produced by small brewers have greater
variation in alcohol content and ingredients than beers within the
existing ``regular beer'' category in USDA's nutrition database.
However, this comment stated that general classifications can be
established that will provide industry members and consumers with
accurate calorie and nutritional information. The comment further
stated that industry members could work with USDA to develop easily
measured criteria, such as original gravity measurement, that would
provide a consistent benchmark for brewers and accurate information for
consumers. The comment also maintained that, absent agreement between
FDA and TTB with respect to labeling formats, action by small brewers
to provide nutrition information pursuant to amended section 403(q)
would contradict current TTB guidance and create uncertainty when a
pending TTB rulemaking on ``serving facts'' is completed.\3\
Accordingly, the comment urged FDA to delay the application of the new
requirements to alcohol beverages pending agreement between FDA and TTB
on a consistent methodology.
---------------------------------------------------------------------------

    \3\ In the Federal Register of July 31, 2007 (72 FR 41860), TTB
published a proposed rule to amend its regulations to require a
statement of the percentage of alcohol on all alcoholic beverages
and a serving facts panel, which would include a statement of
calories, carbohydrates, fat and protein. This proposed rule has not
been finalized.
---------------------------------------------------------------------------

    FDA has considered these comments and consulted with TTB and USDA
in developing this proposed rule. Section 4205 amends section 403(q) of
the FD&C Act (21 U.S.C. 343(q)), which generally provides nutrition
labeling requirements for certain foods. Section 4205 provides
nutrition labeling requirements directed specifically toward standard
menu items sold in covered establishments. FDA tentatively concludes
that the nutrition disclosure requirements in amended section
403(q)(5)(H) for standard menu items offered for sale in covered
establishments apply to foods for human consumption, including meat,
poultry, and processed egg products, even though they are also
regulated by USDA. This tentative conclusion is consistent with FDA's
position that FDA has jurisdiction under the FD&C Act over meat,
poultry, and

processed egg products in interstate commerce.
    While alcohol beverages are ``food'' under the FD&C Act, FDA
recognizes that at least one court has held that TTB has exclusive
jurisdiction over the labels of the alcohol beverages it regulates
under the FAA Act. Brown-Forman Distillers Corp. v. Mathews, 435 F.
Supp. 5 (W.D.Ky. 1976). Providing nutrition information required in
section 4205 for alcohol beverages should result in a similar public
health benefit as providing the information for a food for which the
labeling is exclusively regulated by FDA. However, it is not clear that
Congress intended for the nutrition information disclosures required by
section 4205 to apply to alcohol beverages, given that the labels of
the majority of alcohol beverages are regulated by TTB. For the
purposes of this proposal, FDA tentatively concludes that the new menu
labeling requirements do not apply to alcohol beverages. Therefore,
proposed Sec.  101.11(b)(1)(ii) provides that the labeling requirements
do not apply to alcohol beverages. We request comment on whether
alcohol beverages should be within the scope of the requirements of
section 4205 and proposed 21 CFR 101.11. In any case, the provisions of
section 4205 do not apply to and have no effect on the labels of food
products sold in packaged form, including meat, poultry and processed
egg products that are regulated by USDA or on the labels of alcoholic
beverages regulated by TTB under the FAA Act.
Restaurant Food
    We are proposing in Sec.  101.11(a) that ``restaurant food'' means
food that is served in restaurants or other establishments in which
food is served for immediate human consumption, i.e., to be consumed
either on the premises where the food is purchased or while walking
away, or that is sold for sale or use in such establishment. This
definition corresponds to the way the agency uses the term ``restaurant
food'' in Sec.  101.10, ``Nutrition labeling of restaurant foods.'' See
61 FR 40320 (Aug. 2, 1996). It also reflects the food described in
section 403(q)(5)(A)(i) of the FD&C Act.
Restaurant-Type Food
    We are proposing in Sec.  101.11(a) that ``restaurant-type food''
means food of the type described in the definition of ``restaurant
food'' that is ready for human consumption, offered for sale to
consumers but not for immediate consumption, processed and prepared
primarily in a retail establishment, and not offered for sale outside
of that establishment. This definition reflects the food described in
section 403(q)(5)(A)(ii).
Standard Menu Item
    We are proposing in Sec.  101.11(a) that the term ``standard menu
item'' means a restaurant or restaurant-type food that is routinely
included on a menu or menu board or that is routinely offered as a
self-service food or food on display. FDA notes that, unlike the term
``menu,'' the term ``standard menu item'' is not defined in section
4205. In developing this proposed definition, FDA considered the
relationships between sections 403(q)(5)(H)(i), (ii), and (iii).
Section 403(q)(5)(H)(i), entitled ``General requirements for
restaurants and similar retail food establishments,'' requires covered
establishments to ``disclose the information described in subclauses
(ii) and (iii),'' ``in the case of food that is a standard menu item.''
Sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa) require calorie
declarations on menus and menu boards, respectively, and section
403(q)(5)(H)(iii) requires calorie declarations for self-service food
and food on display.
    FDA considered whether only self-service food and food on display
that appear on menus or menu boards should be covered. However, the
examples Congress provides for self-service food and food on display in
section 403(q)(5)(H)(iii) (``food sold at a salad bar, buffet line,
cafeteria line, or similar self-service facility, and for self-service
beverages or food that is on display and that is visible to
customers'') generally do not appear on menus or menu boards--customers
often simply pick up their selections and pay a cashier. In addition,
in certain establishments where customers do order self-service food or
food on display, e.g., where ``salad bar'' or ``breakfast buffet'' is
listed on a printed menu at a sit-down restaurant, the individual items
on the salad bar or the breakfast buffet generally are not listed on
the printed menu. Any signs identifying the individual foods on the
salad bar or buffet are intended to be viewed after the customer
orders.
    These examples--salad bars, buffet lines, and cafeteria lines--are
explicitly named in section 403(q)(5)(H)(iii), so they must fall within
the scope of the new law. Therefore, FDA proposes to interpret
``standard menu item'' to mean a food that is routinely listed on a
menu or menu board or that is routinely offered as self-service food or
food on display. For example, a hamburger, a combination meal, and a
specific type of pizza (e.g., ``deluxe pizza'') that regularly appear
on a restaurant menu would be considered standard menu items. Potato
salad that is routinely offered at a salad bar, pancakes that are
routinely offered at a buffet, and pudding that is routinely offered at
a cafeteria line would be considered standard menu items, as well. This
interpretation allows for the types of foods on display and self-
service foods described in section 403(q)(5)(H)(iii) to be covered and
gives meaning to the reference in section 403(q)(5)(H)(i) to section
403(q)(5)(H)(iii) (``in the case of food that is a standard menu item *
* * the [covered establishment] shall disclose the information
described in subclauses (ii) and (iii).''). Correspondingly, FDA
tentatively concludes that ``menu item'' should be considered a food
item that is listed on a menu or menu board or that is offered as a
self-service food or food on display. FDA requests comment on the
proposed definition of standard menu item.
Multiple Servings
    Some comments contended that foods sold in multiple servings such
as a bucket of chicken pieces, rotisserie chicken, and full rack of
ribs are not standard menu items because they are not sold for
immediate consumption. Other comments stated that bakery items such as
individually sold bagels or cookies also should not be covered. Other
comments did not oppose a requirement for providing some calorie and
other nutrition information for these multiple-serving foods, but
recommended that the calorie declaration for them be by serving, which,
they contended, would be more meaningful. Two industry comments stated
that they received consumer complaints when the calories were declared
for whole pizzas, as was required by some jurisdictions. The comments
stated that the consumers claimed that this type of declaration was
confusing and impractical, and they asserted that nutrition and calorie
information should be disclosed per slice. Other comments stated that
the calories should be declared for the food offered for sale and not
for each serving.
    FDA disagrees with the comments that stated that multi-serving
foods are not standard menu items. Section 403(q)(5)(H) requires that
calories be disclosed for standard menu items at covered
establishments, regardless of how many servings included in the item.
Multi-serving foods that are routinely included on a menu or menu board
(i.e., the primary writing of the restaurant or similar retail food
establishment from which a customer makes an order selection) or
routinely offered as a self-service food or food on

display would meet FDA's proposed definition of standard menu item. FDA
requests comments on this issue.
Combination Meal
    We are proposing in Sec.  101.11(a) that the term ``combination
meal'' means a standard menu item that consists of more than one food
item; for example, a meal that includes a sandwich, a side item, and a
drink would be a combination meal. A combination meal may be
represented on the menu or menu board in narrative form, numerically,
or pictorially. A combination meal may include one or more variable
items and may itself be a variable menu item, as that term is defined
in this section. For example, the side item may have several options
(e.g., fries, salad, or onion rings) or the drink may vary (e.g., soft
drinks, milk, or juice), and the customer selects which of these items
will be included in the meal.
Variable Menu Item
    We are proposing in Sec.  101.11(a) that the term ``variable menu
item'' means a standard menu item that comes in different flavors,
varieties, or combinations, and is listed as a single menu item. As
examples, variable menu items may have flavoring options, (e.g., a
milkshake that is available in vanilla, chocolate, or strawberry
flavors) or topping options (e.g., pizza prepared with a selection of
toppings).
Self-Service Food
    We are proposing in Sec.  101.11(a) that the term ``self-service
food'' means restaurant or restaurant-type food that is offered for
sale at a salad bar, buffet line, cafeteria line, or similar self-
service facility, and self-service beverages. This definition covers
food that the customer serves himself or herself, such as food at hot
and cold food bars or beverages in a self-service beverage machine in a
restaurant. FDA considers the term ``facility'' as it is used in
section 403(q)(5)(H)(iii) to refer to a self-service fixture in a
covered establishment, and not necessarily to the entire establishment.
For example, a salad bar in a pizzeria would be a self-service
facility, while the pizzeria as a whole would be a covered
establishment if it as part of a chain of 20 or more locations doing
business under the same name and offering for sale substantially the
same menu items. Self-service foods are a subset of food on display.
Food on Display
    We are proposing in Sec.  101.11(a) that the term ``food on
display'' means 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. Under the proposed definition, food on display
would include food packaged at the customer's request, such as a slice
of pizza sold at a counter or an entr[eacute]e item served on a buffet
line, or pre-wrapped by the establishment for direct customer
selection, such as a sandwich prepared on the premises and displayed in
a case. FDA tentatively concludes that this term includes food that is
behind a glass counter or another viewing apparatus for the purposes of
showing a serving or meal suggestion. Food on display would not
encompass meats and cheeses sold at delicatessens in grocery stores,
given that there is an ordinary expectation that the consumer will
further prepare those foods before consumption, e.g., by using the meat
and cheese to make a sandwich.
Custom Order
    We are proposing in Sec.  101.11(a) that the term ``custom order''
means a food order that is prepared in a specific manner based on an
individual consumer's request, which requires the restaurant or similar
retail food establishment to deviate from its usual preparation of a
menu item. For example, a club sandwich ordered without the bacon would
be considered a custom order if the establishment usually includes
bacon in its club sandwich.
Daily Special
    We are proposing in Sec.  101.11(a) that the term ``daily special''
means 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. Often, such items are added
to the menu on a particular day through inserted slips of paper or
written on erasable menu boards. However, an item that is offered for
sale every week on Mondays is routinely offered and therefore would not
be considered a daily special. In addition, if a standard menu item is
offered at a discounted price on a particular day, the item would not
be considered a daily special. For example, if a turkey club sandwich
is a standard menu item at a restaurant and normally costs 5 dollars,
but on Fridays the same turkey club sandwich is specially advertised as
costing only 4 dollars, FDA tentatively concludes that the nutrient
content disclosure requirements for standard menu items would still
apply to the turkey club sandwich on Fridays; the sandwich would not be
considered a ``daily special'' under Sec.  101.11(a) merely because it
is specially discounted. Similarly, if a covered establishment offers
individual menu items together at a discount on a particular day, they
would also not be a daily special. FDA requests comment on this
definition.
Food That Is Part of a Customary Market Test
    We are proposing in Sec.  101.11(a) that the term ``food that is
part of a customary market test'' means food that is marketed in a
covered establishment for fewer than 90 consecutive days in order to
test consumer acceptance of the product.
    Some comments from industry stated that the 90-day time period
should be calculated per market, not per chain, and asked that we
clarify when the 90-day time period begins. These comments also stated
that 90 days may not be long enough for a test market.
    FDA points out that the 90-day time period is a statutory
requirement. FDA proposes to interpret the 90-day time period to mean
consecutive days beginning when the menu item is first offered for sale
in the specific location. This interpretation is based on FDA's
understanding of how test marketing is ordinarily done. FDA requests
comment about our interpretation of a 90-day consecutive time frame on
the test marketing of products.
Temporary Menu Item
    We are proposing in Sec.  101.11(a) that the term ``temporary menu
item'' means a food that appears on a menu or menu board for less than
a total of 60 days per calendar year. As with the 90-day time period
for food that is part of a customary market test, the 60-day time
period for temporary menu items is a statutory requirement. To provide
flexibility, the 60 days includes the total of consecutive and non-
consecutive days the item appears on the menu.

C. Requirements for Covered Establishments

1. Applicability
    FDA is proposing in Sec.  101.11(b)(1)(i) that menu labeling
requirements apply to standard menu items offered for sale in covered
establishments. As discussed in section I.D., under 403(q)(5)(H)(i),
menu labeling requirements apply to food that is a standard menu item
that is offered for sale in 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. Whether a
chain has 20 or more locations does not depend on the type of ownership
of its locations (e.g., whether owned by the corporate owner of the
chain or individual franchisees).
    As discussed in section III.C. of this document, section
403(q)(5)(H)(ix) includes a provision that permits restaurants and
similar retail food establishments not subject to the requirements of
section 403(q)(5)(H) (e.g., a restaurant that is part of a chain with
fewer than 20 locations) to register with FDA to voluntarily elect to
become subject to the requirements of section 403(q)(5)(H).
Consequently, FDA is proposing in Sec.  101.11(b)(1) (ii) that the menu
labeling requirements apply to foods that are standard menu items
offered for sale in chain retail food establishments and restaurants or
similar retail food establishments that voluntarily register with FDA.
2. Foods to Which the Requirements of Section 4205 Do Not Apply
    Section 4205 provides that the menu labeling requirements do not
apply to certain foods. These foods are ``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); daily specials, temporary menu items
appearing on the menu for less than 60 days per calendar year, or
custom orders; or such other food that is part of a customary market
test appearing on the menu for fewer than 90 days, under terms and
conditions established by the Secretary'' (21 U.S.C.
343(q)(5)(H)(vii)).
    FDA received several comments on these foods to which the menu
labeling requirements in section 4205 are nonapplicable. Some comments
stated that these foods should not be exempt from the requirements of
section 4205. Some of these comments stated that condiments that come
with meals should be included as part of the calorie declaration. One
comment stated that if the condiment is non-nutritive, it should be
excluded from the calorie labeling requirement, but if the condiment
contains more than 10 calories per serving (e.g., salad dressing,
mayonnaise, pickles, olives, maple syrup, or honey), calorie labeling
requirements should apply. Another comment suggested that FDA remove
the calorie declaration exemption for 60-90-day temporary items so that
restaurants cannot continually change their menus to avoid calorie
labeling.
    We note that section 403(q)(5)(H)(vii)(I)(aa) provides that the
nutrient content disclosure requirements in sections 403(q)(5)(H)(i)-
(vi) do not apply to ``items not listed on a menu or menu board (such
as condiments and other items placed on the table or counter for
general use).'' (21 U.S.C. 343(q)(5)(H)(vii)(I)(aa)). FDA tentatively
concludes that this provision should be read narrowly, based on the
parenthetical language. If the provision is read broadly to deem all
``items not listed on a menu or menu board'' beyond the scope of the
law, then most self-service food and food on display would not be
covered, including food at salad bars, buffet lines, and cafeteria
lines. Given that Congress explicitly named these as examples of self-
service facilities to which the calorie disclosure requirements in
section 403(q)(5)(H)(iii) apply, the current proposal narrowly
interprets this provision.
    Given the phrase ``for general use,'' FDA tentatively concludes
that it is reasonable to interpret this provision to apply to food,
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. Examples include salt and pepper placed on
tables for use by whomever sits there, large ketchup and mayonnaise
dispensers placed on a counter to be used by any customer, and lemons
placed near a drink station. In contrast, the nutrient content
disclosure requirements in section 403(q)(5)(H) would apply to salad
dressing at a salad bar that is only available to customers who order
the salad bar. The labeling requirements would also apply to salad
dressing at salad bars where customers pay for salad by weight, where
the weight of the salad dressing affects the price of the item.
    FDA tentatively concludes that section 403(q)(5)(H)(vii)(I)(aa)
does not refer to condiments that are part of a standard menu item, as
it is usually prepared and offered for sale (e.g., mustard, mayonnaise,
and ketchup that are part of a hamburger or sandwich as usually
prepared and offered for sale). Sections 403(q)(5)(H)(ii)(I)(aa) and
(II)(aa) specify that covered establishments must provide, on menus and
menu boards, ``the number of calories contained in the standard menu
item, as usually prepared and offered for sale.'' 21 U.S.C.
343(q)(5)(H)(ii)(I)(aa) and (II)(aa). Caloric value of these condiments
must be included as part of the total caloric declaration for a
standard menu item, because the condiments are a part of the standard
menu item as it is usually prepared and offered for sale.
    As discussed in III.B. of this document, FDA proposes to define a
temporary menu item as one that appears on a menu or menu board of a
covered establishment for less than 60 days per calendar year. For
example, a pumpkin-flavored latte that only appears on the menu of a
coffee shop in November would be a temporary menu item. FDA tentatively
interprets the 60-day calendar limit to mean less than 60 days per year
in total; the 60 days do not have to be consecutive.
    Also discussed in III.A. of this document, FDA proposes to define a
food that is part of a customary market test to be a food appearing on
a menu or menu board for less than 90 days for which the covered
establishment wishes to test consumer acceptance. For example, many
restaurants advertise ``for a limited time only'' sandwiches that have
new components. FDA recognizes that in some cases, a chain of
restaurants or similar retail food establishments tests a new product
in different locations within the chain and in more than one region of
the country at different times. FDA tentatively concludes that ``a
customary market test,'' for the purposes of this section, refers to a
test in a single covered establishment. Based on FDA's understanding of
how test marketing is generally conducted, FDA proposes that a food
that is part of a market test is an item that appears on a menu or menu
board of a covered establishment for less than 90 consecutive calendar
days. A food may be part of a customary market test at more than one
location of a chain at a time. A food might also be a standard menu
item at one location while being part of a customary market test at
another.
    Note that self-service food and food on display that do not appear
on menus or menu boards would not be considered temporary menu items or
food that is part of a customary market test. Based on the statutory
language, both of these categories of nonapplicability only capture
food ``appearing on the menu'' for a limited amount of time. Therefore,
even if a self-service food or food on display that does not appear on
a menu or menu board is only offered by a covered establishment for a
limited time, such as a pumpkin-spice muffin available only in
November, the nutrition information declaration requirements in section
403(q)(5)(H) would still apply. Self-service foods or foods on display
in covered establishments that do not appear on menus can still belong
to other categories of food to which the nutrition information
declaration requirements do not apply, such as daily specials or custom
orders.

    Based on the reasons above, FDA is proposing in Sec.
101.11(b)(1)(ii) that the requirements in Sec.  101.11(b)(2) shall not
apply to condiments and other items placed on the table for general
use; daily specials; temporary menu items; custom orders; or food that
is part of a customary market test. In addition, as discussed in III.B.
of this document, FDA is proposing that the requirements in Sec.
101.11(b)(2) shall not apply to alcohol beverages.
3. Information That Must Be Declared by Covered Establishments
    a. Calorie declaration on menus and menu boards. Section
403(q)(5)(H)(ii) requires covered establishments to disclose on menus
and menu boards, in a clear and conspicuous manner, the number of
calories contained in standard menu items as usually prepared and
offered for sale. The covered establishment must provide the calorie
information adjacent to the name of the standard menu item so as to be
clearly associated with the standard menu item (e.g., 21 U.S.C.
343(q)(5)(H)(ii)(I)(aa)).
    Some comments stated that the statutory requirements for menu
labeling should apply only to the menu that most consumers use the
most; for example, one national pizzeria chain stated that most of its
customers order through the Internet and that therefore the information
should only be required to be posted there. Another comment suggested
that each company should be permitted to select its own ``primary''
menu on which calories must be disclosed, based on technological
capabilities and customer ordering patterns. FDA disagrees with these
comments. Based on section 403(q)(5)(H)(ii), FDA tentatively concludes
that these calorie declarations must be provided on all menus and menu
boards of the covered establishment. For example, section
403(q)(5)(H)(ii)(I)(aa) states that a calorie disclosure must appear
``on the menu listing the item for sale.'' The same standard menu item
could be listed on multiple menus, e.g., a 12'' cheese pizza at a
pizzeria might appear on the menu for customers dining in and also on
the online menu for customers ordering over the Internet. The calorie
declaration for each standard menu item must appear on each menu that
lists the standard menu item, in accordance with section
403(q)(5)(H)(ii). FDA requests comments on this approach to calorie
declarations and multiple menus.
    Some comments stated that FDA should allow flexibility for drive-
through menu boards and allow calorie disclosures on stanchions (free-
standing boards, generally placed next to drive-through menu boards,
used to post calorie information) because of lack of space. These
comments stated that the drive-through menu boards are not large enough
to add calorie labeling and that some local zoning laws do not permit
restaurants with drive-through windows to build larger menu boards.
    FDA tentatively concludes that stanchions inadequately convey
calorie information. 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. This is particularly true in the
drive-through context, where customers have a restricted field of
vision from their car windows, and they 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. Moreover, we
note that 403(q)(5)(H)(II)(aa) requires the number of calories
contained in standard menu items to be disclosed on the menu board
itself. Therefore, we have not included separate stanchions as an
option for displaying calories at drive-through restaurants and similar
retail food establishments. FDA requests comment on how the use of
stanchions would enable customers to use calorie information when they
are making selections from a drive-through menu board.
    In the draft implementation guidance that was subsequently
withdrawn, FDA recommended that calories be declared in a type size at
least as large as the name of the standard menu item or price,
whichever is larger, and with the same prominence, i.e., the same color
and contrasting background as the standard menu item.
    Some comments supported FDA's draft guidance on type size, color,
and background. Other comments stated that these recommendations were
too prescriptive and went beyond the statutory requirement that calorie
information must be disclosed in a clear and conspicuous manner. Some
comments stated that having the calories in the same color makes the
calorie declaration less prominent. Other comments suggested different
colors or the use of check marks based on calorie content, e.g., for
particular foods, check marks may be made by the food to inform
consumers how many times a day or week they should consume that food.
One comment suggested that FDA require that the calories be ``easily
readable, in a typeface similar to other information about each
standard menu item, and in a font no less than nine points.''
    FDA recognizes that menus and menu boards come in a variety of
sizes. Therefore, it would not be appropriate to require a specific
type size and font for all menus and menu boards. However, if the
calorie declarations on menus and menu boards are not declared in a
clear and conspicuous manner, the declarations would not be in
compliance with the requirements in section 403(q)(5)(H)(ii). FDA
tentatively concludes that a calorie declaration on a menu or menu
board would not be disclosed in a clear and conspicuous manner if the
declaration is too light in color or is presented in a color that does
not sufficiently contrast with the background. FDA agrees with the
comments asserting that the agency should provide more flexibility with
regard to calorie declarations than was suggested in the draft
implementation guidance. FDA proposes in Sec.  101.11(b)(2)(i)(A)(1)
that a calorie declaration must be made in the same color, or in a
color at least as conspicuous as, the color of the name of the
associated standard menu item on the menu or menu board. Further, FDA
proposes that a calorie declaration must have the same contrasting
background as the background used for the name of the associated
standard menu item on the menu or menu board. In addition, the calorie
declaration must be in a font size large enough to be ``clear and
conspicuous.'' We understand that menus and menu boards often have
limited space. We think that it is important to provide flexibility to
businesses while, at the same time, fulfilling the requirements of the
statute and providing consumers with easily readable information. FDA
is proposing that a calorie declaration must be no smaller than the
type size of the name or price of the associated standard menu item on
the menu or menu board whichever is smaller. We request comment on this
tentative conclusion.
    FDA is proposing in Sec.  101.11(b)(2)(i)(A)(3) that the term
``Calories'' or ``Cal'' must appear as a heading above a column listing
the number of calories for each standard menu item on that menu or menu
board, or adjacent to the number of calories for each standard menu
item. If a column is used for the listing of calories, the term
``Calories'' or ``Cal'' must appear in a type size no smaller than the
smallest type size of the name or price of any menu item and in the
same color, or in a color at least as conspicuous as and in the same
contrasting background as that name or price. If the term ``Calories''
or

``Cal'' appears adjacent to the number of calories for the standard
menu item, the term ``Calories'' or ``Cal'' must appear in the same
type size and in the same color and contrasting background as the
number of calories.
    We tentatively conclude that permitting the flexibility of using
the abbreviation ``Cal'' would assist covered establishments that have
limited space on their menus or menu boards in meeting the requirements
of section 403(q)(5)(H). Allowing calories to be stated as a header of
a column would provide additional flexibility.
    One comment asserted that drive-thru menu boards are limited in
size and space as compared to interior menu boards, thus making it
challenging to list calories in a clear and conspicuous manner. The
comment recommended that FDA only should require the statement
``Nutrition information is available upon request'' on the drive-
through menu boards of a covered establishment and require the
establishment to have brochures available at the drive-through window.
However, FDA notes that section 403(q)(5)(H)(ii)(II) expressly requires
covered establishments to post calorie declarations on menu boards,
including drive-through menu boards. Therefore, proposed Sec.
101.11(b)(2)(i)(A) would apply to all menu boards at covered
establishments, including drive through menu boards.
    FDA is proposing in Sec.  101.11(b)(2)(i)(A)(2) to require that
covered establishments declare calories on menus and menu boards to the
nearest 5-calorie increment up to and including 50 calories, and to the
nearest 10-calorie increment above 50 calories. For foods that have
fewer than 5 calories, the declaration may be expressed as zero. These
rounding rules are consistent with the declaration of calories for
packaged foods as provided in Sec.  101.9(c)(1).
    b. Determination of calories for standard menu items that come in
different flavors, varieties, or combinations. Section 403(q)(5)(H)(v))
requires that FDA establish, by regulation, standards for determining
and disclosing the nutrient content for standard menu items that come
in different flavors, varieties, or combinations, that are listed as
single menu items (21 U.S.C. 343(q)(5)(H)(v)). This section includes as
examples of these foods soft drinks, ice cream, pizza, doughnuts, and
children's combination meals. As discussed in section II.A. of this
document, FDA proposes to define these items as variable menu items.
Section 403(q)(5)(H)(v) states that FDA may establish these standards
as averages, ranges, or other methods.
    FDA recognizes that, under this proposal, some combination meals as
discussed in section III. A. of this document would be variable menu
items, while others would not. The calorie declaration on a menu or
menu board for a combination meal that consists of a fixed combination,
where the customer has no choice as to which flavors, varieties, or
combinations of items are included, would be governed by proposed Sec.
101.11(b)(2)(i)(A) and (B). Such a combination meal would not be
considered a variable menu item.
    Some standard menu items come in different varieties, such as a
single scoop of ice cream that comes in different flavors and a medium
soft drink that comes in a variety of sodas. For some of these variable
menu items, the difference between the number of calories in the lowest
calorie variety and the highest could be wide. For example, calories
for a large soft drink could range from zero calories for a diet soft
drink to more than 400 calories for a non-diet soft drink. For
combination meals, the difference in caloric value has the potential to
be especially large, given that multiple items in the combination meal
might vary. A combination meal may contain a sandwich, side dish and
drink. The side dish may be fries, onion rings, or a salad. The number
of calories may be much fewer if the consumer chooses the salad with
light dressing and bottled water or a diet drink than if the consumer
chooses the fries and a sweetened drink. On the other hand, for other
variable menu items, the range of calories in the possible varieties is
likely small (e.g., donuts with different flavors of icing), such that
a calorie or other nutrient difference among the varieties is not
nutritionally significant.
    Section 403(q)(5)(H)(v) specifically states that we must establish
standards for determining and disclosing the nutrient content
information for standard menu items that come in different flavors,
varieties, or combinations, through means determined by FDA, including
averages, ranges, or other methods. Some comments supported the use of
ranges because, they asserted, displaying an average calorie content
when the lower and upper limits are so dissimilar would be misleading.
Other comments suggested that FDA require median values for calories if
the values for all flavors, varieties, or combinations are within 20
percent of the median and require ranges if calories are not within 20
percent of the median. Some comments maintained that sugar-free (no
calorie or very low calorie) should be listed separately from sugar-
sweetened beverages. A few comments recommended that FDA allow covered
establishments to pick among ranges, medians, and averages. Some
comments disagreed with permitting ranges and suggested that the foods
must be labeled individually. One comment suggested that FDA require
covered establishments to group similar items where the item of
greatest caloric value contains less than 5 percent more calories that
the item of lowest caloric value and display items separately if the
calorie difference is greater than 5 percent. A few comments
recommended that the calorie information for items such as sandwiches,
pizza, or burritos that are intended to be prepared in a large number
of different ways be displayed for the standard preparation of the
item, with the standard preparation of the item clearly noted on the
menu, menu board, or food tag or next to the food on display. The
calorie content for each additional food component, according to the
comment, should then be displayed on the menu, menu board, food tag, or
next to the food on display for each food component.
    FDA is proposing in Sec.  101.11(b)(2)(i)(A)(4) that the calories
must be declared as a range for standard menu items that come in
different flavors, varieties, or combinations but are listed as a
single menu item. For example, the calories for different flavors of
ice cream or combination meals would be disclosed in the format ``xx-
yy'' where ``xx'' is the caloric content of the lowest calorie flavor
or combination, and ``yy'' is the caloric content of the highest
calorie flavor or combination. However, we considered a number of other
options in developing this proposal.
    Option 1: Single value. We considered requiring calorie values for
all variable menu items to be presented as single values, either in the
form of an average (obtained by summing up the calorie content of all
options and then dividing by the number of options) or a median of all
options (obtained by determining the ``middle'' number of calories from
the list of options). For example, if there were three options for a
sandwich, one with 400 calories, one with 450 calories, and one with
600 calories, the average would be 483 calories ((400+450+600)/3 = 483)
(which would be rounded to 480 for the calorie declaration), and the
median would be 450. The tradeoff between using an average or median
value is between closer reflection of the distribution of possible
choices and simplicity of calculation. If the median

is declared, a change in this number would change the declared
calories, even if no other variation had a change in calorie content
and even if the overall range of calories did not change. On the other
hand, changes in numbers other than the middle number would not
generally affect the median. Taking the example above, if the calories
in the middle option for the sandwich changed from 450 to 420 (e.g.,
because the covered establishment changed the cheese in that sandwich
to lower fat cheese), then the number of calories disclosed would be
420, because 420 is the new median. In contrast, if the calories in the
middle option stayed 450, but the calories in the highest option
changed from 600 to 750 (e.g., because the establishment changed the
sandwich's sauce formulation and changed the bun on the sandwich to a
bun with higher fat content), number of calories disclosed would be
450, because 450 remains the median.
    If the average is declared, the calorie declaration would likely
change in response to a calorie change in any option. As a result, the
reported number is less prone to manipulation. For example, if the
calories in the middle option in the sandwich above changed from 450 to
420, the average would change from 483 (rounded to 480 for the calorie
declaration) to 473 (rounded to 470 for the calorie declaration). If
the highest option for the sandwich above changed from 600 to 750, the
average would change from 483 (rounded to 480 for the calorie
declaration) to 533 (rounded to 530 for the calorie declaration).
    Presenting calorie declarations of variable menu items as single
values--whether as averages or median values--offers the benefit of
maximizing space on a menu or menu board. However, single values have a
drawback in that they fail to convey to consumers the nutrient content
of the specific choices available within that variable menu item group.
Posting an average or median value may also mask dramatic differences
that can exist in caloric intake for certain variable menu items,
especially where calorie ranges are large.
    Option 2: Range. We considered requiring calories for all variable
menu items to be reported in the form of a range. FDA recognizes that
there may be some cases where disclosing a range may be more difficult
than disclosing a single value, such as when menu space is limited. In
addition, a range is arguably less useful to consumers in cases where
calorie ranges are very small or where calorie ranges are very large
and consumers cannot distinguish which varieties or combinations of
items may offer lower calories or determine the exact amount of
calories in their specific choice. However, a range format provides
consumers with more information about the caloric content of the
options available within a given variable menu item group; it provides
the lowest value, the highest value, and therefore the window within
which a consumer's choice will fall.
    Option 3: Hybrid combining averages and ranges. We considered a
number of approaches that would require declaration of a single average
value for variable menu items whose calorie ranges fall within
specified bounds and declaration of a range for variable menu items
whose calorie ranges fall outside those bounds. This option has the
benefit of allowing single values to be used on a menu or menu board
for variable items that have relatively narrow ranges, while ensuring
that the full range of calories is provided for wider ranges.
    Within this option, we considered different approaches for
determining when a range and when an average value should be reported.
First, we considered requiring an average value unless the highest
calorie option contains over 25 percent more calories than the lowest
calorie option. At that point, a range would be disclosed instead. For
example, if the lowest calorie item contains 400 calories, the calorie
declaration would be an average unless the highest calorie item exceeds
500 calories (400 x 25% = 100; 400 + 100 = 500). Taking a variable menu
item that has 400, 430, or 490 calories, the number of calories in the
highest calorie item (490) is less than 25% more than the number of
calories in the lowest calorie item (490 < 500), so the calorie
declaration would be the average: 440 ((400+430+480)/3 = 440). Taking a
variable menu item that has 400, 430, or 550 calories, the highest
calorie item (550) has more than 25% more calories than the lowest
calorie item (550 > 500), so the calorie declaration would be a range:
400-550.
    Our rationale for considering the 25 percent is based in our
nutrient content claim regulations. FDA permits a ``reduced calorie''
claim on a food if the food contains at least 25 percent fewer calories
per reference amount customarily consumed than an appropriate reference
food. In the preamble for the regulations on nutrient content claims
(58 FR 2302 at 2348), FDA stated that the terms ``less'' and
``reduced'' should be used only when a nutritionally significant
reduction in the level of the nutrient has been reached so as not to
mislead consumers into believing that a product would provide a
nutritionally significant reduction in the level of a nutrient when it
would not. FDA concluded that an appropriate minimum reduction for the
terms ``reduced'' and ``less'' is 25 percent based on various factors.
    Second, we considered an approach that would require an average
value to be reported for all variables that fall within 20 percent of
the average value; a range would otherwise be required. Using 20
percent as a cutoff for determining whether to use an average or a
range would be consistent with the number used for compliance purposes.
See Sec.  101.9(g). For example, if the calories for a variable menu
item are 400, 430 or 490, the highest calorie option has 22.5% more
calories than the lowest calorie option, so the calorie declaration
under the 20 percent cutoff approach would be the range: 400-490
calories.
    An additional approach could be to have a special rule for low
calorie foods. The number of calories in low calorie foods, i.e., those
with 40 or fewer calories, could be declared by an average even if the
difference in the calories between the lower and higher calorie
variable menu item is greater than 25 or 20 percent. For example, if
the calories for flavored teas ranged from 5 to 20 calories, a
difference of 300 percent ((20-5)/5 x 100), the range would not be
necessary, and an average, e.g., 12.5 calories could be used. In
addition, consistent with calorie declaration of packaged food,
calories less than 5 would be declared as 0. Therefore, the average
calories for the flavored tea would be 10 ((20+0)/2). The rationale for
using 40 calories as the cutoff is that foods that contain 40 calories
or less are eligible to bear a ``low calorie'' claim (Sec.
101.60(b)(2)).
    We note that a difference of 20 or 25 percent may translate into a
substantial amount of calories where the calorie values are high (e.g.,
for some combination meals), resulting in the reporting of single
values for some large calorie ranges. So, we also considered using a
fixed 100 calorie maximum range as a cutoff. Using this approach,
variable items with large numbers of calories in all options would
declare the range of calories more often than if we used a percentage
cutoff. Variable items with smaller numbers of calories for all options
would declare a range less often. For example, a hamburger combination
meal that ranges from 1,000 to 1,200 calories would be listed as a
single calorie value (1,100 calories) under the 25 percent approach,
but as a range (1,000-1,200 calories) under the 100 calorie cutoff
approach, since the

difference between the two values is greater than 100 calories. On the
other hand, under the 25 percent approach, calories for a single ice
cream scoop that varies from 240 to 320 calories depending on the
flavor would be displayed as a range, because the highest calorie
option is 33 percent more caloric than the lowest calorie option ((320-
240)/240 = 33%). But because the difference is only 80 calories, under
the 100 calorie rule, the average, i.e. 280 calories, would be
disclosed.
    Option 4. If only 2 options are available for an item (e.g., a
sandwich with fries or with fruit), provide both numbers with a forward
slash between (e.g., 450/350). If three or more options are available,
provide the range in calories. We considered this option because some
variable menu items may have only two choices and the use of a slash
may be more reflective of the fact that there are two choices than the
use of a dash. For example, for a chicken sandwich that comes in
grilled and crispy versions, with 470 and 610 calories, respectively,
declaring the calories as 470/610 may better reflect the two discrete
choices than declaring the calories as 470-610. On the other hand, the
calorie declaration for a combination meal that comes with a choice of
sides, e.g., tater tots or French fries, and various soft drinks would
be a range (e.g., 1380-1810).
    Option 5. If only 2 options are available for an item (e.g. a
sandwich with fries or with fruit), provide both numbers with a forward
slash between (e.g. 450/350). For foods with 3 or more options, use one
of the hybrid approaches outlined in Option 3.
    Since many of these options could result in menus with different
formats and wide variations in the ranges, we intend to conduct
consumer research to evaluate how well consumers understand the caloric
information presented in each of the formats and whether mixed formats
on a single menu or menu board might be confusing to consumers. FDA
intends to make the results of our consumer research available to the
public prior to publication of the final rule and will allow sufficient
time for interested stakeholders to comment on the results of our
research.
    FDA is proposing that the calorie declaration be in a range for all
variable menu items (Option 2). Requiring a range for all variable menu
items gives consumers a consistent format across all items. FDA
recognizes that in some instances, the calorie range may be so wide
that the consumer may still need the calorie information for the
particular menu item before he or she can make a fully informed
purchase decision. We want to ensure that the calorie declaration is
understood by consumers and will help them make better food choices. We
seek comment on whether the proposed method of declaring calories is
appropriate and would not be misleading to consumers. We are especially
interested in any consumer research on the issue. We are also
interested in comment and research on the options that we considered
but did not propose and whether any of the other options individually
or in combination would be preferable and why. In developing the final
rule on this proposal, we will consider the results of our research and
all relevant comments and data.
    FDA also requests comment on complexities that may be raised by
certain variable menu items. For example, some menus with combination
meals list an option to increase the size of components of those meals
for a discounted additional price. FDA is considering whether those
listings should be labeled with the number or range of calories they
add to the standard combination meal, and requests comment. FDA also
recognizes that the Internet may allow for the use of different methods
for disclosing calories. For example, interactive menus online may
present opportunities for more innovative ways of providing tailored
calorie information, e.g., providing a calorie tracker in the ordering
frame that tallies calories as customers make order selections. FDA
requests comment on this issue. While this may be especially suitable
for ordering certain variable menu items, such as when selecting a
crust and toppings for pizza, FDA requests comment on whether different
methods should be used for nutrient content declarations for
interactive internet menus in general.
4. Succinct Statement Concerning Suggested Daily Caloric Intake
Required on Menus and Menu Boards
    Sections 403(q)(5)(H)(ii)(I)(bb) and (II)(bb) require that chain
retail food establishments post a succinct statement concerning
suggested daily caloric intake (``succinct statement'') on menus and
menu boards, as specified by the Secretary by regulation, that is
designed to enable the public to understand, in the context of a total
daily diet, the significance of the caloric information that is
provided on the menu and menu board (21 U.S.C. 343(q)(5)(H)(ii)(I)(bb)
and (II)(bb)). Some comments stated that the succinct statement should
take into account the different caloric needs of individuals based on
age, gender, and physical activity. Comments suggested various
statements including:
     ``2,000 calories meets the daily caloric needs of most
adults; however, individual dietary needs may vary.''
     ``A 2,000 calorie diet is being used as a basis for
general nutrition advice. However, individual calorie needs may vary.''
     ``This is ---- percent of a 2,000 calorie diet.''
     ``To maintain a healthy weight, most adults need no more
than 2,000 calories per day.''
    Some comments stated that a different statement should be used on
children's menus because children have different caloric needs.
According to one comment, if 2,000 calories is used as a reference
point, parents may overestimate the caloric needs of their children.
One comment suggested the following for a children's menu:

    The recommended caloric intake for a day varies from ---- to --
-- for adolescents and adults, from ---- to ---- for school-age
children, and from ---- to ---- for pre-school children above age
two years.

    Caloric declarations on menus and menu boards in covered