19192 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

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. 

SUMMARY: To implement the menu 

labeling provisions of the Patient 

Protection and Affordable Care Act of 

2010 (Affordable Care Act), the Food 

and Drug Administration (FDA) is 

proposing requirements for providing 

certain nutrition information for 

standard menu items in certain chain 

restaurants and similar retail food 

establishments. The Affordable Care 

Act, in part, amended the Federal Food, 

Drug, and Cosmetic Act (FD&C Act), 

among other things, to require 

restaurants and similar retail food 

establishments that are part of a chain 

with 20 or more locations doing 

business under the same name and 

offering for sale substantially the same 

menu items to provide calorie and other 

nutrition information for standard menu 

items, including food on display and 

self-service food. Under provisions of 

the Affordable Care Act, restaurants and 

similar retail food establishments not 

otherwise covered by the law may elect 

to become subject to the Federal 

requirements by registering every other 

year with the FDA. Providing calorie 

and other nutrition information in 

restaurants and similar retail food 

establishments would assist consumers 

in making healthier dietary choices. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by June 6, 2011. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

May 6, 2011 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). See section III.G of this 

document for the proposed effective 

date of any rule that may publish based 

on this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–F– 

0172 and/or RIN 0910–AG57, by any of 

the following methods, except that 

comments on information collection 

issues under the Paperwork Reduction 

Act of 1995 must be submitted to the 

Office of Regulatory Affairs, Office of 

Management and Budget (OMB) (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• 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) 

§ 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 § 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 (§ 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 § 101.10 

require restaurants and other 

establishments in which food is offered 

for human consumption that make 

either a nutrient content claim (defined 

in § 101.13) or health claim (defined in 

§ 101.14) to provide certain nutrition 

information upon request. For example, 

if a menu lists an entre ́e as being low 

in fat, information about the amount of 

fat in the entre ́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 

§ 101.9(j)(2). The agency also provided 

in § 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 fastfood 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 selfservice food, and to provide, upon 

consumer request, additional written 

nutrition information for standard menu 

items. Such food is deemed to be 

misbranded if these requirements are 

not met. More specifically, the following 

information must be provided for 

standard menu items that are sold in 

chain retail food establishments: 

• The number of calories contained in 

each standard menu item as usually 

prepared and offered for sale on a menu 

or menu board (the calorie declaration 

must be ‘‘adjacent to’’ the name of the 

standard menu item, so as to be ‘‘clearly 

associated with’’ the item); 

• A succinct statement concerning 

suggested daily caloric intake posted 

prominently on the menu or menu 

board designed to enable the public to 

understand in the context of a total 

daily diet, the significance of the calorie 

information provided on menus and 

menu boards; 

• Additional nutrition information for 

standard menu items in a written form 

(‘‘written nutrition information’’), 

available on the premises, which must 

be made available to consumers upon 

request; 

• A ‘‘prominent, clear, and 

conspicuous’’ statement on the menu or 

menu board regarding the availability of 

the written nutrition information; and 

• The number of calories (per item or 

per serving) on a sign adjacent to selfservice 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: 

• Disclosing the number of calories 

contained in each standard menu item 

as usually prepared and offered for sale 

on menus and menu boards; 

• Providing written nutrition 

information to consumers upon request; 

• Providing a ‘‘prominent, clear, and 

conspicuous’’ statement on menus and 

menu boards about the availability of 

the written nutrition information; and 

• Providing calorie information (per 

serving or per food item) for self-service 

items and food on display, on a sign 

adjacent to each food item. 

The law also specifies that FDA must 

issue regulations that: 

• Establish requirements for a 

succinct statement concerning daily 

caloric intake, posted prominently on 

the menu or menu board, designed to 

enable the public to understand in the 

context of a total daily diet, the 

significance of the calorie information 

provided on menus and menu boards; 

• Establish standards for determining 

and disclosing the nutrient content for 

standard menu items that come in 

different flavors, varieties, or 

combinations, but which are listed as a 

single menu item; and 

• Specify how an authorized official 

of any restaurant or similar retail food 

establishment not subject to the 

requirements of section 403(q)(5)(H) 

may elect to be subject to the 

requirements by registering biannually 

the name and address of such restaurant 

or similar retail food establishment with 

FDA. 

Although these provisions became 

requirements at the time the law was 

signed, FDA has previously announced 

that we intend to exercise our 

enforcement discretion until the final 

rule is published and in effect. See 76 

FR 4360 (Jan. 25, 2011). FDA believes 

that this approach to implementing 

section 4205 will minimize uncertainty 

and confusion among all interested 

persons. The agency also believes that 

expeditious completion of the 

rulemaking process will most rapidly 

lead to full and consistent availability of 

the newly required nutrition 

information for consumers. 

Given that FDA does not intend to 

enforce the self-executing provisions at 

this time, we encourage our State and 

local partners to proceed in a similar 

way. We do, however, encourage 

establishments that already have calorie 

and nutrition information available to 

continue to provide that information to 

consumers. 

Section 403(q)(5)(H)(x) requires that 

FDA propose implementing regulations 

no later than one year after enactment 

of the ACA (21 U.S.C. 343(q)(5)(H)(x)). 

In addition, section 4205 authorizes 

FDA to require, by regulation, chain 

retail food establishments to disclose 

information about a nutrient, not 

explicitly required to be disclosed by 

section 4205, in the written nutrition 

information, if FDA determines that 

such information should be disclosed 

for the purpose of providing information 

to assist consumers in maintaining 

healthy dietary practices (21 U.S.C. 

343(q)(5)(H)(vi)). 

Section 403(q)(5)(H)(viii)(I) 

establishes calorie disclosure 

requirements for certain articles of food 

sold from a vending machine that is 

operated by a person who is engaged in 

the business of owning or operating 20 

or more vending machines (21 U.S.C. 

343(q)(5)(H)(viii)(I)). Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a proposal related to calorie 

declaration for food sold in vending 

machines. 

Section 4205 required FDA to publish 

a notice in the Federal Register 

specifying the terms and conditions 

under which restaurants or similar retail 

food establishments and vending 

machine operators not subject to the 

requirements of section 4205 could elect 

to be subject to requirements by 

registering with FDA (21 U.S.C. 

343(q)(5)(H)(ix)). FDA has published 

this notice. See 75 FR 43182, July 23, 

2010. Voluntary registration is 

discussed in section III.C. of this 

document. 

E. FDA Activities Related to 

Implementation of Section 4205 

On July 7, 2010, FDA published a 

notice in the Federal Register entitled 

‘‘Disclosure of Nutrient Content 

Information for Standard Menu Items 

Offered for Sale at Chain Restaurants or 

Similar Retail Food Establishments and 

for Articles of Food Sold From Vending 

Machines’’ (‘‘docket notice’’) (75 FR 

39026 (July 7, 2010)), to solicit 

comments and suggestions on the new 

law. Comments to the docket were due 

September 7, 2010. In response to this 

docket notice, FDA received 

approximately 875 responses, each 

containing one or more comments. 

Many of these comments, in general, 

supported the nutrient disclosure 

requirements in chain retail food 

establishments and for food sold from 

vending machines, whereas some 

comments opposed such requirements. 

On July 23, 2010, FDA published a 

Federal Register notice entitled, 

‘‘Voluntary Registration by Authorized 

Officials of Non-Covered Retail Food 

Establishments and Vending Machine 

Operators Electing to Be Subject to the 

Menu and Vending Machine Labeling 

Requirements Established by Section 

4205 of the Patient Protection and 

Affordable Care Act of 2010’’ 

(‘‘registration notice’’) (75 FR 43182 (July 

23, 2010)). In response to this notice, 

FDA received seven responses, none of 

which addressed registration. 

On August 25, 2010, FDA published 

a ‘‘Guidance for Industry: Questions and 

Answers Regarding the Effect of Section 

4205 of the Patient Protection and 

Affordable Care Act of 2010 on State 

and Local Menu and Vending Machine 

Labeling Laws’’ (‘‘preemption guidance’’) 

(75 FR 52427 (August 25, 2010)). The 

preemption guidance discusses the 

preemptive effect of section 4205 and 

identifies the provisions of amended 

section 403(q) that became requirements 

upon enactment. Our current thinking 

on the preemptive effect of section 4205 

is set out in section IX. of this 

document. 

Also on August 25, 2010, FDA 

published a ‘‘Draft Guidance for 

Industry: Questions and Answers 

Regarding Implementation of the Menu 

Labeling Provisions of Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010’’ (‘‘draft 

implementation guidance’’) (75 FR 

52426, August 25, 2010). The draft 

implementation guidance described 

which provisions became requirements 

upon enactment of the law and which 

provisions FDA would implement 

through rulemaking. FDA received 

approximately 80 responses to this draft 

implementation guidance, each 

containing one or more comments. On 

January 25, 2011, FDA published in the 

Federal Register a notice withdrawing 

the draft implementation guidance (76 

FR 4360 January 25, 2011)). FDA now 

intends to complete the notice and 

comment rulemaking process for section 

4205 before initiating enforcement 

activities. In the course of developing 

this proposed rule, we have considered 

the comments received on the draft 

guidance. 

We describe in more detail and 

respond to the comments to the notices 

and guidance documents, including the 

withdrawn draft implementation 

guidance, in this proposal. Some of the 

comments to the notices and guidances 

are duplicative. Therefore, in this 

document, when responding to 

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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 19195 

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 § 101.11. 

III. The Proposal 

A. Summary 

This proposal would add a new 

section 101.11 to 21 CFR and make 

additional changes to FDA’s regulations 

as needed to conform existing 

regulations to the new statutory 

requirements. In this section, we 

explain the provisions of the new 

proposed section 101.11, beginning with 

the definitions of several key terms in 

the proposal. 

B. Definitions 

The menu labeling requirements of 

section 4205 apply to standard menu 

items offered for sale in ‘‘covered 

establishments’’: 

1. ‘‘Restaurants or similar retail food 

establishments’’ that are 

• Part of a chain with 20 or more 

locations, 

• ‘‘doing business under the same 

name’’, and 

• ‘‘offering for sale substantially the 

same menu items’’; and 

2. Other restaurants or similar retail 

food establishments that have been 

voluntarily registered to be subject to 

the Federal requirements by an 

‘‘authorized official’’. 

Covered establishments must provide 

calorie information on ‘‘menus’’ and 

‘‘menu boards,’’ and other nutrition 

information upon request, for ‘‘standard 

menu items,’’ including ‘‘combination 

meals,’’ ‘‘food on display,’’ ‘‘self-service 

food,’’ and ‘‘variable menu items.’’ The 

new nutrition labeling requirements do 

not apply to ‘‘custom orders,’’ ‘‘daily 

specials,’’ ‘‘food that is part of a 

customary market test,’’ and ‘‘temporary 

menu items.’’ 

To establish the scope of 

establishments, labeling, and food 

covered by section 4205, FDA must 

define these and other key terms. 

Therefore, we are proposing in the 

introductory paragraph of § 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 § 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 § 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 

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(‘‘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 restauranttype 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 readyto-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 onsite 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 § 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 foodservice 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 foodservice 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 

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1Many 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. 

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 ‘‘cafe ́ 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 quickservice (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 restauranttype 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. 

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. 

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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 cafe ́ that appears 

only in other locations of the Superstore 

XYZ chain, the cafe ́ 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 cafe ́, is dedicated 

to the sale of food. Because the cafe ́

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 entertainmenttype 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 restauranttype 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 

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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 themselves publicly as restaurants Convenience stores 

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 § 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 takeout. 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 § 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 

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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 

§ 101.11(a) that the term ‘‘authorized 

official of a restaurant or similar retail 

food establishment’’ means the owner, 

operator, agent in charge, or any other 

person authorized by the owner, 

operator, or agent in charge of a 

restaurant or similar retail food 

establishment not subject to the 

requirements of section 4205 to 

voluntarily register the establishment 

with FDA to become subject to the 

requirements of section 4205. FDA 

tentatively concludes that it is 

appropriate for the owners, operators, or 

agents in charge to be able to authorize 

other persons to register on their behalf. 

Summary of Proposed Scope of Covered 

Establishments 

When is an entity an establishment? 

If an entity is free-standing, it would be 

an establishment. If an entity is inside 

an establishment, then the entity could 

be considered a separate establishment 

or it could be considered part of the 

establishment in which it is situated. If 

the entity is part of a chain with 

locations outside of the chain of the 

larger establishment, then the entity 

would be a separate establishment. If 

not, the entity would be considered part 

of the larger establishment. 

TABLE 3—WHEN IS AN ENTITY AN

ESTABLISHMENT? 

Is the entity an 

establishment? 

The entity is free-standing. Yes. 

The entity is inside an establishment and: 

• It only appears in locations of the larger 

establishment’s 

chain (e.g., 

Superstore XYZ 

Cafe ́ in Superstore 

XYZ).

No. 

• It is part of a chain 

with 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 freestanding).

Yes. 

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: 

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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 locations .......................... The restaurant or similar retail 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 the same menu items ........ Establishments in the chain offer 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 

§ 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. 


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2FDA 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. 

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 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 drivethrough, 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 § 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, takeout 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 selfservice 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. 

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. 

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 

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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. BrownForman 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 

§ 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 § 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 § 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 § 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 § 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 selfservice food and food on display that 

appear on menus or menu boards 

should be covered. However, the 

examples Congress provides for selfservice 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 selfservice 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 selfservice 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 

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display would meet FDA’s proposed 

definition of standard menu item. FDA 

requests comments on this issue. 

Combination Meal 

We are proposing in § 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 § 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 § 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 § 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 entre ́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 § 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 § 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 § 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 § 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 § 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 § 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 

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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 § 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 selfservice 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 pumpkinspice muffin available only in 

November, the nutrition information 

declaration requirements in section 

403(q)(5)(H) would still apply. Selfservice 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. 

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Based on the reasons above, FDA is 

proposing in § 101.11(b)(1)(ii) that the 

requirements in § 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 § 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 drivethrough menu boards and allow calorie 

disclosures on stanchions (free-standing 

boards, generally placed next to drivethrough 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 foodselection 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 drivethrough 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 

§ 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 

§ 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 

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‘‘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 drivethrough 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 § 101.11(b)(2)(i)(A) would 

apply to all menu boards at covered 

establishments, including drive through 

menu boards. 

FDA is proposing in 

§ 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 § 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 § 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 sugarsweetened 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 

§ 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 

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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 × 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 § 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 × 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 (§ 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 

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difference between the two values is 

greater than 100 calories. On the other 

hand, under the 25 percent approach, 

calories for a single ice cream scoop that 

varies from 240 to 320 calories 

depending on the flavor would be 

displayed as a range, because the 

highest calorie option is 33 percent 

more caloric than the lowest calorie 

option ((320–240)/240 = 33%). But 

because the difference is only 80 

calories, under the 100 calorie rule, the 

average, i.e. 280 calories, would be 

disclosed. 

Option 4. If only 2 options are 

available for an item (e.g., a sandwich 

with fries or with fruit), provide both 

numbers with a forward slash between 

(e.g., 450/350). If three or more options 

are available, provide the range in 

calories. We considered this option 

because some variable menu items may 

have only two choices and the use of a 

slash may be more reflective of the fact 

that there are two choices than the use 

of a dash. For example, for a chicken 

sandwich that comes in grilled and 

crispy versions, with 470 and 610 

calories, respectively, declaring the 

calories as 470/610 may better reflect 

the two discrete choices than declaring 

the calories as 470–610. On the other 

hand, the calorie declaration for a 

combination meal that comes with a 

choice of sides, e.g., tater tots or French 

fries, and various soft drinks would be 

a range (e.g., 1380–1810). 

Option 5. If only 2 options are 

available for an item (e.g. a sandwich 

with fries or with fruit), provide both 

numbers with a forward slash between 

(e.g. 450/350). For foods with 3 or more 

options, use one of the hybrid 

approaches outlined in Option 3. 

Since many of these options could 

result in menus with different formats 

and wide variations in the ranges, we 

intend to conduct consumer research to 

evaluate how well consumers 

understand the caloric information 

presented in each of the formats and 

whether mixed formats on a single 

menu or menu board might be confusing 

to consumers. FDA intends to make the 

results of our consumer research 

available to the public prior to 

publication of the final rule and will 

allow sufficient time for interested 

stakeholders to comment on the results 

of our research. 

FDA is proposing that the calorie 

declaration be in a range for all variable 

menu items (Option 2). Requiring a 

range for all variable menu items gives 

consumers a consistent format across all 

items. FDA recognizes that in some 

instances, the calorie range may be so 

wide that the consumer may still need 

the calorie information for the particular 

menu item before he or she can make a 

fully informed purchase decision. We 

want to ensure that the calorie 

declaration is understood by consumers 

and will help them make better food 

choices. We seek comment on whether 

the proposed method of declaring 

calories is appropriate and would not be 

misleading to consumers. We are 

especially interested in any consumer 

research on the issue. We are also 

interested in comment and research on 

the options that we considered but did 

not propose and whether any of the 

other options individually or in 

combination would be preferable and 

why. In developing the final rule on this 

proposal, we will consider the results of 

our research and all relevant comments 

and data. 

FDA also requests comment on 

complexities that may be raised by 

certain variable menu items. For 

example, some menus with combination 

meals list an option to increase the size 

of components of those meals for a 

discounted additional price. FDA is 

considering whether those listings 

should be labeled with the number or 

range of calories they add to the 

standard combination meal, and 

requests comment. FDA also recognizes 

that the Internet may allow for the use 

of different methods for disclosing 

calories. For example, interactive menus 

online may present opportunities for 

more innovative ways of providing 

tailored calorie information, e.g., 

providing a calorie tracker in the 

ordering frame that tallies calories as 

customers make order selections. FDA 

requests comment on this issue. While 

this may be especially suitable for 

ordering certain variable menu items, 

such as when selecting a crust and 

toppings for pizza, FDA requests 

comment on whether different methods 

should be used for nutrient content 

declarations for interactive internet 

menus in general. 

4. Succinct Statement Concerning 

Suggested Daily Caloric Intake Required 

on Menus and Menu Boards 

Sections 403(q)(5)(H)(ii)(I)(bb) and 

(II)(bb) require that chain retail food 

establishments post a succinct statement 

concerning suggested daily caloric 

intake (‘‘succinct statement’’) on menus 

and menu boards, as specified by the 

Secretary by regulation, that is designed 

to enable the public to understand, in 

the context of a total daily diet, the 

significance of the caloric information 

that is provided on the menu and menu 

board (21 U.S.C. 343(q)(5)(H)(ii)(I)(bb) 

and (II)(bb)). Some comments stated that 

the succinct statement should take into 

account the different caloric needs of 

individuals based on age, gender, and 

physical activity. Comments suggested 

various statements including: 

• ‘‘2,000 calories meets the daily 

caloric needs of most adults; however, 

individual dietary needs may vary.’’ 

• ‘‘A 2,000 calorie diet is being used 

as a basis for general nutrition advice. 

However, individual calorie needs may 

vary.’’ 

• ‘‘This is ll percent of a 2,000 

calorie diet.’’ 

• ‘‘To maintain a healthy weight, 

most adults need no more than 2,000 

calories per day.’’ 

Some comments stated that a different 

statement should be used on children’s 

menus because children have different 

caloric needs. According to one 

comment, if 2,000 calories is used as a 

reference point, parents may 

overestimate the caloric needs of their 

children. One comment suggested the 

following for a children’s menu: 

The recommended caloric intake for a day 

varies from ll to ll for adolescents and 

adults, from ll to ll for school-age 

children, and from ll to ll 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 macroand micronutrients for individuals 4 

years of age and older (§ 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 

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4This 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. 

approximates the caloric requirements 

for postmenopausal women who are atrisk 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: 

• The statement should be succinct; 

• The statement should be in plain 

language that consumers can 

understand; 

• The total caloric value should be 

framed appropriately so that it is not 

viewed as a recommendation for daily 

intake for every consumer; 

• The statement should give 

consumers a means to compare the 

calorie declaration for a menu item to 

total calories and; 

• The statement should inform 

consumers that individual needs vary. 

Using these principles and 

considering suggestions from the 

comments, FDA developed the 

following statements: 

• ‘‘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.’’ 

• ‘‘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.’’ 

• ‘‘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

We have also included the following 

statement that was suggested from 

comments because we tentatively 

concluded that the statement satisfied 

the principles described above. 

• ‘‘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 § 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 ll 

years of age is ll to ll 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 § 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 

§ 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 

§ 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 

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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 § 101.11(b)(2)(i)(C) to 

require the following statement 

regarding the availability of the written 

form of additional nutrition information 

proposed in § 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 

§ 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 

§ 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 

§ 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: 

• The total number of calories 

derived from any source, and the total 

number of calories derived from the 

total fat; 

• 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 

§ 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 § 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, 

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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 § 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.’’ § 101.9(f)(1). Further, FDA 

established regulations at § 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 § 101.13 or 

Subpart D of part 101 or a health claim 

as defined in § 101.13 and permitted by 

regulation in Subpart E in part 101. 

In addition, FDA established 

regulations at § 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 onehalf 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, § 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, § 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 § 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 § 101.9(f), 

specifically: Calories (derived from any 

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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 onehalf of the nutrients required to be 

declared in the written nutrition 

information under proposed 

§ 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 

§ 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 

§ 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 ll (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: 

• Total calories: 620–1,150 calories 

• Calories from fat: 220–410 calories 

• Total fat: 24–46 g 

• Saturated fat: 8–15 g 

• Trans fat: 0–1 g 

• Cholesterol: 75–90 mg 

• Sodium: 1,240–1,560 mg 

• Total carbohydrates: 70–155 g 

• Sugars: 21–66 g 

• Dietary fiber: 4–7 g 

• 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: 

• Total calories 470 calories 

• Calories from fat 190 calories 

• Total fat 21 g 

• Saturated fat 8 g 

• Trans fat 1 g 

• Cholesterol 75 mg 

• Sodium 880 mg 

• Total carbohydrate 43 g 

• Sugars 10 g 

• Dietary fiber 2 g 

• Protein 26 g 

Medium fries: 

• Total calories 420 calories 

• Calories from fat 180 calories 

• Total fat 20 g 

• Saturated fat 3.5 g 

• Trans fat 0 g 

• Cholesterol 0 mg 

• Sodium 500 mg 

• Total carbohydrate 54 g 

• Sugars 0 g 

• Dietary fiber 6 g 

• Protein 5 g 

Garden salad with fat-free dressing: 

• Total calories 150 calories 

• Calories from fat 30 calories 

• Total fat: 3 g 

• Saturated fat 0 g 

• Trans fat 0 g 

• Cholesterol 0 mg 

• Sodium 340 mg 

• Total carbohydrate 27 g 

• Sugars 11 g 

• Dietary fiber 2 g 

• Protein 3 g 

Medium Cola: 

• Total calories 200 calories 

• Total fat 0 g 

• Sodium 5 mg 

• Total carbohydrate 56 g 

• Sugars 56 g 

• Protein 0 g 

• Not a significant source of calories 

from fat, saturated fat, trans fat, 

cholesterol, and dietary fiber. 

Medium Diet Cola: 

• Total calories 0 calories 

• Total fat 0 g 

• Sodium 40 mg 

• Total carbohydrate 0 g 

• Sugars 0 g 

• Protein 0 g 

• 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): 

• Total calories 5 calories 

• Total fat 0 g 

• Sodium 15 mg 

• Total carbohydrate 1 g 

• Sugars 0 g 

• Protein 0 g 

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• 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 

§ 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 

§ 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: 

• Total calories: 450/700 calories 

• Calories from fat: 70/200 calories 

• Total fat: 7/23 g 

• Saturated fat: 1.5/4.5 g 

• Cholesterol: 90/90 mg 

• Trans fat: 0/0 g 

• Sodium: 1160/1430 mg 

• Total carbohydrate 63/87 g 

• Sugars 27/9 g 

• Dietary fiber 3/6 g 

• 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 

§ 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 

§ 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 

§ 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 § 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 § 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. § 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 § 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 

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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 selfservice 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 selfservice 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 § 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 selfservice 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 selfservice 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 selfservice 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 

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‘‘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 

§ 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-caneat. 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 § 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. 

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(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 § 101.11(b)(iii)(B) that 

covered establishments may place the 

statements required under 

403(q)(5)(H)(ii) on the individual foodspecific 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 § 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 

§ 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 

§ 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 

§ 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 

§ 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 § 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 

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19218 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

guidance of the Food and Drug 

Administration.’’ 21 U.S.C. 

343(q)(5)(H)(iv). FDA is proposing in 

§ 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 

§ 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 § 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 § 101.9, FDA 

is proposing in § 101.11 an approach for 

determining compliance modeled after 

§ 101.9(g). Proposed § 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 § 101.11 should mirror § 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 § 101.11(c)(2) 

that the authorized official of a 

restaurant or similar retail food 

establishment as defined in 

§ 101.11(a)(10) may register with FDA. 

FDA is also proposing in § 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 § 101.11(c)(3) 

that authorized officials for restaurants 

and similar retail food establishments 

must provide FDA with the following 

information: 

• The name, address, phone number, 

e-mail address, and contact information 

for the authorized official; 

• 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; 

• All trade names the restaurant or 

similar retail food establishment uses; 

• Preferred mailing address (if 

different from location address for each 

establishment) for purposes of receiving 

correspondence; and 

• 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 § 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 

menulawregistration@fda.hhs.gov. If email 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, 

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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 

§ 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 § 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 § 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 § 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 § 101.9(j)(1) 

needs to be amended to reflect that, in 

providing the nutrition information 

required under § 101.11, a covered 

establishment would not become subject 

to § 101.9. In addition, the exemptions 

from nutrition labeling in § 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 

§ 101.11. Similarly, § 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 

§ 101.11(b)(2)(ii)(A) would meet the 

requirements of § 101.10, when 

applicable. Therefore, FDA is proposing 

conforming amendments in § 101.9(j) 

and § 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. 

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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 selfexecuting 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 restauranttype foods, the private market is 

particularly robust and competitive. 

Hundreds of thousands of retail food 

establishments and tens of thousands of 

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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), 

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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 comorbidities, 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 restauranttype 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 

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

estimate 

Low 

estimate 

High 

estimate 

Year 

dollar 

Discount 

rate 

Period 

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/year) ............................ $82.3 

76.8 

$34.9 

33.4 

$130.1 

120.5 

2009 

2009 

7% 

3% 

10 

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 fullservice 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

Summary of options 

Primary 

estimate 

(in millions) 

Low 

estimate 

(in millions) 

High 

estimate 

(in millions) 

Percent 

discount rate 

(10 year horizon) 

Proportional cost 

relative to primary 

estimate of the 

proposed 

requirements 

Proportional dollar 

sales of restaurant 

food relative to 

primary estimate 

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% 

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19224 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

TABLE 5b—SUMMARY OF ESTIMATED ANNUALIZED COMPLIANCE COSTS FOR EACH OPTION—Continued 

Summary of options 

Primary 

estimate 

(in millions) 

Low 

estimate 

(in millions) 

High 

estimate 

(in millions) 

Percent 

discount rate 

(10 year horizon) 

Proportional cost 

relative to primary 

estimate of the 

proposed 

requirements 

Proportional dollar 

sales of restaurant 

food relative to 

primary estimate 

of the proposed 

requirements 

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 

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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: 

• Future costs; 

• Particular regions, communities, or 

industrial sectors; 

• National productivity; 

• Economic growth; 

• Full employment; 

• Job creation; and 

• 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) 

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19226 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

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 § 101.11(b) would require 

third party disclosure to consumers of 

nutrition information by chain retail 

food establishments. Second, proposed 

§ 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 § 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) 

Type of respondent Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours Capital costs 

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 × 80 

items/chain × 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 × 5 items/firm × 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 × 40 items/chain × 

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 × 5 items/firm × 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 

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is 78,720 hours (1,640 chains × 12 

items/chain × 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 § 101.11(B) 

Type of respondent Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure 

(in hours) 

Total hours Capital costs 

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 limitedservice 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 × 3 displays/ 

establishment × 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 × 1 displays/ 

establishment × 2 hours/display). 

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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 × 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 × 1 displays/outlet × 

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 × 2 displays/ 

establishment × 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 § 101.11(c)(3) 1

Type of 

respondent 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total 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 reregistration 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 

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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 × 1 responses/chain/ 

year × 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 × 1 responses/ 

chain/year × 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 × 1 hour/chain + 948 

returning chains × .5 hours/chain × .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 

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19230 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

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, § 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 nonR/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 

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

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L.R. Curtin. ‘‘Prevalence and Trends in 

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www.cdc.gov/obesity/causes/

health.html, accessed on July 15, 2010. 

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Medical Complications of Obesity.’’ QJ 

Med, 99:565–579, 2006. 

4. Flegal K.M., B.I. Graubard, D.F. 

Williamson, and M.H. Gail. ‘‘CauseSpecific 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 

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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 Reports, Number 25, 

June 25, 2010. Available at http:// 

www.cdc.gov/nchs/data/nhsr/ 

nhsr025.pdf, accessed on July 10, 2010. 

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. Fraza ̃o. 

‘‘Nutrient Contribution of Food Away 

From Home.’’ In Chapter 12 of America’s 

Eating Habits: Changes and 

Consequences, Elizabeth Fraza ̃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. Chonie`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. NeumarkSztainer, 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/FoodLabeling

GuidanceRegulatoryInformation/

InformationforRestaurants

RetailEstablishments/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.’’ 

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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: Payerand 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. 

44. USDA, ERS ‘‘Table 1: Food and alcoholic 

beverages: Total 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. 

48. Smith, T.A., B.-H. Lin. and J.-Y. Lee. 

‘‘Taxing Caloric Sweetened Beverages: 

Potential Effects on Beverage 

Consumption, Calorie Intake, and 

Obesity.’’ Economic Research Report, 

ERR–100, July 2010. 

49. Food and Drug Administration. 2003. 

‘‘Registration of Food 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: 

§ 11.1 Scope. 

* * * * * 

(g) This part does not apply to 

electronic signatures obtained under 

§ 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, 

§ 101.10, or § 101.11, as applicable. 

* * * * * 

(2) Except as provided in § 101.11, 

food products that are: 

* * * * * 

(3) Except as provided in § 101.11, 

food products that are: 

* * * * * 

5. Section 101.10 is revised to read as 

follows: 

§ 101.10 Nutrition labeling of restaurant 

foods whose labels or labeling bear nutrient 

content claims or health claims. 

Nutrition labeling in accordance with 

§ 101.9 shall be provided upon request 

for any restaurant food or meal for 

which a nutrient content claim (as 

defined in § 101.13 or in subpart D of 

this part) or a health claim (as defined 

in § 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 § 101.9. For standard menu 

items that are offered for sale in covered 

establishments (as defined in 

§ 101.11(a)), the information in the 

written nutrition information required 

by § 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 § 101.45 

and other reasonable means. 

6. Section 101.11 is added to subpart 

A to read as follows: 

§ 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 

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

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19234 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

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 selfservice 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 § 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 

§ 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 ll’’ (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 

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

§ 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 

§ 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 § 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 

§ 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 

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19236 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Proposed Rules 

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 

menulawregistration@fda.hhs. 

(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 § 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 § 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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