[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Proposed Rules]
[Pages 19192-19236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7940]



[[Page 19191]]

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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> 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, 301-796-4647.

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

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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:
    <bullet> 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);
    <bullet> 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;
    <bullet> 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;
    <bullet> A ``prominent, clear, and conspicuous'' statement on the 
menu or menu board regarding the availability of the written nutrition 
information; and
    <bullet> 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

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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:
    <bullet> Disclosing the number of calories contained in each 
standard menu item as usually prepared and offered for sale on menus 
and menu boards;
    <bullet> Providing written nutrition information to consumers upon 
request;
    <bullet> Providing a ``prominent, clear, and conspicuous'' 
statement on menus and menu boards about the availability of the 
written nutrition information; and
    <bullet> 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:
    <bullet> 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;
    <bullet> 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
    <bullet> 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

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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
    <bullet> Part of a chain with 20 or more locations,
    <bullet> ``doing business under the same name'', and
    <bullet> ``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

[[Page 19196]]

(``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

[[Page 19197]]

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.

[[Page 19198]]



    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

[[Page 19199]]

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

[[Page 19200]]

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:
    <bullet> It only appears in          No.
     locations of the larger
     establishment's chain (e.g.,
     Superstore XYZ Caf[eacute] in
     Superstore XYZ).
    <bullet> 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:

[[Page 19201]]

[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.

[[Page 19202]]

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

[[Page 19203]]

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

[[Page 19204]]

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

[[Page 19205]]

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.

[[Page 19206]]

    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

[[Page 19207]]

``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

[[Page 19208]]

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

[[Page 19209]]

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:
    <bullet> ``2,000 calories meets the daily caloric needs of most 
adults; however, individual dietary needs may vary.''
    <bullet> ``A 2,000 calorie diet is being used as a basis for 
general nutrition advice. However, individual calorie needs may vary.''
    <bullet> ``This is ---- percent of a 2,000 calorie diet.''
    <bullet> ``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 
establishments that provide the number of calories contained in 
standard menu items will give consumers information that is useful in 
selecting more healthful food choices. FDA recognizes that individual 
daily caloric needs may differ based on several factors including 
gender, age, and activity level (Ref. 9 at page 13). For this reason, 
it is important that consumers be able to place the calorie 
declarations in the context of their individual dietary needs. As 
described in section I. B of this document, nutrition labeling on 
packaged foods has been required for approximately 20 years, and 
consumers are familiar with and use this information. The Nutrition 
Facts on packaged foods uses 2,000 calories as a reference amount on 
which to base recommended intake for macro- and micronutrients for 
individuals 4 years of age and older (Sec.  101.9(c)(9)). A 2,000-
calorie reference value is close to the midpoint of the range of energy 
requirements for sedentary adults (1,600-2,600 cals) (Ref. 9 at page 
14).
    FDA initially proposed a reference value of 2,350 for the Nutrition 
Facts (55 FR 29476 at 29486); in response to comments, however, FDA 
selected 2,000 as the reference value in the 1993 final rule. As stated 
in the preamble to the final rule: ``The rationale for selecting 2,000 
calories as opposed to other lower values varied, but reasons given 
included the fact that it is consistent with widely used food plans, it

[[Page 19210]]

approximates the caloric requirements for postmenopausal women who are 
at-risk for excessive intake of calories and fat, and it is a ``rounded 
down'' value for 2,350 calories.'' FDA also noted in the preamble to 
the final rule that some comments noted that ``2,000 calories is easier 
to use in quick, mental calculations compared to other calorie levels 
such as 1,900 or 2,350 calories.'' 58 FR 2206 at 2217.
    FDA tentatively concludes that 2,000 calories is an appropriate 
reference value to include in the succinct statement. However, not 
everyone should eat 2,000 calories per day. Individual caloric needs 
differ depending on various factors such as age, gender, and physical 
activity. For example young children and sedentary adults may have 
caloric needs below 2,000 calories (1,200-1,600 calories) whereas some 
adult men and active adults of either sex may need more than 2,000 
calories (2,200-3,200). Considering the statutory directive and current 
nutrition advice (Ref. 9), FDA tentatively concludes that, to help 
ensure that the succinct statement is designed to enable consumers to 
understand, in the context of a total daily diet, the significance of 
the calorie information provided on menus and menu boards, certain 
principles should be met:
    <bullet> The statement should be succinct;
    <bullet> The statement should be in plain language that consumers 
can understand;
    <bullet> The total caloric value should be framed appropriately so 
that it is not viewed as a recommendation for daily intake for every 
consumer;
    <bullet> The statement should give consumers a means to compare the 
calorie declaration for a menu item to total calories and;
    <bullet> The statement should inform consumers that individual 
needs vary.
    Using these principles and considering suggestions from the 
comments, FDA developed the following statements:
    <bullet> ``Using 2,000 calories per day as a reference point, 
consider how the menu item you select fits within your total daily 
calorie needs, which may be higher or lower depending on age, physical 
activity, gender.''
    <bullet> ``A 2,000 calorie daily diet is used as a general 
reference point for nutrition advice. Individual calorie needs vary 
depending on age, physical activity, gender.''
    <bullet> ``Typical daily caloric intake for women is 1,600 to 2,000 
calories, for men is 2,000 to 3,000 calories and for children (ages 4 
to 14) is 1,800 to 2,500 calories. Be sure to include the calories of 
the menu item you select as a part of your total daily caloric 
intake.'' \4\
---------------------------------------------------------------------------

    \4\ This statement was developed for focus group testing based 
on the data upon which the 2,000 calorie reference value used in the 
Nutrition Facts was derived. The aim was to test a data-derived 
statement that provided specific calorie ranges for various 
subpopulations. More recent data from the 2010 Dietary Guidelines 
suggest that these ranges should be revised; however, the difference 
in numbers does not impact the objective of testing the utility and 
comprehension of the statement by the focus group participants.
---------------------------------------------------------------------------

    We have also included the following statement that was suggested 
from comments because we tentatively concluded that the statement 
satisfied the principles described above.
    <bullet> ``A 2,000 calorie daily diet is used as the basis for 
general nutrition advice; however, individual calorie needs may vary.''
    FDA concludes that the above statements satisfy the principles 
developed by the Agency to ensure that the succinct statement is 
designed to enable consumers to understand, in the context of a total 
daily diet, the significance of the calorie information provided on 
menus and menu boards. FDA seeks comment on the principles developed by 
the agency, including whether all the principles are needed to help 
consumers understand the significance of the calorie information 
provided on menus and menu boards. In addition, we have concerns about 
whether consumers will understand the statements, especially those 
statements that use terms such as ``reference point,'' ``fits within,'' 
and ``calorie needs vary.''
    When deliberating on which of the four (4) bulleted statements 
listed above should be required on menu and menu boards, FDA considered 
the language in each statement, our previously noted concerns with 
certain phrases, the availability of space on menu boards, and the 
statutory directive regarding the succinct statement. Given these 
considerations, we tentatively conclude that the statement that best 
addresses these considerations is ``A 2,000 calorie daily diet is used 
as the basis for general nutrition advice; however, individual calorie 
needs may vary.'' We are proposing in Sec.  101.11(b)(2)(i)(B) to 
require this statement be posted on menus and menu boards.
    FDA seeks comment on whether this proposed statement is adequately 
designed to enable the public to understand, in the context of a total 
daily diet, the significance of the caloric information provided on 
menus and menu boards. FDA is particularly interested in comments with 
alternative suggested statements that are consistent with the 
principles identified above and requests that any such statements be 
accompanied by data, such as consumer research.
    Some comments stated that FDA should consider a different succinct 
statement on children's menus and reference the calorie needs for 
children in specific age ranges. We seek comment on whether FDA should 
require a different statement on menus that are targeted to children. 
Such a statement may include language such as ``The daily caloric 
intake for children ---- years of age is ---- to ---- depending on 
whether they are boys or girls as well as their age and level of 
physical activity.'' (The blanks are to be filled in with information 
on current dietary guidelines.) Comments submitted to the agency on 
whether a different statement should be required or recommended for 
children's menus should provide a rationale, data (e.g. consumer 
research), or other information supporting such statement. The agency 
is particularly interested in any consumer research that demonstrates 
that the statement is understood by consumers.
    We intend to conduct consumer research to evaluate consumer 
response to these statements. FDA intends to make the results of our 
consumer research available to the public prior to publication of the 
final rule and to allow sufficient time for interested stakeholders to 
comment on the results of our research.
    Section 4205 requires that the succinct statement be posted on 
menus and menu boards prominently and in a clear and conspicuous 
manner. We are proposing in Sec.  101.11(b)(2)(i)(B)(1) that the 
required succinct statement appear in a type size no smaller than the 
smallest type size for any calorie declaration appearing on the same 
menu or menu board with the same color, or in a color at least as 
conspicuous, as the caloric declaration and with the same contrasting 
background as the caloric declarations. FDA is proposing in Sec.  
101.11(b)(2)(i)(B)(2) that for menus, the succinct statement must 
appear on the bottom of each page of the menu. On menu pages that also 
bear the statement regarding the availability of the written nutrition 
information described in section III.C.5. of this document, the 
succinct statement must appear directly above that statement of 
availability. FDA is proposing in Sec.  101.11(b)(2)(i)(B)(3) that the 
succinct statement appear on the bottom of menu boards, directly above 
the statement of availability. FDA tentatively concludes that these 
requirements will help ensure that the succinct statement is prominent, 
clear, and conspicuous, as required by sections 343(q)(5)(H)(ii)(I)(bb) 
and (II)(bb) (21

[[Page 19211]]

U.S.C. 343(q)(5)(H)(ii)(I)(bb) and (II)(bb)).
5. Nutrition Information That Must Be Made Available in a Written Form
    Section 403(q)(5)(H)(ii)(III) requires that covered establishments 
must provide, in a written form and upon consumer request, the 
nutrition information required under clauses (C) and (D) of section 
403(q)(1) of the FD&C Act. 21 U.S.C. 343(q)(5)(H)(ii)(III). The written 
nutrition information must be available on the premises of the 
establishment and the establishment must post on the menu or menu board 
a prominent, clear and conspicuous statement regarding the availability 
of the information (21 U.S.C. 343(q)(5)(H)(ii)(III) and (IV)). FDA 
requests comment on interpreting the phrase ``on the premises'' for 
menus appearing on the Internet.
    a. Statement of availability. Section 403(q)(5)(H)(ii)(IV) requires 
that covered establishments post on menus and menu boards a prominent, 
clear, and conspicuous statement regarding the availability of the 
written nutrition information (21 U.S.C. 343(q)(5)(H)(ii)(IV)). 
Therefore, FDA is proposing in Sec.  101.11(b)(2)(i)(C) to require the 
following statement regarding the availability of the written form of 
additional nutrition information proposed in Sec.  101.11(b)(2)(ii)(A) 
on menus and menu boards in covered establishments:

    Additional nutrition information available upon request.

    FDA is also proposing in Sec.  101.11(b)(2)(i)(C) that this 
statement (``statement of availability'') appear in a type size no 
smaller than the smallest type size for any calorie declaration 
appearing on the same menu or menu board, with the same prominence, 
i.e., the same color, or in a color as least as conspicuous as and in 
the same contrasting background as the calorie declarations. FDA is 
proposing that for menus, the statement of availability must appear on 
the bottom of the first page with menu items in the same type size and 
font as the calorie declaration and must appear immediately below the 
succinct statement proposed in Sec.  101.11(b)(2)(i)(B). For menus with 
more than two (2) pages, the statement must appear either on every page 
with menu item, or on the first page, so long as a symbol (e.g., 
asterisk) follows the term ``Calories'' or ``Cal'' where it first 
appears on each subsequent page, clearly referring to the statement of 
availability appearing on the first page of the menu. FDA is proposing 
that the statement appear on the bottom of menu boards, immediately 
below the succinct statement required in Sec.  101.11(b)(2)(i)(B). FDA 
tentatively concludes that this manner of providing the statement of 
availability will satisfy the requirements in amended section 
403(q)(5)(H)(ii)(IV) that the statement be prominent, clear, and 
conspicuous. We seek comment on whether the statement of availability 
will adequately inform consumers about the availability of the written 
nutrition information. In addition, we seek comment on whether the 
placement, font, and background requirements are appropriate to ensure 
that the statement of availability is prominent, clear, and 
conspicuous.
    FDA recognizes that some restaurants or similar retail food 
establishments have relatively few standard menu items, and, as a 
result, may have menu boards that list relatively few items in very 
large font. FDA requests comment on whether it is appropriate in these 
cases to tie the font size of the two statements required to appear at 
the bottom of menu board to the calorie disclosures.
    b. Required nutrients. Section 403(q)(5)(H)(ii)(III) specifies that 
the written form must provide ``the nutrition information required 
under clauses (C) and (D) of subparagraph (1) [21 U.S.C. 343(q)(1)(C) 
and (D)],'' which require declaration of the following nutrition 
information:
    <bullet> The total number of calories derived from any source, and 
the total number of calories derived from the total fat;
    <bullet> The amount of each of the following nutrients: Total fat, 
saturated fat, cholesterol, sodium, total carbohydrates, complex 
carbohydrates, sugars, dietary fiber, and total protein.
    FDA is proposing in Sec.  101.11(b)(2)(ii)(A) to require that the 
nutrition information in written form contain the information listed 
above, with two changes. The nutrition labeling requirements under 
sections 403(q)(1)(C) and (D) were added to the FD&C Act by NLEA and 
are the nutrients originally required to be provided in the mandatory 
nutrition information for packaged foods. FDA has since revised by 
regulation the nutrients required to be provided on the label or 
labeling of food in relevant part by removing the complex carbohydrates 
requirement from section 403(q)(1)(D) and requiring that information 
regarding the amount of trans fats be included in the label or labeling 
of food subject to section 403(q)(1). FDA proposes to make analogous 
revisions with respect to the written form required by section 
403(q)(5)(H)(ii)(III). These are explained further below.
    In addition, we note that, because section 403(q)(5)(H)(ii)(IV) 
refers only to clauses (C) and (D) of section 403(q)(1), covered 
establishments are currently not required to provide the information 
about vitamins and minerals required to be on the labels and labeling 
of foods pursuant to clause (E) of section 403(q)(1).
    c. Removal of complex carbohydrates from the requirements of 
403(q)(1)(D). Section 403(q)(2)(B), which was added to the FD&C Act by 
NLEA, provides that ``[i]f the Secretary determines that the 
information relating to a nutrient required by subparagraph (1)(C), 
(1)(D), or (1)(E) or clause (A) of this subparagraph to be included in 
the label or labeling of food is not necessary to assist consumers in 
maintaining healthy dietary practices, the Secretary may by regulation 
remove information relating to such nutrient from such requirement.'' 
Pursuant to this authority, FDA removed the requirement for bearing the 
amount of complex carbohydrates in the label or labeling of food, based 
on a determination that for complex carbohydrates ``there was no 
consensus on a clear definition for the term `complex carbohydrates' as 
it relates to physiological effects, health benefits, or dietary 
guidelines,'' there was a ``lack of methods for reliably determining 
the amounts present,'' and without a specific definition for ``complex 
carbohydrates it [was] not possible to include quantitative information 
in the nutrition label that would assist consumers in maintaining 
healthy dietary practices.'' (58 FR 2079 at 2101, Jan. 26, 1993); See 
Sec.  101.9(c)(1) (no regulation requiring that labeling bear nutrition 
information regarding complex carbohydrates). Because the agency 
removed the requirement that the label or labeling of food include 
information regarding ``complex carbohydrates'' from section 
403(q)(1)(D), declaration of complex carbohydrates is no longer a 
requirement under section 403(q)(1)(D). As a result, this proposed rule 
does not include complex carbohydrates among the nutrients that must be 
included in the written form required to be available to consumers 
under section 403(q)(5)(H)(ii)(III). FDA also received a comment 
stating that FDA should not include complex carbohydrates in the 
nutrition information in written form because, among other reasons, the 
amount of complex carbohydrates is not required to be included on the 
Nutrition Facts of packaged foods.
    d. Addition of trans fat to the requirements of 
403(q)(5)(H)(ii)(III). Section 403(q)(5)(H)(vi) provides that ``if the 
Secretary determines that a nutrient,

[[Page 19212]]

other than a nutrient required under [section 403(q)(5)(H)(ii)(III)], 
should be disclosed for the purpose of providing information to assist 
consumers in maintaining healthy dietary practices, the Secretary may 
require, by regulation, declaration of such nutrient in the written 
form'' (21 U.S.C. 343(q)(5)(H)(vi)). Similarly, section 403(q)(2)(A) 
(21 U.S.C. 343(q)(2)(A)) provides that ``[i]f the Secretary determines 
that a nutrient other than a nutrient required by subparagraph (1)(C), 
(1)(D), or (1)(E) should be included in the label or labeling of food 
subject to subparagraph (1) for [the] purposes of providing information 
regarding the nutritional value of such food that will assist consumers 
in maintaining healthy dietary practices, the Secretary may by 
regulation require that information relating to such additional 
nutrient to be included in the label or labeling of such food.'' 21 
U.S.C. 343(q)(2)(A).
    In 2003, FDA amended its regulations on nutrition labeling, through 
rulemaking (68 FR 41434, July 11, 2003), to require in Sec.  
101.9(c)(2)(ii) that trans fatty acids be declared in the label or 
labeling of conventional foods subject to section 403(q)(1) of the FD&C 
Act. In that rulemaking, FDA determined that the current scientific 
evidence consistently showed that trans fats are associated with 
increased low density lipoprotein (LDL)-cholesterol levels and, 
therefore, that lower intakes of both saturated and trans fats are 
important dietary factors in reducing the risk of coronary heart 
disease (CHD) in the general population and for those at increased risk 
for CHD. Further, FDA stated that the current authoritative reports at 
that time, such as the 2000 Dietary Guidelines for Americans (Ref. 24 
at p. 30), recommended that Americans cut back or limit the intake of 
trans fats. Thus, the agency concluded that persons interested in 
following these recommendations and maintaining optimal LDL-cholesterol 
levels must be able to determine levels of both saturated and trans 
fats in food products. Information on saturated fat content was already 
available in the Nutrition Facts on the labels of certain foods. The 
agency determined that the most practical way to inform consumers of 
the level of trans fat in these foods was for that information to be 
included in the Nutrition Facts. In the time since the final rule on 
trans fat labeling was published in 2003, the scientific evidence on 
trans fat has continued to support the relationship between trans fat 
and risk of CHD. Authoritative reports published since 2000 have 
included recommendations on the reduction of intake of trans fat. For 
example, the Institute of Medicine (IOM) has stated that trans fat 
consumption should be kept as low as possible while consuming a 
nutritionally adequate diet (Ref. 25). Additionally, the 2010 Dietary 
Guidelines for Americans recommended that trans fat intake be as low as 
possible (Ref. 9 at pp. x and 25). Therefore, for the same public 
health reasons that supported the requirement that the amount of trans 
fat be declared on the label or labeling of conventional foods subject 
to 403(q)(1) of the FD&C Act, we are proposing to require covered 
establishments to declare the amount of trans fat in standard menu 
items in the written form required by section 403(q)(5)(H)(ii)(III).
    e. Nutrients in insignificant amounts. FDA recognizes that some 
standard menu items may contain insignificant amounts of the nutrients 
required to be disclosed in the written form. See 21 U.S.C. 
343(q)(5)(H)(ii)(III). Section 403(q)(5)(C) of the FD&C Act states 
that: `` * * * If a food contains insignificant amounts, as determined 
by the Secretary, of all the nutrients required by subparagraphs (1) 
and (2) to be listed in the label or labeling of food, the requirements 
of such subparagraphs shall not apply to such food if the label, 
labeling or advertising of such food does not make any claim with 
respect to the nutritional value of such food. If a food contains 
insignificant amounts, as determined by the Secretary, of more than 
one-half the nutrients required by subparagraphs (1) and (2) to be in 
the label or labeling of the food, the Secretary shall require the 
amounts of such nutrients to be stated in a simplified form prescribed 
by the Secretary.''
    As directed by this statutory provision, FDA determined that ``[a]n 
`insignificant amount' shall be defined as that amount that allows a 
declaration of zero in nutrition labeling, except that for total 
carbohydrates, dietary fiber, and protein, it shall be an amount that 
allows a declaration of ``less than 1 gram.'' Sec.  101.9(f)(1). 
Further, FDA established regulations at Sec.  101.9(j)(4) that exempt 
foods that contain insignificant amounts of all the nutrients required 
to be included in the declaration of nutrition information on the label 
and labeling of food, provided that the food bears no nutrition claims 
or other nutrition information in any context on the label, labeling or 
advertising. FDA tentatively concludes that if a standard menu item 
contains insignificant amounts of all of the nutrients required to be 
declared in the written form pursuant to section 403(q)(5)(H)(ii)(II) 
(i.e., the nutrition information required under clauses (C) and (D) of 
section 403(q)(1)), a covered establishment is not required to include 
nutrition information regarding such food in the written form provided 
that the food does not make a nutrient content claim as defined in 
Sec.  101.13 or Subpart D of part 101 or a health claim as defined in 
Sec.  101.13 and permitted by regulation in Subpart E in part 101.
    In addition, FDA established regulations at Sec.  101.9(f)(1) that 
allow for the use of a simplified form of nutrition information 
labeling if a food contains insignificant amounts of more than one-half 
of the nutrients required to be disclosed in the label or labeling of 
food in sections 403(q)(1) and (2) of the FD&C Act. Specifically, Sec.  
101.9(f) provides that the declaration of nutrition information may be 
presented in the simplified format, set forth in the regulation, when a 
food contains insignificant amounts of eight (8) or more of the 
following fourteen (14) nutrients: Calories, total fat, saturated fat, 
trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, 
sugars, protein, vitamin A, vitamin C, calcium, and iron. In addition, 
Sec.  101.9(f)(2)(i) requires that the simplified format must include 
information on the following nutrients: Total calories, total fat, 
total carbohydrate, protein, and sodium. In the preamble to the 1993 
final rule on nutrition labeling for packaged food, FDA explained that 
this nutrition information is ``essential to aid consumers in learning 
about the relative nutritional qualities of all foods, and it allows 
them to judge the consequences of the food selections they make.'' (58 
FR 2079, 2142 (Jan. 6, 1993)).
    Section 4205 provides that section 403(q)(5)(C) shall apply to any 
regulations promulgated by FDA regarding the written nutrition 
information required by section 403(q)(5)(H)(ii)(II). However, section 
403(q)(5)(C) and Sec.  101.9(f) address some nutrients that are not 
required to be declared in the written nutrition information, 
specifically vitamin A, vitamin C, calcium, and iron. A covered 
establishments only is required to declare, in the written form, the 
nutrition information required under clauses (C) and (D) of 403(q)(1), 
which does not include vitamins and minerals. See 21 U.S.C. 
343(q)(5)(H)(ii)(III). Consequently, at this time, FDA tentatively 
concludes that a covered establishment is required only to declare, in 
the written nutrition information, ten of the fourteen nutrients 
specified in Sec.  101.9(f), specifically: Calories (derived from any

[[Page 19213]]

source, and derived from the total fat), total fat, saturated fat, 
trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, 
sugars, and protein. As a result, FDA tentatively concludes that if a 
standard menu item contains insignificant amounts of more than one-half 
of the nutrients required to be declared in the written nutrition 
information under proposed Sec.  101.11(b)(2)(ii)(A), this nutrition 
information may be presented in a simplified format for that standard 
menu item. FDA is proposing in Sec.  101.11(b)(2)(ii)(B) that the 
written nutrition information for a standard menu item offered for sale 
in a covered establishment may be presented in a simplified format when 
the standard menu item contains insignificant amounts of six (6) or 
more of the following ten (10) nutrients: Calories, total fat, 
saturated fat, trans fat, cholesterol, sodium, total carbohydrates, 
dietary fiber, sugars and protein. In addition, we are proposing that 
the simplified format must include information on the nutrients 
required in Sec.  101.9(f)(2)(i) and (ii) (i.e., total calories, total 
fat, total carbohydrate, protein, and sodium). The statement ``Not a 
significant source of ---- (with the blank filled in with the names of 
the nutrients required to be declared in the written nutrient 
information and calories from fat that are present in insignificant 
amounts) must appear following the written nutrition information. (See 
example in section III.B.3.e. of this document.) FDA tentatively 
concludes that this nutrition information is essential to aid consumers 
in learning about the relative nutritional qualities of all foods, and 
it allows them to judge the consequences of the food selections they 
make.
    f. Standards for determining and disclosing the nutrient content of 
foods for variable menu items. 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, but which are listed as a single 
menu item, such as soft drinks, ice cream, pizza, doughnuts, or 
children's combination meals (21 U.S.C. 343(q)(5)(H)(v)) (proposed to 
be called ``variable menu items''). Further, this section provides that 
FDA may establish these standards through means determined by the 
agency, including averages, ranges or other methods. Consequently, we 
considered these means in developing standards for disclosing nutrition 
information in the written form for standard variable menu items, as 
well as the comments. FDA considered the following options:
    Option 1. List the nutrition information for each nutrient in the 
variable menu item as a range.
    For example, nutrition information for a meal that consists of a 
cheeseburger, side dish (fries or salad with fat-free dressing), and 
medium soft drink (diet or regular) would be provided in a written form 
that provides the following information:
    <bullet> Total calories: 620-1,150 calories
    <bullet> Calories from fat: 220-410 calories
    <bullet> Total fat: 24-46 g
    <bullet> Saturated fat: 8-15 g
    <bullet> Trans fat: 0-1 g
    <bullet> Cholesterol: 75-90 mg
    <bullet> Sodium: 1,240-1,560 mg
    <bullet> Total carbohydrates: 70-155 g
    <bullet> Sugars: 21-66 g
    <bullet> Dietary fiber: 4-7 g
    <bullet> Protein: 29-34 g
    For variable menu items with variations that contain calorie 
amounts and levels of nutrients that vary widely, this type of nutrient 
declaration minimally assists consumers in maintaining healthy dietary 
practices, since it does not provide them with a way to determine the 
nutrient levels of the particular variations they are choosing between. 
The consumer may not be able to determine how to make a selection to 
get fewer of the nutrients the consumer wishes to avoid and more of the 
nutrients that the consumer wants to consume.
    Option 2. List the nutrition information for each component in the 
variable menu item.
    Using the example described above in option 1, for a meal that 
consists of a cheeseburger, side dish (fries or salad with fat-free 
dressing), and medium soft drink (diet or regular), under option 2, the 
covered establishment would be required to provide information for the 
required nutrients for each component of the meal, i.e., the 
cheeseburger, the fries, the salad with fat-free dressing, a medium 
soft drink, and a diet soft drink. The declaration may appear as 
follows, which includes the proposed simplified formats for the medium 
cola and diet cola:
    Cheeseburger:
    <bullet> Total calories 470 calories
    <bullet> Calories from fat 190 calories
    <bullet> Total fat 21 g
    <bullet> Saturated fat 8 g
    <bullet> Trans fat 1 g
    <bullet> Cholesterol 75 mg
    <bullet> Sodium 880 mg
    <bullet> Total carbohydrate 43 g
    <bullet> Sugars 10 g
    <bullet> Dietary fiber 2 g
    <bullet> Protein 26 g
    Medium fries:
    <bullet> Total calories 420 calories
    <bullet> Calories from fat 180 calories
    <bullet> Total fat 20 g
    <bullet> Saturated fat 3.5 g
    <bullet> Trans fat 0 g
    <bullet> Cholesterol 0 mg
    <bullet> Sodium 500 mg
    <bullet> Total carbohydrate 54 g
    <bullet> Sugars 0 g
    <bullet> Dietary fiber 6 g
    <bullet> Protein 5 g
    Garden salad with fat-free dressing:
    <bullet> Total calories 150 calories
    <bullet> Calories from fat 30 calories
    <bullet> Total fat: 3 g
    <bullet> Saturated fat 0 g
    <bullet> Trans fat 0 g
    <bullet> Cholesterol 0 mg
    <bullet> Sodium 340 mg
    <bullet> Total carbohydrate 27 g
    <bullet> Sugars 11 g
    <bullet> Dietary fiber 2 g
    <bullet> Protein 3 g
    Medium Cola:
    <bullet> Total calories 200 calories
    <bullet> Total fat 0 g
    <bullet> Sodium 5 mg
    <bullet> Total carbohydrate 56 g
    <bullet> Sugars 56 g
    <bullet> Protein 0 g
    <bullet> Not a significant source of calories from fat, saturated 
fat, trans fat, cholesterol, and dietary fiber.
    Medium Diet Cola:
    <bullet> Total calories 0 calories
    <bullet> Total fat 0 g
    <bullet> Sodium 40 mg
    <bullet> Total carbohydrate 0 g
    <bullet> Sugars 0 g
    <bullet> Protein 0 g
    <bullet> Not a significant source of calories from fat, saturated 
fat, trans fat, cholesterol, and dietary fiber
    This option provides the consumer with all the required nutrient 
information for each component of the combination meal in a format that 
facilitates quick comparisons between different menu items. This option 
also likely reduces duplication, particularly for combination meals, 
since most items in combination meals are likely to be available as 
individual standard menu items.
    In addition, when the nutrition information for different flavors, 
varieties, or components of combinations are the same, the nutrition 
information for these food items would need only be listed once, with 
the food items grouped together. For example:
    Raspberry or Peach Flavored Iced Tea (14 ounces):
    <bullet> Total calories 5 calories
    <bullet> Total fat 0 g
    <bullet> Sodium 15 mg
    <bullet> Total carbohydrate 1 g
    <bullet> Sugars 0 g
    <bullet> Protein 0 g

[[Page 19214]]

    <bullet> Not a significant source of calories from fat, saturated 
fat, trans fat, cholesterol, and dietary fiber
    For some variable menu items, the number of possible variations is 
so large that providing the nutrient information required in proposed 
Sec.  101.11(b)(2)(ii)(A) in written form would be impractical if FDA 
required the information to be disclosed for each conceivable option. 
For example, a pizza with a choice among many toppings has a very large 
number of possible permutations. FDA tentatively concludes that it is 
more reasonable to require written nutrition information for the basic 
preparation of the pizza (e.g., plain, deep- dish 12'' pizza) and then 
provide the additional written nutrition information for each possible 
topping. Therefore, FDA proposes that the nutrition information 
required in Sec.  101.11(b)(2)(ii)(A) must be provided for the basic 
preparation of the item and, separately, for each topping or other 
variable component.
    Option 3. If a standard menu item only has two variations (e.g. a 
sandwich with fruit or with fries), provide both numbers for each 
nutrient in each option with a forward slash between (e.g. 450/700). If 
three or more options are available, provide the range in calories. For 
example, for a grilled chicken sandwich with either small fries or 
fruit the nutrients would be declared as:
    <bullet> Total calories: 450/700 calories
    <bullet> Calories from fat: 70/200 calories
    <bullet> Total fat: 7/23 g
    <bullet> Saturated fat: 1.5/4.5 g
    <bullet> Cholesterol: 90/90 mg
    <bullet> Trans fat: 0/0 g
    <bullet> Sodium: 1160/1430 mg
    <bullet> Total carbohydrate 63/87 g
    <bullet> Sugars 27/9 g
    <bullet> Dietary fiber 3/6 g
    <bullet> Protein 35/38 g
    This option could result in a mixed format within the written 
nutrition information, i.e., two different types of declarations, one 
with numbers separated by slashes and one with numbers separated by 
dashes. We question whether this approach has the potential to be 
confusing to consumers due to the mixed format and if consumers would 
be able to distinguish that the nutrient declarations separated by a 
slash represent the actual amount of nutrients in the two options and 
that the nutrients declarations separated by a dash actually represents 
a range of nutrients where the actual amount of nutrients for the item 
they decide to choose could be anywhere within that range.
    For the reasons described above in this section, FDA tentatively 
concludes that Option 2 provides the most direct and clear information 
for consumers. Consequently, we are proposing in Sec.  
101.11(b)(2)(ii)(C) that for foods that come in different varieties, 
flavors, and combinations, the nutrient information in the written form 
required in Sec.  101.11(b)(2)(ii)(A) must be declared for each 
variety, flavor, and each food component of the combination meal. For 
those foods that come in different varieties, flavors, and combinations 
where the number of possible variations is so large that providing the 
nutrition information in written form for each permutation would be 
impractical (e.g., pizza, ice cream), FDA is proposing that the 
nutrition information required in Sec.  101.11(b)(2)(ii)(A) must be 
provided for the basic preparation of the item and, separately, for 
each topping or other variable component. The nutrition information in 
written form may also be provided for every possible variation. FDA 
specifically requests comment on this proposed requirement as well as 
alternatives that would provide clear, truthful, and non-misleading 
information to the consumers about the specific food they purchase.
    FDA is also proposing that if the calories and other nutrients are 
the same for different flavors, varieties, and each substitutable 
component of the combination meal, each variety, flavor, and 
substitutable component of the combination meal is not required to be 
listed separately. All items that have the same nutrient levels could 
be listed together with the nutrient levels listed only once.
    g. Format and manner for the written nutrition information. FDA is 
proposing that the nutrition information must be presented in the order 
listed in proposed Sec.  101.11(2)(ii) and that the information must be 
presented in a clear and conspicuous manner.
    FDA is not proposing a specific manner for providing the written 
nutrition information. Instead, FDA is proposing in Sec.  
101.11(2)(ii)(D) that the written nutrition information may be provided 
on a counter card, sign, poster, handout, loose leaf binder, booklet, 
or electronic device, such as a computer, on a menu or in any other 
material that similarly permits the declaration in written form of the 
required nutrient content information for all standard menu items.
    FDA's proposed approach is consistent with the many comments that 
stated that the manner in which the written nutrition information is 
made available should be flexible. One comment recommended that the 
written nutrition information should be made available electronically 
at kiosks in lieu of paper copies. Some comments recommended that the 
information appear on the register tape and others recommended that it 
appear on the menus themselves. A few comments stated that the 
information should be allowed on food wrappers or tray liners, while 
one comment opposed the use of liners and wrappers, stating that the 
information should be provided immediately prior to or at the point of 
purchase. FDA would not object to the use of tray liners or wrappers to 
be used as a means to provide nutrition information, as long as the 
tray liners or wrappers are available upon request to the consumers, 
and the tray liner or wrapper contains nutrition information for all 
standard menu items offered for sale at the covered establishment.
    Another comment recommended that FDA provide additional nutrition 
information in Spanish and other languages depending on the region of 
the country in which the retail food establishment is located. FDA 
would not object to covered establishments providing information in 
other languages, in addition to English. FDA notes, however, that if 
the information is provided in other languages, all of the required 
information must be provided in that language. This is consistent with 
labeling requirements for packaged foods, except that covered 
establishments in Puerto Rico may provide the information in Spanish 
only. Sec.  101.15(c).
    Unlike the statutory requirements about calorie declarations, which 
must be placed on menus and menu boards, there is more opportunity for 
the industry to determine how best to present the written nutrition 
information. In determining how to present the nutrition information in 
written form, a covered establishment might consider the extensiveness 
of the menu and levels of technology capability, among other factors. 
Allowing flexibility in meeting the requirements of this section is 
consistent with the current regulation for nutrition labeling in 
restaurant foods in Sec.  101.10, which permit the disclosure of 
nutrition information for foods that bear nutrient content or health 
claims by various means. We request comment on whether we should be 
more prescriptive in the format and manner of the declarations in order 
to ensure they are useful to consumers.
    In considering whether to require more specific formats, FDA is 
particularly concerned with whether there are ways to provide 
information to consumers with diseases related to obesity and being 
overweight. For example, we seek comment on whether

[[Page 19215]]

FDA should require nutrients that are particularly important for 
consumers with obesity and diabetes to monitor in order to maintain 
healthy dietary practices (e.g., total calories, total fat, sodium, 
sugar) to be bolded or placed in a separate table of nutritional 
content. In addition, FDA requests comment on whether and how 
additional written nutrition information should be required to be 
available on the Internet, e.g., when a covered establishment provides 
a menu on its Web site.
6. Requirements for Self-Service Food and Food on Display
    a. General requirements for self-service food and food on display. 
Section 403(q)(5)(H)(iii) provides that calories per food item or per 
serving must be disclosed for self-service food and food on display (21 
U.S.C. 343(q)(5)(H)(iii)). Covered establishments must provide this 
calorie information on a sign adjacent to each food offered.
    As discussed in section III.B. of this document, FDA proposes to 
define ``food on display'' as food that is visible to the customer 
before the customer makes an order selection. FDA is proposing to 
define ``self-service food'' as food that is available at a salad bar, 
buffet line, cafeteria line, or similar self-service facility, and 
self-service beverages.
    b. Display of calories for self-service foods or foods on display. 
Section 403(q)(5)(H)(i) and (iii) requires that covered establishments 
place adjacent to each standard menu item that is a self-service food 
and food on display a sign that lists calories per displayed food item 
or per serving (21 U.S.C. 343(q)(5)(H)(i) and (iii)). Some comments 
stated that for foods sold at salad bars or buffet lines, the calorie 
information must be near each item, and not, for example, in a pamphlet 
on or near the salad bar or buffet line. One comment asserted that the 
placement of signs adjacent to each food item creates a potential for 
insanitary conditions, and suggested that the calorie information be 
placed at the beginning of the self-service line and hung above self-
serve stations.
    FDA tentatively concludes that when a self-service food or food on 
display is already accompanied by an individual sign, adjacent to the 
food, that provides the food's name, price, or both, listing calories 
per displayed food item or per serving on that sign satisfies the 
requirement of section 403(q)(5)(H)(iii). Placing a separate sign with 
calorie information adjacent to a food that is already accompanied by a 
sign bearing its name, price, or both, could make it more difficult for 
consumers to clearly associate the calorie information with its 
corresponding self-service food or food on display. Therefore, given 
FDA's authority to specify the manner of nutrient content disclosures 
under section 403(q)(5)(H)(x)(bb), FDA is proposing in Sec.  
101.11(b)(2)(iii) that the calorie declaration appear on the sign with 
the name, price, or both, of the self-service food or food on display, 
if applicable.
    FDA proposes that the calorie declaration on such a sign must state 
the number of calories and use the term ``Calories'' or ``Cal,'' both 
in a type size no smaller than the type size of the name or the price 
of the food item whichever is smaller in the same color, or a color at 
least as conspicuous as that name or price, with the same contrasting 
background. FDA requests comment on whether establishments that already 
provide an individual sign identifying each food on display or self-
service food with its name, price, or both should have the option of 
providing a separate individual sign for each food on display or self-
service food for the calorie declaration, so long as the sign with the 
calorie declaration is adjacent to and clearly associated with its 
corresponding food.
    When a self-service food or food on display is not already 
accompanied by an individual sign, adjacent to the food, that provides 
the food's name, price, or both, FDA proposes that the covered 
establishment place a sign adjacent to each food with the number of 
calories per serving or per item, as appropriate, and the term 
``Calories'' or ``Cal.'' FDA proposes that the calorie declaration on 
these signs be clear and conspicuous, and requests comment on whether 
additional or more specific formatting requirements are necessary.
    Often, self-service food or food on display is displayed per item, 
such that the customer generally takes one item or is generally served 
one item (e.g., a baked potato at a buffet, a cupcake at a bakery, a 
cup of pudding at a cafeteria). FDA tentatively concludes that for 
self-service food or food on display that is displayed per item, where 
an item represents one serving, the calorie declaration should be per 
item.
    For self-service food or food on display that is not displayed per 
item (e.g., potato salad at a buffet or ice cream at an ice cream 
parlor), FDA tentatively concludes that the calorie declaration should 
be per serving. Covered establishments may use the size of the serving 
utensil as the serving measure (e.g. 300 calories per single scoop of 
ice cream), or they may use common household measurements (e.g., 400 
calories per cup of potato salad. FDA requests comment on the 
appropriate measurement units for declaring calories per serving for 
self-service foods and foods on display.
    With respect to multiple-serving foods, FDA tentatively concludes 
that if the food on display or self-service food is a discrete item 
such as a whole rotisserie chicken, and it is sold as such, then the 
calories must be displayed for the whole item. FDA would not object to 
the voluntary declaration of the calories per serving as well as the 
calories per food item, as long as such declaration is truthful and not 
misleading. However, if individual portions of a multi-serving food on 
display or self-service food are served to consumers or available for 
consumers to serve themselves (e.g., cake by the slice or pizza by the 
slice), then, under this proposal, the calories must be displayed per 
serving.
    c. Self-serve beverages. A few comments stated that calorie 
labeling for self-serve beverages, such as soft drinks, juices, shakes, 
smoothies, coffees, teas, and similar drinks is difficult because of 
factors including the wide range of calories per ounce of the different 
types of beverages; the variability in serving size within a chain and 
in different establishments; and the amount of ice dispensed for 
certain beverages. The comments also stated that there is limited space 
on menus and beside beverage dispensers. Some comments asserted that 
the calorie declaration should be on menus or menu boards, because that 
is where the consumer makes decisions; one of these comments stated 
that to the extent that it is appropriate to make calorie information 
available in places other than the menu or menu board, it should be 
provided in a consistent manner (i.e., the calorie declarations on 
menus, menu boards, and adjacent to self-service fountain machines and 
other self-service beverage equipment should all be consistent and 
based on the same serving size or other agreed upon unit of measure).
    The comments stated that FDA must work with covered establishments, 
as well as with the beverage industry, to determine the appropriate 
serving size (e.g., 12 fluid ounces) or other standard (e.g., ranges, 
averages, per cup assuming one-third ice fill, etc.) on which a 
reasonable approximation of beverage calorie content should be based. 
Some comments recommended that FDA exempt self-service fountain 
machines and other self-service beverage dispensing equipment from 
displaying calorie information until FDA satisfies the FD&C Act's 
requirement to

[[Page 19216]]

``establish by regulation 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, such as soft drinks.''
    FDA recognizes that covered establishments may have different sizes 
for beverages that are listed on the menu as small, medium and large. 
Consumers may be confused when they order the same item (e.g., a small 
cola) in two different establishments and are presented with two 
different calorie declarations. For example, in one establishment, a 
small cola may be 140 calories and in another establishment a small 
cola is 190 calories. The difference in the calories could be based on 
the fact that the two cups sold as ``small'' may have different volumes 
(e.g., 12 ounces versus 16 ounces). FDA is considering whether the 
amount of calories declared should be based on the number of ounces. We 
anticipate that if we adopt this view in the final rule, we would not 
object to the covered establishment listing the number of ounces as 
part of the size declaration e.g., ``140 calories per 12 ounces 
(small).'' FDA requests comment on this issue.
    Similar to the ice cream parlor that lists all of its flavors on 
the menu board, some covered establishments list beverages individually 
on a menu or menu board. In such situations, calorie information must 
be provided in both locations, in accordance with section 
403(q)(5)(H)(ii) and (iii). When a general term for a set of beverages 
that includes different flavors or varieties is listed on a menu or 
menu board (e.g., ``soda''), we are proposing that the calories be 
declared as a range, like any other variable menu item (see proposed 
Sec.  101.11(b)(2)(i)(4)). The self-service beverage dispenser itself 
must have calorie declarations for each flavor or variety offered, such 
that the calorie declaration is clearly associated with its 
corresponding flavor or variety. For example, the restaurant may place 
above each dispenser for soft drinks small signs labeled with the 
amount of calories for each beverage. As with other self-service foods 
or foods on display, if a self-service beverage already has an 
individual, identifying sign, the calorie declaration must appear on 
that identifying sign, so long as it is in a type size no smaller than 
the type size of the name of the beverage with the same prominence.
    d. Applicability of 403(q)(5)(H)(ii) to self-service food and food 
on display. Section 403(q)(5)(H)(i) states, ``in the case of food that 
is a standard menu item * * * [the covered] establishment shall 
disclose the information described in subclauses (ii) and (iii).'' The 
word ``and'' between the references to subclause (ii) and subclause 
(iii) indicates that for each standard menu item, including self-
service food and food on display, covered establishments should follow 
requirements in section 403(q)(5)(H)(ii) as applicable and section 
403(q)(5)(H)(iii) as applicable. FDA tentatively concludes that when 
these self-service foods and food on display appear on menus or menu 
boards, the menus or menu boards must bear the calorie declarations 
required by sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa). FDA also 
tentatively concludes that covered establishments must provide the 
nutrition information in written form required under 
403(q)(5)(H)(ii)(III) for these self-service foods and foods on 
display, and the statements required by 403(q)(5)(H)(ii)(I)(bb), 
(II)(bb), and (IV) on their corresponding menus and menu boards.
(1) Calorie Declarations
    As discussed above, FDA proposes to define ``menu'' or ``menu 
board'' as the primary writing of the covered establishment from which 
a consumer makes an order selection. Under this definition, most self-
service food and food on display would not appear on menus or menu 
boards. However, some would. For example, an ice cream parlor might 
list all of its flavors on a menu board and also have bulk containers 
of ice cream on display and visible to customers in a display case. In 
this situation, calorie declarations must be provided adjacent to the 
ice cream flavors on the menu board under 403(q)(5)(H)(ii)(II)(aa) and 
on signs adjacent to the individual ice cream bulk containers 
themselves under 403(q)(5)(H)(iii).
    As another example, a coffee shop might have baked goods identified 
by small signs adjacent to each food declaring the name and, often, the 
price of each baked good. In many cases, these baked goods on display 
do not appear on the establishment's menu board. Because these signs 
are the only writings of the establishment from which consumers select 
baked goods to order, FDA tentatively concludes that they are the 
primary writings from which consumers ordering baked goods make their 
order selections.
    Unlike self-service beverages such as fountain drinks that have 
specific size and product options, for a narrow category of self-
service food or food on display where a general menu item corresponds 
to a wide set of self-service food or food on display, a calorie 
declaration adjacent to the name of the general menu item on a menu or 
menu board might not be helpful to the consumer. For example, the food 
choices on buffet lines are typically extensive, and the customers have 
control over the portions of each food choice they serve themselves. In 
addition, many buffets are all-you-can-eat. FDA notes that it would be 
almost impossible for covered establishments to provide useful calorie 
information for the general menu item ``lunch buffet,'' given that 
there is no clearly identifiable upper bound to the amount of calories 
a customer ordering the ``lunch buffet'' would consume. Therefore, FDA 
tentatively concludes that it would be most useful for consumers, and 
most practical for retail food establishments, if the calorie 
information is provided for each individual item on the lunch buffet in 
accordance with section 403(q)(5)(H)(iii), but not adjacent to the name 
``lunch buffet'' on the menu or menu board. Given FDA's authority to 
under section 403(q)(5)(H)(v), FDA is proposing in Sec.  
101.11(b)(2)(i)(A)(4) to instead require covered establishments to 
include on the menu or menu board a statement referring customers to 
the self-service facility for calorie information, e.g., ``See lunch 
buffet for calorie declarations.'' FDA requests comment on this 
tentative conclusion.
(2) Additional Written Nutrition Information for Self-Service Food and 
Food on Display
    Section 403(q)(5)(H)(ii)(III) requires certain additional nutrition 
information to be available to the consumer in written form upon 
request. Because section 403(q)(5)(H)(i) states that covered 
establishments must disclose the information in section 
403(q)(5)(H)(ii) for standard menu items, FDA tentatively concludes 
that covered establishments must provide the additional written 
nutrition information described in section 403(q)(5)(H)(ii)(III) for 
self-service foods and food on display that are standard menu items.
    Similar to our tentative conclusion regarding calorie declarations 
for general menu items such as ``lunch buffet'' discussed above, FDA 
tentatively concludes that it would be most useful for consumers, and 
most practical for covered establishments, if the additional written 
nutrition information is provided for each individual item on the lunch 
buffet, not for ``lunch buffet'' generally. This tentative conclusion 
is consistent with FDA's proposal for providing additional written 
nutrition information for variable menu items by component. FDA 
requests comment on this tentative conclusion.

[[Page 19217]]

(3) Succinct Statement and Statement of Availability of Additional 
Written Nutrition Information for Food on Display
    As discussed earlier, a narrow set of food on display has 
identifying signs adjacent to each food item that are the primary 
writings of the establishment from which consumers make order 
selections. FDA recognizes that sections 403(q)(5)(H)(ii)(I)(bb), 
(II)(bb), and (IV) apply to these foods under a straightforward reading 
of the statute. However, the obligation to provide the two statements 
related to suggested daily caloric intake and the availability of 
additional written nutrition information under 403(q)(5)(H)(ii) seem to 
pose difficulties, given the generally small size of these individual 
signs. In addition, from a consumer's perspective, it is probably 
unnecessary for these two statements to appear on every single 
individual identifying sign. Lastly, FDA is instructed to ``consider * 
* * space on menus and menu boards'' in promulgating these regulations 
(403(q)(5)(H)(x)).
    FDA tentatively concludes that each individual sign could be 
considered its own menu, but that a set of signs that are in close 
proximity to each other, such as those that might identify items in a 
bakery display counter, could be viewed together as the primary writing 
from which consumers choose among those items to order. Therefore, FDA 
is proposing in Sec.  101.11(b)(iii)(B) that covered establishments may 
place the statements required under 403(q)(5)(H)(ii) on the individual 
food-specific signs, but they also have the option of placing them on a 
separate, larger sign, in close proximity to food on display, that can 
be easily read as the consumer is making his or her order selection. 
Similarly, FDA tentatively concludes that signs identifying food on 
display that are the primary writing from which consumers select the 
corresponding items to order and are in close proximity to a menu 
board, such that the menu board can be easily read as the customer is 
viewing the food on display, could be considered part of that menu 
board. For example, some coffee shops offer baked goods in a display 
case directly in front of the menu board. In these situations, the 
statements that appear on the menu board itself under 
403(q)(5)(H)(ii)(II)(bb) and (IV) would be sufficient. FDA requests 
comment on these conclusions and whether additional restrictions 
related to presenting these statements in these contexts are necessary.
e. Requirements for Self-Service Foods and Foods on Display That Are 
Packaged Foods That Bear the Nutrition Information Required by Section 
403(q)(1) of the FD&C Act and Sec.  101.9
    Some packaged food, such as bags of chips or packages of cookies, 
are offered for sale in covered establishments individually or as parts 
of combination meals. A packaged food that is required to bear 
nutrition information on its label under 403(q)(1) of the FD&C Act and 
FDA's implementing regulations at Sec.  101.9 would not be a restaurant 
or restaurant-type food, because restaurant or restaurant-type food 
includes only food previously exempt from those nutrition labeling 
requirements. Therefore, such food would not be covered by the proposed 
menu labeling requirements. However, FDA tentatively concludes that 
some packaged food offered for sale in covered establishments is ``food 
served in restaurants or other establishments in which food is served 
for immediate consumption or that is sold for sale or use in such 
establishments.'' While it happens to bear Nutrition Facts, it is not 
required to do so. This food would meet the proposed definition of 
``restaurant food'' and therefore would be covered by the menu labeling 
requirements.
    Such packaged food already includes on its label the nutrition 
information that FDA is proposing be required to be disclosed in the 
written form in Sec.  101.11(b)(2)(ii). As noted in section III.B.5. 
this information would include the number of calories, calories from 
fat, total fat, saturated fat, cholesterol, trans fat, sodium, total 
carbohydrates, sugars, dietary fiber, and total protein in the food. In 
some cases, the packaged food is placed on a shelf, rack, counter, or 
other area where the food can be accessed by a consumer before the 
consumer purchases the food. So long as the consumer is able to examine 
the nutrition information on the label of the packaged food before 
purchasing the food and the food complies with the nutrition labeling 
requirements set forth in 403(q)(1) of the FD&C Act and Sec.  101.9, 
the label for the packaged food will provide to consumers, in written 
form, the nutrition information that FDA is proposing be required in 
the written nutrition information. Therefore, FDA tentatively concludes 
that this type of packaged food would satisfy the requirements of Sec.  
101.11(b)(2)(ii), so long as consumers are able to examine the 
nutrition information on the label of the packaged food before 
purchasing the food.
    In addition, the label of such packaged food includes calorie 
information for the food per item or per serving. FDA tentatively 
concludes that a packaged food that is a self-service food or food on 
display that bears the nutrition information required by 403(q)(1) of 
the FD&C Act and Sec.  101.9 satisfies the calorie disclosure 
requirement for self-service food or food on display in section 
403(q)(5)(H)(iii) of the FD&C Act, so long as a consumer is able to 
examine the calorie information on the label prior to purchase. Covered 
establishments would not be required to place signs that list calories 
per displayed food item or per serving adjacent to such packaged foods. 
The agency tentatively concludes that these proposals will provide 
flexibility for industry without sacrificing nutrition information 
provided to consumers.
    Covered establishments still would be required to post calorie 
information on menus and menu boards for packaged foods that are 
standard menu items listed on menus and menu boards. For example, a 
covered establishment may list ``chips'' on its menu board, referring 
to packaged bags of chips that are available as self-service foods or 
foods on display within the establishment. In this situation, the 
establishment would be required to disclose on the menu board calorie 
information for the packaged chips, even though the establishment may 
not be required to place a sign that lists calories per displayed food 
item or per serving adjacent to the packaged chips themselves.
    In addition, if a covered establishment lists on its menu or menu 
board a combination meal that includes a packaged food, the 
establishment would be required to disclose the total calorie 
information for the combination meal, including the packaged food. For 
example, a covered establishment may list on its menu board a 
combination meal that includes a soft drink, sandwich, and packaged 
chips. In this case, the covered establishment would be required to 
disclose on the menu board the total calorie information for the 
combination meal, which would include the soft drink, sandwich, and 
packaged chips, because these food items together make up the 
combination meal. FDA requests comments on these proposals and 
tentative conclusions.
8. Determination of Nutrient Content
    Section 403(q)(5)(H)(iv) requires that a covered establishment 
``shall have a reasonable basis for its nutrient content disclosures, 
including nutrient databases, cookbooks, laboratory analyses, and other 
reasonable means, as described in [21 CFR 101.10] (or any successor 
regulation) or in a related

[[Page 19218]]

guidance of the Food and Drug Administration.'' 21 U.S.C. 
343(q)(5)(H)(iv). FDA is proposing in Sec.  101.11(c)(1) that nutrient 
content disclosures may be determined by nutrient databases, cookbooks, 
laboratory analyses, and other reasonable means, including the use of 
labels on packaged foods that comply with the nutrition labeling 
requirements of section 403(q)(1) of the FD&C Act and Sec.  101.9. FDA 
notes that covered establishments must ensure that the nutrition 
declaration is truthful and not misleading in accordance with section 
403(a)(1) under the FD&C Act. Further, FDA is proposing in Sec.  101.11 
that for compliance purposes, a covered establishment is required to 
upon request provide information on the reasonable basis used to 
determine the nutrient content disclosures for their standard menu 
items, self-serve foods and foods on display. This proposed requirement 
is discussed in more detail below in section E. In addition, because 
the nutrients that are required to be declared in covered 
establishments are a subset of those required to be declared in the 
labeling of food in Sec.  101.9, FDA is proposing in Sec.  101.11 an 
approach for determining compliance modeled after Sec.  101.9(g). 
Proposed Sec.  101.11(c)(2) provides for two classes of nutrients for 
purposes of compliance: Class I (added nutrients) and Class II 
(naturally occurring (indigenous) nutrients). FDA is proposing that for 
Class I protein or dietary fiber, the nutrient content of an 
appropriate composite sample must be at least equal to the value for 
that nutrient declared in the nutrition information in the written 
form. Other requirements would include that the amount of calories, 
sugars, total fat, saturated fat, trans fat, cholesterol, and sodium 
contained in an appropriate composite of a standard menu item must not 
be more than 20 percent in excess of the declared value. Additionally, 
the amount of protein, total carbohydrates and dietary fiber contained 
in an appropriate composite of a standard menu item must not be less 
than 80 percent of the declared value. FDA also is proposing that for 
variable menu items that disclose calories in ranges, the lowest 
calorie declaration in the range would be used to determine compliance. 
FDA requests comments on the appropriate variability from declared 
nutrition information for compliance purposes, including whether Sec.  
101.11 should mirror Sec.  101.9 in this respect.

D. Voluntary Registration for Restaurants or Similar Retail Food 
Establishments That Are Not Chain Retail Food Establishments and Elect 
To Be Subject to the Requirements of Section 4205

    Section 403(q)(5)(H)(ix) provides that restaurants and similar 
retail food establishments not automatically subject to the 
requirements of section 403(q)(5)(H) may elect to become subject to the 
requirements by registering biannually with FDA (21 U.S.C. 
343(q)(5)(H)(ix)). On July 23, 2010, as required by section 
403(q)(5)(H)(ix), FDA published in the Federal Register a notice 
(``registration notice'') specifying the terms and conditions for 
implementation of voluntary registration, pending promulgation of 
regulations (75 FR 43182 (July 23, 2010)).
    Section 4205 preempts State and local nutrition labeling 
requirements for chain retail food establishments that are not 
``identical'' to the Federal requirements, as discussed more fully in 
section IV of this document (21 U.S.C. 343-1(a)(4)). Under amended 
section 403A(a)(4), restaurants and similar retail food establishments 
that are not chain retail food establishments but elect to become 
subject to the Federal requirements by registering voluntarily with FDA 
are not subject to State or local nutrition labeling requirements, 
unless those State or local requirements are ``identical to'' Federal 
requirements. Restaurants and similar retail food establishments that 
register are subject to the requirements of amended section 403(q) and 
FDA's implementing regulations to the same extent as chain retail food 
establishments.
    FDA anticipates that registrations will primarily be submitted by 
restaurants and similar retail food establishments with fewer than 20 
locations in States and localities that have non-identical menu 
labeling requirements. An authorized official would be permitted to 
register multiple restaurants or similar retail establishments within a 
chain on a single registration form, provided that the official is an 
authorized official for all of the restaurants or similar retail food 
establishments included on the form. In addition, the authorized 
official of an individual restaurant or retail food establishment may 
register that restaurant or retail food establishment on a single 
registration form.
    FDA is proposing in Sec.  101.11(c)(2) that the authorized official 
of a restaurant or similar retail food establishment as defined in 
Sec.  101.11(a)(10) may register with FDA. FDA is also proposing in 
Sec.  101.11(c)(2) that an authorized official may register an 
individual restaurant or similar retail food establishment or multiple 
restaurants or similar retail food establishments that are part of 
chain on a single registration form.
    FDA is proposing in Sec.  101.11(c)(3) that authorized officials 
for restaurants and similar retail food establishments must provide FDA 
with the following information:
    <bullet> The name, address, phone number, e-mail address, and 
contact information for the authorized official;
    <bullet> The name, address, and e-mail address of each restaurant 
or similar retail food establishment being registered, as well as the 
name and contact information for an official onsite, such as the owner 
or manager, for each specific restaurant or similar retail food 
establishment;
    <bullet> All trade names the restaurant or similar retail food 
establishment uses;
    <bullet> Preferred mailing address (if different from location 
address for each establishment) for purposes of receiving 
correspondence; and
    <bullet> Certification that the information submitted is true and 
accurate, that the person or firm submitting it is authorized to do so, 
and that each registered restaurant or similar retail food 
establishment will be subject to the requirements of Sec.  101.11.
    FDA has created and made available at a Web site, http://www.fda.gov/menulabeling, a form (OMB No. 0910-0664) that contains 
fields requesting this information. Authorized officials of restaurants 
and similar retail food establishments electing to be subject to the 
requirements of section 403(q)(5)(H) can obtain information to register 
by visiting http://www.fda.gov/menulabeling. Registrants must use this 
form to ensure that complete information is submitted.
    FDA prefers that the information be submitted by e-mail by typing 
complete information into the form (PDF), saving it on the registrant's 
computer, and sending it by e-mail to <a href="/cdn-cgi/l/email-protection#fa979f948f969b8d889f9d93898e889b8e939594ba9c9e9bd4929289"><span class="__cf_email__" data-cfemail="ec81898299808d9b9e898b859f989e8d98858382ac8a888dc284849f">[email protected]</span></a>.gov. 
If e-mail is not available, the registrant can either fill in the form 
(PDF) and print it out (or print out the blank PDF and fill in the 
information by hand or typewriter), and either fax the completed form 
to (301) 436-2804 or mail it to FDA, White Oak Building 22, Room 0209, 
10903 New Hampshire Ave., Silver Spring, MD 20993.
    In section 4205, Congress provided that registration must be 
renewed biannually (21 U.S.C. 343(q)(5)(H)(ix)(I)). Although 
``biannual'' is defined as occurring twice every year,

[[Page 19219]]

the word is also defined as occurring every other year. (Ref. 26). FDA 
tentatively concludes that registration every other year is a more 
reasonable interpretation of this requirement, because it does not seem 
warranted or necessary for a restaurant or similar retail food 
establishment to tell FDA every 6 months that the establishment wants 
to be subject to Federal jurisdiction. Thus, FDA is proposing in Sec.  
101.11(d)(5) that authorized officials must register every other year 
within 60 days prior to the expiration of the establishment's current 
registration with FDA, and the registration will automatically expire 
if not renewed.

E. Substantiation Documentation

    Covered establishments must provide nutrient content disclosures 
that are not false or misleading to comply with section 403(a)(1). 
Covered establishments also must have a reasonable basis for their 
nutrient content disclosures under section 403(q)(5)(H)(iv). It is 
clear under section 403 that covered establishments must substantiate 
the accuracy of their nutrient content disclosures and the fact that 
those disclosures have a reasonable basis. Under section 701(a), FDA 
has authority to issue regulations for the efficient enforcement of 
FD&C Act, including sections 403(a)(1) and 403(q)(5)(H)(iv).
    Without access to substantiation documentation for a covered 
establishment's nutrient content disclosures, FDA cannot efficiently 
determine whether a covered establishment's nutrient content 
disclosures are truthful and not misleading, as required by section 
403(a)(1) of the FD&C Act. Without access to substantiation 
documentation of the bases of nutrient content disclosures, the 
requirement that nutrient content disclosures have reasonable bases in 
particular would be unenforceable. Accordingly, FDA is proposing the 
substantiation requirements in Sec.  101.11(c)(2) as necessary for the 
efficient enforcement of the FD&C Act.

F. Conforming Amendments

    As a result of the amendments to the FD&C Act made by section 4205, 
conforming amendments must be made in part 101 of Title 21 of the CFR. 
Section 4205 amended section 403(q)(5)(A) of the FD&C Act, which 
provided, in part, that the nutrition labeling requirements in section 
403(q)(1)-(4) did not apply to food served in restaurants or other 
establishments in which food is served for immediate consumption or 
which is sold for sale or use in such establishments. It also did not 
apply to food which is processed and prepared primarily in a retail 
establishment, which is ready for human consumption, which is of the 
type described in subclause (i), 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. Based on 
this exemption, FDA promulgated regulations in Sec.  101.9(j) that 
exempt from nutrition labeling requirements these foods, so long as 
they do not bear nutrition claims or other nutrition information in any 
context on the label or in labeling or advertising. Section 101.10 
requires nutrition labeling for a restaurant food that bears a nutrient 
content or health claim, except that information on the nutrient 
amounts that are the basis for the claim may serve as the functional 
equivalent of complete nutrition information.
    With the new requirements of section 403(q)(5)(H) for standard menu 
items offered for sale in certain restaurants and similar retail food 
establishments, provisions in Sec.  101.9(j) need to be amended. In 
particular, covered establishments with annual gross sales made or 
business done in sales to consumers that is not more than $500,000 or 
with annual gross sales made or business done in sales of food to 
consumers of not more than $50,000 are now required to provide 
nutrition information under section 403(q)(5)(H). Thus, the exemption 
in Sec.  101.9(j)(1) needs to be amended to reflect that, in providing 
the nutrition information required under Sec.  101.11, a covered 
establishment would not become subject to Sec.  101.9. In addition, the 
exemptions from nutrition labeling in Sec.  101.9(j)(2) and (3) need to 
be revised to exclude standard menu items sold in covered 
establishments and reference the special labeling requirements for 
those foods in Sec.  101.11. Similarly, Sec.  101.10 needs to be 
amended to include the provision that for restaurant foods sold in 
covered establishments, the information required in the written 
nutrition information required by proposed Sec.  101.11(b)(2)(ii)(A) 
would meet the requirements of Sec.  101.10, when applicable. 
Therefore, FDA is proposing conforming amendments in Sec.  101.9(j) and 
Sec.  101.10.
    FDA is proposing to exempt electronic signatures submitted to 
satisfy the requirements of this proposed section from the requirement 
to comply with part 11--Electronic Records; Electronic Signatures (21 
CFR part 11) and proposing to amend part 11 to reflect this exemption. 
We expect this exemption to facilitate the registration process for 
those who voluntarily choose to register under section 
403(q)(5)(H)(ix).

G. Proposed Effective Date

    FDA received several comments regarding the effective date of the 
final rule that would issue based on this proposal. Many comments 
suggested that FDA provide one to two years before the effective date 
because covered establishments would need that much time to make the 
changes necessary to comply with the regulations. One comment requested 
an effective date of three years because this timeframe was needed to 
defray the costs of new menu boards. Others suggested that six months 
was a reasonable timeframe.
    FDA is proposing that the final rule become effective six months 
from the date of its publication. Compliance is expected to yield 
significant public health benefits because consumers will have calorie 
and other nutrition information when they make menu choices. Because of 
this benefit, the agency finds that it is reasonable to make the 
requirements effective as soon as practicable. Based on the comments 
and on what covered establishments will need to do to come into 
compliance, the agency tentatively finds that making the final rule 
effective six months after publication is practicable. FDA recognizes, 
however, the potential difficulties of implementing the rule in this 
timeframe, and we request comment on whether the effective date should 
be extended for a greater period of time after the publication of the 
final rule. We request comment on whether a nine-month or one-year 
implementation timeframe would be more appropriate.

H. Compliance

    As discussed in section II of this document, FDA is proposing these 
regulations under sections 201(n), 403(a), 403(q), as amended by 
section 4205 of the Patient Protection and Affordable Care Act of 2010, 
and 701(a) of the FD&C Act. Failure to comply with the regulations, if 
adopted by the agency, will render the food misbranded under sections 
201(n), 403(a), or 403(q) of the FD&C Act. Introducing, delivering for 
introduction, or receiving a misbranded food in interstate commerce, or 
misbranding a food while it is in interstate commerce or being held for 
sale after shipment in interstate commerce, are prohibited acts under 
section 301 of the FD&C Act and subject to enforcement action.

[[Page 19220]]

    FDA addressed the issue of enforcement of section 4205 in a draft 
guidance entitled, ``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.'' The 
agency announced the availability of the draft guidance in the Federal 
Register on August 25, 2010 (75 FR 52426). In that draft guidance, FDA 
stated that it expected to refrain from enforcing the provisions of 
section 4205 that became requirements immediately upon enactment of the 
law until a date that it would specify in final guidance. Based on 
extensive comments on the draft guidance, however, FDA decided to 
withdraw the draft guidance and to exercise enforcement discretion 
until after it had completed notice and comment rulemaking (76 FR 4360 
(January 25, 2011)).
    FDA seeks comment on how we should implement these regulations. In 
particular, we seek comment, supported by data, concerning how much 
time is needed for covered establishments to come into compliance with 
the final rule, including, if possible, data on whether specific 
provisions of the rule can be more quickly implemented than others (see 
section V.E., below). We seek comment on whether we should provide for 
staggered implementation based on the size of a chain or of a specific 
franchisee. Again, any suggestions should be supported by data. 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.

IV. Summary of Preliminary Regulatory Impact Analysis

    The summary analysis of benefits and costs included in this 
document is drawn from the detailed Preliminary Regulatory Impact 
Analysis (PRIA) that is available at http://www.regulations.gov, Docket 
No. FDA-2011-F-0172, and is also available on FDA's Web site at http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm.

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive 
Orders 12866 and 13563, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 
Executive Orders 13563 and 12866 direct agencies to assess all costs 
and benefits (both quantitative and qualitative) of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety effects, distributive 
impacts, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. This rule has been 
designated an ``economically'' significant rule, under section 3(f)(1) 
of Executive Order 12866. Accordingly, the rule has been reviewed by 
the Office of Management and Budget.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Using the Small Business Administration (SBA) 
definitions of small for industrial subsectors in accommodations, food 
service, recreation, and retail food stores (NAICS 72, 71, 445), FDA 
tentatively concludes that a significant number of firms affected by 
this proposed rule are small businesses.
    Section 4205 of the Affordable Care Act and the proposed 
requirements apply to chain retail food establishments, as that term is 
used in this document (i.e., 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 for sale substantially the same menu 
items), and establishments that voluntarily register with FDA to become 
subject to the requirements of section 4205. Some chain retail food 
establishments may meet the SBA definitions of: Less than $7 million in 
annual sales for most accommodation and food service or recreation 
subsectors (NAICS 72, 71); less than $20.5 million in annual sales for 
Food Service Contractors (NAICS 722310); or less than $27 million in 
annual sales for supermarkets and convenience store chains (NAICS 44510 
and 445120). In addition, some chain retail food establishments are 
owned or operated by entities, including franchisees or cooperative 
members that may meet the SBA definitions described above.
    Establishments that voluntarily register to be subject to the 
Federal requirements, which may be individually owned or part of a firm 
that controls establishments within a chain of less than 20 locations, 
may meet the SBA definition described above. While the voluntary nature 
of the registration implies that these latter firms see a positive net 
benefit from becoming subject to the Federal requirements, this does 
constitute a potentially significant economic impact. Therefore, the 
agency tentatively concludes that the rule will have a significant 
economic impact on a substantial number of small entities. This 
tentative conclusion is discussed further in section V.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $135 million, using the most current (2009) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects this 
proposed rule to result in 1-year expenditures that would meet or 
exceed this amount. This tentative conclusion is discussed further in 
section VI.
    FDA asks for comments about the data and the methods used for 
estimating the regulatory impact of the proposed rule.

B. Need for This Regulation

    This proposed rule is necessary to implement Section 4205 of the 
Affordable Care Act, which amends sections 403(q)(5) and 403A of the 
FFDCA, and requires disclosure of calorie and other nutrition 
information by covered establishments. These nutrition labeling 
requirements should help consumers to make more informed choices about 
the nutritional content of the food they purchase. The provision of 
calorie and other nutrition information for restaurant and restaurant-
type foods, as those terms are used in this document, offered for sale 
by covered establishments should help consumers limit excess calorie 
intake and understand how the foods that they purchase at these 
establishments fit within their daily caloric and other nutritional 
needs. FDA notes as well that Executive Order 13563 specifically 
directs agencies to ``identify and consider regulatory approaches that 
reduce burdens and maintain flexibility and freedom of choice for the 
public. These approaches include * * * disclosure requirements as well 
as provision of information to the public in a form that is clear and 
intelligible.''
    Economic justifications for regulatory interventions in private 
markets rely on the presence of some market failure. In the case of 
restaurant and restaurant-type foods, the private market is 
particularly robust and competitive. Hundreds of thousands of retail 
food establishments and tens of thousands of

[[Page 19221]]

individual firms vie for consumer dollars across the United States. 
High estimates of failure rates for restaurants (Ref. 27), with 
relatively steady growth rates in number of establishments (Ref. 28) 
indicate that entry in the industry occurs often, and survival is hard 
fought: Restaurants must be responsive to consumer needs and desires in 
order to survive. The competitiveness of the industry suggests that if 
a sizable fraction of consumers were willing to pay for--and 
discriminate based on--the availability of nutrition information, then 
the industry would provide it to them. In fact, many retail food 
establishments do provide nutrition information for at least a fraction 
of their offerings, either through available brochures, or, 
increasingly, on the Internet. A 2006 study found that 34 percent of 
the top 300 chain restaurants (by sales volume) had nutrition 
information available to consumers in some form (Ref. 29).
    Notwithstanding this point, and although many of the usual market 
failures that justify regulatory action, such as the existence of 
market power or public goods, cannot be found here (Refs. 30 and 31), 
the primary support for government intervention is an absence of 
sufficient nutritional information, produced by an inadequate incentive 
for restaurants to produce that information on their own. An absence of 
adequate information is of course a standard market failure, justifying 
disclosure requirements or provision of information in many contexts.
    In terms of explaining the inadequate incentive for restaurants to 
provide sufficient nutrition information, a central reason involves 
consumer demand. There are systematic biases in how consumers weigh 
current or immediate benefits (from eating more, or higher calorie, 
foods) against future or long-term costs (higher probability of obesity 
and its co-morbidities). These biases are directly related to the 
proposed requirements: The temporal disconnect inherent between food 
consumption choices and their potential health costs may work against 
an efficient provision of nutrition information for food (Ref. 32). A 
primary issue here is that long-term risks may not be sufficiently 
salient to produce adequate consumer demand for relevant information 
disclosure. Without that information, consumers may fail to make 
informed choices and may undervalue the future costs of excessive 
calorie consumption, relative to the current benefits from such 
consumption (Refs. 29, 33 and 34).
    Studies suggest that one problem involves the fact that because 
food decisions are made so often, and the marginal effect of any one 
meal on future obesity is small, the cumulative costs of a large number 
of relevant decisions may be neglected. These studies suggest that some 
or many consumers will not demand calorie information, because the 
issue of calories often lacks salience, or relevance, for consumers at 
the time of purchase and consumption, even though they may experience 
regret about their decisions at a latter date. This tendency may 
explain why consumers have not generally demanded calorie and other 
nutrition information for restaurant and restaurant-type food, although 
they do, at a later point in time, value that information. Furthermore, 
restaurants and similar retail establishments face costs in providing 
calorie and other nutrition information, including opportunity costs of 
limited time and space in which to convey information to the consumer. 
That is, just as a firm has to decide which possible menu items to 
leave off a menu board with limited space (thus giving up the 
opportunity to sell those items), it must choose which pieces of 
information about its menu items it wants to convey. Adding an 
additional piece of information means that a firm may need to downplay 
or remove some other valuable piece of information. In addition, 
providing calorie information may have complex and unintended effects 
on revenue and profits as consumers respond to that information. Given 
the costs and the uncertain reception of displayed calorie information 
most restaurants have chosen not to display this information at the 
point of purchase.
    The proposed requirements respond to the apparent market failure in 
information provision stemming from existing restaurant incentives and 
present-biased preferences. Specifically, the proposed requirements 
provide that calorie information for standard menu items must be posted 
in covered establishments. Providing this nutrition information will 
likely increase the salience of the information and promote informed 
choice as well. It will also likely raise consumer awareness regarding 
the number of calories in restaurant and restaurant-type foods, and 
thus may serve to highlight the potential future costs of additional 
calorie consumption. This increased attention to the number of calories 
in food offered for sale by covered establishments may then result in 
an increased availability of lower calorie options, and an increased 
demand for these options.

C. Summary of Costs and Benefits of the Proposed Requirements and 
Regulatory Options

    In this section FDA describes the bases of benefits and costs of 
the proposed requirements and summarizes the results of the detailed 
PRIA.
    Benefits in response to the proposed requirements. Obesity and 
overweight are major public health concerns in the United States and 
among the top leading health indicators addressed by the United States 
Healthy People 2020 goals. Nationally representative data have 
consistently exhibited a steady increase in the prevalence of obesity 
over the past three decades (Ref. 35). As noted in section I.A., 34 
percent of the adult U.S. population is obese and 34 percent is 
overweight (Ref. 1). In addition, about 31 percent of children and 
adolescents, aged 2 to 19, are overweight or obese (Ref. 8).
    Excess body weight has many health (Ref. 36), social (Refs. 37 and 
38), psychological (Refs. 39 and 40), and economic consequences (Ref. 
41) for the affected individuals. Lower life expectancy, elevated risk 
of diabetes, hypertension, stroke and other cardiovascular disease has 
been documented to rise simultaneously with the increased prevalence of 
obesity (Ref. 36). The economic impact is especially evident for 
health-care costs in terms of greater health-care utilization and 
higher medical expenditures (Ref. 42). More specifically, as noted, 
medical expenditures attributable to overweight and obesity accounted 
for more than 9 percent of the total U.S. medical expenditures in 1998, 
or between $86 billion, and $147 billion (Ref. 42). Another estimate 
indicates that obesity costs American families, businesses and 
government approximately $117 billion in 2010 (Ref. 43).
    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).
    One contributor out of the complex and multi-facet set of factors 
is food offered for sale by restaurants and similar retail food 
establishments. The proportion of total food expenditure spent on such 
foods increased from 34 percent during the 1970s up to approximately 50 
percent by 2004, where it has remained through 2009 (Ref. 44). These 
foods are generally high in calories, fat and portion size (Ref. 45),

[[Page 19222]]

and they tend to be lower in fiber and other essential nutrients such 
as calcium as compared to home-prepared foods (Ref. 10).
    Restaurant food and restaurant-type food form a significant and 
increasing part of U.S. diets. According to one study, ``food away from 
home'' (this term is roughly comparable to restaurant and restaurant-
type foods) constituted about a third of calories consumed annually by 
the average adult or child in the United States in the most recent 
comprehensive published study (Ref. 10). Another study of adults found 
that ``food away from home'' adds an additional 130 calories per meal, 
on average, relative to a similar meal prepared at home (Ref. 46). The 
difference in calorie consumption between ``food away from home'' and 
food prepared at home was greater for study participants who were 
overweight or obese; among those individuals, the away-from-home meals 
had 240 more calories per meal relative to meals prepared at home (Ref. 
46).
    Although many factors contribute to obesity, to the extent that the 
proposed requirements would mitigate the prevalence of obesity and of 
co-morbidities, society would gain the opportunity cost of the averted 
medical expenditures and an increase in productivity from averted 
debilitation and death. In addition to informing consumers about the 
calorie content for restaurant and restaurant-type foods offered for 
sale by covered food establishments, major predicted elements of the 
consumer and industry response to this proposed rule may include:
    1. Increased awareness regarding the caloric content for foods 
offered for sale by covered establishments, which may help reduce the 
present-bias in preferences, and thus encourage the consumption of 
lower calorie options.
    2. Increased consumer interest in lower calorie options, and 
greater transparency regarding calorie content of menu items, which may 
give firms an incentive to:
    a. Reduce the calorie content of existing items through 
reformulation or by decreasing portion size.
    b. Provide additional items with lower calorie formulations.
    These changes may reduce consumers' caloric intake from foods sold 
in covered establishments, and this reduction in caloric intake may in 
turn contribute to a reduction in obesity in the U.S. population. Note 
that any reduction in calorie intake in these settings may be at least 
partially offset by increases in calorie intake during other meals or 
snacks. This substitution of one calorie source for another has been 
demonstrated in the context of menu labeling (Ref. 47) and in the 
context of other attempts to modify food choices (Ref. 48). Because FDA 
lacks data on how consumers will substitute between caloric sources, as 
well as specific information on the responsiveness of calorie demand to 
new information, the benefit estimations given here may be higher or 
lower than those that will be realized if the rule is finalized as 
proposed. Finally, there may be additional benefits to the extent that 
consumers use the written nutrition information to make food 
selections.
    Industry and consumer costs in response to the proposed 
requirements. Meeting the proposed requirements will have costs for 
both the industry and consumers. Typically, new costs to an industry 
are borne by both consumers and firms: Prices rise to reflect new 
costs, but generally not by enough to completely offset them. If the 
expense of meeting the proposed requirements cause prices to increase 
for some or all restaurant and restaurant-type foods offered for sale 
by covered establishments, then the consumption of these foods will 
fall, further reducing profits for some, or all, of these 
establishments. Consumers would need to pay more for this food, 
requiring some reduction in other, valued, consumption.
    One difficulty in determining the cost burden stems from the 
relatively complicated ownership structures in some of the covered 
sectors. Restaurants and similar retail food establishments can be 
corporate-owned, franchised as part of a large or small independent 
chain, or cooperatively-organized and doing business under the same 
name. Data for separate firms operating under the same name, such as 
franchises of a particular brand or corporate name, are difficult or 
impossible to acquire. Therefore, for this analysis FDA counts affected 
establishments and chains, which may in fact serve one, several, or 
many, underlying firms. Except for some potential costs of nutrition 
analysis, the costs of the proposed rule are analyzed at either the 
chain or the establishment level, so that the overall costs are not 
primarily a function of the actual number of firms affected.
    The major elements of cost for this proposed rule are:
    1. Collecting and managing records of nutritional analysis for each 
standard menu item.
    2. Revising or replacing existing menus, menu boards and other 
affected displays.
    3. Training employees to understand nutrition information in order 
to help ensure compliance with the proposed requirements.
    Although not required by the proposed requirements, some chains or 
establishments may respond to increased consumer interest on caloric 
content of restaurant and restaurant-type food by reformulating 
existing menu items or by introducing new, lower calorie items. While 
the costs associated with formulating these items have not been 
included in the cost estimation, FDA has included the cost associated 
with analyzing new or reformulated items. Because the rate at which 
these items are introduced may be affected by the propose requirements, 
FDA requests comment and data on whether the proposed requirements will 
accelerate the rate of new item introduction and how the cost of these 
items may be affected by the proposed requirements.
    Finally, because they are not required by the proposal, FDA has not 
included any costs associated with developing online or other 
electronic calorie calculators for variable menu items. FDA requests 
comment and data on the costs of these kinds of calorie tools.
    Summary of benefits and costs. We summarize the estimated costs and 
benefits of the proposed requirements and some regulatory options in 
Tables 5a-5b. The full analysis is provided in the detailed PRIA. Costs 
of complying with the proposed requirements have been estimated for 
three major areas: Cost of nutrition analysis, cost of menu and menu 
board replacement, and costs of training. These costs have been 
aggregated across an estimate of the total number of chains and 
establishments that would be defined as covered under the proposed 
rule. In the case of the proposed rule, FDA estimates that there would 
be approximately 278,600 covered establishments organized under 1,640 
chains. The initial mean estimated cost of complying with the proposed 
requirements is $315.1 million, with an estimated mean ongoing cost of 
$44.2 million. Annualized over 10 years, the mean estimated annual cost 
of the proposed requirements is $76.8 million at a 3 percent discount 
rate, and $82.3 million at a 7 percent discount rate. FDA has estimated 
low and high annualized cost estimates for the proposed requirements of 
$33.4 million and $120.5 million with a 3 percent discount rate, and 
$34.9 million and $130.1 million with a 7 percent discount rate. The 
bases for this wide range of cost estimates and the main drivers of 
this uncertainty are collected and discussed in the detailed PRIA.
    Initial costs are estimated to be $1,100 per covered establishment. 
Note

[[Page 19223]]

however, that this figure combines the average per establishment cost 
of $1,800 per limited service eating establishments--i.e., those most 
likely to have more than one menu board or major display serving as a 
menu--with full service restaurants averaging less than $1,000 per 
establishment. These averages do not show the very wide range of costs 
that individual establishments and chains will bear, based on their 
very different approaches to nutrition analysis, menu design and 
overall market niche.
    FDA has not estimated the actual benefits associated with proposed 
requirements. Food choice and consumption decisions are complex, and 
FDA is unaware of any comprehensive data allowing accurate predictions 
of the effect of the proposed requirements on consumer choice and 
establishment menus. Therefore, FDA has constructed a plausible 
individual effect of the proposed rule, and has conducted a break-even 
analysis in order to determine the proportion of the U.S. obese adult 
population that would need to attain this minimal response in order for 
the proposed requirement to yield a positive net benefit. Using a 100 
calorie per week reduction in intake as the benchmark effect, FDA 
estimates that at least 0.06 percent of the adult obese population 
would need to reach at least this benchmark in order for the rule to 
break even on the primary, or mean annualized cost.

   Table 5a--Accounting Statement: Annualized Cost and Break-Even Benefit Point for the Proposed Requirements
----------------------------------------------------------------------------------------------------------------
                                      Primary        Low          High         Year       Discount      Period
                                      estimate     estimate     estimate      dollar        rate       covered
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($millions/
 year)............................                                 Not quantified
-----------------------------------
Annualized Quantified:
----------------------------------------------------------------------------------------------------------------
Qualitative: FDA estimates that at least 0.06 percent of the adult obese population would need to reduce caloric
 intake by at least 100 calories per week in order for benefits from the proposed requirements to reach a break
 even point on annualized costs (at either 3% or 7%).
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($millions/          $82.3        $34.9       $130.1         2009           7%           10
 year)............................         76.8         33.4        120.5         2009           3%           10
----------------------------------------------------------------------------------------------------------------

    Regulatory Options. In addition to a baseline, FDA has identified 
five regulatory options for this proposed rule as required by Executive 
Order 12866. The estimated benefits and costs of these options relative 
to the proposed rule are given in Table 5b.
    (0) Baseline for the purpose of analysis--No new Federal regulatory 
action.
    (1) Option 1, the proposed rule, the definition of ``restaurants or 
similar retail food establishments,'' limited to retail establishments 
that offer for sale restaurant or restaurant type food where the sale 
of food is the primary business activity of that establishment. This 
option encompasses limited- and full-service restaurants, snack bars 
(including coffee shops, pastry shops, sandwich counters and similar 
establishments), cafeterias, drinking places, convenience stores and 
grocery stores that are chain retail food establishments as defined in 
this proposed rule. The proposed rule has an effective date of six 
months after the publication of the final rule.
    (2) Option 2, with requirements similar to the proposed rule, but 
with ``restaurant or similar retail food establishment'' limited to 
retail establishments where the sale of restaurant food or restaurant-
type food is the primary business activity. This option covers all 
establishments included in Option 1, with the exception that grocery 
and convenience stores would not be subject to the proposed 
requirements.
    (3) Option 3, with requirements similar to the proposed rule, but 
with scope broadened to include a wide variety of establishments that 
serve restaurant or restaurant-type food.
    (4) Option 4, with requirements similar to the proposed rule, but 
with an effective date starting three months after publication of the 
final rule instead of six months after publication of the final rule.
    (5) Option 5, with requirements similar to the proposed rule, but 
with an effective date starting 12 months after publication of the 
final rule instead of six months after publication of the final rule.

                                       Table 5b--Summary of Estimated Annualized Compliance Costs for Each Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Proportional
                                                                                                                    Proportional cost   dollar sales of
                                                            Primary        Low          High     Percent  discount     relative to      restaurant food
                   Summary of options                       estimate     estimate     estimate     rate  (10 year    primary estimate     relative to
                                                              (in          (in          (in           horizon)       of the proposed    primary estimate
                                                           millions)    millions)    millions)                         requirements     of the proposed
                                                                                                                                          requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Baseline)..............................................          N/A          N/A          N/A                N/A                N/A  .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 1: The Proposed Rule.............................        $76.8        $33.4       $120.5                 3%               0.0%               0.0%
                                                                 82.3         34.9        130.1                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 2: Smaller Scope.................................         65.9         29.1        103.2                 3%             -12.5%              -5.0%
                                                                 72.5         31.6        113.8                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 19224]]

 
Option 3: Larger Scope..................................         86.9         38.2        135.5                 3%             +13.3%             +11.2%
                                                                 92.9         39.9        145.8                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 4: Shorter Compliance Time.......................         84.2         35.8        132.4                 3%              +9.4%               0.0%
                                                                 91.0         37.8        144.0                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 5: Longer Compliance Time........................         76.2         31.9        120.5                 3%              -2.4%               0.0%
                                                                 81.6         33.2        130.1                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA estimates that Option 2, which limits the scope of the proposed 
requirements to establishments that either present themselves as 
restaurants or have more than 50 percent of their floor area used for 
restaurant or restaurant-type food, has a ten-year annualized cost of 
between $29.1 million per year and $103.2 million per year with a 3 
percent discount rate, with a primary estimate of $65.9 million. 
Averaged over primary, low and high estimates, the costs of Option 2 
are 12.5 percent lower than those of the proposed requirements. 
Although FDA does not have adequate data on the proportion of calories 
consumed at different types of establishments, as a rough estimate of 
the coverage of Option 2 relative to the proposed requirements, we use 
the proportion of dollar sales of restaurant or restaurant type food 
relative to the establishments covered by the proposed rule. In the 
case of Option 2, limiting the scope of covered establishments would 
reduce the coverage of restaurant or restaurant-type food sales by 5.0 
percent. These changes are discussed more fully in the detailed 
analysis.
    Option 3 which considers a wider set of establishments that service 
restaurant or restaurant-type foods, including lodging, transport, 
entertainment, general retail and other establishments, has costs that 
are 13.3 percent higher than those of the proposed requirements and 
coverage of sales that is 11.2 percent higher. Option 4, which shortens 
the compliance time to 3 months, has costs that are 9.4 percent higher 
than the proposed, and Option 5, which lengthens compliance time to 12 
months has costs that are estimated to be 2.4 percent lower. These 
options do not change the set of covered establishments relative to the 
proposed rule.
    Finally, although registration by firms wishing to register with 
FDA in order to come under the proposed requirements and the associated 
preemption from State or local regulations is voluntary, and is only 
likely to occur to the extent that the costs of registration and 
compliance with Federal regulation is lower than that of State or local 
regulation, this registration constitutes a collection of information 
under the Paperwork Reduction Act of 1995. Therefore, FDA has also 
estimated the burden associated with this collection of information in 
section VII of this document. For full documentation and discussion of 
these estimated costs and benefits see the detailed PRIA, available at 
http://www.regulations.gov, enter Docket No. FDA-2011-F-0172.

V. Initial Regulatory Flexibility Analysis

    FDA has examined the economic implications of this proposed rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities consistent with statutory objectives. FDA tentatively 
concludes that this proposed rule will have a significant economic 
impact on a substantial number of small entities. Although chains with 
20 or more establishments will generally have total sales in excess of 
SBA's small business limits, many of these establishments are actually 
operated by franchisees, independent operators licensing a chain store 
brand, or some other types of small business. The majority of the costs 
of the proposed rule will be borne at the establishment level, in 
particular, the cost of new menus and of employee training. Because of 
this, many of these small businesses will be directly responsible for 
meeting of the costs of compliance.
    FDA has built substantial flexibility into the proposed rule. The 
wide range in cost estimates given in Section IV. of this document is a 
function of the variety of approaches that business may choose to take 
to comply with the proposed requirements. The proposed rule does not 
prescribe the method or materials used to disclose calorie information 
or other nutrition information, beyond format and style requirements. 
In addition, the proposed rule does not require any employee training, 
and it allows for a variety of approaches for nutritional analysis. 
Therefore, businesses may choose among a wide variety of less, or more, 
expensive avenues for compliance depending on their situation.
    Controllers of chain level brands have significant latitude to 
impose lesser or greater costs on their associated establishments. 
Examples include the extent to which franchisors may impose more 
expensive menu board designs on franchisees, or the extent to which 
franchisors impose training requirements. Because the proposed rule 
provides flexibility for the disclosure of nutrition information in 
covered establishments, the proposed rule gives small businesses (and 
gives owners of chain brands) the leeway to select cheaper methods to 
meet the proposed requirements, such as the use of stickers or menu 
strips, or more expensive methods, such as menu redesign or 
replacement.
    Tying additional flexibility to the size of the firm could mean 
greater confusion for customers and competitors, because individual 
establishments within very large chains might differ in how or when 
they disclosed calories. Tying additional flexibility to the size of 
the chain would mean that some small firms in large chains would have 
less flexibility, and potentially higher costs, than large firms in 
small chains. Rather than attempt to

[[Page 19225]]

make a division between large and small firms, FDA has attempted to 
build in substantial flexibility for all firms.
    Finally, section 4205 allows restaurants and similar retail food 
establishments that are not subject to the proposed requirements to 
voluntarily register with FDA to become subject to the requirements. By 
voluntarily registering, such an establishment is in effect indicating 
that the burdens of registering, which include reporting to FDA contact 
information for the authorized official and the establishment, and 
being subject to the Federal requirements, is outweighed by the 
benefits.

VI. Unfunded Mandates

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $135 million, using the most current (2009) Implicit 
Price Deflator for the Gross Domestic Product. FDA has determined that 
this proposed rule has met the threshold under the Unfunded Mandates 
Reform Act. FDA has carried out the cost-benefit analysis in the 
detailed PRIA, available at http://www.regulations.gov, enter Docket 
No. FDA-2011-F-0172. The other requirements under the Unfunded Mandates 
Act of 1995 include assessing the proposed rule's effects on:
    <bullet> Future costs;
    <bullet> Particular regions, communities, or industrial sectors;
    <bullet> National productivity;
    <bullet> Economic growth;
    <bullet> Full employment;
    <bullet> Job creation; and
    <bullet> Exports.
    Note that because restaurant and restaurant-type foods are goods 
that by definition are not transported over long distances, 
international or interstate trade issues are not relevant here: the 
imposition of regulatory costs will not cause firms to shift production 
to locations that are not chain retail food establishments as the term 
is used in this document. Furthermore, because the costs of the 
proposed rule are low relative to the revenue generated by even the 
smallest chain retail food establishments, the proposed rule will not 
significantly affect employment, economic growth or national 
productivity.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the 
PRA). A description of these provisions is given below with an estimate 
of the annual reporting, recordkeeping, and third party disclosure 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Requirements for Nutrition Labeling for Standard Menu Items in 
Restaurants and Similar Retail Food Establishments (OMB Control Nos. 
0910-0664 and 0910-0665)--Revision--Section 4205 of the Affordable Care 
Act, which amends sections 403(q)(5) and 403A of the FD&C Act, requires 
disclosure of calorie and other nutrition information by chain retail 
food establishments, as that term is used in this proposed rule. In 
particular, a restaurant or similar retail food establishment with 20 
or more locations doing business under the same name and offering for 
sale substantially the same menu items must provide nutrition 
information for standard menu items. Section 4205 became effective on 
the date the law was signed, March 23, 2010. A restaurant or similar 
retail food establishment that is not subject to the requirements of 
section 403(q)(5)(H) may elect to become subject to the requirements of 
section 403(q)(5)(H) by registering biannually with FDA. Section 4205 
required FDA to publish a notice in the Federal Register within 120 
days of the date of enactment of the legislation, providing information 
on the terms and conditions for persons who voluntarily elect to be 
subject to nutrition disclosure requirements specified in the 
legislation.

A. Statutory Compliance

    To comply with the PRA and with the statutory deadline under the 
provisions of section 4205 for publication of registration information, 
FDA initially obtained a 6-month OMB approval of the collection of 
information requirements under the emergency processing provisions of 
the PRA. With OMB approval of the collection of information 
requirements of section 4205, FDA took several actions: (1) Developed 
an electronic form, ``Menu And Vending Machine Labeling Voluntary 
Registration,'' Form FDA 3757, (2) as required by section 4205, 
published a notice in the Federal Register of July 23, 2010 (75 FR 
43182) (the July 23, 2010, notice) to explain how retail food 
establishments and vending machine operators not otherwise subject to 
the provisions of section 4205 may voluntarily elect to become subject 
to them, and (3) developed and implemented the guidance entitled, 
``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.'' This 
guidance among other things clarified section 4205's effect on State 
and local menu and vending machine labeling laws, to ensure that 
industry and State and local government understood the immediate 
effects of the law.
    FDA has requested a 3-year approval of the information collection 
requirements under the same assigned OMB Control Nos. 0910-0664 and 
0910-0665. In the Federal Register of January 31, 2011, FDA published 
two notices announcing the submission to OMB of the information 
collection requests for No. 0910-0664 (76 FR 5384) and No. 0910-0665 
(76 FR 5380). As noted, the information collection requests previously 
submitted sought OMB approval of the reporting, recordkeeping, and 
third party disclosure burdens of section 4205, not the provisions of 
this proposed rule. With this proposed rule, FDA is submitting a 
revised information collection request seeking OMB approval of the 
changes caused by the proposed rule.

B. Revision of OMB Control Nos. 0910-0664 and 0910-0665 by the Proposed 
Rule

    This proposed rule provides detail on how chain retail food 
establishments can comply with section 403(q)(5)(H)

[[Page 19226]]

and how restaurant or similar retail food establishments not subject to 
the requirements of section 403(q)(5)(H) can voluntarily register to 
become subject to the requirements. Certain provisions of the proposed 
rule revise the information collection requirements that have been 
approved by OMB under OMB Control Nos. 0910-0664 and 0910-0665. First, 
proposed Sec.  101.11(b) would require third party disclosure to 
consumers of nutrition information by chain retail food establishments. 
Second, proposed Sec.  101.11(d)(3) would require reporting of 
information by restaurants and similar retail food establishments that 
voluntarily register to become subject to the requirements of section 
403(q)(5)(H). In addition, proposed Sec.  101.11(c)(6) would require 
covered establishments to provide certain information to FDA to 
substantiate the nutrition information provided to consumers. The 
following analysis provides FDA's estimate of the changes caused by the 
proposed rule to the previously approved annual reporting, 
recordkeeping, and third party disclosure burdens.

C. Consolidation of OMB Control No. 0910-0664 Under 0910-0665

    This is a revision request in which the burden hours for the 
information collection request under OMB control number 0910-0664, 
``Restaurant Menu and Vending Machine Labeling: Registration for Small 
Chains Under Section 4205 of the Patient Protection and Affordable Care 
Act of 2010'' are being consolidated under the information collection 
request assigned OMB control number 0910-0665, ``Restaurant Menu and 
Vending Machine Labeling: Recordkeeping and Mandatory Third Party 
Disclosure Under Section 4205 of the Patient Protection and Affordable 
Care Act of 2010.'' In addition, these information collection requests 
will be further revised by the proposal related to calorie declaration 
for food sold in vending machines that will be separately published in 
the Federal Register. The revised information collection request for 
0910-0665 will be renamed ``Restaurant Menu and Vending Machine 
Labeling: Registration, Recordkeeping and Mandatory Third Party 
Disclosure Under Section 4205 of the Patient Protection and Affordable 
Care Act of 2010.''

D. Analysis of Changes in Burden Estimates Caused by the Proposed Rule

    The analysis of burden included in this document is drawn from the 
detailed PRIA that is available at http://www.regulations.gov, enter 
Docket No. FDA-2011-F, and is also available on FDA's Web site at 
http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm.
    Description of Respondents: The likely respondents to this 
information collection are covered restaurants and similar retail food 
establishments, including restaurants and similar retail food 
establishments not subject to section 4205 that voluntarily register. 
In this analysis, we use the term ``restaurant'' to refer to the subset 
of restaurants and similar retail food establishments, as defined in 
this document, that self-identify as establishments whose primary 
business activity is the sale of ``meals and beverages for immediate 
consumption'' in economic census surveys.
    FDA estimates the burden of this collection of information as 
follows:

                       Table 6--Estimated Annual Recordkeeping Burden: Nutrition Analysis and Recording for Proposed 101.11(c)(6)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                 Average
                                                                   Number of       Number of       Total       burden per
                      Type of respondent                         recordkeepers    records per      annual     recordkeeping  Total hours   Capital costs
                                                                                 recordkeeper     records      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Restaurant Chains.............................................             514              80       41,088               4      164,352     $11,381,376
Restaurant Firms..............................................          11,560               5       57,800               4      231,200      16,010,600
Grocery and Convenience Store Chains..........................             570              40       22,800               4       91,200       6,315,600
Grocery and Convenience Store Firms...........................           2,350               5       11,750               4       47,000       3,254,750
                                                               -----------------------------------------------------------------------------------------
    Total initial hours.......................................  ..............  ..............  ...........  ..............      533,752      42,226,212
New/Reformulated items........................................           1,640              12       19,680               4       78,720       5,451,360
New chains....................................................              30              80         2400               4        9,600        $664,800
                                                               -----------------------------------------------------------------------------------------
    Total recurring hours.....................................  ..............  ..............  ...........  ..............       88,320       6,116,160
                                                               -----------------------------------------------------------------------------------------
    Total burden hours........................................  ..............  ..............  ...........  ..............      622,072  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

Recordkeeping
    The time burden for nutrition analysis on restaurants and similar 
retail food establishments is the time necessary for creating a record, 
managing the contracts for analysis, and communicating the results of 
the analysis to the establishments. FDA estimates the hourly burden per 
record to be 4 hours. Under the proposed requirements, FDA estimates 
that approximately 514 restaurant chains will be required to acquire 
new calorie and other nutrition information. On average, we estimate 
that a chain retail food establishment has 80 items on its menu. The 
hourly burden for restaurant chains is 164,352 hours (514 chains x 80 
items/chain x 4 hours/item). FDA estimates that an average of 11,560 
firms that are part of the restaurant chains may need to acquire 
nutrition analysis for 5 items that are specific to their 
establishments. The burden for these restaurant firms is 231,200 hours 
(11,560 firms x 5 items/firm x 4 hours/item).
    FDA estimates that there are 570 covered grocery and convenience 
store chains with an average of 40 standard menu items per chain. The 
hourly burden for grocery store chains is 91,200 hours ( =570 chains x 
40 items/chain x 4 hours/item). FDA estimates that an average of 2,350 
firms that are part of the grocery or convenience store chains may need 
to acquire nutrition analysis for 5 items that are specific to their 
establishments. The burden for these restaurant firms is 47,000 hours 
(2,350 firms x 5 items/firm x 4 hours/item).
    FDA has estimated that each of the 1,640 chains with chain retail 
food establishments will introduce new items or reformulate existing 
items on average 12 times per year. The recurring hourly burden of 
recordkeeping for new items

[[Page 19227]]

is 78,720 hours (1,640 chains x 12 items/chain x 4 hours/item).
    FDA estimated that 30 new chains will have chain retail food 
establishments as defined by the proposed rule each year. With an 
average number of menu items of 80 per chain, this would result in 
approximately 9,600 hours (30 chains x 80 items/chain x 4 hours/item). 
Adding the burden from new items to this amount gives a total recurring 
burden of 88,320 hours for recording nutrition information by chains 
associated with restaurants or similar retail food establishments. 
These hourly burdens are given in Table 6.
    The final column of Table 6 gives the estimated capital costs 
associated with calorie and nutrition analysis. These are the costs of 
acquiring nutrition analyses. FDA has estimated that the average cost 
of a full analysis is $277 per menu item. These costs are calculated by 
multiplying this per item cost by the number of items in column 3 
multiplied by the number of recordkeepers in column 2.
    The current total recordkeeping burden for menu labeling as 
required by section 4205, now under review at OMB under No. 0910-0665, 
is 455,304 hours. The estimated recordkeeping burden under the proposed 
rule is 622,072 hours, an increase of 166,768 hours. This increase is 
due to a net increase in the estimated number of respondents.
    The proposed rule caused several changes in our previous estimates 
of the recordkeeping burden. Most significantly, the proposed 
requirements are not extended to a variety of other establishments 
selling restaurant or restaurant-type foods that do not have as their 
primary purpose the sale of food. This change decreased the estimated 
burden by eliminating 67,200 hours previously estimated for other 
chains, and 24,000 hours previously estimated for vending operators 
(recordkeeping burden hours for vending operators are estimated in the 
separately published proposal related to calorie declaration for food 
sold in vending machines). In Line 1 of Table 6, total restaurant chain 
hours have changed from 241,488 hours to 164,352 hours, a decrease of 
77,136 hours, because our estimate of the number of chains has declined 
by 2, from 516 to 514, due to improved data on how these sectors are 
organized and because our estimate of the number of standard menu items 
per recordkeeper has declined from 117 to 80 due to the exclusion of 
alcoholic beverages from the requirements of the proposed rule. Lines 2 
and 4 of Table 6, reflects the addition of 11,560 restaurant firms and 
2,350 grocery or convenience firms that may need to acquire nutrition 
analysis for 5 items that are specific to their establishments. The 
additional burden for these restaurant firms results in an increase of 
231,200 hours and 47,000 hours respectively.
    Better data on the number of new and reformulated items introduced 
yearly, partially offset by a substantial decrease in the set of 
covered sectors, also increased the estimate of this burden from 24,096 
to 78,720 hours, an increase of 54,624 hours. The estimate of the 
burden of new chains having recurring annual costs, increased because 
the estimated number of menu items for these chains increased from 60 
to 80. This increase occurred because the proposed rule is limited to 
establishments with more standard menu items. These changes increased 
the total recurring hours due to new chains from 7,200 to 9,600 hours, 
an increase of 2,400 hours. Finally, this proposed rule does not 
address vending machine operators, so an additional 120 hours were 
dropped. The net effect of these increases and decreases in the burdens 
estimated for different sectors is an increase in the estimated 
recordkeeping burden of 166,768 hours (231,200 hours + 54,624 + 2,400 + 
47,000-67,200 hours-24,000 hours-77,136 hours-120 hours = 247,221 
hours).
    Total initial capital costs increased from $26.9 million to 
$36,962,326 because of the addition of the associated restaurant and 
grocery or convenience firms, and the removal of other sectors, and the 
decrease in the number of items per chain for restaurants. Better data, 
which increased the estimate of the number of new items per firm from 4 
to 12, led to an increase in recurring new item capital costs from $1.6 
million to $5,451,360. New chain recurring capital costs increased from 
$0.5 million to $664,800 because of the increase in the number of items 
per chain.

                       Table 7--Estimated Annual Third Party Disclosure Burden: Nutrient Disclosure for Proposed Sec.   101.11(b)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of                        Average burden
                Type of respondent                     Number of     disclosures per    Total annual     per disclosure     Total hours    Capital costs
                                                      respondents      respondent        disclosures       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Limited Service...................................          91,000                 3           273,000                 2         546,000    $150,150,000
Snack Bars and Cafeterias.........................          25,200                 1            25,200                 2          50,400      13,860,000
Full Service Restaurants..........................          23,900                 1            23,900                 1          23,900       4,349,800
Grocery and Convenience Chains....................          47,400                 1            47,400                 2          94,800      26,070,000
    Total initial hours...........................  ..............  ................  ................  ................         715,100     194,429,800
                                                   -----------------------------------------------------------------------------------------------------
New Chains (Recurring)............................             600                 2             1,200                 2           2,400         660,000
                                                   -----------------------------------------------------------------------------------------------------
    Total recurring hours.........................  ..............  ................  ................  ................           2,400  ..............
                                                   -----------------------------------------------------------------------------------------------------
    Total burden hours............................  ..............  ................  ................  ................         717,500  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

Third Party Disclosure
    The third party disclosure burden for restaurants and similar 
retail food establishments is the time necessary to display calorie 
information on menus, menu boards, displayed food and other required 
locations. In practice, this is the time necessary to change out 
redesigned menus, menu boards, and displays. FDA estimates two hours of 
time per change.
    FDA has estimated that limited-service restaurant chains have an 
average of 3 menu boards or displays per establishment. With 91,000 
establishments, the total hourly burden estimated for third party 
disclosure at these restaurants is 546,000 hours (91,000 establishments 
x 3 displays/establishment x 2 hours/display).
    For the 25,200 snack bars and cafeterias, FDA estimates 1 menu 
board per establishment would need replacement. The total hourly burden 
estimated for third party disclosure at these eating places is 50,400 
hours (25,200 establishments x 1 displays/establishment x 2 hours/
display).

[[Page 19228]]

    For full-service restaurants, FDA estimates that an average of 25 
percent will not be able to coordinate the required menu update with an 
already scheduled change, so that approximately 23,900 establishments 
(95,500 establishments x 25%) will need to replace existing menus. With 
an average 1 hour to change out menus per establishment, the total 
burden hour estimate for full service restaurants is 23,900.
    For grocery and convenience store chains, FDA estimates an average 
of one major menu board or display per establishment. With 47,400 
establishments, the total hourly burden for these establishments is 
94,800 hours ( = 47,400 outlets x 1 displays/outlet x 2 hours/display).
    FDA estimates that initial first year disclosure burden for 
restaurants or similar retail food establishments will be 620,300 
hours.
    FDA estimates that there will be 30 new chains each year with chain 
food retail establishments that will need to disclose calorie and other 
nutrition information under. At 20 establishments per chain, there will 
be 600 new chain food retail establishments each year that will need to 
disclose calorie and other nutrition information. Taking an average 
number of disclosures equal to 2, the total hourly burden for 
disclosure due to new chains is 2,400 hours (600 establishments x 2 
displays/establishment x 2 hours/display).
    The final column of Table 7 gives the estimated capital costs 
associated with third party disclosure. These are the costs of 
acquiring new menu boards or menus. FDA has estimated that the average 
cost of menu board to be $550. Capital costs for limited service chains 
and grocery or convenience chains are calculated by multiplying this 
per menu board cost by the frequency of disclosures in column three 
multiplied by the number of respondents in column two.
    For full-service restaurants without menu boards, the capital costs 
would stem from the initial replacement of menus. With an average of 91 
menus per establishment, at an average cost of $2 per menu, capital 
cost per disclosure is $182. The total capital cost of third party 
disclosure for full-service restaurants is estimated to be $4,349,800.
    The current total third party disclosure burden for menu labeling 
as required by section 4205, now under review at OMB under No. 0910-
0665, is 15,001,748 hours. The estimated third party disclosure burden 
under the proposed rule is 717,500 hours, a decrease of 14,284,248 
hours. This decrease is due to a decrease in the estimated number of 
respondents.
    The proposed rule caused several changes in our previous estimate 
of the third party disclosure burdens. Most importantly, the proposed 
rule covers a substantially smaller set of chains and establishments 
than initially estimated for section 4205. The estimate of the total 
initial hourly burden has decreased from 964,348 hours to 715,100 
hours, a decrease of 249,248 hours, because of this change and because 
of a better estimate of the number of menu boards and menus in 
restaurants that are not limited-service restaurants. The estimated 
number of new chains is unchanged at 600, and the burden estimate 
remains at 2,400 hours. Finally, we decreased the estimated burden by 
eliminating 14,035,000 hours previously estimated for vending operators 
(third party disclosure burden hours for vending operators are 
estimated in the separately published proposal related to calorie 
declaration for food sold in vending machines). The total decrease in 
estimated third party disclosure burden is 14,284,248 hours (249,248 
hours + 14,035,000 hours = 14,284,248 hours).
    The capital costs for initial restaurant third party disclosure 
have dropped from $265.3 million to $194,429,800 for the same reason 
the hourly burden dropped: There is a lower number of estimated 
displays. The recurring capital costs have fallen from $0.7 million to 
$660,000 because of different rounding.

    Table 8--Estimated Annual Reporting Burden, Voluntary Registration Under Proposed Sec.   101.11(c)(3) \1\
----------------------------------------------------------------------------------------------------------------
                                                               Number of                  Average
                                                  Number of    responses      Total      burden per
              Type of  respondent                respondents      per         annual      response   Total hours
                                                               respondent   responses    (in hours)
----------------------------------------------------------------------------------------------------------------
Restaurants....................................          373            1          373            2          746
Grocery and Convenience Stores.................          594            1          594            2        1,188
                                                ----------------------------------------------------------------
    Total initial hours........................  ...........  ...........  ...........  ...........        1,934
----------------------------------------------------------------------------------------------------------------
New registrations..............................           19            1           19            1           19
Re-registrations...............................          948          0.5          474          0.5          237
                                                ----------------------------------------------------------------
    Total recurring hours......................  ...........  ...........  ...........  ...........          256
                                                ----------------------------------------------------------------
    Total burden hours.........................  ...........  ...........  ...........  ...........        2,190
----------------------------------------------------------------------------------------------------------------

Reporting
    The registration provisions of the proposed rule would require an 
every other year reporting to FDA by authorized officials of 
restaurants or similar retail food establishments that are not subject 
to the requirements of section 4205. FDA bases its per respondent 
burden on the PRA analysis for section 415 of the FFDCA (21 U.S.C. 
350d) as laid out for the rule ``Registration of Food Facilities under 
the Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002'' (Ref. 49). FDA estimates that the initial collection of 
the information, and presentation of it in a format that will meet the 
agency's registration regulations, will require a burden of 
approximately two hours per registration for the first year because the 
registration system will not be fully automated.
    FDA estimates that renewal registrations after the first year will 
require substantially less time because chains are expected to be able 
to affirm or edit the existing information in an online account in a 
way similar to other FDA firm registration systems. Therefore, FDA 
estimates that re-registration will take 0.5 hours for each registrant. 
Because some establishments that had previously been registered will 
choose not to do so at some point, and some new establishments will 
become registered, there will also be new registrations once the system 
is fully

[[Page 19229]]

operational. FDA estimates that initial registration under the fully 
operational system will take one hour.
    The pool of potential registrants will be restaurants and similar 
retail food establishments that are not subject to the requirements of 
section 4205, including establishments located in jurisdictions with 
non-identical menu labeling laws that are not preempted. Of the pre-
existing state and local laws, including regulations in New York City, 
Seattle, Philadelphia, Oregon, Massachusetts, Maine, Vermont, 
Nashville, Montgomery County (MD), California, and 5 New York State 
counties, the minimum number of establishments in a chain to which any 
of them currently apply is 15, and section 4205 applies to 
establishments that are part of chains with 20 or more establishments 
(i.e., locations). Therefore, some restaurants and similar retail food 
establishments that are part of chains with between 15-19 
establishments have an incentive to register. However, chains with 
fewer establishments, or chains in other jurisdictions, may choose to 
register because they are growing quickly, or because they are 
concerned about possible regulation. Therefore, for the purposes of 
this analysis, FDA counts chains with between 10 and 19 establishments, 
inclusive.
    From the analysis in the detailed PRIA, approximately 27 percent of 
restaurant establishments are in jurisdictions with State or local menu 
labeling laws. NPD's Spring 2010 ReCount report shows a total of 20,000 
establishments are part of chains with between 10 and 19 establishments 
(Ref. 50). If establishments were evenly distributed geographically, 
then 5,414 establishments from 373 restaurant chains might have an 
incentive to register with the FDA. The initial hourly burden for these 
restaurant chains is 746 hours (373 chains x 1 responses/chain/year x 2 
hours/response).
    The U.S. Census Bureau's County Business Patterns data shows that 
30 percent of grocery stores and 10 percent of convenience stores are 
in jurisdictions that have relevant menu labeling regulations (Ref. 2). 
Taking 30 percent of an estimated 22,000 stores yields 6,600 stores run 
by approximately 455 chains. Taking 10 percent of an estimated 20,100 
convenience stores in the 10 to 19 segment yields 2,011 stores run by 
approximately 139 chains. The hourly burden associated with 
registration for grocery and convenience store chains is 1,188 hours 
(594 chains x 1 responses/chain/year x 2 hours/response).
    FDA estimates that the rate of growth for chains entering the 10-19 
establishment segment will match the rate of growth out of this 
segment, so that the number of registrants will remain constant. County 
Business Patterns data shows an average growth rate in the number of 
establishments to be two percent per year over the eight years from 
1999 to 2007 for restaurants (Ref. 28). Taking the restaurant growth 
rate for establishments of approximately 2 percent per year, new 
registrants will amount to approximately 19 per year, with the 
remaining 948 registrants only renewing their registration every other 
year. The recurring yearly burden for registration will be 1 hour per 
new registrant and 0.25 hours for continuing registrants. This yields a 
recurring hourly burden of 256 hours per year (19 new small chains x 1 
hour/chain + 948 returning chains x .5 hours/chain x .5 response/year). 
These estimates are reported in Table 8.
    The current total reporting burden for menu labeling registration 
as required by section 4205, now under review at OMB under No. 0910-
0664, is 820 hours. The estimated reporting burden under the proposed 
rule is 2,190 hours, an increase of 1,370 hours. This increase is due 
to an increase in the estimated number of respondents.
    The proposed rule caused several changes in our previous estimate 
of the reporting burdens. The estimated number of restaurants that 
would submit initial registrations was increased from 362 to 868, and 
the burden estimate increased from 724 hours to 1,934 hours, an 
increase of 1,210 hours. The estimated number of new registrations 
increased from 7 to 19 and the burden estimate from these new 
registrations also increased from 7 to 19 hours, an increase of 12 
hours. The estimated number of restaurants that would submit re-
registrations was increased from 362 to 948, and the burden estimate 
increased from 89 hours to 237 hours, an increase of 148 hours. Thus, 
the total increase in estimated reporting burden is 1,370 hours (1,210 
hours + 12 hours + 148 hours = 1,370 hours).
    FDA received comments on the initial proposed collection of 
information related to section 4205 in Docket No. FDA-2010-N-0567; 
Agency Information Collection Activities; Proposed Collection; Comment 
Request; Restaurant Menu and Vending Machine Labeling: Recordkeeping 
and Mandatory Third Party Disclosure Under Section 4205 of the Patient 
Protection and Affordable Care Act of 2010. Several comments were 
submitted on the accuracy of the information collection burden analysis 
for convenience stores.
    In compliance with the PRA, the agency has submitted the revised 
information collection provisions of this proposed rule to OMB for 
review. Interested persons are requested to send comments regarding the 
information collection to OMB (see DATES and ADDRESSES sections of this 
document).

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive order requires agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision that preempts ``any requirement for nutrition labeling of 
food that is not identical to the requirement of section [21 U.S.C. 
343(q)]'' 21 U.S.C. 343-1(a)(4), except that this provision does not 
apply ``to food that is offered for sale in a restaurant or similar 
retail food establishment that is not 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 unless such restaurant or similar retail food 
establishment complies with the voluntary provision of nutrition 
information requirements under [21 U.S.C. 343(q)(5)(H)(ix)].'' 21 
U.S.C. 343-1(a)(4). If this proposed rule is made final, the final rule 
would create requirements for nutrition labeling of food under 21 
U.S.C. 343(q) that would preempt certain non-identical State and local 
nutrition labeling requirements.
    Section 4205 of the Affordable Care Act (ACA) also included a Rule 
of Construction providing that ``Nothing in the amendments made by 
[section 4205] shall be construed--(1) to preempt any provision of 
State or local law, unless such provision establishes or continues into 
effect nutrient content disclosures of the type required under section 
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 
343(q)(5)(H)] (as added by subsection (b)) and is expressly preempted 
under subsection (a)(4) of such section; (2) to apply to any State or 
local requirement respecting a statement in the labeling of food that 
provides for a warning concerning the safety of the food or

[[Page 19230]]

component of the food; or (3) except as provided in section 
403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 
343(q)(5)(H)(ix)] (as added by subsection (b)), to apply to any 
restaurant or similar retail food establishment other than a restaurant 
or similar retail food establishment described in section 
403(q)(5)(H)(i) of such Act [21 U.S.C. 343(q)(5)(H)(i)].'' Public Law 
111-148, Sec.  4205(d), 124 Stat. 119, 576 (2010).
    FDA interprets the provisions of Section 4205 of the ACA related to 
preemption to mean that States and local governments may not impose 
nutrition labeling requirements for food sold in restaurants and 
similar retail food establishments (``R/SRFEs'') that must comply with 
the Federal requirements of 21 U.S.C. 343(q)(5)(H), unless the State or 
local requirements are identical to the Federal requirements. In other 
words, States and localities cannot have additional or different 
nutrition labeling requirements for food sold either (1) in R/SRFEs 
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 R/SRFEs'') or (2) in R/SRFEs that voluntarily 
elect to be subject to the requirements of 21 U.S.C. 343(q)(5)(H) by 
registering biannually under 21 U.S.C. 343(q)(5)(H)(ix).
    Otherwise, for certain food that is not subject to the nutrition 
labeling requirements of 21 U.S.C. 343(q), States and localities may 
impose nutrition labeling requirements. First, States and localities 
can have nutrition labeling requirements for food sold in non-chain R/
SRFEs that have not registered under 21 U.S.C. 343(q)(5)(H)(ix). This 
exception to preemption is clear from the language of 21 U.S.C. 343-
1(a)(4) (``except that this paragraph does not apply to food that is 
offered for sale in a restaurant or similar retail food establishment 
that is not part of a chain with 20 or more locations * * * unless such 
[R/SRFE] complies with the voluntary provision of nutrition information 
requirements under [21 U.S.C. 343(q)(5)(H)(ix)'').
    Second, States and localities can have certain nutrition labeling 
requirements for other food that is exempt from nutrition labeling 
under 21 U.S.C. 343(q)(5)(A)(i) or (ii) provided that such food is not 
required to have nutrition labeling under 21 U.S.C. 343(q)(5)(H). For 
example, certain food sold in schools, hospitals, and movie theaters 
would not, under the proposal, be required to have nutrition labeling 
under 21 U.S.C. 343(q)(1)-(4)(see 21 U.S.C. 343(q)(5)(A)(i) and (ii) 
and 21 CFR 101.9(j)(2) and (3)) or under 21 U.S.C. 343(q)(5)(H), as 
interpreted by FDA in the proposed rule, because these establishments 
would not be R/SRFEs. Under FDA's interpretation of the Rule of 
Construction in Section 4205(d)(1), nutrition labeling for food in 
these non-R/SRFEs would not be ``nutrient content disclosures of the 
type required under [21 U.S.C. 343(q)(5)(H)]'' and, therefore, would 
not be preempted. This interpretation of section 4205 of the ACA does 
not alter the ability of the States and localities to regulate 
nutrition labeling except with respect to the chain R/SRFEs and the 
non-chain R/SRFEs that voluntarily register. Therefore, under this 
interpretation, States and localities would be able to continue to 
require nutrition labeling for food sold by entities determined not to 
be R/SRFEs (e.g., for movie theaters and transportation carriers).
    An alternative to FDA's interpretation of the provisions of Section 
4205 of the ACA related to preemption, which is not being proposed, 
could leave less room for States and localities to require nutrition 
labeling on food exempt from Federal nutrition labeling requirements 
under 21 U.S.C. 343(q)(5)(A)(i) or (ii). Under this alternative 
interpretation, State or local nutrition labeling requirements for food 
sold in establishments that are not ``restaurants or similar retail 
food establishments,'' as defined in the proposed rule if made final, 
would be ineligible for the exception to preemption in 21 U.S.C. 343-
1(a)(4), because that exception by its literal terms only covers 
nutrition labeling requirements for food offered for sale in covered R/
SRFEs (i.e., those not part of a chain of 20, etc.). Under this 
alternative interpretation, the Rule of Construction would simply 
clarify that the scope of 21 U.S.C. 343-1(a)(4) does not extend beyond 
the limits expressly identified in 343-1(a)(4). ``Nutrition content 
disclosures of the type required under [21 U.S.C. 343(q)(5)(H)]'' would 
mean, generally, requirements to disclose calories and/or other 
nutrition information (e.g., fat, saturated fat, sodium, protein) in 
written form, on menus or elsewhere.
    Under this alternative interpretation, States and localities could 
not have nutrition labeling requirements covering certain foods in non-
R/SRFEs, such as schools and hospitals unless they successfully 
petitioned FDA. Federal law provides that, upon petition, FDA may 
exempt State or local requirements from the express preemption 
provisions of 21 U.S.C. 343-1(a) under certain conditions. 21 U.S.C. 
343-1(b). FDA has promulgated regulations at 21 CFR 100.1 describing 
the petition process that is available to State and local governments 
to request such exemptions from preemption.
    Under the interpretation being proposed by FDA, for certain food 
that is not subject to the nutrition labeling requirements of 21 U.S.C. 
343(q)(5)(H), States and localities may establish or continue to impose 
nutrition labeling requirements. Under the alternative interpretation 
described above, there would be restaurant and restaurant-type food in 
non-R/SRFEs, such as schools, hospitals, and movie theaters, for which 
the Federal government has not required nutrition labeling and for 
which States and localities would also be precluded from establishing 
such labeling requirements unless they successfully petitioned FDA and 
a rulemaking was completed. This approach would risk creating a 
regulatory gap that would be inconsistent with the purposes of section 
4205. It would also impose a restriction and burden on the States and 
localities that is inconsistent with the Federalism principles 
expressed in Executive Order 13132, as well as a substantial 
administrative burden on FDA in the event states petition for 
exemption.
    FDA requests comments on the agency's interpretation of the 
provisions of Section 4205 of the ACA related to preemption, as well as 
on the alternative interpretation, described in this Federalism 
section. FDA also requests comments on the use of the petition process 
in this context. In addition, the agency requests comments on other 
potential interpretations that interested persons identify as 
appropriate given both the preemption-related language of Section 4205 
and the statutory goals. For example, could 21 U.S.C. 343-1(a)(4), as 
amended by Section 4205, be interpreted as not preempting State or 
local nutrition labeling requirements if 21 U.S.C. 343(q) and FDA's 
implementing regulations do not directly impose nutrition labeling 
requirements on food in an establishment?
    In addition, the express preemption provisions of 21 U.S.C. 343-
1(a)(4) do not preempt any State or local requirement respecting a 
statement in the labeling of food that provides for a warning 
concerning the safety of the food or component of the food. This is 
clear from both the literal language of 21 U.S.C. 343-1(a)(4) with 
respect to the scope of preemption and from the Rule of Construction at 
Section 4205(d)(2) of the ACA.

IX. Environmental Impact

    The agency has determined under 21 CFR 25.30(k) that this action is 
of a type

[[Page 19231]]

that does not individually or cumulatively have a significant effect on 
the human environment. Therefore, neither an environmental assessment 
nor an environmental impact statement is required.

X. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

XI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. Flegal K.M., M.D. Carroll, C.L. Ogden, and L.R. Curtin. 
``Prevalence and Trends in Obesity Among U.S. Adults 1999-2008.'' 
Journal of the American Medical Association, 303:235-241, 2010.
2. CDC, Obesity and Overweight for Professionals Internet Webpage: 
``Health Consequences.'' Available at http://www.cdc.gov/obesity/causes/health.html, accessed on July 15, 2010.
3. Malnick S.D. and H. Knobler. ``The Medical Complications of 
Obesity.'' QJ Med, 99:565-579, 2006.
4. Flegal K.M., B.I. Graubard, D.F. Williamson, and M.H. Gail. 
``Cause-Specific Excess Deaths Associated with Underweight, 
Overweight, and Obesity.'' Journal of the American Medical 
Association, 298:2028-2037, 2007.
5. Orpana H.M., J-M. Berthelot, M.S. Kaplan, D.H. Feeny, B. 
McFarland, and N.A. Ross. ``BMI and Mortality: Results from a 
National Longitudinal Study of Canadian Adults.'' Obesity, 
18(1):214-218, 2010.
6. CDC, Chronic Disease Overview Internet Webpage: ``Chronic 
Diseases and Health Promotion.'' Available at http://www.cdc.gov/chronicdisease/overview/index.htm, accessed on February 18, 2011.
7. Ogden, C.L. and K.M. Flegal 2010. CDC. ``Changes in Terminology 
for Childhood Obesity and Overweight.'' National Health Statistics 
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8. Ogden, C.L., M.D. Carroll, L.R. Curtin, M.M. Lamb, and K.M. 
Flegal, ``Prevalence of High Body Mass Index in US Children and 
Adolescents, 2007-2008,'' Journal of American Medical Association, 
303(3):242-249, 2010.
9. U.S. Department of Health and Human Services (DHHS) and USDA, 
``Dietary Guidelines for Americans, 2010,'' 7th ed., U.S. Government 
Printing Office, Washington DC, 2010. Available at http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm, accessed on March 25, 
2011.
10. Lin, B-H., J. Guthrie and E. Fraz[atilde]o. ``Nutrient 
Contribution of Food Away From Home.'' In Chapter 12 of America's 
Eating Habits: Changes and Consequences, Elizabeth Fraz[atilde]o 
(ed), USDA Agriculture Information Bulletin No. (AIB-750), pp. 213-
242, May 1999.
11. FDA Reports & Research Internet Webpage: ``Backgrounder--
Keystone Forum on Away-From-Home Foods: Opportunities for Preventing 
Weight Gain and Obesity Report,'' Keystone Center, June 2006.
12. USDA, Economic Research Service. ``Table 10: Food away from home 
as a share of food expenditures.'' Food CPI and Expenditures: Food 
Expenditure Tables. Available at http://www.ers.usda.gov/Briefing/CPIFoodAndExpenditures/Data/, accessed on February 18, 2011.
13. Burton, S., E.H. Creyer, J. Kees, and K. Huggins, ``Attacking 
the Obesity Epidemic: The Potential Health Benefits of Providing 
Nutrition Information in Restaurants.'' American Journal of Public 
Health, 96(9):1669-1675, September 2006.
14. Burton, S. and E.H. Creyer. ``What Consumers Don't Know Can Hurt 
Them: Consumer Evaluations And Disease Risk Perceptions Of 
Restaurant Menu Items.'' Journal of Consumer Affairs, 38:121-145, 
2004.
15. Choni[egrave]re, C.J. and A. Lando. Reported Results of the 
``2008 Health and Diet Survey.'' FDA, Consumer Research Internet 
Webpage: ``2008 Health and Diet Survey.'' Available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm, accessed on March 28, 2011.
16. Parker, L., A.C. Burns, and E. Sanchez (editors), IOM, National 
Research Council. Local Government Actions to Prevent Childhood 
Obesity. National Academies Press, Washington, DC, pp. 1-12, 2009.
17. Roberto C.A., M.B. Schwartz, and K.D. Brownell. ``Rationale and 
Evidence for Menu-Labeling Legislation.'' American Journal 
Preventive Medicine, 37(6):546-551, 2009.
18. Dumanovsky T, C.Y. Huang, M.T. Bassett, and L.D. Silver. 
``Consumer Awareness of Fast-Food Calorie Information in New York 
City After Implementation of a Menu Labeling Regulation.'' American 
Journal of Public Health, 2010:e1-e6.
19. Kolodinsky, J., T. W. Reynolds, M. Cannella, D. Timmons, and D. 
Bromberg. ``U.S. Consumer Demand for Restaurant Calorie Information: 
Targeting Demographic and Behavioral Segments in Labeling 
Initiatives.'' American Journal of Health Promotion, 24(1):11-14, 
2009.
20. Fitch, R. C., L. J. Harnack, D. R. Neumark-Sztainer, M. T. 
Story, S. A. French, J. M. Oakes, and S. A. Rydell. ``Providing 
Calorie Information on Fast-Food Restaurant Menu Boards: Consumer 
Views.'' American Journal of Health Promotion, 24(2):129-32, 2009.
21. Stein, K. ``A National Approach to Restaurant Menu Labeling: The 
Patient Protection and Affordable Health Care Act, Section 4205.'' 
American Journal of the American Dietetic Association, 110:1280-
1289, 2010.
22. City of Philadelphia, Bill No. 080167-A, November 19, 2008.
23. DHHS, FDA. ``Guidance for Industry: A Food Labeling Guide for 
Restaurants and Other Retail Establishments Selling Away-From-Home 
Foods, April 2008. Available at http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/InformationforRestaurantsRetailEstablishments/default.htm, accessed 
on March 29, 2011.
24. DHHS and USDA. Dietary Guidelines for Americans, 2005, 6th ed., 
U.S. Government Printing Office, Washington, DC, January 2005.
25. IOM, Food and Nutrition Board. Dietary Reference Intakes for 
Energy, Carbohydrate, Fat, Fatty Acids, Cholesterol, Protein and 
Amino Acids, Summary, The National Academies Press, Washington, DC, 
pp. 1-19, 2005.
26. Merriam Webster Collegiate Dictionary, Tenth Edition, pp. 110 
and 111, 1993.
27. Parsa, H.G., John T. Self, David Njite and Tiffany King. ``Why 
Restaurants Fail.'' Cornell Hotel and Restaurant Administration 
Quarterly, 46(3):304-322, August 2005.
28. U.S. Census Bureau. County Business Patterns, United States 
NAICS 722 2000-2008. Available at http://www.census.gov/econ/cbp/index.html, accessed October 18, 2010.
29. Wootan, M. and M. Osborn. ``Availability of Nutrition 
Information from Chain Restaurants in the United States.'' American 
Journal of Preventive Medicine, 30(3):266-268, March 2006.
30. Finkelstein, E.A. and K.L. Strombotne. ``The Economics of 
Obesity.'' American Journal of Clinical Nutrition, 91(5):1520S-
1524S, May 2010.
31. Philipson, T. and R. Posner. ``Is the Obesity Epidemic a Public 
Health Problem? A Decade of Research on the Economics of Obesity.'' 
NBER Working Paper Series, 14010, May 2008.
32. Downs, J.S., G. Loewenstein, and J. Wisdom. ``Strategies for 
Promoting Healthier Food Choices.'' American Economic Review: Papers 
and Proceedings, 99(2): 1-10, 2009.
33. O'Donoghue, T. and M. Rabin. ``The Economics of Immediate 
Gratification.'' Journal of Behavioral Decision Making, 13(2): 233-
250, 2000.
34. O'Donoghue, T. and M. Rabin. ``Doing it Now or Later.'' American 
Economic Review, 89(1): 103-124, 1999.

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35. Ogden, C.L. and M.D. Carroll. ``Prevalence of Overweight, 
Obesity, and Extreme Obesity Among Adults: United States, Trends 
1976-1980 Through 2007-2008.'' National Center for Health 
Statistics, June 2010. Available at http://www.cdc.gov/NCHS/data/hestat/obesity_adult_07_08/obesity_adult_07_08.pdf., accessed 
on October 17, 2010.
36. Sullivan, P.W., V. Ghusheyan, and R.H. Ben-Joseph. ``The Effect 
of Obesity and Cardiometabolic Risk Factor on Expenditures and 
Productivity in the US.'' Obesity, 16: 2155-2162, 2008.
37. Ali, M.M., A. Amialchuk, and F. Renna, ``Social Network and 
Weight Misperception among Adolescents.'' Southern Economic Journal, 
Forthcoming, 2010a.
38. Cawley, J., K. Joyner, and J. Sobal. ``Size Matters: The 
Influence of Adolescent's Weight and Height on Dating and Sex.'' 
Rationality and Society, 18(1): 67-94, 2006.
39. Ali, M.M., H. Fang, H. and J. Rizzo (2010b). ``Body Weight, 
Self-Perception and Mental Health among Adolescents.'' Journal of 
Mental Health Policy and Economics, 13(2): 53-63, 2010b.
40. Puhl, R., and K.D. Brownell. ``Bias, Discrimination, and 
Obesity.'' Obesity Research, 9(12): 788-805, 2001.
41. Cawley, J. ``The Impact of Obesity on Wages.'' Journal of Human 
Resources, 39(2): 451-474, 2004.
42. Finkelstein, E.A., J.G. Trogdon, J.W. Cohen, and W. Dietz. 
``Annual Medical Spending Attributable to Obesity: Payer- and 
Service-Specific Estimates.'' Health Affairs, 28(5):w822-w831, 2009.
43. Wang, Y., M.A. Beydoun, L. Liang, B. Cabellero, and S.K. 
Kumanyika. ``Will all Americans become Overweight or Obese? 
Estimating the Progression and Cost of the US Obesity Epidemic.'' 
Obesity, 16(10):2323-2330, 2008.
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expenditures.'' Food CPI and Expenditures: Food Expenditure Tables. 
http://www.ers.usda.gov/Briefing/CPIFoodAndExpenditures/Data/, 
accessed on January 6, 2011.
45. McCrory, M.A., P.J. Fuss, E. Saltzman, and S.B. Roberts. 
``Dietary Determinants of Energy Intake and Weight Regulation in 
Healthy Adults.'' Journal of Nutrition, 130:2765-95, 2000.
46. Mancino, L., J. Todd, and B.H. Lin. ``Separating what We Eat 
from where: Measuring the Effect of Food Away from Home on Diet.'' 
Food Policy, 34:557-562, 2009.
47. Robert Wood Johnson Foundation. ``Menu Labeling: Does Providing 
Nutrition Information at the Point of Purchase Affect Consumer 
Behavior?'' Healthy Eating Research, 2009.
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Sweetened Beverages: Potential Effects on Beverage Consumption, 
Calorie Intake, and Obesity.'' Economic Research Report, ERR-100, 
July 2010.
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Facilities under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002.'' Federal Register 
68(197):5392-5403.
50. NPD Group. ``FDA Report,'' ReCount Restaurant Census. Spring 
2010.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology, 
Reporting and recordkeeping requirements.

21 CFR Part 101

    Food Labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 11 and 101 be amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

    1. The authority citation for 21 CFR part 11 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
    2. Section 11.1 is amended by adding paragraph (g) to read as 
follows:


Sec.  11.1  Scope.

* * * * *
    (g) This part does not apply to electronic signatures obtained 
under Sec.  101.11(d) of this chapter.

PART 101--FOOD LABELING

    3. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

    4. Section 101.9 is amended by revising paragraph (j)(1)(i) and 
paragraphs (j)(2) introductory text and (j)(3) introductory text to 
read as follows:
* * * * *
    (j) * * *
    (1)(i) Food offered for sale by a person who makes direct sales to 
consumers (e.g., a retailer) who has annual gross sales made or 
business done in sales to consumers that is not more that $500,000 or 
has annual gross sales made or business done in sales of food to 
consumers of not more than $50,000, provided, that the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section, Sec.  
101.10, or Sec.  101.11, as applicable.
* * * * *
    (2) Except as provided in Sec.  101.11, food products that are:
* * * * *
    (3) Except as provided in Sec.  101.11, food products that are:
* * * * *
    5. Section 101.10 is revised to read as follows:


Sec.  101.10  Nutrition labeling of restaurant foods whose labels or 
labeling bear nutrient content claims or health claims.

    Nutrition labeling in accordance with Sec.  101.9 shall be provided 
upon request for any restaurant food or meal for which a nutrient 
content claim (as defined in Sec.  101.13 or in subpart D of this part) 
or a health claim (as defined in Sec.  101.14 and permitted by a 
regulation in subpart E of this part) is made, except that information 
on the nutrient amounts that are the basis for the claim (e.g., ``low 
fat, this meal provides less than 10 grams of fat'') may serve as the 
functional equivalent of complete nutrition information as described in 
Sec.  101.9. For standard menu items that are offered for sale in 
covered establishments (as defined in Sec.  101.11(a)), the information 
in the written nutrition information required by Sec.  
101.11(b)(2)(ii)(A) will serve to meet the requirements of this 
section. Nutrient levels may be determined by nutrient databases, 
cookbooks, or analyses or by other reasonable bases that provide 
assurance that the food or meal meets the nutrient requirements for the 
claim. Presentation of nutrition labeling may be in various forms, 
including those provided in Sec.  101.45 and other reasonable means.
    6. Section 101.11 is added to subpart A to read as follows:


Sec.  101.11  Nutrition labeling of standard menu items in covered 
establishments.

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for purposes of this section:
    Authorized official of a restaurant or similar retail food 
establishment means the owner, operator, agent in charge, or other 
person authorized by the owner, operator, or agent in charge to 
register the restaurant or similar retail food establishment, which is 
not otherwise subject to section 403(q)(5)(H) of the Federal Food, 
Drug, and Cosmetic Act, with FDA for the purposes of paragraph (d) of 
this section.
    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 
dish, and a drink. A combination meal may be represented on the menu or 
menu board

[[Page 19233]]

in narrative form, numerically, or pictorially. Some combination meals 
may include a variable menu item (or be a variable menu item as defined 
in this paragraph where the components may vary. For example, the side 
dish may vary among several options (e.g., fries, salad, or onion 
rings) or the drinks may vary (e.g., soft drinks, milk, or juice) and 
the customer selects which of these items will be included in the meal.
    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, 
e.g., individual franchises) and offering for sale substantially the 
same menu items, as well as a restaurant or similar retail food 
establishment that is registered to be covered under section 
403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act.
    Custom order means a food order that is prepared in a specific 
manner based on an individual customer's request, which requires the 
restaurant or similar retail food establishment to deviate from its 
usual preparation of a menu item, e.g., a club sandwich without the 
bacon if the establishment usually includes bacon in its club sandwich.
    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.
    Doing business under the same name means sharing the same name. The 
term ``same name'' includes names that are either exactly the same, or 
are slight variations of each other, for example, due to the region, 
location or size (e.g., ``New York Ave. Burgers'' and ``Pennsylvania 
Ave. Burgers'' or ``ABC'' and ``ABC Express'').
    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.
    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.
    Gross floor area means all space, wall to wall, including areas 
under built-in counters, cooking equipment, seating, and similar 
furniture.
    Menu or menu board means the primary writing of the restaurant or 
similar retail food establishment from which a customer makes an order 
selection, including, but not limited to, breakfast, lunch and dinner 
menus; dessert menus; beverage menus, children's menus, other specialty 
menus, electronic menus, and menus on the Internet. The menus may be in 
different forms, e.g., booklets, pamphlets, or single sheets of paper. 
Menu boards include those inside a restaurant or similar retail food 
establishment as well as drive-through menu boards at restaurants or 
similar retail food establishments.
    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, (e.g. ``Bay View 
Crab Cake'' and ``Ocean View Crab Cake''). ``Menu items'' in this 
definition refers to food items that are listed on a menu or menu board 
or that are offered as self-service food or food on display. 
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.
    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. The sale of food is the retail establishment's primary 
business activity if the establishment presents itself, or has 
presented itself publicly as a restaurant, or a total of more than 50 
percent of that retail establishment's gross floor area is used for the 
preparation, purchase, service, consumption, or storage of food.
    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 that the food is 
purchased or while walking away; or which is sold for sale or use in 
such establishments.
    Restaurant-type food means food of the type described in the 
definition of ``restaurant food'' that is ready food 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.
    Self-service food means restaurant or restaurant-type food that is 
available at a salad bar, buffet line, cafeteria line, or similar self-
service facility and that is served by the customers themselves. Self-
service food also includes self-service beverages.
    Standard menu item means a restaurant or restaurant-type food that 
is routinely included on a menu or menu board or routinely offered as a 
self-service food or food on display.
    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. The 60 days 
includes the total of consecutive and non-consecutive days the item 
appears on the menu.
    Variable menu item means a standard menu item that comes in 
different flavors, varieties, or combinations, and is listed as a 
single menu item.
    (b) Requirements for nutrition labeling for food sold in covered 
establishments.--(1) Applicability. (i) The labeling requirements in 
this paragraph (b) apply to standard menu items offered for sale in 
covered establishments.
    (ii) The labeling requirements in this paragraph (b) do not apply 
to alcohol beverages; items such as condiments that are placed on the 
table for general use; daily specials; temporary menu items; custom 
orders; and food that is part of a customary market test.
    (2) Nutrition information. (i) The following must be provided on 
menus and menu boards:
    (A) The number of calories contained in each standard menu item 
listed on the menu or menu board, as usually prepared and offered for 
sale must be declared in the following manner:
    (1) The number of calories must be listed adjacent to the name or 
the price of the associated standard menu item, in a type size no 
smaller than the name or the price of the associated standard menu 
item, whichever is smaller, in the same color, or a color at least as 
conspicuous as the name of the associated standard menu item, and with 
the same contrasting background as the name of the associated standard 
menu item.
    (2) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories, 
except that amounts less than 5 calories may be expressed as zero.
    (3) The term ``Calories'' or ``Cal'' must appear as a heading above 
a column listing the number of calories for each standard menu item or 
adjacent to the number of calories for each standard menu item. If the 
term ``Calories'' or ``Cal'' appears as a heading above a column of 
calorie declarations, the term must be in a type size no smaller than 
the smallest type size of the name or price of any menu item on that 
menu or

[[Page 19234]]

menu board in the same color or a color at least as conspicuous as that 
name or price and in the same contrasting background as that name or 
price. If the term ``Calories'' or ``Cal'' appears adjacent to the 
number of calories for the standard menu item, the term ``Calories'' or 
``Cal'' must appear in the same type size and in the same color and 
contrasting background as the number of calories.
    (4) For variable menu items, the calories must be declared as a 
range, in the format ``xx-yy'' where ``xx'' is the caloric content of 
the lowest calorie variety, flavor, or combination, and ``yy'' is the 
caloric content of the highest calorie variety, flavor, or combination. 
If the variable menu item appears on the menu or menu board and is a 
self-service food or food on display, and there is no clearly 
identifiable upper bound to the range, e.g., all-you-can-eat buffet, 
then the menu or menu board must include a statement, adjacent to the 
name or price of the item, referring customers to the self-service 
facility for calorie information, e.g., ``See buffet for calorie 
declarations.'' This statement must appear in a type size no smaller 
than the name or price of the variable menu item, whichever is smaller, 
and in the same color or a color at least as conspicuous as that name 
or price, with the same contrasting background as that name or price.
    (B) The following statement designed to enable consumers to 
understand, in the context of a total daily diet, the significance of 
the calorie information provided on menus and menu boards: ``A 2,000 
calorie daily diet is used as the basis for general nutrition advice; 
however, individual calorie needs may vary.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest calorie 
declaration appearing on the same menu or menu board and in the same 
color or in a color at least as conspicuous as the calorie declarations 
and with the same contrasting background as the calorie declarations.
    (2) For menus, this statement must appear on the bottom of each 
page of the menu. On menu pages that also bear the statement regarding 
the availability of the written nutrition information required in 
paragraph (b)(2)(i)(C) of this section, this statement must appear 
directly above the statement required in paragraph (b)(2)(i)(C).
    (3) For menu boards, this statement must appear on the bottom of 
the menu board, immediately above the statement required in paragraph 
(b)(2)(i)(C) of this section.
    (C) The following statement regarding the availability of the 
additional written nutrition information required in paragraph 
(b)(3)(i) of this section must be on all forms of the menu or menu 
board: ``Additional nutrition information available upon request.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest calorie 
declaration appearing on the same menu or menu board and in the same 
color or in a color at least as conspicuous as the caloric 
declarations, and with the same contrasting background as the caloric 
declarations.
    (2) For menus, the statement must appear on the bottom of the first 
page with menu items. For menus with more than two pages, the statement 
must appear:
    (i) At the bottom of every page with menu items; or
    (ii) At the bottom of only the first page with menu items, as long 
as a symbol (e.g., asterisk) clearly referring to the required 
statement appearing on the first page of the menu follows the term 
``Calories'' or ``Cal'', where the term first appears on each page 
after the page with the statement.
    (3) For menu boards, the statement must appear on the bottom of the 
menu board immediately above or below the succinct statement required 
in paragraph (b)(2)(i)(B) of this section.
    (ii) The following nutrition information for a standard menu item 
must be available in written form on the premises of the restaurant or 
similar retail food establishment and provided to the customer upon 
request. This nutrition information must be presented in the order 
listed and using the measurements listed, except as provided in 
paragraph (b)(2)(ii)(B) of this section. Rounding of these nutrients 
must be in compliance with Sec.  101.9(c). The information must be 
presented in a clear and conspicuous manner:

(A)(1) Total number of calories derived from any source (cal),
(2) Total number of calories derived from the total fat (fat cal),
(3) Total fat (g),
(4) Saturated fat (g),
(5) Trans fat (g),
(6) Cholesterol (mg),
(7) Sodium (mg),
(8) Total carbohydrate (g),
(9) Dietary fiber (g),
(10) Sugars (g),
(11) Protein (g).

    (B) If a standard menu item contains insignificant amounts of all 
the nutrients required to be disclosed in paragraph (b)(2)(ii)(A) of 
this section, the establishment is not required to include nutrition 
information regarding the standard menu item in the written form. 
However, if the covered establishment makes a nutrient content claim or 
health claim, the establishment is required to provide nutrition 
information on the nutrient that is the subject of the claim in 
accordance with Sec.  101.10. For standard menu items that contain 
insignificant amounts of six or more of the required nutrients, the 
declaration of nutrition information required by paragraph 
(b)(2)(ii)(A) of this section may be presented in a simplified format.
    (1) An insignificant amount is defined as that amount that allows a 
declaration of zero in nutrition labeling, except that for total 
carbohydrates, dietary fiber, and protein, it must be an amount that 
allows a declaration of ``less than one gram.''
    (2) The simplified format must include information on the following 
nutrients: Total carbohydrates, total fat, protein, and sodium, 
calories from fat, and any other nutrients identified in paragraph 
(b)(2)(ii)(A) of this section that are present in more than 
insignificant amounts. These nutrients may be in a column, list, or 
table. If the simplified format is used, the statement ``Not a 
significant source of ----'' (with the blank filled in with the names 
of the nutrients required to be declared in the written nutrient 
information and calories from fat that are present in insignificant 
amounts) must be included at the bottom of the list of nutrients.
    (C) For variable menu items, the nutrition information listed in 
paragraph (b)(2)(ii)(A) of this section must be declared as follows for 
each size offered for sale:
    (1) The nutrition information required in paragraph (b)(2)(ii)(A) 
of this section must be declared for the basic preparation of the item 
and, separately, for each topping, flavor, or variable component.
    (2) If the calories and other nutrients are the same for different 
flavors, varieties, and substitutable components of the combination 
meal, each variety, flavor and substitutable component of the 
combination meal is not required to be listed separately. All items 
that have the same nutrient levels could be listed together with the 
nutrient levels listed only once.
    (D) The written nutrition information required in paragraph 
(b)(2)(ii)(A) of this section may be provided on a counter card, sign, 
poster, handout, booklet, loose leaf binder, or electronic device such 
as a computer, or in a menu, or in any other form that similarly 
permits the written declaration of the required

[[Page 19235]]

nutrient content information for all standard menu items. If the 
written information is not in a form that can be given to the customer 
upon request, it must be readily available in a manner and location on 
the premises that allows the customer/consumer to review the written 
nutrition information upon request.
    (iii) The following must be provided for food that is self service 
or on display.
    (A) When a self-service food or food on display is already 
accompanied by an individual sign, adjacent to the food, that provides 
the food's name, price, or both, the calories per item or per serving 
must be provided on the sign. When a self-service food or food on 
display is not already accompanied by an individual sign, adjacent to 
the food, that provides the food's name, price, or both, the covered 
establishment must place a sign adjacent to each food with the number 
of calories per serving or per item in a clear and conspicuous manner.
    (1) For purposes of Sec.  101.10(b)(2)(ii)(A), ``per item'' means 
per each discrete unit offered for sale, for example, a bagel, a slice 
of pizza, a muffin, or a multi-serving food such as a whole cake.
    (2) For purposes of Sec.  101.10(b)(2)(ii)(A), ``per serving'' 
means:
    (i) Per each common household measure, e.g., cup, scoop, 
tablespoon, offered for sale as dispensed using a serving instrument 
such as a scoop, ladle, cup, or measuring spoon; or
    (ii) Per unit of weight offered for sale, e.g., per half pound or 
pound.
    (3) The calories must be declared in the following manner:
    (i) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increments above 50 calories 
except that amounts less than 5 calories may be expressed as zero.
    (ii) If the food is not already accompanied by a sign with the 
food's name, price or both, the calorie declaration, accompanied by the 
term ``Calories'' or ``Cal'', must appear on a sign adjacent to the 
standard menu item in a clear and conspicuous manner if the food is not 
already accompanied by a sign with the food's name, price or both. If 
the food is already accompanied by a sign with the food's name, price, 
or both, the calorie declaration and the term ``Calories'' or ``Cal'' 
must appear on that sign in a type size no smaller than the name or 
price of the menu item, whichever is smaller, in the same color or a 
color that is at least as conspicuous as that name or price using the 
same contrasting background.
    (B) For food on display identified by a menu adjacent to the food 
itself, the statement that puts the calorie information in the context 
of a recommended total daily caloric intake as required by paragraph 
(b)(2)(i)(B) of this section and the statement regarding the 
availability of the additional written nutrition information required 
by paragraph (b)(2)(i)(C) of this section. These two statements may 
appear either on the sign adjacent to the standard menu item or on a 
separate, larger sign, in close proximity to the food on display, that 
can be easily read as the consumer is making order selections. This 
requirement is satisfied if the two statements appear on a large menu 
board that can be easily read as the consumer is viewing the food on 
display.
    (C) The nutrition information in written form required by 
paragraph(b)(2)(ii) of this section, except for packaged food that 
bears nutrition labeling information required by Sec.  101.9 if the 
packaged food, including its label, can be examined by a consumer 
before purchasing the food.
    (c) Determination of nutrient content. (1) A restaurant or similar 
retail food establishment must have a reasonable basis for its nutrient 
disclosures. Nutrient levels may be determined by nutrient databases, 
cookbooks, laboratory analyses, and other reasonable means, as 
described in Sec.  101.10.
    (2) Two classes of nutrients are defined for purposes of 
compliance:
    (i) Class I. Added nutrients in standard menu items; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. If any 
ingredient which contains a naturally occurring (indigenous) nutrient 
is added to a standard menu item, the total amount of such nutrient in 
the standard menu item is subject to class II requirements unless the 
same nutrient is also added.
    (3) A standard menu item with a nutrient declaration of protein, 
total carbohydrate, or dietary fiber, shall be deemed to be misbranded 
under section 403(a) of the Federal Food, Drug, and Cosmetic Act unless 
it meets the following requirements:
    (i) Class I protein or dietary fiber. The nutrient content of the 
appropriate composite is at least equal to the value for that nutrient 
declared in the nutrition information in written form.
    (ii) Class II protein, total carbohydrate, or dietary fiber. The 
nutrient content of the appropriate composite is at least equal to 80 
percent of the value for that nutrient declared in the nutrition 
information in written form. Provided, that no regulatory action will 
be based on a determination of a nutrient value that falls below this 
level by a factor less than the variability generally recognized for 
the analytical method used in that food at the level involved.
    (4) A standard menu item with a nutrient declaration of calories, 
sugars, total fat, saturated fat, trans fat, cholesterol, or sodium 
shall be deemed to be misbranded under section 403(a) of the Federal 
Food, Drug, and Cosmetic Act if the nutrient content of the appropriate 
composite is greater than 20 percent in excess of the value for that 
nutrient declared on the menu, menu board or in the nutrition 
information in written form for calories or in the nutrition 
information in written form for all other nutrients. Provided, that no 
regulatory action will be based on a determination of a nutrient value 
that falls above this level by a factor less than the variability 
generally recognized for the analytical method used in that food at the 
level involved.
    (5) Reasonable excesses of protein, total carbohydrate, dietary 
fiber, over the declared amounts are acceptable within current good 
manufacturing practice. Reasonable deficiencies of calories, sugars, 
total fat, saturated fat, trans fat, cholesterol, or sodium under 
declared amounts are acceptable within current good manufacturing 
practice.
    (6) A restaurant or similar retail food establishment must provide 
to FDA, within a reasonable period of time upon request, information 
substantiating nutrient values including the method and data used to 
derive these nutrient levels. This information must include the 
following:
    (i) For nutrient databases:
    (A) The identity of the database used.
    (B) The recipe or formula used as a basis for the nutrient 
declarations. The recipe posted on the database must be identical to 
that used by the restaurant or similar retail food establishment to 
prepare the menu item.
    (C) For the specified amounts of each ingredient identified in the 
recipe, a detailed listing (e.g., printout) of the amount of each 
nutrient that that ingredient contributes to the menu item.
    (D) If this information is not available because the nutrition 
information was derived from a computer program, which is designed to 
provide only a final list of nutrient values for the recipe, a 
certificate of validation attesting to the accuracy of the computer 
program.
    (E) A detailed listing (e.g., printout) of the nutrient values 
determined for each menu item.
    (F) If this information is not derived through the aid of a 
computer program

[[Page 19236]]

which provides a final nutrient analysis for the menu item, worksheets 
used to determine the nutrient values for each of these menu items.
    (G) Any other information pertinent to the final nutrient levels of 
the menu item (e.g., information about what might cause slight 
variations in the nutrient profile such as moisture variations).
    (H) A statement signed by a responsible individual employed by the 
covered establishment that can certify that the information contained 
in the nutrient analysis is complete and accurate and that the recipe 
used to prepare the menu item is identical to that used for the 
nutrient analysis.
    (ii) For published cookbooks that contain nutritional information 
for recipes in the cookbook:
    (A) The name, author and publisher of the cookbook used.
    (B) If available, information provided by the cookbook about how 
the nutrition information for the recipes was obtained.
    (C) A copy of the recipe used to prepare the menu item and a copy 
of the nutrition information for that menu item as provided by the 
cookbook.
    (D) A statement signed by a responsible individual employed by the 
covered establishment certifying that the recipe used to prepare the 
menu item by the restaurant or similar retail food establishment is the 
same recipe provided in the cookbook. (Recipes may be divided as 
necessary to accommodate differences in the portion size derived from 
the recipe and that are served as the menu item but no changes may be 
made to the proportion of ingredients used.)
    (iii) For analyses:
    (A) A copy of the recipe for the menu item used for the nutrient 
analysis.
    (B) The identity of the laboratory performing the analysis.
    (C) Copies of analytical worksheets used to determine and verify 
nutrition information.
    (D) A statement signed by a responsible individual employed by the 
covered establishment that can certify that the information contained 
in the nutrient analysis is complete and accurate and an additional 
signed statement certifying that the recipe used to prepare the menu 
item is identical to that used for the nutrient analysis.
    (iv) For nutrition information provided by other reasonable means:
    (A) A detailed description of the method used to determine the 
nutrition information.
    (B) Documentation of the validity of that method.
    (C) A recipe or formula used as a basis for the nutrient 
determination. The recipe used in determining these nutrient values 
must be the same recipe used by the restaurant and similar retail food 
establishment to prepare the item.
    (D) Any data derived in determining the nutrient values for the 
menu item.
    (E) A statement signed by a responsible individual employed by the 
covered establishment that can certify that the information contained 
in the nutrient analysis is complete and accurate and that the recipe 
used to prepare the menu item is identical to that used for the 
nutrient analysis.
    (d) Voluntary registration to be subject to the menu labeling 
requirements. (1) Applicability. A restaurant or similar retail food 
establishment that 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 may voluntarily register to be subject to the 
requirements established in this section. Restaurants and similar 
retail food establishments that voluntarily register will no longer be 
subject to non-identical State or local nutrition labeling 
requirements.
    (2) Who may register? The authorized official of a restaurant or 
similar retail food establishment as defined in paragraph (a) of this 
section, which is not otherwise subject to paragraph (b) of this 
section, may register with FDA.
    (3) What information is required? Authorized officials for 
restaurants and similar retail food establishments must provide FDA 
with the following information on Form FDA 3757 (7/10).
    (i) The contact information (including name, address, phone number, 
and e-mail address for the authorized official);
    (ii) The contact information (including name, address, phone 
number, and e-mail address) of each restaurant or similar retail food 
establishment being registered, as well as the name and contact 
information for an official onsite, such as the owner or manager, for 
each specific restaurant or similar retail food establishment;
    (iii) All trade names the restaurant or similar retail food 
establishment uses;
    (iv) Preferred mailing address (if different from location address 
for each establishment) for purposes of receiving correspondence; and
    (v) Certification that the information submitted is true and 
accurate, that the person submitting it is authorized to do so, and 
that each registered restaurant or similar retail food establishment 
will be subject to the requirements of section 403(q)(5)(H) of the 
Federal Food, Drug and Cosmetic Act and this section.
    (vi) Information should be submitted by e-mail by typing complete 
information into the form (PDF), saving it on the registrant's 
computer, and sending it by e-mail to <a href="/cdn-cgi/l/email-protection#0f626a617a636e787d6a68667c7b7d6e7b6660614f696b6e2167677c"><span class="__cf_email__" data-cfemail="fa979f948f969b8d889f9d93898e889b8e939594ba9c9e9bd4929289">[email protected]</span></a>.
    (vii) If e-mail is not available, the registrant can either fill in 
the form (PDF) and print it out (or print out the blank PDF and fill in 
the information by hand or typewriter), and either fax the completed 
form to 301-436-2804 or mail it to FDA White Oak Building 22, Room 
0209, 10903 New Hampshire Ave., Silver Spring, MD 20993.
    (4) How to register? Authorized officials of restaurants and 
similar retail food establishments who elect to be subject to 
requirements in section 403(q)(5)(H) of the Federal Food, Drug and 
Cosmetic Act can register by visiting http://www.fda.gov/menulabeling. 
FDA has created a form that contains fields requesting the information 
in Sec.  101.11(c)(3) and made the form available at this Web site. 
Registrants must use this form to ensure that complete information is 
submitted.
    (5) When to renew registration? To keep the establishment's 
registration active, the authorized official of the restaurant or 
similar retail food establishment must register every other year within 
60 days prior to the expiration of the establishment's current 
registration with FDA. Registration will automatically expire if not 
renewed.
    (e) Signatures. Signatures obtained under paragraph (d) of this 
section that meet the definition of electronic signatures in Sec.  
11.3(b)(7) of this chapter are exempt from the requirements of part 11 
of this chapter.
    (f) Misbranding. A standard menu item offered for sale in a covered 
establishment shall be deemed misbranded under sections 201(n), 403(a), 
and/or 403(q) of the Federal Food, Drug, and Cosmetic Act if its label 
or labeling is not in conformity with paragraph (b) or (c) of this 
section.

    Dated: March 28, 2011.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2011-7940 Filed 4-1-11; 4:15 pm]
BILLING CODE P


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