71156 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

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: Final rule. 

SUMMARY: To implement the nutrition 

labeling provisions of the Patient 

Protection and Affordable Care Act of 

2010 (Affordable Care Act or ACA), the 

Food and Drug Administration (FDA or 

we) is requiring disclosure of certain 

nutrition information for standard menu 

items in certain restaurants and retail 

food establishments. The ACA, in part, 

amended the Federal Food, Drug, and 

Cosmetic Act (the 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 ACA, restaurants and 

similar retail food establishments not 

otherwise covered by the law may elect 

to become subject to these Federal 

requirements by registering every other 

year with FDA. Providing accurate, 

clear, and consistent nutrition 

information, including the calorie 

content of foods, in restaurants and 

similar retail food establishments will 

make such nutrition information 

available to consumers in a direct and 

accessible manner to enable consumers 

to make informed and healthful dietary 

choices. 

DATES: Effective date: December 1, 2015. 

Compliance date: Covered 

establishments must comply with the 

rule by December 1, 2015. See section 

XXIII for more information on the 

effective and compliance dates. 

Comment Date: Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

December 31, 2014 (see section XXVI, 

the ‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

ADDRESSES: To ensure that comments on 

the information collection are received, 

the Office of Management and Budget 

(OMB) recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910-New and 

title ‘‘Food Labeling: Nutrition Labeling 

of Standard Menu Items in Restaurants 

and Similar Retail Food 

Establishments.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Y. Reese, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–2371, email: Daniel.Reese@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

Executive Summary 

Purpose and Coverage of the Final Rule 

Summary of the Major Provisions of the 

Final Rule 

Costs and Benefits 

I. Background 

II. Legal Authority 

III. General Comments on the Proposed Rule 

A. Introduction 

B. Description of General Comments and 

FDA Response 

IV. Comments and FDA Response on 

Proposed Conforming Amendments 

A. Section 11.1(g)—Electronic Signatures 

B. Sections 101.9(j)(1)(i), (j)(2), and (j)(3)— 

Nutrition Labeling of Food 

C. Section 101.10—Nutrition Labeling of 

Restaurant Foods Whose Labels or 

Labeling Bear Nutrient Content Claims or 

Health Claims 

V. Key Terms That FDA Proposed to Define 

(Proposed § 101.11(a)) 

VI. Comments and FDA Response on the 

Proposed Definitions of Terms Related to 

the Scope of Establishments Covered by 

the Rule (Proposed § 101.11(a)) 

A. Introduction 

B. Restaurant or Similar Retail Food 

Establishment 

C. Restaurant Food and Restaurant-Type 

Food 

D. Part of a Chain With 20 or More 

Locations 

E. Doing Business Under the Same Name 

F. Offering for Sale Substantially the Same 

Menu Items 

G. Authorized Official of a Restaurant or 

Similar Retail Food Establishment 

H. Covered Establishment 

I. Revisions to Several Provisions to Clarify 

the Applicability of the Rule to Those 

Restaurants and Similar Retail Food 

Establishments That Are Covered 

Establishments 

VII. Comments and FDA Response on the 

Proposed Definition of Menu or Menu 

Board (Proposed § 101.11(a)) 

VIII. Comments and FDA Response on the 

Proposed Definition of Terms Related to 

Foods Covered by the Rule (Proposed 

§ 101.11(a)) 

A. Restaurant Food and Restaurant-Type 

Food 

B. Standard Menu Item 

C. Combination Meal 

D. Variable Menu Item 

E. Food on Display 

F. Self-Service Food 

G. Custom Order 

H. Daily Special 

I. Food That Is Part of a Customary Market 

Test 

J. Temporary Menu Item 

IX. Comments and FDA Response on 

Proposed § 101.11(b)(1)(i)—Food Subject 

to the Labeling Requirements 

X. Comments and FDA Response on 

Proposed § 101.11(b)(1)(ii)—Food Not 

Subject to the Labeling Requirements 

A. The Proposed Requirements 

B. Alcohol 

C. Condiments 

D. Daily Specials, Temporary Menu Items, 

Custom Orders, and Food That Is Part of 

a Customary Market Test 

E. Additional Comments on Food That Is 

Part of a Customary Market Test 

XI. Comments and FDA Response on 

Proposed § 101.11(b)(2)(i)(A)(1) to 

(b)(2)(i)(A)(3)—General Requirements for 

Calorie Declaration on Menus and Menu 

Boards 

XII. Additional Format Requirements That 

Apply When Declaring Calories on 

Menus and Menu Boards for Variable 

Menu Items, Combination Meals, and 

Toppings (Final § 101.11(b)(2)(i)(A)(4) 

Through (b)(2)(i)(A)(8)) 

A. Proposed Format for Declaring Calories 

for Variable Menu Items 

B. Decision To Require Option 4 

C. Requirements That Apply to Individual 

Variable Menu Items (Final 

§ 101.11(b)(2)(i)(A)(4)) 

D. Requirements That Apply to a Variable 

Menu Item That Is Offered for Sale With 

the Option of Adding Toppings Listed on 

the Menu or Menu Board (Final 

§ 101.11(b)(2)(i)(A)(5)) 

E. Requirements That Apply to a 

Combination Meal (Final 

§ 101.11(b)(2)(i)(A)(6)) 

F. Format Requirements for Declaring 

Calories for an Individual Variable Menu 

Item, a Combination Meal, and Toppings 

as a Range, if Applicable (Final 

§ 101.11(b)(2)(i)(A)(7)) 

G. Exception for a Variable Menu Item 

When There Is No Clearly Identifiable 

Upper Bound to the Range of Calories 

(Final § 101.11(b)(2)(i)(A)(8)) 

H. Declaring Calories Using Interactive 

Menus or New Technology 

XIII. Additional Requirements That Apply to 

Beverages That Are Not Self-Service or 

on Display (Final § 101.11(b)(2)(i)(A)(9)) 

XIV. Comments and FDA Response on 

Proposed § 101.11(b)(2)(i)(B)—Succinct 

Statement That Must Be on Menus and 

Menu Boards To Provide Context About 

Calories in a Daily Diet 

A. The Proposed Requirements 

B. Principles for Establishing the Succinct 

Statement 


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Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 71157 

C. Wording of the Succinct Statement 

D. Succinct Statement on Menus Targeted 

to Children 

E. Requirements for the Succinct Statement 

To Be Prominent, Clear, and 

Conspicuous 

F. Placement of the Succinct Statement on 

Menus and Menu Boards 

XV. Comments and FDA Response on 

Proposed § 101.11(b)(2)(i)(C)—Statement 

That Must Be on Menus and Menu 

Boards About Availability of Written 

Nutrition Information 

A. Proposed Wording of the Statement of 

Availability 

B. Requirements for the Statement of 

Availability To Be Prominent and 

Conspicuous 

C. Placement of the Statement of 

Availability 

XVI. Comments and FDA Response on 

Proposed § 101.11(b)(2)(ii)—Nutrition 

Information That Must Be Made 

Available in Written Form 

A. Required Nutrients 

B. Manner of Presentation of the Written 

Nutrition Information 

C. Nutrients in Insignificant Amounts 

D. Variable Menu Items 

E. Form of the Written Nutrition 

Information 

XVII. Comments and FDA Response on 

Proposed § 101.11(b)(2)(iii)— 

Requirements for Food That Is SelfService or on Display 

A. Applicability of § 101.11(b)(2)(i) to Food 

That Is Self-Service or on Display 

B. Placement of Calories for Self-Service 

Foods and Foods on Display 

C. Declaring Calories ‘‘Per Item’’ or ‘‘Per 

Serving’’ 

D. Declaring Calories ‘‘Per Serving’’ for 

Self-Service Beverages 

E. Manner of Declaring Calories for SelfService Foods and Foods on Display 

F. Applicability of Requirements for 

Written Nutrition Information, Succinct 

Statement, and Statement of Availability 

to Self-Service Foods and Foods on 

Display 

G. Succinct Statement and Statement of 

Availability for Self-Service Foods and 

Foods on Display 

H. The Written Nutrition Information That 

Must Be Provided for Food That Is SelfService or on Display 

XVIII. Comments and FDA Response on 

Proposed § 101.11(c)(1) to (c)(5)— 

Determination of Nutrient Content (Final 

§ 101.11(c)(1) to (c)(2)) 

XIX. Comments and FDA Response on 

Proposed § 101.11(c)(6)—Substantiation 

Documentation (Final 101.11(c)(3)) 

XX. Comments and FDA Response on 

Proposed § 101.11(d)—Voluntary 

Registration to Elect To Be Subject to the 

Rule 

XXI. Comments and FDA Response on 

Proposed § 101.11(e)—Signatures 

XXII. Comments and FDA Response on 

Proposed § 101.11(f)—Misbranding 

XXIII. Comments and FDA Response on 

Effective Date 

A. Proposed Effective Date and Request for 

Comment 

B. Comments on Proposed Effective Date 

C. Effective Date and Compliance Date for 

This Rule 

XXIV. Comments and FDA Response on 

Compliance 

XXV. Final Regulatory Impact Analysis 

XXVI. Paperwork Reduction Act of 1995 

XXVII. Federalism 

XXVIII. Environmental Impact 

XXIX. References 

Executive Summary 

Purpose and Coverage of the Final Rule 

More than two thirds of adults and 

about a third of children in the United 

States are overweight or obese. 

Overconsumption of calories is one of 

the primary risk factors for overweight 

and obesity. About half of consumers’ 

annual food dollars are spent on, and a 

third of total calories come from, foods 

prepared outside the home, including 

foods from restaurants and similar retail 

food establishments. Many people do 

not know, or underestimate, the calorie 

and nutrient content of these foods. To 

help make nutrition information for 

these foods available to consumers in a 

direct, accessible, and consistent 

manner to enable consumers to make 

informed and healthful dietary choices, 

section 4205 of the ACA requires that 

calorie and other nutrition information 

be provided to consumers in 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 

establishment). Section 4205 of the ACA 

also provides that a restaurant or similar 

retail food establishment that is not a 

chain retail food establishment may 

elect to be subject to section 4205’s 

nutrition labeling requirements by 

registering every other year with FDA. 

To be covered by this rule, an 

establishment must satisfy several 

criteria. First, the establishment must be 

a restaurant or similar retail food 

establishment. Under this rule, that 

means a retail establishment that offers 

for sale restaurant-type food, except if it 

is a school as defined in 7 CFR 210.2 or 

220.2. Restaurants and similar retail 

food establishments include bakeries, 

cafeterias, coffee shops, convenience 

stores, delicatessens, food service 

facilities located within entertainment 

venues (such as amusement parks, 

bowling alleys, and movie theatres), 

food service vendors (e.g., ice cream 

shops and mall cookie counters), food 

take-out and/or delivery establishments 

(such as pizza take-out and delivery 

establishments), grocery stores, retail 

confectionary stores, superstores, quick 

service restaurants, and table service 

restaurants. 

The rule defines ‘‘restaurant-type 

food’’ in a way that both focuses on the 

food most like the food offered for sale 

in restaurants and reflects the statutory 

context of section 4205 of the ACA. The 

table that follows provides examples of 

foods that generally would be 

considered restaurant-type food (e.g., 

foods that are usually eaten on the 

premises, while walking away, or soon 

after arriving at another location), as 

well as examples of foods that generally 

would be not be considered restauranttype food (e.g., foods that are grocerytype items that consumers often store 

for use at a later time or customarily 

further prepare), for the purposes of this 

rule. 


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71158 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

EXAMPLES OF FOODS THAT GENERALLY WOULD OR WOULD NOT BE CONSIDERED RESTAURANT-TYPE FOOD

Examples of foods that generally would be considered 

restaurant-type food 

Examples of foods that generally would not be considered 

restaurant-type food 

• Food for immediate consumption at a sit-down or quick service restaurant.

• Food purchased at a drive-through establishment ...............................

• Food purchased at a drive-through establishment ...............................

• Take-out and delivery pizza; hot pizza at grocery and convenience 

stores that is ready to eat; pizza slice from a movie theater.

• Hot buffet food, hot soup at a soup bar, and food from a salad bar ...

• Foods ordered from a menu/menu board at a grocery store intended 

for individual consumption (e.g., soups, sandwiches, and salads).

• Self-service foods and foods on display that are intended for individual consumption (e.g., sandwiches, wraps, and paninis at a deli 

counter; salads plated by the consumer at a salad bar; cookies from 

a mall cookie counter; bagels, donuts, rolls offered for individual 

sale).

• Certain foods bought from bulk bins or cases (e.g., dried fruit, nuts) 

in grocery stores 

• Foods to be eaten over several eating occasions or stored for later 

use (e.g., loaves of bread, bags or boxes of dinner rolls, whole 

cakes, and bags or boxes of candy or cookies) 

• Foods that are usually further prepared before consuming (e.g., deli 

meats and cheeses) 

• Foods sold by weight that are not self-serve and are not intended 

solely for individual consumption (e.g., deli salads sold by unit of 

weight such as potato salad, chicken salad), either prepacked or 

packed upon consumer request 

Consistent with the statute, to be 

covered by the rule, a restaurant or 

similar retail establishment must be 

‘‘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.’’ A restaurant or similar retail 

food establishment that does not satisfy 

these criteria may choose to be covered 

by the rule by registering with FDA 

using a process established in the rule. 

Under the rule, ‘‘location’’ means a 

fixed position or site. Transportation 

venues such as trains and airplanes are 

not covered by the rule because they do 

not have a fixed position or site. ‘‘Doing 

business under the same name’’ means 

a restaurant or similar retail food 

establishment must share the same 

name as other establishments in the 

chain (regardless of the type of 

ownership of the locations, e.g., 

individual franchises). The term 

‘‘name’’ refers to either the name of the 

establishment presented to the public 

or, if there is no name of the 

establishment presented to the public 

(e.g., an establishment with the generic 

descriptor ‘‘concession stand’’), the 

name of the parent entity of the 

establishment. ‘‘Offering for sale 

substantially the same menu items’’ 

means offering for sale a significant 

proportion of menu items that use the 

same general recipe and are prepared in 

substantially the same way with 

substantially the same food 

components, even if the name of the 

menu item varies. 

The nutrition labeling requirements of 

the rule apply to standard menu items 

offered for sale in covered 

establishments. ‘‘Standard menu item’’ 

means a restaurant-type food that is 

routinely included on a menu or menu 

board or routinely offered as a selfservice food or food on display. The 

nutrition labeling requirements are not 

applicable to certain foods, including 

foods that are not standard menu items, 

such as condiments, daily specials, 

temporary menu items, custom orders, 

and food that is part of a customary 

market test; and self-service food and 

food on display that is offered for sale 

for less than a total of 60 days per 

calendar year or fewer than 90 

consecutive days in order to test 

consumer acceptance. In addition, the 

rule exempts alcohol beverages that are 

food on display and are not self-service 

food (e.g., bottles of liquor behind the 

bar used to prepare mixed drinks) from 

the labeling requirements that apply to 

food on display. 

Summary of the Major Provisions of the 

Final Rule 

The rule includes provisions that: 

• Define terms, including terms that 

describe criteria for determining 

whether an establishment is subject to 

the rule; 

• Establish which foods are subject to 

the nutrition labeling requirements and 

which foods are not subject to these 

requirements; 

• Require that calories for standard 

menu items be declared on menus and 

menu boards that list such foods for 

sale; 

• Require that calories for standard 

menu items that are self-service or on 

display be declared on signs adjacent to 

such foods; 

• Require that written nutrition 

information for standard menu items be 

available to consumers who ask to see 

it; 

• Require, on menus and menu 

boards, a succinct statement concerning 

suggested daily caloric intake (succinct 

statement), designed to help the public 

understand the significance of the 

calorie declarations; 

• Require, on menus and menu 

boards, a statement regarding the 

availability of the written nutrition 

information (statement of availability); 

• Establish requirements for 

determination of nutrient content of 

standard menu items; 

• Establish requirements for 

substantiation of nutrient content 

determined for standard menu items, 

including requirements for records that 

a covered establishment must make 

available to FDA within a reasonable 

period of time upon request; and 

• Establish terms and conditions 

under which restaurants and similar 

retail food establishments not otherwise 

subject to the rule could elect to be 

subject to the requirements by 

registering with FDA. 

Costs and Benefits 

The statute requires nutrition labeling 

for standard menu items on menus and 

menu boards for certain restaurants and 

similar retail food establishments and 

calorie labeling for food sold from 

certain vending machines. FDA is 

issuing two separate final rules (one for 

menu labeling and one for vending 

machine labeling) to implement those 

labeling requirements. Taken together 

the labeling requirements (of the menu 

labeling and vending machine labeling 

rules combined) are estimated to have 

benefits exceeding costs by $477.9 

million on an annualized basis (over 20 

years discounted at 7 percent). 


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Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 71159 

SUMMARY OF COSTS AND BENEFITS OF MENU LABELING AND VENDING MACHINE RULES

[In millions] 

Rate Potential benefits 

Estimated 

costs Net benefits 

Total for Labeling (menu and vending rules) over 20 years* .................................... 3 $9,221.3 $1,697.9 $7,523.4 

7 6,752.8 1,333.9 5,418.9 

Annualized for Labeling (menu and vending rules) over 20 years* .......................... 3 601.9 110.8 491.1 

7 595.5 117.6 477.9 

Total for Menu Labeling over 20 years ..................................................................... 3 9,221.3 1,166.8 8,054.5 

7 6,752.8 932.8 5,820.0 

Annualized for Menu Labeling over 20 years ............................................................ 3 601.9 76.9 525.01 

7 595.5 84.5 510.99 

* Benefits for the vending machine labeling rule are not quantified and are not counted in these values. 

I. Background 

More than two thirds of adults and 

about a third of children in the United 

States are overweight or obese (Refs. 1 

and 2). Overconsumption of calories is 

one of the primary risk factors for 

overweight and obesity (Ref. 3). About 

half of consumers’ annual food dollars 

are spent on, and a third of total calories 

come from, foods prepared outside the 

home, including foods from restaurants 

and similar retail food establishments 

(Refs. 4 to 6). Research indicates that 

many people do not know, or 

underestimate, the calorie and nutrient 

content of these foods (Ref. 7). 

Since the early 1990s, the Nutrition 

Labeling and Education Act of 1990 

(NLEA) and our regulations in § 101.9 

(21 CFR 101.9) implementing the NLEA 

have required that the labeling for many 

foods bear nutrition information, 

including calorie information. However, 

as we noted in the proposed rule (76 FR 

19192 at 19193; April 6, 2011), the 

NLEA left a gap in the Federal 

requirements for nutrition labeling 

through certain exemptions. The NLEA 

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’’ (section 

403(q)(5)(A)(i) of the FD&C Act) (21 

U.S.C. 343(q)(5)(A)(i)). The NLEA 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’’ 

(section 403(q)(5)(A)(ii) of the FD&C 

Act). 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 (21 CFR 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 (21 CFR 101.13)) or health 

claim (defined in 21 CFR 101.14) to 

provide certain nutrition information 

upon request. For example, if a menu 

lists an entree as being low in fat, 

information about the amount of fat in 

the entree must be available upon 

request (§ 101.10). 

Section 101.9(j)(2) of our regulations 

implementing the NLEA includes 

examples of restaurants or other 

establishments in which food sold for 

immediate human consumption 

generally was exempted from nutrition 

labeling requirements under the NLEA. 

Section 101.9(j)(3) of these regulations 

includes 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. 

Several State and local governments 

enacted their own laws requiring 

nutrition labeling on menus and menu 

boards to fill the gap in the Federal 

requirements. However, these State and 

local requirements vary significantly in 

their substantive requirements and the 

set of establishments to which they 

apply. 

On March 23, 2010, the ACA (Pub. L. 

111–148) was signed into law. Section 

4205 of the ACA amends section 403(q) 

of the FD&C Act, which governs 

nutrition labeling requirements, and 

section 403A of the FD&C Act (21 U.S.C. 

343–1), which governs Federal 

preemption of State and local food 

labeling requirements. As amended, 

section 403(q)(5)(H) of the FD&C Act 

requires chain retail food establishments 

with 20 or more locations to provide 

calorie information for standard menu 

items, including food on display and 

self-service food, and to provide, upon 

consumer request, additional written 

nutrition information for standard menu 

items (21 U.S.C. 343(q)(5)(H)(i) to (iii)). 

Section 403(q)(5)(H) of the FD&C Act 

also provides that a restaurant or similar 

retail food establishment not otherwise 

subject to the requirements of section 

403(q)(5)(H) (e.g., a restaurant that is not 

part of a chain with 20 or more 

locations) may elect to be subject to the 

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

registering every other year with FDA 

(21 U.S.C. 343(q)(5)(H)(ix)). Thus, 

‘‘covered establishments’’ include both 

chain retail food establishments and 

other restaurants or similar retail food 

establishments that voluntarily register 

to be subject to the rule. A standard 

menu item offered for sale in a covered 

establishment is deemed to be 

misbranded if the requirements of 

section 403(q)(5)(H) are not met. 

Section 4205 of the ACA became 

effective on the date the law was signed, 

March 23, 2010; however, FDA must 

issue rules before some provisions can 

be required. On July 7, 2010, we 

published a notice in the Federal 

Register to solicit comments and 

suggestions on the new law (2010 

docket notice) (75 FR 39026). On August 

25, 2010, we published for public 

comment 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’’ (draft 

implementation guidance) (Ref. 8) (75 

FR 52426), describing which provisions 

became requirements upon enactment of 

the law, which provisions we would 

implement through rulemaking, and 

draft interpretations of certain 

provisions, including a broad 

interpretation of the scope of 

establishments covered. On January 25, 

2011, we published in the Federal 

Register a notice withdrawing the draft 

implementation guidance (76 FR 4360) 

and announcing our intent to exercise 

our enforcement discretion until we 


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71160 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

complete the notice and comment 

rulemaking process. 

In the Federal Register of April 6, 

2011 (76 FR 19192), we issued a 

proposed rule (proposed rule) to 

implement the requirements of section 

4205 of the ACA for the nutrition 

labeling of standard menu items in 

certain restaurants and similar retail 

food establishments. We requested 

public comments on the proposed 

requirements and some alternatives by 

June 6, 2011. In the Federal Register of 

May 24, 2011 (76 FR 30050), we issued 

a document (correction document) 

correcting errors in the proposed rule, 

including errors in cross-references, an 

incomplete address, and a typographical 

error in the codified section of the 

document. In the Federal Register of 

May 24, 2011 (76 FR 30051), we 

extended the comment period until July 

5, 2011. 

In the proposed rule, we described 

both the provisions that became 

requirements upon enactment (i.e., they 

are self-executing) and the provisions 

that depend on FDA to issue rules 

before they can become effective (76 FR 

19192 at 19194). We also noted that we 

had published the draft implementation 

guidance and described the issues 

addressed by the draft implementation 

guidance. In the proposed rule, we 

reiterated that we intended to exercise 

enforcement discretion for the selfexecuting provisions of section 4205 of 

the ACA and described our reasons for 

doing so (76 FR 19192 at 19194). 

After considering comments to the 

proposed rule, we are issuing this final 

rule to implement the requirements of 

section 4205 of the ACA for the 

nutrition labeling of standard menu 

items in certain chain restaurants and 

similar retail food establishments. 

In addition to the nutrition labeling 

requirements for standard menu items, 

other amendments made by section 

4205 of the ACA to the FD&C Act 

(specifically, section 

403(q)(5)(H)(viii)(I)) establish calorie 

disclosure requirements for certain 

articles of food sold from vending 

machines. We published a proposed 

rule to implement the vending machine 

provisions of section 403(q) of the FD&C 

Act on April 6, 2011 (76 FR 19238; the 

proposed vending machine rule). 

Elsewhere in this issue of the Federal 

Register, we are issuing a final rule to 

implement the vending machine 

provisions of section 403(q)(5)(H)(viii)(I) 

of the FD&C Act. 

II. Legal Authority 

On March 23, 2010, the ACA was 

signed into law. Section 4205 of the 

ACA amended section 403(q)(5) of the 

FD&C Act 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 in the labeling for 

such foods. Under section 403(f) of the 

FD&C Act, any word, statement, or other 

information required by or under 

authority of the FD&C Act to appear on 

the label or labeling of a food is required 

to be prominently placed thereon with 

such conspicuousness (as compared 

with other words, statements, designs, 

or devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use. Under section 

403(a)(1) of the FD&C Act, food labeling 

must be truthful and non-misleading. 

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 made in the labeling or 

with respect to consequences that may 

result from use. Section 403(q)(5)(H)(x) 

of the FD&C Act requires that the 

Secretary of Health and Human Services 

(Secretary) issue regulations to carry out 

requirements in section 403(q)(5)(H). 

Section 701(a) of the FD&C Act (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, we have the authority to issue this 

final rule under sections 201(n), 

403(a)(1), 403(f), 403(q)(5)(H), and 

701(a) of the FD&C Act. 

We have revised our labeling 

regulations by adding new § 101.11 to 

require that covered establishments 

provide calorie and other nutrition 

information for standard menu items, 

including food on display and selfservice food. Also, we are establishing 

the terms and conditions for voluntary 

registration by establishments that are 

not otherwise subject to the 

requirements of section 4205 of the ACA 

but elect to become subject to such 

requirements. 

III. General Comments on the Proposed 

Rule 

A. Introduction 

We received approximately 900 

submissions on the proposed rule by the 

close of the comment period, each 

containing one or more comments. We 

received submissions from consumers; 

consumer groups; trade organizations; 

industry (including restaurants, 

entertainment venues, food service 

operations, and grocery stores); public 

health organizations; public advocacy 

groups; contractors; Congress; Federal, 

State, and local Government Agencies; 

and other organizations. 

We describe and respond to the 

comments in sections III, IV, VI through 

XXIV, and XXVII of this document. To 

make it easier to identify comments and 

our responses, the word ‘‘Comment,’’ in 

parentheses, appears before the 

comment’s description, and the word 

‘‘Response,’’ in parentheses, appears 

before our response. We have also 

numbered each comment and response 

to help distinguish between different 

comments and responses. The number 

assigned to each comment is purely for 

organizational purposes and does not 

signify the comment’s value or 

importance or the order in which it was 

received. 

B. Description of General Comments 

and FDA Response 

Many comments made general 

remarks supporting or opposing the rule 

and did not focus on a particular section 

of the rule. The majority of these 

comments expressed general support for 

nutrition labeling of standard menu 

items in covered establishments, and we 

do not discuss them in detail. In the 

following paragraphs, we discuss 

general comments that did not support 

the rule as proposed. 

(Comment 1) Some comments stated 

that people do not need to be told what 

to eat. Some comments asserted that 

calorie disclosure on menus will either 

cause eating disorders or affect those 

with eating disorders. Other comments 

asserted that the menu labeling 

requirements will not affect consumer 

behavior, there will be information 

overload, and people will ignore the 

information. Some comments 

considered that the menu labeling 

requirements will promote healthier 

choices, whereas other comments 

considered that the menu labeling 

requirements will not promote healthier 

choices. Some comments supported the 

menu labeling requirements but 

considered that education is needed to 

fight obesity. 

(Response 1) The rule does not tell 

consumers what they should or should 

not eat. The nutrition labeling required 

by section 4205 of the ACA will provide 

nutrition information to consumers in 

covered establishments in a direct, 

accessible, and consistent manner to 

enable consumers to make informed 

choices about the foods they purchase 

in such establishments. 


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About half of consumers’ annual food 

dollars are spent on, and a third of total 

calories come from, foods prepared 

outside of the home, including foods 

from restaurants or similar retail food 

establishments (Refs. 4 to 6). Further, 

research indicates that many people do 

not know, or underestimate, the calorie 

and nutrient content of these foods (Ref. 

7). Accordingly, providing direct access 

to nutrition information for these foods 

will enable consumers to make 

informed decisions within the context 

of nutrition regarding the foods they 

purchase in restaurants or similar retail 

food establishments. Providing nutrition 

information to consumers for standard 

menu items offered for sale in covered 

establishments will give consumers 

much needed access to essential 

nutrition information for a large and 

growing number of the foods they 

purchase and consume. In addition, it 

will allow consumers to make informed 

nutritional comparisons between 

different foods and informed purchase 

decisions. Further, section 4205 of the 

ACA and this rule require covered 

establishments to post, on menus and 

menu boards, a succinct statement 

concerning suggested daily caloric 

intake 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. This statement, along 

with the required calorie information, 

will enable consumers to better 

understand the significance of the 

calorie information provided on menus 

and menu boards and the potential 

impacts of overconsumption of calories. 

As a result, the information will enable 

consumers to assess their calorie intake 

during short- or long-term settings and 

better understand how the foods that 

they purchase at covered establishments 

fit within their daily caloric and other 

nutritional needs. 

The comments provided no evidence 

that the provision of nutrition labeling 

at the point of purchase causes or 

adversely affects those with eating 

disorders. For nearly two decades, 

consumers have had access to this type 

of information on the labels of packaged 

foods that bear the Nutrition Facts label 

in accordance with § 101.9. We are not 

aware of data or other information 

demonstrating that the availability of 

nutrition information through the 

Nutrition Facts Panel has either caused 

eating disorders or negatively impacted 

persons with eating disorders. In 

addition, Congress, through section 

4205 of the ACA, requires covered 

establishments to provide calorie and 

other nutrition information for standard 

menu items. This rulemaking 

implements that Congressional 

mandate. 

(Comment 2) Some comments 

considered that the requirements are 

unnecessary because most ‘‘fast food’’ 

restaurants have the information 

already. One comment considered that 

the proposed requirements constitute a 

tax increase designed to relieve the 

individual of personal responsibility. 

(Response 2) Section 4205 of the ACA 

requires covered establishments to 

provide calorie and other information 

for standard menu items on menus, 

menu boards, signs adjacent to selfservice foods and foods on display and 

additional nutrition information for 

standard menu items in written form, 

available on the premises, to consumers 

on request. Therefore, section 4205 of 

the ACA requires covered 

establishments to provide nutrition 

information to consumers in a direct, 

accessible, and consistent manner, 

typically at points of purchase, where 

consumers make order selections. While 

some ‘‘fast food’’ establishments may 

already have some nutrition information 

available to consumers in some fashion, 

these establishments are a subset of the 

establishments required to comply with 

the requirements of this rule, and these 

establishments may not be providing 

nutrition information to consumers in 

the manner required by section 4205 of 

the ACA. 

Regarding the comment asserting that 

the proposed requirements somehow 

negate personal responsibility, we 

reiterate that the requirements do not 

tell consumers what they should or 

should not eat or otherwise interfere 

with a consumer’s ability to purchase 

foods. In fact, as we noted previously, 

this rule requires covered 

establishments to provide accurate 

nutrition information to consumers in a 

direct and accessible manner to enable 

consumers to make informed and 

healthful dietary choices. 

(Comment 3) Some comments 

addressed concerns related to 

enforcement. One comment expressed 

concern that the proposed rule did not 

set forth a clear ‘‘chain of liability’’ for 

food that is misbranded under the rule 

and related provisions of the FD&C Act, 

specifically sections 201(n), 403(a), or 

403(q) of the FD&C Act. The comment 

stated that it is unclear whether FDA 

might impose vicarious liability on the 

franchisor or licensor of a restaurant for 

such misbranded food, particularly 

where the franchisor or licensor retains 

power over the menus and menu boards 

used by the restaurants. The comment 

also expressed concern that restaurants 

that ‘‘unwittingly ’misbrand’ their menu 

offerings’’ will be held liable for their 

food that is misbranded under this rule 

and related provisions of the FD&C Act. 

(Response 3) Persons exercising 

authority and supervisory responsibility 

over a restaurant or similar retail food 

establishment can be held responsible 

for violations under the FD&C Act. See 

United States v. Park, 421 U.S. 658, 659 

(1978). (‘‘The Act imposes upon persons 

exercising authority and supervisory 

responsibility reposed in them by a 

business organization not only a 

positive duty to seek out and remedy 

violations but also, and primarily, a 

duty to implement measures that will 

insure that violations will not occur 

. . . .’’) (citing United States v. 

Dotterweich, 320 U.S. 277 (1943)). 

Agency decisions regarding enforcement 

actions will be determined on a case by 

case basis. 

(Comment 4) Some comments 

addressed issues unrelated to the 

specific nutrition labeling requirements 

of section 4205 of the ACA, such as 

labeling of genetically engineered foods, 

allergens, gluten, food additives 

(including preservatives), artificial 

sweeteners, ingredients, pesticides, and 

organic foods; labeling to indicate 

whether a food has been irradiated; 

labeling of alcohol as a toxin; labeling 

the country of origin; and labeling the 

‘‘gender of meat products.’’ 

(Response 4) Section 4205 of the ACA 

requires covered establishments to 

provide certain nutrition information for 

standard menu items. It does not 

address the labeling issues raised in 

these comments. Therefore, we do not 

address these issues in this document. 

(Comment 5) Some comments 

directed to what establishments would 

be covered by the rule pointed to a 

report submitted by a U.S. House of 

Representatives Appropriations 

Committee explaining an appropriations 

bill for Agriculture, Rural Development, 

Food and Drug Administration, and 

Related Agencies for fiscal year 2012 

(Ref. 9). The comments quoted an 

excerpt from the report (‘‘. . . and the 

Committee believes that the FDA should 

define the term restaurant to mean only 

restaurants doing business marketed 

under the same name or retail 

establishments where the primary 

business is the selling of food for 

immediate consumption . . .’’) to 

signify Congressional intent on the 

scope of establishments subject to 

section 4205 of the ACA or as evidence 

supporting their own recommendations 

regarding the establishments that should 

be covered by the rule. (We note that 

some comments reported the date of the 

report as June 3, 2011, and one 

comment reported the date of the report 


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as May 27, 2011. We identified a report 

dated June 3, 2011 (Ref. 9), but did not 

identify a report dated May 27, 2011. 

For the purpose of this document, we 

assume that the comments are referring 

to the report dated June 3, 2011.) 

(Response 5) We disagree that an 

Appropriations Committee report from a 

Congress subsequent to the Congress 

that passed section 4205 of the ACA can 

be used as evidence of the intent of the 

previous Congress that passed section 

4205. The Appropriations Committee 

report cited by the comments is dated 

after the ACA was passed, so it is not 

part of the relevant legislative history 

and carries no interpretive weight on 

this issue (see, e.g., Bruesewitz v. Wyeth, 

131 U.S. 1068, 1081 (2011)). 

IV. Comments and FDA Response on 

Proposed Conforming Amendments 

A. Section 11.1(g)—Electronic 

Signatures 

Proposed § 11.1(g) (21 CFR 11.1(g)) 

would provide that 21 CFR part 11 

regarding electronic signatures does not 

apply to electronic signatures obtained 

under the voluntary registration 

provision for covered restaurants and 

similar retail food establishments at 

proposed § 101.11(d). 

We received no comments on this 

proposed provision and are finalizing it 

without change. 

B. Sections 101.9(j)(1)(i), (j)(2) and 

(j)(3)—Nutrition Labeling of Food 

Our proposed amendment to 

§ 101.9(j)(1)(i) would specify that claims 

or other nutrition information subject 

the food to the nutrition labeling 

provisions of § 101.11 as well as § 101.9 

or § 101.10 (nutrition labeling of 

restaurant foods), as applicable. 

Our proposed amendments to 

§ 101.9(j)(2) and (j)(3) would change the 

introductory text of paragraphs (j)(2) 

and (j)(3) to add the phrase ‘‘Except as 

provided in § 101.11, food products that 

are:’’. 

We received no comments on these 

proposed provisions and are finalizing 

them without change. However, we also 

are adding a conforming amendment to 

add the phrase ‘‘Except as provided in 

§ 101.11’’ to the beginning of the first 

sentence in § 101.9(j)(4). As with 

§ 101.9(j)(2) and (j)(3), § 101.9(j)(4) 

needs to be revised to exclude standard 

menu items sold in covered 

establishments and reference the special 

labeling requirements for those foods in 

§ 101.11 (see § 101.11(b)(2)(ii)(B)). 

C. Section 101.10—Nutrition Labeling of 

Restaurant Foods Whose Labels or 

Labeling Bear Nutrient Content Claims 

or Health Claims 

Our proposed amendment to § 101.10 

would provide that the information in 

the written nutrition information 

required by § 101.11(b)(2)(ii)(A) for 

standard menu items that are offered for 

sale in covered establishments (as 

defined in § 101.11(a)) will serve to 

meet the requirements of § 101.10. 

We received no comments on this 

proposed provision. Given our removal 

of the term ‘‘restaurant food’’ and our 

revision of the term ‘‘restaurant-type 

food’’ in § 101.11, we are adding a 

conforming amendment to ensure that 

the use of the term ‘‘restaurant foods’’ in 

§ 101.10, which predates the ACA, is 

not confusing. We are inserting three 

sentences between the current first and 

second sentences of § 101.10, to clarify 

that the scope of § 101.10 includes those 

foods described in section 

403(q)(5)(A)(i) and (ii) of the FD&C Act. 

These sentences describe that, for the 

purposes of § 101.10, restaurant food 

includes two categories of food. The 

first category of food is that which is 

served in restaurants or other 

establishments in which food is served 

for immediate human consumption or 

which is sold for sale or use in such 

establishments. The second category of 

food is that which is processed and 

prepared primarily in a retail 

establishment, which is ready for 

human consumption, which is of the 

type described in the first category, and 

which is offered for sale to consumers 

but not for immediate consumption in 

such establishment and which is not 

offered for sale outside such 

establishment. This scope is reflected in 

numerous prior Agency statements, 

including in the preamble to our final 

rule entitled ‘‘Food Labeling: Nutrient 

Content Claims, General Principles, 

Petitions, Definition of Terms; 

Definitions of Nutrient Content Claims 

for the Fat, Fatty Acid, and Cholesterol 

Content of Food’’ (58 FR 2302, 2386, 

January 6, 1993), and in our 2008 

‘‘Guidance for Industry: A Labeling 

Guide for Restaurants and Other Retail 

Establishments Selling Away-FromHome Foods’’ (Ref. 10). This change 

does not alter the meaning or 

applicability of § 101.10. 

V. Key Terms That FDA Proposed To 

Define (Proposed § 101.11(a)) 

To establish the scope of 

establishments, labeling, and food 

covered by section 4205 of the ACA, we 

proposed to define key terms (proposed 

§ 101.11(a)). We also proposed to 

establish that the definitions in section 

201 of the FD&C Act apply when used 

in § 101.11 (proposed § 101.11(a)). We 

received no comments regarding the use 

of statutory definitions in section 201 of 

the FD&C Act, and we are finalizing that 

provision without change. 

In the next section of this document, 

we discuss the final definitions and 

related comments, organized into three 

categories: (1) Terms related to the 

scope of establishments covered by the 

rule, (2) the terms menu and menu 

board, and (3) terms related to foods 

covered. This organization is consistent 

with our discussion of our proposed 

terms in the preamble to the proposed 

rule. 

VI. Comments and FDA Response on 

the Proposed Definitions of Terms 

Related to the Scope of Establishments 

Covered by the Rule (Proposed 

§ 101.11(a)) 

A. Introduction 

To specify establishments that would 

be subject to the nutrition labeling 

requirements of section 4205 of the 

ACA, we proposed to define ‘‘covered 

establishment’’ to mean a restaurant or 

similar retail food establishment that is 

a part of a chain with 20 or more 

locations doing business under the same 

name (regardless of the type of 

ownership, e.g., individual franchises) 

and offering for sale substantially the 

same menu items, as well as a restaurant 

or similar retail food establishment that 

is registered to be covered under section 

403(q)(5)(H)(ix) of the FD&C Act. 

(Emphasis added). 

Importantly, the definition of 

‘‘covered establishment’’ includes 

several terms, identified in italics, that 

are defined in the rule. In addition, the 

proposed definition of one of these 

terms—i.e., ‘‘restaurant or similar retail 

food establishment’’—includes other 

terms we proposed to define—i.e., 

‘‘restaurant food’’ and ‘‘restaurant-type 

food.’’ Thus, any revisions we make to 

the proposed definitions of any of these 

terms may affect whether a particular 

establishment is a ‘‘covered 

establishment’’ for the purposes of this 

rule. As discussed more fully in sections 

VI.B, VI.C, VI.D, VI.E, and VI.F: 

• We have revised the definition of 

‘‘restaurant or similar retail food 

establishment’’ to mean a retail 

establishment that offers for sale 

restaurant-type food, except if it is a 

school as defined in 7 CFR 210.1 or 

220.2; 

• We have revised the definition of 

the term ‘‘restaurant-type food’’ to focus 

on the food most like the food offered 

for sale in restaurants; 


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• We are adding a definition of 

‘‘locations’’ to clarify our interpretation 

of ‘‘part of a chain with 20 or more 

locations’’; 

• We have revised the definition of 

‘‘doing business under the same name’’ 

so that the term ‘‘name’’ refers to either 

(1) the name of the establishment 

presented to the public or (2), if there is 

no name of the establishment presented 

to the public (e.g., an establishment 

with the generic descriptor ‘‘concession 

stand’’), the name of the parent entity of 

the establishment; and 

• We have revised the definition of 

‘‘offering for sale substantially the same 

menu items’’ to add a qualitative 

description of the number of menu 

items that must be shared in order for 

the criterion of ‘‘offering for sale 

substantially the same menu items’’ to 

be met. 

We proposed to define the term ‘‘gross 

floor area’’ because we proposed that it 

be used in the definition of restaurant or 

similar retail food establishment. While 

we received comments on this proposed 

definition, as discussed in section 

VI.B.2 the definition of restaurant or 

similar retail food establishment in this 

rule no longer considers gross floor area. 

Therefore, we are deleting the proposed 

definition of ‘‘gross floor area’’ because 

it is no longer relevant to the scope of 

establishments covered by this rule. 

B. Restaurant or Similar Retail Food 

Establishment 

1. The Proposed Definition 

Proposed § 101.11(a) would define 

‘‘restaurant or similar retail food 

establishment’’ as 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. Proposed § 101.11(a) 

would provide that 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 (primary 

purpose 1), 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 

(primary purpose 2). (See Figure 1 in the 

proposed rule (76 FR 19192 at 19201), 

in which we coined the terms ‘‘primary 

purpose 1’’ and ‘‘primary purpose 2.’’ 

We did not include these coined terms 

in the regulatory text of the definition. 

In this document, we are using these 

coined terms to simplify the discussion. 

We also are coining the term ‘‘primary 

business test’’ to simplify the discussion 

of the criterion for the primary business 

activity of the establishment.) Under an 

alternative approach we discussed in 

the proposed rule (76 FR 19192 at 

19197) (the alternative revenue 

approach), ‘‘primary purpose 2’’ would 

be that more than 50 percent of the 

retail establishment’s gross revenues are 

generated by the sale of food rather than 

that more than 50 percent of the retail 

establishment’s gross floor area is used 

for the preparation, purchase, service, 

consumption, or storage of food. 

In the proposed rule (76 FR 19192 at 

19198), we also discussed an alternative 

(the restaurant-type food alternative) in 

which the sale of restaurant or 

restaurant-type food (rather than the 

sale of food in general) would be the 

primary business activity of the 

establishment. Under the restauranttype food alternative, ‘‘primary purpose 

2’’ would be that 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. 

In the proposed rule (76 FR 19192 at 

19198), we acknowledged that many 

facilities that sell restaurant or 

restaurant-type food are located within 

larger retail establishments, such as 

coffee shops in bookstores or concession 

stands in movie theaters. We considered 

that some of these facilities would be 

separate retail establishments, while 

others would be part of their larger retail 

establishments. We explained that if a 

facility that is inside a larger 

establishment is part of a chain with 

locations outside of the chain of the 

larger establishment, the facility would 

be considered a separate 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. By contrast, if a facility 

is not part of a chain with locations 

outside of the chain of the larger 

establishment, the facility would be 

considered part of the larger 

establishment. Thus, 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. 

As an example of how all of the 

elements of the proposed definition of 

restaurant or similar retail food 

establishment fit together, movie 

theaters would not have met the 

proposed definition of restaurant or 

similar retail food establishment. Movie 

theaters usually do not present 

themselves as restaurants. In addition, 

movie theaters usually neither dedicate 

more than 50 percent of their gross floor 

area to the sale of food, nor generate 

more than 50 percent of their gross 

revenues from the sale of food. Thus, 

under the proposed definition of 

‘‘restaurant or similar retail food 

establishment,’’ movie theater 

concession stands generally would not 

have been covered regardless of whether 

‘‘primary purpose 2’’ is based on the 

percent of gross floor area dedicated to 

the sale of food or on the alternative 

revenue approach based on the percent 

of gross revenues from the sale of food. 

In the proposed rule (76 FR 19192 at 

19197 to 19199), we acknowledged that 

the statutory language is ambiguous 

with respect to the scope of 

establishments covered by section 4205 

of the ACA, and asked for 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; 

• Whether we should use the sale of 

food in general, or the sale of restauranttype food, as the criterion for ‘‘primary 

business activity’’; 

• Whether we should use the 

alternative revenue approach, rather 

than a floor space approach, in ‘‘primary 

purpose 2’’; 

• 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; 

• Whether we should choose a 

different criteria for determining 

primary business activity, such as 

whether the consumer pays for 

admission to the establishment; and 

• Whether a facility selling restaurant 

or restaurant-type food that is not part 

of a chain with locations outside of the 

chain of a larger retail establishment 

should be included within the 

definition of restaurant or similar retail 

food establishment. We particularly 

requested comment on this approach 

with respect to larger retail 

establishments such as movie theaters, 

other entertainment-type venues, and 

superstores that offer restaurant or 

restaurant-type food. 

In the following paragraphs, we 

discuss comments on the proposed 

definition of ‘‘restaurant or similar retail 

food establishment.’’ After considering 

these comments, we have revised the 

proposed definition to eliminate the 

primary business test. 

Importantly, the proposed definition 

of ‘‘restaurant or similar retail food 

establishment’’ included the terms 

‘‘restaurant and restaurant-type food’’ 

and, thus, revisions to those terms also 

may affect whether a particular 

establishment is a ‘‘restaurant or similar 


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71164 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

retail food establishment’’ for the 

purposes of this rule. As discussed more 

fully in section VI.C, we are deleting the 

term ‘‘restaurant food’’ throughout the 

rule and establishing a revised 

definition of ‘‘restaurant-type food’’ that 

better reflects the food most like the 

food offered for sale in restaurants. 

With these changes, in this rule 

‘‘restaurant or similar retail food 

establishment’’ means a retail 

establishment that offers for sale 

restaurant-type food, except if it is a 

school as defined in 7 CFR 210.2 or 

220.2. Establishments such as bakeries, 

cafeterias, coffee shops, convenience 

stores, delicatessens, food service 

facilities located within entertainment 

venues (such as amusement parks, 

bowling alleys, and movie theatres), 

food service vendors (e.g., ice cream 

shops and mall cookie counters), food 

take-out and/or delivery establishments 

(such as pizza take-out and delivery 

establishments), grocery stores, retail 

confectionary stores, superstores, quick 

service restaurants, and table service 

restaurants would be restaurants or 

similar retail food establishments if they 

sell restaurant-type food. 

2. Primary Business Test 

(Comment 6) A few comments 

generally opposed having any primary 

business test within the definition of 

‘‘restaurant or similar retail food 

establishment.’’ One of these comments 

recommended that the primary purpose 

of the definition be related to ‘‘whether 

the establishment optimizes the nation’s 

health through their food distribution 

channels, rather than a profit/commerce 

approach.’’ This comment 

acknowledged that a ‘‘profit/commerce 

approach’’ may be more tangibly 

measured but believed that the 

definition of restaurant or similar retail 

food establishment should reflect what 

the comment considered to be the 

purpose of the ACA: To inform 

consumers on healthy food choices. 

Another comment considered that the 

floor space test we proposed as 

‘‘primary purpose 2’’ is not a rational 

basis for defining a restaurant or similar 

retail food establishment. Another 

comment asserted that both the 

proposed definition of ‘‘restaurant or 

similar retail food establishment’’ and 

the ‘‘alternative revenue approach’’ 

would have covered grocery stores but 

not superstores, putting grocery stores at 

a competitive disadvantage. 

One comment recommended that we 

define a restaurant or similar retail food 

establishment as any chain 

establishment selling restaurant or 

restaurant-type food. The comment 

asserted that this broader interpretation 

is consistent with the language in the 

statute. The comment pointed out that 

the statute does not include text to 

suggest that in order to qualify as a retail 

food establishment, an entity must have 

the sale of food as its primary business 

activity. 

One comment recommended that the 

definition cover all of the 

establishments exempted from nutrition 

labeling by the NLEA. Some comments 

referred to examples of covered 

establishments that we had included in 

our draft implementation guidance 

(which we withdrew on January 25, 

2011) and agreed that these types of 

establishments should be covered by the 

rule. The examples in the draft 

implementation guidance included table 

service restaurants, quick service 

restaurants, coffee shops, delicatessens, 

food take-out and/or delivery 

establishments (e.g., pizza take-out and 

delivery establishments), grocery stores, 

convenience stores, movie theaters, 

cafeterias, bakeries/retail confectionary 

stores, food service vendors (e.g., lunch 

wagons, ice cream shops, mall cookie 

counters, and sidewalk carts), and 

transportation carriers (e.g., airlines and 

trains). These examples reflected the 

establishments that sell certain food 

previously exempted from nutrition 

labeling by the NLEA under sections 

403(q)(5)(A)(i) and (ii) of the FD&C Act, 

including those mentioned in 

§ 101.9(j)(2) and (j)(3) as well as some 

additional examples (i.e., similar food 

served in coffee shops, grocery stores, 

and movie theaters). Some of the 

establishments that would have been 

covered under the draft implementation 

guidance (such as transportation carriers 

and facilities located within movie 

theaters) would be excluded under a 

definition that includes any primary 

business test presented in the proposed 

rule (i.e., regardless of whether the 

criterion is the proposed criterion based 

on the sale of food in general or the 

restaurant-type food alternative based 

on the sale of restaurant-type food, and 

regardless of whether ‘‘primary purpose 

2’’ relates to gross floor area or gross 

revenue). Other examples (such as 

grocery stores and convenience stores) 

would be excluded from coverage under 

the restaurant-type food alternative but 

not under the proposed criterion based 

on the sale of food in general. 

Several comments recommended that 

we define a restaurant or similar retail 

food establishment using the restauranttype food alternative. Some comments 

that opposed coverage of grocery and 

convenience stores asserted that selling 

prepared foods does not make grocery 

stores similar to restaurants or food 

court facilities that have on-premises 

consumption. According to some of 

these comments, the primary purpose of 

grocery stores is to sell packaged food, 

which is already labeled with nutrition 

information. One comment that opposed 

covering convenience stores considered 

that the proposed criterion for a primary 

business activity based on the sale of 

food in general, including prepackaged 

food, is an activity in which restaurants 

do not engage. The comment 

recommended that we view the phrase 

‘‘similar retail food establishment’’ as a 

single cohesive term and define those 

that are in fact similar to restaurants. 

Some comments opposed ‘‘primary 

purpose 1’’ of the proposed primary 

business test because it would be 

difficult to enforce. One comment 

asserted that some bowling alleys list 

themselves as restaurants in the phone 

book or have signs indicating that they 

serve as a restaurant, whereas others do 

not. The comments maintained that 

FDA and State and local inspectors 

would have to determine how many 

establishments in the chain present 

themselves as restaurants, which would 

make enforcement difficult. 

One comment agreed with the 

proposed criterion for ‘‘primary purpose 

2’’—i.e., that greater than 50 percent of 

a retail establishment’s gross floor area 

is used for the preparation, purchase, 

service, consumption, or storage of food. 

One comment asserted that the amount 

of floor space used for the preparation, 

purchase, service, consumption, or 

storage of food would be difficult to 

determine. Another comment 

considered that ‘‘primary purpose 1’’ is 

sufficient for determining whether an 

establishment is covered, but 

considered that the floor space criterion 

would be a more accurate approach than 

the alternative revenue approach if a 

second approach for ‘‘primary business 

activity’’ is needed. One comment asked 

us to clarify that ‘‘gross floor area’’ 

includes outdoor space for parks as part 

of the calculation of the percentage of 

gross floor area used for the preparation, 

purchase, service, consumption, or 

storage of food. A few comments 

recommended that seating areas, 

including outside seating, be included 

in the floor space. 

A few comments preferred the 

alternative revenue approach for 

‘‘primary purpose 2.’’ One comment 

reported that the Internal Revenue 

Service uses revenue to determine a 

business’s primary activity. One 

comment suggested that we add to the 

proposed definition ‘‘or a total of more 

than 50 percent of that retail 

establishment’s revenues are generated 

by the sale of food.’’ 


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A few comments opposed the 

alternative revenue approach for 

‘‘primary purpose 2.’’ These comments 

considered that it would be difficult for 

FDA and the States to ascertain the 

revenue of a restaurant or similar retail 

food establishment and the revenue may 

change from day to day. One comment 

noted that the proposed rule did not 

include a defined time period for 

revenue. Another comment asserted that 

basing ‘‘primary purpose 2’’ on revenue 

would be complicated when a primary 

non-food related service or good is 

paired with an ancillary service such as 

the sale of food in one price. The 

comment asserted that it would be 

difficult to distinguish or separate the 

percentage of the fee for the non-food 

related service or good from the 

percentage of the fee for the food. 

A few comments suggested a lower 

cutoff (20 to 25 percent) for the 

alternative revenue approach but 

provided no rationale for the lower 

cutoff. One comment, which also 

supported the coverage of movie 

theaters, stated that movie theaters 

derive much of their revenue from food 

in concession stands. 

Some comments agreed with our 

discussion in the proposed rule that a 

facility within a larger facility should 

not be considered to be a separate 

establishment if it is not part of a chain 

outside that establishment. Some 

comments specifically agreed that 

facilities located within movie theaters 

and other entertainment venues should 

not be covered by the provisions of 

section 4205 of the ACA. However, 

many comments opposed a definition of 

‘‘restaurant or similar retail food 

establishment’’ that would exclude 

facilities located within a larger facility, 

specifically facilities in movie theaters 

and other entertainment venues. Some 

of these comments provided the 

following reasons for including such 

facilities: 

• Excluding facilities located within 

movie theaters removes information 

from consumers, which defeats the very 

purpose of the law. 

• Food in entertainment venues is 

high in calories and some of these 

venues cater to children and have many 

less healthy options (e.g., fries, ice 

cream, cotton candy). 

• Covering facilities located within 

movie theaters would not be 

burdensome for them because they have 

limited menu options and many 

packaged foods that have Nutrition 

Facts. 

• Movie theaters derive large revenue 

from the sale of food; some much more 

than chain restaurants. It is 

irresponsible to send the message that 

consumption of calories in popcorn 

offered for sale at movie theaters is not 

as important as consumption of calories 

in menu items offered for sale at drivethrough restaurants. 

• Movies attract sedentary people. 

• Congress intended that the law 

apply to movie theaters, bowling alleys, 

bookstore cafes, and other 

establishments; the phrase ‘‘and similar 

retail establishments’’ was used to reach 

beyond restaurants. 

• Excluding facilities located within 

movies theatres and other entertainment 

venues is unfair to competing venues. 

• Providing other services or 

entertainment does not affect the need 

for nutrition information. 

• Menu labeling is feasible in venues 

not covered by the proposed rule. Movie 

theaters in California, New York City, 

and counties in New York are providing 

this information with no problem. To 

capriciously exempt movie theaters 

defeats the purpose of the law. One 

comment asserted that there is 98 

percent compliance for menu labeling 

by movie theaters in New York City. 

• Excluding such venues raises equal 

protection concerns (U.S. Const. 14 

Amend. section 1 for similarly situated 

entities). 

One comment considered that we 

would have to broaden the scope of 

covered establishments to include other 

places (such as bowling alleys, airlines, 

trains, and hotels), regardless of whether 

they fit the proposed definition of a 

restaurant or similar retail food 

establishment, if the rule covered 

establishments such as facilities located 

within movie theaters. This comment 

argued that there is no mention in the 

legislative history, committee reports, or 

Congressional floor debates of facilities 

located within movie theaters being 

covered. The comment considered that 

no one would associate ‘‘chain retail 

food establishment’’ with movie theaters 

because the primary purpose of going to 

movies or other entertainment venues is 

not to eat food and noted that many 

States and localities do not include 

these establishments in their laws. 

Another comment suggested that we 

add the following statement to our 

proposed definition: ‘‘This definition 

does not include businesses or 

establishments that sell food incidental 

to their primary purpose of providing or 

hosting entertainment at venues such as 

movie and live theaters, arenas, 

amusement parks, sports facilities, 

concert venues, and other similar 

establishments.’’ 

(Response 6) We have revised the 

definition of ‘‘restaurant or similar retail 

food establishment’’ to eliminate the 

primary business test. Most of the 

comments opposed one or more aspects 

associated with our proposal to include 

a primary business test, and we are 

persuaded by them. The comments we 

received were diverse and raised 

important considerations, including 

issues related to fairness; public health 

impact; accessibility of nutrition 

information; enabling informed 

decision-making; statutory purpose and 

Congressional intent; enforcement 

challenges; and feasibility of complying 

with the rule. We are convinced that 

any primary purpose test presented in 

the proposed rule will be problematic. 

Congress did not define the term 

‘‘restaurant or similar retail food 

establishment’’ in section 4205 of the 

ACA or elsewhere in the FD&C Act. As 

we stated in the proposed rule, we look 

to statutory context as a starting point 

for the regulatory definition of 

‘‘restaurant or similar retail food 

establishment.’’ As we noted, 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 use in such establishments,’’ 

(termed ‘‘restaurant food’’ in the 

proposed rule); and (2) food ‘‘which is 

processed and prepared primarily in a 

retail establishment, which is ready for 

human consumption, which is of 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’’ 

(termed ‘‘restaurant-type food’’ in the 

proposed rule). Section 4205 of the ACA 

amended both of these statutory 

exemptions. In determining the scope of 

section 4205 of the ACA, we must 

determine which of these foods should 

remain wholly exempt from Federal 

nutrition labeling requirements and 

which should be covered by the new 

nutrition labeling requirements in this 

rule. 

Instead of using a primary purpose 

test within the definition of restaurant 

or similar retail food establishment to 

set the scope of the new law, we are 

finalizing a broader definition of 

restaurant or similar retail food 

establishment, consistent with many of 

the comments. In response to concerns 

about overreaching in establishments 

that sell a significant amount of food 

that is not typical of food sold in 

restaurants, such as grocery and 

convenience stores (see also discussion 

in section VI.B.3), we are narrowing the 

set of food covered by removing the 

term ‘‘restaurant food’’ from this rule 

and redefining ‘‘restaurant-type food’’ to 


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include only the set of food described in 

sections 403(q)(5)(A)(i) and (ii) of the 

FD&C Act that is most like the food 

served in restaurants (see discussion in 

section VI.C). Retail food establishments 

that offer for sale this type of food are 

either restaurants or are relevantly 

similar to restaurants in that they offer 

for sale the kind of food that restaurants 

do. Therefore, the final definition 

focuses on those establishments that 

offer for sale food that is most like food 

served in restaurants; overall, it is 

generally broader than the definition 

provided in the proposed rule, but 

narrower than what we put forward in 

the draft implementation guidance. 

Most of the comments that addressed 

the floor space approach or the 

alternative revenue approach to 

‘‘primary purpose 2’’ expressed a 

preference for one or the other without 

providing strong and convincing 

arguments as to why their preferred 

alternative is superior to the alternative 

that they opposed. Several comments 

identified challenges to enforcing the 

rule if the definition of ‘‘restaurant or 

similar retail food establishment’’ 

included either the floor space approach 

or the alternative revenue approach. 

We agree with several points made by 

the comments about facilities within 

entertainment venues such as movie 

theaters and amusement parks—e.g., 

that providing nutrition information to 

consumers at such venues will make 

such nutrition information available to 

consumers in a direct and accessible 

manner to enable consumers to make 

informed and healthful dietary choices; 

food in entertainment venues is similar 

to food offered for sale in other 

restaurants or similar retail food 

establishments; and covering 

entertainment venues would create a 

level playing field. Under the revised 

definition of ‘‘restaurant or similar retail 

food establishment,’’ such facilities in 

entertainment venues will be covered by 

the rule if they offer for sale restauranttype food and satisfy the other criteria 

in the definition of ‘‘covered 

establishment’’—i.e., part of a chain 

with 20 or more locations, doing 

business under the same name, and 

offering for sale substantially the same 

menu items. Similarly, some superstores 

that may not have been covered under 

the proposed definition likewise may be 

considered a ‘‘restaurant or similar retail 

food establishment’’ under the final 

definition established in the rule. Under 

the definition of ‘‘restaurant or similar 

retail food establishment’’ in this rule, a 

superstore, like a grocery store, would 

be covered if it sells restaurant-type 

food and 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. 

Hotel restaurants are another type of 

establishment that we stated generally 

would not have been covered under the 

proposed rule (76 FR 19192 at 19198), 

but would be covered under the final 

rule if they sell restaurant-type food and 

are part of a chain of hotel restaurants 

with 20 or more fixed locations, doing 

business under the same name, and 

offering for sale substantially the same 

menu items. 

We disagree that the legislative 

history of section 4205 of the ACA 

demonstrates any express intent of 

Congress to exclude facilities located 

within entertainment venues such as 

movie theaters and bowling alleys from 

the rule. The legislative history of 

section 4205 of the ACA is very sparse; 

the section was discussed on few 

occasions, and when it was discussed, 

few specifics were mentioned, including 

specifics about the scope of the law. 

We discuss transportation venues 

later in this document (see Response 

27). 

(Comment 7) One comment 

considered the proposed requirement 

that the sale of food be the retail 

establishment’s primary business to be 

at odds with the approach taken in the 

proposed vending machine rule. The 

comment pointed out that we concluded 

that only 5,000 of 10,000 vending 

machine operators operate vending 

machines as their primary business, yet 

the proposed vending machine rule 

would apply to those with 20 or more 

machines, which includes all 10,000 of 

the vending machine operators. 

(Response 7) The provisions of the 

proposed vending machine rule, 

including criteria for determining 

coverage of that rule, are not relevant to 

the criteria for determining coverage of 

this rule. Regardless, this comment is 

moot because the definition of 

‘‘restaurant or similar retail food 

establishment’’ established in this rule 

no longer includes a primary business 

test. 

(Comment 8) A few comments 

recommended that we separately define 

‘‘restaurant’’ and ‘‘similar retail food 

establishment.’’ One of these comments 

recommended that we define 

‘‘restaurant’’ separately from ‘‘similar 

retail food establishment’’ because 

Congress uses the word ‘‘or’’ in the 

phrase ‘‘restaurant or similar retail food 

establishment,’’ and thus ‘‘restaurants’’ 

and ‘‘similar retail food establishments’’ 

are clearly two separate things. Another 

comment recommended that we define 

a restaurant as one that uses greater than 

50 percent gross floor space for 

preparation, purchase, service, 

consumption of restaurant food and a 

similar retail food establishment as an 

establishment that meets the same 

standard but does not present itself as 

a restaurant. 

(Response 8) We disagree that we 

should separately define ‘‘restaurant’’ 

and ‘‘similar retail food establishment.’’ 

As an initial matter, while Congress 

does use the word ‘‘or’’ between 

‘‘restaurant’’ and ‘‘similar retail food 

establishment’’ in some places, it also 

uses the word ‘‘and’’ between them in 

others. For example, section 

403(q)(5)(H)(i) of the FD&C Act contains 

both constructions (‘‘General 

requirements for restaurants and similar 

retail food establishments’’ and ‘‘the 

restaurant or similar retail food 

establishment shall disclose’’). We 

interpret the choice of the words ‘‘and’’ 

and ‘‘or’’ in section 403(q)(5)(H) of the 

FD&C Act to be a function of 

appropriate grammar, not to indicate 

Congressional intent to conceptualize 

‘‘restaurants’’ separately from ‘‘similar 

retail food establishments.’’ Moreover, 

given that the requirements in section 

403(q)(5)(H) of the FD&C Act are the 

same for restaurants and similar retail 

food establishments, we see no practical 

reason to create separate regulatory 

definitions. 

(Comment 9) One comment 

recommended that we include as part of 

the regulation table 1 from the proposed 

rule to help the public interpret the 

regulation. 

(Response 9) In the proposed rule (77 

FR 19192 at 19198 and 19199), tables 1 

and 2 identify establishments that 

generally would, or would not, be a 

‘‘restaurant or similar retail food 

establishment’’ for the purposes of this 

rule. We included these tables to 

demonstrate the likely impact for many 

establishments of the proposed and 

alternative criteria for a ‘‘primary 

business test’’ within the definition of 

‘‘restaurant or similar retail food 

establishment.’’ The definition of 

‘‘restaurant or similar retail food 

establishment’’ established in this rule 

no longer has a primary business test. 

Any establishment that sells restauranttype food is a ‘‘restaurant or similar 

retail food establishment’’ for the 

purposes of this rule. Therefore, we see 

no value added in including such tables 

in this final rule. 

3. Coverage of Grocery Stores and 

Convenience Stores 

(Comment 10) Several comments 

recommended that grocery stores be 

covered. Some of these comments 

considered that grocery stores should be 

covered because they sell a great deal of 

food for immediate consumption. One 


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of these comments referred to the ‘‘Food 

Marketing Institute’s 2010 U.S. Grocery 

Shopper Trends’’ (Ref. 11) as evidence 

that the number of consumers who 

express interest in supermarket readyto-eat food is at its highest point in 4 

years. One comment asserted that the 

law does not exempt grocery stores or 

take-out food. 

(Response 10) We agree with these 

comments. Grocery stores that sell 

restaurant-type food and 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 are covered by the rule. 

(Comment 11) One comment argued 

that the plain meaning of section 4205 

of the ACA precludes including grocery 

stores as ‘‘restaurants and similar retail 

food establishments.’’ The comment 

stated that Congress used other words 

elsewhere in the FD&C Act to refer to 

the set of establishments that include 

grocery stores, such as ‘‘food retailer’’ 

and ‘‘retail establishment’’ in section 

403(q) of the FD&C Act. In addition, our 

regulation at 21 CFR 1.227 defines 

‘‘retail food establishment’’ to include 

grocery stores for the purposes of food 

facility registration. Given that Congress 

chose a different term here, the 

comment argued that we must assume 

‘‘similar retail food establishments’’ has 

a different meaning. 

(Response 11) We disagree with this 

comment. We do interpret the phrase 

‘‘similar retail food establishment’’ to 

have a different meaning than the terms 

‘‘food retailer’’ and ‘‘retail 

establishment’’ that appear elsewhere in 

section 403(q) of the FD&C Act or ‘‘retail 

food establishment’’ in 21 CFR 1.227. 

Both our proposed and final definitions 

are different from the definitions of 

these other terms. If a retail food 

establishment does not offer for sale 

restaurant-type food, it would not be a 

‘‘restaurant or similar retail food 

establishment’’ for the purposes of 

section 403(q)(5)(H) of the FD&C Act, 

even though it could be a ‘‘food retailer’’ 

or a ‘‘retail establishment’’ or ‘‘retail 

food establishment.’’ 

(Comment 12) One comment argues 

that the heading of section 4205 of the 

ACA, ‘‘Nutrition Labeling of Standard 

Menu Items at Chain Restaurants,’’ 

indicates that ‘‘restaurants or similar 

retail food establishments’’ is an 

ambiguous term, and should be 

interpreted narrowly to exclude grocery 

stores. 

(Response 12) We disagree with this 

comment. First, while we recognize that 

the heading of a statute may be 

considered part of a section’s legislative 

history, the heading is not part of the 

law itself (Ref. 12). Second, it is clear 

that the heading is not meant to describe 

the scope of the requirements in section 

4205 of the ACA, given that section 

4205 includes requirements for 

‘‘restaurants and similar retail food 

establishments’’ and requirements for 

vending machine operators. 

(Comment 13) One comment argued 

that the legislative history of section 

4205 of the ACA demonstrates that 

grocery stores should not be included in 

the menu labeling requirements. The 

comment cited a floor speech by Senator 

Harkin where he favorably compares the 

nutrition information available in 

grocery stores to the lack of nutrition 

information available at restaurants. For 

example, ‘‘It makes no sense that 

American consumers can go to a grocery 

store and find nutrition information on 

just about anything, but then they are 

totally in the dark when they go to a 

restaurant for dinner.’’ (Ref. 13) The 

comment also argued that the legislative 

history does not include any hearing or 

debate indicating that we were being 

given authority to regulate chain grocery 

stores through section 4205 of the ACA. 

Some comments stated that some 

State and local jurisdictions did not 

cover grocery stores. One comment 

remarked that State and local laws 

related to menu labeling referred to in 

the legislative history of section 4205 of 

the ACA did not cover grocery stores. 

Specifically, the comment mentions that 

the New York City Health Code 

provisions on menu labeling, which the 

comment characterizes as the first and 

most extensively discussed law cited by 

Senator Harkin, does not regulate 

supermarkets. 

(Response 13) We disagree that the 

legislative history demonstrates that 

grocery stores should not be included in 

the nutrition labeling requirements of 

this rule. First, the most straightforward 

interpretation of Senator Harkin’s 

statements is that the food in grocery 

stores he had in mind was packaged 

food already required to bear nutrition 

information under Federal law. 

Second, the fact that none of the State 

or local jurisdictions with menu 

labeling requirements explicitly covered 

grocery stores does not mean that 

Congress did not intend to cover grocery 

stores under the Federal law. Many 

State and local jurisdictions with menu 

labeling requirements predating the 

ACA did not cover self-service food or 

food on display, which is most likely to 

be the type of food in grocery stores 

covered by this rule. However, it is clear 

that Congress intended for self-service 

food and food on display to be covered, 

because section 403(q)(5)(H)(iii) 

explicitly establishes statutory 

requirements specific to self-service 

food and food on display. In addition, 

for at least some local governments, 

including New York City, the regulation 

of grocery stores fell outside of their 

jurisdiction (Ref. 14). So, the fact that 

grocery stores were not covered by New 

York City cannot be assumed to be a 

choice by local authorities. 

Finally, we recognize that the 

legislative history of section 4205 of the 

ACA does not include any hearing or 

debate indicating specifically 

mentioning chain grocery stores. 

However, this does not imply that 

Congress intended for grocery stores to 

be excluded. As already noted, the 

legislative history of section 4205 of the 

ACA is very sparse; the section was 

discussed on few occasions, and when 

it was discussed, few specifics were 

raised, including specifics about the 

scope of the law. The comment does not 

provide evidence to the contrary. Our 

final rule represents a reasonable 

interpretation of the statute, given the 

language of section 4205 of the ACA and 

the scant legislative history. 

(Comment 14) Some comments 

asserted that if Congress had intended 

broad application, it would have 

overhauled 21 U.S.C. 343(q)(5)(A)(i) and 

(ii) of the FD&C Act rather than letting 

those stand and adding 21 U.S.C. 

343(q)(5)(H). Further, these comments 

stated that if Congress had wanted to 

include all establishments exempted by 

the NLEA, it would have crossreferenced to the NLEA exemption or 

just removed the exemption. 

(Response 14) We agree with some of 

these comments and disagree with 

others. We agree that Congress did not 

intend for all establishments exempted 

by the NLEA to be covered by section 

4205 of the ACA. Under the rule, there 

are many establishments, including 

establishments that meet the regulatory 

definition of restaurant or similar retail 

food establishment, that will not be 

covered. For example, food described in 

section 403(q)(5)(A)(i) of the FD&C Act 

served in certain sit-down restaurants 

that are not part of a chain of 20 or more 

locations will continue to be exempt 

from the Federal nutrition labeling 

requirements in sections 403(q)(1) to (4). 

In addition, section 403(q)(5)(A)(i) and 

(ii) of the FD&C Act continue to exempt 

all food that is described in sections 

403(q)(5)(A)(i) and (ii), including food 

offered for sale in restaurants and 

similar retail food establishments, from 

the nutrition labeling requirements in 

sections 403(q)(3) and (4). Therefore, 

irrespective of the breadth of section 

403(q)(5)(H) of the FD&C Act, Congress’s 

amendment to sections 403(q)(5)(A)(i) 

and (ii) leaves a large portion of the 

exemption intact. Congress could not 


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have removed the exemption in sections 

403(q)(5)(A)(i) and (ii) of the FD&C Act 

and achieved the same result. 

Instead, Congress amended sections 

403(q)(5)(A)(i) and (ii) of the FD&C Act 

to cross-reference section 403(q)(5)(H). 

The cross-references to section 

403(q)(5)(H) of the FD&C Act in sections 

403(q)(5)(A)(i) and (ii) indicate that the 

requirements in 403(q)(5)(H) must apply 

to at least a subset of those foods 

described in both sections 

403(q)(5)(A)(i) and (ii). Congress did not 

provide a statutory definition of 

‘‘restaurant or similar retail food 

establishment’’ in section 403(q)(5)(H) 

of the FD&C Act, leaving ambiguity in 

the statute as to the breadth of the set 

of establishments covered. Our 

definition of restaurant or similar retail 

food establishment is a reasonable 

interpretation of this ambiguous term, 

and is consistent with section 4205’s 

amendments to section 403(q)(5)(A)(i) 

and (ii) of the FD&C Act. 

(Comment 15) One comment argued 

that the restaurant industry supported 

section 4205 of the ACA, because the 

law would provide them with a 

nationally uniform regulatory scheme. 

The comment asserted that grocery 

stores ‘‘did not ask for this law,’’ and 

should therefore not be covered. 

(Response 15) In general, whether an 

industry asks to be regulated is not 

determinative of whether that industry 

should be regulated. In addition, grocery 

stores are increasingly offering for sale 

restaurant-type food, including food for 

immediate consumption that is 

prepared and processed on the 

premises. 

(Comment 16) A few comments 

maintained that there is too much 

variability in grocery store food because 

food is seasonal and grocery stores make 

prepared food from food in the store. 

Some comments also noted that some 

grocery stores offer unique menu items, 

such as a unique chicken salad based on 

the personal recipe of a chef at a 

particular grocery store’s location, that 

are not available at all grocery stores in 

the chain. These comments asserted that 

it would be difficult to calculate the 

nutrient information if grocery stores 

were covered under the final rule. 

(Response 16) A grocery store is 

required to make calorie declarations for 

its standard menu items if it meets the 

definition of ‘‘covered establishment’’ in 

this rule; including, in relevant part, 

that the grocery store is ‘‘offering for 

sale substantially the same menu items’’ 

as other grocery stores in the chain (see 

section VI.F for discussion on ‘‘offering 

for sale substantially the same menu 

items’’). However, if a food is not 

routinely included on a menu or menu 

board or routinely offered as a selfservice food or food on display at a 

covered establishment, it is not a 

standard menu item at that 

establishment and therefore not covered 

by this rule (see section VIII.B for 

discussion on the definition of standard 

menu item). For example, if a food’s 

ingredients and recipe changes daily 

based on food available in the store, it 

is likely that such food would not be a 

standard menu item. However, for food 

offerings that are standard menu items, 

even if unique to only one location in 

the chain, a covered establishment has 

many options for determining nutrient 

content, including, for example, 

calculating the required nutrient 

information from the recipe for the food 

offering using nutrient databases (see 

§ 101.11(c)). Per the statute, in those 

cases where seasonal availability is 

limited to less than 60 days, the food 

offering may be exempt from the 

nutrition labeling requirements of this 

rule as a temporary menu item or a selfservice food and food on display that is 

offered for sale for less than a total of 

60 days per calendar year. 

(Comment 17) One comment 

maintained that menu labeling is 

needed in small grocery stores and 

convenience stores because of the 

disparity in low-income neighborhoods 

that do not have many large grocery 

stores or superstores but do have small 

grocery stores and convenience stores. 

According to the comment, grocery 

stores, convenience stores, and drug 

store chains have expanded their 

businesses to include ready-to-eat food 

offerings. The comment maintained that 

these establishments are in direct 

competition with restaurants and have 

grown so rapidly over the past decade 

that some are being called ‘‘grocerants.’’ 

(Response 17) Small grocery stores 

and convenience stores are covered by 

the rule if they sell restaurant-type food 

and 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. 

(Comment 18) One comment 

considered that grocery stores should 

not be covered by the menu labeling 

requirements because they do not have 

menus and menu boards. 

(Response 18) We disagree with this 

comment. First, the comment suggests 

that no grocery stores have menus or 

menu boards. However, some grocery 

stores do have menus and menu boards, 

including for example, menus and menu 

boards for sandwiches that are prepared 

upon the consumer’s request. Second, 

the comment implies that a restaurant or 

similar retail food establishment must 

have a menu or menu board in order to 

be covered by this rule. This is not the 

case. Consistent with section 

403(q)(5)(H) of the FD&C Act, this rule 

requires that covered establishments 

provide certain nutrition information for 

standard menu items, even the standard 

menu items that do not appear on 

menus or menu boards. For example, 

section 403(q)(5)(H)(iii) of the FD&C Act 

requires nutrition labeling for standard 

menu items that are self-service foods 

and foods on display, irrespective of 

whether they are listed on a menu or 

menu board. 

4. Confectionery Stores 

(Comment 19) A few comments 

recommended that confectionery stores 

not be covered because they do not sell 

restaurant food. According to one of 

these comments, most candy sold in 

retail confectionery stores is not 

generally consumed immediately where 

purchased or while walking away. 

Instead, the comment stated, most 

candy sold in retail confectionery stores 

is either prepackaged (e.g., boxed 

chocolates) or selected by the consumer 

and placed in a box or other packaging 

for consumption at a later time. Thus, 

according to this comment, food served 

in retail confectionery stores without 

facilities for consumption on the 

premises would continue to be covered 

by the nutrition labeling requirements 

in § 101.9. Another comment 

acknowledged that some confectionary 

stores do sell some restaurant-type 

foods, such as chocolate from display 

cases, shakes, and specialty items 

dipped in chocolate, but that the 

primary focus of the business was the 

sale of packaged food such as ‘‘gift box’’ 

packaged chocolates. 

(Response 19) We disagree that 

confectionery stores, as a class of retail 

food establishments, should not be 

covered. Based on these comments, 

some foods sold in some confectionery 

stores are restaurant-type foods. As 

discussed in section VI.C, we are 

establishing a revised definition of 

‘‘restaurant-type food’’ that would cover 

food that is usually eaten on the 

premises, while walking away, or soon 

after arriving at another location (see 

Response 24). A prepackaged box of 

candy sold in a confectionery store is 

not likely to be a restaurant-type food, 

because a box of candy is not usually 

eaten on the premises, while walking 

away, or soon after arriving at another 

location. However, individual pieces of 

candy sold to a consumer from a display 

case, shakes, and specialty items dipped 

in chocolate likely would be restauranttype foods, because they are generally 

consumed on the premises, while 

walking away, or soon after arriving at 


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another location. Under this rule, a 

confectionery store that sells restauranttype food would be covered 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. We note that the only 

foods covered by this rule in a covered 

establishment are restaurant-type foods 

that are standard menu items. 

5. Facilities Within Facilities 

(Comment 20) One comment asked us 

to clarify that the independent franchise 

restaurant that operates within an 

amusement park is liable for adherence 

to the final regulation, not the park. The 

comment maintained that the park 

would have no way of knowing if the 

franchisee is compliant. 

(Response 20) The covered 

establishment bears the responsibility to 

comply with the rule. In addition, see 

Response 3. 

6. Schools 

(Comment 21) One comment asked us 

to clarify whether a school food service 

contractor that uses a central kitchen or 

cooks the same food for 20 schools 

would be covered. One comment stated 

that these establishments should 

provide calories on menu boards, online 

menus, and menus sent home to 

parents. 

(Response 21) We have decided not to 

include schools in the definition of 

‘‘restaurant or similar retail food 

establishment’’ for the purposes of this 

rule. As previously discussed (see 

Response 6) Congress did not define the 

term ‘‘restaurant or similar retail food 

establishment’’ in section 4205 of the 

ACA or elsewhere in the FD&C Act. The 

term is ambiguous, and we look to 

statutory context as a starting point for 

our regulatory definition. As discussed 

in section I of this document, while the 

NLEA required that the labeling of many 

foods bear nutrition information, it 

exempted certain food from such 

nutrition labeling requirements, 

including food that is ‘‘served in 

restaurants or other establishments in 

which food is served for immediate 

human consumption’’ (section 

403(q)(5)(A)(i) of the FD&C Act). In 

FDA’s regulations implementing the 

NLEA, we included schools among the 

list of examples of ‘‘other 

establishments in which food is served 

for immediate human consumption’’ 

(§ 101.9(j)(2)) Section 4205 of the ACA 

amended this statutory exemption, 

among others, to account for new 

nutrition labeling requirements for 

standard menu items in restaurants and 

similar retail food establishments. 

Therefore, we must determine whether 

standard menu items in schools should 

remain wholly exempt from FDA 

nutrition labeling requirements or 

whether they should be eligible to be 

covered by the new nutrition labeling 

requirements in this rule. 

Traditionally, the U.S. Department of 

Agriculture (USDA) has exercised a 

primary role in setting the standards for 

foods served in schools through school 

lunch and breakfast programs. USDA 

regulates such foods, under various 

Federal statutes, including the Child 

Nutrition Act of 1996 and the Richard 

B. Russell National School Lunch Act. 

Given the traditional and long-standing 

role of USDA in setting standards, 

including nutrition requirements, for 

foods served in schools through school 

lunch and breakfast programs, as 

established by Federal legislation and 

implemented by Federal Agencies, we 

conclude that it is reasonable to 

interpret the term ‘‘restaurant or similar 

retail food establishment’’ to not include 

schools. Therefore, we have revised the 

definition ‘‘restaurant or similar retail 

food establishment’’ to mean a retail 

establishment that offers for sale 

restaurant-type food, except if it is a 

school as defined in 7 CFR 210.2 or 

220.2. 

C. Restaurant Food and RestaurantType Food 

A key term in the final definition of 

‘‘restaurant or similar retail food 

establishment’’ is the term ‘‘restauranttype food.’’ The terms ‘‘restaurant food’’ 

and ‘‘restaurant-type food’’ also were 

important to the proposed definition of 

‘‘restaurant or similar retail food 

establishment.’’ Proposed § 101.11(a) 

would define ‘‘restaurant food’’ as 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 food is purchased or while 

walking away; or which is sold for sale 

or use in such establishments. (As a 

typographical error, the proposed rule 

incorrectly stated ‘‘where that the food 

is purchased’’ rather than ‘‘where that 

food is purchased.’’) Proposed 

§ 101.11(a) would define ‘‘restauranttype food’’ as 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. 

In the following paragraphs, we 

discuss comments on these proposed 

definitions. After considering 

comments, we are deleting the proposed 

definition of ‘‘restaurant food’’ and 

establishing a revised definition of 

‘‘restaurant-type food’’ that better 

reflects the food most like the food 

offered for sale in restaurants. As 

conforming amendments, we are 

deleting the term ‘‘restaurant food’’ from 

other proposed definitions that had 

included this term—i.e., the proposed 

definitions for ‘‘food on display,’’ 

‘‘restaurant or similar retail food 

establishment,’’ ‘‘self-service food,’’ and 

‘‘standard menu item.’’ 

(Comment 22) One comment 

recommended that food be covered if 

prepared for immediate human 

consumption regardless of whether 

consumers choose to consume on or off 

the premises. The comment 

recommended that we remove the term 

‘‘walking away’’ from the definition of 

restaurant food because it would be 

clearer to state simply that foods that are 

served in restaurants or similar retail 

food establishments and are prepared 

for immediate human consumption are 

covered, whether customers choose to 

consume them on or off the premises. 

The comment considered that whether 

foods are actually consumed on or off 

the premises should not be a 

determining factor as to whether a food 

or facility is covered by the rule. The 

comment asked us to clarify that food 

from facilities serving take-away food 

that meet the other criteria are covered. 

(Response 22) We decline the specific 

suggestion that we replace our proposed 

criterion that food may be ‘‘consumed 

either on the premises where the food 

is purchased or while walking away’’ 

with a criterion mentioning that 

consumers may consume the food ‘‘on 

or off the premises.’’ The comment did 

not disagree that restaurant food should 

include food that is consumed while 

walking away but rather suggested 

communicating this differently. 

While restaurants do offer for sale 

food that is consumed off the premises, 

in general that food is consumed while 

walking away or upon arriving at 

another location. Other foods, like 

groceries, are also consumed ‘‘off the 

premises’’ of the store that sells them 

(e.g., a grocery or convenience store), 

but they are often consumed at a later 

time or over a period of days. Our aim 

is to cover the food most like the food 

offered for sale in restaurants, and not 

food that is more similar to food 

traditionally thought of as groceries. 

Therefore, the phrase ‘‘on or off the 

premises’’ is too broad for our final 

definition of restaurant-type food. 

In general, take-away food is 

consumed while walking away or upon 

arriving at another location. Therefore, 

take-away food is likely to be 

‘‘restaurant-type food,’’ and retail 


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establishments that offer for sale takeaway food are likely to meet the 

definition of restaurant or similar retail 

food establishment. Take-away food that 

satisfies the definition of ‘‘restauranttype food’’ established in this rule 

would be subject to the nutrition 

labeling requirements of this rule if it is 

a standard menu item that is offered for 

sale in a covered establishment. 

(Comment 23) One comment 

recommended that the phrase ‘‘not 

offered for sale outside that 

establishment’’ be deleted from the 

definition of restaurant food because 

some restaurants market frozen meals 

from their restaurants. 

(Response 23) We are retaining the 

phrase ‘‘not offered for sale outside such 

establishment’’ in the definition of 

restaurant-type food. This phrase comes 

from section 403(q)(5)(A)(ii) of the 

FD&C Act. FDA previously has 

interpreted this phrase (see 58 FR 2079 

at 2146 (January 6, 1993)). The frozen 

meals described by the comment appear 

to be packaged foods. Most packaged 

foods are subject to the labeling 

requirements of § 101.9. The sale of 

such packaged, frozen food outside of a 

restaurant, e.g., in a grocery store, will 

not affect whether the food in a 

restaurant is covered by this rule. 

(Comment 24) One comment urged us 

to remove the term ‘‘restaurant-type 

food’’ from the rule and recognize that 

the sale of food to consumers for 

immediate consumption is a primary 

distinguishing factor of a restaurant. The 

comment contended that our definition 

of restaurant or similar retail food 

establishment is overly broad because it 

includes an establishment that sells not 

only restaurant food but also restauranttype food. The comment maintained 

that we did not explain our rationale for 

including restaurant-type food in the 

proposed rule, especially when our 

existing regulation on restaurants refers 

only to restaurant food. 

A few comments were concerned that 

because of the definition of restauranttype food grocery stores would have to 

label prepared foods for immediate 

consumption as well as every loaf of 

bread, roll, cookie and deli item except 

cold cuts; these comments estimated 

that approximately 6,400 service deli, 

prepared foods, and bakery items would 

be included, which would be very 

costly. One comment contended that the 

increase in cost may limit the items that 

grocery stores would carry, which 

would limit sales growth. According to 

a few comments 95 percent of items in 

grocery stores have Nutrition Facts and 

the costs to cover the remaining 5 

percent vastly outweighs benefits. 

(Response 24) We agree that sale of 

food to consumers for immediate 

consumption is a common characteristic 

of restaurants but disagree that it 

follows that only ‘‘restaurant food’’ is 

relevant to this rulemaking. In the 

proposed rule, we explained that 

section 4205 of the ACA amended both 

sections 403(q)(5)(A)(i) and (ii) of the 

FDA&C Act. Under section 

403(q)(5)(A)(ii) of the FD&C Act, except 

as provided in section 

403(q)(5)(H)(ii)(III) of the FD&C Act (i.e., 

the requirement for written nutrition 

information for food covered by this 

rule) the nutrition labeling requirements 

of section 403(q)(1), (2), (3), and (4) of 

the FD&C Act shall 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 section 

403(q)(5)(A)(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 

(emphasis added). To implement the 

phrase ‘‘except as provided in section 

403(q)(5)(H)(ii)(III)’’ of the FD&C Act, 

some set of food described in section 

403(q)(5)(A)(ii)—that is not for 

immediate consumption—is covered by 

this rule. 

We acknowledge that the proposed 

definition of restaurant-type food 

includes some foods that are sold in 

grocery or convenience stores that are 

not generally offered for sale in 

restaurants, foods that are more like 

groceries, and we have amended that 

definition in the final rule. After 

considering all of the comments 

directed to the proposed definitions of 

‘‘restaurant food’’ or ‘‘restaurant-type 

food,’’ in addition to the comments 

related to the scope of the rule more 

generally, given the relationship 

between these terms and the definition 

of restaurant or similar retail food 

establishment, we are convinced that 

this rule should cover only those foods 

described in sections 403(q)(5)(A)(i) and 

(ii) of the FD&C Act that are most like 

the food sold in restaurants and should 

not cover foods that are more commonly 

considered to be groceries. Therefore, 

we are deleting the proposed definition 

of ‘‘restaurant food’’ and establishing a 

revised definition of ‘‘restaurant-type 

food’’ that reflects the food most like the 

food offered for sale in restaurants. 

Under that new definition, restauranttype food means food that is (1) usually 

eaten on the premises, while walking 

away, or soon after arriving at another 

location; and (2) either (i) served in 

restaurants or other establishments in 

which food is served for immediate 

human consumption or which is sold 

for sale or use in such establishments; 

or (ii) processed and prepared primarily 

in a retail establishment, ready for 

human consumption, of the type 

described in (i), and offered for sale to 

consumers but not for immediate 

human consumption in such 

establishment and which is not offered 

for sale outside such establishment. The 

first part of this definition focuses on 

the food most like the food offered for 

sale in restaurants, while the second 

part of this definition reflects the 

statutory context of sections 

403(q)(5)(A)(i) and (ii) of the FD&C Act. 

The new definition includes food for 

immediate consumption at a sit-down or 

quick service restaurant; food purchased 

at a drive-through establishment; takeout and delivery pizza; hot pizza at 

grocery and convenience stores that is 

ready to eat; pizza slice from a movie 

theater; hot buffet food, hot soup at a 

soup bar, and food from a salad bar; 

foods ordered from a menu/menu board 

at a grocery store intended for 

individual consumption (e.g., soups, 

sandwiches, and salads); and selfservice foods and foods on display that 

are intended for individual 

consumption (e.g., sandwiches, wraps, 

and paninis at a deli counter; salads 

plated by the consumer at a salad bar; 

cookies from a mall cookie counter; 

bagels, donuts, rolls offered for 

individual sale). Foods that are similar 

to grocery items that may be ready for 

immediate consumption but that 

consumers usually store for use at a 

later time or customarily further prepare 

would not be included within the 

meaning of ‘‘restaurant-type food.’’ 

Foods that we therefore would not 

consider to be within the meaning of 

‘‘restaurant-type food’’ include foods to 

be eaten over several eating occasions or 

stored for later use (e.g., loaves of bread, 

bags or boxes of dinner rolls, whole 

cakes, and bags or boxes of candy or 

cookies); foods sold by weight that are 

not self-serve and are not intended 

solely for individual consumption (e.g., 

deli salads sold by unit of weight such 

as potato salad, chicken salad), either 

prepacked or packed upon consumer 

request; and foods that are usually 

further prepared before consuming (e.g., 

deli meats and cheeses). 

(Comment 25) One comment asked us 

to clarify that only food offered ‘‘for 

sale’’ in a restaurant or similar retail 

food establishment should be 

considered in determining whether an 

establishment is a covered 

establishment. The comment noted that 

the statute expressly limits the 


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application of food labeling to items that 

are ‘‘offered for sale,’’ and considered 

that the menu labeling regulations 

should adopt a similar limitation. 

(Response 25) The rule only applies to 

food offered for sale. 

D. Part of a Chain With 20 or More 

Locations 

In the proposed rule (76 FR 19192 at 

19195), we noted that we did not 

propose a definition of the statutory 

criterion ‘‘part of a chain with 20 or 

more locations’’ and that we were 

assuming the common meaning of the 

words in the phrase. However, we 

requested comment on whether the 

phrase should be defined in the final 

rule, and particularly on whether the 

terms ‘‘chain’’ and ‘‘location’’ should be 

defined in context of the various types 

of corporate or other business 

arrangements that may be relevant, 

including contracting arrangements. 

In the following paragraphs, we 

discuss comments on the terms ‘‘chain’’ 

and ‘‘location.’’ After considering these 

comments, we are adding a definition of 

‘‘locations’’ to clarify our interpretation 

of ‘‘part of a chain with 20 or more 

locations.’’ 

(Comment 26) A few comments 

responded to our request for comment 

on the term ‘‘chain.’’ One comment 

recommended that we define ‘‘chain’’ as 

a covered establishment doing business 

under the same name as those that share 

the same name under the ownership, 

control, and operation of a single 

corporate entity. This comment 

considered that this is consistent with 

the commonly accepted dictionary 

definition of a chain as ‘‘a group of 

enterprises or institutions of the same 

kind or function under a single 

ownership, management, or control.’’ 

Another comment cited the following 

dictionary definition for ‘‘chain’’: ‘‘A 

range of retail outlets which share a 

brand and central management, usually 

with standardized business methods’’. 

This comment also cited the following 

dictionary definition for ‘‘restaurant 

chain’’: ‘‘A set of restaurants, usually 

with the same name in many different 

locations either under shared corporate 

ownership or franchising agreements. 

Typically, the restaurants within a chain 

are built to a standard format and offer 

a standard menu.’’ 

(Response 26) Section 4205 of the 

ACA covers restaurants or 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.’’ Both definitions 

suggested by comments refer to 

management structure, corporate 

control, and/or ownership. Because the 

statute directs us to disregard the type 

of ownership of the locations when 

determining whether an establishment 

is ‘‘part of a chain with 20 or more 

locations doing business under the same 

name,’’ neither of these definitions for 

the word ‘‘chain’’ is appropriate. 

According to the dictionary 

definitions, the word ‘‘chain’’ means, 

among other things, ‘‘a group of 

enterprises, establishments, institution, 

or constructions of the same kind or 

function linked together into a single 

system’’ (Ref. 15), a ‘‘series or group of 

things or people that are connected to 

each other in some way’’ (Ref. 15), and 

‘‘a series of closely linked or connected 

things’’ (Ref. 16). In section 

403(q)(5)(H)(i) of the FD&C Act, 

Congress provides the ways in which 

restaurants or similar retail food 

establishments must be connected to or 

linked to each other in order to be 

covered by the new law: They must be 

doing business under the same name 

and offering for sale substantially the 

same menu items, and there must be 20 

or more locations of them. Therefore, we 

continue to use the common meaning of 

the word ‘‘chain’’ and do not consider 

an additional regulatory definition 

necessary for this broad term. The 

statute specifies the particular criteria 

for the set of chains that are relevant for 

this rulemaking, and we provide 

regulatory definitions for those criteria 

specifically. 

(Comment 27) One comment 

recommended that we not rely solely on 

the terms ‘‘chain’’ and ‘‘location’’ 

because some restaurants and food 

establishments have locations at the 

same address, such as a mall. The 

comment asked us to either use the term 

‘‘selling post’’ or to clarify that the 

location includes chains with 

restaurants in the same physical 

building. Another comment asked us to 

clarify that mobile facilities (such as 

food trucks) are covered. Some 

comments noted that transportation 

venues have menus that look like those 

in sandwich shops. Other comments 

noted that it is feasible for 

transportation venues to comply with 

the rule. 

(Response 27) We disagree that we 

should add the term ‘‘selling post’’ to 

the definition to specify restaurants and 

similar retail food establishments that 

are part of the same chain and are 

located in the same shopping mall or 

otherwise in the same physical building. 

However, this comment demonstrates 

that there is a need to define the term 

‘‘locations,’’ even assuming its common 

meaning. Unlike ‘‘chain,’’ where a 

definition is unnecessary given that we 

are establishing definitions for more 

specific, relevant criteria, we are 

convinced that establishing a regulatory 

definition of ‘‘locations’’ would provide 

clarity and facilitate a better 

understanding of regulatory 

expectations. 

The dictionaries define ‘‘location’’ to 

mean, among other things, ‘‘a position 

or site occupied . . . a tract of land 

designated for a purpose’’ (Ref. 17); ‘‘an 

area or tract of land’’ (Ref. 18); ‘‘a place 

where something is or could be located; 

a site . . . a tract of land that has been 

surveyed and marked off’’ (Ref. 19). This 

evidences that the common meaning of 

the word ‘‘location’’ involves a specific 

or fixed position on land or portion of 

land. For clarity, we are defining 

‘‘location’’ to mean ‘‘a fixed position or 

site.’’ Therefore, for the purposes of 

determining whether an establishment 

is part of a chain with ‘‘20 or more 

locations,’’ we would consider each of 

the establishments occupying separate 

fixed positions or sites within the same 

shopping mall or physical building as 

separate establishments. One result of 

this definition of ‘‘location’’ is to 

exclude food facilities that do not have 

a fixed position or site, such as trains 

and airplanes. Additionally, mobile 

food operations such as food trucks 

without a fixed position or site are not 

covered by the rule. 

E. Doing Business Under the Same 

Name 

Proposed § 101.11(a) would define 

‘‘doing business under the same name’’ 

as sharing the same name, where ‘‘same 

name’’ would include 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’’). In the proposed 

rule (76 FR 19192 at 19199), we 

requested comment on whether the term 

should be understood to refer to the 

underlying name of ownership such as 

the name of the parent company, or the 

name of the entity conducting corporate 

business on behalf of the establishment, 

e.g., the name of a contractor operating 

the establishment, regardless of the 

public name used by the individual 

establishment. 

In the following paragraphs, we 

discuss comments on this proposed 

definition. After considering comments, 

we have revised the definition to clarify 

that the term ‘‘name’’ refers to either (a) 

the name of the establishment presented 

to the public or (b), if there is no name 

of the establishment presented to the 

public (e.g., an establishment with the 

generic descriptor ‘‘concession stand’’), 


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the name of the parent entity of the 

establishment. 

(Comment 28) Several comments 

supported the proposed definition. One 

comment recommended that the 

definition be broadened to include those 

with the same underlying name of 

ownership (parent company or 

contractor). A few comments 

recommended that the definition not be 

based on the underlying name of 

ownership. Based on the language of the 

statute, the comments considered that 

‘‘regardless of . . . ownership’’ means 

that the ownership is not determinative 

and, therefore, the term should refer to 

the name used when doing business 

with the public and not the parent 

company, franchise owner, or other 

ownership entity. One comment argued 

that the phrase ‘‘regardless of . . . 

ownership’’ means that the corporate 

structure should not be considered 

when determining coverage; instead, the 

determining factor should be whether 

the name of the restaurant is the same. 

Another comment maintained that to 

include the underlying name of 

ownership in the definition would stifle 

investment in smaller locally based 

restaurants, i.e., it would place a cap on 

the number of restaurants an investor or 

entity could have before subjecting them 

to menu labeling. 

One comment recommended that the 

definition not be based on the name of 

the parent company because the name 

of the parent company has no bearing 

on the similarity of menu offerings. The 

comment argued that to do so would 

ignore the plain language of the statute, 

which clearly meant the public name of 

the location. One comment asserted that 

our proposed definition would expand 

the definition beyond the statutory 

language and Congress’ express intent 

by covering smaller restaurant chains 

that offer creative menus and, thus, 

thwart the purpose and intent behind 

thoughtfully designed restaurants. 

(Response 28) We agree with 

comments that considered that the 

statutory phrase ‘‘regardless of the type 

of ownership of the locations’’ means 

that the type of ownership is not 

determinative. We also agree that 

‘‘doing business under the same name’’ 

should, in general, refer to the name 

used when doing business with the 

public (e.g., the branded name that 

appears on the establishment’s signage) 

rather than the name of the person or 

legal entity that owns the establishment. 

However, we are aware that some 

establishments have no specific name 

presented to the public. For example, 

concession stands in entertainment 

venues or cafeterias in office buildings 

may simply have a sign with a general 

descriptor, such as ‘‘Hot Dogs’’ or 

‘‘Concession Stand’’ or ‘‘Building 1 

Cafe ́,’’ or they may have no sign at all. 

In instances where there is no specific 

name presented to the public, we find 

it reasonable to conclude that the name 

under which they are doing business is 

the name of the parent entity of the 

facility. Consequently, we have revised 

the definition of the term ‘‘doing 

business under the same name’’ in 

§ 101.11(a) to add that the term ‘‘name’’ 

refers to the name of the facility 

presented to the public or, if there is no 

name of the facility presented to the 

public (e.g., a facility with the generic 

descriptor ‘‘concession stand’’), the 

name of the parent entity of the facility. 

(Comment 29) One comment 

addressed the examples we included in 

the proposed definition of 

establishments doing business under the 

same name. As discussed in the 

proposed rule (76 FR 19192 at 19199), 

these examples include names that are 

slight variations on each other due, for 

example, to the region, location, or size. 

The comment asserted that it is 

inappropriate to imply that same name 

means slight variation. Another 

comment recommended that the rule 

apply to facilities in grocery stores with 

20 or more locations even if the 

facilities’ names vary from store to store. 

(Response 29) We disagree that the 

examples we included in the proposed 

definition of establishments doing 

business under the same name are 

inappropriate. Establishments that are 

part of large chains have slight 

variations in the name, e.g., to reflect a 

limited menu based on the space that 

the establishment occupies. For 

example, ‘‘XYZ’’ chain may have ‘‘XYZ’’ 

restaurant in a free-standing store and 

‘‘XYZ Express’’ in an airline terminal, 

food court in a shopping mall, or 

grocery store. Even though the names 

are slight variations of each other, they 

are sufficiently similar that it is clear 

that the establishments are affiliated 

with one another. Generally, these 

establishments also have the same trade 

dress (e.g., trade name, logo, graphics 

and other distinctive elements of a 

brand) as the other establishments in the 

chain. 

(Comment 30) One comment 

recommended that we require that a 

chain remain covered if it initially is 

subject to the rule but the parent 

company changes the name of some 

locations to get below 20. 

(Response 30) Individual restaurants 

and similar retail food establishments 

would be subject to the rule if they 

satisfy the criteria for a ‘‘covered 

establishment.’’ If a restaurant or similar 

retail food establishment satisfies all the 

criteria for a covered establishment, and 

subsequently changes its name, it must 

reconsider whether it continues to 

satisfy all the criteria for a covered 

establishment, including whether it ‘‘is 

part of a chain with 20 or more locations 

doing business under the same name.’’ 

We anticipate that the benefits to an 

establishment to continue to do 

business under the same name as other 

establishments in the chain will keep 

establishments from changing their 

names in order to avoid being covered 

by this rule. 

F. Offering for Sale Substantially the 

Same Menu Items 

Proposed § 101.11(a) would define 

‘‘offering for sale substantially the same 

menu items’’ as 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’’). Under the proposed definition, 

‘‘menu items’’ would refer to food items 

that are listed on a menu or menu board 

or that are offered as self-service food or 

food on display. The proposed 

definition would also provide that 

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. 

In the following paragraphs, we 

discuss comments on this proposed 

definition. After considering comments, 

we have revised the definition to: 

• Add a qualitative description of the 

number of menu items that must be 

shared in order for the criterion of 

‘‘offering for sale substantially the same 

menu items’’ to be met; and 

• Add a statement that having the 

same name may indicate, but does not 

necessarily guarantee, that menu items 

are substantially the same. 

(Comment 31) Several comments 

supported the definition. One comment 

asserted that the proposed rule was not 

clear on what ‘‘substantially’’ the same 

menu items means quantitatively and 

suggested that it could mean anywhere 

between 51 and 99 percent. Another 

comment asked us to clarify what 

constitutes ‘‘offering for sale menu items 

that use the same general recipe and are 

prepared with substantially the same 

food components even if the name 

varies.’’ This comment pointed out that 

some restaurants in a chain may have 

some unique items or may vary the 

recipes and therefore, it is not clear if 

the restaurant is ‘‘offering for sale 

substantially the same menu items.’’ 


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The comment gave as an example a 

kosher restaurant that uses the same 

name as non-kosher restaurants that are 

part of the same chain. The comment 

noted that due to the kosher restaurant’s 

following of the kosher laws, the kosher 

restaurant may offer for sale some menu 

items that vary from the menu items 

offered for sale in a non-kosher 

restaurant in the chain. In addition, the 

comment noted that the kosher 

restaurant may offer for sale unique 

menu items, such as schwarma, that are 

not offered for sale in the non-kosher 

restaurants in the chain. This comment 

requested an exemption for franchise 

restaurants that offer specialty menu 

items or items altered to accommodate 

a specific dietary practice (e.g., kosher). 

One comment pointed out that menu 

items in chain restaurants and similar 

retail food establishments vary between 

States and within States to 

accommodate local tastes, even if the 

menu items have the same name. The 

comment cited chili as an example, 

stating that in Cincinnati it is common 

for chili to be made with cocoa and 

cinnamon thinned out with finely 

ground meat over spaghetti, whereas in 

Texas, chili is made with large chunks 

of meat, often with beans, served alone 

in a bowl. 

One comment stated that some food 

service contractors provide clients with 

menus that may change daily, weekly, 

or monthly and with rotating cycle 

menus that can use up to several 

hundred recipes with cycle menus that 

vary from 3, 4, or 5 week cycles and 

from 5, 6, or 7 day service weeks. Due 

to the variability in menus in locations 

that rely on contract food services, the 

comment recommended that the 

definition of ‘‘offering for sale 

substantially the same menu item’’ be 

changed to ‘‘establishments in a chain 

that offer standard menus comprised of 

menu items that use the same general 

recipes and are prepared in 

substantially the same ways with 

substantially the same food 

components, even if the name of the 

menu item varies.’’ 

(Response 31) We decline to name a 

proportion or percentage of menu items 

that must be shared between 

establishments. Restaurants and similar 

retail food establishments regularly offer 

new and reformulated menu items in 

their establishments. It would be 

burdensome and impractical for 

establishments and inspectors to 

continually evaluate all of the 

establishments in the chain to count the 

numbers of standard menu items in 

common in order to determine whether 

a given establishment is covered. In 

addition, some establishments that are 

part of a large chain may not offer for 

sale all of the standard menu items 

offered in other locations of that chain. 

For example, some chains have a 

handful of locations in airports or other 

venues notated by the term ‘‘Express’’ 

added to the name, that sell a subset of 

the foods that are carried by the larger 

establishments in the chain. Finally, as 

the comments point out, some 

restaurants that are part of large chains 

have some unique or regional items or 

may vary recipes in a unique way. 

These types of minor variations should 

not exclude establishments from the 

requirements of this rule. 

Based on the comments and on the 

considerations discussed previously in 

this document, we are not finalizing a 

specific proportion or percentage of 

menu items that covered establishments 

within a chain must share. However, we 

understand from the comments that our 

definition should speak to the number 

of menu items that must be shared more 

clearly. Therefore, we are adding a 

qualitative, not quantitative, description 

of the number of menu items that must 

be shared in order for the criterion of 

‘‘offering for sale substantially the same 

menu items’’ to be met. Given the 

statutory language, along with the 

practicalities of and variations within 

the industry, we are adding ‘‘offering for 

sale a significant proportion of menu 

items’’ to the definition of ‘‘offering for 

sale substantially the same menu 

items.’’ For example, if establishments 

only share one or two menu items, those 

establishments would not meet the 

criterion of ‘‘offering for sale 

substantially the same menu items.’’ 

We recognize that some 

establishments in a chain may have 

some menu items with ingredients that 

vary based on regional taste or source. 

Some menu items may be designed or 

prepared to meet certain dietary 

practices (e.g., Kosher or Halal) or 

contain a ‘‘secret ingredient.’’ This is 

why our definition of ‘‘offering for sale 

substantially the same menu items’’ 

includes the criteria ‘‘us[ing] the same 

general recipe, prepared in substantially 

the same way, with substantially the 

same food components.’’ By ‘‘the same 

general recipe,’’ we mean that the 

establishments share a recipe, even if 

one establishment subsequently tweaks 

that recipe due to regional tastes or 

dietary practices. By ‘‘prepared in 

substantially the same way,’’ we mean 

to include slight deviations from the 

recipe, because of, for example, food 

service worker variability. By ‘‘with 

substantially the same food 

components,’’ we mean to include 

situations where ingredients may vary 

based on local availability or sourcing, 

including those used to conform to 

certain dietary practices (e.g., Kosher 

meat). 

We also agree with comments that 

having the same name may indicate that 

the menu items are substantially the 

same, but it does not always do so. As 

comments pointed out, menu items that 

reflect regional differences may be so 

different that the name of the menu item 

sheds little light on whether the menu 

items use the same general recipe and 

are prepared in substantially the same 

way with substantially the same food 

components. For example, in some 

regions of the United States a menu item 

named ‘‘barbecue’’ may refer to a food 

prepared from pulled pork, whereas in 

other regions a menu item named 

‘‘barbecue’’ may refer to a food prepared 

from beef ribs. Therefore, we have 

revised the definition to add a new 

sentence stating that having the same 

name may indicate, but does not 

necessarily guarantee, that menu items 

are substantially the same. 

The definition for ‘‘substantially the 

same menu items’’ would also apply to 

establishments relying on food 

contractors. If such an arrangement 

caused menu rotations, the relevant 

question would still be whether those 

establishments are offering for sale 

substantially the same menu items, 

including whether they are selling a 

significant proportion of menu items 

that use the same general recipe and are 

prepared in substantially the same way 

with substantially the same food 

components, even if not necessarily at 

the same time. In other words, the focus 

is on whether the menu items are 

substantially the same, not on whether 

the menus or menu boards are 

substantially the same. We decline to 

accept the suggestion from the comment 

to revise the definition to include 

‘‘establishments in a chain that offer 

standard menus comprised of menu 

items that . . .’’ because it reflects a 

misunderstanding that an establishment 

needs to have a menu, or a ‘‘standard 

menu’’ more specifically, to be covered 

by the new law. 

(Comment 32) One comment 

maintained that convenience stores in a 

chain do not have identical business 

plans and the same food; the food varies 

per establishment and is not prepared to 

corporate policy as it is in restaurants. 

(Response 32) As explained 

previously in this document, 

establishments can be ‘‘offering for sale 

substantially the same menu items’’ 

even if not all of their menu items are 

exactly the same. Depending on the 

extent to which the menu items vary, a 

convenience store may or may not meet 

the criterion of offering for sale 


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71174 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

substantially the same menu items as 

defined in the rule. 

(Comment 33) One comment 

described itself as a family-owned 

restaurant operator with 25 restaurants 

located entirely within a single State. 

Two of its restaurants also contain sushi 

operations, each under a different name 

and with entirely different menus than 

the larger establishment. The comment 

asked us to confirm that the rule would 

not apply to these sushi operations. 

(Response 33) Based on the 

information in the comment, the two 

sushi operations do not appear to be 

covered by the rule because they are 

neither doing business under the same 

name (see section VI.E) nor offering for 

sale substantially the same menu items 

as 18 other establishments. 

G. Authorized Official of a Restaurant or 

Similar Retail Food Establishment 

Proposed § 101.11(a) would define 

‘‘Authorized official of a restaurant or 

similar retail food establishment’’ as the 

owner, operator, agent in charge, or 

other person authorized by the owner, 

operator, or agent in charge to register 

the restaurant or similar retail food 

establishment, which is not otherwise 

subject to section 403(q)(5)(H) of the 

FD&C Act, with FDA for the purposes of 

§ 101.11(d). (Section 101.11(d) pertains 

to voluntary registration to become 

subject to the requirements of section 

403(q)(5)(H) of the FD&C Act.) 

We received no comments on the 

proposed definition and are finalizing it 

without change. 

H. Covered Establishment 

As already noted in section VI.A, 

proposed § 101.11(a) would define 

‘‘covered establishment’’ as a restaurant 

or similar retail food establishment that 

is a part of a chain with 20 or more 

locations doing business under the same 

name (regardless of the type of 

ownership, e.g., individual franchises) 

and offering for sale substantially the 

same menu items, as well as a restaurant 

or similar retail food establishment that 

is registered to be covered under section 

403(q)(5)(H)(ix) of the FD&C Act. 

(Emphasis added). 

In the following paragraphs, we 

discuss general comments on this 

proposed definition. We are finalizing 

the definition of ‘‘covered 

establishment’’ without change, except 

to refer to § 101.11(d) instead of section 

403(q)(5)(H)(ix) of the FD&C Act. 

However, as already discussed (see 

sections VI.B, VI.C, VI.D, VI.E, and 

VI.F), changes we are making to other 

terms (i.e., adding a definition of 

‘‘location,’’ revising the definition of 

‘‘restaurant or similar retail food 

establishment,’’ revising the definition 

of ‘‘restaurant-type food,’’ revising the 

definition of ‘‘doing business under the 

same name,’’ and revising the definition 

of ‘‘offering for sale substantially the 

same menu items’’) affect the overall set 

of covered establishments. 

1. General Comments on the Definition 

of Covered Establishment 

(Comment 34) One comment 

considered that our proposed definition 

would make it conceivable for the 

requirements to apply to a single, 

completely unique ‘‘restaurant concept’’ 

that is owned by a chain with 20 or 

more other restaurants. The comment 

described a ‘‘restaurant concept’’ as 

separate and distinct operations by 

virtue of the individual restaurant’s 

menu offerings or recipes, name, decor, 

and other distinguishing characteristics 

such as different dining experiences 

with higher quality food and different 

menu items that may be unrecognizable 

to the average diner as being operated 

by the larger chain. This comment also 

considered that applying the menu 

labeling requirements to these 

individual ‘‘restaurant concepts’’ would 

not be consistent with the statute or 

intent of Congress. Another comment 

expressed concern that a person who 

operates more than 20 chain retail food 

establishments and wants to start a 

‘‘new concept’’ would be required to 

provide nutrition information if this 

‘‘new concept’’ is only in one location. 

(Response 34) We disagree that we 

need to revise the definition of a 

covered establishment to prevent a 

misinterpretation that a single, 

completely unique ‘‘restaurant concept’’ 

that is owned by a chain with 20 or 

more other restaurants generally would 

be covered by the rule. An 

establishment that is ‘‘single’’ and a 

‘‘completely unique restaurant concept’’ 

is unlikely to have ‘‘20 or more 

locations’’ and be ‘‘offering for sale 

substantially the same menu items’’ as 

20 or more other restaurants. Thus, such 

an establishment is unlikely to satisfy 

the criteria in the proposed definition to 

be a ‘‘covered establishment’’ as it is 

currently written. Likewise, if a person 

operates more than 20 chain retail food 

establishments and starts a ‘‘new 

concept,’’ that ‘‘new concept’’ 

establishment would not be a covered 

establishment unless it is part of a chain 

with 20 or more locations doing 

business under the same name and 

offering for sale substantially the same 

menu items. We are retaining our 

definition, which, as we described in 

the proposed rule, is derived from 

sections 403(q)(5)(H)(i) and (xi)(I) of the 

FD&C Act (76 FR 19192 at 19195). 

(Comment 35) One comment 

recommended that we revise the 

definition of covered establishment to 

use the following language from its 

State’s regulation: ‘‘A food 

establishment that: (1) Is engaged in the 

business of preparing and selling food 

items for immediate human 

consumption on the premises or off the 

premises, . . . and (2) offers for sale 

substantially the same menu items, 

utilizing menus, menu boards or food 

item tags, in servings that are 

standardized for portion size and 

content, and (3) is one of a group of . . . 

food establishments . . . that (a) 

operates under common ownership or 

control, or (b) operates as franchised 

outlets of a parent business, or (c) does 

business under the same name.’’ The 

comment cited only those portions of its 

regulation relevant to the questions 

raised by the definition of covered 

establishment in our proposed rule, and 

used ellipses to indicate text that was in 

the State regulation but not being 

offered as part of the definition of 

‘‘covered establishment’’ in this rule. 

(Response 35) We disagree with this 

comment and are not revising the 

definition of ‘‘covered establishment’’ to 

incorporate its suggestions. Our 

definition of covered establishment is 

derived from the Federal statutory 

language. The only basis offered by the 

comment was that the suggestions are 

used in a State law; the comment did 

not state why these changes were 

necessary from a policy perspective or 

legally justified under the Federal law. 

(Comment 36) One comment 

recommended that the rule apply to 

most restaurants, and not just those with 

more than 20 locations, possibly 

excluding only establishments with a 

very small seating capacity. The 

comment contended that consumers 

already know that fast food is ‘‘bad for 

you’’ and they need to know the 

nutrition information about the food in 

other restaurants. 

(Response 36) This rule implements 

section 4205 of the ACA, which, in 

general, covers only restaurants and 

similar retail food establishments that 

are part of a chain with 20 or more 

locations. Section 4205 of the ACA 

allows other restaurants and similar 

retail food establishments to register 

with FDA to become subject to the 

Federal requirements, but it does not 

require them to do so. 

(Comment 37) One comment asked us 

to clarify whether the rule would apply 

to foreign establishments of a particular 

chain that has 20 or more 

establishments in the United States, and 

also has an establishment located in a 

foreign location, such as Italy. 


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(Response 37) The rule applies to 

locations in the United States, including 

any State or Territory of the United 

States, the District of Columbia, and the 

Commonwealth of Puerto Rico. This 

geographic scope is consistent with the 

definitions of ‘‘State’’ and ‘‘Territory’’ in 

section 201(a) of the FD&C Act. 

(Comment 38) A few comments asked 

us to clarify that contractors and 

managed food service operations would 

be covered if they offer for sale 

substantially the same menu items. 

(Response 38) Whether any other 

specific contractor or managed food 

service would be subject to the rule 

would depend on whether it satisfied all 

criteria established within the definition 

of ‘‘covered establishment.’’ Thus, to be 

a covered establishment, an 

establishment operated by a contractor 

or managed food service must be a 

restaurant or similar retail food 

establishment that is a part of a chain 

with 20 or more locations doing 

business under the same name and 

offering for sale substantially the same 

menu items. We expect that some 

establishments operated by contractors 

and managed food services will satisfy 

all of these criteria. 

2. Cooperatives 

(Comment 39) Some comments 

addressed cooperatives and discussed 

multiple aspects related to the 

definition of ‘‘covered establishment,’’ 

including ‘‘part of a chain,’’ ‘‘doing 

business under the same name,’’ and 

‘‘offering for sale substantially the same 

menu items.’’ One comment considered 

that cooperatives should not be exempt 

because the law expressly states 

‘‘regardless of . . . ownership.’’ One 

comment considered that the type of 

ownership of grocery stores, such as a 

cooperative, is irrelevant to whether a 

store is part of a chain. This comment 

maintained that the law clearly requires 

chains operating under the same name 

to disclose calories, regardless of the 

type of ownership. This comment also 

maintained that grocery store 

cooperatives face a similar situation as 

that faced by independent franchise 

owners of chain restaurants. 

Other comments generally expressed 

the view that cooperatives should not be 

covered by the rule. One comment 

asserted that establishments associated 

with the same wholesaler or cooperative 

should not be considered ‘‘part of a 

chain’’ regardless of whether they 

operate under the same ‘‘banner’’ or 

under a different ‘‘banner.’’ The 

comment considered that cooperatives 

are the opposite of chains because they 

are owned by individual members, 

operate independently, and are not 

bound by franchise agreements, whereas 

chains are centrally controlled with 

little say or choice by participants. The 

comment asked us to recognize that 

independent grocers are not part of a 

chain of 20, doing business under same 

name and selling the same items, even 

if we believe cooperatives are similar 

retail food establishments. 

A few comments maintained that the 

definition for ‘‘doing business under the 

same name’’ does not apply to 

cooperatives because they are 

independent and exercise their 

independence more than franchised 

restaurants. According to one comment, 

independent retailers own, control, and 

operate their stores independently as 

customers of voluntary wholesalers and 

members of cooperatives. The comment 

explained that the food distribution 

system allows independent retailers to 

take advantage of economies of scale 

when procuring goods and services, as 

well as marketing and advertising, thus 

helping independent operators 

effectively compete with large national 

chain stores. The comment also 

explained that these entities are 

independently owned and operated 

businesses that often compete with 

other stores under the same banner 

name, and that menu items can have 

different general recipes and be 

prepared in substantially different ways 

with substantially different food 

components. 

One comment asked us to recognize 

that members of cooperatives are not 

‘‘doing business under the same name.’’ 

For example, the comment considered 

that ‘‘Fred’s Thriftway’’ is not the same 

as ‘‘Bob’s Thriftway.’’ The comment 

considered that ‘‘Thriftway’’ signals that 

these establishments are part of a 

cooperative but maintained that they are 

two different stores. 

One comment contended that the 

term ‘‘offering for sale substantially the 

same menu items’’ may not apply to 

some foods, such as brownies or potato 

salad, made in grocery store 

cooperatives, although those foods may 

be offered for sale under the same name 

in those stores. According to the 

comment, ‘‘Bob’s Thriftway’’ and 

‘‘Mike’s Thriftway’’ may both sell 

brownies made from the same general 

recipe, (e.g., flour, sugar, eggs, chocolate 

and butter); however, because 

independent grocers compete with each 

other, each is likely to include a secret 

ingredient, and as a result, the brownies 

are not the same. 

(Response 39) We agree with some 

comments that the type of ownership of 

an establishment is not relevant to 

whether it is covered. To be subject to 

the rule, a cooperative must satisfy all 

the criteria in the definition of ‘‘covered 

establishment.’’ In other words, to be 

subject to the rule a cooperative must be 

a restaurant or similar retail food 

establishment that sells restaurant-type 

food and is a part of a chain with 20 or 

more locations doing business under the 

same name (regardless of the type of 

ownership, e.g., individual franchises) 

and offering for sale substantially the 

same menu items. As we explain in 

section VI.D., we are not defining the 

term ‘‘chain’’ in this rulemaking. In 

addition, for the reasons we provide in 

section VI.E., we continue to define 

doing business under the same name to 

include names that are slight variations 

of each other. Independent businesses 

that are cooperatives, even those that are 

similarly named, are not covered 

establishments if, for example, they are 

only connected insofar as they take 

advantage of economies of scale when 

procuring goods and services, or for 

marketing and advertising purposes, but 

are not ‘‘offering for sale substantially 

the same menu items.’’ 

However, given the way cooperatives 

generally are structured, we do not 

expect that two cooperatives would be 

offering for sale substantially the same 

menu items. Unless a food such as a 

brownie offered for sale in Bob’s 

Thriftway has the same general recipe, 

prepared in substantially the same way, 

with substantially the same food 

components as a brownie offered for 

sale in Mike’s Thriftway, the two 

cooperatives’ brownies would not be 

‘‘substantially the same.’’ However, if 

Bob’s Thriftway and Mike’s Thriftway 

share a recipe such as a brownie recipe, 

and the only difference between the two 

brownie recipes is that Mike’s Thriftway 

has added a ‘‘secret ingredient,’’ the 

brownies could be considered 

substantially the same menu item, 

depending on the importance of that 

ingredient. Note that even in this 

circumstance, Bob’s Thriftway and 

Mike’s Thriftway would not be ‘‘offering 

for sale substantially the same menu 

items’’ if the brownie is the only menu 

item that the two cooperatives share. 

In addition, we note that a 

cooperative that is a restaurant or 

similar retail food establishment and 

does not satisfy all of the criteria to be 

a covered establishment, but voluntarily 

registers to be covered in accordance 

with § 101.11(d), would be subject to the 

rule. 


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71176 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

I. Revisions to Several Provisions To 

Clarify the Applicability of the Rule to 

Those Restaurants and Similar Retail 

Food Establishments That Are Covered 

Establishments 

This rule applies to restaurants and 

similar retail food establishments that 

satisfy the definition of ‘‘covered 

establishment’’ in this rule. Several 

provisions of the proposed rule that 

would apply to ‘‘covered 

establishments’’ used the term 

‘‘restaurant or similar retail food 

establishment’’ rather than ‘‘covered 

establishment.’’ To make clear that 

those provisions only apply to those 

restaurants and similar retail food 

establishments that satisfy the definition 

of ‘‘covered establishment,’’ we are 

replacing the term ‘‘restaurant or similar 

retail food establishment’’ with 

‘‘covered establishment’’ in those 

provisions. The affected provisions are: 

• The definition of ‘‘custom order’’ 

(§ 101.11(a)); 

• The definition of ‘‘menu or menu 

board’’ (§ 101.11(a)); 

• The introductory text of 

§ 101.11(b)(2)(ii) regarding nutrition 

information for a standard menu item 

that must be available in written form; 

• The introductory paragraph of 

proposed § 101.11(c)(6) (which we are 

establishing in § 101.11(c)(3)) regarding 

information that must be provided to 

FDA substantiating nutrient 

information; and 

• A subparagraph of proposed 

§ 101.11(c)(6) regarding specific 

substantiation documentation (i.e., 

proposed paragraph (c)(6)(ii)(D), which 

we are establishing as paragraph 

(c)(3)(ii)(D)). 

We note these changes in our 

discussion of each of these specific 

provisions. 

VII. Comments and FDA Response on 

the Proposed Definition of Menu or 

Menu Board (Proposed § 101.11(a)) 

Proposed § 101.11(a) would define 

‘‘menu or menu board’’ as the primary 

writing of the restaurant or similar retail 

food establishment from which a 

customer makes an order selection, 

including, but not limited to, breakfast, 

lunch, and dinner menus; dessert 

menus; beverage menus; children’s 

menus; other specialty menus; 

electronic menus; and menus on the 

Internet. The proposed definition would 

also provide that menus may be in 

different forms, e.g., booklets, 

pamphlets, or single sheets of paper and 

that menu boards include those inside 

a restaurant or similar retail food 

establishment as well as drive-through 

menu boards at restaurants or similar 

retail food establishments. 

In the proposed rule, we stated that 

given the importance for all consumers 

to have access to nutrition information 

when making order selections, ‘‘primary 

writing’’ should be interpreted from a 

consumer’s vantage point (76 FR 19192 

at 19202). For example, while a printed 

menu may be the ‘‘primary writing’’ of 

a restaurant used by a customer ordering 

food while dining inside the restaurant 

itself, a menu mailed as a flyer to 

another customer’s home could be the 

‘‘primary writing’’ of the restaurant used 

by that customer ordering take-out or 

delivery from the same restaurant. Both 

the printed menu and the menu flyer 

would meet the definition of ‘‘menu’’ or 

‘‘menu board’’ under proposed 

§ 101.11(a). 

In the following paragraphs, we 

discuss comments on this proposed 

definition. We have revised the 

definition by replacing the term 

‘‘restaurant or similar retail food 

establishment’’ with ‘‘covered 

establishment’’ in three locations in the 

definitions for clarity (see explanation 

in section VI.I). We are also including 

factors used to determine whether a 

writing is or is part of the primary 

writing from which a consumer makes 

an order selection. 

(Comment 40) Many comments 

supported the proposed definition and 

agreed that ‘‘primary writing’’ should be 

interpreted from the perspective of 

consumers, so that each writing of the 

establishment that is the primary 

writing used by consumers in making 

order selections would be considered a 

menu or menu board. Several comments 

asserted that consumers need to see 

calorie information when making order 

selections in order for the information to 

be useful to them. One comment noted 

that Congress did not intend for covered 

establishments to only provide calorie 

declarations on a single medium in each 

establishment, as evidenced by the fact 

that section 4205 of the ACA requires 

calorie declarations on drive-through 

menu boards and menus and menu 

boards located inside establishments. 

Another comment suggested that we 

emphasize that any list or display of a 

standard menu item that is primary to 

the consumer placing an order would 

constitute a menu or menu board. 

One comment considered that a single 

store that has multiple menus or menu 

boards should be able to select the menu 

on which the calories must be disclosed. 

For example, a single store might have 

more than one menu board—with one 

such board being handwritten and 

highlighting specific special options. As 

long as every food offered for sale in the 

establishment is listed on one menu 

board and that menu board includes the 

necessary information, the comment 

considered that requiring calories on 

that one menu board should be 

sufficient. Alternatively, the comment 

suggested that the calorie declaration be 

required on the ‘‘menu board of 

prominence,’’ which the comment 

considered to be the menu board from 

which the order is placed. 

Another comment similarly asserted 

that covered establishments must post 

the required information on the menu 

used most often rather than on all 

menus. Alternatively, the comment 

suggested that we provide an exemption 

for menus not commonly used by 

customers. In support of its suggestion, 

the comment pointed out that the 

statute uses the singular term ‘‘writing’’ 

and not a plural term. The comment 

stated that 90 percent of pizza 

customers order over the phone or the 

Internet or may order from memory. The 

comment asserted that to require 

nutrient information on every menu, 

menu board, Internet menu, or other 

writing is expensive, time consuming, 

and burdensome. The comment stated 

that it already uses in-store brochures to 

provide nutrition information to the 

small percentage of in-store customers. 

Although each franchisee in the 

applicable chain is required to carry 

certain menu items, the comment 

considered that each franchisee has the 

latitude to add items to the menu. 

Because the franchisee can add menu 

items to its menu, the comment asserted 

that it would be costly to a franchisee 

to change menu boards, because the 

franchisee will be required to order new 

menu boards and request calorie 

information for the new menu items. 

One comment referred to an ‘‘industry 

proposal’’ for posting calories only on 

menus and menu boards that have the 

highest percentage of sales for that 

particular establishment, e.g., Web sites 

used for Internet ordering and paper 

menus for phone ordering. This 

comment was opposed to any such 

proposal. The comment asserted that 

this approach would be an unfair 

business advantage for certain 

restaurants because it would allow some 

restaurants to provide calorie 

declarations on less expensive menus 

such as paper take-out menus or 

Internet Web sites while others would 

have to provide calorie declarations for 

more expensive in-restaurant menus 

and menu boards. The comment also 

expressed concern that any requirement 

for a covered establishment to declare 

calories on only the menus that listed 

substantially all menu items would 

exclude children’s menus and dessert 

menus. 


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Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 71177 

(Response 40) We agree with the 

comments in support of the proposed 

definition. We disagree that the required 

information should only be posted on 

the menu or menu board most often 

used by consumers in a covered 

establishment, the ‘‘menu board of 

prominence,’’ or only on the menus and 

menu boards that have the highest 

percentage of sales for a particular 

covered establishment. The critical 

factor is whether written material is or 

is part of the primary writing of a 

covered establishment from which a 

customer makes an order selection. It is 

not a matter of physical prominence of 

a menu, or the proportion of customers 

who order from a menu. Some 

consumers may want to select from a 

subset of standard menu items sold in 

the covered establishment. For example, 

if a consumer wanted to order only a 

dessert, he or she may ask for a dessert 

menu. As raised by one comment, if 

calorie information is listed only on the 

dinner menu, the consumer would not 

have access to the calorie information 

for the desserts if he or she is ordering 

from the dessert menu. As we stated in 

the proposed rule, given the importance 

for all consumers to have access to 

nutrition information when making 

order selections, we believe that the 

term ‘‘primary writing’’ should be 

interpreted from a consumer’s vantage 

point (76 FR 19192 at 19202). 

In addition, in the proposed rule, we 

tentatively concluded that a ‘‘menu’’ or 

‘‘menu board’’ includes any writing of 

the covered establishment that is the 

primary writing from which a consumer 

makes an order selection (76 FR 19192 

at 19201). We affirm this conclusion. 

The ‘‘primary writing’’ of an 

establishment can include more than 

one form of written material, such as a 

paper menu, a delivery menu, and a 

menu board; the critical factor is 

whether the written material is or is part 

of the primary writing of a covered 

establishment from which a customer 

makes an order selection. Further, we 

clarify that determining whether a 

writing is or is part of the primary 

writing from which a consumer makes 

an order selection depends on a number 

of factors, including whether the 

writing, such as a paper menu, delivery 

menu, or sign, lists the name of a 

standard menu item (or an image 

depicting the standard menu item) and 

the price of the standard menu item, 

and whether the writing can be used by 

a consumer to make an order selection 

at the time the consumer is viewing the 

writing (e.g., the writing is posted at the 

cash register in a covered establishment, 

or the writing lists the phone number or 

email address of a covered 

establishment for purposes of placing an 

order). 

Accordingly, a writing of a covered 

establishment that contains the name (or 

image) and price of a standard menu 

item, and that can be used by a 

consumer to make an order selection 

from the establishment at the time the 

consumer is viewing the writing would 

be a menu or menu board regardless of 

whether, for example, the writing is not 

the menu used most often by 

consumers. Another writing, such as a 

poster on a storefront, a banner or 

billboard located along a road or 

highway, or a tray-liner or table-tent at 

a quick-service restaurant, could be 

considered a ‘‘secondary’’ writing 

within this context and would not meet 

the definition of a ‘‘menu or menu 

board,’’ provided that such writing does 

not contain the name (or image) and 

price of a standard menu item, and 

cannot be used by a consumer to make 

an order selection at the time the 

consumer is viewing the writing. 

We interpret the comment asserting 

that section 403(q)(5)(H)(xi) of the FD&C 

Act uses the singular term ‘‘writing’’ in 

defining the term ‘‘menu or menu 

board’’ as raising the question of what 

Congress intended ‘‘primary writing’’ to 

mean within the context of section 

403(q)(5)(H)(xi) of the FD&C Act. In 

construing section 403(q)(5)(H)(xi) of 

the FD&C Act, FDA is confronted with 

two questions. First, has Congress 

directly spoken to the precise question 

presented (Chevron step one)? (Chevron, 

U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 

842 (1984).) If the ‘‘intent of Congress is 

clear,’’ an Agency ‘‘must give effect to 

the unambiguously expressed intent of 

Congress.’’ (Id. at 843.) However, if 

‘‘Congress has not directly addressed 

the precise question at issue,’’ and the 

statute is ‘‘silent or ambiguous with 

respect to the specific issue,’’ then our 

interpretation of the term ‘‘primary 

writing’’ will be upheld as long as it is 

based on a ‘‘permissible construction of 

the statute (Chevron step two). 

(Chevron, 467 U.S. at 842–43; FDA v. 

Brown & Williamson Tobacco Corp, 529 

U.S. 120, 132 (2000).) To find no 

ambiguity, Congress must have clearly 

manifested its intention with respect to 

the particular issue. (See e.g., Young v. 

Community Nutrition Institute, 476 U.S. 

974, 980 (1986).) 

We have determined that, in enacting 

section 403(q)(5)(H)(xi) of the FD&C Act, 

Congress did not speak directly and 

precisely to the meaning of ‘‘primary 

writing’’ within the definition of ‘‘menu 

or menu board.’’ In conducting the 

Chevron step one analysis, we began 

with the language of section 

403(q)(5)(H)(xi) of the FD&C Act. (See 

e.g., Touche Ross & Co. v. Redington, 

442 U.S. 560, 568 (‘‘[A]s with any case 

involving the interpretation of a statute, 

our analysis must begin with the 

language of the statute itself.’’).) The 

term ‘‘primary writing’’ is not defined in 

section 403(q)(5)(H) of the FD&C Act or 

elsewhere in the FD&C Act. In general, 

a term that is undefined in a statute 

carries its ordinary meaning. (See e.g., 

Perrin v. United States, 444 U.S. 37, 42 

(1979) (‘‘A fundamental canon of 

statutory construction is that, unless 

otherwise defined, words will be 

interpreted as taking their ordinary 

contemporary, common meaning.’’).) 

One common definition of the term 

‘‘writing’’ is ‘‘something written, 

especially (a) meaningful letters or 

characters that constitute readable 

matter . . . (b) a written work, 

especially a literary composition’’ (Ref. 

20). Similarly, another common 

definition of the term ‘‘writing’’ is 

‘‘something written: As (a) letters or 

characters that serve as visible signs of 

ideas, words, or symbols; (b) a letter, 

note, or notice used to communicate or 

record; (c) a written composition.’’ (Ref. 

21; see also Ref. 22). 

One common definition of the term 

‘‘primary’’ is ‘‘first or highest in rank or 

importance; principal’’ (Ref. 23; see also 

Refs. 24 and 25). Another common 

definition of the term ‘‘primary’’ is 

‘‘functioning or transmitting without 

intermediary: Direct’’ (Ref. 25; see also 

Ref. 24). 

Where, as here, the statutory language 

on its face does not clearly establish 

Congressional intent, it is appropriate to 

also consider other traditional tools of 

statutory construction, including other 

language in the section, the language, 

design, and purpose of the statute as 

whole, and legislative history. (See e.g., 

Pharmaceutical Research & 

Manufacturers of America v. Thompson, 

251 F.3d 219, 224 (D.C. Cir. 2001); Davis 

v. Michigan Department of Treasury, 

489 U.S. 803, 809 (1989); Martini v. 

Federal National Mortgage Association, 

178 F.3d 1336, 1345 (D.C. Cir. 1999).) 

The other language in section 

403(q)(5)(H)(xi) of the FD&C Act 

indicates that the writing at issue is 

writing of the establishment ‘‘from 

which a consumer makes an order 

selection.’’ Further, other provisions 

within section 403(q)(5)(H) of the FD&C 

Act indicate that requirements apply to 

more than one form of writing within a 

covered establishment. (See sections 

403(q)(5)(H)(ii)(I) and (II) of the FD&C 

Act.) In addition, a general purpose of 

section 4205 of the ACA is to make 

calorie and other nutrition information 

available to consumers in a direct and 


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71178 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

accessible manner to enable consumers 

to make informed and healthful dietary 

choices. Lastly, the legislative history 

does not suggest that Congress intended 

to limit the term to only one writing of 

the establishment. 

Having determined that the meaning 

of ‘‘primary writing’’ in section 

403(q)(5)(H)(xi) of the FD&C Act is 

ambiguous, we have determined that the 

final rule’s interpretation of ‘‘primary 

writing’’ is a permissible construction of 

the statute (Chevron step two). In 

conducting the Chevron step two 

analysis, the same tools of statutory 

construction are available as those for 

the step one analysis. 

First, the interpretation in the final 

rule is consistent with the plain 

meaning of the statute (Ref. 26). (See 

also Perrin v. United States, 444 U.S. 37, 

42 (1979).) Under the final rule, a 

‘‘primary writing’’ is ‘‘something 

written,’’ such as letters or characters on 

a sign or board. Further, determining 

whether the ‘‘writing’’ is ‘‘primary,’’ 

meaning of the most relevance or 

importance within this context or 

functioning without intermediary, or 

direct, depends on a number of factors, 

including whether the writing lists the 

name of a standard menu item (or an 

image depicting the standard menu 

item) and the price of the standard 

menu item, and whether the writing can 

be used by a consumer to make an order 

selection at the time the consumer is 

viewing the writing. In developing these 

factors, we considered other language in 

section 403(q)(5)(H)(xi) of the FD&C Act, 

specifically that the writing of the 

establishment is one ‘‘from which a 

consumer makes an order selection.’’ 

We also considered other language 

within section 403(q)(5)(H) of the FD&C 

Act, including sections 403(q)(5)(H)(i) 

and (ii)(I) and (II) of the FD&C Act, 

which together require a covered 

establishment to post calorie and other 

information on a menu and menu board. 

Further, in considering the general 

purpose of the section 4205 of the ACA, 

we determined that construing the term 

‘‘primary writing’’ within the meaning 

of section 403(q)(5)(H)(xi) of the FD&C 

Act so as to include more than one form 

of writing, dependent on specific 

factors, would better serve the purposes 

of section 4205. 

For all of these reasons, § 101.11(a) 

continues to specify that a menu or 

menu board is defined as the primary 

writing of the restaurant or similar retail 

food establishment from which a 

consumer makes an order selection. 

In response to the comment regarding 

costs related to adding new menu items 

to a menu or menu board, we first note 

that section 403(q)(5)(H)(ii) of the FD&C 

Act requires covered establishments to 

declare calories on menus and menu 

boards for standard menu items listed 

on such menu and menu boards. 

Therefore, to the extent a covered 

establishment adds a new standard 

menu item to the establishment’s menu 

or menu board, the establishment would 

be required to declare calories on the 

menu or menu board for the new 

standard menu item. Further, a covered 

establishment that decides to add a new 

menu item to a menu or menu board has 

already decided to incur the cost of 

redesigning or replacing the menu or 

menu board for such change—i.e., to 

display the new standard menu item. In 

this situation, the additional cost to the 

establishment is the cost for 

determining the calorie information that 

must be declared for the new standard 

menu item. 

Regarding costs related to determining 

nutrition information for standard menu 

items, we note that this rule also 

provides flexibility in order to minimize 

such costs. As discussed in section 

XVIII, section 403(q)(5)(H)(iv) of the 

FD&C Act provides that a restaurant or 

similar retail food establishment must 

have a reasonable basis for its nutrient 

content disclosures. As also discussed 

in section XVIII, this rule provides that 

a covered establishment can satisfy the 

requirements of 403(q)(5)(H)(iv) of the 

FD&C Act by various means, including 

use of nutrient databases, cookbooks, 

laboratory methods, and other 

reasonable means, including the use of 

Nutrition Facts on labels on packaged 

foods that comply with the nutrition 

labeling requirements of section 

403(q)(1) of the FD&C Act and § 101.9, 

FDA nutrient values for raw fruits and 

vegetables in Appendix C of part 101 

(21 CFR part 101), or FDA nutrient 

values for cooked fish in Appendix D of 

part 101 (see § 101.11(c)(1)). In addition, 

this rule provides that a covered 

establishment can satisfy the 

requirements of 403(q)(5)(H)(iv) of the 

FD&C Act by relying on nutrition 

information for a standard menu item 

determined by the establishment’s 

corporate headquarters or parent entity 

(see § 101.11(c)(3)(i)(F), (c)(3)(iii)(D), 

and (c)(3)(iv)(D)). In some cases, a 

corporate headquarters or parent entity 

could decide to maintain a nutrient 

database and use it to determine 

nutrition information for specialty 

standard menu items offered for sale by 

one or a few individual establishments 

in the chain. Therefore, this rule 

provides flexibility for covered 

establishments in order to minimize 

costs while also helping to ensure that 

calorie and other nutrition information 

is made available to consumers in a 

direct and accessible manner to enable 

consumers to make informed and 

healthful dietary choices. 

(Comment 41) A few comments 

appeared to believe that the proposed 

rule would require covered 

establishments to post or otherwise have 

menu boards for disclosing calorie 

information. These comments asked for 

other options for disclosing calories. 

One comment suggested that large menu 

boards should not be required because 

they will obscure the consumers’ view 

of the preparation of their food and 

thereby create a food safety issue. One 

comment suggested that we consider 

‘‘technological solutions’’ instead of 

menu boards, e.g., use of a kiosk near 

the point of sale. The comment also 

suggested that we provide flexibility to 

cover alternative sources such as a daily 

feature board. 

One comment asked us to provide 

flexibility for facilities that operate in 

locations too small to display a menu 

board by allowing establishments to 

choose among several different options 

for display methods. As one alternative 

to the traditional menu board, the 

comment asked us to permit the use of 

a display terminal to provide nutrition 

information for menu items or allow 

‘‘menu identifiers’’ (a term the comment 

did not define) at the point of selection, 

and to permit nutrition information to 

be displayed adjacent to the food item 

in cafeteria and buffet type settings. 

(Response 41) Some comments may 

have misinterpreted the proposed rule. 

We did not propose to require that 

covered establishments post or 

otherwise have menu boards. Rather, 

within this context, we proposed to 

define the terms ‘‘menu’’ and ‘‘menu 

board,’’ based on the statutory definition 

at section 403(q)(5)(H)(xi) of the FD&C 

Act, and to provide direction regarding 

what information must be disclosed on 

menus and menu boards for covered 

establishments that have menus and 

menu boards. That proposed definition 

relies on the concept of a primary 

writing. If an electronic display is the 

primary writing of the covered 

establishment from which a customer 

makes an order selection, it would 

satisfy our definition of a menu or menu 

board. As such, electronic menus may 

be used by covered establishments, and 

we have retained electronic menus as an 

example of menus in the definition of 

menu or menu board in § 101.11(a). 

Standard menu items offered for sale 

in covered establishments with 

cafeteria- and buffet-type settings are 

most likely foods on display or selfservice foods. As discussed in section 

XVII.B, for a food on display or a selfVerDate Sep<11>2014 14:24 Nov 28, 2014 Jkt 235001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\01DER2.SGM 01DER2

rljohnson on DSK3VPTVN1PROD with RULES2
Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 71179 

service food, section 403(q)(5)(H)(iii) of 

the FD&C Act and § 101.11(b)(2)(iii) 

require covered establishments to place 

a sign adjacent to the food listing 

calories per displayed food item or per 

serving. This rule provides flexibility for 

covered establishments by providing a 

number of options for meeting the 

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

of the FD&C Act and § 101.11(b)(2)(iii). 

For example, covered establishments are 

permitted to declare calories for a food 

on display or a self-service food by 

posting calorie declarations on signs 

adjacent to the food, on a sign attached 

to a sneeze guard, or on a single sign or 

placard (§ 101.11(b)(2)(iii)(A)). 

Therefore, this rule provides flexibility, 

as requested by some comments, for 

covered establishments to choose among 

several options for declaring calorie 

information for standard menu items, 

including self-service foods or foods on 

display in cafeteria and buffet-type 

settings. 

(Comment 42) In the proposed rule, 

we noted that many consumers order 

restaurant-type food from restaurants or 

similar retail food establishments over 

the phone or Internet. We tentatively 

concluded that if consumers can order 

from a covered establishment online, 

over the phone, or by fax, using a 

writing of the covered establishment on 

the Internet as the primary writing from 

which he or she makes his or her order 

selection, then the writing on the 

Internet is a menu for the purposes of 

section 403(q)(5)(H) of the FD&C Act (76 

FR 19192 at 19202). Some comments 

asked us to keep in mind the need to 

keep up with technology and not have 

a rigid standard. 

(Response 42) The definition of 

‘‘menu or menu board’’ clearly specifies 

that menus may be in different forms 

and does not establish a standard for the 

technology used on a menu or menu 

board. The definition lists a number of 

examples of primary writings that may 

be menus or menu boards, including 

electronic menus and menus on the 

Internet, that are not meant to be allinclusive, as indicated by use of the 

terms ‘‘including, but not limited to’’ 

before the examples. Because a menu or 

menu board is defined as the primary 

writing of the covered establishment 

from which a customer makes an order 

selection, the definition is adequate to 

capture methods and media other than 

those specifically listed in that 

definition, so long as such methods and 

media otherwise satisfy the criteria in 

the definition. 

(Comment 43) Several comments 

noted that some local zoning laws do 

not permit restaurants with drivethrough windows to build larger menu 

boards. These comments expressed 

concern about how to comply with the 

new requirements for menu boards in 

light of State or local size restrictions. 

One comment asked us to provide more 

flexibility for compliance, including 

permitting the use of a pamphlet next to 

the drive-through menu board. Some 

comments suggested that we allow 

nutrition information on a large poster 

adjacent to the menu board. 

A few comments supported the use of 

stanchions (i.e., free-standing boards 

that are not connected to the menu 

board and are often placed near drivethrough menu boards) to post calorie 

information. One comment maintained 

that restaurants and similar retail food 

establishments have a vested interest in 

customer satisfaction in the context of 

drive-through windows and have 

concluded that clear and organized 

space, presented within the framework 

of a known brand, is the most critical 

success factor in presenting information 

to consumers on menu boards. This 

comment considered that stanchions 

adjacent or close to menu boards are 

‘‘complete thoughts’’ if the information 

is relevant, well organized, and clearly 

marked, and that such stanchions will 

help consumers with their menu 

choices. The comment considered that 

in many cases information on 

stanchions is more clear and 

conspicuous than on menu boards. The 

comment noted that calorie information 

is provided on stanchions in some 

jurisdictions that require nutrition 

labeling on menus and menu boards, 

including Montgomery County 

(Maryland), New York City, 

Philadelphia, and certain counties in 

New York. The comment maintained 

that the current use of stanchions in 

some jurisdictions is evidence of its 

effectiveness, and noted that some 

States and localities permit stanchions 

because information is hard to read on 

already crowded drive-through menu 

boards. 

A comment from a quick-service 

restaurant chain asserted that 

stanchions are less costly to update and 

replace than menu boards. The chain 

had conducted a consumer survey of 

customers who purchased food from the 

chain’s drive-through windows in 13 of 

the chain’s restaurants that use 

stanchions, as permitted in King 

County, Washington, and submitted a 

report of this survey to the docket for 

this rule (Ref. 27). For the 128 customers 

surveyed, the comment reported that 92 

percent felt it was easy to find calories, 

98 percent felt calories were easy to 

understand, 95 percent thought the 

stanchion location was clearly visible to 

consumers, 95 percent noted nothing 

blocked view of stanchion, and 76 

percent felt they had adequate time to 

review before ordering. 

One comment considered that while 

‘‘the statute’’ refers to menus and menu 

boards, it also gives us authority to 

define those terms. (We assume this 

comment is referring to section 4205 of 

the ACA.) The comment stated that we 

could include stanchions as a method to 

communicate calorie information that is 

clear and conspicuous. 

Several comments agreed with our 

tentative conclusion that stanchions 

inadequately convey calorie 

information. The comments asserted 

that it is challenging for consumers to 

read different information in different 

locations at a drive-through window 

especially when trying to read the 

information from a car, where 

consumers have limited mobility and a 

limited field of vision. The comments 

also asserted that, even with different 

zoning laws, drive-through menu boards 

have enough room for calories, although 

photos and other marketing information 

may need altering. One comment 

pointed out that separate stanchions 

would not comply with section 

403(q)(5)(H)(ii) of the FD&C Act, which 

requires that calories be on the menu 

board itself. 

(Response 43) We disagree that the 

rule should provide for declaration of 

calorie information in pamphlets or on 

posters or stanchions, rather than on the 

menu board at a drive-through in a 

covered establishment. In the proposed 

rule, we tentatively concluded that 

stanchions inadequately convey calorie 

information because a situation in 

which customers need to look to one 

board (the menu board) for important 

food-selection information, such as 

price, and another (the stanchion) for 

calories, is likely to be more difficult for 

customers attempting to use the 

declared calorie information at the point 

of selection (76 FR 19192 at 19206). We 

also tentatively concluded that this is 

particularly true in the drive-through 

context, where customers have a 

restricted field of vision from their car 

windows, and may have a relatively 

short time to consider the menu board 

prior to ordering, because customers 

often cannot view the full menu while 

waiting in line. As discussed further in 

the following paragraphs, the comments 

provide insufficient basis for us to 

conclude otherwise, and as a result, we 

affirm our conclusion from the proposed 

rule. 

In addition, section 

403(q)(5)(H)(ii)(II)(aa) of the FD&C Act 

requires the number of calories 

contained in standard menu items to be 

disclosed on the menu board itself. 


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71180 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

Section 403(q)(5)(H)(xi) of the FD&C Act 

defines ‘‘menu’’ or ‘‘menu board’’ as 

‘‘the primary writing of the restaurant or 

similar retail food establishment from 

which a customer makes an order 

selection.’’ Because a stanchion is a freestanding board that is not connected to 

a drive-through menu board and 

therefore typically is not used by 

consumers to make order selections, we 

do not consider it to meet the definition 

of ‘‘menu’’ or ‘‘menu board’’ as defined 

in this rule and section 403(q)(5)(H)(xi) 

of the FD&C Act. Accordingly, we 

concluded that a stanchion cannot be 

the means by which a covered 

establishment discloses calorie 

declarations on menus and menu boards 

as required under section 

403(q)(5)(H)(ii) of the FD&C Act and this 

rule. 

We considered the consumer survey 

results provided with one comment and 

did not find the information adequate to 

overcome the concerns we raised in the 

proposed rule regarding the use of 

stanchions (Ref. 28). Although the 

participants expressed favorable 

impressions of the stanchions, the 

survey data: 

• Did not provide a comparison with 

other calorie displays, including calorie 

declarations on drive-through menu 

boards without stanchions; 

• Did not show whether participants 

would have more or less favorable 

impressions of calorie declarations on 

drive-through menu boards without 

stanchions. 

• Only showed that the participants 

liked the display and not whether the 

display was useful for them in making 

their order selections; and 

• Did not assess the use of stanchions 

in situations where the consumer needs 

to make quick decisions because other 

consumers are in the drive-through line 

behind them. 

For all of the reasons discussed in 

response to this comment, this rule does 

not provide for declaration of calories in 

a pamphlet or on a stanchion at a drivethrough of a covered establishment as a 

means of satisfying the requirement that 

the number of calories contained in a 

standard menu item be disclosed on the 

menu and the menu board, as required 

by section 403(q)(5)(H)(ii) of the FD&C 

Act and § 101.11(b)(2)(i). 

(Comment 44) Some comments 

asserted that the proposed rule allows 

the Secretary to amend the nutrition 

information that must be disclosed and 

that this will further burden restaurants 

to replace drive-through and interior 

menu boards multiple times. 

(Response 44) We interpret the 

comments as referring to section 

403(q)(5)(H)(vi) of the FD&C Act. Under 

section 403(q)(5)(H)(vi) of the FD&C Act, 

the Secretary (and, by delegation, FDA) 

may, by regulation, require the 

disclosure of a nutrient, other than a 

nutrient required under section 

403(q)(5)(H)(ii)(III) of the FD&C Act, in 

the written nutrition information that is 

available to consumers upon request if 

FDA determines that the nutrient 

information should be disclosed for the 

purpose of providing information to 

assist consumers in maintaining healthy 

dietary practices. If this is indeed what 

the comments mean, the comments 

appear to have confused section 

403(q)(5)(H)(vi) of the FD&C Act with 

the requirements in section 

403(q)(5)(H)(ii)(I)(aa) related to the 

disclosure of calories on a menu or 

menu board. The statutory authority in 

section 403(q)(5)(H)(vi) of the FD&C Act 

for FDA to require disclosure in the 

written nutrition information of a 

nutrient other than one required under 

section 403(q)(5)(H)(ii)(III) of the FD&C 

Act does not address the calories 

declarations that must be on a menu or 

menu board. 

(Comment 45) In the proposed rule, 

we stated that we recognize that some 

establishments may send menus as a 

form of advertising. We tentatively 

concluded that advertisements for food 

fall outside the scope of section 4205 of 

the ACA. However, take-out and 

delivery menus, which include all or a 

significant portion of items offered for 

sale and serve as the primary writing 

from which consumers make their order 

selections, would be menus under the 

proposed rule (76 FR 19192 at 19201). 

Several comments considered that the 

proposal did not adequately distinguish 

between menus and menu boards and 

advertisements or promotional material. 

One comment considered that it is not 

appropriate to require calorie disclosure 

in advertising, such as a postcard 

announcing a new restaurant that has 

pictures of a few sample dishes. 

However, the comment also considered 

that when the advertising is the menu 

itself and can be used as the ‘‘primary 

writing’’ a customer uses to make an 

order, calorie disclosure should be 

required. The comment recommended 

that the test be whether customers can 

use the menu as a primary writing for 

making their selection, not the way in 

which the menu is presented or 

delivered to the customers by the 

restaurant or similar retail food 

establishment. One comment asked us 

to clarify that calorie disclosure should 

be on any menu regardless of whether 

the menu also serves as a marketing 

tool. One comment stated that any list 

of covered food items that is the primary 

vehicle from which a customer places 

his or her order constitutes a menu. The 

comment noted that in some instances, 

an in-store sign that looks like an 

advertisement (e.g., promotional poster) 

for a menu item is the primary vehicle 

from which the customer orders the 

menu item when the menu item is not 

included on the menu but is included 

only on that sign. This comment asked 

us to make clear that a sign listing a 

menu item that is only listed on that 

sign makes it a menu board. 

One comment asked us to make clear 

that covered menus include 

individualized order sheets used at 

certain restaurants. Another comment 

asked us to make clear that take-out 

menus are included and suggested that 

a take-out menu be added as an example 

to the definition in the regulation. 

Some comments asked us to make a 

clear statement that advertisements and 

promotional material such as table top 

stands, newspaper advertisements and 

flyers, tray liners and point of purchase 

marketing materials are not menus, even 

if they list some names and prices. One 

comment noted that, in the proposed 

rule, we tentatively concluded that 

‘‘advertisements for food fall outside the 

scope of section 4205’’ but did not 

include this statement in the proposed 

definition. The comment asserted that 

we hinted at potential grounds for 

excluding some menus from coverage, 

when we stated that ‘‘take-out and 

delivery menus, which include all or a 

significant portion of items offered for 

sale and serve as the primary writing 

from which consumers make their order 

selections, would be menus under the 

proposed rule’’ (76 FR 19192 at 19202; 

emphasis added by comment). The 

comment expressed concern that, 

without specific language in the final 

regulation that advertisements are not 

menus and thus fall outside the scope 

of section 4205 of the ACA, the terms 

‘‘menu’’ or ‘‘menu board’’ could be 

construed to encompass materials that 

list menu items but that are in fact used 

as advertisements. The comment 

maintained that this clarity is needed to 

ensure consistent enforcement. The 

comment also recommended that we 

expand on our statement that such 

promotional materials are menus subject 

to the menu labeling requirements if 

they ‘‘include all or a significant portion 

of items offered for sale.’’ The comment 

asserted that limiting labeling 

requirements, for example, to only 

menus listing more than a certain 

percentage of standard menu items sold 

by the restaurant would have the 

practical effect of limiting the number of 

pieces covered, excluding many 

promotional items (such as door hangers 

and pizza box tops) and creating an 


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objective standard that could guide both 

restaurant behavior and enforcement. 

The comment considered that requiring 

calorie disclosures on promotional 

material is especially burdensome for 

some of the franchises who pay for this 

promotional material. 

One comment stated that circular 

advertisements should not be menus. 

Another comment recommended that 

grocery store signs that highlight the 

attributes of a food in the store not be 

considered a menu or menu board. One 

comment supported including nutrition 

information on any food advertisement 

that makes a health claim. 

(Response 45) As discussed 

previously in this document, the term 

‘‘menu’’ or ‘‘menu board’’ includes any 

writing of the covered establishment 

that is the primary writing from which 

a consumer makes an order selection. 

As discussed in Response 40, 

determining whether a writing is or is 

part of the primary writing from which 

a consumer makes an order selection 

depends on a number of factors, 

including whether the writing, such as 

a take-out menu, sign, or poster, lists the 

name of a standard menu item (or an 

image depicting the standard menu 

item) and the price of the standard 

menu item, and whether the writing can 

be used by a consumer to make an order 

selection at the time the consumer is 

viewing the writing (e.g., the writing is 

posted at the cash register in a covered 

establishment, or the writing lists the 

phone number or email address of a 

covered establishment for purposes of 

placing an order). Accordingly, a 

writing of a covered establishment that 

contains the name (or image) and price 

of a standard menu item, and that can 

be used by a consumer to make an order 

selection from the establishment at the 

time the consumer is viewing the 

writing would be a menu or menu board 

regardless of whether, for example, the 

writing is mailed to a consumer’s home 

or is posted inside a covered 

establishment. In contrast, written 

material of an establishment that does 

not satisfy this criteria, such as a poster 

on a storefront, a coupon or other 

promotional material, banners, tray 

liners, billboards, and stanchions, could 

be considered a ‘‘secondary writing’’ of 

an establishment. 

We recognize that, in the proposed 

rule, we tentatively concluded that takeout and delivery menus would be 

considered menus within the meaning 

of section 403(q)(5)(H)(xi) of the FD&C 

Act to the extent that such menus 

include all or a significant portion of 

items offered for sale (76 FR 19192 at 

19201). However, we are not affirming 

this conclusion for a number of reasons. 

First, we agree with the comment 

asserting that the critical factor should 

be whether the take-out or delivery 

menu is or is part of the primary writing 

from which a consumer makes an order 

selection, not the way in which the 

menu is presented or delivered to 

consumers. 

Second, as discussed previously in 

this document, in this rule we clarified 

the factors to be considered in 

determining whether a writing is or is 

part of the primary writing from which 

a consumer makes an order selection, 

and these factors help clarify whether a 

writing constitutes a menu or menu 

board or an advertisement or 

promotional material, as requested by 

several comments. Further, in light of 

these factors, if we were to conclude 

that delivery or take-out menus would 

only be considered menus if they 

included all or a significant portion of 

items offered for sale, that conclusion 

would be inconsistent with how we will 

be determining whether other written 

material constitutes a primary writing of 

an establishment from which a 

consumer makes an order selection, 

particularly since consumers can use 

take-out and delivery menus to make 

order selections in generally the same 

way as they would use dine-in menus. 

In addition, menus vary in size and 

selection. A covered establishment that 

has a single menu for daily use, 

including menu offerings for breakfast, 

lunch, and dinner, may nonetheless 

have separate take-out menus directed 

only to breakfast, lunch, or dinner. We 

see no reason to treat a take-out menu 

that only includes menu offering for 

breakfast any differently than we would 

treat a breakfast menu used by 

consumers to order and consume 

breakfast while seated at the 

establishment. 

For these reasons, in this rule we are 

not affirming the proposed rule’s 

tentative conclusion that take-out and 

delivery menus would be considered 

menus within the meaning of section 

403(q)(5)(H)(xi) of the FD&C Act to the 

extent that such menus include all or a 

significant portion of items offered for 

sale. Instead, in this document we 

identify factors we would use to 

determine whether a writing is the 

primary writing from which a consumer 

makes an order selection—i.e., the name 

(or image) and price of the standard 

menu item food and a means to make 

an order selection at the time the 

consumer is viewing the writing. 

Accordingly, determining whether a 

writing is a menu or menu board does 

not depend on how many items are 

listed. If a writing constitutes a menu or 

menu board within the meaning of 

section 403(q)(5)(H)(xi) of the FD&C Act 

and § 101.11(a), it must contain the 

information required under section 

403(q)(5)(H) of the FD&C Act and 

§ 101.11(b), regardless of the number of 

items on that menu or menu board. 

Any written material that is or is part 

of the primary writing from which a 

consumer makes an order selection, 

whether it is an individualized order 

sheet or a take-out menu, would be a 

menu for purposes of this rule if it 

includes the name (or image) and price 

of a standard menu item and a means by 

which a consumer can make an order 

selection from the establishment at the 

time the consumer is viewing the 

writing. Providing calorie and other 

required information on menus and 

menu boards will make such 

information available to consumers in a 

direct and accessible manner to enable 

consumers to make informed and 

healthful dietary choices. 

Using these factors, other writings of 

a covered establishment, such as 

newspaper ads, circular advertisements, 

banners, or postcards that announce a 

new restaurant and provide pictures of 

sample dishes generally would not be 

menus or menu boards. Although it is 

possible that such writings could 

include the name (or image) and price 

of standard menu items, they generally 

would not provide a means by which a 

consumer can make an order selection 

at the time the consumer is viewing the 

writing and therefore such a writing 

would not constitute a primary writing 

from which a consumer makes an order 

selection within the meaning of section 

403(q)(5)(H)(xi) of the FD&C Act. 

Likewise, a sign in a grocery store that 

highlights attributes of a standard menu 

item (e.g., by the name or image of the 

menu item), without including the 

price, would not be a menu or menu 

board. 

While a writing may constitute a 

menu or menu board, not all of the 

menu items listed on such writing 

would require calorie declarations. For 

example, if the requirements of section 

4205 of the ACA do not apply to a food 

(e.g., as a daily special, temporary menu 

item, or customary market test item), a 

covered establishment would not be 

required to declare calories or other 

nutrition information for such food 

under this rule, meaning that a writing 

listing a daily special or temporary 

menu item would not be required to 

bear a calorie declaration for such item. 

Further, as discussed later in this 

document (see Response 79), for certain 

‘‘mix and match’’ situations, where the 

menu or menu board describes an 

opportunity for a consumer to combine 

standard menu items for a special price 


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(e.g., ‘‘Combine Any Sandwich with 

Any Soup or Any Salad for $8.99’’), and 

the calories for each standard menu 

item, including each size option if 

applicable, available for the consumer to 

combine are declared elsewhere on the 

menu or menu board, a covered 

establishment would not be required to 

declare the calories for such item (see 

§ 101.11(b)(2)(i)(A)(6)(iv)). 

The comment supporting nutrition 

information on any food advertisement 

that makes a health claim is outside the 

scope of this rule, which establishes 

requirements for declaring nutrition 

information for standard menu items 

offered for sale in establishments 

covered by the requirements of section 

4205 of the ACA. We note, however, 

that material that constitutes food 

labeling within the meaning of section 

201(m) of the FD&C Act would be 

subject to the requirements in § 101.10. 

Under section 201(m) of the FD&C Act, 

the term ‘‘labeling’’ means all labels and 

other written, printed, or graphic matter 

(1) upon any article or any of its 

containers or wrappers, or (2) 

accompanying such article. 

(Comment 46) One comment 

recommended that menu labeling 

requirements apply to airline magazines 

that include menus. 

(Response 46) In the proposed rule, 

we tentatively concluded that most 

airplanes would not satisfy the 

definition of ‘‘restaurant or similar retail 

food establishment’’ because, in general, 

they do not present themselves to the 

public as restaurants, nor are they likely 

to meet the floor space (or revenue) 

threshold. As discussed in section VI.D, 

under the definition of ‘‘covered 

establishment’’ established in this rule 

airplanes are not covered establishments 

that must comply with the rule. 

Therefore, the nutrition labeling 

requirements of this rule do not apply 

to airline magazines that include menus. 

VIII. Comments and FDA Response on 

the Proposed Definition of Terms 

Related to Foods Covered by the Rule 

(Proposed § 101.11(a)) 

A. Restaurant Food and RestaurantType Food 

As discussed in section VI.C, after 

considering comments, we are deleting 

the proposed definition of ‘‘restaurant 

food’’ and establishing a revised 

definition of ‘‘restaurant-type food’’ that 

better reflects the food most like the 

food offered for sale in restaurants. We 

discussed these changes to two terms 

related to foods covered by the rule 

within section VI because the definition 

of ‘‘restaurant-type food’’ established in 

this rule is one of several terms related 

to the scope of establishments covered 

by the rule. 

B. Standard Menu Item 

Proposed § 101.11(a) would define 

‘‘standard menu item’’ as a restaurant or 

restaurant-type food that is routinely 

included on a menu or menu board or 

routinely offered as a self-service food 

or food on display. In the following 

paragraphs, we discuss comments on 

this proposed definition. We are 

finalizing it without change, except to 

revise ‘‘restaurant or restaurant-type 

food’’ to ‘‘restaurant-type food’’ to 

conform with our deletion of the term 

‘‘restaurant food’’ throughout the rule 

(see section VI.C). 

(Comment 47) Several comments 

supported the proposed definition. One 

comment opposed the proposed 

definition because it is ‘‘incomplete’’ 

and misunderstands the meaning of 

‘‘standard’’ within the context of a chain 

of 20 or more restaurants and similar 

retail food establishments doing 

business under the same name and 

offering for sale substantially the same 

menu items. The comment argued that 

it is not the regularity with which a 

menu item is sold at a given restaurant 

that renders the item ‘‘standard’’ within 

the context of a restaurant chain; rather, 

it is the fact that the menu item is 

offered across many establishments in 

the chain, in substantially the same 

form, and is prepared according to the 

same recipe and using the same 

ingredients. The comment maintained 

that when foods are standardized, 

nutrition information can be derived. 

On the other hand, according to the 

comment, if foods do not have a 

common recipe, nutrition information 

would be determined case-by-case, 

which is impractical and cost 

prohibitive. The comment suggested the 

following definition: ‘‘A menu item that 

appears on the menus of substantially 

all restaurants in a chain that uses the 

same general recipe and that is prepared 

in substantially the same way with 

substantially the same food 

components, even if the name of the 

menu item varies.’’ 

The comment also recommended that, 

for a chain that prints a single 

standardized menu for all its restaurants 

or establishments or for those in a given 

region, the term ‘‘standard menu item’’ 

be interpreted to refer to menu items 

that appear on those centrally printed 

and distributed menus. The comment 

maintained that adopting this definition 

would harmonize the terms ‘‘standard 

menu item’’ and ‘‘covered 

establishment’’ and ensure that the 

requirements apply to the foods that are 

subject to the type of standardization 

that would allow them to be 

consistently prepared. The comment 

also requested that a covered 

establishment be allowed but not 

required to provide the nutrition 

information in writing at the point of 

sale for menu items offered for sale in 

only some establishments in a chain if 

we decide to include such menu items 

within the definition of standard menu 

item in the final rule. Otherwise, the 

comment considered that a chain retail 

food establishment would have to 

include, in nutrition brochures, 

information on many menu items that 

are sold in a small percentage of stores, 

which could be confusing and costly. 

(Response 47) We disagree that the 

definition of ‘‘standard menu item’’ 

should be based on whether the menu 

item is offered across substantially all of 

the establishments within the chain, in 

substantially the same form, and is 

prepared according to the same recipe 

and using the same ingredients. Section 

403(q)(5)(H)(i) of the FD&C Act 

provides, in relevant part, that ‘‘in the 

case of food that is a standard menu 

item that is offered for sale in a 

restaurant or similar retail food 

establishment that is part of a chain 

with 20 or more locations doing 

business under the same name . . . and 

offering for sale substantially the same 

menu items, the restaurant or similar 

retail food establishment shall disclose 

the [required] information. . . .’’. The 

statutory language does not indicate that 

a menu item must be offered for sale in 

all of the restaurants or similar retail 

food establishments within a chain in 

order for it to be a ‘‘standard menu 

item’’ at a particular covered 

establishment. Indeed, it would be 

burdensome and impractical for 

establishments and inspectors to 

continually evaluate all of the menu 

items offered by a chain to determine 

which items are offered by all 

establishments in the chain in order to 

determine whether a given menu item is 

a standard menu item subject to 

requirements of this rule. In addition, 

we have no evidence that it would be 

impractical and cost prohibitive to 

require covered establishment to 

provide the nutrition required by this 

rule for menu items that they routinely 

offer. We continue to believe that it is 

reasonable to interpret ‘‘standard menu 

item’’ to mean a restaurant-type food 

routinely included on a menu or menu 

board or routinely offered as a selfservice food or food on display in a 

given covered establishment. 

We would not object to central 

printing of a single, standardized menu 

for use by all covered establishments 

within a chain, provided that the 


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centrally printed menu complies with 

the requirements of this rule and 

applicable provisions of the FD&C Act. 

However, if an individual covered 

establishment offers for sale an 

additional standard menu item that is 

not offered by every establishment in 

the chain and, therefore, is not included 

on the centrally printed menu, that 

establishment still must comply with all 

applicable requirements of this rule for 

that standard menu item, including 

where and how the nutrition 

information must be disclosed. 

We disagree that a covered 

establishment would have to include, in 

nutrition brochures, information on 

many menu items that are sold in a 

small percentage of stores. A covered 

establishment need only provide the 

required information for the standard 

menu items it offers for sale. 

(Comment 48) A few comments stated 

that grocery stores use items from other 

departments within the grocery store 

(e.g., meat department, produce 

department) to make its prepared food 

items. The ingredients for a given 

prepared food can vary significantly 

depending on the availability of items in 

the store. These comments argued that 

labeling and determining calorie 

information for these items would be 

difficult. 

(Response 48) If a prepared food item 

varies significantly depending on what 

ingredients a covered establishment 

happens to have available, the item may 

not meet the definition of standard 

menu item. For example, if a grocery 

store with a hot soup bar offers a 

different vegetable soup every day based 

on whatever vegetables the store 

happens to have in surplus (e.g., 

cabbage and tomatoes soup one day, 

carrots and leeks the next, spinach and 

squash on a third day), and if none of 

these vegetable soups is offered for sale 

routinely, then none of the vegetable 

soups would meet the definition of 

standard menu item. Even if the grocery 

store names each version of the soup as 

‘‘vegetable soup,’’ the item would not be 

considered a standard menu item, 

because the soup’s ingredients 

significantly differ daily. 

C. Combination Meal 

Proposed § 101.11(a) would define 

‘‘combination meal’’ as a standard menu 

item that consists of more than one food 

item, for example a meal that includes 

a sandwich, a side dish, and a drink. 

The proposed definition would further 

provide that a combination meal may be 

represented on the menu or menu board 

in narrative form, numerically, or 

pictorially. Some combination meals 

may include a variable menu item (or be 

a variable menu item as defined in 

§ 101.11(a)) where the components may 

vary. For example, the side dish may 

vary among several options (e.g., fries, 

salad, or onion rings) or the drinks may 

vary (e.g., soft drinks, milk, or juice) and 

the customer selects which of these 

items will be included in the meal. 

Comments that addressed the 

proposed definition agreed with it. 

Therefore, we are finalizing it without 

change, except to correct a 

typographical error by removing an 

open parenthesis mark between ‘‘may 

include a variable menu item’’ and ‘‘or 

be a variable menu item . . .’’ 

D. Variable Menu Item 

Proposed § 101.11(a) would define 

‘‘variable menu item’’ as a standard 

menu item that comes in different 

flavors, varieties, or combinations, and 

is listed as a single menu item. In the 

following paragraphs, we discuss 

comments on this proposed definition. 

We are finalizing it without change. 

(Comment 49) Several comments 

considered that the term ‘‘variable menu 

item’’ does not include items listed on 

a menu that can be assembled in varying 

combinations, such as pizza. These 

comments suggested that the definition 

of variable menu item be revised to ‘‘a 

standard menu item that comes in 

different flavors, varieties, or 

combinations, and is listed as a single 

menu item. It does not include foods, 

beverages, or meals that are listed as 

separate menu items but could be 

combined in a variety of combinations 

or that are different sizes of the same 

menu item.’’ 

Several comments asked that we 

clarify that the definition for ‘‘variable 

menu item’’ does not mean different 

sizes. They maintained that each size 

should be accompanied by a calorie 

declaration. In contrast, one comment 

opposed the posting of calories for 

different sizes, maintaining that 

providing calorie information for each 

size would take too much space and 

might force the reduction in font size. 

This comment asked us to permit 

covered establishments to provide a 

range of calories to reflect the calorie 

content range from the smallest to the 

largest size for beverages offered as 

standard menu items. This comment 

considered that the statute provides us 

discretion to allow covered 

establishments to provide calorie 

information for different sized beverages 

using ranges, as long as the calorie 

information is clear and conspicuous. 

(Response 49) We disagree that 

variable menu items do not include 

foods such as pizza. Our proposed 

definition is consistent with section 

403(q)(5)(H)(v) of the FD&C Act, which 

expressly includes pizza as an example 

of a standard menu item that comes in 

different flavors, varieties, or 

combinations, but is listed as a single 

menu item. For example, a menu or 

menu board can list a pizza with a 

particular price and up to four toppings. 

This is an example of a food that comes 

in different varieties because the 

consumer has the choice of various 

toppings. 

We agree with the comments asserting 

that different sizes of a standard menu 

item are not variable menu items, but 

disagree with the comment opposing the 

posting of calories for different sizes. 

Section 403(q)(5)(H)(v) of the FD&C Act 

provides, in relevant part, that FDA 

shall establish by regulation standards 

for disclosing the nutrient content for 

standard menu items that come in 

different flavors, varieties, or 

combinations, but which are listed as 

single menu items. When a standard 

menu item, including a beverage, is 

listed on a menu or menu board by 

name with different sizes, or each size 

has its own price, each size would 

constitute a standard menu item rather 

than a different flavor, variety, or 

combination, and each standard menu 

item must include a calorie declaration. 

E. Food on Display 

Proposed § 101.11(a) would define food 

on display as restaurant or restauranttype food that is visible to the customer 

before the customer makes a selection, 

so long as there is not an ordinary 

expectation of further preparation by the 

consumer before consumption. In the 

following paragraphs, we discuss 

comments on this proposed definition. 

After considering comments, we are 

finalizing the definition without 

changes, except to revise ‘‘restaurant or 

restaurant-type food’’ to ‘‘restauranttype food’’ to conform with our deletion 

of the term ‘‘restaurant food’’ 

throughout the rule (see section VI.C). 

(Comment 50) A few comments 

agreed with the proposed definition. 

Other comments suggested 

modifications to the definition. Some 

comments recommended that the 

definition clarify that the food can be 

self-serve or served by the restaurant 

staff and that the food could be in the 

open or behind glass. The comments 

suggested that the following language be 

added to the proposed definition: ‘‘It 

includes food that is served by 

restaurant staff or self-served by 

customers and foods with Nutrition 

Facts labels that customers cannot 

examine without assistance. Food on 

display can be behind glass or other 


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material or in an open display 

accessible to consumers.’’ 

(Response 50) We decline the requests 

to revise the proposed definition. The 

definition applies regardless of whether 

the food is self-serve or served by the 

restaurant staff, whether it is in the open 

or behind glass, or whether it has a 

Nutrition Facts label that can be 

examined by a consumer without 

assistance. In addition, we do not want 

to appear to limit the definition to only 

those foods described in the language 

suggested by the comment. 

(Comment 51) One comment asserted 

that food on display, such as deli meats 

and cheeses, should be covered even if 

there is an expectation that there will be 

further preparation before consuming. A 

few comments asked that we clarify that 

foods on display and self-service food 

do not include fresh breads, cheese 

wheels, bulk olives, bulk sauces, 

condiments, and salads sold by the 

pound like ‘‘tuna salad, egg salad, 

chicken salad, etc.’’ One comment 

recommended that grocery stores 

provide calories for bakery items, 

prepared deli foods such as salads and 

sandwiches, prepared meals and side 

dishes, freshly cooked pizza, fountain 

drinks, salad bars, and other foods sold 

for immediate consumption. One 

comment requested an exemption for 

certain food items prepared for home 

consumption, such as fruit slices, fruit 

cups, fruit salads, containers of fresh-cut 

fruit, fresh squeezed juices, bulk or 

packaged nuts, seeds, or dried fruit, and 

similar items that are packaged (or in 

the case of bulk products, are sold in 

containers that are available for selfpackaging). 

(Response 51) As discussed in section 

VI.C, we are establishing a revised 

definition of ‘‘restaurant-type food’’ that 

better reflects the food most like the 

food offered for sale in restaurants (see 

Comment 24 and Response 24). Because 

restaurants typically sell food that is 

fully prepared, deli meats and cheese 

generally will not meet the definition of 

‘‘restaurant-type food,’’ and therefore 

generally will not be covered. However, 

certain foods offered for sale in grocery 

stores that are visible to the consumer 

before the consumer makes a selection, 

such as prepared sandwiches, freshly 

cooked pizza, and salad and hot food 

bars would meet the definition of 

restaurant type food and do not have an 

ordinary expectation of further 

preparation by the consumer before 

consumption. These foods meet the 

definition of foods on display. Other 

foods commonly offered for sale by 

grocery stores are not within the 

definition of ‘‘restaurant-type food’’ and 

would not be subject to the nutrition 

disclosure requirements of this rule 

(e.g., foods such as dried fruit and nuts 

bought from bulk bins or cases; foods 

such as loaves of bread, bags or boxes 

of dinner rolls, whole cakes, bags or 

boxes of candy or cookies to be eaten 

over several eating occasions or stored 

for later use; foods such as deli salads 

sold by unit of weight that are not selfserve and are not intended solely for 

individual consumption, either 

prepacked or packed upon consumer 

request). 

F. Self-Service Food 

Proposed § 101.11(a) would define 

‘‘self-service food’’ as restaurant or 

restaurant-type food that is available at 

a salad bar, buffet line, cafeteria line, or 

similar self-service facility and that is 

served by the customers themselves. 

Self-service food also includes selfservice beverages. Comments that 

addressed the proposed definition 

supported it. We are finalizing it 

without changes, except to revise 

‘‘restaurant or restaurant-type food’’ to 

‘‘restaurant-type food’’ to conform with 

our deletion of the term ‘‘restaurant 

food’’ throughout the rule (see section 

VI.C). 

G. Custom Order 

Proposed § 101.11(a) would define 

‘‘custom order’’ as a food order that is 

prepared in a specific manner based on 

an individual customer’s request, which 

requires the restaurant or similar retail 

food establishment to deviate from its 

usual preparation of a menu item, e.g., 

a club sandwich without the bacon if 

the establishment usually includes 

bacon in its club sandwich. In the 

following paragraphs, we discuss 

comments on this proposed definition. 

We are finalizing it without change, 

except for two clarifications. First, we 

are clarifying that the deviation is from 

the usual preparation of a standard 

menu item (emphasis added). Second, 

we are replacing the term ‘‘restaurant or 

similar retail food establishment’’ with 

‘‘covered establishment’’ to clarify the 

applicability of the definition (see the 

discussion in section VI.I). 

(Comment 52) Several comments 

agreed with the proposed definition. 

Some comments considered that the 

custom order exemption should apply 

to custom birthday cakes and 

sandwiches made to order, because they 

have no standard preparation from 

which to deviate. 

One comment maintained that 

supermarkets often preprint labels or 

previously affix them to packaging (e.g., 

a paper bag for a sandwich or bread) to 

improve efficiency or to save costs. 

Because consumers may request that 

toppings be added or removed from a 

food item that is sold in the prelabeled 

packaging, the comment considered that 

this would be a custom order that would 

be exempt from the menu labeling 

requirements. The comment asked us to 

clarify that the product would not be 

misbranded if the packaging contained 

nutrition information based on the 

standard preparation. 

(Response 52) If a custom birthday 

cake that is made to order is not 

routinely included on a menu or menu 

board or routinely offered as a selfservice food or food on display, it would 

not be covered by the rule, because it is 

not a standard menu item. 

We agree that a sandwich that is made 

to order can be a custom order if the 

sandwich is prepared in a specific 

manner based on an individual 

customer’s request, which requires the 

covered establishment to deviate from 

its usual preparation of a standard menu 

item. However, some sandwiches that 

are made to order can be variable menu 

items, depending on how the food is 

depicted on a menu or menu board or 

otherwise offered for sale. We discuss 

the definition of variable menu item in 

section VIII.D. 

We also agree that if a customer asks 

that toppings be changed or removed 

from a standard menu item, and the 

standard menu item normally includes 

certain toppings, the customer’s order is 

a custom order. In response to the 

question regarding the use of a 

preprinted label on a food product, 

which is subject to modification, we 

first note that a food order that is 

prepared in a specific manner based on 

an individual customer’s request, which 

requires a covered establishment to 

deviate from its usual preparation of a 

standard menu item, is a custom order 

and is not subject to the requirements of 

section 403(q)(5)(H) of the FD&C Act 

and this rule. Nevertheless, food 

labeling, including nutrition labeling, 

for a food must be truthful and not 

misleading (section 403(a)(1) of the 

FD&C Act). If a label on a food bears 

nutrition information for such food that 

is false or is otherwise misleading, the 

food would be misbranded under 

section 403(a)(1) of the FD&C Act. 

Accordingly, if a custom order, such as 

a club sandwich without the bacon if 

the establishment usually includes 

bacon in its club sandwich, bears 

nutrition information in a preprinted 

label that is false or is otherwise 

misleading, such food could be 

misbranded under the FD&C Act. We 

recommend that covered establishments 

refrain from affixing preprinted labels 

on custom orders unless the information 


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included on such labels is truthful and 

not misleading. 

H. Daily Special 

Proposed § 101.11(a) would define 

‘‘daily special’’ as a menu item that is 

prepared and offered for sale on a 

particular day, that is not routinely 

listed on a menu or offered by the 

covered establishment, and that is 

promoted by the covered establishment 

as a special menu item for that 

particular day. 

Comments that addressed the 

proposed definition agreed with it. 

Therefore, we are finalizing it without 

change, except to add ‘‘or menu board’’ 

after ‘‘not routinely listed on a menu.’’ 

We inadvertently omitted ‘‘or menu 

board’’ in the proposed definition. 

I. Food That Is Part of a Customary 

Market Test 

Proposed § 101.11(a) would define 

‘‘food that is part of a customary market 

test’’ as food that is marketed in a 

covered establishment for fewer than 90 

consecutive days in order to test 

consumer acceptance of the product. 

Comments that addressed the proposed 

definition agreed with it. Therefore, we 

are finalizing it without change, except 

for changes to clarify that food that is 

part of a customary market test is food 

‘‘that appears on a menu or menu board 

for less than 90 consecutive days’’ rather 

than food ‘‘that is marketed in a covered 

establishment for fewer than 90 

consecutive days.’’ These changes are 

consistent with section 

403(q)(5)(H)(vii)(I)(cc) of the FD&C Act, 

our description of ‘‘food that is part of 

a customary market test’’ in the 

proposed rule (76 FR 19192 at 19205), 

and with the definition for ‘‘temporary 

menu item’’ in § 101.11(a). 

J. Temporary Menu Item 

Proposed § 101.11(a) would define 

‘‘temporary menu item’’ as a food that 

appears on a menu or menu board for 

less than a total of 60 days per calendar 

year. Proposed § 101.11(a) would 

explain that the 60 days includes the 

total of consecutive and nonconsecutive days the item appears on 

the menu. In the following paragraphs, 

we discuss comments on this proposed 

definition. We are finalizing it without 

change. 

(Comment 53) Several comments 

agreed with the proposed definition. 

One comment agreed that the 60 days 

need not be consecutive, but considered 

that seasonal items (such as the 

pumpkin-flavored latte example we 

included in the proposed rule (76 FR 

19192 at 19205)) should not be exempt 

if they are routinely offered each year. 

One comment recommended that we 

change the definition for temporary 

menu item to shorten the time period 

from 60 to 45 days, to discourage 

restaurants from continuously changing 

menus to avoid calorie disclosure. 

(Response 53) The proposed 

definition for ‘‘temporary menu item’’ 

focused on the explicit statutory 

language in section 403(q)(5)(H)(vii) of 

the FD&C Act, which provides in 

relevant part that the requirements of 

section 403(q)(5)(H)(i) through (vi) of 

the FD&C Act do not apply to 

‘‘temporary menu items appearing on 

the menu for less than 60 days per 

calendar year.’’ Accordingly, we decline 

to shorten the 60-day time period for 

temporary menu items to 45 days, as 

suggested by the comment, because 

doing so would not be consistent with 

section 403(q)(5)(H)(vii) of the FD&C 

Act. We did not propose to go beyond 

the language of section 403(q)(5)(H)(vii) 

of the FD&C Act by developing a new 

category of foods called ‘‘seasonal 

items.’’ We disagree that seasonal items 

should not be exempt if they are 

routinely offered each year. Whether a 

‘‘seasonal item’’ would be exempt 

would be determined by whether the 

seasonal item satisfied the definition of 

a ‘‘temporary menu item’’ as determined 

by the total number of consecutive and 

non-consecutive days per calendar year 

that the menu item appears on the menu 

or menu board. 

IX. Comments and FDA Response on 

Proposed § 101.11(b)(1)(i)—Food 

Subject to the Labeling Requirements 

Proposed § 101.11(b) would establish 

requirements for nutrition labeling of 

food sold in covered establishments. 

Proposed § 101.11(b)(1)(i) would 

provide that the labeling requirement 

would apply to standard menu items 

offered for sale in covered 

establishments. We are finalizing it 

without change. 

Most comments we received about 

how the nutrition labeling requirements 

of the rule apply to standard menu 

items addressed specific labeling 

requirements (e.g., the provisions of 

§ 101.11(b)(2)(i) for what must be 

provided on menus and menu boards), 

and we discuss these comments as they 

relate to such specific requirements. 

Immediately following, we discuss one 

comment more generally directed to the 

applicability of the labeling 

requirements of this rule. 

(Comment 54) One comment 

recommended that foods that are 

preordered and picked up at a later date, 

such as birthday cakes, boxed lunches, 

deli trays, and sandwich platters, not be 

covered by the menu labeling 

requirements because they are not foods 

on display, standard menu items, 

restaurant-type foods, or ordered from a 

menu or menu board. The comment 

asserted that restaurant foods are 

ordered for consumption within a 

proximate time from when they are 

ordered, and the person ordering the 

food intends to eat a portion of the food, 

whereas catered foods are ordered on 

behalf of a larger group of people and 

further ahead of time. 

(Response 54) The rule applies to 

standard menu items offered for sale in 

covered establishments. The rule 

defines standard menu item as 

restaurant-type food that is routinely 

included on a menu or menu board or 

routinely offered as a self-service food 

or food on display (see § 101.11(a)). The 

definition of ‘‘restaurant-type food’’ in 

§ 101.11(a) captures the time when the 

food will be eaten relative to when it is 

purchased or picked up (i.e., usually 

eaten on the premises, while walking 

away, or soon after arriving at another 

location) but when the food is ordered 

in relation to when it is picked up, and 

how many people will share the food, 

have no bearing on the applicability of 

the rule. 

X. Comments and FDA Response on 

Proposed § 101.11(b)(1)(ii)—Food Not 

Subject to the Labeling Requirements 

A. The Proposed Requirements 

Proposed § 101.11(b)(1)(ii) would 

provide that the labeling requirements 

would not apply to alcohol beverages; 

items such as condiments that are 

placed on the table for general use; daily 

specials; temporary menu items; custom 

orders; and food that is part of a 

customary market test. In sections X.B 

through X.E of this document, we 

discuss comments on this proposed 

provision. After considering comments, 

we are: 

• Narrowing the proposed exemption 

of alcohol beverages from all of the new 

requirements for nutrition labeling; 

• Clarifying that the exemption 

applies to condiments that are for 

general use, including those placed on 

the table or on or behind the counter; 

and 

• Clarifying that the labeling 

requirements of paragraph (b) do not 

apply to self-service food and food on 

display that is offered for sale for less 

than a total of 60 days per calendar year 

or fewer than 90 consecutive days in 

order to test consumer acceptance. 

B. Alcohol 

1. Alcoholic Beverages 

(Comment 55) Some comments agreed 

with our proposal that alcoholic 


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beverages should not be covered. Some 

comments stated that alcoholic 

beverages should not be considered food 

within the context of menu labeling. 

Some comments supporting FDA’s 

proposal to exclude alcoholic beverages 

referenced Alcohol and Tobacco Tax 

and Trade Bureau’s (TTB’s) oversight of 

alcoholic beverage labels, which 

includes premarket approval. One 

comment referred to the district court 

decision cited in FDA’s proposed rule 

(76 FR 19192 at 19203), Brown-Forman 

Distillers Corp. v. Mathews, 435 F. 

Supp. 5 (W.D.Ky. 1976), as evidence 

that TTB has jurisdiction over the 

labeling of alcoholic beverages under 

the Federal Alcohol Administration Act 

(FAA Act). Another comment argued 

that requiring calorie declarations for 

alcoholic beverages will not affect 

obesity, because obesity is the result of 

years of poor diet and lack of exercise. 

Another comment mentioned a 2011 

survey of adult consumers and stated 

that it showed that most consumers do 

not want to see calorie counts on drink 

menus and want to order what they 

want. The comment did not include or 

provide a reference for the survey. 

In contrast, many comments argued 

that alcoholic beverages should be 

covered in the final rule. Some 

comments asserted that it was not the 

intent of Congress to exclude alcoholic 

beverages from the menu labeling 

requirements. According to these 

comments, Congress excluded some 

foods from menu labeling, but did not 

exclude alcoholic beverages. One 

comment, referring to a press release of 

two Senators (Ref. 29), contended that 

Congress rejected lobbyists who wanted 

to exclude alcoholic beverages. 

Several comments argued that FDA 

has jurisdiction to require menu 

labeling for alcoholic beverages and not 

TTB. According to these comments, 

Congress directed FDA to require menu 

labeling for all food, including alcoholic 

beverages. Some comments maintained 

that FDA currently has exclusive 

authority to regulate labeling of certain 

alcoholic beverages (such as wines 

containing less than 7 percent alcohol 

by volume and some beers), and another 

comment stated that FDA had asserted 

its authority over alcoholic beverages 

when FDA and the Federal Trade 

Commission took action on caffeinated 

alcohol drinks. One comment 

maintained that in the absence of a 

specific prohibition or direct conflict, 

each Agency can regulate alcoholic 

beverages in line with its mandate. 

Another comment stated that the U.S. 

Supreme Court has noted, ‘‘The courts 

are not at liberty to pick and choose 

among congressional enactments, and 

when two statutes are capable of 

coexistence, it is the duty of the courts, 

absent a clearly expressed congressional 

intention to the contrary, to regard each 

as effective,’’ citing Morton v. Mancari, 

417 U.S. 535, 551 (1974). Thus, this 

comment asserted that there is no need 

to pick and choose between the FAA 

Act and section 4205 of the ACA 

because these statutes are capable of 

coexistence in that they apply to 

different groups and different practices. 

Several comments questioned the 

applicability of the Brown-Forman 

Distillers v. Matthews case to section 

4205 of the ACA and contended that 

Brown-Forman addressed the FAA Act 

and FDA’s authority to impose 

ingredient labeling on alcoholic 

beverage labels, not nutrition labeling 

on menus. 

Some comments also argued that 

FDA’s proposed position with regard to 

alcoholic beverage menu labeling 

contrasts markedly with its position on 

meat and poultry menu items, the labels 

for which are regulated by the USDA. 

One comment remarked that alcohol 

used in non-beverage foods, such as 

bananas foster, would be covered under 

the proposed rule, so not covering 

alcohol in foods that are beverages 

would not be consistent. 

Comments supported covering 

alcoholic beverages on public health 

grounds. Some comments argued that 

excluding alcoholic beverages is 

problematic because it may give the 

false impression that alcoholic drinks 

do not contribute to the overall caloric 

consumption of consumers, working 

against the underlying goal of section 

4205 of the ACA. Other comments 

remarked that alcoholic beverages 

contribute a substantial portion of 

average total calories consumed by 

Americans, representing the fifth 

leading source of calories in American 

adults’ diets. One comment stated that 

alcoholic beverages provide more 

calories per day on average than many 

of the food items required to be labeled 

under this law including pizza, 

hamburgers, and fried potatoes. Another 

comment argued that calories in 

alcoholic beverages count toward 

overweight and obesity just like calories 

in foods and other beverages. 

According to some comments, if some 

drinks are labeled and some are not, 

consumers might be confused, and they 

would not have the information to 

compare beverage options and make 

informed choices. Comments also stated 

that the calorie content of alcoholic 

beverages can vary widely and cited 

studies indicating that consumers are 

likely to have difficulty identifying 

lower calorie options. Comments argued 

that failing to provide consumers with 

calorie information for alcoholic 

beverages will make it more difficult for 

them to follow the 2010 Dietary 

Guidelines’ advice to control total 

calorie intake to manage body weight. 

(Response 55) The final rule does not 

provide a general exemption for 

alcoholic beverages. As we stated in the 

proposed rule, alcoholic beverages are 

‘‘food’’ under the FD&C Act. Section 201 

of the FD&C Act defines ‘‘food’’ to 

include ‘‘articles used for . . . drink for 

man,’’ ‘‘for the purposes of this Act.’’ 

The nutrition labeling requirements of 

section 403(q)(5)(H) of the FD&C Act 

apply to ‘‘food that is a standard menu 

item.’’ In addition, as some comments 

indicated, section 403(q)(5)(H)(vii) of 

the FD&C Act deems the requirements 

of section 403(q)(5)(H) of the FD&C Act 

inapplicable to certain foods, and 

alcoholic beverages are not one of them. 

While section 4205 of the ACA 

amends section 403(q) of the FD&C Act, 

which generally provides nutrition 

labeling requirements for certain foods, 

the nutrition labeling requirements in 

section 4205 are directed specifically 

toward standard menu items sold in 

covered restaurants or similar retail food 

establishments. Within this context, 

providing nutrition information for an 

alcoholic beverage for which other 

labeling is also regulated by TTB 

provides the same public health benefit 

as providing the information for other 

foods. The provisions of section 4205 of 

the ACA do not apply to and have no 

effect on the labels of food products sold 

in packaged form, including alcoholic 

beverages regulated by TTB. 

Thus, we conclude that the nutrient 

content disclosure requirements in 

amended section 403(q)(5) of the FD&C 

Act for standard menu items offered for 

sale in covered establishments apply to 

alcoholic beverages, even though the 

labeling of alcoholic beverage containers 

under the FAA Act is regulated by TTB. 

FDA’s decision to include alcoholic 

beverages in the menu labeling 

regulations is not inconsistent with the 

Brown-Forman decision, which 

addressed the labeling of containers of 

distilled spirits, wines, and malt 

beverages subject to the requirements of 

the FAA Act. This conclusion will not 

subject the regulated alcohol beverage 

industry ‘‘to ‘duplication and 

inconsistent standards,’ ’’ a key basis for 

the Brown-Forman decision. (BrownForman at 14, citing United States v. 

National Ass’n of Securities Dealers, 

422 U.S. 694, 735 (1975)). The 

requirements we are finalizing here do 

not directly conflict with any TTB 

requirements. As comments pointed 

out, the nutrition labeling requirements 


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of section 4205 of the ACA do not apply 

to and have no effect on the labels of 

alcoholic beverage containers. In 

addition, this final rule applies to 

covered establishments, while the FAA 

Act’s labeling and advertising 

regulations generally apply to distillers, 

brewers, rectifiers, blenders, producers, 

importers, wholesalers, bottlers, and 

warehousemen of alcoholic beverages 

(see 27 U.S.C. 205). In short, the two 

regulatory schemes address different 

labeling and different actors; they are 

‘‘capable of coexistence.’’ (See Manconi, 

cited previously in this document.) 

We also recognize that applying this 

final rule to alcoholic beverages also 

regulated by TTB is more consistent 

with the inclusion of meat, poultry, and 

egg products that are also regulated by 

USDA. 

From a public health perspective, we 

agree that requiring nutrition labeling of 

alcoholic beverages that are standard 

menu items is more likely to enable 

consumers to compare beverage options 

and make informed order selections in 

covered establishments. In addition, 

while obesity may be related to poor 

diet generally and a lack of exercise, 

calories in alcoholic beverages 

contribute to obesity and overweight 

just like calories in other foods. 

Alcoholic beverages contribute a 

substantial portion of average total 

calories consumed by American adults 

(Ref. 3). Table 2–2 in the 2010 Dietary 

Guidelines for Americans (‘‘2010 

Dietary Guidelines’’), jointly developed 

and issued by HHS and the USDA, 

reports that alcoholic beverages rank 

sixth in a list of the top 25 food sources 

of calories among Americans ages 2 

years and older, and fifth in a list of the 

top 25 food sources of calories among 

adult Americans ages 19 years and older 

(Ref. 3). The 2010 Dietary Guidelines 

also discuss alcohol in Chapter Three, 

entitled ‘‘Foods and Food Components 

to Reduce’’ (Ref. 3). 

As to the 2011 survey mentioned in 

one comment, FDA is unable to draw 

regulatory conclusions from such a 

survey without being able to evaluate 

the survey itself. 

(Comment 56) Several comments 

argued that providing calorie and other 

nutrition labeling for alcoholic 

beverages on menus is feasible, and one 

comment provided an example of a 

menu which included nutrient content 

disclosures for alcoholic beverages. 

(Response 56) We agree with these 

comments. We see no basis for why 

providing calorie and other nutrient 

content information for alcoholic 

beverages on menus would be less 

feasible for covered establishments than 

providing that same information for 

most other standard menu items. 

(Comment 57) Some comments noted 

that TTB and FDA currently work 

together through a Memorandum of 

Understanding (MOU) and asserted that 

under this MOU, TTB ensures adequate 

and non-misleading labeling, and FDA 

ensures safety. One comment that 

mentioned this MOU indicated that 

FDA should not begin to regulate the 

labeling of alcoholic beverages, while 

another comment that mentioned the 

MOU indicated that FDA’s coverage of 

alcoholic beverages would not be 

inconsistent with the specific language 

of the MOU. 

(Response 57) We agree that FDA’s 

coverage of alcoholic beverages in this 

context does not affect the delineation 

of responsibilities between FDA and 

TTB articulated in the MOU. FDA and 

TTB continue to work together under 

the MOU, and FDA has consulted with 

TTB during this rulemaking. 

(Comment 58) A few comments 

maintained that establishing menu 

labeling requirements for alcoholic 

beverages could lead to inconsistencies 

with TTB requirements. One comment 

pointed out that TTB has rulemaking 

underway for ‘‘serving facts’’ on 

alcoholic beverage labels and asserted 

that, if FDA establishes menu labeling 

requirements for alcoholic beverages, 

there could be inconsistencies between 

nutrition information on labels and 

menus. 

At the time that the proposed rule was 

issued, alcoholic beverages subject to 

the labeling regulations under the FAA 

Act were required to include a 

statement of average analysis if the label 

or advertisement made a claim with 

regard to the calorie or carbohydrate 

content of the product, and were 

allowed to include a statement of 

average analysis for any product. The 

statement of average analysis listed the 

number of calories and the number of 

grams of carbohydrates, fat, and protein 

per serving (see TTB Ruling 2004–1). In 

the Federal Register of July 31, 2007 (72 

FR 41860), TTB published a proposed 

rule to amend its regulations to require 

a Serving Facts statement, which would 

include a statement of calories, 

carbohydrates, fat, and protein per 

serving, on alcohol beverage labels. As 

of December 1, 2014, the TTB proposed 

rule has not been finalized. On May 28, 

2013, TTB issued a ruling (TTB Ruling 

2013–2) (Ref. 30) that allows alcohol 

beverage industry members to provide 

consumers with nutritional information 

on alcoholic beverage container labels 

by using the format of a statement of 

average analysis or a Serving Facts 

statement. 

The comment stated that TTB’s 

rulemaking should be completed before 

FDA takes further action or FDA should 

exclude alcoholic beverages from the 

menu labeling requirements 

permanently. According to another 

comment, the labels currently approved 

by TTB with a statement of average 

analysis apply to a small portion of the 

total volume of beers produced by small 

brewers. The comment stated that the 

format is not consistent with FDA’s 

proposed rule, because TTB only 

requires the disclosure of calories, 

carbohydrates, protein, and fat, while 

FDA’s proposed rule would require 

disclosure of additional nutrients. 

Without agreement on formats, the 

comment asserted, compliance with 

FDA proposed menu labeling could 

contradict TTB guidance. This comment 

also stated that without a final rule from 

TTB, beer sold in bottles and cans on 

display in covered establishments will 

not be required to bear nutrition 

information. Comments stated that if 

FDA decides to cover alcoholic 

beverages in its menu labeling rule, FDA 

should coordinate with TTB to ensure 

consistency. 

Some comments that were against 

including alcoholic beverages 

maintained that the cost of laboratory 

analysis for alcoholic beverages, which 

they assumed would fall on the 

alcoholic beverage manufacturers, 

would be significant, especially for 

alcoholic beverage manufacturers that 

are small businesses. One comment 

asserted that the number of brands and 

styles of beer produced by small 

brewers varies dramatically in 

comparison to large brewers, and 

without in-house laboratories, which 

the comment believed large breweries 

would have, covering alcoholic 

beverages would have a 

disproportionate effect on small 

brewers. Several comments argued that 

sufficiently accurate calorie values for 

various types of alcohol are readily 

available from easily accessible 

databases, such as the USDA’s National 

Nutrient Database for Standard 

Reference. One comment suggested 

allowing covered establishments to list 

estimated or approximate calorie values 

by category on wine lists rather than by 

each brand, recognizing that some types 

of alcoholic beverages, like red or white 

wines, contain substantially the same 

calories regardless of variety. 

(Response 58) We agree with some 

comments and disagree with others. As 

previously mentioned, the nutrition 

labeling requirements finalized here do 

not apply to and have no effect on the 

labels of alcoholic beverage containers. 

In addition, the new requirements apply 


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to covered establishments, not to 

alcoholic beverage manufacturers. In 

contrast, TTB’s ‘‘Serving Facts’’ 

rulemaking would establish new 

requirements for disclosures on 

alcoholic beverage labels and would 

apply to alcoholic beverage bottlers and 

importers. 

Under this final rule, covered 

establishments have significant 

flexibility in choosing a reasonable basis 

for their nutrient content disclosures, 

which can include a database such as 

the USDA’s National Nutrient Database 

for Standard Reference (see § 101.11(c) 

and the discussion in sections XVIII and 

XIX). The USDA’s National Nutrient 

Database for Standard Reference 

includes the categories, ‘‘alcoholic 

beverage, wine, table, red,’’ ‘‘alcoholic 

beverage, wine, table, white,’’ among 

several other general categories for 

alcoholic beverages. Consistent with our 

treatment of other standard menu items 

(see section XVIII of this document), we 

will allow covered establishments to use 

these entries as the bases for their 

nutrient content disclosures for 

alcoholic beverages that are standard 

menu items. 

In addition, we recognize that 

statements of average analysis and 

nutrient content disclosures under 

current TTB guidance include four 

nutrients, and our final rule requires 

that covered establishments make 

additional nutrient content disclosures 

for most standard menu items. However, 

we do not see these differences as 

conflicts. Nutrient content information 

on alcoholic beverage labels that is 

required by or consistent with TTB 

regulations or guidance could be a 

reasonable basis for a covered 

establishment’s corresponding nutrient 

content disclosures. In addition, many 

alcoholic beverages will be eligible for 

the simplified format (see discussion re: 

§ 101.11(b)(2)(ii)(B)(2)). As provided in 

§ 101.11(c)(1), covered establishments 

may also choose to use a database such 

as the USDA National Nutrient Database 

for Standard Reference as the reasonable 

basis for making their nutrient content 

disclosures, including disclosures for 

nutrients that do not currently appear 

on alcoholic beverage labels. This 

should address the comment’s concerns 

about malt beverages or other alcoholic 

beverages that do not currently include 

nutrient information. FDA has 

consulted with TTB on this rulemaking 

and intends to continue to consult with 

TTB in the future. 

(Comment 59) Some comments 

recommended that drinks that are 

ordered by customers at the bar and that 

are not listed on the menu should be 

exempt from this rule. 

(Response 59) We agree with these 

comments. The final rule covers 

alcoholic beverages that are standard 

menu items that are listed on a menu or 

menu board. However, we are finalizing 

the proposed exemption for a subset of 

alcoholic beverages that are not listed 

on a menu or menu board. Specifically, 

§ 101.11(b)(1)(ii)(B) of the final rule 

provides that the labeling requirements 

of § 101.11(b)(2)(iii) do not apply to 

those alcoholic beverages that are food 

on display. Our reasons follow. Because 

these reasons do not apply equally to 

alcoholic beverages that are self-service 

foods, § 101.11(b)(1)(ii)(B) of the final 

rule clarifies that alcoholic beverages 

that are self-service foods are covered. 

First, it is unclear whether covered 

establishments could provide nutrient 

content disclosures for alcoholic 

beverages on display behind a bar that 

would assist consumers in making 

informed and healthful order selections. 

Covered establishments often serve such 

beverages in mixed drinks, and the 

amount of each alcoholic beverage and 

other mixers they serve to consumers 

may vary depending on the drink 

ordered. Section 403(q)(5)(H)(iii) of the 

FD&C Act requires that calories for selfservice food and food on display be 

declared per serving or per item. 

Examples of other food on display 

include: Burrito fillings behind a 

counter at a burrito restaurant where 

burritos are made to order and salad 

ingredients behind a counter at a quickservice salad restaurant where salads are 

made to order. An employee generally 

adds a standard serving of each burrito 

filling or salad ingredient when asked 

by the customer, e.g., a standard 

measured weight of meat or a standard 

spoonful of beans. Nutrient content 

declarations based on those 

standardized servings are directly 

applicable to consumers’ order 

selections. 

Even for some foods on display that 

have servings that vary, e.g., ice cream 

(where a customer can order one, two, 

or three scoops) or burrito fillings 

(where a customer can order extra 

cheese), the amount the customer 

receives is generally a simple multiple 

of a base serving. Ice cream would likely 

be labeled per scoop and cheese would 

likely be labeled per standard portion, 

with extra cheese being double the 

standard portion. 

In contrast, covered establishments 

with bottles of alcoholic beverages on 

display behind a bar generally serve 

varying amounts of alcohol and mixers 

depending on the establishment’s 

recipes for the various beverages 

ordered. For example, at a given covered 

establishment, a martini recipe might 

have 2 ounces (oz.) of gin and 0.5 oz. 

vermouth; a cosmopolitan recipe might 

have 3.5 oz. vodka, a dash of triple sec, 

a dash of cranberry juice, 1 tsp of sugar, 

and 1 oz. of lime juice; and a 

grasshopper recipe might have 1 oz. 

white cre`me de cacao, 1 oz. green cre`me 

de menthe, and milk or cream to fill the 

glass (Ref. 31). As a result, the covered 

establishment does not have a standard 

serving on which to base a nutrient 

content declaration for each ingredient 

that will be directly applicable to all 

routinely ordered mixed drinks. In 

addition, recipes for even well-known 

drinks, like margaritas, may differ from 

one chain of restaurants to another, and 

consumers are unlikely to know a 

particular establishment’s recipe while 

ordering (Ref. 31). It is difficult to see 

how a consumer would use an 

establishment’s nutrient content 

disclosure on a bottle of alcohol behind 

a bar in choosing which mixed drink to 

order. 

Section 403(q)(5)(H)(x)(II)(aa) of the 

FD&C Act requires FDA to ‘‘consider 

standardization of recipes and methods 

of preparation’’ and ‘‘variations in 

ingredients’’ in issuing these 

regulations. Therefore, in finalizing the 

exemption for alcoholic beverages that 

do not appear on menus or menu 

boards, we considered that recipes and 

methods of preparation for alcoholic 

mixed drinks are not standardized 

throughout the industry. In addition, we 

considered the variations of the 

amounts of alcoholic beverages and 

other mixers served in mixed drinks in 

a given covered establishment. 

Alcoholic beverages that are on 

display differ from other food on 

display in additional relevant ways. 

Alcoholic beverages that are on display, 

particularly bottles of alcohol that are 

behind a bar, often appear to be on 

display primarily for decoration or 

storage, not to aid consumers in 

selecting among food options. This 

contrasts with most food that is on 

display, which is on display in order to 

aid consumers in selecting among food 

options (e.g., food choices at a salad bar, 

cookie varieties at a mall cookie 

counter). Once covered establishments 

comply with these new regulations, 

consumers in covered establishments 

who look at food on display to decide 

which displayed food they would like to 

consume will be able to consider calorie 

information on signs adjacent to the 

food and adjust their selection if they 

choose. 

In contrast, bottles of alcoholic 

beverages often are displayed very close 

together, layered on top of each other, 

staged in low lighting or back lighting, 

or placed very high. In other words, 


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they are displayed in a manner that does 

not enable consumers to easily identify 

the particular alcoholic beverages 

available to assist them in making their 

selections. In addition, bartenders often 

use bottles of alcoholic beverages under 

the bar—that are not on display—to mix 

alcoholic drinks. Finally, at many 

covered establishments that serve 

alcoholic beverages, mixed drinks and 

other alcoholic beverages that are not on 

menus or menu boards are ordered by 

customers sitting at tables, from which 

the bar could be completely out of sight. 

Based on the above considerations, 

we are exempting alcoholic beverages 

that are food on display and are not selfservice food. Because these 

considerations do not apply readily to 

self-service alcoholic beverages (e.g., 

bottles of beer in a cooler near the 

register at a quick service restaurant), 

self-service alcoholic beverages are 

covered by the final rule. Therefore, 

§ 101.11(b)(1)(ii)(B) of the final rule 

provides that the labeling requirements 

of § 101.11(b)(2)(iii) for standard menu 

items that are self-service or on display 

do not apply to alcoholic beverages that 

are foods on display and are not selfservice foods. 

C. Condiments 

(Comment 60) Several comments 

recommended that covered 

establishments provide calorie 

information for all condiments. Other 

comments maintained that calorie 

information should be provided for 

condiments if they are part of the 

standard menu item. One comment 

recommended that the following be 

added to the provision: ‘‘Condiments 

and sauces included as an ingredient or 

standard accompaniment to a menu 

item must be included in the nutrition 

information calculated for that item.’’ 

Another comment asked us to clarify 

that if condiments are provided for 

optional use, they should not be 

included in the calorie declaration. As 

an example, if a container of ketchup is 

provided on the side with a hamburger 

and the consumer can decide whether to 

use it, the container of ketchup should 

be treated the same as a bottle on the 

table and be exempted from calorie 

declaration. Another comment asked 

that the words ‘‘on the table’’ be 

removed from the provision and that the 

statute be interpreted to encompass 

condiments and other items kept behind 

the counter for general use. This 

comment explained that its 

establishment does not typically have 

tables as most of the business is takeout, and the condiments are kept behind 

the counter and available to the 

consumer upon request. 

One comment suggested that the 

exemption for condiments include only 

those self-serve items that are calorie 

free or that have a Nutrition Facts label. 

Another comment recommended that 

self-serve restaurants have the flexibility 

to determine which items can 

reasonably be considered condiments 

for general use, noting that many of its 

restaurants have an extensive ‘‘spice 

bar’’ that contains dozens of different 

spices, seasonings, and other 

condiments that any customer can use, 

regardless of that customer’s order or 

food selections. The comment 

maintained that the regulation should 

be clear that all spices and seasonings 

fall in this exempt category. 

(Response 60) We are clarifying the 

exemption for condiments. Section 

403(q)(5)(H)(vii)(I)(aa) of the FD&C Act 

provides that the requirements of 

section 403(q)(5)(H) of the FD&C Act do 

not apply to ‘‘items that are not listed 

on a menu or menu board (such as 

condiments and other items placed on 

the table or counter for general use).’’ 

We affirm our tentative conclusion in 

the proposed rule that, given the phrase 

‘‘for general use,’’ it is reasonable to 

interpret section 403(q)(5)(H)(vii)(I)(aa) 

of the FD&C Act to apply to foods, such 

as many condiments, that are available 

for use by any customer in the covered 

establishment, regardless of the 

customer’s particular order or food 

selection (76 FR 19192 at 19205). For 

example, it is reasonable to apply 

section 403(q)(5)(H)(vii)(I)(aa) of the 

FD&C Act to maple syrup that is 

provided in a bulk container or bottles 

of ketchup that are available for any 

customer to add to his or her food. 

However, we agree that the calorie 

declaration for a standard menu item 

must include the number of calories in 

the condiment if the condiment is used 

as a component in the standard menu 

item, as usually prepared and offered for 

sale. In such situation, the nutrient 

declarations for the standard menu item 

in the written nutrition information 

required by section 403(q)(5)(H)(ii)(III) 

of the FD&C Act and § 101.11(b)(2)(ii) 

must also include the nutrient amounts 

from the condiment because the 

condiment is used as a component in 

the standard menu item. The exemption 

in section 403(q)(5)(H)(vii)(I)(aa) of the 

FD&C Act does not apply to condiments 

that are part of a standard menu item, 

as the standard menu item is usually 

prepared and offered for sale. For 

example, if a covered establishment 

ordinarily offers for sale burgers 

containing ketchup and mayonnaise 

added by the establishment, the ketchup 

and mayonnaise would be part of the 

standard menu item as usually prepared 

and offered for sale, and the calorie 

declaration for the standard menu item 

would include the calories in the 

ketchup and mayonnaise. Likewise, if a 

covered establishment ordinarily 

provides each customer who orders 

pancakes with a single serving container 

of maple syrup, the maple syrup would 

be part of the standard menu item as 

usually prepared and offered for sale, 

and the calorie declaration for the 

standard menu item would include the 

calories in the single serving container 

of maple syrup. Similarly, as noted 

previously in this document, in these 

situations, the nutrient declarations for 

the standard menu item in the written 

nutrition information required by 

section 403(q)(5)(H)(ii)(III) of the FD&C 

Act and § 101.11(b)(2)(ii) must also 

include the nutrient amounts from the 

condiment because the condiment is 

used as a component in the standard 

menu item. 

We see no difference between a 

condiment brought to the table for 

general use and a condiment kept 

behind the counter for general use (and 

then provided to a customer who 

requests it), provided that such 

condiments are not listed on the menu 

or menu board separately or as part of 

a standard menu item. Therefore, we 

agree that condiments that are behind 

the counter for general use are exempt 

from the nutrition labeling requirements 

of section 403(q)(5)(H) of the FD&C Act 

under section 403(q)(5)(H)(vii)(I)(aa) of 

the FD&C Act. For clarity, we have 

revised § 101.11(b)(1)(ii) to explicitly 

provide that the labeling requirements 

in paragraph (b) do not apply to items 

such as condiments that are for general 

use, including those placed on the table 

or on or behind the counter. (Emphasis 

added.) As revised, § 101.11(b)(1)(ii) 

includes condiments placed ‘‘on’’ the 

counter in accordance with section 

403(q)(5)(H)(vii)(I)(aa) of the FD&C Act 

and in order to take into account 

varying business practices. 

We disagree that the exemption for 

condiments should include only those 

self-serve items that are calorie free or 

that have a Nutrition Facts label. The 

exemptions under § 101.11(b)(1)(ii) are 

based on the language of section 

403(q)(5)(H)(vii) of the FD&C Act. 

Section 403(q)(5)(H)(vii) of the FD&C 

Act generally provides that the nutrition 

labeling requirements of section 

403(q)(5)(H) of the FD&C Act do not 

apply to certain foods, including certain 

condiments. Section 403(q)(5)(H)(vii) of 

the FD&C Act does not qualify such 

exemptions based on the caloric content 

of the food or the fact that some food 

would be available in packaged form 

that provides a Nutrition Facts label. 


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However, we note that under 

§ 101.11(b)(2)(iii)(C), a covered 

establishment would not be required to 

provide the written nutrition 

information required by section 

403(q)(5)(H)(ii)(III) of the FD&C Act and 

§ 101.11(b)(2)(ii) for a self-service food 

or food on display that is a packaged 

food insofar as it bears nutrition labeling 

information required by and in 

accordance with § 101.11(b)(2)(ii) and 

the packaged food, including its label, 

can be examined by a consumer before 

purchasing the food. 

We also note that spices and 

seasonings (such as crushed dried 

peppers) are considered condiments 

that are exempt from the requirements 

of section 403(q)(5)(H) of the FD&C Act 

under section 403(q)(5)(H)(vii)(I)(aa) of 

the FD&C Act, provided that they are for 

general use by customers regardless of 

their particular order selection. 

D. Daily Specials, Temporary Menu 

Items, Custom Orders, and Food That Is 

Part of a Customary Market Test 

(Comment 61) Several comments 

agreed with the proposed exemption for 

daily specials. One comment disagreed 

with the proposed exemption because 

the burden to calculate the calories and 

other nutrition information is not so 

great for daily specials to justify this 

exemption. The comment maintained 

that consumers often buy what is on 

sale and that excluding daily specials 

from the requirements of section 

403(q)(5)(H) of the FD&C Act would 

undermine the purpose of the statute. 

One comment opposed the proposed 

exemption for temporary menu items 

because temporary menu items 

represent a large portion of what is 

ordered on a single day at some 

establishments. 

Several comments agreed with the 

proposed exemption for food that is part 

of a customary market test. One 

comment opposed the proposed 

exemption because chain restaurants 

test market their menu items carefully 

before they mass market menu items 

and the determination of the nutrient 

content should be part of that process. 

The comment asserted that disclosing 

the calorie content of the food may 

impact the consumer’s decision to 

purchase the food and may impact the 

establishment’s decision whether to 

include that food on the regular menu. 

(Response 61) We are retaining in 

§ 101.11(b)(1)(ii) the exemptions for 

daily specials, temporary menu items, 

custom orders, and food that is part of 

a customary market test. Section 

403(q)(5)(H)(vii) of the FD&C Act 

specifically exempts such items from 

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

of the FD&C Act regardless of the factors 

identified by the comments, such as 

how the burden to calculate calories for 

these items compares to the burden to 

calculate calories for standard menu 

items; the tendency of consumers to buy 

what is on sale; and whether a chain 

restaurant could determine nutrition 

information. 

Section 403(q)(5)(H)(vii) of the FD&C 

Act generally provides that the nutrition 

labeling requirements of section 

403(q)(5)(H) of the FD&C Act do not 

apply to certain foods, including daily 

specials, temporary menu items 

appearing on the menu for less than 60 

days per calendar year, custom orders, 

and food that is part of a customary 

market test appearing on the menu for 

less than 90 days under terms and 

conditions established by FDA. 

Accordingly, § 101.11(b)(1)(ii) provides 

that the labeling requirements of 

§ 101.11(b) do not apply to such foods 

and § 101.11(a) defines the terms for 

such foods. We note that, as discussed 

in Response 62, self-service food and 

food on display that are temporary 

menu items or part of a customary 

market test, but do not appear on a 

menu, are also exempt from the 

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

the FD&C Act because these foods are 

not standard menu items. 

However, neither section 403(q)(5)(H) 

of the FD&C Act nor this rule would 

prevent a covered establishment from 

voluntarily declaring calories or 

providing written nutrition information 

for condiments, daily specials, 

temporary menu items, or food that is 

part of a customary market test. 

Regarding daily specials, we note that 

we would not consider an item that is 

offered every week on a particular day 

(e.g., the Monday special) to be a ‘‘daily 

special’’ because it is being routinely 

offered for sale (i.e., every Monday). In 

addition, we would not consider a 

standard menu item, as defined in this 

rule, to be a ‘‘daily special’’ if it is 

offered at a discounted price on a 

particular day (e.g., a turkey club 

sandwich that is a standard menu item 

and normally costs 5 dollars, but is 

specially advertised as costing only 4 

dollars on Fridays). 

(Comment 62) In the proposed rule 

(76 FR 19192 at 19205), we noted that 

self-service food and food on display 

that do not appear on menus or menu 

boards would not be considered 

temporary menu items or food that is 

part of a customary market test. 

Therefore, even if a self-service food or 

food on display that does not appear on 

a menu or menu board is only offered 

by a covered establishment for a limited 

time, such as a pumpkin spice muffin 

available only in November, we 

tentatively concluded that the nutrition 

information declaration requirements in 

section 403(q)(5)(H) of the FD&C Act 

would still apply. 

Several comments that addressed the 

exemption in proposed § 101.11(b)(1)(ii) 

for temporary menu items and food that 

is part of a customary market test 

considered that this exemption should 

apply to self-service food and food on 

display even though such foods may not 

‘‘appear[ ] on a menu’’ as described in 

section 403(q)(5)(H)(vii) of the FD&C 

Act. These comments said that Congress 

excluded temporary menu items and 

customary market test items from the 

nutrition labeling requirements of 

section 403(q)(5)(H) of the FD&C Act 

because it recognized that restaurants 

should be able to test products (many of 

which fail and are discontinued 

quickly) without incurring the 

significant costs associated with 

changing their menu and compiling 

nutritional information. The comments 

considered that this same reasoning 

applies to temporary menu items and 

customary market test items offered in 

self-service restaurants (whether the 

restaurant displays items on a menu, 

menu board, or individual signs). The 

comments asserted that for buffet-type 

restaurants, there would be significant 

costs in attempting to improve and 

change their menus for temporary menu 

items and food that is being market 

tested and that these costs would not be 

incurred by other kinds of non-buffettype restaurants. 

(Response 62) We agree with these 

comments that the statutory exemptions 

for temporary menu items appearing on 

the menu for less than 60 days per 

calendar year and customary market test 

items appearing on the menu for less 

than 90 days apply to self-service foods 

and foods on display that fall into those 

categories, as defined in § 101.11(a). We 

also agree that a self-service food and 

food on display that does not appear on 

a menu or menu board but otherwise 

meets the definition for temporary menu 

items or food that is part of a customary 

market, in that the food is offered for 

sale in a covered establishment for less 

than a total of 60 days per calendar year 

or fewer than 90 consecutive days in 

order to test consumer acceptance, 

should not be required to comply with 

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

of the FD&C Act and § 101.11. The 

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

the FD&C Act and § 101.11 apply to 

foods that are standard menu items. 

However, self-service foods and foods 

on display that do not appear on a menu 

or menu board, but otherwise meet the 

definitions for temporary menu items or 


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food that is part of customary market 

test, along with the foods described in 

section 403(q)(5)(H)(vii) of the FD&C 

Act, do not meet the definition for a 

standard menu item in § 101.11(a) 

because such self-service foods and 

foods on display are neither ‘‘routinely 

included on a menu or menu board’’ nor 

‘‘routinely offered as a self-service food 

or food on display.’’ Like temporary 

menu items or food that is part of a 

customary market test appearing on a 

menu or menu board, as described in 

section 403(q)(5)(H)(vii) of the FD&C 

Act, self-service foods and foods on 

display that do not appear on a menu 

or menu board but otherwise meet the 

definitions for temporary menu items or 

food that is part of a customary market 

are offered for a limited time and are 

subject to variation and discontinuation 

depending on the seasonality and 

consumer response. Thus, these foods, 

like the foods described in section 

403(q)(5)(H)(vii) of the FD&C Act, are 

not standard menu items and the 

requirements of this rule do not apply 

to such foods. 

For these reasons, we are modifying 

§ 101.11(b)(1)(ii)(A). First, we are 

specifying in § 101.11(b)(1)(ii)(A) that 

the labeling requirements in paragraph 

(b) do not apply to foods that are not 

standard menu items. Second, we are 

specifying in § 101.11(b)(1)(ii)(A)(1) that 

such foods that are not standard menu 

items include items such as condiments 

that are for general use, including those 

placed on the table or on or behind the 

counter; daily specials; temporary menu 

items; custom orders; and food that is 

part of a customary market test. Third, 

we are specifying in 

§ 101.11(b)(1)(ii)(A)(2) that such foods 

that are not standard menu items also 

include self-service food and food on 

display that is offered for sale for less 

than a total of 60 days per calendar year 

or fewer than 90 consecutive days in 

order to test consumer acceptance. 

E. Additional Comments on Food That 

Is Part of a Customary Market Test 

(Comment 63) Some comments asked 

us to clarify that if a food is tested in 

more than one location, the 90-day 

period is applied to each location. These 

comments maintained that it is common 

for restaurants and similar retail food 

establishments to conduct iterative tests 

to evaluate the performance of a menu 

item and change the menu in light of 

test results. For example, the results of 

iterative tests may lead to ‘‘changes in 

product makeup, including size, shape, 

taste profile, and preparation,’’ with 

accompanying changes to the 

underlying nutrient content. The 

comment asked us to clarify that a food 

that changes in such a manner during a 

market test is a new food, and the 90- 

day period would begin again. One 

comment asked us to confirm that a 

market test may be conducted in 

multiple locations and that the 90-day 

period starts when the testing begins in 

a particular location. 

(Response 63) As we discussed in the 

proposed rule (76 FR 19192 at 19205) 

and as suggested by the comments, in 

some cases, a chain of restaurants and 

similar retail food establishments may 

test a new product in different locations 

within the chain and in more than one 

region of the country at different times. 

We conclude that a ‘‘customary market 

test,’’ for the purposes of § 101.11, refers 

to a test in a single covered 

establishment. Therefore, we agree with 

the comments that the 90-day period for 

the food that is part of a customary 

market test applies to each covered 

establishment that offers for sale food 

that is part of a customary market test. 

Further, we recognize that restaurants 

and similar retail food establishments 

may change the foods that they are 

market testing in an iterative process. 

Therefore, we agree that if a food 

changes in ways such as those noted in 

the comments (e.g., changes in product 

makeup, including size, shape, taste 

profile, and preparation), it would be a 

new food and the 90-day period would 

begin again. We would consider the 

food to be a new food if it is not made 

with the same general recipe or same 

ingredients or otherwise has a 

significant change in the nutrient profile 

during the market test. For example, we 

would consider a soup prepared 

without meat, and a soup prepared with 

added sausage, to be different foods and 

would expect differences between the 

nutrient profiles of these different foods. 

XI. Comments and FDA Response on 

Proposed § 101.11(b)(2)(i)(A)(1) to 

(b)(2)(i)(A)(3)—General Requirements 

for Calorie Declaration on Menus and 

Menu Boards 

Proposed § 101.11(b)(2)(i)(A)(1) to 

(b)(2)(i)(A)(3) would require that 

covered establishments declare the 

number of calories contained in each 

standard menu item listed on the menu 

or menu board, as usually prepared and 

offered for sale in the following manner: 

• The number of calories must be 

listed adjacent to the name or the price 

of the associated standard menu item, in 

a type size no smaller than the name or 

the price of the associated standard 

menu item, whichever is smaller, in the 

same color, or a color at least as 

conspicuous as the name of the 

associated standard menu item, and 

with the same contrasting background 

as the name of the associated standard 

menu item (proposed 

§ 101.11(b)(2)(i)(A)(1)). 

• The calories must be declared to the 

nearest 5-calorie increment up to and 

including 50 calories and to the nearest 

10-calorie increment above 50 calories, 

except that amounts less than 5 calories 

may be expressed as zero (proposed 

§ 101.11(b)(2)(i)(A)(2)). 

• The term ‘‘Calories’’ or ‘‘Cal’’ must 

appear as a heading above a column 

listing the number of calories for each 

standard menu item or adjacent to the 

number of calories for each standard 

menu item. If the term ‘‘Calories’’ or 

‘‘Cal’’ appears as a heading above a 

column of calorie declarations, the term 

must be in a type size no smaller than 

the smallest type size of the name or 

price of any menu item on that menu or 

menu board in the same color or a color 

at least as conspicuous as that name or 

price and in the same contrasting 

background as that name or price. If the 

term ‘‘Calories’’ or ‘‘Cal’’ appears 

adjacent to the number of calories for 

the standard menu item, the term 

‘‘Calories’’ or ‘‘Cal’’ must appear in the 

same type size and in the same color 

and contrasting background as the 

number of calories (proposed 

§ 101.11(b)(2)(i)(A)(3)). 

In the following paragraphs, we 

discuss comments on these proposed 

provisions. After considering the 

comments, we are: 

• Revising § 101.11(b)(2)(i)(A) to 

specify that in the case of multipleserving standard menu items, the calorie 

declaration must be for the whole menu 

item as listed on the menu or menu 

board, as usually prepared and offered 

for sale (e.g., ‘‘pizza pie: 1600 calories’’), 

or per discrete serving unit as long as 

the discrete serving unit (e.g., pizza 

slice) and total number of discrete 

serving units are declared on the menu 

or menu board, and the menu item is 

usually prepared and offered for sale 

divided in discrete serving units (e.g., 

‘‘pizza pie: 200 cal/slice, 8 slices’’). 

• Revising § 101.11(b)(2)(i)(A)(1) to 

provide additional flexibility for the 

contrasting background used for the 

calorie declaration; 

• Making a conforming editorial 

change to the requirement for the color 

used for the calorie declaration for 

grammatical consistency; and 

• Making an editorial correction for 

clarity to insert ‘‘the type size of’’ 

between ‘‘no smaller than’’ and ‘‘the 

name or the price’’ in 

§ 101.11(b)(2)(i)(A)(1). 

(Comment 64) Many comments 

regarding the proposed requirement that 

the number of calories contained in 

each standard menu item listed on the 


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71192 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

menu or menu board be declared as 

usually prepared and offered for sale 

addressed the discussion in the 

proposed rule regarding how the calorie 

labeling requirements on menus and 

menu boards would apply to multipleserving foods that are standard menu 

items (76 FR 19192 at 19203–19204). 

Many comments agreed with the view 

we expressed in the proposed rule that 

section 403(q)(5)(H) of the FD&C Act 

requires that calories be declared for 

standard menu items regardless of how 

many servings are included in the item 

(76 FR 19192 at 19203). The comments 

asserted that servings vary by product 

and by portions taken by consumers. 

One comment considered that if a menu 

item is to be shared, it would be easier 

for consumers to determine how many 

people will share the item and divide 

the calories accordingly than for the 

restaurant to choose how many servings 

are in a menu item. The comment said 

that we should not allow restaurants to 

choose how many servings are in a 

menu item. 

Many other comments opposed listing 

the calories for the entire standard menu 

item and instead supported the listing of 

calories per serving. Some comments 

asserted that listing calories per serving 

would be less confusing, would be 

consistent with calorie declarations on 

packaged food, and would not require 

consumers to do a calculation. One 

comment agreed with our determination 

that a multiple-serving food is a 

standard menu item but disagreed with 

our tentative conclusion that the calorie 

declaration should be for the entire 

multiple-serving food because providing 

calories for the entire multiple-serving 

food would not be helpful and would be 

detrimental for those who need the 

information per serving (e.g., diabetics). 

A few comments asked us to provide an 

option to permit either the declaration 

of calories for the entire multipleserving menu item, or the declaration of 

the number of servings and the calories 

per serving. As an example, one 

comment suggested that a restaurant 

selling a four-serving family-style platter 

of pasta could comply either by 

disclosing that the whole menu item 

contains 2,000 calories, or by disclosing 

that the menu item consists of 4 

servings, 500 calories per serving. 

One comment pointed out that if we 

required calorie declaration for an entire 

multiple-serving food, nutrition 

information would be inconsistent in 

some instances. For example, a 

cheesecake from a display case would 

have different nutrition information 

than the same cheesecake in 

prepackaged form, because the first 

would list calories for the entire item 

whereas the second would list calories 

per serving. One comment suggested 

that, for foods that are not appetizers or 

desserts that are intended to serve more 

than one person, calorie disclosure 

should include the number of persons 

intended to be served and the calorie 

content per serving. 

A few comments recommended that 

calories for pizza be listed per slice. One 

comment reported that it received 

complaints when it provided calorie 

information for the entire listed pizza. 

The comment provided a report of 

consumer research showing that 60 

percent of consumers preferred calorie 

information per slice. The report of this 

survey was submitted with the comment 

(Ref. 32). Some comments referred to 

our previous statements that nutrition 

information should be declared per 

serving. For example, in our proposed 

rule on ‘‘Food Labeling: Serving Sizes,’’ 

we stated that for ‘‘[f]oods in large 

discrete units,’’ ‘‘the household measure 

most meaningful for these products is a 

fraction of the whole unit.’’ (56 FR 

60394 at 60410, November 27, 1991). 

Another comment referred to statements 

in our 2008 ‘‘Guidance for Industry: A 

Labeling Guide for Restaurants and 

Other Retail Establishments Selling 

Away-From-Home Foods (the 2008 

restaurant labeling guide) (Ref. 10) that 

generally the nutrition information 

should be presented on a per serving 

basis. For example, the 2008 restaurant 

labeling guide states that ‘‘[i]t is 

especially important that the basis be 

declared when a food is available in 

more than one size serving (e.g., pizza 

that is available whole and by 

slice). . . . The restaurant may provide 

additional information, such as ‘8 slices 

per medium 16-inch pizza, 1 slice 

contains . . .’ to help consumers put 

nutrition information in context.’’ 

Other comments urged us to clarify 

that a covered establishment can 

voluntarily provide nutrition 

information per serving. These 

comments suggested that we revise the 

rule to indicate that fact. These 

comments suggested adding the 

following to § 101.11(b)(2)(i)(A): ‘‘(5) For 

items that could serve more than one 

person, such as a large pizza or a bucket 

of chicken, calories must be listed per 

standard menu item as offered for sale 

and listed on the menu or menu board 

or as placed on display. In addition, 

restaurants and similar retail food 

establishments may also voluntarily 

provide nutrition information per 

serving.’’ 

(Response 64) Listing calories for 

multiple-serving standard menu items 

as usually prepared and offered for sale 

by a covered establishment is consistent 

with section 403(q)(5)(H) of the FD&C 

Act. As discussed in the proposed rule, 

section 403(q)(5)(H) of the FD&C Act 

requires covered establishments to 

disclose calorie information for standard 

menu items as usually prepared and 

offered for sale, regardless of how many 

servings are included in the menu item 

(76 FR 19192 at 19203). 

Based on the comments that 

supported calorie declarations for 

multiple-serving standard menu items 

‘‘per serving,’’ the complexity of 

consumer eating habits and preferences 

described by the comments, and the 

variety of ways that covered 

establishments may choose to usually 

prepare and offer their foods for sale, we 

have revised the rule’s calorie 

declaration requirements for multipleserving standard menu items on menus 

and menu boards. 

Where a multiple-serving standard 

menu item is usually prepared and 

offered for sale divided in discrete 

serving units (e.g., slices of pizza), we 

are allowing covered establishments to 

provide the calorie declaration per 

discrete serving unit, subject to some 

additional requirements. If a covered 

establishment declares calories for a 

multiple-serving standard menu item 

per discrete serving unit, the 

establishment must also declare the 

discrete serving unit and the total 

number of discrete serving units in the 

menu item on the menu or menu board 

so that the consumer can make a fullyinformed decision before selecting the 

item. 

We are allowing calorie declarations 

per discrete serving unit for multipleserving standard menu items that are 

usually prepared and offered for sale 

divided in discrete serving units 

because such division will likely enable 

consumers to easily identify the discrete 

serving unit (e.g., pizza slice) and 

therefore keep track of the number of 

serving units consumed. Pizza slices 

that come in a pie, or breadsticks that 

come in a bunch (e.g., ‘‘pizza pie: 200 

cal/slice, 8 slices;’’ ‘‘breadsticks: 150 

cal/stick, 5 sticks’’) are examples of 

multiple-serving standard menu items 

that are usually prepared and offered for 

sale divided in discrete serving units. If 

consumers share such a menu item, the 

discrete serving units provide a distinct 

division along which portions can be 

divided, thereby allowing consumers to 

keep track of calories consumed by 

either adding or multiplying the per 

discrete serving unit calorie declaration 

based on the number of serving units 

consumed. Providing the number of 

calories per discrete serving unit and 

the total number of discrete serving unit 

contained in the menu item for 


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multiple-serving standard menu items 

that are usually prepared and offered for 

sale divided in discrete units enables 

consumers to determine the number of 

calories they may actually consume and 

therefore enables consumer to make 

informed dietary choices. 

However, where a multiple-serving 

standard menu item is not usually 

prepared and offered for sale divided in 

discrete serving units, covered 

establishments must declare calories for 

the entire menu item listed on the menu 

or menu board, as usually prepared and 

offered for sale. We disagree with the 

comment that said a calorie declaration 

for a whole multiple-serving standard 

menu item would be unhelpful or 

detrimental. If consumers decide to 

share a multiple-serving standard menu 

item, they can divide the total number 

of calories by the number of individuals 

sharing it. We clarify—as one comment 

suggested—that for multiple-serving 

standard menu items that are not 

usually prepared and offered for sale 

divided in discrete serving units, we 

would not object if a covered 

establishment decided to voluntarily 

declare calories per serving, in addition 

to the calories for the entire standard 

menu item. 

(Comment 65) A few comments 

recommended that calories be declared 

per reference amount customarily 

consumed (RACC) or by household 

measure. A RACC represents the 

amount of food customarily consumed 

at one eating occasion (§ 101.12 (21 CFR 

101.12)). A few comments considered 

that listing calories per serving based on 

the RACC would be consistent with the 

labeling of packaged food. One 

comment noted that customers are used 

to seeing information per serving even 

though actual consumption may not be 

aligned with the RACC. 

(Response 65) We assume that 

‘‘household measure’’ refers to measures 

such as ‘‘cups’’ or ‘‘tablespoons.’’ 

RACCs represent the amount of food 

customarily consumed at one eating 

occasion and are calculated for a variety 

of foods purchased by consumers in 

establishments such as grocery stores 

(see § 101.12). RACCs are based on data 

set forth in national food consumption 

surveys and other sources of 

information on serving sizes of food, 

including serving sizes used in dietary 

guidance recommendations or 

recommended by other authoritative 

systems or organizations, serving sizes 

used by manufacturers and grocers, and 

serving sizes used by other countries 

(§ 101.12(a)). We developed RACCs as 

the basis for determining serving sizes 

for specific products for the purpose of 

declaration of nutrition information on 

product labels. 

We disagree that calories for standard 

menu items should be declared per 

RACC or by household measure. Section 

403(q)(5)(H) of the FD&C Act requires 

covered establishments to disclose the 

number of calories contained in a 

standard menu item ‘‘as usually 

prepared and offered for sale.’’ Although 

many standard menu items may have an 

associated RACC, others may not. Even 

if some standard menu items have an 

associated RACC, each covered 

establishment is free to choose the 

amount of food offered for sale in its 

standard menu items, and section 

403(q)(5)(H) of the FD&C Act does not 

require covered establishments to 

prepare and offer standard menu items 

in particular amounts, such as RACCs. 

(Comment 66) Some comments 

considered that calories should be 

declared for each size of a menu item 

(such as ‘‘upgrades’’ or ‘‘upsized 

options’’ and ‘‘downsized options’’) 

offered on menus and menu boards. 

Some comments linked the requirement 

to declare calories for different sizes to 

different prices—e.g., by considering 

that calories must be declared for any 

size option that has a distinct price on 

the menu or menu board. Some 

comments specifically addressed fixed 

combination meals and considered that 

calories should be declared for fixed 

combination meals available in multiple 

sizes. 

One comment asked us to allow the 

restaurant to list calories for a 6-inch 

version of a sandwich and provide a 

statement on the menus and menu 

boards that the 12-inch sandwich is 

double that amount. 

(Response 66) The calorie labeling 

requirements of § 101.11(b)(2)(i)(A) 

apply to each standard menu item listed 

on the menu or menu board, as usually 

prepared and offered for sale. Thus, if a 

standard menu item (such as fries or 

onion rings) is listed on the menu or 

menu board in more than one size (such 

as ‘‘small’’ and ‘‘large’’), the menu or 

menu board must provide calories for 

each size, following the format 

requirements of § 101.11(b)(2)(i)(A)(1), 

(b)(2)(i)(A)(2), and (b)(2)(i)(A)(3). 

Likewise, if a fixed combination meal 

(i.e., a meal consisting of components 

that are not subject to a consumer’s 

selection, such as a burger and fries) is 

listed on the menu or menu board in 

more than one size (e.g., a hamburger 

with small fries or large fries), the menu 

or menu board must provide calories for 

each size of the fixed combination meal, 

also following the format requirements 

of § 101.11(b)(2)(i)(A)(1), (b)(2)(i)(A)(2), 

and (b)(2)(i)(A)(3). 

If a 6-inch sandwich and a 12-inch 

sandwich are both standard menu items 

listed on a menu or menu board, or are 

on display in a covered establishment, 

the establishment must disclose the 

number of calories for each sandwich 

size, following the format requirements 

of § 101.11(b)(2)(i)(A)(1), (b)(2)(i)(A)(2), 

and (b)(2)(i)(A)(3) or § 101.11(b)(2)(iii) 

as applicable, unless the sandwich is 

exempt from the nutrition labeling 

requirements under section 

403(q)(5)(H)(vii) of the FD&C Act. 

(Comment 67) One comment 

interpreted the phrase ‘‘as usually 

prepared’’ within ‘‘as usually prepared 

and offered for sale’’ in proposed 

§ 101.11(b)(2)(i)(A) to be a ‘‘standard 

formula,’’ ‘‘recommended formula,’’ 

‘‘standard build,’’ or any other term that 

means a predetermined method of 

preparation designed to ensure that all 

menu offerings are nutritionally 

consistent and uniform throughout all 

covered establishments in a chain. 

One comment agreed that the number 

of calories for a standard menu item 

should be measured based on how the 

standard menu item is usually prepared 

and offered for sale, but expressed 

concern about build-as-you-go menu 

items. The comment explained that, a 

covered establishment might post the 

number of calories for a build-as-you-go 

menu item as an ‘‘undressed’’ sandwich 

(the comment did not define this term), 

giving the false impression that the 

sandwich has fewer calories than it may 

actually contain as prepared by the 

covered restaurant and then consumed 

by a customer. This comment contended 

that this type of sandwich should be 

considered a variable menu item with 

calories posted as a range (i.e., in 

accordance with proposed 

§ 101.11(b)(2)(i)(A)(4)) that includes the 

undressed sandwich and the fully built 

one, because there is standardization 

with respect to the specific amount of 

each particular food item or condiment 

that consumers can add to the build-asyou-go menu item. As evidence for this 

view, the comment referred to the 

standard extra charge for items such as 

an extra scoop of guacamole. 

(Response 67) We agree that 

‘‘standard build’’ or ‘‘recommended 

formula’’ is consistent with the term ‘‘as 

usually prepared and offered for sale.’’ 

However, it is the build that is standard 

to any given covered establishment, 

rather than recommendations or 

standards by or from the chain as a 

whole, that dictates the nutrition 

information that would be required to 

be declared for standard menu items in 

a particular covered establishment. 

Regarding the comment expressing 

concern about build-as-you-go menu 


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items, we first note that a build-as-yougo menu item, such as a sandwich with 

the option of adding different fixings, 

that is a standard menu item, likely 

would be considered a variable menu 

item. As discussed previously in this 

document (see sections VIII.B and 

VIII.D), § 101.11(a) defines the terms, 

‘‘standard menu item’’ and ‘‘variable 

menu item.’’ A variable menu item is 

defined in § 101.11(a) as a standard 

menu item that comes in different 

flavors, varieties, or combinations, and 

is listed as a single menu item. A 

variable menu item is one type of 

standard menu item. In the proposed 

rule, we provided examples of 

‘‘standard menu items’’—e.g., a 

hamburger, a combination meal, a 

specific type of pizza (e.g., deluxe 

pizza), potato salad that is routinely 

offered at a salad bar, pancakes that are 

routinely offered at a buffet, and 

pudding that is routinely offered at a 

cafeteria line (76 FR 19192 at 19203). 

We also provided examples of variable 

menu items—i.e., foods that may have 

flavoring options (e.g., a milkshake that 

is available in vanilla, chocolate, or 

strawberry flavors) or topping options 

(e.g., pizza prepared with a selection of 

toppings) (76 FR 19192 at 19204). In the 

following paragraphs, we provide 

additional examples relevant to buildas-you-go menu items and explain how 

the calorie labeling requirements of 

§ 101.11(b)(2)(i)(A) would apply. 

A standard menu item that is listed on 

a menu or menu board that is not a 

variable menu item, in that it does not 

come in different flavors, varieties, or 

combinations that are listed as a single 

menu item, (e.g., a turkey and Swiss 

cheese sandwich on whole wheat bread 

with mustard), would be subject to the 

calorie declaration format requirements 

of § 101.11(b)(2)(i)(A)(1) to 

(b)(2)(i)(A)(3), but would not be subject 

to the additional format requirements 

for variable menu items (proposed 

§ 101.11(b)(2)(i)(A)(4)), established in 

this rule as § 101.11(b)(2)(i)(A)(4) 

through (b)(2)(i)(A)(8); see the 

discussion of the additional format 

requirements for variable menu items in 

section XII). However, a standard menu 

item that comes in different flavors, 

varieties, or combinations, and is listed 

as a single menu item on a menu or 

menu board (e.g., a ‘‘turkey and cheese 

sandwich,’’ with different options for 

the type of bread (e.g., whole wheat or 

white), cheese (e.g., Swiss, provolone, 

cheddar), fixings (e.g., onions, lettuce, 

tomato), and condiments (mustard, 

ketchup, mayonnaise)) would be a 

variable menu item subject to both the 

general calorie declaration format 

requirements of § 101.11(b)(2)(i)(A)(1) to 

(b)(2)(i)(A)(3) for all standard menu 

items and the additional format 

requirements for variable menu items as 

applicable in § 101.11(b)(2)(i)(A)(4) 

through (b)(2)(i)(A)(8). 

(Comment 68) Several comments 

agreed with proposed 

§ 101.11(b)(2)(i)(A)(2) and the flexibility 

in proposed § 101.11(b)(2)(i)(A)(3) to 

permit the abbreviation ‘‘Cal’’ for 

calories. 

Several comments addressed the 

placement provisions for the calorie 

declarations in proposed 

§ 101.11(b)(2)(i)(A)(1) and (b)(2)(i)(A)(3). 

A few comments agreed that the number 

of calories be posted next to the name 

or price of the menu item (proposed 

§ 101.11(b)(2)(i)(A)(1)) and that the term 

‘‘Calories’’ or ‘‘Cal’’ be next to the 

number of calories (proposed 

§ 101.11(b)(2)(i)(A)(3)). One comment 

found that customers in its restaurants 

confused calorie declarations with price 

declarations and noted that declaring 

calories in the same font, size, and 

contrast as the price would create 

confusion, even if the color is different. 

Another comment from a chain 

restaurant found that consumers in its 

restaurants were confused when calories 

were posted next to the name of the 

menu item and thought the number of 

calories was the order number; to 

address this confusion, the restaurant 

put the number of calories after the 

price and in a different color, font, and 

size. This comment emphasized its 3 

years of experience with posting calorie 

declarations and provided examples of 

its menu boards to demonstrate how it 

communicates calorie information about 

its menu offerings. This comment 

agreed that calorie information should 

be listed in a manner that allows the 

customer to easily identify the calories 

associated with a particular menu item, 

but disagreed that listing calories 

adjacent to a menu item is the only way 

(or even the best way) for customers to 

understand the information associated 

with their menu choice. This comment 

asserted that it had specifically learned 

from practical application and guest 

feedback that this generally is not the 

most useful method of providing caloric 

information. This comment suggested 

that the rule require a logical and clear 

association between the menu item and 

calorie declaration, but provide 

flexibility for how that logical and clear 

association occurs. 

(Response 68) We appreciate 

receiving the sample menu boards from 

the comment as a means of sharing 

experience with us. However, we are 

retaining in § 101.11(b)(2)(i)(A)(1) the 

requirement that the number of calories 

be listed adjacent to the name or the 

price of the associated standard menu 

item. This requirement is consistent 

with section 403(q)(5)(H)(ii)(I)(aa) of the 

FD&C Act, which requires that the 

calorie declaration be ‘‘adjacent to the 

name of the standard menu item, so as 

to be clearly associated with the 

standard menu item.’’ Placing calorie 

declarations adjacent to the names of 

standard menu items provides a clear 

and logical association between the 

standard menu item and the calorie 

declaration and helps to ensure that 

consumers are able to see the 

declarations. In addition, 

§ 101.11(b)(2)(i)(A)(3) provides that the 

term ‘‘Calories’’ or ‘‘Cal’’ must appear as 

a heading above a column listing the 

number of calories for each standard 

menu item or adjacent to the number of 

calories for each standard menu item. 

As such, § 101.11(b)(2)(i)(A)(3) helps to 

further ensure that the calorie 

declaration is clearly associated with a 

particular standard menu item, and the 

required use of the term ‘‘Calories’’ or 

‘‘Cal’’ will help inform consumers that 

the number listed refers to calories. 

Section 101.11(b)(2)(i)(A)(1) also 

provides flexibility by requiring a 

covered establishment to declare 

calories adjacent to either the name or 

the price of the standard menu item. 

This flexibility is consistent with what 

one comment described doing in a 

restaurant. As finalized, 

§ 101.11(b)(2)(i)(A)(1) also provides 

sufficient flexibility to accommodate 

different types of menus and menu 

boards and the various ways that 

standard menu items may be listed on 

menus and menu boards. Specifically, 

in this rule § 101.11(b)(2)(i)(A)(1): 

• Provides flexibility to use a color 

‘‘at least as conspicuous’’ as that of the 

name of the associated standard menu 

item and, thus, allows for the use of a 

different color; 

• Provides flexibility to use a 

contrasting background ‘‘at least as 

conspicuous’’ as that used for the name 

of the associated standard menu item 

and, thus, allows for the use of a 

different contrasting background (see 

Response 73); 

• Provides flexibility to use a type 

size ‘‘no smaller than the type size of 

the name or price’’ of the associated 

standard menu item and, thus, allows 

for the use of a different type size; and 

• Does not restrict the font style. 

We also note that the sample menu 

boards of the chain restaurant provided 

in the comment generally followed the 

provisions of the proposed rule in terms 

of type size and placement of calorie 

declarations. For example, the menu 

boards listed calorie declarations 


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adjacent to the names of standard menu 

items in a type size no smaller than the 

name or the price of the associated 

standard menu item, whichever is 

smaller, in a column with a heading 

‘‘Calories.’’ Therefore, while the 

comment opposed the requirement that 

calorie declarations be placed adjacent 

to the names of standard menu items on 

menus and menu boards, the menu 

boards of the chain restaurant, 

nevertheless, generally used the same 

method of calorie declaration on menus 

and menu boards as required by this 

rule. 

(Comment 69) In the proposed rule, 

we tentatively concluded that some 

packaged foods offered for sale in 

covered establishments are covered by 

the menu labeling requirements (see 76 

FR 19192 at 19217, proposed 

§ 101.11(b)(2)(iii)(C)). For example, a 

covered establishment may list ‘‘chips’’ 

on its menu board, referring to packaged 

bags of chips that are available as selfservice foods or foods on display within 

the establishment. In this situation, the 

establishment would be required to 

disclose on the menu board calorie 

information for the packaged chips. In 

addition, if a covered establishment lists 

on its menu or menu board a 

combination meal that includes a 

packaged food, the establishment would 

be required to disclose the total calorie 

information for the combination meal, 

including the packaged food. 

One comment agreed with requiring 

the total calorie information of a 

combination meal that includes a 

packaged food to include the calories for 

the packaged food. Another comment 

disagreed that calories should be 

declared on a menu or menu board for 

packaged foods, particularly packaged 

soft drinks. 

(Response 69) As required by section 

403(q)(5)(H) of the FD&C Act, covered 

establishments must provide calorie 

information for all standard menu items, 

including foods that are packaged. In 

addition, sections 403(q)(5)(H)(ii)(I)(aa) 

and (II)(aa) of the FD&C Act requires 

that covered establishments disclose the 

number of calories contained in a 

standard menu item, ‘‘as usually 

prepared and offered for sale.’’ As such, 

we agree that a covered establishment 

that lists on its menu or menu board a 

combination meal that includes a 

packaged food must disclose the total 

number of calories in the combination 

meal, including the calories for the 

packaged food. 

(Comment 70) One comment stated 

that the total calorie declaration for a 

standard menu item must include all 

ingredients of a standard menu item, as 

it is usually prepared and offered for 

sale, e.g., for a teaspoon of sugar added 

to oatmeal and salad dressings served 

on or with salad. 

(Response 70) We agree that the total 

calorie declaration for a standard menu 

item must include all ingredients of the 

standard menu item, as it is usually 

prepared and offered for sale, e.g., for a 

teaspoon of sugar added to oatmeal and 

salad dressings served on or with salad. 

As with the scenario discussed in 

Response 69 for a combination meal that 

includes a packaged food, doing so is 

required by section 403(q)(5)(H) of the 

FD&C Act and by sections 

403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the 

FD&C Act. 

(Comment 71) One comment 

suggested that we require that covered 

establishments provide the Reference 

Daily Intakes (RDIs) of calories, fat, 

cholesterol, and ‘‘salt’’ on menus and 

menu boards. The comment 

acknowledged that there is no RDI for 

sugar, but requested that it nonetheless 

be included on menus and menu 

boards. The comment also 

recommended that menus and menu 

boards only list percent Daily Value 

(DV) of calories, fat, cholesterol, sugar, 

and ‘‘salt’’ and not list vitamins and 

minerals because ‘‘too many details may 

lead to information overload and defeat 

the purpose.’’ 

(Response 71) We disagree with the 

comment’s suggestions, and we are not 

requiring covered establishments to 

include RDIs or percent DVs for certain 

nutrients on menus and menu boards. 

On menus and menu boards, we are 

requiring the number of calories 

contained in standard menu items, as 

usually prepared and offered for sale, 

and a succinct statement concerning 

suggested daily caloric intake, as 

required by sections 403(q)(5)(H)(ii)(I) 

and (II) of the FD&C Act. The succinct 

statement will adequately enable the 

public to understand, in the context of 

a total daily diet, the significance of the 

caloric information provided on menus 

or menu boards. We further note that 

percent DVs cannot be expressed for 

sugar or calories because Daily 

Reference Values (DRVs) have not been 

established for these nutrients. (See 

§ 101.9(c)(9), which lists DRVs for fat, 

cholesterol, sodium, and other food 

components.) The term Reference Daily 

Intake (RDI) applies to a vitamin or 

mineral but does not apply to calories, 

fat, cholesterol, sugar, or salt. (See 

§ 101.9(c)(8)(iv), which lists the RDIs for 

vitamins and minerals that are essential 

for human nutrition.) For the Nutrition 

Facts Label, the amount of a nutrient is 

calculated as a percentage of the RDI or 

DRV, as appropriate, and expressed 

using the same term—i.e., percent DV. 

Because ‘‘salt’’ can be either a general 

term applicable to substances such as 

calcium chloride or potassium chloride, 

or a synonym for the specific food 

substance ‘‘sodium chloride,’’ and 

because nutrition information generally 

is directed to information about the 

sodium content of food, we considered 

the request of the comment to be 

directed to the declaration of percent 

DV for ‘‘sodium’’ rather than to ‘‘salt.’’ 

(Comment 72) A few comments 

agreed with the proposed requirement 

(in proposed § 101.11(b)(2)(i)(A)(1)) that 

the type size for the calorie disclosure 

be no smaller than the name or the price 

of the associated standard menu item, 

whichever is smaller. Other comments 

considered that the proposed type size 

requirements are too prescriptive and 

recommended that we require only that 

the type size be ‘‘clear and 

conspicuous.’’ One comment stated that 

restaurants located in one State have 

already complied with a clear and 

conspicuous standard; therefore, to 

move to a type size no smaller than the 

smaller of the name or price of the menu 

item would require changes. Another 

comment asked us to provide guidance 

that if the calorie declaration is as large 

as the name, price, or description of the 

menu item, whichever is smaller, it is 

presumptively clear and conspicuous 

and complies with section 4205 of the 

ACA, rather than require a specific font 

size relative to the price or name; as an 

alternative, the type size of the calorie 

declaration could be the same size as 

the description of the menu item (rather 

than the name of the menu item) 

(emphasis added). One comment 

recommended that any required 

minimum type size for the calorie 

declaration be half the size of the name 

or price, whichever is smaller. Another 

recommended that the calorie 

declaration be the same size and font as 

either the name or price. 

A few comments recommended that 

we require that the calorie declaration 

be at least as large as (or no smaller 

than) the name or price, whichever is 

larger. One comment recommended that 

the type size of the calorie declaration 

be no less than 10 point font on menus 

and no less than 22 point font on menu 

boards or a type size equal to the type 

size of the food listed. 

(Response 72) We are retaining the 

type size requirements for the calorie 

declaration without change. We disagree 

that the requirements for the type size 

of the calorie declaration are too 

prescriptive. Some type size 

requirements suggested in the 

comments would be more restrictive 

than what we proposed. This would be 

true for those comments specifying a 


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type size at least as large as (or no 

smaller than) the name or price, 

whichever is larger; a type size the same 

as the type size of the name or price; a 

type size the same size as the 

description of the menu item; or a 

specific type size. Such type size 

requirements would not take into 

consideration the various types and 

sizes of menus and menu boards that 

may be used in covered establishments. 

We have concerns that a type size that 

is half the size of the name or price, 

whichever is smaller, would result in a 

calorie declaration that is not clear and 

conspicuous and, therefore, not 

compliant with sections 

403(q)(5)(H)(ii)(I) and (II) and 403(f) of 

the FD&C Act. Sections 

403(q)(5)(H)(ii)(I) and (II) of the FD&C 

Act require, in relevant part, that calorie 

declarations required on menus and 

menu boards be clear and conspicuous 

and clearly associated with the 

corresponding standard menu item. 

Further, section 403(f) of the FD&C Act 

provides that a food shall be deemed 

misbranded ‘‘if any word, statement, or 

other information required by or under 

authority of this Act to appear on the 

label or labeling is not prominently 

placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ The calorie 

declaration specified in 

§ 101.11(b)(2)(i)(A)(1) is tied to the name 

and price of the standard menu item, 

which typically are included on menus 

and menu boards and are two primary 

features of a menu or menu board 

typically used by consumers to make 

order selections. The type size 

requirements for calorie declarations 

balance the statutory requirements of 

sections 403(q)(5)(H)(ii)(I) and (II) and 

403(f) of the FD&C Act that calorie 

declarations be clear and conspicuous 

with the mandate in section 

403(q)(5)(H)(x)(II)(aa) of the FD&C Act to 

consider space on menus and menu 

boards and, thus, provide flexibility for 

different covered establishments. 

(Comment 73) A few comments 

discussed the proposed requirements (in 

proposed § 101.11(b)(2)(i)(A)(1)) for the 

color and contrasting background of the 

calorie declaration. Some comments 

suggested changes to the proposed 

requirements for color and contrasting 

background. One comment emphasized 

that some menus and menu boards may 

have different contrasting background 

colors and provided two suggestions to 

accommodate such menus and menu 

boards. One suggestion was that we 

require that the calorie declaration have 

the same contrasting background, or a 

background at least as contrasting as the 

background used for the name of the 

associated standard menu item on the 

menu or menu board. As an alternative, 

the comment suggested that we could 

require that the calorie declaration have 

a background at least as contrasting as 

that used for the price and that menus 

using the same contrasting background 

as the price of the standard menu item 

will be presumed to comply. 

One comment asserted that the color 

and contrast requirements are too 

restrictive and maintained that many 

menu boards have a variety of colors to 

enhance customer experiences. One 

comment suggested that the color of the 

calorie declaration should not be fainter 

or less obvious than that of the other 

items on the menu. Another comment 

asked us to permit the calorie 

declaration to be in the same color as 

the subtext that lists ingredients. One 

comment that opposed the proposed 

requirement for color asserted that ‘‘the 

eye becomes overwhelmed’’ when all 

copy is the same size and color, and the 

consumer misses the information or 

gives up looking for the information. 

This comment requested flexibility in 

color and ‘‘weight of calorie 

information’’ (a term the comment did 

not define). This comment also asked us 

to clarify whether ‘‘type’’ is limited to 

font type (e.g., Arial) or whether it also 

includes text effects (e.g., bold, italics, 

color). 

One comment stated that the proposal 

was written with menu boards in mind 

and noted that some restaurants use 

translites (lighted boxes) where the 

name and price are in ‘‘oversized type’’ 

for marketing purposes. It asked us to 

permit the use of ‘‘reverse type’’ (which 

is white or light colored type printed on 

a dark background) and varied 

backgrounds if translites are used. 

(Response 73) We have revised the 

contrasting background portion of 

§ 101.11(b)(2)(i)(A)(1) to require that the 

number of calories be in the same 

contrasting background, or a 

background at least as contrasting as 

that used for the name of the associated 

standard menu item. We agree that this 

revision provides additional flexibility 

related to the prominence requirements 

to take into account that there may be 

different backgrounds on a single menu 

or menu board. 

We disagree that the color 

requirements of the calorie declarations 

should be revised. Section 

403(q)(5)(H)(ii) of the FD&C Act requires 

that the calories be disclosed in a clear 

and conspicuous manner and clearly 

associated with the standard menu item. 

Further, section 403(f) of the FD&C Act 

provides that a food shall be deemed 

misbranded ‘‘if any word, statement, or 

other information required by or under 

authority of this Act to appear on the 

label or labeling is not prominently 

placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ Requiring the 

calorie declaration to be in the same 

color, or in a color at least as 

conspicuous as the color of the name of 

the associated standard menu item 

helps ensure that the calorie 

declarations are clear and conspicuous, 

prominently placed on the menu or 

menu board with such conspicuousness 

as compared to other words on the 

menu or menu board and likely to be 

read and understood by the ordinary 

individual under customary conditions 

of purchase and use, and clearly 

associated with the standard menu item. 

However, to match the grammatical 

construction of the revised requirement 

for the contrasting background used for 

the calorie declaration, we are making a 

conforming editorial change to require 

that the color used for the calorie 

declaration be in the same color, or a 

color at least as conspicuous as that 

used for the name of the associated 

standard menu item (emphasis added). 

In addition, we are not requiring 

calorie declarations to be in a specific 

font or to include particular text effects 

because we recognize that menus and 

menu boards come in a variety of sizes 

and include different fonts and type 

sizes. We are providing flexibility by 

taking into consideration the space on 

menus and menu boards (see section 

403(q)(5)(H)(x)(II)(aa) of the FD&C Act), 

along with the fonts and type sizes 

already in use by the covered 

establishments, while also establishing 

requirements that help ensure calorie 

declarations are disclosed in a manner 

that is clear and conspicuous and that 

otherwise satisfies the requirements of 

applicable sections of the FD&C Act. 

We would not object to reverse type 

and varied backgrounds on translites, 

provided that the calorie declarations 

are clear and conspicuous and satisfy 

the requirements of applicable sections 

of the FD&C Act and § 101.11. Calorie 

declarations on translites would be 

subject to the same general requirements 

as disclosures on other types of menu 

boards, as specified in 

§ 101.11(b)(2)(i)(A). 


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(Comment 74) Some comments asked 

us to require a comma for declaring 

more than 1,000 calories because 

consumers are accustomed to seeing a 

comma in numbers of one thousand or 

greater. The comments suggested that 

we revise proposed § 101.11(b)(2)(i)(A) 

to include a new subparagraph to state 

‘‘(4) Calorie numbers over 1,000 must 

include a comma after the thousands 

place.’’ 

(Response 74) We would not object to 

the voluntary use of a comma for calorie 

declarations of 1,000 or more, but 

decline to revise the rule to require a 

comma. The requirements we have 

established in § 101.11(b)(2)(i)(A) 

adequately ensure that calorie 

declarations are disclosed in a clear and 

conspicuous manner, as required by 

section 403(q)(5)(H) of the FD&C Act, 

and render the calorie declarations 

likely to be read and understood by the 

ordinary individual under customary 

conditions of purchase and use, as 

required by section 403(f) of the FD&C 

Act. A covered establishment may 

choose to declare numbers over 1,000 

with or without a comma. 

(Comment 75) One comment 

suggested that we accommodate visionimpaired consumers by providing for 

alternate menus and availability of other 

nutrition information. This comment 

asserted that vision-impaired consumers 

suffer more from hypertension, heart 

problems, and diabetes. 

(Response 75) We recognize that 

vision-impaired consumers should have 

access to nutrition information for 

standard menu items in covered 

establishments. However, we are only 

implementing the nutrition labeling 

requirements specified in section 

403(q)(5)(H) of the FD&C Act, at this 

time. Covered establishments may 

voluntarily provide visually impaired 

individuals with nutrition information 

for standard menu items in a way that 

is accessible to them. For example, we 

would not object to a covered 

establishment providing nutrition 

information for standard menu items 

through a Braille menu or a menu that 

gives information about menu items 

orally, in addition to providing nutrition 

information in accordance with 

§ 101.11. 

XII. Additional Format Requirements 

That Apply When Declaring Calories on 

Menus and Menu Boards for Variable 

Menu Items, Combination Meals, and 

Toppings (Final § 101.11(b)(2)(i)(A)(4) 

Through (b)(2)(i)(A)(8)) 

A. Proposed Format for Declaring 

Calories for Variable Menu Items 

Section 403(q)(5)(H)(v) of the FD&C 

Act requires FDA to establish by 

regulation standards for determining 

and disclosing the nutrient content for 

variable standard menu items that are 

listed as a single menu item ‘‘through 

means determined by the Secretary, 

including ranges, averages, or other 

methods.’’ (See the discussion of the 

definition of the term ‘‘variable menu 

item’’ in section VIII.D) In the proposed 

rule, we considered five options for 

implementing this statutory provision, 

and selected Option 2 (76 FR 19192 at 

19207–19209). Consistent with Option 

2, proposed § 101.11(b)(2)(i)(A)(4) 

would require, in relevant part, that for 

variable menu items, the calories must 

be declared as a range, in the format 

‘‘xx-yy’’ where ‘‘xx’’ is the caloric 

content of the lowest calorie variety, 

flavor, or combination, and ‘‘yy’’ is the 

caloric content of the highest calorie 

variety, flavor, or combination. The 

other options we considered were as 

follows: 

• Option 1. Single value; either in the 

form of an average (obtained by 

summing up the calorie content of all 

options and then dividing by the 

number of options) or a median of all 

options (obtained by determining the 

‘‘middle’’ number of calories from the 

list of options). 

• Option 3. Hybrid combining 

averages and ranges; declaration of a 

single average value for variable menu 

items whose calorie ranges fall within 

specified bounds and declaration of a 

range for variable menu items whose 

calorie ranges fall outside those bounds. 

• Option 4. If only 2 options are 

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

with fries or with fruit), provide both 

numbers with a forward slash between 

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

are available, provide the range in 

calories. 

• Option 5. If only 2 options are 

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

with fries or with fruit), provide both 

numbers with a forward slash between 

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

are available, use one of the hybrid 

approaches outlined in Option 3. 

We also proposed specific 

requirements that would apply when a 

variable menu item appears on the 

menu or menu board and is a selfservice food or food on display, and 

there is no clearly identifiable upper 

bound to the range, e.g., all-you-can-eat 

buffet. In the following paragraphs, we 

discuss comments on these proposed 

provisions. After considering these 

comments, we have revised the 

provisions to: 

• Require Option 4 instead of 

Option 2; 

• Specify additional format 

requirements that apply when declaring 

calories on menus and menu boards for 

variable menu items, combination 

meals, and toppings 

(§ 101.11(b)(2)(i)(A)(4) through 

(b)(2)(i)(A)(7)); and 

• Redesignate the requirements that 

apply to a variable menu item when 

there is no clearly identifiable upper 

bound to the range of calories to 

§ 101.11(b)(2)(i)(A)(8) and clarify that 

such item is otherwise exempt from the 

requirements of § 101.11(b)(2)(i)(A) for 

what must be provided on menus and 

menu boards. 

B. Decision To Require Option 4 

(Comment 76) Several comments 

supported our proposal to require 

Option 2 because they considered that 

ranges provide more detailed 

information. Several comments 

addressed one or more of the other four 

options we described. One comment 

stated that the use of ranges does not 

require customers to make calculations 

as would be the case for medians and 

means. This comment asserted that 

declaring calories in mixed options and 

hybrids would be confusing because 

consumers would need to understand 

why and when a single value (e.g., 

mean) is used rather than a range. One 

comment asserted that if single calorie 

values for each flavor and size were 

used rather than ranges, the menu board 

would be unreadable and consumers 

would be confused by too much 

information or would ignore the 

information. Another comment asserted 

that without a range, a single value 

calorie declaration for a variable menu 

item would be false. 

Other comments supported the use of 

hybrid approaches (such as in Options 

3 and 5) that would provide calorie 

information in both ranges and averages. 

One comment recommended that 

§ 101.11(b)(2)(i)(A)(4) be revised to 

include specific exceptions that would 

limit the use of ranges—i.e., (1) very low 

or no calorie beverages should be listed 

separately from other beverages; (2) the 

mean must be used for menu items that 

come in different flavors, varieties, or 

combination meals if all options are 

within 40 calories of each other and all 

of the options contain fewer than 400 

calories, or if all options are within 80 


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calories of each other and one or more 

options contain more than 400 calories; 

and (3) if there is a fixed or default 

option for a combination meal, calories 

should be posted for that option. This 

comment explained that it suggested the 

40-calorie range because 40 calories is 

used as the basis for low calorie claims, 

and that it suggested a cut-off of 400 

calories because 400 is 20 percent of a 

2,000 calorie diet and is high according 

to our labeling principles. 

One comment recommended that a 

covered establishment be able to declare 

one range for a variable menu item that 

comes in different sizes only if the 

difference between the upper and lower 

limits is less than 5 percent. This 

comment did not explain the basis for 

its recommendation to use 5 percent to 

limit the use of ranges. 

One comment stated a preference for 

Option 4, but also requested that we 

limit the use of calorie ranges, within 

the constraints of Option 4. This 

comment considered that ranges are not 

particularly useful to customers in 

putting their choices into context. 

Several other comments opposed 

Option 4 because they considered that 

it would be confusing. 

(Response 76) After considering all 

five options in light of the totality of the 

comments and the advantages and 

disadvantages of each option as 

described in the proposed rule (76 FR 

19192 at 19207 through 19209), we are 

requiring Option 4, rather than Option 

2, as the format for declaring calories for 

variable menu items on menus and 

menu boards. 

Option 4 is similar to proposed 

§ 101.11(b)(2)(i)(A)(4) in that it 

continues to provide for the declaration 

of calories using a range, which some 

comments supported. However, Option 

4 also provides for the use of a different 

communication tool—i.e., a slash (e.g., 

110/230)—that is more tailored to a 

situation in which there are only two 

options available for a variable menu 

item. Using a slash instead of a dash 

(e.g., 110–230) better reflects the fact 

that there are only two options for a 

variable menu item available (see the 

discussion in 76 FR 19192 at 19209), 

and more accurately informs consumers 

about the calories for each of the two 

options, whereas using a range 

represented by a dash is more 

appropriate when there are more than 

two options. As we discussed in the 

proposed rule, we recognize that in 

some instances, a calorie range may be 

so wide that a consumer may still need 

the calorie information for the particular 

menu item before he or she can make a 

fully informed purchase decision (76 FR 

19192 at 19209). For example, the 

potential calorie range for a variable 

menu item that is offered for sale with 

the option of adding toppings (e.g., 

pizza) may be very wide. We are 

establishing specific requirements for 

such variable menu items when the 

toppings are listed on a menu or menu 

board in § 101.11(b)(2)(i)(A)(5), in part 

to address the potentially large variation 

in calories and to provide more specific 

calorie information to consumers 

regarding their order selections. 

In general, however, we agree with 

the comments that use of a range is less 

confusing than hybrids and single 

values where consumers may not 

understand how a single value is 

derived if a median or mean is used. 

Requiring a range for variable menu 

items where three or more options are 

available gives consumers a consistent 

format across such variable menu items 

and may allow covered establishments 

to save some space on menus and menu 

boards. 

We disagree that we should limit the 

use of ranges to calorie declarations for 

variable menu items where the 

difference between the upper and lower 

limits is less than 5 percent. While this 

approach may provide for smaller range 

variations, such limitations likely would 

require additional calorie declarations 

on menus and menu boards and 

significant redesigns of menus and 

menu boards. Taking into consideration 

the space on menus and menu boards 

and the fact that calorie declarations for 

individual variable menu items will be 

included in the written nutrition 

information required under section 

403(q)(5)(H)(ii)(III) of the FD&C Act and 

§ 101.11(b)(2)(ii), we are not requiring 

limits on the use of ranges where the 

difference between the upper and lower 

limits is less than 5 percent, at this time. 

Further, the comment provided no basis 

to use 5 percent to limit the use of 

ranges. 

For these reasons, we have revised 

§ 101.11(b)(2)(i)(A)(4) to require Option 

4 for the declaration of calories on the 

menu or menu board for variable menu 

items. Requiring the declaration of 

calories of each option for a variable 

menu by using a slash where only two 

options are available will reduce or 

limit the number of times that calories 

are declared as a range, as requested by 

some comments, while also providing 

specific calorie information about each 

option. If there are three or more options 

available, the calories must be provided 

in a range in the format ‘‘xx–yy,’’ where 

‘‘xx’’ is the caloric content of the lowest 

calorie variety, flavor, or combination, 

and ‘‘yy’’ is the caloric content of the 

highest calorie variety, flavor, or 

combination. The use of a slash to 

declare calories for each option for a 

variable menu item where only two 

options are available and the use of a 

range where three or more options are 

available satisfy the requirements of 

section 403(q)(5)(H)(v) of the FD&C Act. 

We have revised 

§ 101.11(b)(2)(i)(A)(4) to specify, in 

subparagraphs (b)(2)(i)(A)(4) through 

(b)(2)(i)(A)(7): 

• Specific requirements that apply to 

individual variable menu items 

(§ 101.11(b)(2)(i)(A)(4)); 

• Specific requirements that apply to 

a variable menu item that is offered for 

sale with the option of adding toppings 

listed on the menu or menu board 

(§ 101.11(b)(2)(i)(A)(5)); 

• Specific requirements that apply to 

a combination meal 

(§ 101.11(b)(2)(i)(A)(6)); and 

• Specific format requirements for 

declaring calories for an individual 

variable menu item, a combination 

meal, and toppings as a range, if 

applicable (§ 101.11(b)(2)(i)(A)(7)). 

We discuss these specific 

requirements in sections XII.C through 

XII.F. 

We note that variable menu items that 

are self-service food or food on display 

are subject to the calorie declaration 

requirements, in § 101.11(b)(2)(iii), for 

food that is self-service or on display, as 

discussed in section XVII.B. 

C. Requirements That Apply to 

Individual Variable Menu Items (Final 

§ 101.11(b)(2)(i)(A)(4)) 

(Comment 77) One comment stated 

that the proposed rule suggests that a 

calorie range is only appropriate when 

a general term such as ‘‘soda’’ is used 

for a set of beverages, but not when 

specific flavors or brands are also 

named. The comment considered that 

the proposed rule therefore would 

require a calorie declaration for each 

specific size or each specific brand of a 

beverage listed on the menu. The 

comment referred to a discussion in the 

proposed rule (76 FR 19192 at 19216) 

where we compared individually listed 

beverages to individually listed flavors 

of ice cream and indicated that calorie 

declarations must be provided on 

menus and menu boards for the 

individually listed flavors. The 

comment contended that there is not 

enough space to list the calorie content 

for each size of each beverage offered for 

sale in the required type size. The 

comment also stated that this 

requirement will force covered 

establishments to refrain from listing the 

beverage options. 

(Response 77) We are establishing in 

§ 101.11(b)(2)(i)(A)(4)(i) through 

(b)(2)(i)(A)(4)(iii) requirements for 


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declaring calories on the menu or menu 

board for individual variable menu 

items. First, we are establishing in 

§ 101.11(b)(2)(i)(A)(4)(i) the principle, 

discussed in the proposed rule, that 

calorie declarations must be provided 

on menus and menu boards for the 

individually listed flavors (76 FR 19192 

at 19216). Section 403(q)(5)(H)(v) of the 

FD&C Act provides, in relevant part, 

that FDA shall establish by regulation 

standards for disclosing the nutrient 

content for standard menu items that 

come in different flavors, varieties, or 

combinations, but which are listed as a 

single menu item through means 

determined by FDA, including ranges, 

averages, or other methods. 

Accordingly, § 101.11(b)(2)(i)(A)(4)(i) 

specifies that when the menu or menu 

board lists flavors or varieties of an 

entire individual variable menu item 

(such as soft drinks, ice cream, 

doughnuts, dips, and chicken that can 

be grilled or fried), the calories must be 

declared separately on the menu or 

menu board for each listed flavor or 

variety. 

We acknowledge the comment’s 

concern about space on menus and 

menu boards. However, a covered 

establishment could group together 

varieties or flavors that have the same 

number of calories (after rounding in 

accordance with § 101.11(b)(2)(i)(A)(2)) 

and declare the calories for that group 

as a single calorie declaration, 

specifying that the calorie declaration 

represents the calorie amount for each 

individual flavor or variety (e.g., ‘‘Diet 

Lemon Lime or Diet Cola (0 cal); Cola 

or Lemon Lime (150 cal)’’). We have 

revised § 101.11(b)(2)(i)(A)(4)(i) to 

include this option for grouping flavors 

and varieties that have the same calorie 

amounts. We discuss in more detail the 

specific requirements for calorie 

declarations for self-service beverages in 

section XVII.E.3. 

Flavors or varieties of variable menu 

items such as soft drinks, ice cream, 

doughnuts, dips, and chicken are not 

always listed on the menu or menu 

board. When the menu or menu board 

does not list flavors or varieties for an 

entire individual variable menu item, 

and only includes a general description 

of the variable menu item (e.g. ‘‘soft 

drinks’’), § 101.11(b)(2)(i)(A)(4)(ii) 

specifies that the calories must be 

declared for each option with a slash 

between the two calorie declarations 

where only two options are available 

(e.g., ‘‘150/250 calories’’) or as a range 

in accordance with the requirements of 

§ 101.11(b)(2)(i)(A)(7) where more than 

two options are available (e.g., ‘‘100–250 

calories’’). As discussed in section XII.F, 

§ 101.11(b)(2)(i)(A)(7) specifies the 

format requirements for declaring 

calories as a range. 

Some menus or menu boards describe 

flavors or varieties for only part of an 

individual variable menu item (such as 

different types of cheese offered in a 

sandwich). To address these types of 

variable menu items, 

§ 101.11(b)(2)(i)(A)(4)(iii) specifies that 

when the menu or menu board 

describes flavors or varieties for only 

part of an individual variable menu item 

(such as different types of cheese offered 

in a grilled cheese sandwich (e.g., 

‘‘Grilled Cheese (Cheddar or Swiss)’’)), 

the calories must be declared for each 

option with a slash between the two 

calorie declarations where only two 

options are available (e.g., ‘‘450/500 

calories’’) or as a range in accordance 

with the requirements of 

§ 101.11(b)(2)(i)(A)(7) where more than 

two options are available (e.g., ‘‘450–550 

calories’’). 

D. Requirements That Apply to a 

Variable Menu Item That Is Offered for 

Sale With the Option of Adding 

Toppings Listed on the Menu or Menu 

Board (Final § 101.11(b)(2)(i)(A)(5)) 

(Comment 78) A few comments 

recommended that the calories either be 

declared as a range as proposed or be 

declared for the basic preparation of the 

item together with a separate calorie 

declaration for each topping. These 

comments supported separate calorie 

declarations for sauces and dressings 

served on the side. 

One comment appeared to believe 

that covered establishments must list a 

range providing calories for pizzas with 

no toppings and pizzas with everything 

on them. The comment asserted that 

this calorie range would be too wide 

and ‘‘useless.’’ The comment also 

asserted that measuring toppings is not 

an ‘‘exact science.’’ The comment 

recommended that calories be disclosed 

on menus and menu boards for the 

standard build pizzas but not for 

toppings, because the nutrient 

information for the toppings would be 

required in the written nutrition 

information. However, the comment 

suggested that a single calorie listing for 

all toppings as a range from lowest to 

highest would be appropriate if we 

require calorie disclosures for pizza 

toppings on menus and menu boards. 

One comment recommended that 

ranges not be the only option for pizza. 

The comment asserted that pizzas can 

have up to 34 million combinations 

with a range as wide as 1,610 calories. 

The entity submitting the comment said 

it had received complaints from 

consumers in one jurisdiction where 

calorie information for pizza is provided 

by a range and found that the customers 

questioned the usefulness of a wide 

range of calories for a whole pizza. This 

comment stated that some jurisdictions 

have attempted to address this problem 

by requiring that the covered 

establishments list calories per each 

component or topping. The comment 

asserted that listing calories for each 

component or topping would not be 

useful for pizza because each topping 

has a different portioning based on the 

size of the pizza and the total number 

of toppings on the pizza. The comment 

explained that the amount of an 

individual topping selection (e.g., 

pepperoni, sausage, mushrooms, green 

peppers) added to a pizza is reduced 

based on the total number of individual 

toppings selections ordered. For 

example, a one-topping medium pizza 

where ham is the topping may have 10 

grams of ham per slice (adding 10 

calories from the ham per slice) whereas 

a medium pizza with ham as a topping 

and three other toppings may have 6 

grams of ham per slice (adding 5 

calories from the ham per slice). 

Therefore, the comment contended that 

individual labeling of toppings would 

lead to large calorie ranges that would 

not be useful information for the 

consumer. This comment stated that 

under one State law, pizza is a custom 

order and nutrition information is not 

required for toppings. The comment 

maintained that the best way to make 

calorie declarations for pizza is to 

declare calorie information for the 

standard build and provide calorie 

information for other customizations in 

a brochure or an online calculator. 

One comment noted that, in the 

proposed rule, we discussed the 

possibility of listing calories for both the 

standard preparation of pizza and for 

each topping (76 FR 19192 at 19207) but 

did not codify this as we did for the 

written nutrition information. One 

comment asked us to clarify that 

calories should be listed for each 

separate pizza topping. Another 

comment recommended that calories for 

items such as pizzas and sundaes be 

posted for the standard preparation only 

if calories for each topping or option are 

also listed. 

(Response 78) In 

§ 101.11(b)(2)(i)(A)(5)(i) through 

(b)(2)(i)(A)(5)(iv), we are specifying 

format requirements that apply to a 

variable menu item that is offered for 

sale with the option of adding toppings 

listed on the menu or menu board. 

Doing so is consistent with section 

403(q)(5)(H)(v) of the FD&C Act, 

responds to the comments making 

specific suggestions for how to declare 

calories for toppings such as those used 


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on pizza and sundaes, and 

acknowledges some of the unique 

characteristics of such toppings (e.g., 

that the amount of each topping added 

to a menu item such as pizza may 

decrease with the total number of 

toppings ordered). 

As noted by the comments, the 

proposed rule acknowledged that some 

comments received in response to the 

2010 docket notice recommended that 

the calorie information for items such as 

pizza be displayed for the standard 

preparation of the item, with the 

standard preparation of the item clearly 

noted on the menu, menu board, or food 

tag or next to the food on display. The 

calorie content for each additional food 

component would then be displayed on 

the menu, menu board, food tag, or next 

to the food on display for each food 

component (76 FR 19192 at 19207). In 

light of these comments to the 2010 

docket notice and the comments 

received to the proposed rule, 

§ 101.11(b)(2)(i)(A)(5)(i) specifies that 

when the menu or menu board lists 

toppings that can be added to a menu 

item (such as pizza or ice cream), the 

calories must be declared for the basic 

preparation of the menu item as listed 

(e.g., ‘‘small pizza pie,’’ or ‘‘single scoop 

ice cream’’). Section 

101.11(b)(2)(i)(A)(5)(ii) specifies that the 

calories must be separately declared for 

each topping listed on the menu or 

menu board (e.g., pepperoni, sausage, 

green peppers, onions on pizza; fudge, 

almonds, sprinkles on ice cream), and 

the menu or menu board must specify 

that the calories are added to the 

calories contained in the basic 

preparation of the menu item. For 

example: 

ICE CREAM SCOOP: 300 CAL

Toppings Added cal 

Almonds ................................ 25 

Fudge .................................... 50 

Furthermore, a covered establishment 

could group toppings that have the same 

calorie amounts (after rounding in 

accordance with § 101.11(b)(2)(i)(A)(2)), 

and declare the calories for such 

toppings as a single calorie declaration 

adjacent to the toppings, specifying that 

the calorie declaration represents the 

calorie amount for each individual 

topping (e.g., ‘‘Red Peppers or sweet 

onions (adds 10 cal);’’ ‘‘Red peppers, 

sweet onions (adds 10 cal per 

topping)’’). We have revised 

§ 101.11(b)(2)(i)(A)(5)(ii) to include this 

option for grouping toppings that have 

the same calorie amounts. 

We note that if the general term, 

‘‘toppings’’ is used on a menu or menu 

board, but the individual toppings are 

not listed, then the format requirements 

of § 101.11(b)(2)(i)(A)(4)(ii) would apply 

(i.e., the calories must be declared for 

each option with a slash between the 

two calorie declarations where only two 

options are available (e.g., ‘‘150/250 

calories’’) or as a range where more than 

two options are available (e.g., ‘‘100–250 

calories’’). 

Foods such as pizza and ice cream are 

often offered for sale in different sizes 

(e.g., a small, medium, or large pizza 

pie, and ice cream dishes that contain 

one, two, or three scoops of ice cream). 

As mentioned by a comment, the 

amount of a topping added to a variable 

menu item may vary based on the size 

of the variable menu item ordered by a 

consumer. The calorie content of each 

topping will likely vary accordingly, 

depending on the size of the variable 

menu item ordered. To account for the 

potential variability in calorie content of 

each topping based on the size of the 

variable menu item ordered, 

§ 101.11(b)(2)(i)(A)(5)(iii) specifies that 

the calories for the basic preparation of 

the menu item must be declared for 

each size of the menu item, and the 

calories for each topping listed on the 

menu or menu board must either be 

declared separately for each size of the 

menu item, or declared using a slash 

between the two calorie declarations for 

each topping where only two sizes of 

the menu item are available (e.g., ‘‘adds 

150/250 cal’’) or as a range for each 

topping in accordance with the 

requirements of paragraph (b)(2)(i)(A)(7) 

of the rule where more than two sizes 

of the menu item are available (e.g., 

‘‘adds 100–250 cal’’). If a slash between 

two calorie declarations or a range of 

calorie declarations is used, the menu or 

menu board must indicate that the 

variation in calories for each topping 

arises from the size of the menu item to 

which the toppings are added. For 

example: 

PLAIN PIZZA PIE: SMALL (12′′) 500 CAL

* MEDIUM (14′′) 750 CAL * LARGE

(16′′) 1000 CAL

Toppings 

Added cal 

Small Med Large 

Pepperoni ... 200 300 400 

Sausage ...... 250 350 450 

Green Peppers ......... 15 20 25 

or 

PLAIN PIZZA PIE: SMALL (12′′) 500 CAL

* MEDIUM (14′′) 750 CAL * LARGE

(16′′) 1000 CAL

Toppings Added cal 

(S/M/L pie) 

Pepperoni ............................. 200–400 

Sausage ................................ 250–450 

Green Peppers ..................... 15–25 

In the proposed rule, we requested 

comment on complexities that may be 

raised by certain variable menu items, 

such as those offered for sale with the 

option of adding toppings (such as pizza 

or ice cream) (76 FR 19192 at 19209). As 

mentioned by the comments, the 

amount of a topping added to a variable 

menu item, and therefore the calorie 

content of each topping, may vary not 

only based on the size of the menu item, 

but also based on the total number of 

toppings ordered by a consumer. 

Specifically, the amount of each topping 

added to a variable menu item may 

decrease as the total number of toppings 

ordered by a consumer increases. 

Therefore, to address this complexity, 

we have established a specific calorie 

declaration requirement in 

§ 101.11(b)(2)(i)(A)(5)(iv) for variable 

menu items offered for sale with the 

option of adding toppings listed on the 

menu or menu board, where the amount 

of the topping included on the basic 

preparation of the menu item decreases 

based on the total number of toppings 

ordered (such as sometimes is the case 

with pizza toppings). In such situation, 

the calories for each topping listed on 

the menu or menu board must be 

declared as single values representing 

the calories for each topping when 

added to a one-topping menu item, and 

the menu or menu board must specify 

that the calorie declaration is for the 

topping when added to a one-topping 

menu item. The following table 

provides an example of calorie 

declarations that would satisfy the 

requirements of § 101.11(b)(2)(i)(A)(5)(i) 

through (iv): 

PLAIN PIZZA PIE: SMALL (12′′) 500 CAL

* MEDIUM (14′′) 750 CAL * LARGE

(16′′) 1000 CAL

Toppings 

Added cal 

(single topping 

S/M/L pie) 

Pepperoni ............................. 200–400 

Sausage ................................ 250–450 

Green peppers ...................... 15–25 

Structuring the requirement in this 

way helps ensure that consumers are 

given accurate and consistent 

information about the calories of each 


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topping that are added to the calories 

contained in the basic preparation of the 

menu item. We would not object if a 

covered establishment voluntarily 

includes a statement on the menu or 

menu board explaining how the calories 

per topping might fluctuate if ordering 

multiple toppings; for example, for a 

pizza pie, the statement might say, 

‘‘Calories per topping may decrease as 

the number of toppings per pizza 

increases.’’ 

In § 101.11(b)(2)(i)(A)(5)(i) through 

(b)(2)(i)(A)(5)(iv), we are establishing 

requirements for declaring calorie 

information for variable menu items 

with toppings listed on a menu or menu 

board, and specifying the format and 

manner of such declarations, as required 

by sections 403(q)(5)(H)(v) and 

(x)(II)(bb) of the FD&C Act. Because the 

requirements in § 101.11 

(b)(2)(i)(A)(5)(iii) and (b)(2)(i)(A)(5)(iv) 

address the potential variability in 

calorie content of each topping based on 

the size of the menu item, and the total 

number of toppings ordered, the 

required calorie declarations will 

provide accurate calorie information to 

consumers regarding the calorie content 

of each topping they order. In addition, 

the requirement in 

§ 101.11(b)(2)(i)(A)(5)(iii) for toppings 

added to menu items that come in 

different sizes provides covered 

establishments with flexibility to choose 

one of two options that best fits their 

establishments and menus and menu 

boards. Allowing covered 

establishments to use a range for each 

topping to represent the added calories 

across various sizes of the menu item 

may save some space on menus and 

menu boards while still providing the 

necessary calorie information for 

consumers to make informed dietary 

choices. 

We disagree that pizza with toppings 

generally would be a custom order for 

the purposes of this rule and that 

nutrition information is not required for 

such foods for a number of reasons. 

First, the requirements of section 

403(q)(5)(H) of the FD&C Act and this 

rule apply to standard menu items. This 

rule defines a standard menu item as 

restaurant-type food that is routinely 

included on a menu or menu board or 

routinely offered as a self-service food 

or food on display. To the extent a pizza 

with toppings meets the definition of a 

standard menu item, the requirements 

of section 403(q)(5)(H) of the FD&C Act 

and § 101.11(b) would apply to such 

pizza. 

Second, while section 

403(q)(5)(H)(vii) of the FD&C Act 

exempts from the nutrition labeling 

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

the FD&C Act items that are custom 

orders, a pizza with toppings that meets 

the definition of a standard menu item 

would not be a custom order within the 

meaning of § 101.11. Under the 

definition of ‘‘custom order’’ in 

§ 101.11(a), a custom order is a food 

order that is prepared in a specific 

manner based on an individual 

consumer’s request, which requires the 

covered establishment to deviate from 

its usual preparation of a menu item. 

For example, if a covered establishment 

offers a ‘‘Meat Lovers’’ pizza containing 

ground meat and sausage as a standard 

menu item, and a customer orders a 

‘‘Meat Lover’s’’ pizza without sausage, 

that order could be considered a custom 

order. In contrast, a pizza with toppings 

routinely listed on the menu or menu 

board of a covered establishment would 

meet the definition of a standard menu 

item, and toppings can be added to a 

pizza as part of the establishment’s 

usual preparation of the menu item. 

Third, pizza is explicitly identified in 

section 403(q)(5)(H)(v) of the FD&C Act 

as a variable menu item for which the 

nutrition information must be disclosed. 

If Congress had meant for pizza, 

including pizza with toppings, not to be 

covered by the requirements of section 

403(q)(5)(H) of the FD&C Act, it would 

not have had reason to specifically 

include pizza as an example of the foods 

described in section 403(q)(5)(H)(v) of 

the FD&C Act. 

We also disagree that calorie 

declarations for different toppings 

should not be required on menus or 

menu boards because these calorie 

declarations will be provided in the 

written nutrition information or can be 

provided in a brochure. When toppings 

are listed on a menu or menu board, 

consumers can use such information to 

make order selections. Accordingly, 

when toppings are listed on a menu or 

menu board, a covered establishment 

must declare calories for each topping 

on the menu or menu board in 

accordance with 

§ 101.11(b)(2)(i)(A)(5)(ii) through 

(b)(2)(i)(A)(5)(iv). Requiring calorie 

declarations for toppings when they are 

listed on the menu or menu board helps 

to inform consumers’ decisions by 

providing the calorie content of menu 

items before consumers make their 

order selections. Further, providing 

such information will enable consumers 

to make informed and healthful dietary 

choices. 

E. Requirements That Apply to a 

Combination Meal (Final 

§ 101.11(b)(2)(i)(A)(6)) 

(Comment 79) Some comments 

recommended that, when practicable, 

calorie amounts for all components of a 

variable menu item that is a 

combination meal be listed on the menu 

or menu board. One comment provided 

an example of a variable menu item for 

a pancake combination meal with a 

choice of bacon strips or pork sausages 

to accompany pancakes, eggs, and hash 

browns. In the comment’s example, the 

calories for the two options ranged from 

1,200 to 1,420 calories, and the 

comment stated that the covered 

establishment could list the calories as 

‘‘Two pancakes (600 calories) served 

with two eggs (200 calories), hash 

browns (300 calories) and your choice of 

2 bacon strips (100 calories) or 2 pork 

sausages (320 calories).’’ 

A few comments acknowledged that 

ranges are a better mechanism for 

presenting calorie information about 

variable menu items that are 

combination meals than are medians or 

means, but also pointed out that ranges 

have a disadvantage in that they do not 

sufficiently convey the necessary 

information to the consumer. One 

comment maintained that its consumer 

research shows that calorie ranges are 

confusing and not informative for 

variable menu items. Another comment 

recommended that if calorie ranges are 

used, the calories for the menu options 

that are included in that range must be 

disclosed, either on the menu, through 

signs for foods on display, or through 

the device used to provide the other 

written nutrition information required 

in section 403(q)(5)(H)(ii)(III) of the 

FD&C Act. 

Another comment provided sample 

menu boards that offered for sale menu 

items in a meal described as ‘‘You Pick 

2’’ (YP2), such as a meal consisting of 

a half sandwich and a half salad. For 

each menu item, the sample menu 

boards declared the number of calories 

in the menu item when ordered by a 

consumer individually and when 

ordered as one of the components of the 

‘‘You Pick 2’’ meal, if available as a 

‘‘You Pick 2’’ component (e.g., ‘‘Chicken 

Caesar Salad, YP2 360, Whole 720’’). 

The comment asserted that declaring 

calories for each menu item 

individually, rather than declaring the 

calories for all possible combinations of 

its ‘‘You Pick 2’’ menu items in a range, 

was the best way to ensure that 

consumers have the necessary 

information to make choices about their 

calorie consumption. 

(Response 79) We disagree that we 

should require calories to be listed on a 

menu or menu board for each 

component of a variable menu item that 

is a combination meal. In many cases, 

one or more components of a variable 

menu item (such as the pancakes, eggs, 


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hash browns, bacon, and pork sausages 

in the comment’s example) are also 

included on a menu or menu board as 

standard menu items, and the calories 

for such components would already be 

on the menu or menu board when this 

is the case. However, we would not 

object if a covered establishment 

voluntarily lists the calories for each 

component of a variable menu item that 

is a combination meal, provided that the 

covered establishment also complies 

with the format requirements for 

declaring calories for variable menu 

items on menus and menu boards in 

§ 101.11(b)(2)(i)(A)(4) through 

(b)(2)(i)(A)(7). 

Section 403(q)(5)(H)(v) of the FD&C 

Act provides, in relevant part, that FDA 

shall establish standards for disclosing 

the nutrient content for standard menu 

items that come in different flavors, 

varieties, or combinations, but which 

are listed as a single menu item through 

means determined by FDA, including 

ranges, averages, or other methods. 

Accordingly, § 101.11(b)(2)(i)(A)(6)(i) 

through (b)(2)(i)(A)(6)(iii) require calorie 

declarations for combination meals. 

Consistent with our selection of Option 

4 for declaring calories for variable 

menu items generally (see discussion in 

section XII.B), § 101.11(b)(2)(i)(A)(6)(i) 

specifies that when the menu or menu 

board lists two options for menu items 

in a combination meal (e.g., a sandwich 

with a side salad or chips), the calories 

must be declared for each option with 

a slash between the two calorie 

declarations (e.g., ‘‘350/450 calories’’). 

Section 101.11(b)(2)(i)(A)(6)(ii) specifies 

that when the menu or menu board lists 

three or more options for menu items in 

a combination meal (e.g., a sandwich 

with chips, a side salad, or fruit), the 

calories must be declared as a range in 

accordance with the requirements of 

§ 101.11(b)(2)(i)(A)(7) (e.g., ‘‘350–500 

calories’’). 

As such, the requirements for calorie 

declarations for combinations meals in 

§ 101.11(b)(2)(i)(A)(6)(i) through 

(b)(2)(i)(A)(6)(iii) are consistent with the 

view of comments asserting that ranges 

are a better mechanism for presenting 

calorie information than are medians or 

means. The requirements in 

§ 101.11(b)(2)(i)(A)(6)(i) 

through(b)(2)(i)(A)(6)(iii) also address 

the concerns of other comments that 

ranges do not sufficiently convey the 

necessary information to the consumer 

by limiting the use of a range to 

combination meals with three or more 

options, and providing specific calorie 

information about each option of a 

combination meal where only two 

options are available. In addition, we 

find that the small sample size (n = 127) 

of the consumer research submitted 

with one comment limits it as support 

for the comment’s assertion that calorie 

ranges are confusing and not 

informative for variable menu items 

(Ref. 33). Further, although this small 

study suggests possible consumer 

preference among different declaration 

formats, it does not provide evidence 

about how consumers understand and 

use the formats (Ref. 33). 

Immediately following, in Response 

80, we discuss the third provision we 

are establishing in § 101.11(b)(2)(i)(A)(6) 

regarding the format of declaring 

calories on the menu or menu board for 

combination meals—i.e., for ‘‘upsize’’ 

and ‘‘downsize’’ options for 

combination meals. 

Regarding the ‘‘You Pick 2’’ meal 

described by one comment, we note that 

the sample menu board provided by the 

comment had a separate section 

describing an opportunity for a 

consumer to combine standard menu 

items for a special price, such as by 

combining any half sandwich with any 

half salad. The comment’s sample menu 

board declared the number of calories 

for each standard menu item available 

for consumers to combine for a special 

price (e.g., ‘‘Chicken Caesar Salad, YP2 

360, Whole 720’’). Generally, the 

calories for a combination meal must be 

declared as a range in accordance with 

§ 101.11(b)(2)(i)(A)(7) as required by 

§ 101.11(b)(2)(i)(A)(6)(ii) if the menu or 

menu board lists three or more options 

for the menu items in the combination 

meal. However, in the sample menu 

boards provided by the comment, the 

section describing an opportunity for a 

consumer to combine standard menu 

items merely informed consumers of a 

special price when standard menu items 

separately listed on the menu board, 

each with declared calories, are 

combined in a ‘‘mix and match’’ 

situation. In this type of ‘‘mix and 

match’’ situation, as displayed in the 

sample menu board provided by the 

comment, a consumer would have the 

calorie information for each standard 

menu item available for the consumer to 

combine before he or she selects one or 

more standard menu items. Because the 

covered establishment would be 

providing calorie declarations for each 

standard menu item available for the 

consumer to combine on the menu or 

menu board that would be visible to 

consumers when making order 

selections, and taking into consideration 

space on menus and menu boards, we 

agree with the comment that requiring 

the disclosure of additional calorie 

ranges in such a situation, particularly 

where there are a large number of 

combinations available, likely would 

not be necessary. For these reasons, in 

this type of ‘‘mix and match’’ situation, 

where the menu or menu board 

describes an opportunity for a consumer 

to combine standard menu items for a 

special price (e.g., ‘‘Combine Any 

Sandwich with Any Soup or Any Salad 

for $8.99’’), and the calories for each 

standard menu item, including each size 

option as described in 

§ 101.11(b)(2)(i)(A)(6)(iii) if applicable, 

available for the consumer to combine 

are declared elsewhere on the menu or 

menu board, we would not require a 

covered establishment to also declare 

the calories for the combination in a 

range. To make this clear, 

§ 101.11(b)(2)(i)(A)(6)(iv) of the final 

rule specifies that where the menu or 

menu board describes an opportunity 

for a consumer to combine standard 

menu items for a special price (e.g., 

‘‘Combine Any Sandwich with Any 

Soup or Any Salad for $8.99’’), and the 

calories for each standard menu item, 

including each size option as described 

in § 101.11(b)(2)(i)(A)(6)(iii) if 

applicable, available for the consumer to 

combine are declared elsewhere on the 

menu or menu board, the requirements 

of § 101.11(b)(2)(i)(A)(6)(i), (ii), and 

(b)(2)(i)(A)(6)(iii) do not apply. 

In establishing 

§ 101.11(b)(2)(i)(A)(6)(iv), we have 

considered space on menus and menu 

boards and how to minimize the burden 

on covered establishments to comply 

with this rule while ensuring that the 

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

the FD&C Act and other applicable 

sections of the FD&C Act are satisfied 

and nutrition information for standard 

menu items is made available to 

consumers in a direct and accessible 

manner. Further, our approach to this 

‘‘mix and match’’ situation is similar to 

our approach to a situation where a 

covered establishment includes 

packaged food (such as chips) as part of 

a combination meal. As discussed later 

in this document (see section XVII.H), a 

packaged food that is a food on display 

that bears Nutrition Facts information, 

including the nutrition information 

specified in section 403(q)(5)(H)(ii)(III) 

of the FD&C Act and § 101.11(b)(2)(ii) 

satisfies the calorie disclosure 

requirement for self-service food or food 

on display in section 403(q)(5)(H)(iii) of 

the FD&C Act and § 101.11(b)(2)(iii), so 

long as a consumer is able to examine 

the calorie information on the label 

prior to purchase. 

(Comment 80) As another example of 

complexities that may be raised by 

certain variable menu items, we noted 

in the proposed rule that some menus 

with combination meals list an option to 

increase the size of components of those 


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meals for a discounted additional price 

(76 FR 19192 at 19209). ‘‘Add 25 cents 

to Upgrade to Large Fries & Large 

Drink’’ is an example of such an option. 

We stated that we were considering 

whether those listings should be labeled 

with the number or range of calories 

they add to the standard combination 

meal, and requested comment on this 

issue. 

Several comments responded to this 

request for comment. In general, these 

comments considered that calories 

should be declared for each size of a 

menu item (such as ‘‘upgrades’’ or 

‘‘upsized options’’ and ‘‘downsized 

options’’) offered on menus and menu 

boards. Some comments linked the 

requirement to declare calories for 

different sizes to different prices—e.g., 

by considering that calories must be 

declared for any size option that has a 

distinct price on the menu or menu 

board. Some comments addressed 

combination meals, including fixed 

combination meals and combination 

meals that are variable menu items and 

considered that calories should be 

declared for fixed or variable 

combination meals available in multiple 

sizes. 

(Response 80) We previously 

addressed comments directed to 

standard menu items other than variable 

menu items when the menu or menu 

board lists an option to change the size 

of the standard menu item (see 

Response 66). Here, we focus on calorie 

declarations for ‘‘upsized options’’ and 

‘‘downsized options’’ for combination 

meals that are variable menu items. 

Consistent with our selection of Option 

4 (see discussion in section XII.B), 

§ 101.11(b)(2)(i)(A)(6)(iii) specifies that 

when the menu or menu board includes 

a choice to increase or decrease the size 

of a combination meal, the calorie 

difference must be declared for the 

increased or decreased size with a slash 

between two calorie declarations (e.g., 

‘‘Adds 100/150 calories,’’ ‘‘Subtracts 

100/150 calories’’) if the menu or menu 

board lists two options for menu items 

in the combination meal, or as a range 

in accordance with the requirements of 

§ 101.11(b)(2)(i)(A)(7) (e.g., ‘‘Adds 100– 

250 calories,’’ ‘‘Subtracts 100–250 

calories’’) if the menu or menu board 

lists three or more options for menu 

items in the combination meal. 

For example, if a covered 

establishment offers for sale a 

combination meal that is a variable 

menu item consisting of a sandwich 

with fries or with onion rings, and the 

menu or menu board includes a choice 

to increase the size of the fries or the 

onion rings, the number of calories 

added by the larger size must be 

declared using a slash (e.g., ‘‘Adds 250/ 

300 calories’’) since there are only two 

options for menu items in the 

combination meal (e.g., fries or onion 

rings). 

As another example, if a covered 

establishment offers for sale a 

combination meal that is a variable 

menu item consisting of a sandwich 

with fries, onion rings, or tater tots, and 

the menu or menu board includes an 

option to increase the size of the fries, 

onion rings, or tater tots, the number of 

calories added by the larger size must be 

declared as a range in accordance with 

the requirements of 

§ 101.11(b)(2)(i)(A)(7) (e.g., ‘‘Adds 250– 

450 calories’’), because there are three 

options for menu items in the 

combination meal (e.g., fries, onion 

rings, or tater tots). 

(Comment 81) A few comments 

requested flexibility and recommended 

that the rule allow a covered 

establishment to choose the option for 

declaring calories for variable menu 

items that best fits its business and 

menu, and display calories for variable 

menu items in the best way, as 

determined by the establishment, that 

allows consumers to choose healthier 

options. One comment presented a 

series of specific recommendations for 

disclosing calories, including specific 

recommendations that did not fit 

squarely within any of the five options 

for disclosing calories for variable menu 

items discussed in the proposed rule. 

This comment recommended that 

calories for variable menu items be 

disclosed by (1) providing an average or 

range, for each size or price of the 

variable menu item accompanied by the 

term ‘‘Avg. Cal’’; (2) declaring calories 

for the flavors, components, or toppings 

that make up that variable menu item 

elsewhere on the primary writing; or (3) 

displaying the calorie amount for one 

preset ‘‘build’’ of the variable menu 

item. Under the comment’s third option, 

the ‘‘build’’ would be representative of 

a finished version of the typical order 

and could not be a rarely ordered base 

product to which additional fixings are 

added. The comment also recommended 

that a covered establishment declare the 

calories for the additional options 

available for the variable menu item in 

a separate writing (such as an electronic 

kiosk, a nutrition brochure, a menu 

addendum, a nutrition poster, or an 

online nutrition application) available 

before or at the point of sale. 

For combination meals that are fixed, 

this comment recommended that 

calories be disclosed by (1) providing 

total calories for the fixed combination 

meal or (2) providing calories for each 

item or component of the fixed 

combination meal elsewhere on the 

primary writing. For combination meals 

that contain variable menu items, the 

comment recommended that calories be 

disclosed by (1) providing calories as a 

range reflecting the lowest and highest 

total meal calorie content among the 

variations available; (2) providing a 

median or average accompanied by the 

term ‘‘Avg. Cal’’ if the calories for all 

variations within a variable combination 

meal are within 20 percent of the 

median calorie value; (3) providing 

calorie information for each item of the 

variable combination meal elsewhere on 

the primary writing; or (4) providing the 

calories for one specified variation of 

the variable combination meal. A 

covered establishment that elects to 

provide calories for one specified 

variation of the combination meal 

would identify the items in the variation 

specified, and disclose calories for the 

other variations of the variable 

combination meal in a separate writing 

available at the point of sale. 

(Response 81) We decline the requests 

of these comments to allow a covered 

establishment to determine the method 

for declaring calories for variable menu 

items based on factors determined by 

the establishment. While this rule 

provides flexibility where appropriate, 

taking into account different business 

practices, standard menu items, and 

menus and menu boards, it also 

provides for uniform nutrition labeling 

requirements to be applied in covered 

establishments. Such consistency was 

one of the primary purposes of section 

4205 of the ACA (see e.g., section 

4205(c)). Further, section 403(q)(5)(H)(v) 

of the FD&C Act specifically directs 

FDA to establish by regulation 

requirements for disclosing nutrition 

information for variable menu items 

through means determined by FDA. In 

addition, section 403(q)(5)(H)(x)(II)(bb) 

of the FD&C Act directs FDA to issue 

regulations specifying the format and 

manner of the nutrition information 

disclosure requirements of section 

403(q)(5)(H) of the FD&C Act. This rule 

establishes requirements for disclosing 

the nutrition information required 

under section 403(q)(5)(H) of the FD&C 

Act while also providing flexibility. For 

example, we are establishing specific 

format requirements for calorie 

declarations for individual variable 

menu items, toppings listed on a menu 

or menu board, and combination meals 

(§ 101.11(b)(2)(i)(A)(4) through 

(b)(2)(i)(A)(7)), and we also are 

providing an exemption from the 

requirements for calorie declarations for 

combination meals in 

§ 101.11(b)(2)(i)(A)(6)(i) through 


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(b)(2)(i)(A)(6)(iii) under the 

circumstances described in 

§ 101.11(b)(2)(i)(A)(6)(iv). In addition, 

§ 101.11(b)(2)(i)(A)(3) provides 

flexibility on where to place the term 

‘‘Calories’’ or ‘‘Cal’’ on a menu or menu 

board, and § 101.11(b)(2)(i)(A)(1) 

provides flexibility for the color and 

contrasting background of calorie 

declarations. The calorie declaration 

requirements for variable menu items in 

this rule help ensure that consumers get 

consistent information when ordering 

from different covered establishments 

and even when ordering within a single 

covered establishment. For example, the 

approach suggested by the comments 

could lead to an inconsistent 

presentation on the same menu or menu 

board within a single establishment if a 

covered establishment determined that 

one approach worked best for some of 

its menu items and another approach 

worked best for other menu items. 

(Comment 82) A few comments 

recommended that calories for 

combination meals be declared for the 

standard, ‘‘default,’’ or most popular 

build. As an example, one comment 

recommended that calories declared for 

a combination meal include the calories 

for fries if the meal is depicted on a 

menu board as including fries. As 

another example, the comment 

recommended that calories declared for 

a combination meal include the calories 

in a full-calorie drink if more than 50 

percent of a covered establishment’s 

combination meals are sold with a fullcalorie drink. One comment considered 

that the standard or default is the meal 

depicted that accounts for more than a 

majority (51 percent) of the sales for that 

meal. 

(Response 82) We disagree with the 

comments in part. A combination meal, 

including those described by the 

comments, could be listed on a menu or 

menu board as a variable menu item, 

meaning that it could be listed as a 

single menu item that comes in different 

flavors, varieties, or combinations. 

Where a combination meal is listed on 

a menu or menu board as a variable 

menu item, the meal would not have a 

typical ‘‘default build’’ because some 

components that make up the meal (e.g., 

hamburger, fries or onion rings, soft 

drink) come in different flavors, 

varieties, or combinations that 

consumers are able to select. Section 

403(q)(5)(H)(v) of the FD&C Act 

requires, in relevant part, that FDA 

establish by regulation standards for 

disclosing the nutrient content for 

variable menu items, through means 

determined by FDA, including ranges, 

averages, or other methods. 

Accordingly, we have established the 

requirements for calorie declarations for 

variable menu items that are 

combination meals in 

§ 101.11(b)(2)(i)(A)(6)(i) through 

(b)(2)(i)(A)(6)(iii). These calorie 

declaration requirements communicate 

the variability of calorie content in the 

combination meal to consumers by 

providing the calorie information for 

each option when there are only two 

options available or in a range when 

there are three or more options 

available. In contrast, the methods for 

declaring calories for combination meals 

that are variable menu items suggested 

by the comments would not inform 

consumers that the calorie content of 

their order selection may vary based on 

the options selected in the combination 

meal. 

Where a combination meal is not 

listed on a menu or menu board as a 

variable menu item, but is instead listed 

as a menu item that comes in only one 

flavor, variety, or combination, the 

combination meal would have a 

‘‘default build.’’ As with a combination 

meal that comes in different sizes, in 

this situation, § 101.11(b)(2)(i)(A) 

requires a covered establishment to 

provide the number of calories 

contained in the combination meal 

listed on the menu or menu board, as 

usually prepared and offered for sale. 

(See discussion about fixed combination 

meals offered for sale in different sizes 

in Response 66.) 

F. Format Requirements for Declaring 

Calories for an Individual Variable 

Menu Item, a Combination Meal, and 

Toppings as a Range, if Applicable 

(Final § 101.11(b)(2)(i)(A)(7)) 

As discussed previously in this 

document (see section XII.B), we are 

revising § 101.11(b)(2)(i)(A)(4) to require 

Option 4. One such revision 

(established in § 101.11(b)(2)(i)(A)(7)) 

specifies the format requirements that 

must be followed when declaring 

calories as a range. Under 

§ 101.11(b)(2)(i)(A)(7), calories that are 

declared as a range must be in the 

format ‘‘xx-yy,’’ where ‘‘xx’’ is the 

caloric content of the lowest calorie 

variety, flavor, or combination, and 

‘‘yy’’ is the caloric content of the highest 

calorie variety, flavor, or combination. 

We are establishing these specific 

format requirements as a separate 

subparagraph so that the rule does not 

need to include this format information 

each time the rule requires use of a 

range. 

G. Exception for a Variable Menu Item 

When There Is No Clearly Identifiable 

Upper Bound to the Range of Calories 

(Final § 101.11(b)(2)(i)(A)(8)) 

Proposed § 101.11(b)(2)(i)(A)(4) would 

require, in relevant part, that if a 

variable menu item appears on the 

menu or menu board and is a 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. 

Comments that addressed this 

proposed provision supported it. 

Therefore, we are finalizing it without 

change, except to: 

• Redesignate it as 

§ 101.11(b)(2)(i)(A)(8) and clarify that it 

is an ‘‘exception’’ to the requirements of 

§ 101.11(b)(2)(i)(A) for calorie 

declarations that must be provided on 

menus and menu boards; 

• Make a conforming change to 

§ 101.11(b)(2)(i)(A) to acknowledge the 

exception in § 101.11(b)(2)(i)(A)(8); 

• Provide the same flexibility for the 

contrasting background used for the 

statement referring customers to the 

self-service facility for calorie 

declarations as for the calorie 

declaration in § 101.11(b)(2)(i)(A)(1); 

• Make the same conforming editorial 

change to the requirement directed to 

the color of this statement as for the 

calorie declaration in 

§ 101.11(b)(2)(i)(A)(1); 

• Make an editorial correction for 

clarity to insert ‘‘the type size of’’ 

between ‘‘no smaller than’’ and ‘‘the 

name or price.’’ 

Characterizing the provisions of 

§ 101.11(b)(2)(i)(A)(8) as an ‘‘exception’’ 

will clarify that the requirements of 

§ 101.11(b)(2)(i)(A)(1) through 

(b)(2)(i)(A)(7) do not apply when a 

variable menu item appears on the 

menu or menu board and is a selfservice food or food on display, and 

there is no clearly identifiable upper 

bound to the range of calories. Providing 

the same flexibility for the contrasting 

background as for the contrasting 

backgrounds for calorie declarations in 

§ 101.11(b)(2)(i)(A)(1) will provide a 

consistent approach to background 

requirements on menus and menu 


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boards. Making the conforming editorial 

change to the requirement directed to 

the color will promote consistency in 

terminology in the rule. 

With these changes, 

§ 101.11(b)(2)(i)(A)(8) specifies that if a 

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, the menu or menu board must 

include a statement, adjacent to the 

name or price of the item, referring 

customers to the self-service facility for 

calorie information, e.g., ‘‘See buffet for 

calorie declarations.’’ This statement 

must appear in a type size no smaller 

than the type size of the name or price 

of the variable menu item, whichever is 

smaller, and in the same color or a color 

at least as conspicuous as that used for 

that name or price, with the same 

contrasting background or a background 

at least as contrasting as that used for 

that name or price. 

H. Declaring Calories Using Interactive 

Menus or New Technology 

(Comment 83) In the proposed rule, 

we recognized that the Internet may 

allow for the use of different methods 

for disclosing calories, such as by 

providing a calorie tracker in the 

ordering frame to tally calories as 

customers make order selections (76 FR 

19192 at 19209). We requested comment 

on whether different methods should be 

used for nutrient content declarations 

for interactive Internet menus in general 

(76 FR 19192 at 19209). One comment 

asked that we acknowledge the potential 

for advances in technology and establish 

a petition process to request alternative 

methods of nutrition information 

disclosure via technological 

innovations, e.g., via smart phone 

applications. The comment also asked 

us to establish a process to approve 

methods that reflect technological 

advances that we did not anticipate but 

that comply with the statute. 

(Response 83) We are not establishing 

a petition process to approve future 

methods for calorie declarations at this 

time. As suggested by the comment, we 

specifically acknowledged that potential 

technological advances may allow for 

the use of different methods in 

disclosing calories in covered 

establishments and requested comments 

on such methods. To the extent that the 

technological advances described by the 

comment provide methods for declaring 

calorie information in accordance with 

section 403(q)(5)(H) of the FD&C Act 

and § 101.11, such methods would be 

permissible. We will continue to 

consider whether specific advances in 

technology may result in alternative 

methods for nutrient content 

declarations under section 403(q)(5)(H) 

of the FD&C Act. 

Later in this document (see Comment 

113 and Response 113 in section XVI.E), 

we address a similar comment from the 

perspective of new technologies for 

providing written nutrition information. 

XIII. Additional Requirements That 

Apply to Beverages That Are Not SelfService or on Display (Final 

§ 101.11(b)(2)(i)(A)(9)) 

(Comment 84) One comment noted 

that the proposed rule did not address 

the issue of ice fill for the declaration of 

calories for beverages. The comment 

asked us to permit covered 

establishments to calculate calories 

based on their standard ice fill as long 

as the level of ice fill is disclosed to 

consumers. The comment recommended 

that we expressly permit, regardless of 

whether there is a standard ice fill, the 

following statement regarding ice fill: 

‘‘Calorie content may vary based on the 

amount of ice used.’’ 

(Response 84) For beverages that are 

standard menu items and are dispensed 

by an employee of a covered 

establishment (and, thus, are not selfservice), we acknowledge that some of 

the beverage would be displaced by any 

ice added by the covered establishment. 

In addition, the amount of beverage 

displaced may vary based on the 

amount and type of added ice (e.g., 

crushed, cubed, shaved). Whereas some 

covered establishments may dispense a 

standard beverage fill (i.e., a fixed 

amount that is less than the full volume 

of the cup per cup size), others may not. 

Likewise, whereas some covered 

establishments may have a standard ice 

fill (i.e., a fixed amount of ice per cup 

size), others may not. Accordingly, 

§ 101.11(b)(2)(i)(A)(9) of the final rule 

requires that, for beverages that are not 

self-service, calories must be declared 

based on the full volume of the cup 

served without ice, unless the covered 

establishment ordinarily dispenses and 

offers for sale a standard beverage fill 

(i.e., a fixed amount that is less than the 

full volume of the cup per cup size) or 

dispenses a standard ice fill (i.e., a fixed 

amount of ice per cup size). If the 

covered establishment usually prepares 

and offers for sale a beverage using a 

standard beverage fill or dispenses a 

standard ice fill, the covered 

establishment must declare calories 

based on such standard beverage fill or 

standard ice fill. Section 

101.11(b)(2)(i)(A)(9) of the final rule 

does not require a covered 

establishment to set a standard beverage 

fill or standard ice fill. Instead, 

§ 101.11(b)(2)(i)(A)(9) requires the 

covered establishment to disclose the 

number of calories contained in a 

beverage with a standard beverage fill or 

ice fill ‘‘as usually prepared and offered 

for sale,’’ as required by section 

403(q)(5)(H)(ii) of the FD&C Act. The 

rule also does not specify how a covered 

establishment should dispense a 

standard beverage fill or standard ice 

fill. A covered establishment may 

choose a method that is suited to its 

establishment—e.g., by using equipment 

that automatically dispenses a volume 

specified by the establishment, by using 

cups that have markings that enable an 

employee to manually add a certain 

volume of beverage or ice, or by using 

a particular ice scoop. 

Section 101.11(b)(2)(i)(A)(9) is 

consistent with section 403(q)(5)(H)(ii) 

of the FD&C Act, which requires 

covered establishments to declare on 

menus and menu boards the number of 

calories contained in standard menu 

items listed on such menus and menu 

boards, as usually prepared and offered 

for sale. In establishing 

§ 101.11(b)(2)(i)(A)(9), we considered 

among other things, reasonable 

variations in serving sizes used by 

covered establishments, and therefore 

are allowing covered establishments to 

disclose calories based on the full 

volume of the cup served without ice, 

unless the covered establishment 

ordinarily dispenses and offers for sale 

a standard beverage fill or dispenses a 

standard ice fill. We do not expect that 

a statement that the calorie content of 

the beverage may vary based on the 

amount of ice used, such as the one 

suggested by the comment, will be 

necessary in light of the requirements of 

§ 101.11(b)(2)(i)(A)(9). 

In section XVII.D, we discuss ice fill 

for self-service beverages. 

XIV. Comments and FDA Response on 

Proposed § 101.11(b)(2)(i)(B)—Succinct 

Statement That Must Be on Menus and 

Menu Boards To Provide Context About 

Calories in a Daily Diet 

A. The Proposed Requirements 

Proposed § 101.11(b)(2)(i)(B) would 

require the following statement 

designed to enable consumers to 

understand, in the context of a total 

daily diet, the significance of the calorie 

information provided on menus and 

menu boards: A 2,000 calorie daily diet 

is used as the basis for general nutrition 

advice; however, individual calorie 

needs may vary. 

In the proposed rule, we referred to 

the statement in this provision as the 

‘‘succinct statement’’ and discussed 

principles that should be met to help 


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ensure that the succinct statement is 

designed to enable consumers to 

understand, in the context of a total 

daily diet, the significance of the calorie 

information provided on menus and 

menu boards (76 FR 19192 at 19210). 

These principles are: 

• The succinct statement should be 

succinct; 

• The succinct statement should be in 

plain language that consumers can 

understand; 

• The total caloric value should be 

framed appropriately so that it is not 

viewed as a recommendation for daily 

intake for every consumer; 

• The succinct statement should give 

consumers a means to compare the 

calorie declaration for a menu item to 

total calories; and 

• The succinct statement should 

inform consumers that individual needs 

vary. 

In the following paragraphs, we 

discuss comments on this proposed 

provision. After considering these 

comments, we are: 

• Revising the succinct statement; 

and 

• Providing for an optional succinct 

statement (which this document refers 

to as the ‘‘children’s succinct 

statement’’) for use on menus and menu 

boards targeted to children as a 

substitute for, or in addition to, the 

succinct statement. 

B. Principles for Establishing the 

Succinct Statement 

(Comment 85) Several comments 

supported the principles we discussed 

in the proposed rule for establishing the 

succinct statement. 

(Response 85) We acknowledge these 

comments. 

C. Wording of the Succinct Statement 

(Comment 86) In the proposed rule, 

we signaled an intent to conduct 

consumer research to evaluate consumer 

response to the proposed succinct 

statement as well as to alternative 

succinct statements (which we 

discussed in the proposal) (76 FR 19192 

at 19210). One comment supported such 

research, but suggested that more 

research should be done to assess if 

there is a permanent behavioral change. 

(Response 86) Although the proposed 

rule contemplated consumer research to 

guide the design of the succinct 

statement, we are foregoing such 

research at this time in light of the 

number of comments providing useful 

insight regarding the proposed succinct 

statement, related principles, and 

whether we should provide a succinct 

statement for children. 

(Comment 87) Several comments 

supported the proposed wording of the 

succinct statement. Other comments 

opposed the proposed wording of the 

succinct statement. Some comments 

considered that the information that 

calorie needs vary should not be 

included because it is obvious, it will 

clutter menus and menu boards, and 

there is no such phrase on packaged 

food. Another comment expressed 

concern about the use of 2,000 calories 

in the succinct statement and 

recommended that the succinct 

statement be better phrased to 

emphasize ‘‘individual needs may 

vary,’’ e.g., by including information 

that many adults need fewer than 2,000 

calories. This comment opposed adding 

phrases about the amount of exercise 

needed to burn a particular number of 

calories. One comment asserted that the 

proposed succinct statement is not 

specific enough and recommended that 

it focus on suggested calorie intake 

rather than on a typical caloric intake. 

(Response 87) We are retaining the 

use of 2,000 calories as an appropriate 

reference value to include in the 

succinct statement. As discussed in the 

proposed rule, the Nutrition Facts on 

packaged foods uses 2,000 calories as a 

reference amount on which to base 

recommended intake for some nutrients 

for individuals 4 years of age and older, 

and the Nutrition Facts on packaged 

foods have been required for nearly 20 

years. Moreover, a 2,000-calorie 

reference value is close to the midpoint 

of the range of energy requirements for 

sedentary adults (76 FR 19192 at 19209). 

We also are retaining information that 

individual calorie needs may vary, 

albeit in shortened form (calorie needs 

vary). As discussed in the proposed rule 

and emphasized by the comments, 

although 2,000 calories is an 

appropriate reference value, not 

everyone should eat 2,000 calories per 

day (76 FR 19192 at 19210). As a result, 

a factor that FDA considered in 

establishing a succinct statement was 

whether the succinct statement should 

be framed appropriately so that it is not 

viewed as a recommendation for daily 

intake for every consumer because 

individual calorie needs vary. For these 

reasons, we conclude that the succinct 

statement should inform consumers that 

calorie needs vary. 

(Comment 88) Several comments 

suggested specific revisions to the 

succinct statement as follows: 

• ‘‘Most adults should eat less than 

2,000 calories a day, or less than 600 

calories per meal.’’ (A few comments 

cited New York State Department of 

Health focus groups that showed 

participants preferred per meal calorie 

messages over daily calorie messages. 

The comments stated that consumers 

could not calculate the distribution of a 

daily calorie budget between meals.) 

• ‘‘2,000 calories a day is an estimate 

of what adults need, but individual 

needs vary.’’ 

• ‘‘Consumption of 2,000 calories 

each day is used as the basis for general 

nutrition advice; however, individual 

daily calorie needs may be higher or 

lower.’’ 

• ‘‘The recommended caloric intake 

for a day varies from ____ to ____ for 

adolescents and adults, from ____ 

to ____ for school-age children, and 

from ____ to _____ for preschool 

children above age 2 years, although 

diets may vary.’’ 

• ‘‘2,000 calories a day is used for 

general nutrition advice, but calorie 

needs vary.’’ 

• ‘‘A 2,000 calorie daily diet is 

recommended for most adults; however, 

individual needs vary depending on 

age, gender, and physical activity.’’ 

• ‘‘To maintain a healthy diet, most 

adults need no more than 2,000 calories 

per day. Caloric needs for most children 

and less active adults range from 1,200 

to 1,600 calories.’’ One comment noted 

that this statement reflects a separate 

range for children and recommended 

that the statement with the range for 

children be on all menus, not only 

children’s menus. 

(Response 88) We have revised 

§ 101.11(b)(2)(i)(B) to require that the 

following succinct statement be posted 

on menus and menu boards: 2,000 

calories a day is used for general 

nutrition advice, but calorie needs vary. 

Most of the suggested alternatives were 

variations of the succinct statement we 

proposed. The alternative we selected 

captures the principles discussed in the 

proposed rule in a more concise fashion 

than the succinct statement that we 

proposed. 

We disagree that the succinct 

statement should include the amount of 

calories per meal because individuals 

can choose many different ways to 

distribute their caloric intake 

throughout the day, and simply dividing 

the total calories into three meals does 

not acknowledge this variation or give 

consumers flexibility to distribute their 

own caloric intake. In addition, section 

403(q)(5)(H) of the FD&C Act applies to 

standard menu items offered for sale in 

a variety of covered establishments, 

including establishments that do not 

serve foods that may constitute meals, 

such as chain ice cream shops and chain 

pretzel vendors. 

We disagree that the succinct 

statement required on the menu or 

menu board should include specific 

reference calorie intake values or ranges 

for different ages or should specify the 


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types of factors (such as age, gender, and 

physical activity) that impact the caloric 

needs of individuals. Such details are 

adequately captured by the phrase 

‘‘calorie needs vary’’ and would 

unnecessarily increase the wordiness of 

the statement (i.e., make it less 

‘‘succinct’’). Because the Nutrition Facts 

label on packaged foods has been 

required for nearly 20 years, and the 

Nutrition Facts uses 2,000 calories as a 

reference amount, consumers are 

already familiar with this single 

reference amount for daily calorie 

consumption for individuals 4 years of 

age and older. However, as discussed 

later in this document (see Comment 90 

and Response 90), we are providing for 

the optional use of a children’s succinct 

statement on a menu or menu board 

targeted to children as a substitute for, 

or in addition to, the succinct statement. 

(Comment 89) One comment noted 

that ‘‘a 2,000 calorie diet’’ may be 

misleading without the terms ‘‘daily’’ or 

‘‘per day.’’ The comment also 

recommended adding a message that 

calorie content alone is not the only 

nutritional factor to consider when 

choosing a diet for optimal health, 

because a focus on calories may 

incorrectly lead consumers to choose 

options that are nutrient poor instead of 

nutrient rich. 

(Response 89) We agree that the 

succinct statement should provide the 

context that 2,000 calories refers to a 

daily diet and the succinct statement we 

are establishing in the final rule 

provides this context by informing 

consumers that ‘‘2,000 calories a day is 

used for general nutrition advice.’’ 

However, we disagree that the succinct 

statement should state that calorie 

content alone is not the only nutritional 

factor to consider. Sections 

403(q)(5)(H)(ii)(I) and (II) of the FD&C 

Act specifically require a covered 

establishment to disclose the number of 

calories contained in standard menu 

items and post a ‘‘succinct statement 

concerning suggested daily caloric 

intake’’ on menus or menu boards. The 

succinct statement we are establishing 

in the final rule adequately enables 

consumers to understand, in the context 

of a total daily diet, the significance of 

the calorie information provided on the 

menu or menu board, as required by 

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

(II)(bb) of the FD&C Act. By allowing 

consumers to compare the caloric 

content of a standard menu item to the 

reference value of 2,000 calories a day, 

the succinct statement will enable 

consumers to make informed and 

healthful dietary choices and highlight 

the potential effects of additional calorie 

consumption throughout the day. 

Further, as required by sections 

403(q)(5)(H)(ii)(III) and (IV) of the FD&C 

Act, a covered establishment must also 

provide, in a written form and upon 

consumer request, additional nutrition 

information, and post on the menu or 

menu board a prominent, clear, and 

conspicuous statement regarding the 

availability of this additional nutrition 

information. Consumers therefore will 

have access to additional nutrition 

information and are notified of the 

availability of this information on the 

menu or menu board so that they are 

able to use the information to make 

informed and healthful dietary choices. 

D. Succinct Statement on Menus 

Targeted to Children 

(Comment 90) In the proposed rule, 

we requested comment on whether we 

should require a different succinct 

statement on menus that are targeted to 

children (76 FR 19192 at 19210). One 

comment opposed a separate succinct 

statement for children and a few 

comments recommended such a 

statement. One comment recommended 

a separate children’s succinct statement 

if there is a separate children’s menu. 

Another comment recommended a 

different succinct statement for 

children’s menus to inform consumers 

that calorie needs differ because of age, 

sex, or activity (the comment stated that 

calorie needs are about 1,000 to 1,400 

calories for 2- to 3-year old children, 

and can be up to 2,200 to 2,700 calories 

for 14- to 18-year old active boys). 

The comments suggested the 

following succinct statements for 

children: 

• ‘‘Most children 4 to 8 years old 

need 1,500 calories a day, or less than 

500 calories a meal.’’ 

• ‘‘The daily calorie requirement for 

children 4 to 8 years is about 1,500 

calories, though individual needs vary.’’ 

• ‘‘Calorie needs for young children 

range from 1,000 to 2,000 calories per 

day and vary based on age and physical 

activity levels.’’ 

• ‘‘Most children 4 to 8 years old 

need about 1,500 calories a day 

including snacks, or fewer than 500 

calories a meal.’’ 

One comment suggested that we 

conduct consumer research on the 

following succinct statements: 

• ‘‘Most children 4 to 8 years old 

need 1,500 calories a day, or less than 

500 calories a meal. Most children 2 to 

3 years old need 1,200 calories a day, or 

less than 400 calories a meal.’’ 

• ‘‘Children need smaller food 

portions than adults. Calorie needs vary 

by child. For information on healthy 

eating, go to www.choosemyplate.gov.’’ 

• ‘‘Children’s calorie needs vary by 

age and the individual child’s nutrition 

and health status. Please consult your 

child’s physician or health care 

professional.’’ 

(Response 90) We have revised 

§ 101.11(b)(2)(i)(B) to provide for the 

optional use of either of the following 

children’s succinct statements on menus 

and menu boards targeted to children as 

a substitute for, or in addition to, the 

succinct statement: 

• 1,200 to 1,400 calories a day is used 

for general nutrition advice for children 

ages 4 to 8 years, but calorie needs vary. 

• 1,200 to 1,400 calories a day is used 

for general nutrition advice for children 

ages 4 to 8 years and 1,400 to 2,000 

calories a day for children 9 to 13 years, 

but calorie needs vary. 

Under § 101.11(b)(2)(i)(B), a covered 

establishment may use one of these 

children’s succinct statements on a 

menu or menu board targeted to 

children (e.g., on a standalone 

children’s menu or menu board, or in 

the children’s section of a general menu 

or menu board) as a substitute for, or in 

addition to, the succinct statement 

required in § 101.11(b)(2)(i)(B). To 

ensure consistency, a covered 

establishment that includes a children’s 

succinct statement on a menu or menu 

board may only use the children’s 

succinct statements listed in 

§ 101.11(b)(2)(i)(B). If the covered 

establishment chooses not to use the 

children’s succinct statements listed in 

§ 101.11(b)(2)(i)(B), it must use the 

succinct statement required in 

§ 101.11(b)(2)(i)(B). 

We realize that many covered 

establishments offer food selections that 

may only be purchased for children 

under a certain age specified by the 

covered establishment (e.g., under 9 

years). Some of these children’s food 

selections are offered on separate 

children’s menus, while others are 

included on the general menu or menu 

board along with items for all 

consumers. We have concluded that 

covered establishments should have the 

option of providing a succinct statement 

more relevant to children on menus and 

menu boards that provide food 

selections targeted to children. 

Childhood obesity is an important 

public health concern, and a succinct 

statement specifically targeted to the 

calorie needs of children may enable 

parents and children to make informed 

dietary choices. 

We considered whether covered 

establishments should be required to 

provide both the 2,000-calorie succinct 

statement and an additional children’s 

succinct statement on menus and menu 

boards. Sections 403(q)(5)(H)(ii)(I)(bb) 


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and (II)(bb) of the FD&C Act require that 

covered establishments post on menus 

and menu boards ‘‘a succinct statement 

concerning suggested daily caloric 

intake . . . 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. (Emphasis 

added.) Therefore, it is reasonable to 

interpret these sections to only require 

one succinct statement on menus and 

menu boards, and we are providing for 

the optional use by a covered 

establishment of a children’s succinct 

statement on menus or menu boards 

targeted to children. Accordingly, the 

rule does not require that a covered 

establishment that includes a children’s 

succinct statement on a menu or menu 

board targeted to children also include 

the succinct statement required by 

§ 101.11(b)(2)(i)(B) on that menu or 

menu board. 

To develop the children’s succinct 

statement, we used the 2010 Dietary 

Guidelines as the reference for the 

estimated calorie needs of children (Ref. 

3). The 2010 Dietary Guidelines are 

based on the review of scientific 

evidence by a committee of scientific 

experts. The 2010 Dietary Guidelines 

provide information and advice for 

choosing a healthy eating pattern that 

focuses on nutrient-dense foods and 

beverages, and that contributes to 

achieving and maintaining a healthy 

weight. One goal of the 2010 Dietary 

Guidelines is to aid policymakers in 

designing and carrying out nutritionrelated programs. As such, the 2010 

Dietary Guidelines are well suited to 

serve as the reference for the estimated 

calorie needs of children for the purpose 

of this rule. 

As the comments noted, there is broad 

variability in the daily caloric needs of 

children, and this variability is captured 

in table 2–3 in the 2010 Dietary 

Guidelines. Table 2–3 reports the 

estimated calorie needs per day by age, 

gender, and physical activity level. The 

relevant data and information in table 

2–3, which we used to develop the 

children’s succinct statement, covers 

four age groups (ages 2 to 3 years, 4 to 

8 years, 9 to 13 years, and 14 to 18 

years) and three activity levels 

(sedentary, moderately active, and 

active). Male and female children are 

grouped together in the group aged 2 to 

3 years but reported separately in the 

groups aged 4 to 8 years, 9 to 13 years, 

and 14 to 18 years. Although most 

comments suggesting specific wording 

for the children’s succinct statement 

focused on the calorie needs of children 

ages 8 and younger, some covered 

establishments may offer food selections 

targeted to somewhat older children— 

e.g., for ‘‘kids under 12.’’ Therefore, we 

focused on estimated caloric needs for 

children aged 4 to 8 and children aged 

9 to 13. We did not focus on the 

estimated caloric needs for the youngest 

age group (aged 2 to 3 years) and the 

oldest age group (aged 14 to 18 years). 

Although one comment suggested that 

we include the youngest age group (aged 

2 to 3 years), we considered a number 

of factors and ultimately decided not to 

include the youngest age group (aged 2 

to 3 years) and the oldest age group 

(aged 14 to 18 years). First, we 

considered space on menus and menu 

boards, the types of standard menu 

items offered in covered establishments, 

and different practices among covered 

establishments. Second, we were 

concerned that a children’s succinct 

statement with four age groups would 

cross a reasonable threshold for one of 

the principles governing the succinct 

statement—i.e., that it be succinct. 

Third, we concluded that covered 

establishments might be deterred from 

voluntarily posting a children’s succinct 

statement on menus and menu boards if 

such statement was not succinct. 

Fourth, children’s menus are typically 

not targeted to the youngest and the 

oldest age groups. 

In developing the specific language of 

the two options for the children’s 

succinct statement, we considered the 

principles that apply to the succinct 

statement, the comments, data and 

information discussed in the proposed 

rule, and the wording established in 

§ 101.11(b)(2)(i)(B) for the succinct 

statement. As with the succinct 

statement, we concluded that the 

children’s succinct statement should be 

directed to an estimated daily caloric 

need rather than the amount of calories 

per meal. 

In contrast to the succinct statement, 

which uses a single reference value 

(2,000 calories) regardless of age group, 

we concluded that the children’s 

succinct statement needed to both 

reflect a range of calories and link that 

range of calories to a specific age group 

to adequately enable parents and 

possibly some children to understand 

the significance of the calorie 

information in the context of their total 

daily diet. We focused on estimated 

caloric needs for sedentary children and 

did not focus on additional calories 

consumed by active children. This is 

consistent with our approach to the 

succinct statement, where the 2,000 

calorie daily diet does not take into 

account additional calories consumed 

by persons such as athletes or persons 

with a regular fitness regime. As with 

the succinct statement, the children’s 

succinct statement addresses the 

differential caloric consumption 

associated with activity and other 

factors by informing consumers that 

‘‘calorie needs vary.’’ 

Table 2–3 in the 2010 Dietary 

Guidelines reports the same estimated 

daily caloric needs for sedentary males 

and females aged 4 to 8 years (i.e., 1,200 

to 1,400 calories) and, thus, we selected 

1,200 to 1,400 calories as the range to 

include for children aged 4 to 8 years in 

each of the two options listed in 

§ 101.11(b)(2)(i)(B) for the children’s 

succinct statements. Table 2–3 in the 

2010 Dietary Guidelines reports 

different estimated daily caloric needs 

for sedentary males aged 9 to 13 years 

(i.e., 1,600 to 2,000 calories) and 

sedentary females aged 9 to 13 years 

(i.e., 1,400 to 1,600 calories). For the 

option listed in § 101.11(b)(2)(i)(B) for a 

children’s succinct statement that 

includes the estimated caloric needs of 

children aged 9 to 13 years, we simply 

reported the range as the lowest 

estimated caloric needs for sedentary 

males and females aged 9 to 13 years 

(i.e., 1,400 calories for females) and the 

highest estimated caloric needs for 

sedentary males and females aged 9 to 

13 years (i.e., 2,000 calories for males). 

Thus, the listed option that includes the 

group aged 9 to 13 years reports the 

range of estimated caloric needs as 

1,400 to 2,000 calories. 

(Comment 91) One comment 

suggested that children’s menus may 

benefit from a traffic light concept (e.g., 

green, yellow, and red signage) that 

indicates which foods should be eaten 

more or less frequently. 

(Response 91) Section 403(q)(5)(H) of 

the FD&C Act generally requires covered 

establishments to provide calorie 

declarations for standard menu items on 

menus, menu boards, and signs adjacent 

to self-service food and food on display, 

and other nutrition information in a 

written form. Section 403(q)(5)(H) also 

requires covered establishments to post 

on menus and menu boards a succinct 

statement concerning daily caloric 

intake and a statement regarding the 

availability of the written nutrition 

information. FDA is establishing 

requirements to implement only what is 

specified in section 403(q)(5)(H) of the 

FD&C Act and information that is 

necessary for the efficient enforcement 

of such requirements. 

E. Requirements for the Succinct 

Statement To Be Prominent, Clear, and 

Conspicuous 

Proposed § 101.11(b)(i)(2)(B)(1) would 

require that the succinct statement be 

posted prominently and in a clear and 

conspicuous manner in a type size no 


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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. In the proposed rule, we 

recognized that some restaurants and 

similar retail food establishments may 

have menu boards that list very few 

items in very large font. We asked for 

comment on whether the succinct 

statement and statement of availability 

should be tied to the type size for some 

menus that have few items and that may 

be listed in large type size (76 FR 19192 

at 19211). 

In the following paragraphs, we 

discuss comments on this proposed 

provision. After considering these 

comments, we are: 

• Revising the proposed provision to 

provide additional flexibility for the 

contrasting background of the succinct 

statement; 

• Making a conforming editorial 

change to the requirement for the color 

used for the succinct statement for 

grammatical consistency; and 

• Making an editorial correction for 

clarity to insert ‘‘the type size of’’ 

between ‘‘no smaller than’’ and ‘‘the 

smallest calorie declaration.’’ 

(Comment 92) One comment 

suggested that the size of the succinct 

statement be ‘‘no smaller than the menu 

description or what any ordinary person 

can read without any trouble.’’ Due to 

space limitations on menus, this 

comment considered that the succinct 

statement should not be tied to the type 

size on menus that list relatively few 

items that are listed in very large type 

size. One comment asked us to permit 

a type size smaller than the smallest 

calorie declaration appearing on the 

menu or menu board due to the limited 

space on menu boards and the amount 

of text required to be included in the 

statement. Another comment 

maintained that the succinct statement 

takes up too much space and would 

force covered establishments to decrease 

the type size used for calories. A few 

comments suggested that we require the 

succinct statement to be no smaller than 

the type size most frequently used 

throughout the menu and in the same 

color and contrast, or in color and 

contrast at least as conspicuous and 

contrasting as the color and contrast 

most frequently used throughout the 

menu for the names of standard menu 

items. 

(Response 92) We agree, in part, and 

disagree, in part, with these comments. 

As a practical matter, the type size of 

the succinct statement would, as 

requested by the comments, likely be no 

smaller than the menu description or 

what any ordinary person can read 

without any trouble, because 

§ 101.11(b)(2)(i)(B)(1) requires that the 

type size for the succinct statement be 

no smaller than the smallest type size of 

any calorie declaration and, under 

§ 101.11(b)(2)(i)(A)(1), the type size of 

the calorie declaration would be in a 

type size no smaller than the type size 

of the name or the price of the 

associated standard menu item, 

whichever is smaller. Because 

consumers typically view the name and/ 

or price of a standard menu item to 

place an order, our decision to anchor 

the type size of the succinct statement 

to the type size of information already 

on the menu or menu board acts, in 

essence, as an objective and measurable 

performance standard and helps ensure, 

among other things, that the succinct 

statement will be clear and conspicuous 

to consumers and posted prominently, 

as required by sections 403(q)(5)(H)(ii) 

and 403(f) of the FD&C Act. 

We disagree that the type size, color, 

and contrast should be tied to the type 

size, color, and contrast most frequently 

used throughout the menu. Section 

101.11(b)(2)(i)(A)(1) provides flexibility 

for the type size, color, and contrasting 

background used for the calorie 

declaration (and, accordingly, 

§ 101.11(b)(2)(i)(B)(1) provides 

flexibility for the type size, color, and 

contrasting background used for the 

succinct statement), by anchoring these 

three parameters to the name or price of 

standard menu items. The suggestion in 

this comment would establish an 

additional burden for a covered 

establishment, particularly when a 

covered establishment has more than 

one menu or menu board, to determine 

the type size most frequently used. The 

comment provided no basis, such as 

apparent benefit for either the restaurant 

or the consumer, to justify this 

additional burden. 

However, we agree that we should 

provide additional flexibility for the 

contrasting background of the succinct 

statement by permitting the statement to 

be in a background at least as 

contrasting as that used for the calorie 

declarations. Consequently, we have 

revised § 101.11(b)(2)(i)(B)(1) to do so. 

We also are making a conforming 

editorial change to the grammatical 

construction of the requirement for the 

color used for the succinct statement to 

match the grammatical construction of 

the revised requirement for the 

contrasting background used for the 

succinct statement. With these changes, 

§ 101.11(b)(2)(i)(B)(1) requires that the 

succinct statement be posted 

prominently and in a clear and 

conspicuous manner in a type size no 

smaller than the smallest type size of 

any calorie declaration appearing on the 

same menu or menu board and in the 

same color or in a color at least as 

conspicuous as that used for the calorie 

declarations, and with the same 

contrasting background or a background 

at least as contrasting as that used for 

the calorie declarations (emphasis 

added). 

F. Placement of the Succinct Statement 

on Menus and Menu Boards 

For menus, proposed 

§ 101.11(b)(2)(i)(B)(2) would require that 

the succinct statement 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 

§ 101.11(b)(2)(i)(C), proposed 

§ 101.11(b)(2)(i)(B)(2) also would require 

that the succinct statement appear 

directly above the statement of 

availability required in 

§ 101.11(b)(2)(i)(C). For menu boards, 

proposed § 101.11(b)(2)(i)(B)(3) would 

require that the succinct statement 

appear on the bottom of the menu 

board, immediately above the statement 

of availability required in 

§ 101.11(b)(2)(i)(C). 

In the following paragraphs, we 

discuss comments on these proposed 

provisions. After considering these 

comments, we have revised the 

proposed provisions for placement of 

the succinct statement to provide 

additional flexibility for the succinct 

statement to appear immediately above, 

below, or beside the statement of 

availability of the written nutrition 

information. 

(Comment 93) Several comments 

agreed with the proposed placement 

requirements for the succinct statement. 

One comment recommended that 

covered establishments be permitted to 

put the succinct statement on a separate 

sign near the menu boards because of 

space constraints. 

(Response 93) We are not revising the 

rule to allow a covered establishment to 

post the succinct statement on a 

separate sign near a menu board as 

suggested by the comment. First, we are 

concerned that if a covered 

establishment were to post the succinct 

statement on a separate sign, the 

statement would not be posted 

prominently, and therefore, consumers 

would not be able to use the statement 

to understand, in the context of a total 

daily diet, the significance of the calorie 

information that is provided on the 

menu board. Second, this rule provides 

flexibility regarding posting calorie 

declarations and other information on 


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menus and menu boards, including 

flexibility regarding the size of the 

calorie declarations and placement of 

the statement of availability of 

additional written nutrition 

information, such that covered 

establishments have a number of ways 

to satisfy the requirements based on 

their menus and menu boards and 

business operations. Lastly, sections 

403(q)(5)(H)(ii)(I)(bb) and (II)(bb) of the 

FD&C Act require that covered 

establishments post the succinct 

statement on menus and menu boards 

prominently and in a clear and 

conspicuous manner. The comment’s 

request would be inconsistent with the 

express requirements of sections 

403(q)(5)(H)(ii)(I)(bb) and (II)(bb) of the 

FD&C Act. Later in this document, we 

discuss the requirements for placement 

of the succinct statement on small signs 

for self-service food and food on display 

that may meet the definition of a 

‘‘menu’’ or ‘‘menu board’’ in section 

403(q)(5)(H)(xi) of the FD&C Act, in that 

such signs are the primary writings of 

the establishment from which 

consumers make order selections (see 

the discussion of § 101.11(b)(2)(iii)(B) in 

section XVII.G). 

(Comment 94) A few comments 

expressed concern about the space that 

the succinct statement would take on 

menus and the proposed requirement 

that the statement appear on every page, 

in light of other statements on menus 

(such as the advisory statements in our 

Food Code, footnotes regarding daily 

availability of various menu items, and 

footnotes referencing ‘‘net weight before 

cooking’’). The comments asserted that 

menus would become cluttered. One 

comment asserted that the message we 

want to convey would ‘‘get lost in the 

noise at the bottom of each page.’’ The 

comments agreed that the succinct 

statement should appear at the bottom 

of menus and menu boards, but asked 

us to clarify that it would appear only 

once on each menu or menu board and 

not on each page or panel. The 

comments recommended that for 

menus, the succinct statement must 

appear either on the first or last page. 

One comment suggested that the 

succinct statement need only appear on 

one panel of the main menu board that 

is visible at all times to consumers. 

One comment asserted that because 

space is finite, adding the required 

succinct statement to multiple pages of 

a menu would lead to removal of 

‘‘optional information,’’ such as some 

menu offerings. This comment 

expressed concern that menu items, 

such as seafood dishes, will be dropped 

from menus to make room for this 

additional information to appear on 

each page of the menu. The comment 

noted that the 2010 Dietary Guidelines 

have outlined the importance of 

including seafood in a healthy diet, and 

that roughly 67 percent of the seafood 

consumed in the United States is 

consumed away from the home. 

(Response 94) We disagree that the 

succinct statement needs to appear only 

once on menus. In particular, we are 

concerned that for large multi-paged 

menus, consumers may not read the 

entire menu and instead may turn to a 

specific section of the menu (e.g., the 

section for burgers and sandwiches). 

Unless the succinct statement is on the 

page for that particular section, it is 

possible that consumers could miss the 

succinct statement and therefore be 

unable to use the statement ‘‘to 

understand, in the context of a daily 

diet, the significance of the caloric 

information that is provided on the 

menu,’’ as specified by section 

403(q)(5)(H)(I)(bb) of the FD&C Act. 

Therefore, in § 101.11(b)(2)(i)(B)(2), we 

are requiring the succinct statement to 

appear on the bottom of each page of the 

menu. 

However, we agree that the succinct 

statement needs to appear only once on 

a menu board, including a menu board 

consisting of more than one panel in 

one physical location (a multi-paneled 

menu board). For the purpose of this 

rule, we consider such a multi-paneled 

menu board to be a single menu board, 

provided that the entire multi-paneled 

menu board is visible to consumers 

when consumers are placing order 

selections for the standard menu items 

listed on such menu board. A multipaneled menu board is different from a 

menu with multiple pages because all 

panels are visible to consumers when 

they place an order, regardless of the 

specific panel containing the menu item 

the consumer selects. A succinct 

statement on a single panel of a multipaneled board is likely to be clear and 

conspicuous to the consumer and 

posted prominently, provided that the 

type size, color, and background of the 

succinct statement meet the applicable 

requirements in § 101.11(b)(2)(i)(B)(1) 

and the entire multi-paneled menu 

board is visible to consumers when 

consumers are placing order selections 

for the standard menu items listed on 

such menu board. 

Regarding one comment’s assertion 

that requiring the succinct statement to 

appear on each page of a menu could 

lead to the removal from a menu or 

menu board of information that a 

covered establishment views as 

optional, we note that a decision to 

remove ‘‘optional information’’ or to 

drop certain menu items from menus 

belongs to the covered establishment. 

The succinct statement is necessary on 

the bottom of each page of a menu that 

includes standard menu items and 

calorie information because the succinct 

statement is designed to enable 

consumers ‘‘to understand, in the 

context of a total daily diet, the 

significance of the caloric information 

that is provided on the menu,’’ as 

required by section 403(q)(5)(H)(I)(bb) of 

the FD&C Act. However, we have also 

considered the space on menus and 

therefore provided flexibility where 

appropriate. For example, in addressing 

comments on the statement of 

availability of written nutrition 

information, we concluded that this 

statement of availability need appear 

only once on a menu or menu board. In 

reaching that conclusion, we considered 

the goals of the succinct statement and 

the statement of availability, which are 

different (see the discussion of 

§ 101.11(b)(2)(i)(C) in section XV.C). 

(Comment 95) A few comments 

maintained that the proposed order of 

the succinct statement (i.e., in relation 

to the statement of availability of 

additional written nutrition 

information) limits flexibility. The 

comments asserted that both statements 

could be just as clear and conspicuous 

if they were placed in some other way. 

(Response 95) We agree with the 

comments, and are providing flexibility 

for the placement of the succinct 

statement in relation to the statement of 

availability of the written nutrition 

information. Consequently, we have 

revised § 101.11(b)(2)(i)(B)(2) and 

(b)(2)(i)(B)(3) to provide that on menu 

pages that also bear the statement of 

availability and on menu boards, the 

succinct statement must appear 

immediately above, below, or beside the 

statement of availability. In addition, as 

an editorial change for consistency 

throughout § 101.11, we have revised 

the cross-references within 

§ 101.11(b)(2)(i)(B)(2) and (b)(2)(i)(B)(3) 

referring to the statement of availability 

to read ‘‘the statement required by 

paragraph (b)(2)(i)(C) of this section’’ 

(i.e., § 101.11(b)(2)(i)(C)). With these 

changes, § 101.11(b)(2)(i)(B)(2) requires 

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 required by 

§ 101.11(b)(2)(i)(C), the succinct 

statement must appear immediately 

above, below, or beside the statement 

required by § 101.11(b)(2)(i)(C). In 

addition, with these changes 

§ 101.11(b)(2)(i)(B)(3) requires that for 

menu boards, the succinct statement 

must appear on the bottom of the menu 

board, immediately above, below, or 


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beside the statement required by 

§ 101.11(b)(2)(i)(C). 

XV. Comments and FDA Response on 

Proposed § 101.11(b)(2)(i)(C)— 

Statement That Must Be on Menus and 

Menu Boards About Availability of 

Written Nutrition Information 

A. Proposed Wording of the Statement 

of Availability 

Proposed § 101.11(b)(2)(i)(C) would 

require the following statement 

regarding the availability of the 

additional written nutrition information 

required in § 101.11(b)(3)(i) on all forms 

of the menu or menu board: Additional 

nutrition information available upon 

request. In a correction document, we 

corrected the regulatory designation of 

the requirement for the statement of 

availability to be § 101.11(b)(2)(ii) rather 

than § 101.11(b)(3)(i) (76 FR 30050 at 

30051). 

One comment supported the wording 

of the statement of availability and no 

comments opposed the wording. We are 

finalizing the proposed wording of the 

statement of availability without 

change. 

B. Requirements for the Statement of 

Availability To Be Prominent and 

Conspicuous 

Proposed § 101.11(b)(2)(i)(C)(1) would 

require that the statement of availability 

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. 

In the following paragraphs, we 

discuss comments on this proposed 

provision. After considering these 

comments, we are: 

• Revising the proposed provision to 

provide additional flexibility for the 

contrasting background used for the 

statement of availability; 

• Making a conforming editorial 

change to the requirement for the color 

used for the statement of availability for 

grammatical consistency; and 

• Making an editorial correction for 

clarity to insert ‘‘type size of any’’ 

between ‘‘no smaller than the smallest’’ 

and ‘‘calorie declaration.’’ 

(Comment 96) One comment 

recommended that the type size of the 

statement of availability ‘‘be no smaller 

than the menu description or what any 

ordinary person can read without any 

trouble.’’ Some comments 

recommended that we permit a smaller 

type size for the statement of 

availability. A few comments suggested 

that we require the statement of 

availability to be in a type size no 

smaller than the type size most 

frequently used throughout the menu. 

Some comments suggested that the 

statement of availability be in the same 

color or a color at least as conspicuous 

as the color most frequently used 

throughout the menu for the names of 

standard menu items and with the same 

contrasting background or a contrasting 

background at least as contrasting as the 

background most frequently used 

throughout the menu for the names of 

standard menu items. 

(Response 96) These comments on the 

proposed requirements for type size, 

color, and contrasting background of the 

statement of availability are analogous 

to certain comments on the proposed 

requirements for the succinct statement 

(see Comment 92), and our response to 

these comments is analogous to our 

response to Comment 92 (see Response 

92). Specifically, we disagree that a 

smaller type size should be used for the 

statement of availability for the reasons 

discussed in Response 92. We disagree 

that the type size, color, and contrasting 

background of the statement of 

availability should be tied to the type 

size, color, and contrasting background 

most frequently used throughout the 

menu for the names of standard menu 

items for the reasons discussed in 

Response 92. However, we agree that we 

should provide additional flexibility for 

the contrasting background of the 

statement of availability by permitting 

the statement to be in a background at 

least as contrasting as that used for the 

calorie declarations. Consequently, we 

have revised § 101.11(b)(2)(i)(C)(1) to do 

so. In addition, we are making a 

conforming editorial change to the 

grammatical construction of the 

requirement used for the color of the 

statement of availability to match the 

grammatical construction of the revised 

requirement for the contrasting 

background used for the statement of 

availability. We also are making an 

editorial correction for clarity to insert 

‘‘type size of any’’ between ‘‘no smaller 

than the smallest’’ and ‘‘calorie 

declaration.’’ With these changes, 

§ 101.11(b)(2)(i)(C)(1) requires that the 

statement of availability be posted 

prominently and in a clear and 

conspicuous manner in a type size no 

smaller than the smallest type size of 

any calorie declaration appearing on the 

same menu or menu board and in the 

same color or in a color at least as 

conspicuous as that used for the caloric 

declarations, and with the same 

contrasting background or a background 

at least as contrasting as that used for 

the caloric declarations. (Emphasis 

added.) We conclude that the type size, 

color, and contrasting background 

requirements for the statement of 

availability in § 101.11(b)(2)(i)(C)(1) will 

help ensure that the statement of 

availability is prominent, clear, and 

conspicuous, as required by sections 

403(q)(5)(H)(ii)(IV) and 403(f) of the 

FD&C Act. 

C. Placement of the Statement of 

Availability 

For menus, proposed 

§ 101.11(b)(2)(i)(C)(2) would require that 

the statement of availability appear on 

the bottom of the first page with menu 

items. For menus with more than two 

pages, it would also require that the 

statement of availability appear either at 

the bottom of every page with menu 

items (proposed 

§ 101.11(b)(2)(i)(C)(2)(i)), or 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 (proposed 

§ 101.11(b)(2)(i)(C)(2)(ii)). For menu 

boards, proposed § 101.11(b)(2)(i)(C)(3) 

would require that the statement of 

availability appear on the bottom of the 

menu board immediately above or 

below the succinct statement. In the 

following paragraphs, we discuss 

comments on these proposed 

provisions. After considering these 

comments, we are: 

• Revising proposed 

§ 101.11(b)(2)(i)(C)(2) to require that the 

statement of availability appear on the 

first page of a menu with menu items 

and to delete the proposed provisions 

that would have required the statement 

of availability, or a symbol referring to 

the statement of availability, on 

subsequent menu pages; 

• Revising both proposed 

§ 101.11(b)(2)(i)(C)(2) and (b)(2)(i)(C)(3) 

to provide that the statement of 

availability must appear immediately 

above, below, or beside the succinct 

statement; and 

• Making additional editorial changes 

for consistency. 

(Comment 97) Some comments 

supported the proposed requirements 

for placement of the statement of 

availability. A few comments disagreed 

with our proposal that a symbol (e.g., 

asterisk) can be used to refer to the 

statement of availability on the first 

page, if the statement does not appear 

on every page. These comments 

considered that requiring the placement 


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of asterisks on each subsequent page in 

reference to a disclosure on the first 

page with menu items would only 

confuse a reader who, upon seeing an 

asterisk, has been trained since 

elementary school to look for the 

associated footnote at the bottom of the 

page on which the asterisk appears. 

A few comments expressed concern 

about the space that the statement of 

availability would take in light of other 

statements on menus (such as consumer 

advisories), and recommended that the 

statement of availability appear only 

once on the menu, either on the first or 

last page. The comments agreed that the 

statement of availability should appear 

at the bottom of menus and menu 

boards, but recommended that we 

require that the statement appear only 

once on menus and menu boards, and 

not on each page or panel. One 

comment recommended that covered 

establishments be able to put the 

statement of availability on a separate 

sign near the menu boards. 

(Response 97) We are not revising the 

rule to allow a covered establishment to 

post the statement of availability on a 

separate sign near a menu board as 

suggested by the comment. This 

comment is analogous to a comment on 

the proposed requirements for the 

placement of the succinct statement (see 

Comment 93), and our response to this 

comment is analogous to our response 

to Comment 93 (see Response 93). 

Section 403(q)(5)(H)(ii)(IV) of the FD&C 

Act requires that covered establishments 

post a prominent, clear, and 

conspicuous statement of availability on 

menus and menu boards. The 

comment’s request is inconsistent with 

the express statutory direction. Later in 

this document, we discuss the 

requirements for placement of the 

statement of availability on small signs 

for self-service food and food on display 

that may meet the definition of a 

‘‘menu’’ or ‘‘menu board’’ in section 

403(q)(5)(H)(xi) of the FD&C Act, in that 

such signs are the primary writings of 

the establishment from which 

consumers make order selections (see 

the discussion of § 101.11(b)(2)(iii)(B) in 

section XVII.G). 

We agree that an asterisk referring to 

a statement on the first page of a menu 

may confuse consumers. We also agree 

that the statement of availability only 

needs to appear on one page of a menu. 

Unlike the succinct statement, which is 

designed to enable the public to 

understand the significance of the 

caloric information in the context of a 

total daily diet and is therefore needed 

on each page of a menu that includes 

standard menu items and calorie 

information, the statement of 

availability informs consumers that 

there is additional written nutrition 

information available on the premises of 

the covered establishment upon request. 

We believe that posting the statement of 

availability on one page of a menu will 

be adequate to achieve that goal. 

Consequently, we have revised 

§ 101.11(b)(2)(i)(C)(2) to require that the 

statement of availability appear on the 

first page of a menu with menu items 

and to delete the proposed provisions 

that would have required the statement 

of availability, or an asterisk referring to 

the statement of availability, on 

subsequent menu pages. 

(Comment 98) A few comments 

maintained that the proposed order of 

the statement of availability in relation 

to the succinct statement limits 

flexibility. The comments contended 

that both statements would be just as 

clear and conspicuous if they were to 

appear in some other position such as 

side by side or in some other place on 

the page. 

(Response 98) For menu boards, we 

note that there was an inconsistency in 

the proposed rule between the preamble 

and the codified regarding the proposed 

order of the statement of availability in 

relation to the succinct statement. 

According to the preamble, the 

statement of availability would have 

been required to appear immediately 

below the succinct statement (76 FR 

19192 at 19211), while in the codified 

text, proposed § 101.11(b)(2)(i)(C)(3) 

would require that the statement of 

availability appear on the bottom of the 

menu board immediately above or 

below the succinct statement. For both 

menus and menu boards, we agree with 

the comments and are providing 

additional flexibility for the placement 

of the statement of availability of the 

written nutrition information in relation 

to the succinct statement. We have 

revised proposed § 101.11(b)(2)(i)(C)(2) 

and (b)(2)(i)(C)(3) to provide that for 

menus and menu boards, the statement 

of availability must appear immediately 

above, below, or beside the succinct 

statement. For clarity and consistency, 

we are specifying the placement of the 

statement of availability in 

§ 101.11(b)(2)(i)(C)(2) in relation to the 

succinct statement even though 

proposed § 101.11(b)(2)(i)(C)(2) did not 

do so. 

XVI. Comments and FDA Response on 

Proposed § 101.11(b)(2)(ii)—Nutrition 

Information That Must Be Made 

Available in Written Form 

A. Required Nutrients 

Proposed § 101.11(b)(2)(ii) would 

require, in relevant part, that: 

• Certain nutrition information for a 

standard menu item be available in 

written form on the premises of the 

restaurant or similar retail food 

establishment and provided to the 

customer upon request; 

• The nutrition information be 

presented in the order listed and using 

the measurements listed, except as 

provided in § 101.11(b)(2)(ii)(B); 

• Rounding of these nutrients be in 

compliance with § 101.9(c); and 

• Covered establishments include the 

following nutrition information in the 

written form, as specified in 

§ 101.11(b)(2)(ii)(A)(1) through 

(b)(2)(ii)(A)(11): 

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) 

In the following paragraphs, we 

discuss comments on this proposed 

provision. After considering these 

comments, we have revised the 

provision to: 

• Replace the terms ‘‘total number of 

calories derived from any source’’ and 

‘‘total number of calories derived from 

the total fat’’ with the terms ‘‘total 

calories’’ and ‘‘calories from fat’’; 

• Provide that covered establishments 

may use the abbreviations allowed for 

Nutrition Facts for certain packaged 

foods in § 101.9(j)(13)(ii)(B); and 

• Clarify that the information must be 

provided on the premises of the 

‘‘covered establishment’’ rather than the 

‘‘restaurant or similar retail food 

establishment’’ (see the discussion in 

section VI.I). 

(Comment 99) One comment 

suggested that we come up with a 

standard list of abbreviations for the 

nutrients for consistency and consumer 

understanding. This comment pointed 

out that we proposed ‘‘Cal’’ as an 

abbreviation for calories but did not 

suggest abbreviations for the other 

nutrients. 

(Response 99) We agree with this 

comment. Providing abbreviations for 

the written nutrition information will 

improve the consistency of the written 

nutrition information provided by 

different covered establishments. 

Therefore, we have revised 

§ 101.11(b)(2)(ii) to provide that covered 

establishments may use the 

abbreviations allowed for Nutrition 


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Facts for certain packaged foods in 

§ 101.9(j)(13)(ii)(B) for the nutrient 

information required to be disclosed in 

the written nutrition information under 

section 403(q)(5)(H)(ii)(III) of the FD&C 

Act. For example, a covered 

establishment may use ‘‘sat fat’’ for 

saturated fat and ‘‘cholest’’ for 

cholesterol. 

(Comment 100) One comment 

suggested that ‘‘total number of calories 

derived from any source’’ (required 

under section 403(q)(1)(C) of the FD&C 

Act) be changed to ‘‘total number of 

calories,’’ which, according to the 

comment, is clear and concise. 

(Response 100) We agree with the 

comment’s suggestion that the term 

‘‘total number of calories derived from 

any source’’ can be revised to be more 

concise. Specifically, we are replacing 

the term ‘‘total number of calories 

derived from any source’’ (which had 

been specified by section 403(q)(1)(C) of 

the FD&C Act) with ‘‘total calories.’’ 

This change is consistent with how the 

‘‘total number of calories derived from 

any source’’ is disclosed in the Nutrition 

Facts under § 101.9. For consistency, we 

are making an analogous revision to 

replace the term ‘‘total number of 

calories derived from the total fat’’ with 

‘‘calories from fat.’’ This change is 

consistent with section 403(q)(1)(C) of 

the FD&C Act, and the declaration of 

‘‘total calories’’ and ‘‘calories from fat’’ 

will be consistent with the terms used 

for nutrition labeling for packaged food 

(see § 101.9(c)). 

(Comment 101) Several comments 

supported the proposed nutrients that 

must be listed in the written nutrition 

information. Some comments suggested 

that the written nutrition information 

also include the weight in grams of the 

standard menu item. These comments 

considered that the weight of the 

standard menu item is an important 

indicator of portion size and allows 

consumers to compare similar products 

more easily, and that including the 

weight of the standard menu item 

would be consistent with the Nutrition 

Facts for packaged foods. 

(Response 101) We disagree that we 

should require that the written nutrition 

information include the weight in grams 

for each standard menu item. Section 

403(q)(5)(H)(ii)(III) of the FD&C Act 

specifically requires covered 

establishments to provide in a written 

form, available on the premises of the 

covered establishment and to the 

consumer upon request, the nutrition 

information required under clauses (C) 

and (D) of section 403(q)(1) of the FD&C 

Act. We are only requiring that covered 

establishments provide in the written 

nutrition information the nutrition 

information specified in section 

403(q)(5)(H)(ii)(III) of the FD&C Act, 

along with trans fat, for standard menu 

items as usually prepared and offered 

for sale, or in the case of standard menu 

items that are self-service food or food 

on display, by displayed food item or 

per serving. Although the weight of a 

standard menu item may give some 

indication of portion sizes, it does not 

necessarily correlate with how many 

calories are contained in a food or with 

what nutrients are in a food. For 

example, some foods may weigh less 

than other similar foods but have more 

calories because of the source of the 

calories. At this time, we conclude that 

the written nutrition information 

required by § 101.11(b)(2)(ii)(A) will 

allow consumers to make comparisons 

between menu items and help inform 

their dietary choices. A covered 

establishment may voluntarily provide 

the weight of the standard menu item in 

the written nutrition information. We 

also note that for some foods, the weight 

is already provided as part of the name 

or description of the standard menu 

item on the menu or menu board, e.g., 

a 10-ounce steak versus a 12-ounce 

steak. 

(Comment 102) One comment 

recommended that the written nutrition 

information include calcium, 

potassium, and phosphorus because 

patients with kidney disease may have 

diabetes, hypertension, or both. The 

comment suggested that covered 

establishments give information on the 

need to limit these nutrients and to limit 

sodium. 

(Response 102) We disagree with 

these comments. Section 

403(q)(5)(H)(ii)(III) of the FD&C Act 

requires in relevant part that covered 

establishments provide, in written form, 

the nutrition information required 

under clauses (C) and (D) of section 

403(q)(1) of the FD&C Act. Sections 

403(q)(1)(C) and (D) of the FD&C Act do 

not require the disclosure of calcium, 

potassium, and phosphorus in food 

labeling. Section 403(q)(5)(H)(vi) of the 

FD&C Act provides that ‘‘[i]f the 

Secretary determines that a nutrient, 

other than a nutrient required under 

[section 403(q)(5)(H)(ii)(III) of the FD&C 

Act], should be disclosed for the 

purpose of providing information to 

assist consumers in maintaining healthy 

dietary practices, the Secretary may 

require, by regulation, disclosure of 

such nutrient in the written form 

required under [section 

403(q)(5)(H)(ii)(III) of the FD&C Act].’’ 

However, the comment did not provide 

any supporting information showing 

that the disclosure of calcium, 

potassium, and phosphorus in the 

written nutrition information will assist 

consumers in maintaining healthy 

dietary practices. At this time, we 

conclude that the nutrition information 

specified in section 403(q)(5)(H)(ii)(III) 

of the FD&C Act, along with trans fat 

information, is sufficient to assist 

consumers in maintaining healthy 

dietary practices within the context of 

section 403(q)(5)(H) of the FD&C Act. If 

we determine that other nutrient 

information should be disclosed in the 

written form required under section 

403(q)(5)(H)(ii)(III) of the FD&C Act, we 

will make changes to such requirements 

as appropriate. We note that consumers 

who have a particular disease or healthrelated condition may be able to use the 

written nutrition information to follow 

advice they have received from a health 

care professional concerning dietary 

practices relevant to their conditions. 

(Comment 103) One comment asked 

us to permit voluntary declaration of 

micronutrients such as vitamins and 

minerals. 

(Response 103) We would not object 

to the voluntary declaration of vitamins 

and minerals that may be declared on 

the Nutrition Facts Label of a packaged 

food (see § 101.9(c)(8)(ii)), provided that 

the declaration is truthful and not 

misleading, as required by section 

403(a)(1) of the FD&C Act. 

(Comment 104) One comment 

recommended that if future changes are 

made to the Nutrition Facts of packaged 

foods, then the requirements for the 

written nutrition information should be 

made consistent with such changes. 

(Response 104) If future changes are 

made to the requirements regarding the 

Nutrition Facts for packaged foods, we 

will consider whether changes should 

also be made to the requirements 

regarding the written nutrition 

information required by this rule. 

(Comment 105) One comment 

recommended that the nutrient values 

in the written nutrition information be 

reviewed and updated yearly or when 

changes are made. 

(Response 105) We agree, in part, and 

disagree, in part, with this comment. 

Under § 101.11(c), a covered 

establishment must have a reasonable 

basis for its nutrient content 

declarations. Under section 403(a)(1) of 

the FD&C Act, covered establishments 

must also ensure that their nutrient 

content declarations are truthful and not 

misleading. To do so, a covered 

establishment would need to update the 

written nutrition information when 

certain changes are made, e.g., as a 

result of a recipe change that affects the 

nutrient content of a standard menu 

item. However, we see no reason why 

nutrition information for a standard 


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menu item must be updated on a 

recurring basis (such as yearly) when 

there are no changes to the standard 

menu item or its method of preparation. 

(Comment 106) One comment 

recommended that covered 

establishments provide references for 

their nutrient values to consumers on 

request. 

(Response 106) We are not requiring 

a covered establishment to provide 

supporting references for the nutrient 

values in its written nutrition 

information to consumers upon request. 

Section 403(q)(5)(H) of the FD&C Act 

generally requires covered 

establishments to provide calorie and 

other nutrition information for standard 

menu items. Further, as required by 

section 403(q)(5)(H)(iv) of the FD&C Act, 

a covered establishment must have a 

reasonable basis for its nutrient content 

disclosures. Covered establishments 

must also ensure that their nutrient 

content disclosures are truthful and not 

misleading in accordance with section 

403(a)(1) of the FD&C Act. Section 

403(q)(5)(H) of the FD&C Act does not 

require that covered establishments 

provide supporting references for their 

nutrient content disclosures to 

consumers. However, we would not 

object if a covered establishment 

provides this information voluntarily. 

(Comment 107) Several comments 

generally agreed that trans fat must be 

included with the written nutrition 

information. Some comments expressed 

the view that providing information 

about trans fat is warranted because of 

concern with partially hydrogenated 

vegetable oils. 

Comments that opposed including 

trans fat in the written nutrition 

information generally focused on the 

distinction between ‘‘industrial trans 

fat’’ (i.e., trans fat chemically 

manufactured from vegetable oils) and 

trans fat naturally occurring in food 

such as ruminant animals. Some 

comments expressed concern that 

listing such naturally occurring trans fat 

in the written nutrition information, 

particularly when it is present in small 

amounts, could lead to problems in 

States and localities that have banned 

the use of trans fat in restaurants, or 

could lead consumers to think that a 

covered establishment is breaking State 

or local law. These comments stated 

that eliminating the requirement to list 

trans fat in the written nutrition 

information, or limiting the listing for 

trans fat to industrial trans fat, would 

prevent such problems. Other comments 

expressed the view that the health 

effects of naturally occurring trans fat 

from ruminants may be different from 

the health effects of trans fat chemically 

manufactured from vegetable oils. Some 

comments stated that, in Europe, 

scientists and regulators have not 

singled out ruminant trans fat for 

pejorative labeling. Some comments 

stated that naturally occurring trans fats 

derived from high fat ruminant animal 

products (namely, beef and dairy 

products) are converted to conjugated 

linoleic acid, which the comments 

reported have been associated with 

health benefits. These comments 

considered that industrial and naturally 

occurring trans fat should therefore be 

distinguished on food nutrition labels 

and menus to give consumers a more 

accurate assessment of nutritional 

quality. 

(Response 107) We disagree that we 

should require the declaration of only 

‘‘industrial trans fat’’ in the written 

nutrition information. For purposes of 

the current Nutrition Facts label, our 

regulatory definitions of nutrients (such 

as for trans fat, total fat, or saturated fat) 

have traditionally been based on 

chemical definitions. For example, 

under § 101.9(c)(2)(ii), the declaration of 

nutrition information on the label and 

in labeling of a food must contain a 

statement of the number of grams of 

trans fat in a serving, defined as the sum 

of all unsaturated fatty acids that 

contain one or more isolated (i.e., 

nonconjugated) double bonds in a trans 

configuration. Analytically, this 

definition captures all trans fatty acid 

isomers that have isolated bonds, 

regardless of the origin of the trans fatty 

acid. For example, vaccenic acid (one of 

the most abundant trans fatty acids in 

ruminant fat) is included in the 

chemical definition of trans fat. 

Therefore, listing the sum of all 

unsaturated fatty acids that contain one 

or more isolated double bonds in a trans 

configuration regardless of the source of 

such trans fat is consistent with the 

requirements for declaring the amount 

of trans fat in a packaged food on the 

label for such food (see § 101.9(c)(2)(ii)). 

Further, in the rulemaking to require the 

declaration of trans fat, we responded to 

comments regarding functional or 

metabolic aspects of trans fatty acids 

(e.g., their metabolic transformations to 

other types of fatty acids) rather than on 

their actual chemical structures, 

including potential differences between 

trans fat from industrial sources and 

trans fat from ruminant sources. We 

concluded that we should define trans 

fat based on its chemical definition 

rather than any functional attributes (68 

FR 41434 at 41461, July 11, 2003). The 

comments provided insufficient 

information to overturn the conclusion 

we previously reached about declaring 

trans fat on the label of packaged food. 

We also decline to require the 

declaration of ‘‘industrial trans fat’’ in 

the written nutrition information 

because declaration of ruminant trans 

fat may lead inspectors or consumers to 

believe that covered establishments are 

violating State or local requirements in 

jurisdictions that ban artificial trans fat. 

We recognize that, in the United States, 

some jurisdictions, such as the State of 

California (Ref. 34), New York City (Ref. 

35), the City of Baltimore (Ref. 36), and 

Montgomery County, Maryland (Ref. 37) 

have imposed restrictions on the use of 

industrial trans fat ingredients in food 

service establishments. However, a trans 

fat declaration of 0.5 grams or more for 

a standard menu item in the written 

nutrition information of a covered 

establishment does not necessarily 

mean that the covered establishment is 

violating a State or local requirement 

that prohibits industrial trans fat 

ingredients. So long as such standard 

menu item does not contain the 

restricted trans fat ingredients and is 

otherwise in compliance with the 

applicable State or local trans fat 

requirement, a trans fat declaration of 

0.5 grams or more for such standard 

menu item could mean that the menu 

item contains a certain amount of 

naturally occurring trans fat. States and 

localities would be able to continue to 

enforce requirements restricting 

artificial trans fat ingredients relying on 

the same measures they already use to 

determine if establishments under their 

jurisdiction are using a prohibited 

ingredient. 

We also note that we recently 

published a tentative determination that 

partially hydrogenated oils, the source 

of industrially produced trans fat, are 

not generally recognized as safe for any 

use in food based on current scientific 

evidence establishing the health risks 

associated with the consumption of 

trans fat (78 FR 67169, November 8, 

2013). If this determination is finalized, 

we will consider whether the trans fat 

requirements of this rule should be 

amended. 

B. Manner of Presentation of the Written 

Nutrition Information 

Proposed § 101.11(b)(2)(ii) would 

require, in relevant part, that the written 

nutrition information be presented in a 

clear and conspicuous manner. We 

received several comments on this 

proposed provision. After considering 

these comments, we have revised the 

provision to specify that the written 

nutrition information must be ‘‘clear 

and conspicuous,’’ including in a color, 

type size, and in a contrasting 


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background that render the information 

likely to be read and understood by the 

ordinary individual under customary 

conditions of purchase and use. 

(Comment 108) One comment 

supported the proposed requirements 

that the written nutrition information be 

clear and conspicuous. Some comments 

asked us to give more guidance on 

format and on the standard for the 

written nutrition information to be 

presented in a clear and conspicuous 

manner—e.g., that it be easy to read, 

have a large enough font, have a 

contrasting background, and not use all 

capital letters for the names of standard 

menu items. One comment 

recommended that we include 

specifications for font size. 

(Response 108) We disagree that we 

should specify the particular type size 

and contrasting background that must 

be used in the written nutrition 

information, and prohibit the use of all 

capital letters for the names of standard 

menu items in the written nutrition 

information. Section 403(q)(5)(H)(ii) of 

the FD&C Act requires covered 

establishments to provide the written 

nutrition information required by 

section 403(q)(5)(H)(ii)(III) of the FD&C 

Act in a clear and conspicuous manner. 

As discussed later in this document (see 

the discussion of § 101.11(b)(2)(ii)(D) in 

section XVI.E), we are providing 

covered establishments with the 

flexibility to use different types of 

media (e.g., flyers, posters, booklets, 

kiosks) to provide the written nutrition 

information. Whether the written 

nutrition information is clear and 

conspicuous depends on the media 

through which a covered establishment 

chooses to provide the written nutrition 

information. For example, a specific 

type size and contrasting background 

may result in written nutrition 

information that is clear and 

conspicuous on a tray liner or brochure, 

but not on a poster that a consumer may 

view from several feet away. Thus, we 

are not establishing specific 

requirements for type size, contrasting 

background, or use of capital letters for 

the written nutrition information so that 

covered establishments have the 

flexibility to provide the written 

nutrition information in a clear and 

conspicuous manner based on the 

particular media through which the 

information is presented. 

However, we agree that some 

guidance is needed on the requirement 

that the written nutrition information be 

provided in a clear and conspicuous 

manner. Section 403(f) of the FD&C Act 

provides that a food will be deemed to 

be misbranded ‘‘[i]f any word, 

statement, or other information required 

by or under authority of this Act to 

appear on the label or labeling is not 

prominently placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ Accordingly, we 

conclude that in order for the written 

nutrition information to be clear and 

conspicuous, the information must be 

presented in a manner that renders it 

likely to be read and understood by the 

ordinary individual under customary 

conditions of purchase and use. 

Specifically, we have revised 

§ 101.11(b)(2)(ii) to require that the 

written nutrition information be 

presented in a clear and conspicuous 

manner, including using a color, type 

size, and contrasting background that 

render the information likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use. We are also 

revising § 101.11(f) to state that a 

standard menu item offered for sale in 

a covered establishment shall be 

deemed misbranded under sections 

201(n), 403(a), 403(f), and/or 403(q) of 

the FD&C Act if its label or labeling is 

not in conformity with paragraph (b) or 

(c) of the section. 

(Comment 109) One comment asked 

us to require that standard menu items 

in the written nutrition information be 

listed in the same order as they are on 

menus and menu boards. 

(Response 109) We disagree that we 

should require covered establishments 

to list standard menu items in the 

written nutrition information in the 

same order as on menus and menu 

boards. The comment provided no basis 

for why this particular order of listing 

standard menu items is the only order 

that would be useful to consumers. We 

are providing flexibility for a covered 

establishment to list its standard menu 

items in the written nutrition 

information in a manner that is best 

suited to its menu offerings, and 

conclude that the written nutrition 

information can enable consumers to 

make informed dietary choices 

regardless of the order in which the 

standard menu items are listed. 

(Comment 110) One comment 

responded to our request for comment 

on whether to require that 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) be bolded or placed in a 

separate table of nutritional content (76 

FR 19192 at 19214–19215). This 

comment opposed such measures 

because doing so would highlight the 

negative aspects of food even though the 

food also has positive nutrients. 

Another comment supported the 

bolding of nutrients of concern to 

consumers with obesity and diabetes, 

such as saturated fat and sodium. 

(Response 110) We disagree that we 

should decide whether to require 

measures for highlighting nutrient 

declarations important to maintain 

healthy dietary practices for consumers 

with obesity and diabetes based on a 

concern that doing so would highlight 

the ‘‘negative’’ aspects of a menu item 

even though the menu item also has 

‘‘positive’’ aspects. However, we did not 

receive sufficient information in the 

comments to warrant adding a 

requirement to emphasize certain 

nutrients, and we are not requiring such 

a requirement in this rule. The 

requirements for the written nutrition 

information in § 101.11(b)(2)(ii) make 

nutrition information available to 

consumers in a direct and accessible 

manner to enable consumers to make 

informed and healthful dietary choices. 

C. Nutrients in Insignificant Amounts 

Proposed § 101.11(b)(2)(ii)(B) would 

provide that if a standard menu item 

contains insignificant amounts of all the 

nutrients required to be disclosed in 

§ 101.11(b)(2)(ii)(A), the establishment 

is not required to include nutrition 

information regarding the standard 

menu item in the written form. 

Proposed § 101.11(b)(2)(ii)(B) would 

explain, however, that 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. Proposed § 101.11(b)(2)(ii)(B) 

would provide that covered 

establishments may present the written 

nutrition information in a simplified 

format for standard menu items that 

contain insignificant amounts of six or 

more of the required nutrients and 

proposed § 101.11(b)(2)(ii)(B)(1) would 

define what is an insignificant amount. 

We note that there is an inconsistency 

regarding the nutrients that must be 

included in the simplified format 

between the preamble discussion and 

the regulatory text in proposed 

§ 101.11(b)(2)(ii)(B)(2). In the preamble 

discussion, we stated: ‘‘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).’’ 

(76 FR 19192 at 19213). However, 

proposed § 101.11(b)(2)(ii)(B)(2) 


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specified that the simplified format 

must include information on total 

carbohydrates, total fat, protein, and 

sodium, calories from fat, and any other 

nutrients identified in 

§ 101.11(b)(2)(ii)(A) that are present in 

more than insignificant amounts. 

Proposed § 101.11(b)(2)(ii)(B)(2) did not 

specify that the simplified format must 

include information on total calories, as 

we intended. In addition, proposed 

§ 101.11(b)(2)(ii)(B)(2) did not make it 

clear that the simplified format must 

include calories from fat only if calories 

from fat are present in more than 

insignificant amounts, as would be 

consistent with § 101.9(f)(2)(ii). We have 

revised and redesignating 

§ 101.11(b)(2)(ii)(B)(2) so that it contains 

three separate subparagraphs that more 

clearly communicate the requirements. 

As revised, § 101.11(b)(2)(ii)(B)(2) 

requires that the simplified format must 

include information, in a column, list, 

or table, on the nutrients specified in 

§ 101.11(b)(2)(ii)(B)(2)(i) and (ii). Section 

101.11(b)(2)(ii)(B)(2)(i) specifies that the 

simplified format must include 

information on total calories, total fat, 

total carbohydrates, protein, and 

sodium. Section 101.11(b)(2)(ii)(B)(2)(ii) 

specifies that the simplified format must 

include calories from fat and any other 

nutrients identified in 

§ 101.11(b)(2)(ii)(A) that are present in 

more than insignificant amounts. 

Section 101.11(b)(2)(ii)(B)(3) specifies 

that if the simplified format is used, the 

statement ‘‘Not a significant source 

of _____’’ (with the blank filled in with 

the names of the nutrients required to be 

declared in the written nutrient 

information and calories from fat that 

are present in insignificant amounts) 

must be included at the bottom of the 

list of nutrients. 

In the following paragraphs, we 

discuss comments on proposed 

§ 101.11(b)(2)(ii)(B)(2). We are finalizing 

it without change other than to revise 

§ 101.11(b)(2)(ii)(B)(2) to correct the 

discrepancy between the description of 

the proposed requirement in the 

preamble and the regulatory text and to 

clarify the requirements. 

(Comment 111) One comment 

recommended that the simplified format 

we proposed in § 101.11(b)(2)(ii)(B)(2), 

when a standard menu item contains 

insignificant amounts of more than onehalf of the nutrients required to be 

declared in the written nutrition 

information, include information on 

fiber. The comment contended that fiber 

is an important element in considering 

the overall nutritional value of a certain 

food, both in addressing obesity and 

diabetes. The comment stated that only 

knowing information on the total 

carbohydrates without information on 

the fiber will not allow consumers to 

make sufficiently healthy choices or 

will undermine their intent to do so. 

(Response 111) If a standard menu 

item has an insignificant amount of six 

or more of the required nutrients, the 

simplified format must include 

information on total calories, total fat, 

total carbohydrates, protein, and sodium 

(§ 101.11(b)(2)(ii)(B)(2)(i)) as well as 

information on calories from fat and any 

other nutrient that is present in the food 

in more than insignificant amounts 

(§ 101.11(b)(2)(ii)(B)(2)(ii)). Thus, if fiber 

is present in a standard menu item at a 

level that is more than insignificant (i.e., 

one gram or more), the amount of fiber 

must appear in the simplified format. 

On the other hand, if an insignificant 

amount of fiber is present in a standard 

menu item, the simplified format must 

disclose this information through the 

statement, ‘‘Not a significant source 

of _____’’ (with the blank filled in with 

‘‘fiber’’ since fiber is required to be 

declared in the written nutrition 

information) (§ 101.11(b)(2)(ii)(B)(3)). 

Therefore, the simplified format for the 

written nutrition information already 

must include information on fiber, and 

there is no need to revise proposed 

§ 101.11(b)(2)(ii)(B) to include fiber as 

recommended by the comment. 

D. Variable Menu Items 

Proposed § 101.11(b)(2)(ii)(C) would 

require that, for variable menu items, 

the nutrition information listed in 

§ 101.11(b)(2)(ii)(A) must be declared as 

follows for each size offered for sale: 

(1) The nutrition information required 

in § 101.11(b)(2)(ii)(A) 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. 

In the proposed rule, we considered 

the following options for providing the 

nutrition information in the written 

form for a variable menu item: 

• Option 1. List the nutrition 

information for each nutrient in the 

variable menu item as a range. 

• Option 2. List the nutrition 

information for each component in the 

variable menu item (the proposed 

requirement). 

• 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. 

In the proposed rule, we stated that 

option 2 provides the consumer with all 

the required nutrient information for 

each flavor or variety of a variable item, 

or each component of a combination 

meal in a format that facilitates quick 

comparisons between different menu 

items (76 FR 19192 at 19213). In the 

following paragraphs, we discuss 

comments on this proposed provision. 

We are making no changes in response 

to these comments. 

However, similar to the specific 

format requirements we established for 

declaring calories on a menu or menu 

board for toppings listed on a menu or 

menu board, where the amount of the 

topping on the menu item decreases 

based on the total number of toppings 

ordered, we are establishing in 

§ 101.11(b)(2)(ii)(C)(2) specific format 

requirements for providing the written 

nutrition information for toppings if the 

amount of the topping included on the 

basic preparation of the menu item 

decreases based on the total number of 

toppings ordered for the menu item 

(such as is sometimes the case with 

pizza toppings). Section 

101.11(b)(2)(ii)(C)(2) of the final rule 

specifies that if the amount of the 

topping included on the basic 

preparation of the menu item decreases 

based on the total number of toppings 

ordered for the menu item, the nutrients 

for each topping must be declared as 

single values representing the nutrients 

for each topping when added to a onetopping menu item, specifying that the 

nutrient declaration is for the topping 

when added to a one-topping menu 

item. The nutrients for each topping 

must also be declared for each size of 

the menu item offered for sale, as 

required by § 101.11(b)(2)(ii)(C). We are 

establishing requirements for providing 

the written nutrition information for 

variable menu items offered for sale 

with the option of adding toppings, and 

specifying the format and manner of 

such nutrient content disclosures, as 

required by sections 403(q)(5)(H)(v) and 

(x)(II)(bb) of the FD&C Act. Section 

101.11(b)(2)(ii)(C)(2) helps ensure that 

consumers are given accurate and 

consistent information about the 

nutrient of each topping on a menu 

item. We would not object if a covered 

establishment voluntarily includes a 

statement on the written nutrition 

information explaining how the 

nutrients per topping might fluctuate if 

ordering multiple toppings; for example, 


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such a statement regarding a pizza pie 

might say, ‘‘Nutrient values per topping 

may decrease as the number of toppings 

per pizza increases.’’ Section 

101.11(b)(2)(ii)(C)(2) is therefore 

consistent with the requirements for 

declaring calories for toppings listed on 

the menu or menu board, where the 

amount of the topping on the menu item 

decreases based on the total number of 

toppings ordered. 

Because we added this requirement in 

§ 101.11(b)(2)(ii)(C)(2) to address the 

potential variation in nutrient content 

for each topping based on the total 

number of toppings ordered, proposed 

§ 101.11(b)(2)(ii)(C)(2), which allows 

items that have the same nutrient values 

to be listed together with the nutrient 

values listed only once, is renumbered 

for the final rule as 

§ 101.11(b)(2)(ii)(C)(3). We are replacing 

the phrase ‘‘substitutable component’’ 

in two places in the first sentence of 

§ 101.11(b)(2)(ii)(C)(3) with ‘‘variable 

component.’’ We are making this change 

for consistency with the term used in 

§ 101.11(b)(2)(ii)(C)(1). We also are 

replacing the phrase ‘‘nutrient levels’’ in 

two places in the final sentence of 

§ 101.11(b)(2)(ii)(C)(3) with ‘‘nutrient 

values.’’ We are making this change for 

consistency with § 101.11(c), which we 

have revised to consistently use the 

term ‘‘values’’ in the requirements for 

determination of nutrient content. 

(Comment 112) A few comments 

supported option 2. Some comments 

opposed the use of slashes for different 

flavors and considered that slashes 

would be confusing and unclear because 

consumers are not used to nutrition 

information in restaurants. 

(Response 112) We are retaining 

Option 2 in the rule for providing the 

written nutrition information for 

variable menu items generally. Option 2 

does not specify the use of the slashes 

opposed by some comments. 

E. Form of the Written Nutrition 

Information 

Proposed § 101.11(b)(2)(ii)(D) would 

permit the written nutrition information 

required in § 101.11(b)(2)(ii)(A) to 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 nutrient content 

information for all standard menu items. 

Proposed § 101.11(b)(2)(ii)(D) would 

explain that 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. 

In the proposed rule, we discussed 

the flexibility provided by proposed 

§ 101.11(b)(2)(ii)(D) for the written 

nutrition information and requested 

comment on whether we should be 

more prescriptive in the format and 

manner of providing the written 

nutrition information in order to ensure 

they are useful to consumers (76 FR 

19192 at 19214). We also stated that we 

would not object to the use of tray liners 

or wrappers 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 (76 FR 19192 at 19214). 

In the following paragraphs, we 

discuss comments on this proposed 

provision. We are finalizing it without 

change, except for an editorial change 

from ‘‘written information’’ to ‘‘written 

nutrition information’’ in the final 

sentence. With this editorial change, 

§ 101.11(b)(2)(ii)(D) will consistently 

use the same phrase (‘‘written nutrition 

information’’). 

(Comment 113) One comment 

supported our proposal to permit 

flexibility in how the written nutrition 

information would be provided but 

questioned the use of wrappers, arguing 

that it is unlikely that there would be 

enough room on a wrapper to list the 

nutrition information for all standard 

menu items in a covered establishment 

and to make the information easily 

readable. Another comment 

recommended that § 101.11(b)(2)(ii)(D) 

specify the media allowed for the 

written nutrition information, with a 

petition and approval process for 

alternate media, rather than include a 

‘‘catch-all phrase’’ such as ‘‘any other 

form that similarly permits the written 

declaration of the required nutrient 

content information for all standard 

menu items,’’ which was included in 

proposed § 101.11(b)(2)(ii)(D). Another 

comment recommended that we 

expressly recognize that Nutrition Facts 

labels can be used to convey the written 

nutrition information. 

(Response 113) Section 

101.11(b)(2)(ii) specifies that the written 

nutrition information must be provided 

in a clear and conspicuous manner, 

including using a color, type size, and 

contrasting background that render the 

information likely to be read and 

understood by the ordinary individual 

under customary conditions of purchase 

and use. A covered establishment could 

use a wrapper if the written nutrition 

information for all standard menu items 

offered for sale at the covered 

establishment can be presented in a 

clear and conspicuous manner on the 

wrapper, is available upon request to 

the consumers, in accordance with 

§ 101.11(b)(2)(ii), and otherwise 

complies with the applicable sections of 

the FD&C Act and § 101.11(b)(2)(ii). For 

example, there may be enough room on 

a wrapper to include the written 

nutrition information for all standard 

menu items in a clear and conspicuous 

manner when a covered establishment 

offers for sale a small number of 

standard menu items. 

In addition, § 101.11(b)(2)(ii) ensures 

that the written nutrition information is 

presented in a clear and conspicuous 

manner without prescribing a list of 

allowed media or the exact format of the 

written nutrition information. If we 

amended § 101.11(b)(2)(ii)(D) to specify 

the particular types of media that can be 

used by covered establishments to 

provide the required written nutrition 

information, as recommended by one 

comment, § 101.11(b)(2)(ii)(D) would 

limit the types of media that can be used 

by covered establishments, including 

those developed based on technological 

advancements. Further, § 101.11(b)(2)(ii) 

would need to amended every time a 

covered establishment sought to use a 

type of media not specified. Rather than 

specify the media allowed for the 

written nutrition information, we 

conclude that the public health goal of 

this rule would be better served by 

providing flexibility to covered 

establishments to use any media to 

provide the written nutrition 

information in the way that is best 

suited to their establishments, as long as 

the written nutrition information is 

available on the premises of the covered 

establishment and to the consumer 

upon request, is clear and conspicuous, 

and otherwise complies with the 

requirements of the applicable sections 

of the FD&C Act and § 101.11(b)(2)(ii). 

Providing such flexibility satisfies the 

requirements of section 

403(q)(5)(H)(ii)(III) of the FD&C Act 

while taking into consideration the 

varying practices at different covered 

establishments. With this flexibility, the 

petition and approval process suggested 

by the comment is unnecessary. 

We agree that Nutrition Facts labels 

can be used to provide the written 

nutrition information required under 

§ 101.11(b)(2)(ii) for packaged foods, 

and this rule provides flexibility to do 

so (see the discussions of 

§ 101.11(b)(2)(iii)(C) in Response 133, 

and of § 101.11(c)(1) in section XVIII). 

(Comment 114) Some comments 

stated that the written nutrition 

information should not have to be 


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provided with carry out menus. The 

comments recommended that carry out 

menus could contain a link to the 

covered establishment’s Internet menu 

where the written nutrition information 

may be found. Another comment stated 

that the written nutrition information 

should be permitted on Internet menus 

but not required. 

(Response 114) We agree with the 

comments stating that the written 

nutrition information should not be 

required with carry out menus. We are 

not requiring a specific manner for 

providing the written nutrition 

information, as long as the written 

nutrition information is available on the 

premises of the covered establishment 

and provided to the consumer upon 

request, is disclosed in a clear and 

conspicuous manner, and otherwise 

complies with the applicable sections of 

the FD&C Act and § 101.11(b)(2)(ii). If a 

consumer who orders from a menu such 

as a carry out menu or an Internet menu 

requests the written nutrition 

information, the covered establishment 

must provide the information to the 

consumer. For example, if a covered 

establishment delivers a menu item to a 

consumer, the covered establishment 

could deliver the written nutrition 

information with the menu item if the 

consumer requests the information. As 

another example, if a consumer orders 

from an Internet menu, a covered 

establishment could provide the written 

nutrition information on its Web site or 

include a link directing the consumer to 

a Web site providing the written 

nutrition information. Similarly, as 

suggested by the comments, a covered 

establishment could provide a link on 

carry out menus that directs consumers 

to a Web site providing the written 

nutrition information. We note that all 

menus, including carry out menus, and 

menu boards must include a prominent, 

clear, and conspicuous statement 

regarding the availability of the written 

nutrition information, as required by 

section 403(q)(5)(H)(ii)(IV) of the FD&C 

Act. 

(Comment 115) Some comments 

recommended that we require that the 

written nutrition information be readily 

available upon request to consumers 

before ordering. The comments also 

recommended that the information be 

provided in a manner that allows 

consumers to compare the information 

between different menu items before 

ordering and without losing their place 

in line or having to leave the table. The 

comments stated that if the written 

nutrition information is not in a form 

that can be given to the consumer upon 

request, it must be readily available in 

a manner and location on the premises 

that allows the consumer to review the 

written nutrition information when 

ordering (i.e., the consumer should be 

able to see and review both the menu or 

menu board and the written nutrition 

information at the same time). One 

comment recommended that the 

information be provided at the place 

where consumers place their orders and 

not upon request. One comment 

recommended that we ensure that all 

consumers have access to the 

information. The comment maintained 

that information on a poster or on a 

computer in a fixed location may not be 

accessible to the mobility impaired. 

(Response 115) We decline to require 

that covered establishments make the 

written nutrition information readily 

available to consumers where 

consumers place their orders rather than 

providing such information to 

consumers upon request. Section 

403(q)(5)(H)(ii)(III) of the FD&C Act 

specifically requires covered 

establishments to provide the written 

nutrition information ‘‘to the consumer 

upon request.’’ In addition, nothing in 

§ 101.11(b)(2)(ii) would preclude 

consumers from requesting the written 

nutrition information before ordering. 

We disagree that the rule must require 

a format and manner of providing the 

written nutrition information that 

ensures that a consumer who requests 

written nutrition information will avoid 

losing a place in an ordering line or 

leaving a table. A covered establishment 

has flexibility to use a format (e.g., a 

poster) that may be readily seen by 

consumers even if they do not 

specifically ask to see it. 

We agree that covered establishments 

must make the written nutrition 

information available to all consumers, 

including consumers with mobility 

impairment, upon request, and must 

ensure that the information is presented 

in a clear and conspicuous manner to all 

consumers. Section 101.11(b)(2)(ii)(D) 

specifically identifies formats such as 

on a counter card, sign, poster, handout, 

booklet, loose leaf binder, or electronic 

device such as a computer, or in a menu 

through which a covered establishment 

may provide the written nutrition 

information. 

XVII. Comments and FDA Response on 

Proposed § 101.11(b)(2)(iii)— 

Requirements for Food That Is SelfService or on Display 

A. Applicability of § 101.11(b)(2)(i) to 

Food That Is Self-Service or on Display 

Under sections 403(q)(5)(H)(ii)(I)(aa) 

and (II)(aa) of the FD&C Act, we 

proposed to establish requirements for 

the declaration of calories for standard 

menu items on menus and menu boards 

in proposed § 101.11(b)(2)(i). Under 

section 403(q)(5)(H)(iii), we proposed to 

establish requirements for the 

declaration of calories for self-service 

food and food on display in proposed 

§ 101.11(b)(2)(iii). In the proposed rule, 

we tentatively concluded that when 

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) of the 

FD&C Act (76 FR 19192 at 19216). In 

other words, we tentatively concluded 

that self-service food and food on 

display that appear on a menu or menu 

board are subject to both requirements 

for the declaration of calories—i.e., the 

requirements in § 101.11(b)(2)(i) 

applicable to declaration on a menu or 

menu board and the requirements in 

§ 101.11(b)(2)(iii) applicable to selfservice food and food on display. 

(Comment 116) One comment 

disagreed with our tentative conclusion 

that the proposed requirements for 

calorie declaration of standard menu 

items on menus and menu boards 

(§ 101.11(b)(2)(i)(A)) apply to food on 

display and self-service food that is also 

listed on menus and menu boards. The 

comment asserted that this tentative 

conclusion is against the plain language 

of section 403(q)(5)(H) of the FD&C Act 

and that to require covered 

establishments to label menu boards 

and display cases is unnecessary. The 

comment asserted that only requiring 

calorie labeling on signs adjacent to 

food on display and self-service food 

would provide information at the point 

of ordering and therefore would be more 

consistent with the requirement of 

section 403(q)(5)(H) of the FD&C Act 

that calorie information be provided on 

menus and menu boards, as defined in 

section 403(q)(5)(H)(xi) of the FD&C Act 

(‘‘the primary writing of the . . . 

establishment from which a consumer 

makes an order selection’’). 

(Response 116) We disagree with this 

comment. The plain language of section 

403(q)(5)(H)(i) of the FD&C Act provides 

that ‘‘in the case of food that is a 

standard menu item . . . [the covered] 

establishment shall disclose the 

information described in subclauses (ii) 

and (iii)’’ (emphasis added). As 

discussed in the proposed rule, 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 

must follow the requirements in section 

403(q)(5)(H)(ii) of the FD&C Act as 

applicable and section 403(q)(5)(H)(iii) 

of the FD&C Act as applicable. Further, 


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if Congress had meant for section 

403(q)(5)(H)(ii) of the FD&C Act not to 

apply to self-service food and food on 

display, it could have included an 

exception for such foods within that 

section, as it did for foods described in 

section 403(q)(5)(H)(vii) of the FD&C 

Act, but it did not include such an 

exception. See e.g., Russello v. U.S., 464 

U.S. 16, 23 (1983) (‘‘[W]here Congress 

includes particular language in one 

section of a statute but omits it in 

another section of the same [statute], it 

is generally presumed that Congress acts 

intentionally and purposely in the 

disparate inclusion or exclusion.’’) 

(internal citations omitted). In addition, 

a consumer may make his or her order 

selection by using information provided 

on a traditional menu or menu board or 

on a sign adjacent to a self-service food 

or food on display. Disclosing calorie 

information for self-service food and 

food on display on traditional menus 

and menu boards, where such menus 

and menu boards list self-service food 

and food on display, and on signs 

adjacent to self-service food and food on 

display would help ensure that 

consumers are able to see the calorie 

declarations before making order 

selections and is consistent with the 

plain language of sections 

403(q)(5)(H)(ii) and (iii) of the FD&C 

Act. 

Therefore, when a self-service food or 

food on display is listed on a menu or 

menu board, the food is subject to both 

§ 101.11(b)(2)(i) for declaration of 

calories on menus and menu boards and 

to § 101.11(b)(2)(iii) for foods on 

display. 

B. Placement of Calories for Self-Service 

Foods and Foods on Display 

Proposed § 101.11(b)(2)(iii)(A) would 

require 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, 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. 

In the following paragraphs, we 

discuss comments on this proposed 

provision. After considering these 

comments, we have revised the 

provision to provide more options for 

the declaration of calories for selfservice food and food on display and to 

require that if the individual sign does 

not already include the serving, the 

amount of the serving on which the 

calories are based must also be provided 

on the sign, e.g., ‘‘150 calories per 

scoop.’’ 

We also are correcting the 

introductory text in § 101.11(b)(2)(iii) by 

inserting a hyphen between ‘‘self’’ and 

‘‘service.’’ 

(Comment 117) Several comments 

supported the requirements in proposed 

§ 101.11(b)(2)(iii). Some comments 

recommended that foods on display be 

labeled with calorie information 

regardless of whether the food is served 

by the customer or employee. Some 

comments asked us to clarify that a 

calorie declaration is also required for 

displayed foods such as pastries and 

doughnuts at bakeries and ice cream 

behind a glass case in an ice cream 

shop. 

(Response 117) The definition of 

‘‘self-service food’’ includes restauranttype food that is served by the 

customers themselves, and the 

definition of ‘‘foods on display’’ 

includes restaurant-type food that is 

visible to the customer before the 

customer makes a selection. In general, 

pastries, donuts, and ice cream on 

display, such as behind a glass case, 

meet the definition of food on display. 

Under these definitions, the 

requirements in proposed 

§ 101.11(b)(2)(iii) apply to standard 

menu items that are foods served by the 

customers themselves as well as to 

standard menu items that are foods such 

as pastries, donuts, and ice cream that 

are behind a glass case or in an ice 

cream shop and are served by an 

employee. 

(Comment 118) Some comments 

requested flexibility to determine the 

placement of calorie information that 

works best for them. Some comments 

recommended that the calorie 

declaration be permitted to be placed on 

a single sign, or electronically via kiosks 

or touch screen computers, and not on 

all individual signs. One comment 

asserted that, for buffets, the layout and 

number of items make it difficult to 

display signs for hundreds of items 

without cluttering the space or 

obstructing the view. The comment also 

asserted that customers may 

inadvertently move the signs, and 

therefore, the calorie declaration should 

instead appear on counters or in display 

cases. 

Some comments stated that buffets are 

unique because foods vary and change 

often. For example, according to one 

comment, a restaurant may have as 

many as 175 different menu items in a 

meal period. One comment stated that 

the foods are changed multiple times a 

day, the items may change from day to 

day, and the rotation of foods would 

create confusion if the food signs are not 

accurately changed with each new 

menu item. 

One comment stated that the location 

and size of the food signs are affected by 

health and safety regulations because 

the food signs could lead to 

contamination of the food and because 

food signs adjacent to heated areas or 

grills for food items cooked to order 

could create a hazard. Moreover, the 

comment noted that multiple menu 

items may be simultaneously prepared 

to order on open grills. This comment 

recommended that these types of 

restaurants be permitted to place the 

calorie information on individual signs 

adjacent to or in close proximity to the 

food by using a variety of options (e.g., 

sneeze guards; partition or placard; 

menu board or placard adjacent to the 

buffet with all the items listed with 

nutrition content; pamphlet adjacent to 

the buffet; written or electronically 

displayed information using kiosks; 

tablet computers; or touch screen 

computers). 

(Response 118) We agree that placing 

individual signs adjacent to a selfservice food or food on display may 

pose a hazard in certain circumstances, 

such as when there is an open heat 

source (such as a grill) in close 

proximity to the sign that could create 

a fire hazard. We also agree that more 

flexibility is needed for foods that are 

constantly being replenished or 

changed. Therefore, to provide more 

flexibility and reduce the potential for a 

sign used to declare calories for selfservice food or food on display to create 

a hazard, we have revised 

§ 101.11(b)(2)(iii)(A) to allow covered 

establishments to declare calories for 

standard menu items that are selfservice or on display, and the serving or 

unit used to determine the calorie 

content (e.g., ‘‘per scoop’’ or ‘‘per 

muffin’’), using one of the following 

options: 

• On a sign, adjacent to and clearly 

associated with the corresponding food 

item; 

• On a sign attached to a sneeze guard 

with the calorie declaration and the 

serving or unit used to determine the 

calorie content above each specific 

menu item so that the consumer can 

clearly associate the calorie declaration 

with the standard menu item. For 

example, if a buffet has several menu 

items in the serving display case 

including, in particular, a broccoli and 

cheese casserole, the sign attached to 

the sneeze guard right above the 

broccoli and cheese casserole may 

declare the calories, e.g., ‘‘200 calories 


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per scoop.’’ If it is not clear to which 

food the calorie declaration and serving 

or unit refers, then the sign must also 

include the name of the food, e.g., 

‘‘Broccoli and cheese casserole—200 

calories per scoop;’’ or 

• On a single sign or placard listing 

the calorie declaration for several menu 

items along with the names of the menu 

items, so long as the sign or placard is 

located where a consumer can view the 

name, calorie declaration, and serving 

or unit of a particular menu item while 

the consumer is selecting that item. The 

sign must list the names of the menu 

items along with their corresponding 

calorie declarations. For example, for a 

soup station, the sign or placard must 

list all the soups that are available at 

that station along with each calorie 

declaration, e.g., ‘‘chicken noodle soup, 

125 calories per cup,’’ ‘‘minestrone 

soup, 100 calories per cup.’’ This sign 

may be placed on the wall behind the 

station, on a sign at the beginning or end 

of the station, or at another location so 

long as the consumer can read the name, 

calorie declaration, and serving or unit 

of a particular menu item while 

selecting the menu item. 

Each option, when implemented 

appropriately, associates the calorie 

declaration with the appropriate food on 

display or self-service food to help 

ensure that consumers can see such 

declarations when making their 

selections. 

(Comment 119) In the proposed rule, 

we stated that 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 (76 FR 19192 at 19215). We 

requested comment on whether 

establishments that already provide an 

individual sign identifying each food on 

display or self-service food with its 

name, price, or both should have the 

option of providing a separate 

individual sign for each food on display 

or self-service food for the calorie 

declaration, so long as the sign with the 

calorie declaration is adjacent to and 

clearly associated with its 

corresponding food. 

One comment recommended that 

calories appear on the same sign as the 

name or price of the food rather than on 

a separate sign, because more than one 

sign could cause confusion. 

(Response 119) We acknowledge the 

comment’s concern, which mirrored a 

concern we raised in the proposed rule. 

However, in light of the 

recommendations in the comments 

describing the need for more flexibility 

in declaring calories for self-service 

foods and foods on display, we have 

concluded that there are a number of 

ways in which a covered establishment 

can comply with section 

403(q)(5)(H)(iii) of the FD&C Act to 

provide calorie declarations for selfservice foods and foods on display 

based on the establishment’s particular 

operations, including the use of a 

separate sign placed adjacent to a selfservice food or food on display that is 

clearly associated with the food (see 

Comment 118 and Response 118). 

Therefore, we have revised 

§ 101.11(b)(2)(iii)(A) by removing the 

sentence requiring that when a selfservice 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. In addition, we 

have revised § 101.11(b)(2)(iii)(A) by 

providing options for a covered 

establishment to provide calorie 

declarations on signs for self-service 

food and food on display, including the 

options described in Response 118. We 

are making these changes based on the 

reasons discussed in Response 118 and 

because we recognize that existing 

individual signs for these foods may be 

quite small and either not have enough 

space for the calorie declaration, or 

cause the sign to be so crowded that the 

calorie declaration may not be easily 

read or clear and conspicuous enough 

for the consumer to read the 

information. (See, e.g., the discussions 

in Comment 126 and Response 126, and 

in Comment 127 and Response 127, 

about the requirements for type size of 

the calorie declaration when a selfservice food or food on display is 

already accompanied by a sign with the 

food’s name, price, or both.) 

C. Declaring Calories ‘‘Per Item’’ or ‘‘Per 

Serving’’ 

Proposed § 101.11(b)(2)(iii)(A)(1) 

would specify that for purposes of 

§ 101.11(b)(2)(iii)(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. Proposed 

§ 101.11(b)(2)(iii)(A)(2) would specify 

that for purposes of 

§ 101.10(b)(2)(iii)(A), ‘‘per serving’’ 

means: (1) 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 (2) 

per unit of weight offered for sale, e.g., 

per half pound or pound. 

In the following paragraphs, we 

discuss comments on these proposed 

provisions. After considering these 

comments, we are: 

• Deleting ‘‘a multi-serving food such 

as a whole cake’’ from the list of 

examples of what the rule means by 

‘‘per item.’’ As discussed in section 

VI.C, the definition of ‘‘restaurant-type 

food’’ established in the rule includes 

food that is usually eaten on the 

premises, while walking away, or soon 

after arriving at another location, and 

whole cakes that are self-service food or 

food on display are not likely to meet 

this definition. 

• Providing the options to declare 

calories ‘‘per serving instrument’’ or 

‘‘per common household measure’’ in 

separate subparagraphs, rather than in 

the same subparagraph, to emphasize 

that these are distinct alternatives for 

declaration of calories ‘‘per serving.’’ 

• Revising the examples of what we 

mean by ‘‘per unit of weight offered for 

sale’’ to be ‘‘per quarter pound’’ or ‘‘per 

4 ounces.’’ We are making this change 

because examples of a quarter pound or 

4 ounces are more likely to reflect a 

serving of self-service food or food on 

display. 

• Changing § 101.11(b)(2)(iii)(A)(1) 

and (b)(2)(iii)(A)(2) to read ‘‘paragraph 

(b)(2)(iii)(A) of this section’’ rather than 

‘‘§ 101.11(b)(2)(iii)(A)’’ to be more 

consistent with FDA’s general practice. 

We note that the proposed rule had 

identified the cross-reference as 

‘‘§ 101.10(b)(2)(ii)(A).’’ We revised this 

to ‘‘§ 101.11(b)(2)(iii)(A)’’ in the 

correction document, but did not 

identify the format change at that time. 

(Comment 120) One comment 

suggested that the portion of the 

standard menu item used to calculate 

the calorie content also be clearly 

displayed in the same font, color, and 

size as the item name and be posted on 

or next to the available food on display 

or self-service food. 

(Response 120) We agree that the 

serving or unit of a standard menu item 

that is a self-service food or food on 

display used to determine the calorie 

content for such food must be included 

in the calorie declaration. Without 

information about the serving or unit of 

a self-service food or food on display, 

the consumer would not be able to 

ascertain the calorie content of the 

amount of food that would be 

consumed. This would defeat the 

purpose of the calorie declaration. 

Therefore, we have revised 

§ 101.11(b)(2)(iii)(A) to require that the 

calorie declaration for foods on display 

and self-service food include the serving 

or unit on which the calorie content is 

based. The requirements in 


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§ 101.11(b)(2)(iii)(A)(3)(ii) for font size 

and color will apply to the entire calorie 

declaration, including the serving or 

unit used to determine calorie content. 

(See the discussion of 

§ 101.11(b)(2)(iii)(A)(3)(ii) in section 

XVII.E.2.) 

(Comment 121) One comment asked 

us to allow a covered establishment to 

list nutrition information for standard 

menu items that are self-service or on 

display per serving size and requested 

clarification on how the RACC would be 

used in this case. The comment asked 

us to keep in mind that many retailers 

would like to align their calorie 

declarations for menu items with 

serving sizes for packaged food so as not 

to have two different serving sizes. 

(Response 121) In Response 65 in 

section XI, we explained why a calorie 

declaration for a multiple-serving 

standard menu item that is not selfservice or on display must declare ‘‘the 

number of calories contained in the 

standard menu item, as usually 

prepared and offered for sale’’ instead of 

per RACC (to the extent that there is a 

RACC for such standard menu item). 

Similarly, we disagree that a calorie 

declaration for a standard menu item 

that is a self-service food or food on 

display should be declared per RACC or 

per serving size used on packaged food, 

unless such RACC or serving size is the 

portion or serving used by the covered 

establishment to display or otherwise 

offer such standard menu item for sale. 

Self-service food and food on display 

may be portioned differently than a 

RACC or serving size used on packaged 

food. Section 403(q)(5)(H) of the FD&C 

Act does not require a covered 

establishment to prepare and offer 

standard menu items in particular sizes 

or amounts, such as RACCs or serving 

sizes used on packaged foods. Instead, 

section 403(q)(5)(H)(iii) of the FD&C Act 

expressly requires covered 

establishments to disclose the number 

of calories for self-service foods and 

foods on display ‘‘per displayed food 

item or per serving.’’ Accordingly, a 

covered establishment may choose the 

portion or serving of the food that it 

offers for sale, and must base the calorie 

declaration for a self-service food or 

food on display per displayed item (e.g., 

‘‘per muffin’’) or per serving (e.g., ‘‘per 

scoop’’) as offered for sale. 

(Comment 122) A few comments 

expressed concern with portion sizes 

and with declaring nutrient values for 

items that vary in size and content (e.g., 

baked potato, chicken breast). Some 

comments asked for guidance on serving 

sizes for calorie declarations pertaining 

to foods on display. One comment asked 

us to clarify that the calories should be 

declared per item or serving as offered 

for sale and not for a portion of a food 

item that is smaller than the food 

offered for sale. For example, a covered 

establishment that offers a large muffin 

for sale should be required to declare 

calories per item (i.e., the large muffin) 

and should not be permitted to declare 

calories per serving and describe the 

large muffin as containing two servings. 

One comment maintained that 

calories of foods at salad bars should be 

declared per cup and not per serving. 

Several comments asked us to require 

that calories be based on serving utensil 

sizes where possible. One comment 

recommended that we require the same 

serving size as for packaged food if no 

utensil is used. The comment suggested 

that calories be declared per cup if tongs 

are used for lettuce at a salad bar. The 

comment suggested that the rule be 

revised to include: 

(iii) The following must be provided 

for food that is self-service or on 

display. 

‘‘(1) Calories must be provided for 

each standard serving size offered, e.g., 

each beverage cup size offered for a 

fountain beverage dispenser or each 

container size available for a deli salad. 

(2) For purposes of 

§ 101.10(b)(2)(iii)(A), ‘‘per item’’’ means 

per each discrete unit offered for sale— 

for example, a bagel, a muffin, a 

sandwich, or a multi-serving food, such 

as a whole cake. 

(3) If the item is not sold as a discrete 

unit, it can be labeled per serving. For 

purposes of § 101.10(b)(2)(iii)(A), ‘‘per 

serving’’’ means: 

(i) Per each scoop or container as 

dished up using the serving instrument 

provided, such as a ladle, cup, or 

measuring spoon, or per weight or 

container-size offered, such as a quarter 

pound of potato salad or a container of 

soup. 

(ii) If the item is not served using a 

ladle or other measuring instrument or 

per container size, the item must be 

labeled in the common household 

measure closest to the Reference 

Amount Customarily Consumed (RACC) 

for that item, e.g., per cup or 

tablespoon.’’ 

(Response 122) We agree that a calorie 

declaration for a self-service food or 

food on display per displayed food item 

should be declared for the entire item as 

offered for sale and not based on a 

portion of the food item that is smaller 

than the food item offered for sale. For 

example, if a covered establishment 

offered a muffin for sale as a self-service 

food or food on display, the 

establishment should declare calories 

for the entire muffin rather than just a 

portion of the muffin (e.g., one-half or 

one-third of the muffin) because the 

entire muffin is the standard menu item 

offered for sale by the establishment. 

We also agree with the comment 

asserting that the rule should be revised 

to require that when a self-service food 

or food on display is offered for sale per 

displayed food item, meaning per a 

discrete unit offered for sale, such as a 

bagel, a slice of pizza, or a muffin, the 

calorie declaration for such food should 

be based on the discrete unit offered for 

sale rather than another amount. In the 

proposed rule, we tentatively concluded 

that for self-service food or food on 

display that is displayed per item, 

where the item represents one serving, 

the calorie declaration should be per 

item (76 FR 19215). We affirm this 

conclusion. 

We also agree with the comment 

asserting that the rule should be revised 

to require that when a self-service food 

or food on display is not offered for sale 

per displayed food item, the calorie 

declaration for such food should be 

based on the serving offered for sale. In 

the proposed rule, we tentatively 

concluded that 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), the 

calorie declaration should be per 

serving (76 FR 19215). We affirm this 

conclusion. 

For these reasons, we have revised 

§ 101.11(b)(2)(iii)(A) to further specify 

that a covered establishment must 

declare calories for a self-service food or 

food on display per displayed food item, 

or if the food is not sold in a discrete 

unit, per serving as offered for sale. 

Under § 101.11(b)(2)(iii)(A)(1), ‘‘per 

displayed food item’’ means per each 

discrete unit offered for sale, for 

example, a bagel, a slice of pizza, or a 

muffin. Accordingly, if a covered 

establishment offers a food that is selfservice or on display for sale in a 

discrete unit, such as a muffin, the 

establishment would have to declare 

calories for the food per such discrete 

unit offered for sale, and not based on 

a different amount. 

As discussed in Response 65 and 

Response 121, we disagree that the rule 

should require that calories for selfservice food and food on display be 

declared per RACC and, therefore, we 

are not revising § 101.11(b)(2)(iii)(A)(2) 

to require that an item that is not served 

using a measuring instrument be labeled 

in the common household measure 

closest to the RACC for that item. 

However, we agree that specifying that 

calories for a self-service food or food on 

display be disclosed per displayed food 

item, if applicable, and providing other 

options to declare calories ‘‘per serving 


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71222 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

instrument’’ and ‘‘per common 

household measure’’ in separate 

subparagraphs, as suggested by this 

same commenter, would provide a 

clearer framework regarding how calorie 

declarations must be provided for selfservice foods and foods on display. 

Therefore, in addition to the revisions 

we made to § 101.11(b)(2)(iii)(A)(1) as 

described previously, we have revised 

§ 101.11(b)(2)(iii)(A)(2)(i) to specify that, 

for the purposes of § 101.11(b)(2)(iii)(A), 

‘‘per serving’’ means (1) per serving 

instrument used to dispense the food 

offered for sale, provided that the 

serving instrument dispenses a uniform 

amount of the food (e.g., a scoop or 

ladle); or (2) if a serving instrument that 

dispenses a uniform amount of food is 

not used to dispense the food, per each 

common household measure (e.g., cup 

or tablespoon) offered for sale or per 

unit of weight offered for sale (e.g., per 

quarter pound or per 4 ounces). As 

revised, §§ 101.11(b)(2)(iii)(A)(1), and 

(b)(2)(iii)(A)(2)(i) to (b)(2)(iii)(A)(2)(ii) 

establish a logical hierarchy for 

determining how to declare calories for 

a self-service food or food on display. 

For example, if a covered establishment 

offered a self-service food for sale in a 

discrete unit, such as a muffin, the 

establishment would have to declare 

calories for the muffin as a whole. If the 

covered establishment offered another 

self-service food for sale, but the food 

was not offered for sale in a discrete 

unit, such as pasta salad, the 

establishment would have to declare 

calories for the food ‘‘per serving’’ as 

defined in § 101.11(b)(2)(iii)(A)(2). 

Under § 101.11(b)(2)(iii)(A)(2)(i), the 

covered establishment would have to 

declare calories for the pasta salad per 

serving instrument used to dispense the 

pasta salad if the serving instrument 

dispensed a uniform amount of the food 

(e.g., per scoop or ladle). If the covered 

establishment used a serving instrument 

that does not dispense a uniform 

amount of the food, such as tongs, 

declaring calories per that serving 

instrument used to dispense the food 

would not be appropriate because the 

calorie declarations would not always 

be consistent with the amount of food 

dispensed, and therefore the covered 

establishment would look to the 

remaining options to declare calories, 

which include declaring calories per 

common household measure or per unit 

of weight offered for sale (in 

§ 101.11(b)(2)(iii)(A)(2)(ii)). If a covered 

establishment offers food for sale per 

unit of weight, and the unit of weight 

offered for sale is in ounces, then it 

would be required to declare calories 

per ounce (or per some number of 

ounces)—i.e., using the same unit of 

weight (ounces) as the unit of weight 

offered for sale. 

We disagree that we should establish 

specific examples of portion sizes in the 

rule or add details such as specifying 

that a ‘‘container of soup’’ is an 

appropriate portion size for soup. A 

covered establishment has flexibility to 

establish the portion sizes for standard 

menu items offered for sale in such 

establishment. 

As discussed in section VI.C, the 

definition of ‘‘restaurant-type food’’ 

generally covers food that usually is 

eaten on the premises, while walking 

away, or soon after arriving at another 

location. Foods (such as whole cakes 

and deli salads that are sold from a 

display case rather than from a salad 

bar) that are grocery-type items that 

consumers usually store for use at a 

later time or customarily further prepare 

would not be included within the 

meaning of ‘‘restaurant-type food.’’ 

Thus, we have deleted ‘‘a multi-serving 

food such as a whole cake’’ from 

§ 101.11(b)(2)(iii)(A)(1). We decline to 

add ‘‘deli salad’’ as an example in what 

we mean by ‘‘per serving’’ because 

doing so could incorrectly imply that a 

deli salad sold at a deli counter as a 

grocery-type item is likely to be covered 

by the rule. We are adding 

§ 101.11(b)(2)(iii)(A)(2)(iii) to specify 

what we mean by ‘‘per serving’’ for selfservice beverages—i.e., per total number 

of fluid ounces in the cup in which a 

self-service beverage is served and, if 

applicable, the description of the cup 

size (e.g., ‘‘140 calories per 12 fluid 

ounces (small)’’). See Response 125 in 

the next section of this document for an 

explanation of this new provision. 

(Comment 123) One comment noted 

that some foods on display are offered 

in different flavors or varieties such as 

ice cream or doughnuts. The comment 

asked us to clarify that a covered 

establishment may disclose the 

nutrition information for such items by 

using a range per serving (or one of the 

other options being considered for other 

variable menu items). 

(Response 123) A standard menu item 

on display may meet the definition for 

a variable menu item in § 101.11(a) 

when it is offered for sale in different 

flavors, varieties, or combinations, and 

is listed on a menu or menu board as a 

single menu item. When this is the case, 

the format requirements for variable 

menu items in § 101.11(b)(2)(i)(A)(4) 

through (b)(2)(i)(A)(8) would apply to 

calories declared on the menu or menu 

board. Accordingly, to the extent that 

standard menu items on display offered 

for sale in different flavors or varieties 

are listed as single menu items on 

menus or menu boards, a covered 

establishment would be required to 

declare calories on such menus and 

menu boards for such foods using the 

same methods applicable to other 

variable menu items, including ranges, 

as specified in § 101.11(b)(2)(i)(A)(4) 

through (b)(2)(i)(A)(8). However, when 

these foods are on display, they would 

also be subject to the requirements of 

section 403(q)(5)(H)(iii) of the FD&C Act 

and § 101.11(b)(2)(iii). For a standard 

menu item that is a self-service food or 

food on display, section 403(q)(5)(H)(iii) 

of the FD&C Act requires the covered 

establishment to ‘‘place adjacent to each 

food offered a sign that lists the calories 

per displayed food item or per serving’’ 

(emphasis added). Typically, a standard 

menu item that is on display is 

presented to the consumer as a unique 

menu item, in that the food is made 

visible to the consumer, and the 

consumer can see what other standard 

menu items are available, including 

other standard menu items that come in 

different flavors, varieties, or 

combinations, such as various muffins 

or pastries in a display case. Because 

these standard menu items typically are 

on display in a manner that allows 

consumers to see each menu item 

individually, as well as the other menu 

items available, including menu items 

offered in different flavors or varieties, 

the way in which these items are offered 

for sale is not analogous to standard 

menu items that come in different 

flavors or varieties but are listed as a 

single menu item on a menu or menu 

board. For example, a covered 

establishment may offer for sale 

different flavors of ice cream (e.g., 

vanilla, chocolate, strawberry) in 

individual containers in a display case 

visible to consumers. In this situation, 

because the consumer can see each 

flavor of ice cream offered for sale, the 

consumer should also be able to see the 

number of calories contained for each 

flavor of ice cream offered for sale. As 

a result, the covered establishment 

would be required to place a sign 

adjacent to each flavor of ice cream in 

the display case that lists the calories 

per each individual displayed food item 

or per serving in accordance with 

§ 101.11(b)(iii). 

D. Declaring Calories ‘‘Per Serving’’ for 

Self-Service Beverages 

In the proposed rule, we discussed 

the serving size of beverages following 

our discussion of the declaration of 

calories for self-service food and food on 

display ‘‘per item’’ and ‘‘per serving’’ 

(76 FR 19192 at 19216). We recognized 

that covered establishments may have 

different sizes for beverages that are 


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listed on the menu as small, medium, 

and large and stated that we were 

considering whether the amount of 

calories declared should be based on the 

number of ounces. In the proposed rule, 

we anticipated 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).’’ We requested 

and received comment on this issue. 

After considering these comments, we 

are establishing a new provision to 

specify that, for beverages that are selfservice or on display, ‘‘per serving’’ 

means per total number of fluid ounces 

in the cup in which a self-service 

beverage is served and, if applicable, the 

description of the cup size (e.g., ‘‘140 

calories per 12 fluid ounces (small)’’) 

(§ 101.11(b)(2)(iii)(A)(2)(iv)). As an 

operational companion to new 

§ 101.11(b)(2)(iii)(A)(2)(iii), we also are 

establishing a new provision 

(§ 101.11(b)(2)(iii)(A)(3)(iii)) to require 

that calorie declarations for self-service 

beverages be accompanied by the term 

‘‘fluid ounces’’ and, if applicable, the 

description of the cup size (e.g., 

‘‘small,’’ ‘‘medium’’). (See also Response 

129 in section XVII.E.3 of this 

document.) 

(Comment 124) One comment noted 

that the proposed rule did not address 

the issue of ice fill for the declaration of 

calories for beverages. The comment 

asked us to permit covered 

establishments to calculate calories 

based on their standard ice fill as long 

as the level of ice fill is disclosed to 

consumers. The comment recommended 

that we expressly permit, regardless of 

whether there is a standard ice fill, the 

following statement regarding ice fill: 

‘‘Calorie content may vary based on the 

amount of ice used.’’ 

(Response 124) We previously 

addressed this comment with respect to 

beverages that are not self-service (see 

the discussion of § 101.11(b)(2)(i)(A)(9) 

in section XIII). Under section 

403(q)(5)(H)(iii) of the FD&C Act, 

calories for standard menu items that 

are self-service foods and foods on 

display, including ‘‘soft drinks,’’ must 

be declared ‘‘per displayed food item or 

per serving’’ (emphasis added). For 

beverages that are self-service, the actual 

amount of a beverage dispensed by 

consumers will vary depending on the 

size of the cup and the amount of ice or 

beverage that a consumer may add to 

the cup. For these reasons, the 

provisions we are establishing in this 

rule for self-service beverages require 

declaration of calories based on the full 

volume of the cup (i.e., without ice), and 

do not provide for the declaration of 

calories based on a standard beverage 

fill or standard ice fill. (See discussion 

of § 101.11(b)(2)(iii)(A)(2)(iii) of the final 

rule immediately following.) 

We would not object to a covered 

establishment posting a statement (at 

the self-service beverage dispenser, on 

the menu or menu board, or both) 

indicating that the calories for the selfservice beverages may vary depending 

on the amount of ice dispensed (e.g., 

‘‘calorie content may vary based on the 

amount of ice used’’). 

(Comment 125) One comment 

asserted that calories for self-service 

beverages should not be listed for an 

‘‘appropriate serving size’’ such as 12 

ounces because this may not correspond 

to the sizes that are actually sold in the 

covered establishment. 

(Response 125) We agree that the 

number of ounces in a beverage cup 

may vary between covered 

establishments and we agree that the 

rule should not establish ‘‘an 

appropriate serving size’’ for self-service 

beverages. We also agree that consumers 

should be given calorie information 

based on the number of ounces in the 

cup which the consumer uses to 

dispense a self-service beverage. Section 

403(q)(5)(H)(iii) of the FD&C Act 

provides that calories for self-service 

foods and foods on display be declared 

‘‘per displayed food item or per serving’’ 

(emphasis added). For self-service 

beverages, the serving units depend, in 

part, on the cups provided by the 

covered establishment to consumers for 

use at the self-service beverage 

dispenser. The actual amount of 

beverage dispensed by consumers will 

vary based on the size of the cup and 

the amount of beverage that a consumer 

dispenses into the cup. As already 

discussed in Response 124, the actual 

amount of beverage dispensed by 

consumers also will vary based on the 

amount of ice that a consumer may add 

to the cup, and in contrast to some nonself-service beverages offered for sale by 

a covered establishment, self-service 

beverage dispensers typically do not 

have a standard beverage fill or standard 

ice fill. In addition, for any given 

establishment, the cups provided for 

self-service beverages may be in a single 

size or may be in different sizes, e.g., in 

cups labeled ‘‘small,’’ ‘‘medium,’’ or 

‘‘large.’’ Further, as already noted, 

covered establishments may have 

different sizes for beverages that are 

listed on menus as small, medium, and 

large. For these reasons, we are 

specifying that, for self-service 

beverages, calories ‘‘per serving’’ within 

the meaning of section 403(q)(5)(H)(iii) 

of the FD&C Act must be based on the 

number of ounces in the cup in which 

the beverage is served. 

Therefore, § 101.11(b)(2)(iii)(A)(2)(iii) 

of the final rule specifies that, for 

purposes of § 101.11(b)(2)(iii)(A), ‘‘per 

serving’’ means, for beverages that are 

self-service, per total number of fluid 

ounces in the cup in which a selfservice beverage is served and, if 

applicable, the description of the cup 

size (e.g., ‘‘140 calories per 12 fluid 

ounces (small)’’). As an operational 

companion to 

§ 101.11(b)(2)(iii)(A)(2)(iii), we also are 

establishing specific format 

requirements applicable to the 

declaration of calories for self-service 

beverages. 

Section 101.11(b)(2)(iii)(A)(3)(iii) of 

the final rule requires that, for selfservice beverages, calorie declarations 

must be accompanied by the term ‘‘fluid 

ounces’’ and, if applicable, the 

description of the cup size (e.g., 

‘‘small,’’ ‘‘medium’’). By providing the 

number of fluid ounces in the cup in 

which the self-service beverage is served 

and a description of the size of the cup, 

if applicable, along with the calories for 

the self-service beverage, the calorie 

declaration will provide necessary 

context regarding the amount of the 

beverage (i.e., the number of fluid 

ounces dispensed) upon which to base 

the number of calories for the selfservice beverage. This information will 

enable consumers to determine how 

many calories are contained in a serving 

of the self-service beverage in a direct 

and consistent manner. 

E. Manner of Declaring Calories for SelfService Foods and Foods on Display 

1. Increments of Calories 

Proposed § 101.11(b)(2)(iii)(A)(3)(i) 

would require that calories for selfservice food and food on display be 

declared 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. 

We received no comments on this 

proposed provision and are finalizing it 

without change, except for an editorial 

change to express ‘‘nearest 10-calorie 

increments’’ in the singular (i.e., 

‘‘nearest 10-calorie increment’’). 

2. Requirements for Declaration of 

Calories To Be Clear and Conspicuous 

Proposed § 101.11(b)(2)(iii)(A)(3)(ii) 

would require that 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 


rljohnson on DSK3VPTVN1PROD with RULES2
71224 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

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. Proposed 

§ 101.11(b)(2)(iii)(A)(3)(ii) inadvertently 

included the clause ‘‘if the food is not 

already accompanied by a sign with the 

food’s name, price, or both’’ in two 

locations within the provision. 

In the proposed rule, we requested 

comment on whether additional or more 

specific formatting requirements are 

necessary (76 FR 19192 at 19215). In the 

following paragraphs, we discuss 

comments on the proposed provision. 

We also discuss comments in response 

to our specific request on whether 

additional or more specific formatting 

requirements are necessary. After 

considering these comments, we are 

finalizing it with the following changes: 

• For consistency with the provisions 

we are establishing in 

§ 101.11(b)(2)(iii)(A), we are specifying 

that the calorie declarations must 

include the amount of the serving on 

which the calories are based. 

• For consistency with the provisions 

we are establishing in § 101.11(b)(2)(iii), 

we are making a series of changes to 

address options that a covered 

establishment can use to declare 

calories for self-service food or food on 

display, including the use of an 

additional sign even if a food is already 

accompanied by a sign with the food’s 

name, price, or both. 

• To provide for a consistent 

approach to the requirements for a 

contrasting background throughout the 

rule, we are providing additional 

flexibility for the contrasting 

background used for the calorie 

declaration and making a conforming 

editorial change to the grammatical 

construction of the requirement for the 

color used for the calorie declaration. 

• As an editorial correction for 

clarity, we are inserting ‘‘the type size 

of’’ between ‘‘no smaller than’’ and ‘‘the 

name or price.’’ 

(Comment 126) One comment 

recommended that we require the 

calorie declaration to be clear and 

conspicuous but not in a type size as 

large as the food’s name or price. The 

comment maintained that if these foods 

already have signs, there is likely no 

room for calorie declarations. 

One comment pointed out that 

fountain machines have small signs or 

‘‘valve decals’’ on which the name is 

placed. According to the comment these 

valve decals can be as small as 0.7 x 1 

inches to 5.25 x 5.25 inches and these 

signs do not have enough space to list 

the calorie declarations. The comment 

recommended that a covered 

establishment not have to list the 

calories adjacent to the dispenser if 

calories for fountain drinks are listed on 

menus and menu boards and the written 

nutrition information is available, 

because to do so would be burdensome. 

One comment asked us to allow a 

covered establishment to use a sign or 

placard placed adjacent to the fountain 

beverage machine that lists the calories. 

Another comment recommended that 

calorie declarations for self-serve 

beverages be posted on menus, menu 

boards, or brochures, and not at the 

dispensers. One comment 

recommended that calorie declarations 

be listed both on the menu boards and 

the dispenser for each type of beverage 

dispensed. 

One comment noted that brand names 

are stylized and therefore the names of 

beverages may be in different type sizes. 

The comment maintained that tying the 

type size of the calories to the name of 

the beverage would result in differing 

sizes for calories, which could be 

confusing. 

(Response 126) Section 

403(q)(5)(H)(iii) of the FD&C Act 

requires covered establishments to place 

adjacent to each standard menu item 

that is a self-service food or food on 

display, including self-service 

beverages, a sign that lists calories per 

displayed food item or per serving. As 

discussed previously in this document 

(see Response 116), a covered 

establishment must also declare calories 

on a menu or menu board, and follow 

all applicable requirements of 

§ 101.11(b)(2)(i) for declaration of 

calories on the menu or menu board, 

when self-service food or food on 

display is listed on the menu or menu 

board. 

We acknowledge that there may be 

space limitations on signs used for selfservice food (including valves used for 

self-service beverages) and foods on 

display. As already discussed in section 

XVII.B, we have revised 

§ 101.11(b)(2)(iii)(A) to provide more 

options for the declaration of calories 

for self-service food and food on 

display, including the use of additional 

signs, signs attached to a sneeze guard, 

or a single sign or placard listing the 

calorie information for several standard 

menu items that are self-service or on 

display provided that certain conditions 

are met. These options provide 

additional flexibility for a covered 

establishment that offers self-service 

foods, including self-service beverages, 

to declare the calories in a manner that 

works best for it. For example, a covered 

establishment has an option to declare 

the calories on a sign separate from the 

sign containing the food’s name and 

price, provided the calories are clearly 

associated with the particular food item. 

Doing so would no longer link the type 

size requirements for a self-service 

beverage to those for the name of the 

beverage. As a result, we have revised 

§ 101.11(b)(2)(iii)(A)(3)(ii) to provide 

that if a calorie declaration for a selfservice food or food on display is 

provided on a sign that includes the 

food’s name, price, or both, the calorie 

declaration, accompanied by the term 

‘‘Calories’’ or ‘‘Cal’’ and the amount of 

the serving or displayed food item on 

which the calorie declaration is based, 

must be in a type size no smaller than 

the type size of the name or price of the 

food, whichever is smaller, in the same 

color, or a color that is at least as 

conspicuous as that used for the name 

or price, using the same contrasting 

background, or a background at least as 

contrasting. 

(Comment 127) One comment 

addressed the different proposed 

requirement for self-service food and 

food on display depending on whether 

the food is already accompanied by a 

sign with the food’s name, price, or 

both. If the food is already accompanied 

by such a sign, the comment said that 

the proposed provision would be 

prescriptive with respect to type size, 

color, and contrast requirements for the 

calorie declarations, whereas if the food 

is not already accompanied by such a 

sign, the proposed provision would be 

less prescriptive by merely requiring 

that calorie declarations be ‘‘clear and 

conspicuous.’’ The comment asked us to 

revise the rule to establish the less 

prescriptive requirement that the calorie 

information be clear and conspicuous 

regardless of whether the food is 

accompanied by a sign with the name or 

price of the food. The comment 

considered that a prescriptive 

requirement linked to type size, color, 

and contrast requirements of the food’s 

name, price, or both would be 

misleading because it would imply that 

the number of calories in a food, which 

is just one attribute of the food, is as 

important as the name of a food. 

One comment stated that the type size 

of calorie declarations should be no 

smaller than the name or price, 

whichever is larger. Another comment 

stated that the calories for food on 

display should be permitted to be 


rljohnson on DSK3VPTVN1PROD with RULES2
Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 71225 

displayed in a font that is smaller than 

the font size of the name of the menu 

item. (By ‘‘menu item,’’ we assume that 

the comment means the food’s name, 

price, or both.) One comment suggested 

that the provision be revised to include 

‘‘The calorie information on the sign 

must be readable from the point where 

consumers are choosing their food, and 

it must be readily apparent which sign 

labels which item, both by proximity 

and by including the name of the 

product on the sign.’’ 

(Response 127) We disagree that we 

should require the type size of the 

calorie declaration for food on display 

to be no smaller than the type size of the 

name or price, whichever is larger. All 

other requirements of this rule that 

anchor a type size to information 

already presented to consumers allow a 

covered establishment to use a type size 

no smaller than (rather than no larger 

than) the type size of the information 

already presented, and the comment 

provided no basis for why the rule 

should have a different standard for 

calorie declarations on signs for food on 

display and self-service food. 

We also disagree that calories for food 

on display and self-service food should 

be permitted to be displayed in a font 

that is smaller than the font size of the 

name or price of the menu item. 

Because consumers need to see the 

name and price to place an order, 

anchoring the type size of the calorie 

declaration to the type size of 

information already on the sign acts, in 

essence, as an objective and measurable 

performance standard for whether a 

disclosure is clear, conspicuous, and 

prominent. Thus, we do not agree that 

a smaller type size should be used for 

the calorie declaration, because doing so 

would no longer provide for such an 

objective and measurable performance 

standard. Therefore, we are retaining the 

type size requirements for the calorie 

declaration for food on display and selfservice food that are already 

accompanied by individual signs. 

However, to be consistent with changes 

we are making to other provisions of the 

rule, we have revised 

§ 101.11(b)(2)(iii)(A)(3)(ii) to provide 

additional flexibility for the contrasting 

background of the calorie declaration by 

permitting the calorie declaration to be 

in a background at least as contrasting 

as that used for the name or price of the 

menu item. We also are making a 

conforming editorial change to the 

grammatical construction of the 

requirement for the color used for the 

calorie declaration to match the 

grammatical construction of the revised 

requirement for the contrasting 

background used for the calorie 

declaration. We also are making an 

editorial correction to insert ‘‘the type 

size of’’ between ‘‘no smaller than’’ and 

‘‘the name or price.’’ 

No comments suggested specific 

formatting requirements for calorie 

declarations when there are no preexisting signs with the name or price of 

the food to which the calorie declaration 

can be anchored. Covered 

establishments have the flexibility to 

post the calorie information in a manner 

that ensures that it is clear, 

conspicuous, and prominent. 

3. Manner of Declaring Calories for SelfService Beverages 

In the proposed rule, we stated that 

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 

(76 FR 19192 at 19216). We received 

comment on calorie declarations for 

self-service beverages. After considering 

these comments, we are adding a new 

provision to require, for self-service 

beverages, that calorie declarations be 

accompanied by the term ‘‘fluid 

ounces’’ and, if applicable, the 

description of the cup size (e.g., 

‘‘small,’’ ‘‘medium’’). 

(Comment 128) A few comments 

recommended that calories be posted at 

self-service fountain dispensers for each 

beverage size offered in the covered 

establishment. One comment asked us 

to permit a sign or placard placed 

adjacent to a fountain beverage machine 

to separate calorie ranges for specific 

subcategories, e.g., regular soda, diet 

soda, milk, coffees, teas, juice by cup 

size. A few comments recommended 

that calorie declarations should provide 

the amount of calories as a range per 

size. 

(Response 128) We agree that calories 

must be posted at self-service fountain 

dispensers for each beverage size offered 

in the covered establishment. As noted 

previously, section 403(q)(5)(H)(iii) of 

the FD&C Act requires covered 

establishments to place adjacent to each 

standard menu item that is a self-service 

food or food on display, including selfservice beverages, a sign that lists 

calories per displayed food item or per 

serving. As already discussed (see 

section XVII.B), § 101.11(b)(2)(iii)(A) 

provides several options for where and 

how a covered establishment could 

place a sign or placard. 

Earlier in this document, we 

discussed another comment directed to 

the declaration of calories for selfservice beverages (see Comment 126 and 

Response 126). A self-service standard 

menu item, including a self-service 

beverage, is subject to § 101.11(b)(2)(i) 

(in addition to § 101.11(b)(2)(iii)) when 

such food is listed on a menu or menu 

board (see Comment 116 and Response 

116). The format requirements for 

variable menu items in 

§ 101.11(b)(2)(i)(A)(4) through 

(b)(2)(i)(A)(7) would apply to calorie 

declarations on a menu or menu board. 

Accordingly, to the extent that selfservice beverages offered for sale in 

different flavors or varieties are listed as 

single menu items on menus or menu 

boards (e.g., ‘‘soft drinks’’), a covered 

establishment would be required to 

declare calories on such menus and 

menu boards for such foods using the 

same methods applicable to other 

variable menu items, including ranges, 

as specified in § 101.11(b)(2)(i)(A)(4) 

through (b)(2)(i)(A)(8). However, at the 

point of self-service, a self-service 

beverage would be subject to the 

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

of the FD&C Act and § 101.11(b)(2)(iii). 

For a standard menu item that is a selfservice food, such as a self-service 

beverage, section 403(q)(5)(H)(iii) of the 

FD&C Act requires the covered 

establishment to ‘‘place adjacent to each 

food offered a sign that lists the calories 

per displayed food item or per serving.’’ 

Typically, a self-service fountain 

beverage machine separately dispenses 

each flavor or variety of beverage from 

individual valves or dispensers that list 

the flavor or variety of the beverage 

(such as orange soda, cola, diet cola), 

and the consumer can see what beverage 

flavors and varieties are available. 

Otherwise, consumers would not be 

able to determine which flavor or 

variety of beverage is dispensed from a 

particular valve or dispenser at the selfservice fountain beverage machine. 

Because these self-service beverages 

typically are presented in a manner that 

allows consumers to see each beverage 

individually, as well as the other 

beverages available, including other 

beverages offered in different flavors or 

varieties, the way in which these 

standard menu items are offered for sale 

is not analogous to standard menu items 

that come in different flavors or 

varieties but are listed as a single menu 

item on a menu or menu board. Further, 

because consumers can see flavor or 

variety of self-service beverage offered 

for sale, the consumer should also be 

able to see the number of calories 

contained in each flavor or variety 

offered for sale at the self-service 

machine. For these reasons, calories 

must be declared for each specific flavor 

or type of beverage available at a selfservice machine rather than declared as 

a range. 


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71226 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

(Comment 129) A few comments 

recommended that covered 

establishment should declare the 

amount of calories for self-service 

beverages based on the number of 

ounces served. A few other comments 

opposed declaring the number of 

calories per ounces served. These 

comments contended that it is more 

practical to estimate the size of a 

beverage with a household measure 

than to guess the ounces without 

measuring the beverage. The comments 

maintained that calories per ounce 

would be confusing. One comment 

stated that there is not enough space on 

menus for declaring the number of 

calories per ounce served. 

(Response 129) We disagree that 

declaring calories based on the volume 

in fluid ounces for self-service 

beverages, as required by 

§ 101.11(b)(2)(iii)(A)(2)(iii) of the final 

rule, would be overly confusing. Fluid 

ounces are commonly used to describe 

the volume of beverages in packaged 

food sold in the United States and, thus, 

consumers who purchase beverages 

likely would be familiar with ‘‘fluid 

ounces’’ in the context of beverages. 

Further, as discussed previously (see 

Response 125), 

§ 101.11(b)(2)(iii)(A)(2)(iii) of the final 

rule specifies that, for self-service 

beverages, ‘‘per serving’’ means per total 

number of fluid ounces in the cup in 

which a self-service beverage is served 

and, if applicable, the description of the 

cup size (e.g., ‘‘140 calories per 12 fluid 

ounces (small)’’). As an operational 

companion to 

§ 101.11(b)(2)(iii)(A)(2)(iii), we also are 

establishing in 

§ 101.11(b)(2)(iii)(A)(3)(iii) of the final 

rule specific format requirements 

applicable to the declaration of calories 

for self-service beverages. Section 

101.11(b)(2)(iii)(A)(3)(iii) of the final 

rule requires that, for self-service 

beverages, calorie declarations must be 

accompanied by the term ‘‘fluid 

ounces’’ and, if applicable, the 

description of the cup size (e.g., 

‘‘small,’’ ‘‘medium’’). For example, 

calories could be declared as ‘‘small 

Orange Fizz (12 fluid ounces)—150 

calories.’’ Accordingly, the calorie 

declaration will provide information 

regarding the number of fluid ounces 

served, and in some cases, the size of 

the cup, along with the number of 

calories. Typically, self-service 

beverages are offered for sale, including 

listed or otherwise separated by price, 

based on size (e.g., ‘‘small—$1.59,’’ ‘‘12 

ounces—$1.59’’), and the sizes are 

described using general descriptors (e.g., 

‘‘small,’’ ‘‘medium,’’ or ‘‘large,’’) or by 

fluid ounces. Therefore, in such 

situations, consumers will have further 

context regarding the number of fluid 

ounces served in a self-service beverage, 

and, in some cases, the size of the cup. 

F. Applicability of Requirements for 

Written Nutrition Information, Succinct 

Statement, and Statement of 

Availability to Self-Service Foods and 

Foods on Display 

In the proposed rule, we tentatively 

concluded that covered establishments 

must provide written nutrition 

information for self-service foods and 

foods on display that are standard menu 

items as required by section 

403(q)(5)(H)(ii)(III) of the FD&C Act (76 

FR 19192 at 19216). 

(Comment 130) One comment argued 

that applying certain requirements of 

section 403(q)(5)(H)(ii) of the FD&C Act 

to self-service food and food on display 

is not a reasonable construction of the 

statute, given that calorie disclosure 

requirements for self-service food and 

food on display appear ‘‘in a wholly 

different subclause.’’ The comment 

asserted that because the ‘‘subclause’’ 

(section 403(q)(5)(H)(iii)) of the FD&C 

Act) does not require additional written 

nutrition information or a succinct 

statement concerning suggested daily 

caloric intake and section 

403(q)(5)(H)(ii) of the FD&C Act does, 

Congress deliberately omitted those 

requirements from section 

403(q)(5)(H)(iii) of the FD&C Act. The 

comment argued that, given that every 

word excluded from a statute must be 

presumed to have been excluded 

intentionally, it is not permissible to 

interpret the statute to require covered 

establishments to provide additional 

written nutrition information and a 

succinct statement concerning suggested 

daily caloric intake for self-service food 

and food on display. 

(Response 130) We agree in part, and 

disagree in part, with the comment. As 

we discussed in the proposed rule and 

Response 116, section 403(q)(5)(H)(i) of 

the FD&C Act 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)’’ (emphasis added). The 

word ‘‘and’’ between the references to 

subclauses (ii) and (iii), as opposed to a 

disjunctive ‘‘or,’’ indicates that covered 

establishments must follow the 

requirements in subclause (ii) for all 

standard menu items, as applicable, and 

subclause (iii) for all standard menu 

items, as applicable. 

We acknowledge that a principle of 

statutory interpretation is that ‘‘where 

Congress includes particular language in 

one section of a statute but omits it in 

another section of the same [statute], it 

is generally presumed that Congress acts 

intentionally and purposely in the 

disparate inclusion or exclusion.’’ 

Russello v. U.S., 464 U.S. 16, 23 (1983) 

(internal citations omitted). We 

considered this principle when 

interpreting section 403(q)(5)(H) of the 

FD&C Act. Section 403(q)(5)(H)(ii)(III) of 

the FD&C Act—the section requiring 

additional written nutrition 

information—omits certain important 

words. Sections 403(q)(5)(H)(ii)(I), (II), 

and (IV) of the FD&C Act specify that 

certain disclosures must appear ‘‘on the 

menu,’’ ‘‘on the menu board,’’ and ‘‘on 

the menu or menu board,’’ respectively. 

Section 403(q)(5)(H)(ii)(III) of the FD&C 

Act does not mention menus or menu 

boards at all. Because section 

403(q)(5)(H)(i) of the FD&C Act states 

that covered establishments must 

disclose the information in section 

403(q)(5)(H)(ii) and (iii) of the FD&C Act 

for standard menu items, it is reasonable 

to apply section 403(q)(5)(H)(ii)(III) of 

the FD&C Act to standard menu items, 

regardless of whether they appear on 

menus or menu boards. Therefore, the 

rule requires that covered 

establishments provide the additional 

written nutrition information described 

in section 403(q)(5)(H)(ii)(III) of the 

FD&C Act for all standard menu items, 

including self-service food and food on 

display regardless of whether such 

standard menu items appear on menus 

or menu boards. 

We agree that the succinct statement 

concerning suggested daily caloric 

intake is required only on menus or 

menu boards, based on the plain 

language of sections 

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

403(q)(5)(H)(ii)(II)(bb) of the FD&C Act. 

Similarly, the statement of availability 

of the written nutrition information is 

only required on menus or menu 

boards, based on the plain language of 

section 403(q)(5)(H)(ii)(IV) of the FD&C 

Act. 

We discuss the specific requirements 

related to the succinct statement and 

statement of availability for self-service 

food and food on display in the next 

section. We discuss the specific 

requirements related to the written 

nutrition information for self-service 

food and food on display in section 

XVII.H. 

G. Succinct Statement and Statement of 

Availability for Self-Service Foods and 

Foods on Display 

Proposed § 101.11(b)(2)(iii)(B) would 

require that for food on display 

identified by a menu (meaning an 

identifying sign) adjacent to the food 

itself, the statement that puts the calorie 


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information in the context of a 

recommended total daily caloric intake 

as required by § 101.11(b)(2)(i)(B) and 

the statement regarding the availability 

of the additional written nutrition 

information required by 

§ 101.11(b)(2)(i)(C) must be provided in 

one of two ways. Proposed 

§ 101.11(b)(2)(iii)(B) would permit these 

two statements to 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. Proposed 

§ 101.11(b)(2)(iii)(B) would explain that 

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. 

In the following paragraphs, we 

discuss comments on this proposed 

provision. After considering these 

comments, we have revised the 

provision to clarify that the 

requirements to provide the statement 

that puts the calorie information in the 

context of a recommended total daily 

caloric intake (also referred to as the 

‘‘succinct statement’’) and the statement 

of availability for foods on display apply 

to all types of food on display, including 

those that are self-service. Further, we 

are also providing further flexibility for 

how to satisfy those requirements. 

(Comment 131) In the proposed rule, 

we noted that signs identifying food on 

display placed adjacent to such foods 

meet the definition of a ‘‘menu’’ or 

‘‘menu board’’ within the meaning of 

section 403(q)(5)(H)(xi) of the FD&C Act, 

in that such signs are the primary 

writings of the establishment from 

which consumers make order selections 

(76 FR 19192 at 19217). Further, we 

noted that, as a result, the requirements 

to disclose the succinct statement and 

statement of availability on menus and 

menu boards under sections 

403(q)(5)(H)(ii)(I)(bb), (II)(bb), and (IV) 

of the FD&C Act would apply to such 

small signs (76 FR 19192 at 19217). 

However, we noted that the 

requirements to post the statements on 

small signs seem to pose difficulties 

given the size of such signs, and from 

a consumer’s perspective, it is probably 

unnecessary for the two statements to 

appear on every single individual 

identifying sign. 

Taking these issues into 

consideration, along with the space on 

small signs that constitute menus and 

menu boards, as provided in section 

403(q)(5)(H)(x) of the FD&C Act, we 

tentatively concluded 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 (76 FR 19192 at 

19217). As a result, we proposed in 

§ 101.11(b)(2)(iii)(B) that covered 

establishments may place the succinct 

statement and statement of availability 

on individual specific signs or 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 (76 FR 19192 at 

19217). In addition, we tentatively 

concluded 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 the menu board, such 

that the menu board can be easily read 

as the consumer is viewing the food on 

display, could be considered part of that 

menu board. 

One comment asserted that menu 

boards, tags, and other signs within an 

establishment are used by consumers to 

identify standard menu items and make 

order selections. The comment argued, 

however, that tags or other signs should 

not be considered menus or menu 

boards because a menu board lists 

multiple items from which a consumer 

can make an order selection. 

One comment argued that if the 

succinct statement and statement of 

availability already appeared on a menu 

board, they should not have to appear 

again on signs adjacent or in close 

proximity to self-service foods or foods 

on display. The comment stated that the 

final rule should provide that posting 

the statement of availability and the 

succinct statement on the menu board of 

the covered establishment is sufficient 

to inform consumers who are selecting 

food on display and self-service food. 

(Response 131) We agree that an 

individual small sign adjacent to a selfservice food or food on display that 

contains the name (or image) and price 

of a standard menu item, and that can 

be used by a consumer to make an order 

selection from the establishment at the 

time the consumer is viewing the sign 

would meet the definition of a menu or 

menu board within the meaning of 

section 403(q)(5)(H)(xi) of the FD&C Act. 

As a result, the requirements of sections 

403(q)(5)(H)(ii)(I)(bb), (II)(bb), and (IV) 

of the FD&C Act for a succinct statement 

and statement of availability apply to 

such signs. However, as we noted in the 

proposed rule, the obligation to provide 

the succinct statement and statement of 

availability on every individual small 

sign likely would pose difficulties given 

the small size of these individual signs, 

and it likely would not be necessary, 

from a consumer’s perspective, for the 

two statements to appear on every 

individual sign (76 FR 19192 at 19217). 

Considering these factors and the 

limited space on these individual small 

signs that constitute menus or menu 

boards, as described by section 

403(q)(5)(H)(x)(II) of the FD&C Act, we 

conclude that, while each individual 

sign could be considered its own menu, 

a set of signs that are in close proximity 

to each other could also be viewed 

together as the primary writing from 

which consumers choose among items 

in making order selections. Further, we 

conclude that a covered establishment 

can satisfy the requirements for posting 

a succinct statement and statement of 

availability for self-service foods and 

foods on display by posting such 

statements on the individual sign 

adjacent to the food itself, on a separate, 

larger sign, in close proximity to the 

food that can be easily read as the 

consumer is making an order selection, 

or on a large menu board that can be 

easily read as the consumer is ordering 

the food. Accordingly, we are retaining 

§ 101.11(b)(2)(iii)(B) and making 

revisions for clarity. We have revised 

§ 101.11(b)(2)(iii)(B) to clarify that the 

provision applies to food that is selfservice or on display and is identified 

by an individual sign adjacent to the 

food itself where such sign meets the 

definition of a menu or menu board 

under paragraph (a) of this section. As 

an inadvertent error, proposed 

§ 101.11(b)(2)(iii)(B) opened with the 

clause ‘‘For food on display’’ and did 

not specifically identify food that is selfservice as being covered by the 

proposed requirements for providing the 

succinct statement and statement of 

availability on signs that are menus. As 

a practical matter, food that is ‘‘selfservice’’ is ‘‘on display’’ and, thus, the 

requirements apply to ‘‘self-service 

food’’ regardless of whether ‘‘selfservice food’’ is specified or not. 

Comments that addressed proposed 

§ 101.11(b)(2)(iii)(B) from the 

perspective of both food on display and 

self-service food implicitly 

acknowledged that self-service foods 

would be subject to proposed 

§ 101.11(b)(2)(iii)(B). Moreover, 

§ 101.11(b)(2)(iii)(B) is a subparagraph 

of § 101.11(b)(2)(iii), which establishes 

requirements for ‘‘food that is selfservice or on display.’’ For clarity, and 

to ensure that covered establishments 

are aware that § 101.11(b)(2)(iii)(B) and 

the flexibility it provides applies to selfservice foods identified by a menu 

adjacent to the food itself, we have 

revised the opening clause of 


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§ 101.11(b)(2)(iii)(B) to read ‘‘For food 

that is self-service or on display . . .’’ 

We also are making associated edits 

throughout the provision to remove any 

narrow reference only to food that is on 

display. 

H. The Written Nutrition Information 

That Must Be Provided for Food That Is 

Self-Service or on Display 

Proposed § 101.11(b)(2)(iii)(C) would 

require that the nutrition information in 

written form required by 

§ 101.11(b)(2)(ii) be provided for food 

that is self-service or on display, 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. In the following 

paragraphs, we discuss comments on 

this proposed provision. After 

considering these comments, we have 

revised § 101.11(b)(2)(iii)(C) to clarify 

the regulatory requirements that apply 

to the nutrition labeling information on 

the packaged food. 

(Comment 132) One comment asked 

us to provide more detail on what 

format establishments may use to 

provide the written nutrition 

information for foods on display and 

self-service food to ensure that the 

information is readily available and 

easily readable. 

(Response 132) Section 

101.11(b)(2)(ii) both requires that 

written nutrition information be 

available for standard menu items and 

establishes format requirements for that 

written nutrition information. With one 

exception, the format requirements of 

§ 101.11(b)(2)(ii) apply to standard 

menu items that are self-service food or 

food on display. See § 101.11(b)(2)(ii) 

and the discussion of § 101.11(b)(2)(ii) 

in section XVI. The exception is for 

packaged foods, insofar as they bear 

nutrition labeling required by section 

403(q)(5)(H)(ii)(III) of the FD&C Act and 

§ 101.11(b)(ii)(2)(D). We discuss this 

exception further in Response 133. 

(Comment 133) Two comments asked 

us to broaden the exception in 

§ 101.11(b)(2)(iii)(C) for packaged food 

in compliance with § 101.9, regardless 

of whether the nutrition information can 

be examined prior to purchase. One 

comment pointed out that some 

packaged confectioneries may be placed 

near the cash register in a covered 

establishment. The comment stated that 

these confectioneries may be exempt 

from the nutrition labeling requirements 

of § 101.9 because they have fewer than 

12 square inches of available label space 

or may be in gift packages. This 

comment stated that if a food is subject 

to and in compliance with § 101.9, it 

should not also be subject to § 101.11. 

The comment maintained that a food 

should be required to comply with one 

nutrition labeling regulation or the 

other, but not both. Another comment 

stated that some foods, such as food in 

small packages, foods with insignificant 

amounts of all the nutrients required on 

the labels of packaged food (e.g., bottled 

water) and foods sold in gift packages, 

which may provide the nutrition 

information inside the box or package, 

should be exempt from the menu 

labeling requirements even though their 

nutrient content cannot be examined by 

consumers prior to purchase. The 

comment also stated that if these foods 

included front of package labeling, they 

would lose the exemption from 

nutrition labeling. 

(Response 133) Section 403(q)(5)(H) of 

the FD&C Act does not establish any 

new requirements regarding the labels 

of packaged food. Furthermore, to 

clarify that the requirements of § 101.11 

do not affect the exemptions from 

nutrition labeling under § 101.9(j)(2) 

and (j)(3), we proposed conforming 

amendments to § 101.9(j)(2) and (j)(3). 

As discussed in the proposed rule, the 

NLEA amendments to the FD&C Act 

included an exemption, at sections 

403(q)(5)(A)(i) and (ii) of the FD&C Act, 

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’’ (76 FR 19192 at 19193 

(citing 21 U.S.C. 343(q)(5)(A)(i)). The 

NLEA amendments also included an 

exemption for food of the type described 

in section 403(q)(5)(A)(i) of the FD&C 

Act 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)). We issued 

regulations for these exemptions at 

§ 101.9(j)(2) and (j)(3); however, these 

exemptions were contingent on there 

being no nutrient content claims or 

other nutrition information in any 

context on the labeling or in the labeling 

or advertising. As discussed in section 

IV.B, we are finalizing the conforming 

amendments to § 101.9(j)(2) and (j)(3). 

Likewise, as discussed in section IV.B, 

we also have made a conforming 

amendment to § 101.9(j)(4), which 

applies to foods that contain 

insignificant amounts of nutrients and 

food components required to be 

included in the declaration on nutrition 

information under § 101.9(c). As a 

result, a food that is exempt from the 

requirements of § 101.9 under 

§ 101.9(j)(2), (j)(3), and (j)(4) would not 

fall out of such exemption by complying 

with the requirements of § 101.11. We 

also note that, for a standard menu item 

that contains insignificant amounts of 

all of the nutrients required in 

§ 101.11(b)(2)(ii)(A), including, if 

applicable, a packaged food, a covered 

establishment generally would not be 

required to provide written nutrition 

information for that standard menu item 

(see § 101.11(b)(2)(ii)(B)). 

Section 101.11 does not change the 

food label requirements under 

§ 101.9(h)(3) for food products with 

separately packaged ingredients or foods 

where a package contains a variety of 

foods, or an assortment of foods, and is 

in a form intended to be used as a gift. 

Similarly, § 101.11 does not change the 

exception at § 101.9(j)(13)(i) for foods in 

small packages that have a total surface 

area of less than 12 square inches of 

available label space. To the extent that 

such foods are offered for sale in 

covered establishments, they generally 

would fall within the exceptions at 

§ 101.9(j)(2) and (j)(3); when this is the 

case, the conforming amendments to 

§ 101.9(j)(2) and (j)(3) would preserve 

the pre-existing exemptions under 

§ 101.9 for such foods. 

While section 403(q)(5)(H) of the 

FD&C Act does not establish any new 

requirements regarding the labels of 

packaged food, there may be some 

situations in which a covered 

establishment (rather than the 

manufacturer of a packaged food) must 

disclose nutrition information for a food 

on display or a self-service food that is 

a packaged food, such as a packaged 

food that is offered for sale at a cash 

register in a covered establishment. For 

example, if a standard menu item, such 

as a package of chips, is on display (e.g., 

a package of chips that is part of a 

combination meal or listed individually 

on a menu or menu board and is 

available at a cash register), the covered 

establishment would be required to post 

a calorie declaration on a sign adjacent 

to the package of chips and provide 

written nutrition information for the 

package of chips unless the label for the 

chips bears calorie and certain other 

nutrition information and can be 

examined by the consumer prior to 

purchase. Further, the covered 

establishment would be required to post 

a calorie declaration for the package of 

chips on a menu and menu board to the 

extent the package of chips is listed on 

such menu and menu board. 

In the proposed rule, we tentatively 

concluded that a packaged food that is 

self-service or food on display that bears 


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nutrition information required by 

section 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 and the written nutrition 

information requirement of section 

403(q)(5)(H)(ii)(III) of the FD&C Act (see 

76 FR 19192 at 19217 and 19235). In 

addition, we tentatively concluded that, 

in such a situation, a covered 

establishment would still be required to 

post calorie declarations on menus and 

menu boards for packaged foods that are 

standard menu items and are listed on 

such menus and menu boards (e.g., 

where ‘‘chips’’ is listed on a menu board 

and refers to packaged bags of chips that 

are available as self-service foods or 

foods on display) (76 FR 19192 at 

19217). We affirm these conclusions; 

however, we have revised the exception 

at § 101.11(b)(2)(iii)(C). 

Under proposed § 101.11(b)(2)(iii)(C), 

self-service food and food on display 

would be subject to the written nutrition 

information requirement of 

§ 101.11(b)(2)(ii), except for packaged 

food that bears nutrition labeling 

information required by § 101.9 if the 

packaged food can be examined by a 

consumer before purchasing. In 

response to comments regarding a food 

that is in compliance with § 101.9 but 

does not otherwise bear nutrition 

labeling, we have revised the exception 

at § 101.11(b)(2)(iii)(C) to clarify in 

relevant part that a covered 

establishment is not required to provide 

the written nutrition information in 

§ 101.11(b)(2)(ii) for a packaged food, 

insofar as that packaged food bears the 

nutrition information specified in 

section 403(q)(5)(H)(ii)(III) of the FD&C 

Act and the written nutrition 

information requirements of 

§ 101.11(b)(2)(ii). For example, if the 

package of chips described previously 

includes Nutrition Facts information, 

including the nutrition information 

specified in section 403(q)(5)(H)(ii)(III) 

of the FD&C Act and § 101.11(b)(2)(ii), a 

covered establishment would not be 

required to provide written nutrition 

information for the chips as required by 

§ 101.11(b)(2)(ii), provided that the 

packaged food, including its label, can 

be examined by a consumer before 

purchasing the food. However, if the 

package of chips does not bear the 

nutrition information specified in 

section 403(q)(5)(H)(ii)(III) of the FD&C 

Act and § 101.11(b)(2)(ii) (e.g., because 

it is exempt from the nutrition label 

requirements of § 101.9, such as a food 

in a small package that has fewer than 

12 square inches of available label space 

as provided by § 101.9(j)(13)), the 

covered establishment would be 

required to provide written nutrition 

information for the chips as required by 

§ 101.11(b)(2)(ii). Moreover, if the 

package of chips does not bear the 

nutrition information specified in 

section 403(q)(5)(H)(ii)(III) of the FD&C 

Act and § 101.11(b)(2)(ii), the food 

would not satisfy the calorie disclosure 

requirement for self-service food or food 

on display in section 403(q)(5)(H)(iii) of 

the FD&C Act, and the covered 

establishment would be required to 

disclose the number of calories 

contained in the package of chips on a 

sign adjacent to the food, in accordance 

with § 101.11(b)(2)(iii). In either 

situation, the establishment would be 

required to post a calorie declaration for 

the package of chips on the menu and 

menu board to the extent the package of 

chips is listed on such menu and menu 

board, as required by § 101.11(b)(2)(i). 

XVIII. Comments and FDA Response on 

Proposed § 101.11(c)(1) to (c)(5)— 

Determination of Nutrient Content 

(Final § 101.11(c)(1) to (c)(2)) 

Under section 403(q)(5)(H)(iv) of the 

FD&C Act, a covered establishment 

must have a reasonable basis for its 

nutrient content disclosures, including 

nutrient databases, cookbooks, 

laboratory analyses, and other 

reasonable means, as described in 

§ 101.10. Proposed § 101.11(c)(1) would 

establish this reasonable basis 

requirement in this rule. 

In addition, proposed § 101.11(c)(2), 

(c)(3), (c)(4), and (c)(5) would establish 

requirements for determining 

compliance with proposed 

§ 101.11(c)(1). As discussed in the 

proposed rule, because the nutrition 

information that is required to be 

disclosed by covered establishments is a 

subset of the nutrition information 

required in § 101.9, we modeled 

proposed § 101.11(c)(2), (c)(3), (c)(4), 

and (c)(5) after our regulation for 

compliance with the nutrition labeling 

requirements for packaged foods in 

§ 101.9(g) (76 FR 19192 at 19218). In 

brief, for purposes of compliance, 

proposed § 101.11(c)(2), (c)(3), (c)(4), 

and (c)(5) would establish the following: 

• Proposed § 101.11(c)(2) would 

define two classes of nutrients. ‘‘Class I’’ 

nutrients would be ‘‘added’’ nutrients 

and ‘‘Class II’’ nutrients would be 

‘‘naturally occurring’’ (indigenous) 

nutrients in standard menu items; 

• Proposed § 101.11(c)(3) would 

establish conditions under which a 

standard menu item with a nutrient 

declaration of protein, total 

carbohydrate, or dietary fiber would be 

deemed to be misbranded under section 

403(a) of the FD&C Act, including a 

requirement that, for Class II protein, 

total carbohydrate, or dietary fiber, the 

nutrient content of an appropriate 

composite of a standard menu item not 

be less than 80 percent of the declared 

value; 

• Proposed § 101.11(c)(4) would 

establish conditions under which a 

standard menu item with a nutrient 

declaration of calories, sugars, total fat, 

saturated fat, trans fat, cholesterol, or 

sodium would be deemed to be 

misbranded under section 403(a) of the 

FD&C Act, including a requirement that 

the nutrient content of an appropriate 

composite of a standard menu item not 

be more than 20 percent in excess of the 

declared value; and 

• Proposed § 101.11(c)(5) would 

allow for reasonable excesses of protein, 

total carbohydrate, dietary fiber and 

reasonable deficiencies of calories, 

sugars, total fat, saturated fat, trans fat, 

cholesterol, or sodium. 

Comments commonly referred to the 

combined provisions of proposed 

§ 101.11(c)(3) and (c)(4) as ‘‘the 80/120 

rule.’’ 

In the following paragraphs, we 

discuss comments on proposed 

§ 101.11(c)(1), (c)(2), (c)(3), (c)(4), and 

(c)(5). After considering these 

comments, we are: 

• Finalizing § 101.11(c)(1) with 

several changes and making a 

companion change to the substantiation 

requirements of proposed § 101.11(c)(6) 

(which is being established in 

§ 101.11(c)(3)); 

• Replacing proposed § 101.11(c)(2), 

(c)(3), (c)(4), and(c)(5) with a new 

§ 101.11(c)(2); and 

• Establishing revised certification 

requirements (in § 101.11(c)(3)(i)(G), 

(c)(3)(ii)(D), (c)(3)(iii)(E), and 

(c)(4)(iv)(E)) directed to reasonable steps 

that a covered establishment takes to 

ensure that the method of preparation 

(e.g., types and amounts of ingredients 

in the recipe, cooking temperatures) and 

amount of a standard menu item offered 

for sale adhere to the factors on which 

the nutrient values were determined. 

(Comment 134) One comment 

asserted that the menu labeling 

requirements would have an impact on 

the manufacturers of foods sold to 

covered establishments, because 

covered establishments would look to 

the food manufacturers to supply them 

with the nutrition information that the 

covered establishments must provide to 

consumers. For the most part, food 

manufacturers do not currently provide 

restaurants and similar retail food 

establishments with this information. 

The comment maintained that some 

manufacturers may elect to provide the 

nutrition information in inserts and 


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other forms of labeling, which will 

require development of guidelines on 

how the nutrition information should be 

provided to restaurant customers. 

One comment asked us to consider 

nutritional information provided by a 

producer to a covered establishment to 

be a reasonable basis for the covered 

establishment’s nutrition declarations. 

Another comment maintained that 

because food suppliers are not required 

to provide nutrition information to 

retailers, compliance with the rule will 

be challenging for covered 

establishments. The comment asked us 

to consider requiring suppliers to 

provide nutrition information to 

covered establishments. 

(Response 134) The nutrition labeling 

provisions of this rule only apply to 

covered establishments as specified in 

§ 101.11(a). Section 4205 of the ACA 

does not require distributors of food 

sold to covered establishments to 

provide nutrition information to those 

establishments. In addition, section 

4205 of the ACA did not remove or 

amend section 403(q)(5)(G) of the FD&C 

Act, which provides that the nutrition 

labeling requirements of section 

403(q)(1) through (4) of the FD&C Act do 

not apply to ‘‘food which is sold by a 

food distributor if the distributor 

principally sells food to restaurants and 

other establishments in which food is 

served for immediate human 

consumption and does not manufacture, 

process, or repackage the food it sells.’’ 

Accordingly, this rule does not require 

distributors of food sold to covered 

establishments to provide nutrition 

information to covered establishments. 

Nevertheless, we have revised 

§ 101.11(c)(1), in relevant part, to 

expressly specify that the use of 

Nutrition Facts on labels on packaged 

foods that comply with the nutrition 

labeling requirements of section 

403(q)(1) of the FD&C Act and § 101.9 is 

an additional means that may be used 

as a reasonable basis to determine 

nutrient values. 

We encourage cooperation between 

food distributors and covered 

establishments so that covered 

establishments are able to efficiently 

comply with the requirements of this 

rule. We would consider nutrition 

information otherwise provided by food 

distributors to covered establishments 

for food sold by such distributors to be 

captured within the provision that 

nutrient values may be determined by 

using ‘‘other reasonable means’’ 

provided that such nutrition 

information is truthful and not 

misleading and otherwise in compliance 

with the requirements of sections 

403(a)(1) and (q)(5)(H) of the FD&C Act 

and § 101.11. 

We also have revised § 101.11(c)(1) to 

include another example of ‘‘other 

reasonable means’’—i.e., FDA nutrient 

values for raw fruits and vegetables in 

Appendix C of part 101 and FDA 

nutrient values for cooked fish in 

Appendix D of part 101. We developed 

this nutrition information to encourage 

retail stores that sell raw fruits, 

vegetables, and cooked fish to 

participate in the voluntary point-ofpurchase nutrition program (§§ 101.42 

through 101.45). 

(Comment 135) Many comments 

agreed that a covered establishment 

must have a reasonable basis for its 

nutrient content disclosures and the 

means for determining them, which 

include nutrient databases, cookbooks, 

laboratory analyses, and other 

reasonable means, as described in 

§ 101.10. Some comments suggested that 

we replace the language in proposed 

§ 101.11(c) with the language in 

§ 101.13(q)(5)(ii). Section 101.13(q)(5) 

sets forth requirements for nutrient 

content claims for 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. Section 

101.13(q)(5)(ii) provides that for 

nutrient content claims made for such 

food, in lieu of analytical testing, 

compliance may be determined using a 

reasonable basis for concluding that the 

food that bears the claim meets the 

definition for the claim. It continues by 

stating that this reasonable basis may 

derive from recognized databases for 

raw and processed foods, recipes, and 

other means to compute nutrient levels 

in the foods or meals and may be used 

provided reasonable steps are taken to 

ensure that the method of preparation 

adheres to the factors on which the 

reasonable basis was determined (e.g., 

types and amounts of ingredients, 

cooking temperatures). Furthermore, 

according to § 101.13(q)(5)(ii), firms 

making claims on foods based on this 

reasonable basis criterion are required to 

provide to appropriate regulatory 

officials on request the specific 

information on which their 

determination is based and reasonable 

assurance of operational adherence to 

the preparation methods or other basis 

for the claim. 

(Response 135) We agree that some 

aspects of § 101.13(c)(5)(ii) that we did 

not include in § 101.11(c) should be 

added to the rule. In particular, 

§ 101.13(c)(5)(ii) requires that 

reasonable steps be taken to ensure that 

the method of preparation adheres to 

the factors on which the reasonable 

basis was determined (e.g., types and 

amounts of ingredients, cooking 

temperatures) when the reasonable basis 

for a nutrient disclosure is derived using 

databases for raw and processed foods, 

recipes, or other means (e.g., means 

other than analytical testing). As 

discussed later in this document (see 

Comment 136), several comments 

opposed our proposal for using a 

compliance approach for determining 

compliance modeled after § 101.9(g) and 

some comments discussed the problems 

that can occur when the preparation of 

a menu item does not adhere to a recipe 

or deviates from the parameters used as 

the reasonable basis. In Response 136, 

we discuss the provisions of 

§ 101.11(c)(2) that we are establishing in 

this rule in lieu of the provisions of 

proposed § 101.11(c)(2), (c)(3), (c)(4), 

and (c)(5) that were modeled after 

§ 101.9(g). Those new provisions 

specify, in relevant part, that a covered 

establishment must take reasonable 

steps to ensure that the method of 

preparation (e.g., types and amounts of 

ingredients, cooking temperatures) and 

amount of a standard menu item offered 

for sale adhere to the factors on which 

its nutrient values were determined. 

We also agree that § 101.11(c) should 

require, among other things, that a 

covered establishment provide to FDA 

on request specific information about 

the basis for its nutrient declarations 

and reasonable assurance of operational 

adherence to the preparation methods 

used as the basis for its nutrient 

declarations. As discussed in Response 

136, we have revised the rule to 

establish these requirements. 

We disagree that § 101.11(c) need 

specify that a reasonable basis may 

derive from recognized databases for 

raw and processed foods, recipes, and 

other means to compute nutrient levels 

in the foods or meals ‘‘in lieu of 

analytical testing.’’ Proposed 

§ 101.11(c)(1) already provides for the 

use of databases, cookbooks, and ‘‘other 

reasonable means’’ in addition to 

analytical testing. However, we 

acknowledge that this may not have 

been clear in part because we used the 

conjunction ‘‘and’’ in proposed 

§ 101.11(c)(1). To make clear that any of 

the listed means for determining 

nutrient content may be used, we have 

revised § 101.11(c)(1) to replace the 

conjunction ‘‘and’’ with the conjunction 

‘‘or’’ in the second sentence. 

As a companion change, we have 

revised proposed § 101.11(c)(6)(iv)(A) 

(which is renumbered as 

§ 101.11(c)(3)(iv)(A) in the final rule), 

which addresses the information that 

must be provided to FDA, within a 

reasonable period of time upon request, 


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when ‘‘other reasonable means are used 

to provide the nutrition information.’’ 

To emphasize that ‘‘other reasonable 

means’’ does not require analytical 

testing, § 101.11(c)(3)(iv)(A)) now 

requires a detailed description of the 

‘‘means’’ (rather than the ‘‘method’’) 

used to determine the nutrition 

information. 

We are finalizing § 101.11(c)(1) with 

the following additional changes: 

• We are substituting the term 

‘‘nutrient declarations’’ for the term 

‘‘nutrient disclosures’’ for consistency 

in terms used throughout § 101.11. For 

example, § 101.11(b)(2)(i)(A) establishes 

requirements to ‘‘declare’’ calories, and 

§ 101.11(b)(2)(i)(A)(3) refers to calorie 

‘‘declarations.’’ 

• We are clarifying that nutrient 

databases may be used to determine 

nutrient values regardless of whether 

they use computer software programs. 

For example, a covered establishment 

may use a nutrient database that both 

lists nutrient values for certain food 

items and provides software that a 

covered establishment could use to 

calculate nutrient values for a standard 

menu item prepared with several of the 

listed foods in varying amounts. 

Alternatively, a covered establishment 

may use a nutrient database that lists 

nutrient values for certain food items, 

but does not provide such software. In 

such a circumstance, a covered 

establishment would perform and 

document its own calculations. 

• We are substituting the term 

‘‘nutrient values’’ for the proposed term 

‘‘nutrient levels.’’ We are making this 

change throughout § 101.11(c), as well 

as throughout the rule, to consistently 

use the single term ‘‘nutrient values.’’ 

• We are deleting ‘‘as described in 

§ 101.10.’’ Section 403(q)(5)(H)(iv) of the 

FD&C Act provides that a restaurant or 

similar retail food 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 

FDA guidance. 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. Under § 101.10, 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. 

In this rule, § 101.11(c)(1) is patterned 

after § 101.10, as required by section 

403(q)(5)(H)(iv) of the FD&C Act, in that 

it provides for nutrient values to be 

determined by nutrient databases, 

cookbooks, or analyses or by other 

reasonable bases. However, given that 

we incorporated the applicable 

regulatory text from § 101.10 into 

§ 101.11(c)(1), there is no need to refer 

to § 101.10 within § 101.11(c)(1). 

Indeed, including ‘‘as described in 

§ 101.10’’ within § 101.11(c)(1) could 

mistakenly signal, to both covered 

establishments and investigators who 

would evaluate compliance with this 

rule, that a covered establishment must 

look to § 101.10 to determine how to 

fully comply with § 101.11(c)(1). 

As finalized, § 101.11(c)(1) states that 

a covered establishment must have a 

reasonable basis for its nutrient 

declarations. Nutrient values may be 

determined by using nutrient databases 

(with or without computer software 

programs), cookbooks, laboratory 

analyses, or other reasonable means, 

including the use of Nutrition Facts on 

labels on packaged foods that comply 

with the nutrition labeling requirements 

of section 403(q)(1) of the FD&C Act and 

§ 101.9, FDA nutrient values for raw 

fruits and vegetables in Appendix C of 

part 101 of the chapter, or FDA nutrient 

values for cooked fish in Appendix D of 

part 101 of the chapter. 

(Comment 136) One comment agreed 

with our proposal for using an approach 

for determining compliance modeled 

after § 101.9(g). The comment 

recognized that the proposed approach 

is consistent with the accuracy 

standards for Nutrition Facts 

information and stated that even 

relatively small variances can be 

significant in influencing cardiovascular 

health. 

The majority of comments opposed 

our proposal for using an approach for 

determining compliance modeled after 

§ 101.9(g), particularly with respect to 

using the ‘‘80/120 rule’’ for compliance 

purposes. Some comments maintained 

that the proposed criteria for 

compliance modeled after § 101.9(g) are 

not consistent with § 101.10. Some 

comments stated that use of the ‘‘80/120 

rule’’ for determining compliance with 

the menu labeling requirements of 

section 403(q)(5)(H) of the FD&C Act 

contradicts 20 years of FDA precedence 

regarding determining compliance for 

nutrient content claims made for 

restaurant foods. The comments referred 

to our statements in the final rule 

establishing § 101.10 regarding claims 

for restaurant food (58 FR 2302 at 2387, 

January 6, 1993) and in our 2008 

guidance for restaurant food (Ref. 10). 

Based on these statements, the 

comments asserted that we understood 

the difficulty in determining 

compliance for restaurant foods making 

nutrient content claims or health claims 

and acknowledged the variations unique 

to restaurant foods (e.g., by recognizing 

that restaurant foods are generally hand 

assembled and, therefore, subject to 

individual product variation), and 

therefore did not require that restaurants 

conduct nutrient analyses for such 

claims. The comments asserted that 

reasons such as these led us to require 

in § 101.10 that restaurants have a 

reasonable basis for making a nutrient 

content or health claim, and that the 

proposed rule did not provide any 

factual basis or evidence that the 

circumstances that justified the original 

‘‘reasonable basis standard’’ have 

changed. 

Some comments asserted that using 

the ‘‘80/120 rule’’ for determining 

compliance with the menu labeling 

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

the FD&C Act was not the intent of 

Congress. Some comments considered 

that use of the ‘‘80/120 rule’’ would 

make the reasonable basis statutory 

provision at section 403(q)(5)(H)(iv) of 

the FD&C Act irrelevant. Some 

comments asserted that use of the ‘‘80/ 

120 rule’’ in the proposed rule 

contradicts the plain language of section 

403(q)(5)(H)(iv) of the FD&C Act, and 

therefore, violates the Administrative 

Procedure Act (APA). One comment 

asserted that section 4205 of the ACA 

proposes a specific standard at section 

403(q)(5)(H)(iv) of the FD&C Act for 

determining nutrient content 

disclosures under section 4205, and 

such a specific standard ‘‘does not 

permit an agency to impose a more 

rigorous standard than one required by 

Congress.’’ The comment stated that 

under the framework articulated in 

Chevron, U.S.A., Inc. v. Natural 

Resource Defense Counsel, 467 U.S. 837 

(1984), ‘‘courts ask as the threshold 

question of ‘whether Congress has 

directly spoken to the precise question 

at issue,’’ and ‘‘[i]f the intent of 

Congress is clear, that is the end of the 

matter.’’ The comment stated that 

section 4205 of the ACA is 

unambiguous ‘‘in adopting the preexisting reasonable basis standard’’ in 

§ 101.10 to determine compliance with 

the nutrition labeling requirements of 

section 4205, and ‘‘this reflects a clear 

directive to FDA which does not 

contemplate, nor permit, any deviation 

of the kind contemplated in the 

proposed rule.’’ 

Some comments asserted that 

Congress expressly directed us to 

consider ‘‘standardization of recipes and 

methods of preparation, reasonable 

variation in serving size and 


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formulation of menu items . . . 

inadvertent human error, training of 

food service workers, variations in 

ingredients, and other factors’’ in 

issuing regulations to implement section 

4205 of the ACA, including those 

regarding reasonable basis. The 

comments maintained that by including 

this language in section 403(q)(5)(H)(x) 

of the FD&C Act and directing us to 

consider such factors, Congress 

demonstrated its familiarity with the 

challenges involved in requiring 

nutrition labeling for restaurant food, 

identifying many of the same factors 

that led us to implement the reasonable 

basis standard in § 101.10. 

Some comments maintained that it is 

not practical to require a compliance 

standard for covered establishments that 

is the same as had been developed for 

packaged food manufacturers that use 

modern manufacturing calibrated 

equipment and methods for which the 

‘‘80/120 rule’’ is appropriate. Some 

comments asserted that restaurant food 

is not standardized like packaged food. 

For example, some comments explained 

that the mere addition of five to seven 

extra French fries in an order of small 

fries would increase calories more than 

20 percent and make the food product 

misbranded under the ‘‘80/120 rule.’’ 

The comment stated, as an example, 

that cheese sticking together and an 

extra squirt of mayonnaise in a food are 

not negligent practices, but would make 

the nutrient content declaration for the 

food out of compliance. Another 

comment stated that if a lobster tail is 

6 ounces rather than 5 ounces, the 

calories would be 20 percent higher. 

Some comments asserted that using the 

‘‘80/120 rule’’ for compliance is 

impractical and will require frequent 

analysis that will add costs. Some 

comments contrasted manufacturers 

that test for nutrient variations at a 

single point or a handful of points of 

manufacture with restaurants that have 

thousands of points of manufacture, 

each of which would require separate 

analysis. One comment asserted that the 

‘‘80/120 standard’’ was not practicable 

and is inflexible for covered 

establishments and would create 

increased and unnecessary compliance 

and litigation costs for covered 

establishments. 

One comment asked us to provide 

flexibility for variations in portion size 

and recipes and allow for disparities 

between the amount of a food used to 

calculate the calories and the actual size 

that might be served to or taken by 

customers. This comment recommended 

that the final rule create specific 

guidelines for displaying caloric 

information for non-uniform menu 

items (e.g. fresh fruit or pieces of 

chicken). 

Some comments pointed to the 

variability in the nutrient content of 

restaurant foods based on changes in 

ingredients and recipes, and seasonal 

changes in the ingredients as reasons for 

why complying with the ‘‘80/120 rule’’ 

would be difficult. One comment noted 

that moisture leaves hot foods at hotfood bars after a certain period of time 

and as a result nutrient values for such 

foods change from those values listed in 

recipe books. The comment asked us to 

expand the tolerance by 10 percent at 

both ends if we kept compliance 

requirements similar to the ‘‘80/120 

rule’’ rather than a more flexible 

‘‘reasonable basis’’ standard. Some 

comments pointed out that there is 

variability in menu items due to using 

locally grown ingredients and that the 

nutrient content of these ingredients can 

vary by region. One comment asserted 

that if we do not account for this 

variation in the final rule, it will be a 

disincentive to covered establishments 

to use local farmers and suppliers. 

One comment asserted that use of the 

‘‘80/120 rule’’ will discourage voluntary 

opting in by restaurants and similar 

retail food establishments not covered 

by section 403(q)(5)(H) of the FD&C Act, 

which would lead to less national 

uniformity. The comment stated that 

many State and local restaurant menu 

labeling laws measure compliance using 

a standard akin to ‘‘the Federal 

reasonable basis standard’’ and even 

where no State nutrition labeling laws 

apply, a restaurant making nutrient 

content claims would be subject to the 

‘‘reasonable basis standard’’ under 21 

U.S.C. 343(r) (i.e., § 101.10). Therefore, 

according to the comment, under the 

proposed rule, small-chain restaurants 

voluntarily registering with us to be 

subject to the Federal requirements 

would subject themselves to more 

potential liability under the ‘‘Federal 

80/120 standard’’ and would thus be 

less likely to voluntarily participate in 

the Federal menu labeling scheme. The 

comment maintained that in turn, there 

would be less national uniformity in 

menu labeling, consumers would see 

less consistent nutrition information on 

menus, and State and local inspectors 

would have to apply a more complex 

patchwork of regulatory schemes. 

One comment asserted that the ‘‘80/

120 rule’’ imposes a stricter compliance 

standard for foods with smaller amounts 

of a particular nutrient that should be 

consumed in limited quantities (e.g., fat 

and cholesterol) because the ‘‘80/120 

rule’’ measures compliance as a 

percentage of the declared nutrient 

levels. For example, a deviation of 1 

gram of fat in a salad declared to have 

3 grams of fat would make the covered 

establishment out of compliance. The 

comment asserted that this is a 

disincentive for low fat, low sodium 

foods and is contrary to the purpose of 

the rule. 

One comment recommended that the 

amount of protein, total carbohydrates, 

and dietary fiber contained in an 

appropriate composite of a standard 

menu item be equal to the declared 

value, not at least 80 percent of the 

declared value. 

(Response 136) Proposed 

§ 101.11(c)(2), (c)(3), (c)(4), and (c)(5) 

were modeled after § 101.9(g), including 

use of the ‘‘80/120 rule.’’ Based on what 

the comments said, we believe that 

some comments misinterpreted the 

proposed rule as requiring covered 

establishments to determine nutrition 

information through laboratory analyses 

only. We did not intend to suggest such 

a limited requirement. Laboratory 

analysis was merely one of several 

options we proposed to establish in 

§ 101.11(c)(1) to satisfy the requirement 

for a reasonable basis for nutrient levels. 

Instead, proposed § 101.11(c)(2), (c)(3), 

(c)(4), and (c)(5), were provisions 

modeled after § 101.9(g), including use 

of the ‘‘80/120 rule,’’ explaining how we 

would determine whether a covered 

establishment is in compliance with the 

requirement (in proposed § 101.11(c)(1)) 

for a covered establishment to have a 

reasonable basis for its nutrient 

disclosures. We did not intend for 

proposed § 101.11(c)(2), (c)(3), (c)(4), 

and (c)(5) to require a covered 

establishment to use laboratory analyses 

in all circumstances to determine 

nutrition information for standard menu 

items. A covered establishment would 

have been free to choose any reasonable 

basis so long as it produced accurate 

results. 

While we do not agree with some of 

the comments, particularly those 

asserting that our proposal to use the 

‘‘80/120 rule’’ to determine compliance 

would violate the APA, we agree that 

using the ‘‘80/120 rule’’ for determining 

compliance with the nutrition labeling 

requirements likely would raise 

practical problems such as some of 

those described in the comments. Given 

these practical problems, we have 

replaced proposed § 101.11(c)(2), (c)(3), 

(c)(4), and (c)(5) with other 

requirements in a new § 101.11(c)(2). 

First, § 101.11(c)(2) specifies that 

nutrient declarations for standard menu 

items must be accurate and consistent 

with the specific basis used to 

determine nutrient values. For example, 

for a nutrient declaration to be accurate, 

a covered establishment that relies on a 


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nutrient database for a list of nutrient 

values, and then uses those nutrient 

values to perform its own calculation of 

the nutrient values in a standard menu 

item, must correctly add the nutrient 

values for all ingredients in the standard 

menu item taking into consideration the 

recipe and ingredient amounts used to 

prepare the standard menu item among 

other factors. Second, § 101.11(c)(2) also 

specifies that a covered establishment 

must take reasonable steps to ensure 

that the method of preparation (e.g., 

types and amounts of ingredients in the 

recipe, cooking temperatures) and 

amount of a standard menu item offered 

for sale adhere to the factors on which 

its nutrient values were determined. 

Accordingly, under § 101.11(c)(2), a 

covered establishment that selects a 

recipe from a cookbook and relies on the 

cookbook’s nutrition information for 

such recipe as a basis for the 

establishment’s nutrient declarations 

must take reasonable steps to ensure 

that employees who prepare the 

standard menu item do not depart from 

that recipe, including the recipe’s 

instructions and ingredient amounts. 

For example, if a covered establishment 

determines nutrition information for a 

turkey sandwich based on a recipe along 

with nutrition information provided in 

a cookbook for the turkey sandwich, and 

the recipe specifies using one 

tablespoon of mayonnaise, the 

establishment must take reasonable 

steps to ensure that its employees use 

one tablespoon of mayonnaise when 

preparing the turkey sandwich—e.g., 

through appropriate instruction about 

the importance of the consistent 

application of one tablespoon of 

mayonnaise to satisfy the requirements 

of this rule. 

Although we recognize inadvertent 

human error and variations in 

ingredients, covered establishments 

must ensure that the nutrient 

declarations are truthful and not 

misleading in part by having standard 

methods of preparation for standard 

menu items and taking reasonable steps 

to ensure that the methods of 

preparation used for a standard menu 

item adhere to the factors on which the 

nutrient levels were determined. To 

make clear that a covered establishment 

has this responsibility, we are also 

replacing each of the proposed 

requirements (in proposed 

§ 101.11(c)(6)(i)(H), (c)(6)(ii)(D), 

(c)(6)(iii)(D), and (c)(6)(iv)(E)) for a 

certification statement regarding the 

recipe used to prepare the standard 

menu item with a requirement for a 

statement signed and dated by a 

responsible individual employed at the 

covered establishment certifying that 

the covered establishment has taken 

reasonable steps to ensure that the 

method of preparation (e.g., types and 

amounts of ingredients in the recipe, 

cooking temperatures) and amount of a 

standard menu item offered for sale 

adhere to the factors on which its 

nutrient values were determined. These 

provisions are in § 101.11(c)(3)(i)(G), 

(c)(3)(ii)(D), (c)(3)(iii)(E), and 

(c)(3)(iv)(E) of the final rule. (See the 

discussion of these provisions in section 

XIX.) 

We acknowledge that the calorie 

content of non-uniform menu items 

such as whole fresh fruit and pieces of 

chicken vary depending on the size and, 

in some cases composition (e.g., chicken 

breast, thigh, or drumstick) of the items. 

A covered establishment may take such 

variation into consideration when 

determining the calorie content and 

calorie declaration for the menu item. 

For example, a covered establishment 

could base its nutrient declarations on 

the average size of a piece of fruit, or on 

a weighted average of nutrient values for 

a box of chicken that contains a fixed 

number of chicken breasts, thighs, or 

drumsticks. 

In assessing compliance with 

§ 101.11(c), we will consider the factors 

and criteria specified in both 

§ 101.11(c)(1) and (c)(2), including 

whether the establishment took 

reasonable steps to ensure that the 

method of preparation for a standard 

menu item adheres to the factors on 

which the reasonable basis was 

determined. We will assess compliance 

on a case by case basis, taking into 

consideration a number of factors, 

including the covered establishment’s 

nutrition labeling, the method (e.g., 

laboratory analysis, nutrient database, 

cookbook, or nutrient information 

provided on the labels of packaged food) 

used by the covered establishment to 

determine nutrition information, and 

the steps taken by the establishment to 

ensure that the method of preparation 

and amount of a standard menu item 

adhered to the factors on which its 

nutrient values were determined. 

Further, we may conduct our own 

analysis, including laboratory analysis, 

as needed, including if we find that 

nutrient declarations appear to be false 

or misleading or the basis upon which 

the covered establishment based its 

nutrient declaration appears to be 

unreasonable or is otherwise 

questionable. 

XIX. Comments and FDA Response on 

Proposed § 101.11(c)(6)—Substantiation 

Documentation (Final § 101.11(c)(3)) 

Proposed § 101.11(c)(6) would require 

that a restaurant or similar retail food 

establishment 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. 

Proposed § 101.11(c)(6) would require 

that covered establishments provide the 

following information: 

• For nutrient databases: 

Æ The identity of the database used. 

Æ 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. 

Æ 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. 

Æ 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. 

Æ A detailed listing (e.g., printout) of 

the nutrient values determined for each 

menu item. 

Æ If this information is not derived 

through the aid of a computer program 

which provides a final nutrient analysis 

for the menu item, worksheets used to 

determine the nutrient values for each 

of these menu items. 

Æ 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). 

Æ 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. 

• For published cookbooks that 

contain nutritional information for 

recipes in the cookbook: 

Æ The name, author, and publisher of 

the cookbook used. 

Æ If available, information provided 

by the cookbook about how the 

nutrition information for the recipes 

was obtained. 

Æ 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. 


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Æ 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.). 

• For analyses: 

Æ A copy of the recipe for the menu 

item used for the nutrient analysis. 

Æ The identity of the laboratory 

performing the analysis. 

Æ Copies of analytical worksheets 

used to determine and verify nutrition 

information. 

Æ 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. 

• For nutrition information provided 

by other reasonable means: 

Æ A detailed description of the 

method used to determine the nutrition 

information. 

Æ Documentation of the validity of 

that method. 

Æ 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. 

Æ Any data derived in determining the 

nutrient values for the menu item; and 

Æ 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. 

In the following paragraphs, we 

discuss comments on the proposed 

substantiation requirements. After 

considering comments, including 

comments (discussed in the previous 

section of this document) that caused us 

to remove proposed § 101.11(c)(2), 

(c)(3), (c)(4), and (c)(5), we are: 

• Redesignating proposed 

§ 101.11(c)(6) as § 101.11(c)(3); 

• Clarifying the applicability of the 

requirements by replacing the term 

‘‘restaurant or similar retail food 

establishment’’ with ‘‘covered 

establishment’’ in the introductory 

paragraph in § 101.11(c)(3) and in the 

subparagraph in § 101.11(c)(3)(ii)(D). 

• Providing that the statement 

certifying that the information 

contained in the nutrient analysis is 

complete and accurate may be signed by 

a responsible individual employed by 

‘‘the covered establishment or its parent 

entity’’ (proposed § 101.11(c)(6)(i)(H), 

(c)(6)(iii)(D), and (c)(6)(iv)(E), 

redesignated as § 101.11(c)(3)(i)(F), 

(c)(3)(iii)(D), and (c)(6)(iv)(D), 

respectively); 

• Requiring a certification that the 

covered establishment has taken 

reasonable steps to ensure that the 

method of preparation (e.g., types and 

amounts of ingredients, cooking 

temperatures in the recipe) and amount 

of a standard menu item offered for sale 

adhere to the factors on which its 

nutrient values were determined; 

• Requiring that all certification 

statements be dated as well as signed; 

• Specifying what we mean by ‘‘the 

identity of the database used’’ in 

proposed § 101.11(c)(6)(i)(A) 

(redesignated as § 101.11(c)(3)(i)(A)); 

• Combining and replacing certain 

proposed details of the substantiation 

documentation when nutrient databases 

are used (i.e., proposed 

§ 101.11(c)(6)(i)(C), (c)(6)(i)(D), and 

(c)(6)(i)(F)) with requirements (in 

§ 101.11(c)(3)(i)(C)) to present the 

requirements in a simplified and 

streamlined format; 

• Specifying what we mean by ‘‘the 

identity of the laboratory performing the 

analysis’’ in proposed 

§ 101.11(c)(6)(iii)(B) (redesignated as 

§ 101.11(c)(3)(iii)(B)); 

• Specifying that copies of analytical 

worksheets used to determine and verify 

nutrition information must include the 

analytical method in proposed 

§ 101.11(c)(6)(iii)(C) (redesignated as 

§ 101.11(c)(3)(iii)(C)); 

• Revising proposed 

§ 101.11(c)(6)(iv)(A) (redesignated as 

§ 101.11(c)(3)(iv)(A)) to require a 

detailed description of the ‘‘means’’ 

(rather than the ‘‘method’’) used to 

determine the nutrition information ‘‘by 

other reasonable means’’; 

• Deleting proposed 

§ 101.11(c)(6)(iv)(B) and redesignating 

proposed § 101.11(c)(6)(iv)(C), 

(c)(6)(iv)(D) and (c)(6)(iv)(E) as 

§ 101.11(c)(3)(iv)(B), (c)(3)(iv)(C), and 

(c)(3)(iv)(D), respectively; and 

• Revising proposed 

§ 101.11(c)(6)(iv)(D) (redesignated as 

§ 101.11(c)(3)(iv)(C)) to provide an 

example of any ‘‘data derived in 

determining the nutrient values.’’ 

In addition, as nonsubstantive 

editorial changes we are: 

• Replacing all instances of the term 

‘‘nutrient levels’’ with the term 

‘‘nutrient values’’ to consistently use the 

same term throughout § 101.11(c); 

• Replacing all instances of the term 

‘‘menu item’’ with ‘‘standard menu 

item’’ to emphasize that the 

requirements for determination of 

nutrient content apply only to standard 

menu items; and 

• Adding the conjunction ‘‘and’’ 

between § 101.11(c)(3)(i)(F) and 

§ 101.11(c)(3)(i)(G), between 

§ 101.11(c)(3)(ii)(C) and 

§ 101.11(c)(3)(ii)(D), between 

§ 101.11(c)(3)(iii)(D) and 

§ 101.11(c)(3)(iii)(E), and between 

§ 101.11(c)(3)(iv)(D) and 

§ 101.11(c)(3)(iv)(E), to clarify that all of 

the items listed under § 101.11(c)(3)(i), 

§ 101.11(c)(3)(ii), § 101.11(c)(3)(iii), and 

§ 101.11(c)(3)(iv) are required. 

(Comment 137) As discussed in more 

detail in section XVIII (see Comment 

136), several comments opposed the 

nutrient determination requirements in 

proposed § 101.11(c)(2), (c)(3), (c)(4), 

and (c)(5). 

(Response 137) As discussed in more 

detail in section XVIII (see Response 

136), we are deleting those requirements 

from the rule. Some comments 

misinterpreted these provisions, e.g., by 

concluding that we intended to require 

the use of laboratory analysis as a 

reasonable basis in all circumstances. 

To reduce the potential for future 

misunderstanding about the 

substantiation provisions in the final 

rule, we have made the following 

revisions to the requirements for 

substantiation documentation. 

First, we have revised proposed 

§ 101.11(c)(6)(iii) (redesignated as 

§ 101.11(c)(3)(iii) in the final rule) to 

clarify that the analyses governed by the 

provision are ‘‘laboratory analyses.’’ 

Some of the specific requirements of 

§ 101.11(c)(3)(iii)) (such as for analytical 

worksheets) may not apply to other 

means used by a covered establishment 

as a reasonable basis for its nutrient 

determinations. 

Second, we are providing more 

specific information about the 

requirements for substantiation 

information. Specifically: 

• We have revised proposed 

§ 101.11(c)(6)(i)(A) (redesignated as 

§ 101.11(c)(3)(i)(A) in the final rule) to 

specify that substantiation 

documentation for nutrient databases 

must include the name and version 

(including the date of the version) of the 

database, and, as applicable, the name 

of the applicable software company and 

any Web site address for the database. 

The name and version of a database 

would include the name and version of 


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the computer software, if applicable. 

Any database suitable for use as a 

reasonable basis for the purposes of 

§ 101.11 would have a name and version 

number; in some cases, the version 

number is a date. The version number 

is necessary to fully identify a database 

because databases may be updated to 

reflect more recent data and 

information, and nutrient values 

generated with one version of a database 

may be different from nutrient values 

generated by a different database. If, for 

example, a covered establishment used 

‘‘version x’’ of a database for its nutrient 

determinations, and we used ‘‘version 

y’’ of that database to evaluate 

compliance with the nutrient 

determination requirements of rule, we 

inadvertently could conclude that the 

covered establishment is out of 

compliance with the rule if the nutrient 

values we obtained using ‘‘version y’’ do 

not match those obtained using ‘‘version 

x.’’ Some databases may be provided by 

a public source (such as USDA), 

whereas others may be provided by a 

private vendor. If we have any questions 

about the database, we may need to 

contact the public source or private 

vendor. Some databases are available on 

the Internet; the Web site address would 

enable us to obtain any necessary 

followup information on an Internetbased database. 

• We have revised proposed 

§ 101.11(c)(6)(iii)(B) (redesignated as 

§ 101.11(c)(3)(iii)(B) in the final rule) to 

specify that substantiation 

documentation for laboratory analyses 

must include the name and address of 

the laboratory. Some laboratories that 

conduct nutrient analyses have more 

than one facility, and the name of the 

laboratory alone would not be sufficient 

to identify the laboratory that conducted 

the analysis. 

• We have revised proposed 

§ 101.11(c)(6)(iv)(D) (redesignated as 

§ 101.11(c)(3)(iv)(C) in the final rule) to 

provide ‘‘nutrition information about 

the ingredients used, including the 

source of the nutrient information’’ as 

an example of what we mean by any 

‘‘data derived in determining nutrient 

values.’’ 

Third, we are reorganizing and 

combining the provisions of proposed 

§ 101.11(c)(6)(i)(C), (c)(6)(i)(D), and 

(c)(6)(i)(F) (in § 101.11(c)(3)(i)(C)) to 

simplify the requirements and make 

them more clear. In particular, we 

reorganized the requirements to clarify 

that the substantiation documentation 

that would be provided to FDA can vary 

depending on characteristics of the 

database. For example, in some cases, 

the information and calculations 

provided by a database are transparent 

to a person using the database, whereas, 

in other cases, such information and 

calculations are not transparent to the 

user. Section § 101.11(c)(3)(i)(C) 

addresses these different situations in 

separate subparagraphs (i.e., in 

§ 101.11(c)(3)(i)(C)(1) and (c)(3)(i)(C)(2)). 

Under § 101.11(c)(3)(i)(C)(1), the 

substantiation information for nutrient 

databases must include information on: 

(1) The amount of each nutrient that the 

specified amount of each ingredient 

identified in the recipe contributes to 

the menu item; and (2) How the 

database was used including 

calculations or operations (e.g., 

worksheets or computer printouts) to 

determine the nutrient values for the 

standard menu items. Under 

§ 101.11(c)(3)(i)(C)(2), if the information 

in § 101.11(c)(3)(i)(C)(1) is not available, 

the substantiation documentation for 

nutrient databases must include 

certification attesting that the database 

will provide accurate results when used 

appropriately and that the database was 

used in accordance with its instructions. 

Fourth, we have revised proposed 

§ 101.11(c)(6)(iii)(C) (redesignated as 

§ 101.11(c)(3)(iii)(C) in the final rule) to 

specify that copies of analytical 

worksheets used to determine and verify 

nutrition information must include the 

analytical method used to determine 

and verify nutrition information. An 

analytical worksheet cannot be 

evaluated for compliance purposes 

unless the method is identified. A key 

aspect of evaluating analytical results is 

determining whether the procedure was 

carried out correctly, by comparing the 

data in the work sheets to the procedure 

in the applicable analytical method. 

(Comment 138) One comment 

recommended that covered 

establishments provide references for 

their nutrient values to consumers on 

request. Another comment 

recommended that establishments be 

required to maintain the reasonable 

basis verification only at headquarters, 

‘‘and not in-store and available upon 

customer request or online.’’ This 

comment considered that providing 

hard copies on site at many locations 

would be costly, administratively 

burdensome, and environmentally 

unsustainable. 

(Response 138) We did not propose to 

require that the substantiation 

documentation be available to 

consumers in a covered establishment 

or online. The provisions for making 

substantiation documentation available 

to us were directed to our enforcement 

of the rule rather than to informing 

consumers. Hard copies of the 

substantiation documentation would 

only need to be provided to FDA 

‘‘within a reasonable period of time 

upon request.’’ Thus, a covered 

establishment need not generate any 

hard copies of the substantiation 

information until we request the 

information. We would request 

substantiation documentation from 

individual covered establishments 

during inspections. However, a covered 

establishment could wait to physically 

obtain substantiation documentation 

generated by its corporate headquarters 

or parent entity until we ask for it, 

provided that the covered establishment 

can obtain the information within a 

reasonable period of time. 

(Comment 139) One comment stated 

that it was unclear whether each 

independently operated unit, including 

a franchisee, will have to substantiate 

the accuracy of the nutrient information. 

Some comments disagreed that the 

responsible person of the covered 

establishment needs to sign a statement 

certifying that the nutrient analysis is 

complete and accurate and that recipes 

used to prepare menu items are 

identical to those used for the nutrient 

analysis. The comments asserted that 

this information is mostly gathered at 

corporate headquarters and there is no 

comparable requirement for packaged 

food. 

(Response 139) We agree, in part, and 

disagree, in part, with these comments. 

We agree that the responsible individual 

certifying that the nutrient analysis is 

complete and accurate need not be 

employed at the covered establishment; 

instead, the individual could be 

employed at the establishment’s 

corporate headquarters or parent entity. 

Whether such individual is employed at 

the covered establishment or the 

establishment’s corporate headquarters 

or parent entity, it is critical that the 

individual who signs the certification 

has a factual basis for certifying that the 

nutrient analysis is complete and 

correct. 

We disagree that a responsible 

individual employed at the covered 

establishment’s corporate headquarters 

or parent entity, rather than a 

responsible individual employed at the 

covered establishment, could sign a 

certification regarding the use of a 

recipe within a covered establishment. 

A responsible individual employed at 

the establishment’s corporate 

headquarters or parent entity likely 

would not have a factual basis for 

certifying the actions of a specific 

covered establishment because the 

individual would not be present in the 

establishment where the standard items 

are prepared, and, thus, likely could not 

certify the actions the establishment 

takes to comply with the rule. 


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After considering these comments, we 

have revised the requirements for 

certification statements (i.e., proposed 

§ 101.11(c)(6)(i)(H), (c)(6)(ii)(D), 

(c)(6)(iii)(D), and (c)(6)(iv)(E), which we 

have renumbered in the final rule as 

described in the following sentences) to 

distinguish certifications that must be 

signed and dated by a responsible 

individual employed at the covered 

establishment from certifications that 

may be signed and dated by a 

responsible individual employed at 

either the covered establishment or at its 

corporate headquarters or parent entity. 

First, § 101.11(c)(3)(i)(F), (c)(3)(iii)(D), 

and (c)(6)(iv)(D) of the final rule require 

a statement signed and dated by a 

responsible individual, employed at the 

covered establishment or its corporate 

headquarters or parent entity, who can 

certify that the information contained in 

the nutrient analysis is complete and 

accurate. We are using the term ‘‘parent 

entity’’ in addition to ‘‘corporate 

headquarters’’ because some business 

entities may not be ‘‘corporations.’’ 

Second, § 101.11(c)(3)(i)(G), 

(c)(3)(ii)(D), (c)(3)(iii)(E), and 

(c)(6)(iv)(E) of the final rule require a 

statement signed and dated by a 

responsible individual employed at the 

covered establishment certifying that 

the covered establishment has taken 

reasonable steps to ensure that the 

method of preparation (e.g., types and 

amounts of ingredients in the recipe, 

cooking temperatures) and amount of a 

standard menu item offered for sale 

adhere to the factors on which its 

nutrient values were determined. 

We are requiring that all certification 

statements be dated as well as signed. A 

date is standard practice on such 

documents and would be necessary, for 

example, to establish whether a 

certification signed in advance by a 

responsible individual at the parent 

entity can address nutrient analyses 

conducted over time. 

(Comment 140) One comment 

opposed the proposed requirement that 

a covered establishment turn over its 

recipes to a governmental agency, 

because a covered establishment cannot 

be assured that its proprietary 

information will be protected and will 

not make it into the hands of 

competitors or unscrupulous 

governmental employees looking to sell 

or pass on trade secrets. 

(Response 140) While we understand 

that some establishments may have 

concerns about the confidentiality of 

information inspected by FDA under 

§ 101.11, we emphasize that we protect 

confidential information from 

disclosure, consistent with applicable 

statutes and regulations. Our disclosure 

of information is subject to the Freedom 

of Information Act (FOIA) (5 U.S.C. 

552), the Trade Secrets Act (18 U.S.C. 

1905), the FD&C Act, and our 

implementing disclosure regulations 

under part 20 (21 CFR part 20), which 

include protection for confidential 

commercial or financial information and 

trade secrets. To the extent that the 

comment is asserting that we have no 

procedures in place to protect the 

confidentiality of proprietary 

information, we disagree. We receive 

trade secret or confidential information 

on a regular and recurring basis. As 

noted previously, trade secrets and 

commercial or financial information 

that are privileged or confidential are 

protected from disclosure under the 

FOIA, the Trade Secrets Act, the FD&C 

Act, and our implementing disclosure 

regulations (see, e.g., 21 U.S.C. 331(j), 18 

U.S.C. 1905; 21 CFR 20.61(c)). Our 

disclosure regulations set forth specific 

procedures for assuring such protection 

(see part 20). A covered establishment 

that provides substantiation 

documentation to us may identify any 

information in such documentation that 

the establishment considers to be trade 

secret or confidential commercial or 

financial information (21 CFR 20.61(d)). 

Information so marked will not be 

disclosed to the extent such information 

is protected under the FOIA and our 

disclosure regulations (part 20). 

(Comment 141) A few comments 

asserted that the proposed requirement 

that a responsible individual of the 

covered establishment certify that the 

recipe used for the standard menu item 

is identical to that used for the nutrient 

analysis is unreasonable and beyond the 

scope of the law. The comments 

considered that Congress directed us (in 

section 403(q)(5)(H)(x)(II)(aa) of the 

FD&C Act) to consider standardization 

of recipes, reasonable variation in 

serving size and formulation of menu 

items, inadvertent human error, training 

of food service workers, variations in 

ingredients, and other factors. One 

comment noted that this certification is 

not required by statute, and considered 

that it is not clear what regulatory 

purpose it would serve. The comments 

asserted that it is unreasonable to expect 

a covered establishment to prepare a 

standard menu item in a manner that is 

identical to the recipe on each given 

day. A few comments opposed asking 

employees to attest that they have 

followed recipes exactly and considered 

such a requirement to be unfair to 

employees because there are several 

factors that affect the recipe such as 

seasonal variations, market availability 

of certain ingredients, and modifying 

recipes to accommodate regional taste 

preferences. One comment suggested 

deleting the following proposed 

requirements in § 101.11(c)(6): 

• For nutrient databases 

Æ 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. 

Æ 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. 

Æ 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. 

Æ 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. 

• For published cookbooks that 

contain nutritional information for 

recipes in the cookbook: 

Æ 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. 

Æ 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.) 

• For analyses: 

Æ 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. 

• For nutrition information provided 

by other reasonable means: 

Æ The word ‘‘detailed’’ from the 

provision in § 101.11(c)(6)(iv)(A). 

Æ Documentation of the validity of 

that method. 

Æ A statement signed by a responsible 

individual employed by the covered 

establishment that can certify that the 


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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. 

(Response 141) As discussed in 

Response 136, we are replacing each 

requirement (in proposed 

§§ 101.11(c)(6)(i)(H), (c)(6)(ii)(D), 

(c)(6)(iii)(D), and (c)(6)(iv)(E)) that a 

responsible individual of the covered 

establishment certify that the recipe 

used for the standard menu item is 

identical to that used for the nutrient 

analysis used to prepare the standard 

menu item with a requirement for a 

statement signed and dated by a 

responsible individual employed at the 

covered establishment certifying that 

the establishment has taken reasonable 

steps to ensure that the method of 

preparation (e.g., types and amounts of 

ingredients in the recipe, cooking 

temperatures) and amount of a standard 

menu item offered for sale adhere to the 

factors on which its nutrient values 

were determined. Therefore, § 101.11(c) 

will not require a responsible individual 

of the covered establishment to certify 

that the recipe used for the standard 

menu item is identical to that used for 

the nutrient analysis used to prepare the 

standard menu item; nor will it require 

that a covered establishment prepare a 

standard menu item using a recipe that 

is identical to that used in a database (as 

proposed in § 101.11(c)(6)(i)(B)). 

Nevertheless, a covered establishment 

must ensure that its nutrition labeling is 

truthful and not misleading and that it 

has a reasonable basis for its nutrient 

content disclosures, as further discussed 

in Response 136. 

As requested in Comment 136 and 

discussed in Response 136, we have 

revised the rule to require (in 

§ 101.11(c)(2)) that the covered 

establishment take reasonable steps to 

ensure that the method of preparation 

(e.g., types and amounts of ingredients 

in the recipe, cooking temperatures) and 

amount of a standard menu item offered 

for sale adhere to the factors on which 

its nutrient values were determined. As 

discussed in Response 135, we have 

revised proposed § 101.11(c)(6)(iv)(A) 

(which is renumbered as 

§ 101.11(c)(3)(iv)(A) in the final rule), 

which addresses the information that 

must be provided to FDA, within a 

reasonable period of time upon request, 

when ‘‘other reasonable means are used 

to provide the nutrition information.’’ 

To emphasize that ‘‘other reasonable 

means’’ does not require analytical 

testing, § 101.11(c)(3)(iv)(A)) requires a 

detailed description of the ‘‘means’’ 

(rather than the ‘‘method’’) used to 

determine the nutrition information. 

We also have removed proposed 

§ 101.11(c)(6)(iv)(B), which would have 

required documentation of the validity 

of the method for ‘‘nutrition information 

provided by other reasonable means.’’ 

As evidenced by the examples we now 

provide of ‘‘other reasonable means’’ in 

§ 101.11(c)(1), ‘‘documentation of 

validity of that method’’ generally 

would not apply to ‘‘other reasonable 

means’’ that are reasonably foreseeable. 

Other than by removing proposed 

§ 101.11(c)(6)(iv)(B) and the proposed 

provisions requiring that the recipe used 

to prepare a standard menu item be 

identical to the recipe used to determine 

the nutrition information for the 

standard menu item described 

previously, we are not deleting the 

remaining specific proposed provisions 

that one comment recommended 

deleting. The comment provided no 

explanation or basis for deleting those 

specific provisions. Further, these 

provisions establish requirements for 

substantiating determination of nutrient 

content for standard menu items 

provided by covered establishments. As 

we discussed in the proposed rule (76 

FR 19192 at 19219), to determine 

whether a covered establishment has a 

reasonable basis for its nutrient content 

disclosures, as required by section 

403(q)(5)(H) of the FD&C Act, and 

whether a standard menu item is 

otherwise misbranded under section 

403(a)(1) of the FD&C Act, we must have 

access to the information substantiating 

the covered establishment’s 

determination of nutrient content. 

Without these requirements, which 

provide access to substantiation 

documentation, we would not be able to 

efficiently determine whether a covered 

establishment’s nutrition labeling is 

truthful and not misleading. Further, 

without access to substantiation 

documentation of the basis of a covered 

establishment’s nutrient content 

disclosures, including recipe and 

ingredient information, we would not be 

able to determine whether an 

establishment has a reasonable basis for 

its nutrition content disclosures, as 

required by section 403(q)(5)(H)(iv) of 

the FD&C Act. Accordingly, such 

requirements are necessary for the 

efficient enforcement of the FD&C Act. 

XX. Comments and FDA Response on 

Proposed Section 101.11(d)—Voluntary 

Registration To Elect To Be Subject to 

the Rule 

Proposed § 101.11(d)(1) would 

provide that 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 could voluntarily register to 

provide the nutrition information 

required by § 101.11(b), and that in 

doing so they would no longer be 

subject to non-identical State or local 

nutrition labeling requirements. 

Proposed § 101.11(d)(2) would provide 

that the authorized official of a 

restaurant or similar retail food 

establishment as defined, may register 

with FDA. Proposed § 101.11(d)(3) 

would list the types of information (in 

brief, the contact information of each 

restaurant or similar retail food 

establishment, as well as contact 

information of an official onsite, trade 

names the restaurant or similar retail 

food establishment uses, preferred 

mailing address, and certification) that a 

restaurant or similar retail food 

establishment would need to provide to 

us in order to register voluntarily. 

Proposed § 101.11(d)(3) and (d)(4) 

would also describe the mechanism for 

submission by email, fax, mail, or 

online form. Finally, proposed 

§ 101.11(d)(5) would require reregistration every other year within 60 

days prior to the expiration of the 

current registration with FDA, and 

would provide that registration will 

automatically expire if not renewed. 

In the following paragraphs, we 

discuss comments on these proposed 

provisions. We are finalizing them with 

the following changes for clarity. 

• We are amending the titles of 

§ 101.11(d)(4) and (d)(5) by replacing 

the question mark in each title with a 

period because these titles are not 

questions. 

• We are deleting the revision date of 

Form FDA 3757 (i.e., 7/10) from 

§ 101.11(d)(3). The FDA form number is 

sufficient to identify the form. 

Moreover, the revision date may change 

as a result of the renewal of the form 

every 3 years under the Paperwork 

Reduction Act. 

• We are moving proposed 

§ 101.11(d)(3)(vi) and (d)(3)(vii) to be 

subparagraphs of § 101.11(d)(4) rather 

than § 101.11(d)(3) and redesignating 

them as § 101.11(d)(4)(i) and (d)(4)(ii), 

respectively. These provisions are 

directed to ‘‘How to register’’ rather than 

to ‘‘What information is required?’’ 

• For clarity, we are adding the form 

number (i.e., Form FDA 3757) to the 

second sentence of § 101.11(d)(4). 

• For completeness, we have added 

‘‘.gov’’ to the end of the email address 

provided for voluntary registration 

under § 101.11(d)(4)(i). The complete 

email address now reads 

‘‘menulawregistration@fda.hhs.gov.’’ 

• We have revised the format of the 

cross-reference, within § 101.11(d)(4) to 

§ 101.11(d)(3) to read ‘‘paragraph (d)(3) 


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of this section’’ rather than 

‘‘§ 101.11(d)(3).’’ We note that the 

proposed rule had identified the crossreference as ‘‘§ 101.11(c)(3).’’ We revised 

this to ‘‘§ 101.11(d)(3)’’ in the correction 

document, but did not revise the format 

at that time. 

(Comment 142) One comment 

supported the proposed registration 

requirements. One comment 

recommended that retail food 

establishments not covered by section 

403(q)(5)(H) of the FD&C Act, regardless 

of whether they have fewer than 20 

locations or if the sale of food is not the 

primary business activity, be allowed to 

elect to become subject to the 

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

the FD&C Act by registering biannually 

with us. One comment referred to our 

discussions in the proposed rule that 

establishments such as cafeterias in 

schools and hospitals would not be 

covered by the rule under the proposed 

definition of ‘‘restaurant or similar retail 

food establishment’’ (see Footnote 1 at 

76 FR 19192 at 19197 and discussion at 

19230). This comment asked us to 

clarify whether there are some 

establishments (e.g., hospitals or school 

cafeterias) that are not restaurants or 

similar retail food establishments and 

therefore cannot voluntarily register to 

be subject to the Federal menu labeling 

requirements. The comment also asked 

us to clarify whether certain food 

service contractor facilities can 

voluntarily register even if other 

facilities in the overall set of operations 

do not. The comment recommended 

that we allow a restaurant or similar 

retail food establishment to voluntarily 

register on an establishment-byestablishment basis and not require the 

chain or company to make a single 

corporate-wide determination. The 

comment asked us to allow a food 

service contract business to register 

some of their establishments in order to 

make well-informed decisions on 

whether to register the other 

establishments and modify their 

establishments and contracts 

accordingly (‘‘rolling adoption’’). The 

comment also asked if there were 

requirements for opting out of the 

Federal requirements after voluntarily 

registering. The comment asked whether 

a restaurant or similar retail food 

establishment is required to be covered 

by the menu labeling requirements for a 

specific length of time, once it has 

voluntarily registered. 

(Response 142) The final rule defines 

‘‘restaurant or similar retail food 

establishment’’ to mean a retail 

establishment that offers for sale 

restaurant-type food, except if it is a 

school as defined in 7 CFR 210.2 or 

220.2. Under § 101.11(d), a restaurant or 

similar retail food establishment, as 

defined in § 101.11(a), 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 (and, thus, is not subject to 

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

of the FD&C Act) may voluntarily 

register to be subject to the requirements 

established in this rule. It does not 

matter whether the sale of food is the 

establishment’s primary business 

activity, because the definition of 

restaurant or similar retail food 

establishment in this rule does not 

include a primary business test. Many 

establishments that would not have 

been a ‘‘restaurant or similar retail food 

establishment’’ under the definition we 

proposed (including establishments in 

hospitals) would be a restaurant or 

similar retail food establishment under 

the definition established in this rule 

(see the discussion of the definition of 

restaurant or similar retail food 

establishment in section VI.B). Whether 

any such establishment is automatically 

covered by the rule generally would 

depend on whether the establishment 

satisfies all other criteria in the 

definition of ‘‘covered establishment’’ 

(i.e., 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). 

Section 403(q)(5)(H)(ix) of the FD&C 

Act provides that 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 become subject to the 

requirements by registering with FDA. 

Accordingly, any establishment that 

meets the definition for a restaurant or 

similar retail food establishment, as 

provided in § 101.11(a), that is not 

already subject to the requirements of 

section 403(q)(5)(H) of the FD&C Act 

can voluntarily register to become 

subject to the requirements under 

§ 101.11(d). Establishments that do not 

meet the definition of ‘‘restaurant or 

similar retail food establishment’’ (e.g., 

drug stores that do not offer for sale any 

restaurant-type food) cannot voluntarily 

register. 

Under § 101.11(d), an authorized 

official is permitted to register an 

individual restaurant or similar retail 

food establishment on an establishmentby-establishment basis, in that the 

authorized official may register a single 

restaurant or similar retail food 

establishment or multiple restaurants or 

similar retail food establishments within 

a chain on a single registration form, 

provided that the individual is 

authorized to do so for all of the 

restaurants or similar retail food 

establishments included on the form 

(Form FDA 3757) submitted. Whether a 

decision to register is made on an 

establishment-by-establishment basis or 

is a corporate-wide decision applying to 

many or all establishments within a 

chain is a matter for the restaurant or 

similar retail establishments and any 

corporate management to determine. 

This is as true for restaurants or similar 

retail food establishments operated by 

contractors as it is for other restaurants 

or similar retail food establishments. 

The rule does not establish a date by 

which a restaurant or similar retail food 

establishment must register in order to 

‘‘opt in’’ as a covered establishment and, 

thus, establishments within a chain 

could approach the voluntary 

registration using the ‘‘rolling adoption’’ 

requested by one comment. 

A restaurant or similar retail food 

establishment that has voluntarily 

registered under § 101.11 must comply 

with the requirements of sections 

403(a)(1), 403(f), and 403(q)(5)(H) of the 

FD&C Act and § 101.11 for 2 years after 

the date of registration and may not ‘‘opt 

out’’ until the 2 years has passed. If the 

restaurant or similar retail food 

establishment wants to ‘‘opt out,’’ the 

mechanism to do so would be to let the 

registration lapse (i.e., not re-register) 

after the 2 years have passed. 

XXI. Comments and FDA Response on 

Proposed § 101.11(e)—Signatures 

Proposed § 101.11(e) would provide 

that signatures obtained under the 

voluntary registration provisions that 

meet the definition of electronic 

signatures in § 11.3(b)(7) would be 

exempt from the requirements of part 11 

of the CFR (requirements for electronic 

records and signatures). 

We received no comments on this 

proposed provision and are finalizing it 

without change. 

XXII. Comments and FDA Response on 

Proposed § 101.11(f)—Misbranding 

Proposed § 101.11(f) would provide 

that ‘‘a standard menu item offered for 

sale in a covered establishment’’ would 

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 the requirements for 

nutrition labeling and determination of 

nutrient content at § 101.11(b) and (c). 

While we received no comments on 

this proposed provision, we are 

finalizing this provision with one 

change. We are including a reference to 

section 403(f) of the FD&C Act to clarify 


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that failure to comply with the 

requirements of § 101.11(b) could cause 

a food to be misbranded under section 

403(f) of the FD&C Act. Section 403(f) of 

the FD&C Act provides that a food shall 

be deemed misbranded ‘‘if any word, 

statement, or other information required 

by or under authority of this Act to 

appear on the label or labeling is not 

prominently placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ For example, as 

discussed in Response 127, if a calorie 

declaration for a standard menu item 

that is a self-service food or food on 

display is not declared in a manner that 

complies with 

§ 101.11(b)(2)(iii)(A)(3)(ii), in that the 

declaration is not clear and 

conspicuous, the standard menu item 

would be misbranded under section 

403(f) of the FD&C Act in addition to 

section 403(q) of the FD&C Act. 

XXIII. Comments and FDA Response on 

Effective Date 

A. Proposed Effective Date and Request 

for Comment 

The proposed rule specified that the 

final rule would become effective 6 

months from the date of its publication 

in the Federal Register (76 FR 19192 at 

19219). We noted that 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, we 

stated that it is reasonable to make the 

requirements effective as soon as 

practicable. We recognized, however, 

the potential difficulties of 

implementing the rule in this 

timeframe, and requested comment on 

whether the effective date should be 

extended for a greater period of time 

after the publication of the final rule. In 

particular, we requested comment on 

whether a 9-month or 1-year 

implementation timeframe would be 

more appropriate. 

We also requested comment, 

supported by data, concerning how 

much time is needed for covered 

establishments to come into compliance 

with the rule, including, if possible, 

data on whether specific provisions of 

the rule can be more quickly 

implemented than others. We also 

requested comment on whether we 

should provide for staggered 

implementation based on the size of a 

chain or of a specific franchisee and 

again requested that suggestions be 

supported by data. 

B. Comments on Proposed Effective 

Date 

(Comment 143) Many comments 

supported our proposed 6-month 

effective date. Some comments noted 

that State and local jurisdictions with 

menu labeling requirements 

implemented and enforced the 

requirements in 6 or 7 months. One 

comment stated that many large chains 

have already conducted nutrient 

analyses for their menu items. In 

contrast, another comment reported the 

implementation time frames for 12 State 

and local requirements. This comment 

noted that restaurants subject to State or 

local menu labeling requirements have 

had no less than 6 months to comply 

with such requirements. This comment 

reported that one city (Philadelphia) 

provided more than 1 year for 

compliance and one State (Oregon) 

provided 6 months for implementation 

of Phase 1 of its requirements, and an 

additional year for compliance with 

Phase 2 of its requirements. This 

comment urged us to allow 

establishments at least 1 year to come 

into compliance with the Federal 

requirements. 

Several comments opposed the 6- 

month effective date and requested an 

effective date of at least 1 year. Some 

comment noted that an effective date of 

at least 1 year would be necessary for 

covered establishments to develop and 

install redesigned menus. In particular, 

one comment from national associations 

representing a number of restaurants 

estimated that there are 250,000 to 

275,000 covered restaurants in the 

United States, not including similar 

retail food establishments that would be 

covered under the rule. This comment 

recommended that we adopt an 

implementation period of not less than 

1 year after the publication of the final 

rule and noted that extending the time 

period to 1 year would allow most 

restaurants to incorporate adding calorie 

declarations to menus and associated 

menu redesigns with regular menu 

replacement cycles, thereby reducing 

costs. This comment identified several 

specific steps necessary for covered 

establishments to comply with the rule, 

including: 

• ‘‘Digest the final rule,’’ including 

determining what are menus and menu 

boards, what are standard menu items, 

what are custom orders, and what are 

temporary menu items or otherwise 

excluded foods; 

• Determine nutrient content levels 

and ensure that their bases for 

determining such nutrient information 

are sound; 

• Prepare and print written nutrition 

information; 

• Redesign menus and menu boards 

to include calories; 

• Roll out new menus and menu 

boards simultaneously to chain 

restaurants nationwide; 

• Update food preparation procedures 

to ensure consistency and ensure that 

reasonable steps are in place to ensure 

standard menu items are prepared 

consistently; 

• Create processes where information 

related to standard menu items, e.g., 

ingredients supplier data, is periodically 

updated; and 

• Develop and conduct training. 

This comment also presented the 

following estimated time frames to 

conduct some of these steps: 

• Four weeks to digest the 

requirements of the rule; 

• Twenty-four weeks to design new 

layouts, obtain reviews and approvals, 

and for production and kitting; and 

• Eight weeks for shipping. 

Other comments that supported a 1- 

year effective date presented similar 

reasons, noting that a 1 year effective 

date would allow restaurants to 

properly review the final rule, analyze 

covered food items, and incorporate 

nutrition labeling into their truck stop 

and travel plaza restaurants. Some 

comments expressed concern that 

demand for menu item nutrient analysis 

and redesigning menu boards will 

skyrocket upon publication of the final 

rule, thereby overwhelming testing 

laboratories and companies that design 

menus and menu boards. 

(Response 143) We agree that covered 

establishments will need more than 6 

months to come into compliance with 

the rule, including making changes to 

menus and menus boards. While some 

establishments already are subject to 

State or local nutrition labeling 

requirements for foods sold in such 

establishments, others are not. 

Moreover, even those establishments 

that already are subject to State or local 

requirements nutrition labeling 

requirements may not be required to 

disclose such nutrition information in 

the format and manner specified in 

section 403(q)(5)(H) of the FD&C Act 

and this rule. We carefully considered 

the activities and associated time frames 

identified by the comments, including 

the comment from national 

organizations representing restaurants, 

and we agree that the rule should 

provide for an effective date of 1 year to 

comply with the Federal requirements. 

Most comments, even the comment 

noting that one State and one local 


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government provided more than 1 year 

for full implementation, requested an 

effective date of ‘‘at least 1 year.’’ 

We also agree that a time frame that 

enables establishments to make changes 

to menus and menu boards during a 

time period that coincides with their 

regular menu replacement cycles would 

save time and resources. In addition, we 

acknowledge that companies that design 

and produce menu boards will receive 

many orders to update menu boards to 

comply with the rule. We note that a 

covered establishment that experiences 

difficulty obtaining new menus or menu 

boards as a result of increased demand 

as the effective date draws near will 

have other ways to comply with the rule 

without replacing the menus or menu 

boards. For example, we would not 

object if a covered establishment 

declares calorie information by applying 

stickers or pieces of paper to menus or 

menu boards. For packaged foods, we 

have taken the position for some time 

that the Nutrition Facts label may be 

printed on a sticker and affixed to a 

package, as long as the sticker adheres 

to the product under the intended 

storage conditions (Ref. 38; see L16). We 

also have long taken the position that 

stickers may be used to make changes in 

labeling such as correcting label 

mistakes provided that the final label is 

correct and complies with all 

regulations at the time of retail sale, the 

stickers do not cover other mandatory 

labeling, and the stickers adhere tightly 

(Ref. 38, see L55). 

Likewise, we acknowledge that there 

could be some increased demand for 

nutrient analysis by testing laboratories 

as the effective date draws near. 

Importantly, the rule does not require 

analytical testing of standard menu 

items; analytical testing is merely one 

option available to a covered 

establishment to determine nutrient 

values. Other options include use of 

nutrient databases, cookbooks, or other 

reasonable means, including the use of 

Nutrition Facts on labels on packaged 

foods that comply with the nutrition 

labeling requirements of section 

403(q)(1) of the FD&C Act and § 101.9, 

FDA nutrient values for raw fruits and 

vegetables in Appendix C of part 101, or 

FDA nutrient values for cooked fish in 

Appendix D (see § 101.11(c)(1)). In 

addition, as noted by the comments, 

many establishments that are part of 

large chains have already determined 

nutrient values for their menu items. As 

discussed in Response 138 and 

Response 139, this rule provides that 

corporate headquarters or a parent 

entity, rather than each individual 

covered establishment, may determine 

and certify nutrient values, as requested 

by comments. Thus, to the extent 

establishments’ corporate headquarters 

or parent entity have determined 

nutrient values for standard menu items 

offered for sale in such establishments, 

individual covered establishments can 

come into compliance with this rule 

without significantly overwhelming 

testing laboratories, even if such 

establishments choose analytical testing 

as the means to determine nutrient 

values. 

For all of these reasons, and as 

discussed in more detail in section 

XXIII.C, we have established an 

effective date for this rule that is 1 year 

from the date of publication of this 

document. Thus, the final rule is 

effective on December 1, 2015. 

(Comment 144) One comment that 

recommended a minimum of 12 to 18 

months for establishments to comply 

with the rule provided information 

about its experience from a 2010 rollout 

of new menu boards for all its domestic 

stores. This comment identified the 

following steps and corresponding time 

frames for this 2010 rollout: 

• 2 months to develop new menu 

board templates for the seven types of 

menu boards for its various types of 

store locations (mall stores, mall kiosks, 

mall carts, stadium stores, stadium 

carts, etc.); 

• 8 months to develop, program, and 

test an ordering site to accommodate 

more than 850 individual store menus; 

• 2 months to receive the orders and 

lay out all custom menu boards; and 

• 2 months to produce and ship new 

menu boards to its stores. 

(Response 144) We appreciate that 

this comment provided its specific 

experience from a company-wide 

rollout of new menu boards. The steps 

identified by this comment are similar 

to the steps identified by the comment 

from national associations representing 

restaurants, although with longer 

timeframes. However, as discussed in 

Comment 143 these national 

associations also noted that extending 

the time period to 1 year would allow 

most restaurants to incorporate adding 

calorie declarations to menus and 

associated menu redesigns with regular 

menu replacement cycles. We therefore 

disagree that the time frames 

experienced by one entity during a 

company-initiated rollout of new menu 

boards should determine the time frame 

for compliance by all covered 

establishments. 

(Comment 145) Some comments 

requested an effective date of more than 

12 months. One comment requested an 

18-month effective date because it 

considered that many requirements are 

still unclear. Another comment 

requested an 18-month to 2-year 

effective date for similar retail food 

establishments, even if there is a shorter 

time for restaurants. According to this 

comment, establishments need time to 

comply properly with the requirements 

and rushing through compliance could 

result in mistakes that may be confusing 

to consumers and would require 

additional industry resources to correct. 

A few comments requested a 2-year 

effective date. One comment asserted 

that there will be a steep learning curve 

and time is needed to train employees 

and develop and print display materials. 

A few comments maintained that a 2- 

year compliance period is appropriate 

because, according to one comment, we 

used a 2-year uniform compliance 

period when implementing the NLEA. 

According to another comment, a 2-year 

timeframe is reasonable as long as 

nutrition information is available in 

brochures and online. 

(Response 145) We disagree that an 

effective date over 1 year (such as 18 

months or 2 years, as suggested by the 

comments) is necessary. Many 

comments seeking a longer effective 

date focused on the need to train 

employees. Such training does not need 

to wait until all implementation 

activities are complete—e.g., such 

training can begin while an 

establishment is waiting for delivery of 

its revised menus and menu boards. 

We also disagree with the comment 

asserting that similar retail food 

establishments need more time than 

restaurants to comply with the rule. The 

comment provided no basis for why 

similar retail food establishments 

should be treated differently from 

restaurants or why such establishments 

would need more time for compliance 

than restaurants. 

We discuss the applicability of the 

uniform compliance date in section 

XXIII.C. 

(Comment 146) One comment 

asserted that there will be an unfair 

competitive advantage for larger 

companies because of the ability of 

larger companies to leverage their 

market position with the menu board 

producers. One comment requested a 

grace period to come into compliance if 

a covered establishment has adopted 

and followed a reasonable program to 

monitor changing nutrient values and 

update menus and menu boards at 

reasonable intervals coinciding with 

typical cycles. 

(Response 146) In the proposed rule, 

we specifically requested that comments 

about whether we should provide for 

staggered implementation based on the 

size of a chain or of a specific franchisee 

be supported by data. The comment 


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asserting that there will be an unfair 

competitive advantage for larger 

companies (because of their ability to 

leverage their market position with the 

menu board producers) provided no 

data for its assertion; therefore we have 

no information that could assist us in 

considering whether or how much 

additional time might be appropriate. 

Further, as discussed in Response 143, 

covered establishments can use a 

number of ways to comply with this 

rule without replacing menus or menu 

boards; for example, they can apply 

stickers or pieces of paper to menus or 

menu boards. For these reasons, we do 

not believe there is a sufficient basis to 

establish a staggered implementation 

period based on the size of the chain or 

of a specific franchise. 

Nevertheless, we can work with 

establishments that are not in 

compliance by the effective date of this 

rule on a case-by-case basis, taking into 

consideration a number of factors, 

including specific steps an 

establishment has taken towards 

compliance. 

(Comment 147) One comment 

requested that we allow 1 year for 

implementation, rather than 6 months, 

to provide covered establishments with 

adequate time to come into compliance 

given contractual requirements. For 

example, the comment said that it 

maintains a database with over 35,000 

recipes which, in turn, may be modified 

or adapted by the specific restaurant or 

similar retail food establishment for 

local needs and tastes, limitations of the 

establishment, contractual 

specifications, and other restrictions 

(e.g., an establishment’s determinations 

as to types of offerings). In addition, the 

comment stated that contractors rely on 

suppliers to provide nutritional 

information and, therefore, we should 

allow adequate time to retrieve data 

from these sources. 

(Response 147) As discussed in 

section XXIII.C, we are establishing an 

effective date of 1 year from the date of 

publication of this rule. We note that the 

comment refers to recipes that may be 

modified or adapted by a specific 

restaurant or similar retail food 

establishment. In section VI.F, we 

discuss how such modifications can 

affect whether an establishment is 

offering for sale substantially the same 

menu items (and, thus, satisfies this 

criterion in the definition of covered 

establishment). 

C. Effective Date and Compliance Date 

for This Rule 

We are establishing the effective date 

to be 1 year from the date of publication 

of this document, i.e., the final rule is 

effective on December 1, 2015, (see 

DATES). We believe that extending the 

effective date from 6 months to 1 year 

provides sufficient time for covered 

establishments to come into compliance 

with the requirements without a 

significant negative impact on public 

health. 

We expect covered establishments to 

come into compliance with the 

requirements of this rule by December 1, 

2015, i.e., the same date as the effective 

date of this rule. Although we are 

issuing this final rule after January 1, 

2013, there is sufficient justification for 

establishing a compliance date of 

December 1, 2015, to enforce the 

provisions of this final rule, rather than 

January 1, 2016, which FDA has 

established as the next uniform 

compliance date for other food labeling 

changes required by food labeling 

regulations that are issued between 

January 1, 2013, and December 31, 2014 

(77 FR 70885; November 28, 2012). 

Typically, our uniform compliance 

dates for food labeling regulations focus 

on changes made to the requirements for 

labels of packaged foods and seek to 

minimize the economic impact of such 

label changes, in relevant part, by 

allowing manufacturers to come into 

compliance with such regulations by 

one particular compliance date rather 

than several different dates (e.g., 77 FR 

70885; 75 FR 78155 (December 15, 

2010)). By providing one uniform 

compliance date, we enable 

manufacturers to avoid multiple shortterm label revisions that would 

otherwise occur if not for the uniform 

compliance date. However, this rule 

does not establish requirements for the 

labels of packaged foods, and therefore 

would not cause food label revisions 

comparable to other food labeling 

regulations typically addressed by our 

uniform compliance dates. In addition, 

standard menu items offered for sale in 

covered establishments were not subject 

to Federal nutrition labeling 

requirements before the enactment of 

section 4205 of the ACA. As a result, 

unlike packaged foods, standard menu 

items currently are not subject to several 

different Federal food labeling 

regulations that may provide for 

different compliance dates. Further, a 

comment from national associations 

representing restaurants reported that 

extending the time period from the 6 

months that we proposed, to 1 year, 

would allow most restaurants to comply 

with the rule as part of regular menu 

replacement cycles, thereby lessening 

costs. For these reasons, along with the 

reasons discussed previously, we 

believe that 1 year is sufficient time for 

covered establishments to come into 

compliance with the requirements of 

this rule. Waiting until FDA’s next 

uniform compliance date of January 1, 

2016, would create unnecessary delay in 

the enforcement of this rule and could 

minimize public health benefits. 

XXIV. Comments and FDA Response on 

Compliance 

In the proposed rule, we noted that 

some provisions of section 4205 of the 

ACA became requirements immediately 

upon enactment of the law and that we 

intended to exercise enforcement 

discretion until after we had completed 

notice and comment rulemaking. We 

encouraged our State and local partners 

to proceed in a similar way. We 

requested comment on how we should 

implement the rule, including whether 

specific provisions of the rule can be 

more quickly implemented than others 

(76 FR 19192 at 19220). 

(Comment 148) One comment asked 

us to develop a protocol for checking 

the accuracy of the nutritional 

information provided by covered 

establishments. One comment 

recommended that we undertake 

random testing as resources allow. 

Another comment recommended that 

testing be done annually and kept on a 

public file to ensure that the portions 

continue to be within 5 percent 

tolerance of the original nutritional 

information. The comment suggested 

that if deviations are found, the 

company would either retest in 30 days 

or pay a penalty fee that would be 

passed to a childhood obesity campaign. 

(Response 148) The rule provides 

several options for how covered 

establishments can determine nutrition 

information. While analytical testing of 

standard menu items may be 

appropriate in some cases (e.g., when 

the reasonable basis that a covered 

establishment uses to determine 

nutrient values is analytical testing), we 

expect our routine approach to 

evaluating the accuracy of the nutrition 

information to be based on the 

particular facts at issue, including the 

reasonable basis used by the covered 

establishment, which may be means 

other than analytical testing. Consistent 

with our approach to inspection of food 

processing facilities, we do not expect to 

establish a public file with the results of 

any testing we conduct. Under the 

Freedom of Information Act and our 

regulations in part 20, a person who 

wishes to see the results of our 

inspections may submit a request to do 

so. 

Regarding the comment suggesting 

that we develop a protocol for checking 

the accuracy of the nutritional 


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information provided by covered 

establishments, we decline to include 

such a protocol for checking the 

accuracy of the nutritional information 

in the rule at this time. Section 

101.11(c) includes requirements for 

determining nutrient content and 

section XVII further discusses such 

requirements, including the requirement 

that nutrient declarations be accurate 

and consistent with the specific basis 

used to determine nutrient values. After 

we have had experience in evaluating 

compliance with the rule, we will 

consider whether to develop such a 

protocol. 

(Comment 149) A few comments 

asked us to clarify our enforcement 

strategy and quickly establish an 

enforcement protocol. One comment 

stated that the proposed rule is virtually 

silent on how the menu labeling 

requirements will be enforced and 

encouraged us to permit the industry to 

comment on our enforcement strategy 

before it is included in the rule. One 

comment recommended that we issue 

guidance documents to the industry to 

better clarify matters of uncertainty that 

will persist following issuance of the 

rule. 

One comment asked us to provide 

details on the penalties for 

noncompliance. Another comment 

recommended that we issue warning 

letters prior to instituting civil penalties 

against a covered establishment, 

particularly if the proposed rule’s 

ambiguities are not clarified in the final 

rule. The comment maintained that a 

covered establishment may have made a 

good faith effort to comply and that 

warning letters will encourage 

compliance and inform establishments 

how they have fallen short of 

compliance. The comment 

recommended that we use a tiered 

penalty structure, whereby minor 

violations (e.g., inadequate font size of 

nutrition information) are treated less 

harshly than more serious violations 

(e.g., a clear lack of effort to place 

calorie information on printed menus). 

The comment also encouraged us to 

have a progressive penalty system for 

violations, whereby first violations are 

treated less harshly (e.g., a warning 

letter) than repeated violations. The 

comment maintained that this is 

especially crucial in the first few years 

the rules are being implemented as 

covered establishments familiarize 

themselves with the new requirements. 

(Response 149) We are establishing 

these regulations under sections 201(n), 

403(a)(1), 403(f), and 403(q)(5)(H) of the 

FD&C Act, as well as under section 

701(a) of the FD&C Act. As discussed in 

the proposed rule and in section XXII, 

failure to comply with the rule will 

render the food misbranded under 

section(s) 201(n), 403(a), 403(f), or 

403(q) of the FD&C Act (76 FR 19192 at 

19219). Penalties are already set forth in 

the FD&C Act, and violations of § 101.11 

may result in enforcement action 

consistent with those penalties. For 

example, 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 (21 U.S.C. 

331), carrying criminal penalties under 

section 303 of the FD&C Act (21 U.S.C. 

333). In addition, under section 302 of 

the FD&C Act (21 U.S.C. 332), the 

United States can bring a civil action in 

Federal court to enjoin a person who 

commits a prohibited action. Under 

section 304(a)(1) of the FD&C Act (21 

U.S.C. 334(a)(1)), a food that is 

misbranded when introduced into or 

while in interstate commerce or while 

held for sale after shipment in interstate 

commerce may be seized by order of a 

Federal court. We expect to issue 

guidance to help covered establishments 

with compliance. 

The tiered enforcement approach 

described by the comment is similar to 

the approach we currently take for other 

misbranded food, and we generally 

expect our enforcement approach to 

misbranding violations of this rule to be 

similar to that for other misbranded 

food. Nevertheless, enforcement will be 

considered on a case-by-case basis 

depending on the specific facts and 

circumstances. 

(Comment 150) One comment asked 

us to focus our enforcement actions on 

helping with compliance, rather than 

seeking monetary penalties, at least 

until establishments have an 

opportunity to fully adopt the 

requirements. This comment 

maintained that flexibility is needed in 

the initial phases of implementation for 

facilities that operate under Federal 

Government contracts so that they can 

continue to comply with requirements 

mandated by specific Government 

Agencies. As a result, the comment 

recommended that we provide 

flexibility for contract food providers 

that provide services to Government 

facilities under a specified program. 

(Response 150) We recognize that 

covered establishments will need time 

to comply with the nutrition labeling 

requirements of this rule during the 

initial phase of implementation. To 

provide more time to do so, this rule is 

not becoming effective until 1 year after 

the date of publication of this document 

(see the discussion in section XXIII.C of 

this document). 

A covered establishment has 

responsibility to comply with all 

requirements of the rule. We 

acknowledge that a covered 

establishment may need to update its 

business and contractual relationships 

with its suppliers in order to do so. 

(Comment 151) One comment asked 

us to permit stores to register points of 

contact to which we will address 

enforcement because experience shows 

that involving ‘‘corporate parents’’ of 

individual franchises or the owner of 

multi-store chains is the most effective 

way to manage enforcement issues. The 

comment recommended that we notify 

these contacts in the event of an 

enforcement action. Similarly, the 

comment recommended that we 

designate specific contacts for informal 

guidance and advice and develop a 

menu labeling hotline telephone 

number or email address to which store 

operators can ask specific questions. 

The comment considered that doing so 

would increase compliance and ease the 

administrative burden on its members. 

(Response 151) Each individual 

restaurant or similar retail food 

establishment is responsible for 

disclosing the required nutrition 

information for its standard menu items 

and otherwise complying with the 

requirements of sections 403(q)(5)(H), 

403(a)(1), and 403(f) of the FD&C Act 

and § 101.11. Persons exercising 

authority and supervisory responsibility 

over such establishments may also be 

held liable for violations of the FD&C 

Act. See Response 3. Our decisions 

regarding enforcement actions will be 

determined on a case by case basis. In 

general, we intend to notify a ‘‘corporate 

parent’’ as appropriate (see e.g., Refs. 39 

and 40). Although § 101.11(d) provides 

for voluntary registration for restaurants 

and similar retail food establishments 

that are not subject to the nutrition 

labeling requirements of section 

403(q)(5)(H) of the FD&C Act, and 

requires contact information, these 

requirements only apply to such 

establishments that would not be 

subject to the rule without registering. 

We already maintain a telephone 

hotline where industry may contact us 

for questions about compliance with our 

regulations (1–888–SAFEFOOD (1–888– 

723–3366)). Staff who are assigned to 

the hotline will have or obtain the 

information to answer questions about 

this rule. In addition, a covered 

establishment may direct questions to 

the contact person identified in this 

document (see FOR FURTHER INFORMATION

CONTACT), to the contact telephone 

number provided in any subsequent 


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guidance, and to a general email 

mailbox for industry questions 

(industry@fda.gov). A covered 

establishment also may send written 

inquiries to Center for Food Safety and 

Applied Nutrition (HFS–009), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. 

(Comment 152) A few comments 

recommended that we preapprove 

menus and menu boards. One of these 

comments recommended that we do so 

even if a fee was required. The comment 

maintained that an approval process 

would alleviate covered establishments 

from having to pay the costs to replace 

menus that they thought met the menu 

labeling requirements. 

(Response 152) We decline the 

request of these comments. Section 

403(q)(5)(H) of the FD&C Act does not 

require that we preapprove menus and 

menu boards, nor do we have the 

resources to do so at this time. Section 

403(q)(5)(H) of the FD&C Act and this 

rule set forth and specify the 

requirements for menus and menu 

boards such that a covered 

establishment should be able to 

determine whether its menu or menu 

board meets the applicable 

requirements. Further, a covered 

establishment may contact us with 

questions about compliance, as 

discussed previously in Response 151. 

(Comment 153) One comment asked 

us to clarify that compliance is the 

responsibility of each establishment and 

that if someone fails to comply, only 

that standard menu item in the 

particular establishment is misbranded. 

The comment expressed concern that 

without clarity on this point, States and 

localities may cite franchisors for 

violations by franchisees, and plaintiffs’ 

attorneys may sue franchisors for 

violations by franchisees under 

consumer protection laws. 

(Response 153) With regard to what 

food is misbranded if there is a failure 

to comply with the regulations, this 

would be determined based on the 

particular facts of the situation (see also 

Response 3). 

(Comment 154) Some comments 

asked us to allow flexibility for when a 

covered establishment must update 

menus to reflect changes in nutrient 

content. One of these comments asked 

us to clarify that any temporary 

inconsistencies resulting from periodic 

updating will not result in a violation of 

the law. The comment expressed 

concern that nutrient values may change 

because of ingredient changes, use of 

different suppliers, suppliers updating 

nutritional analysis with no changes in 

formulation, and reformulation of menu 

items based on consumer feedback. The 

comment asked us to state that values 

found not current will not raise a 

compliance issue if the covered 

establishment can demonstrate that it 

has adopted a reasonable program to 

monitor changing values and that it 

updates materials at reasonable intervals 

based on the manner and frequency in 

which it changes menus and other 

labeling. The comment also 

recommended that covered 

establishments be able to update their 

menus and menu boards at reasonable 

intervals coinciding with typical cycles 

to change menus and, at a maximum, 

values that require updating be updated 

at least once a year. One comment asked 

that the final rule clearly state that 

covered establishments are responsible 

for maintaining the accuracy of their 

nutrient declarations, including keeping 

this information up-to-date as their 

menus change. 

(Response 154) Nutrition labeling for 

a standard menu item must be truthful 

and not misleading, consistent with the 

specific basis used to determine nutrient 

values, and otherwise in compliance 

with the requirements of sections 

403(a)(1), 403(f), and 403(q)(5)(H) of the 

FD&C Act and § 101.11. We recognize 

that changes in nutrition information for 

standard menu items could cause a 

covered establishment to change a menu 

or menu board even if the list of menu 

items has not changed. In general, 

revised nutrition must be posted before 

serving the food. Compliance will be 

determined on a case-by-case basis 

depending on the specific facts and 

circumstances. We recommend that a 

covered establishment coordinate 

changes in menu items that are 

significant enough to affect nutrient 

content with the introduction of new 

items that also require updating a menu 

or menu board to help minimize costs. 

As discussed in Response 143, covered 

establishment may also use measures 

such as stickers to update nutrient 

content on menus or menu boards. 

(Comment 155) Several comments 

requested clarification on who would 

enforce the rule. One comment asked 

that delegation of inspection authority 

to the States be explicit, and asserted 

that the provision in 21 U.S.C. 337 

authorizing States to enforce Federal 

law has rarely been used. This comment 

stated that we could use 21 U.S.C 

372(a)(1)(A) to provide technical 

assistance and funding to States and 

locals for enforcement. The comment 

suggested that we set up a simple 

process for local health inspectors to 

report violations to us, e.g., a postcard 

to be filled in and sent to us with a tear 

off receipt to be left with the restaurant 

manager. The comment also suggested 

that we develop a system to collect and 

store reports of violations in a database. 

A few comments recommended that the 

final rule specify that enforcement 

procedures of States are not affected by 

section 4205 of the ACA. 

One comment recommended that we 

work with headquarters of chain 

restaurants and similar retail food 

establishments to ensure compliance 

and then have our District Offices assess 

compliance in the States. 

One comment stated that States and 

locals cannot be expected to enforce the 

Federal menu labeling requirements 

without significant funding. The 

comment stated that the enforcement 

process in its State is already 

overburdened and, therefore, the 

Federal Government should enforce the 

requirements. Other comments 

recommended that we rely on States 

and localities and provide training and 

funding. A few comments stated that 

historically restaurant inspections are 

done by the States and localities, and 

one comment recommended that we use 

the contractual regime of food safety 

inspections used with the enforcement 

of the NLEA. One comment stated that 

local restaurant inspectors can add the 

enforcement of menu labeling to their 

current inspections. One comment 

recommended that we enforce fines and 

penalties for noncompliance and direct 

any resulting funds to inspection 

programs enforcing the menu labeling 

requirements. 

One comment stated that it is not 

always practical for States and locals to 

enforce section 4205 of the ACA as 

delegates of FDA; rather we should 

encourage and support enactment of 

identical requirements that fit into local 

and State food codes. 

One comment suggested that the rule 

include specific provisions that would 

be binding on State and local 

jurisdictions relative to enforcing the 

rule. The comment stated that the right 

to a notice of a violation, the 

opportunity to cure a violation, and the 

opportunity to have a re-inspection 

before an adverse decision by the 

enforcing agent, e.g. a citation, vary 

enormously from jurisdiction to 

jurisdiction, at the State and at the local 

level. The comment suggested that we 

include specifics such as: 

• The enforcement agency at initial 

inspection provides written notice of 

violations; 

• The enforcement agency gives the 

establishment a period of time to cure 

the violations (e.g., 15–30 days); 

• The enforcement agency would reinspect after cure period; and 

• If violations are not cured, the 

enforcement agency would issue 


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adverse decision applying fine or other 

action that would apply under the 

enforcement agency’s regulations or 

applicable State or local laws. 

The comment stated that these actions 

would only apply to calorie labeling and 

not to other violations related to safety. 

(Response 155) Collectively, these 

comments address three mechanisms by 

which States (and, in some cases, local 

jurisdictions) could have a role in 

enforcing the provisions of section 

403(q)(5)(H) of the FD&C Act and this 

rule: 

• In general, a State or political 

subdivision of a State may establish 

food nutrition labeling requirements 

that are identical to applicable Federal 

requirements, including the 

requirements of this rule. In this case, 

the State or local jurisdiction would act 

on its own behalf to enforce its own 

requirements, albeit requirements that 

are identical to the Federal 

requirements. 

• Under 702(a)(1)(A) of the FD&C Act 

(21 U.S.C. 372(a)(1)(A)), FDA is 

authorized to conduct examinations and 

investigations for the purposes of the 

FD&C Act through any health, food, or 

drug officer or employee of any State, 

Territory, or political subdivision 

thereof (such as a locality), duly 

commissioned to act on behalf of FDA. 

In this case, the State or local 

representative would act on our behalf 

to enforce the Federal requirements. 

• In general, under section 310(b) of 

the FD&C Act (21 U.S.C. 337(b)), a State 

may bring in its own name and within 

its jurisdiction proceedings for the civil 

enforcement, or to restrain violations, of 

section 403(q) of the FD&C Act, 

including the nutrition labeling 

requirements for standard menu items 

under section 403(q)(5)(H) of the FD&C 

Act, if the food that is the subject of the 

proceedings is located in the State 

provided that other requirements and 

conditions are met. In this case, the 

State acts on its own behalf to enforce 

the Federal requirements. 

We have successfully partnered with 

States to conduct examinations and 

inspections in other contexts, including 

inspections of food processing facilities 

on our behalf (Ref. 41). We expect to 

continue to cooperatively leverage the 

resources of Federal, State, and local 

Government Agencies as we strive to 

obtain industry-wide compliance with 

this rule. 

XXV. Final Regulatory Impact Analysis 

FDA has examined the impacts of this 

final rule under Executive Order 12866, 

Executive Order 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 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). We 

have developed a detailed Regulatory 

Impact Analysis (RIA) that presents the 

benefits and costs of this final rule (Ref. 

42) which is available at http://

www.regulations.gov (enter Docket No. 

FDA–2011–F–0172). The full economic 

impact analyses of FDA regulations are 

no longer (as of April 2012) published 

in the Federal Register but are 

submitted to the docket and are 

available at http://www.regulations.gov. 

We also post the full economic impact 

analyses of FDA regulations at the 

following Web site: http://www.fda.gov/ 

AboutFDA/ReportsManualsForms/

Reports/EconomicAnalyses/default.htm. 

This rule is designated an 

‘‘economically’’ significant rule, under 

section 3(f)(1) of Executive Order 12866. 

Accordingly, the rule was reviewed by 

OMB. In particular, Executive Order 

12866 directs each Agency engaged in 

rulemaking to ‘‘identify the problem 

that it intends to address’’—that is, the 

essential purpose of the rule. As a 

separate step in its rulemaking, 

Executive Order 12866 directs the 

Agency to ‘‘assess both the costs and the 

benefits of the intended 

regulation . . . , recognizing that some 

costs and benefits are difficult to 

quantify.’’ 

Executive Order 13563 confirms that 

‘‘each agency is directed to use the best 

available techniques to quantify 

anticipated present and future benefits 

and costs as accurately as possible. 

Where appropriate and permitted by 

law, each Agency may consider (and 

discuss qualitatively) values that are 

difficult or impossible to quantify.’’ 

Here, the essential purpose of the rule 

is to make nutrition information for 

certain foods available to consumers in 

a direct, accessible, and consistent 

manner to enable consumers to make 

informed and healthful dietary choices. 

The full analysis—contained in the 

RIA—of anticipated and quantifiable 

costs and benefits from the 

promulgation of the rule does not alter 

this fundamental purpose. Nor does it 

fully capture the unquantifiable benefits 

of greater consumer understanding 

regarding dietary choices and their 

impact on health. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. According to our analysis, we 

believe that the final rule will have a 

significant economic impact on a 

substantial number of small entities, 

and we have accordingly analyzed 

regulatory options that would minimize 

the economic impact of the rule on 

small entities consistent with statutory 

objectives. We have crafted the final 

rule to provide flexibility for 

compliance. 

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 $141 

million, using the most current (2013) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA has determined 

that this final rule has met the threshold 

under the Unfunded Mandates Reform 

Act. 

The analyses that we have performed 

to examine the impacts of this final rule 

under Executive Order 12866, Executive 

Order 13563, the Regulatory Flexibility 

Act, and the Unfunded Mandates 

Reform Act of 1995 are included in the 

RIA (Ref. 42). 

We had prepared a ‘‘Preliminary 

Regulatory Impact Analysis’’ (Ref. 43) in 

connection with the proposed rule. We 

also included sections titled ‘‘Summary 

of Preliminary Regulatory Impact 

Analysis’’ and ‘‘Initial Regulatory 

Flexibility Analysis’’ in the preamble to 

the proposed rule (76 FR 19192 at 19220 

through 19225). We received comments 

on our analysis of the impacts presented 

in those sections, and the RIA (Ref. 42) 

contains our responses to those 

comments. 

XXVI. Paperwork Reduction Act of 

1995 

This final rule contains information 

collection provisions that are subject to 

review by OMB under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). A description of 

these provisions is given in this section 

of the document with estimates of the 

annual reporting, recordkeeping, and 

third-party disclosure burden. Included 

in each burden 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. 


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We had included a section titled 

‘‘Paperwork Reduction Act of 1995’’ in 

the preamble to the proposed rule (76 

FR 19192 at 19225 through 19229). We 

received one comment on our analysis 

of the burdens presented in that section. 

(Comment 156) One comment stated 

that the recordkeeping burdens of the 

proposed rule would impose millions of 

dollars in cost per year. The comment 

stated that these burdens are needless. 

(Response 156) We disagree that the 

burdens are needless. Providing 

accurate, clear, and consistent nutrition 

information, including the calorie 

content of foods, in restaurants and 

similar retail food establishments will 

make such nutrition information 

available to consumers in a direct and 

accessible manner to enable consumers 

to make informed and healthful dietary 

choices. 

We invite comments on these topics: 

(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. 

Title: Information Collection Provisions 

of the Final Rule on Food Labeling: 

Nutrition Labeling of Standard Menu 

Items in Restaurants and Similar Retail 

Food Establishments 

A. Reporting Requirements 

Description of Respondents: The 

likely respondents to this information 

collection are restaurants and similar 

retail food establishments that 

voluntarily elect to be subject to the 

Federal requirements of this rule by 

registering with FDA. These 

establishments include chain retail food 

establishments and eating and drinking 

places such as full- and limited-service 

restaurants, snack bars (including, for 

example, ice cream, donut, and bagel 

shops and similar establishments), 

cafeterias and drinking places, managed 

food service facilities, grocery stores, 

supermarkets, convenience stores, 

general merchandise stores, lodging 

facilities, recreational venues, sports 

venues, performing arts venues, and 

movie theaters. 

Description: Restaurants and similar 

retail food establishments not subject to 

the ACA’s requirements may voluntarily 

elect to be subject to the Federal 

requirements by registering with FDA. 

Authorized officials for restaurants and 

similar retail food establishments must 

provide FDA with the following 

information on Form FDA 3757: Their 

contact information including name, 

address, phone number, and email 

address for their authorized official; the 

contact information including name, 

address, phone number, and email 

address for 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; 

and 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 FD&C Act and 

§ 101.11 of the final rule. 

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. 

TABLE 1—ESTIMATED REPORTING BURDEN 1

21 CFR part 101 Number of 

respondents 

Number of 

responses per 

respondent 

per year 

Total annual 

responses 

Average burden per 

response 

(in hours) 

Total hours 

Initial Burden (annualized over 3 years): 

§ 101.11(d) Initial Registration ....................... 3,559 1 3,559 2 .................................... 7,118 

Annual Burden: 

§ 101.11(d) Registration Renewal ................. 5,340 1 5,340 0.5 (30 minutes) ........... 2,670 

Total Burden Hours ....................................... ........................ ........................ ........................ ....................................... 9,788 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We lack data on the number of 

restaurants and similar retail food 

establishments that might voluntarily 

register to comply with this final rule. 

We do not expect the net benefit for 

voluntary registration for many noncovered establishments to be positive 

and in the RIA (Ref. 42) we indicate that 

as of the conducting of this analysis, no 

establishments have voluntarily 

registered with FDA. Therefore we did 

not estimate a significant burden in the 

RIA. However, in the event that a few 

register anyway, or find positive 

incentive to do so, for the purposes of 

this PRA analysis, we estimate the 

burden such establishments will face. 

We believe that implementation of the 

final rule, and the resulting attention to 

the nutrition content of standard menu 

items, may give non-covered 

establishments an incentive to 

voluntarily disclose calorie and other 

nutrition information. We believe that 

the only types of establishments that 

would likely face a positive incentive to 

voluntarily register are some restaurants 

and some grocery, convenience, and 

general merchandise stores that do not 

already provide this information in 

some form or another at the point of 

purchase. We estimate that 5 percent of 

these establishments may register, or 

10,678 [(5% volunteer × 47% no 

nutrition info × 348,200 non-covered 

restaurants) + (5% volunteer × 49,900 

non-covered grocery, convenience, and 

general merchandise stores)] (Refs. 44 

and 45). We estimate it will require 

approximately 2 hours per initial 

registration. Given 10,678 

establishments and one initial 

registration per establishment at 2 hours 

per registration, we estimate the initial 

hourly burden for these establishments 

is 21,356 hours (10,678 establishments × 

1 initial registration per establishment × 

2 hours per registration). Annualizing 


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this value over 3 years yields 7,118 

hours per year (10,678 establishments/3 

years × 1 initial registration per 

establishment × 2 hours per 

registration). (10,678 establishments/3 

years = 3,559 establishments per year.) 

We expect that renewal registrations 

will require substantially less time 

because establishments are expected to 

be able to affirm or update the existing 

information in an online account in a 

way similar to other FDA firm 

registration systems. We estimate that 

re-registration will take 30 minutes (0.5 

hours) for each registrant. This would 

indicate that biennial registration would 

impose a burden of 5,340 hours (10,678 

establishments × 0.5 hours) every 2 

years, or 2,670 hours every year (10,678 

establishments/2 years × 0.5 hours). 

B. Recordkeeping Requirements 

The preamble to the proposed rule 

provided an estimate of the 

recordkeeping burden, which consisted 

of the burden associated with nutrition 

analysis and the burden associated with 

generating, providing, or maintaining 

records. Upon further consideration, we 

have omitted the burden estimate 

associated with generating or 

maintaining records previously 

estimated in the proposed rule because 

the rule does not require restaurants and 

similar retail food establishments to 

generate or maintain records. This 

section now includes only the burden 

estimate associated with providing 

information substantiating nutrient 

values of standard menu items to FDA 

as required by the final rule. Further, as 

discussed in section C of this analysis, 

we have included a burden estimate for 

nutrition analysis as part of the third 

party disclosure burden, since the total 

time, effort, or financial resources 

expended by covered establishments to 

declare nutrition information likely 

includes time, effort, or financial 

resources to determine the nutrition 

content of covered menu items. 

Description of Respondents 

The likely respondents to this 

information collection are restaurants 

and similar retail food establishments 

that are subject to the Federal 

requirements of this rule or that 

volunteer to be subject to the rule. These 

establishments include chain retail food 

establishments and eating and drinking 

places such as full- and limited-service 

restaurants, snack bars (including, for 

example, ice cream, donut, and bagel 

shops and similar establishments), 

cafeterias and drinking places, and 

managed food service facilities. Chain 

retail food establishments would also 

include some grocery stores, 

supermarkets, convenience stores, 

general merchandise stores, lodging 

facilities, recreational venues, sports 

venues, performing arts venues, and 

movie theaters (Ref. 46). 

Description 

The paperwork burden for the 

recordkeeping requirements of the final 

rule is to provide substantiation of the 

nutrient values of standard menu items 

to FDA. The likely respondents for the 

nutrition analysis are restaurants and 

similar retail food establishments that 

are subject to the Federal requirements 

of this rule or that volunteer to be 

subject to the rule. These establishments 

must produce records with information 

substantiating nutrient values for their 

standard menu items. 

The likely respondents are the 

universe of retail food establishments 

and retail chains that are covered by the 

final rule. Our estimate includes eating 

and drinking places such as full- and 

limited-service restaurants, snack bars 

including, for example, ice cream, 

donut, and bagel shops and similar 

establishments, cafeterias and drinking 

places, and managed food service 

facilities. Covered establishments also 

include some grocery stores, 

supermarkets, convenience stores, 

general merchandise stores, lodging 

facilities, recreational venues, sports 

venues, performing arts venues, and 

movie theaters. 

TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1

21 CFR part 101 Number 

recordkeepers 

Annual 

frequency per 

recordkeeper 

Total annual 

records Hours per record Total hours 

Initial Burden (Annualized over 3 years) 

§ 101.8(c)(2)(i)(A) Initial Nutrition Analysis Records .... 69,017 1 69,017 0.25 (15 minutes) .. 17,254 

Annual Burden 

§ 101.8(c)(2)(i)(A) Recurring Nutrition Analysis 

Records.

30,059 1 30,059 0.25 (15 minutes) .. 7,515 

Total Burden Hours ............................................... ........................ ........................ ........................ ............................... 24,769 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Initial Nutrition Analysis 

We estimate the annual number of the 

largest restaurant chains that will need 

to produce substantiation of their 

standard menu items to be 541 (503 

covered restaurant chains + 38 

voluntary restaurant chains) with an 

average of 117 unique menu items that 

will require an initial nutrition analysis. 

This leads to 63,297 (541 chains × 117 

items) individual chains-specific 

restaurant records. In addition to chainlevel nutrition analysis, each individual 

restaurant establishment will likely 

have a small variety of standard menu 

items that are unique to the individual 

establishment. We estimate there are 

11,684 restaurants establishments 

(10,866 covered + 818 voluntary) with 

establishment-specific items. Each of 

these restaurant establishments has an 

average of five establishment-specific 

menu items. This leads to 58,420 

(11,684 establishments × 5 items) 

individual establishment-specific 

restaurant records. 

In addition to restaurants, other 

similar retail food establishments have 

both chain-specific and establishmentspecific menu items. Other covered 

retail food establishments include: 

Grocery stores, supermarkets, 

convenience stores, general 

merchandise stores, lodging facilities, 

recreational venues, sports venues, 

performing arts venues, and movie 

theaters. We estimate there are 691 

grocery, convenience, and general 

merchandise (GCGM) store chains (660 

covered + 31 voluntary) with an average 

of 40 menu items each (= 27,640 

records); 5,309 GCGM establishments 


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(5,060 covered + 249 voluntary) with an 

average of 5 establishment-specific 

menu items each (= 26,545 records); 50 

managed food service (MFS) chains 

with an average of 80 menu items (= 

4,000 records); 450 MFS establishments 

with an average of 5 establishmentspecific menu items (= 2,250 records); 

100 lodging chains with an average of 

40 menu items (= 4,000 records); 620 

lodging establishments with an average 

of 5 establishment-specific menu items 

(= 3,100 records); 250 sports, recreation 

and entertainment (SRE) chains with an 

average of 59 menu items (= 14,750 

records); and 610 SRE establishments 

with an average of 5 establishmentspecific menu times (= 3,050 records). 

In total, we estimate there are 207,052 

records (63,297 restaurant chain-level + 

58,420 restaurant establishment-level + 

27,640 GCGM chain-level + 26,545 

GCGM establishment-level + 4,000 MFS 

chain-level + 2,250 MFS establishmentlevel + 4,000 lodging chain-level + 3,100 

lodging establishment-level + 14,750 

SRE chain-level + 3,050 SRE 

establishment-level). Annualized over 3 

years, this value yields 69,017 (= 

207,052 records/3 years) per year. We 

estimate that each nutrition analysis 

will require a burden of 15 minutes to 

produce each record. We estimate the 

total recordkeeping burden for the 

initial nutrition analysis to be 17,254.25 

hours (= 69,017 records × 0.25 hours per 

record). 

Recurring Nutrition Analysis 

From Mintel Menu Insights data, we 

estimate that restaurant chains 

introduced, on average, 24 new menu 

items in 2009 (Ref. 47). Because the 

final requirements do not apply to 

temporary menu items, daily specials, 

and foods that are part of a customary 

market test, only a fraction of these 

items will need nutrition analysis. We 

estimate that existing restaurant chains 

or individual establishments would 

need new nutrition analysis for 25 

percent of new standard menu items, or 

six new standard menu items per year. 

If in addition to these new standard 

menu items, chains need nutrition 

analysis on 6 reformulated standard 

menu items, there would be a total of 12 

nutrition analyses per chain needed on 

an annual basis. Thus we estimate there 

will be 26,904 annual records associated 

with new or reformulated items of 

covered chains [= (1,151 restaurant 

chains + 691 GCGM chains + 50 MFS 

chains + 100 lodging chains + 250 SRE 

chains) × 12 menus items]. 

In addition we estimate that each year 

there will be the number of covered 

chains to increase in each category as 

companies expand. As discussed in the 

final RIA, each year there will be some 

existing non-covered chains that, 

through expansion of their business, 

will become subject to the rule’s 

requirements (for example, a chain 

expanding from 19 to 20 locations). We 

estimate there will be 20 new restaurant 

chains, each with an average of 117 

menu items; 5 new GCGM chains each 

with an average of 40 menu items; 3 

new MFS chains each with an average 

of 80 menu items; 2 new lodging chains 

each with an average of 40 menu items; 

5 new SRE chains each with an average 

of 59 menu items. Thus we estimate 

there will be 3,155 annual records [= (20 

restaurants × 117 items) + (5 GCGM × 40 

items) + (3 MFS × 80 items) + (2 lodging 

× 40 items) + (5 SRE × 59 items] 

associated with nutrition analysis for 

new covered chains. 

Based on data from FDA’s 

Recordkeeping Cost Model, we estimate 

that it will take approximately 15 

minutes per standard menu item for 

providing the information of nutrition 

analysis to FDA (Ref. 48). We estimate 

the total recurring recordkeeping burden 

for the nutrition analysis to be 7,515 

hours [(26,899 records for new/

reformulated standard menu items 

under existing chains + 3,155 records 

for items under new chains) × 0.25 

hours per record)]. 

C. Third-Party Disclosure Requirements 

Description of Respondents: 

Restaurants and similar retail food 

establishments that are subject to 

statutory menu labeling requirements or 

that voluntarily elect to be subject to the 

Federal requirements by registering with 

FDA. 

Description: There will be five types 

of third-party disclosure burdens under 

the rule related to: Initial nutrition 

analysis, initial menu replacement, 

chain-level written nutrition 

information, establishment-level 

nutrition information, recurring 

nutrition analysis, and recurring menu 

replacement. 

TABLE 3—ESTIMATED THIRD PARTY DISCLOSURE BURDEN

21 CFR Part 101 Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

Total operating 

and maintenance 

costs 

Initial Burden (Annualized over 3 years) 

§ 101.8(c)(2)(i)(A) Initial Nutrition 

Analysis.

69,017 1 69,017 4 ............................ 276,068 ..............................

§ 101.8(c)(2)(i)(A) Initial Menu Replacement.106,168 1 106,168 0.5 (30 minutes) .... 53,084 $248,767,000 

§ 101.8(c)(2)(i)(A) Written Nutrition Information Chain-level.1,632 1 1,632 3 ............................ 4,896 ..............................

§ 101.8(c)(2)(i)(A) Written Nutrition Information Establishment-level.18,673 1 18,673 0.5 (30 minutes) .... 9,337 ..............................

Annual Burden 

§ 101.8(c)(2)(i)(A) Recurring Nutrition 

Analysis.

30,054 1 30,054 4 ............................ 120,216 ..............................

§ 101.8(c)(2)(i)(A) Recurring Menu 

Replacement.

700 1 700 0.5 (30 minutes) .... 350 $529,000 

Total ............................................ ........................ ........................ ........................ ............................... 463,951 $249,296,000 


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Initial Nutrition Analysis 

The first burden is the time and effort 

expended by restaurants and other retail 

food establishments to determine the 

nutrition content of their covered menu 

items, which we refer to as ‘‘Nutrition 

Analysis.’’ A nutrition analysis entails 

the burden of determining nutrition 

content for covered and voluntary 

establishment menus by analyzing the 

food product and summarizing the 

nutritional information results. Note 

that the recordkeeping portion of this 

burden was estimated in the previous 

subsection. 

Our estimate for the annual number of 

the restaurant and similar retail food 

chains and individual establishments 

that will be burdened with initial 

nutrition analysis is identical to our 

estimate for the chains and 

establishments under the recordkeeping 

subsection. The total number of 

respondents estimated for the thirdparty disclosure burden of initial 

nutrition analysis is 207,052. 

Annualized over 3 years, this value 

becomes 69,017. We estimate that each 

nutrition analysis will require a burden 

of 4 hours (this estimate of 4 hours was 

used in the final RIA (Ref. 42)), thus 

total burden for the initial nutrition 

analysis is 276,068 hours (207,052 

records/3 years × 4 hours per record). 

Recurring Nutrition Analysis 

The second burden is the time and 

effort expended by restaurants and other 

retail food establishments in recurring 

nutrition analysis. As discussed in the 

recordkeeping subsection of this PRA, 

recurring nutrition analysis will be 

required for new and reformulated 

standard menu items. Our estimate for 

the annual number of the restaurant and 

similar retail food chains and individual 

establishments that will be burdened 

with recurring nutrition analysis is 

identical to our estimate for the chains 

and establishments under the 

recordkeeping subsection. The total 

number of respondents estimated for the 

third-party disclosure burden of 

recurring nutrition analysis is 30,054. 

We estimate that each nutrition analysis 

will require a burden of 4 hours (this 

estimate of 4 hours was used in the final 

RIA (Ref. 42)), thus total third party 

disclosure burden recurring nutrition 

analysis is 120,216 hours (30,054 

records × 4 hours per record). 

Initial Menu Replacement 

The third burden is for the time 

expended by restaurants and similar 

retail food establishments to physically 

produce and install the menus, menu 

boards that include the new calorie 

declarations, which we refer to as 

‘‘Calorie Declaration Signs.’’ As 

described in the final RIA (Ref. 42), 

chain retail food establishments will 

need to redesign and replace their 

existing menus and menu boards in 

order to comply with the final 

requirements. For full service 

restaurants and drinking places with 

only personal menus and no menu 

boards, this burden will be relatively 

low. Most menus are replaced 

frequently anyway as they wear out, are 

lost, or as prices and menu items 

change. For many of these 

establishments, the burden of updating 

menus to comply with the final 

requirements would be limited to design 

and associated administrative hours. 

The longer lifespan of menu boards in 

limited-service eating places would 

likely require the redesign of menu/

menu boards and the replacement of 

one or more menu boards. In addition, 

some chains would need to update selfserve and display signs. The number of 

menus that an establishment will keep 

on hand is highly variable. A fullservice restaurant, where each order is 

placed using a menu, will need more 

than a quick-service establishment that 

uses menus just for takeout orders. The 

number of menus is also tied to the 

seating capacity of the restaurant, and 

whether the menu is laminated or 

paper. Because paper menus are more 

fragile and cheaper to print in bulk, an 

establishment may keep a large reserve 

in stock, whereas establishments using 

more durable and expensive laminated 

menus may only keep a few extra on 

hand. Estimates for the burden of 

updating menu boards, other major 

displays that serve as menus, such as 

electronic displays, or major materials 

needed to disclose calories for self-serve 

or displayed foods to comply with the 

final requirements, will vary widely 

across chains and establishments 

because of different menu board and 

display types. 

As described in the RIA, we estimate 

that the average full-service restaurant 

establishment must discard and reprint 

one menu for each seat, plus 10 extra, 

for a total of 91 menus per restaurant 

each year. We estimate that GCGM 

stores have an average of two menu 

boards per establishment based on 

public comments that we received. We 

estimate that MFS and SRE 

establishments will each have an 

average of one menu board. Lodging 

establishments generally have menus 

instead of menu boards, and we 

estimate the menu replacement burden 

for establishments in the lodging sector 

to be 87 menu replacements per 

establishment. Since each covered and 

voluntarily registered establishment will 

need to replace menus and/or menu 

boards, we estimate this total value to be 

318,505 (= 248,610 restaurants + 53,095 

GCGM + 4,500 MFS + 6,200 lodging + 

6,100 SRE). (In the previous calculation, 

248,610 restaurants = 231,200 covered 

restaurants + 17,410 voluntary; and 

53,095 GCGM = 50,600 covered + 2,495 

voluntary.) Annualized over 3 years, 

this value becomes 106,168 (= 318,505/ 

3 years). We estimate the labor burden 

for ordering new menus and menu 

boards to be 30 minutes (0.5 hours) per 

establishment. Thus the total burden for 

initial menu replacement is 53,084 

hours per year. At an average wage 

(which includes an extra 50 percent to 

account for overhead costs and 

employee benefits) of $30 per hour for 

managers across the covered industries, 

the labor burden comes to $1,593,000 (= 

53,084 hours × $30 per hour). In the 

final RIA (Ref. 42), we estimated the 

total average costs associated with 

initial menu replacement to be $250.36 

million. This value takes into 

consideration costs of menu/menu 

board design, printing, and installation. 

Subtracting the labor costs of ordering 

new menus, $1,593,000, from the total 

costs for initial menu replacement, 

$250,360,000, yields total initial 

operating and maintenance costs of 

$248,767,000. 

Recurring Menu Replacement for New 

Chains 

The fourth burden is for the time 

expended by new restaurants and 

similar retail food establishments to 

physically replace menus and menu 

boards that include the new calorie 

declarations. All restaurants and similar 

retail food chains that become covered 

as the number of their associated 

establishments grows beyond the 

coverage threshold of 20 will need to 

replace their menus and menu boards. 

We estimated in the final RIA (Ref. 42) 

that the annual number of new covered 

restaurants and similar retail food 

establishments is 700. Again, we 

estimate the labor burden for ordering 

new menus and menu boards to be 30 

minutes (0.5 hours) per establishment. 

Thus the total annual burden for 

recurring menu replacement is 350 

hours per year. At an average wage 

(which includes an extra 50 percent in 

overhead costs and employee benefits) 

of $30 per hour for managers across the 

covered industries, the recurring labor 

burden comes to $11,000 (= 350 hours 

× $30 per hour). In the final RIA, we 

estimated the total average annual 

operating and maintenance costs 

associated with recurring menu 

replacement to be $540,000. This value 


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takes into consideration costs of menu/ 

menu board design, printing, and 

installation. Subtracting the recurring 

labor costs of ordering new menus, 

$11,000, from the total costs for 

recurring menu replacement of 

$540,000, yields total recurring 

operating and maintenance costs of 

$529,000. 

Written Nutrition Information 

The fifth burden is for the time 

expended by restaurants and similar 

retail food establishments to make 

written nutrition information available 

to customers upon request. The number 

of chains (and associated 

establishments) that do not already 

provide this information was estimated 

in the recordkeeping subsection under 

initial nutrition analysis, or 1,632 

chains (503 covered restaurant + 38 

voluntary restaurant + 660 covered 

GCGM + 31 voluntary GCGM + 50 

covered MFS + 100 covered lodging + 

250 covered SRE) and 18,673 

establishments with establishment 

specific-menu items (10,866 covered 

restaurant + 818 voluntary restaurant + 

5,060 covered GCGM + 249 voluntary 

GCGM + 450 covered MFS + 620 

covered lodging + 610 covered SRE). We 

estimate the time it takes to provide 

written nutrition information at the 

chain level to be 3 hours per 

respondent. Since the average number 

of establishment-specific menu items is 

only five per establishment, we estimate 

the time it takes to provide written 

nutrition information at the 

establishment level (for those menu 

items that are specific only to the 

establishment) to be 30 minutes per 

respondent. Thus the total burden hours 

for chain-level and establishment level 

written nutrition information disclosure 

are 4,896 and 9,336.5 hours, 

respectively. Therefore the total third 

party disclosure burden for the rule is 

463,950.5 hours with total operating and 

maintenance costs of $249,296,000. 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB Control Number 0910–NEW, and 

title ‘‘Information Collection Provisions 

of the Final Rule on Food Labeling: 

Nutrition Labeling of Standard Menu 

Items in Restaurants and Similar Retail 

Food Establishments.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), we have resubmitted the 

information collection provisions of this 

final rule to OMB for review, because 

the final rule provides additional 

modifications to § 101.11. These 

requirements will not be effective until 

we obtain OMB approval. Interested 

persons are requested to submit 

comments regarding information 

collection to OMB (see DATES and 

ADDRESSES). 

Prior to the effective and compliance 

date of this final rule, we will publish 

a notice in the Federal Register 

announcing OMB’s decision to approve, 

modify, or disapprove the information 

collection provisions in this final rule. 

An Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

XXVII. Federalism 

We have analyzed this final 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 403(q) [of the 

FD&C Act] [21 U.S.C. 343(q)]’’, 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 section 

403(q)(5)(H)(ix) [of the FD&C Act].’’ In 

the proposed rule, we provided an 

interpretation of the preemptive 

provisions of section 4205 of the ACA, 

as well as an alternative interpretation 

(76 FR 19192 at 19203). (21 U.S.C. 343– 

1(a)(4)). The final rule creates 

requirements for nutrition labeling of 

food under section 403(q) of the FD&C 

Act that would preempt certain nonidentical State and local nutrition 

labeling requirements. 

Section 4205 of the ACA also includes 

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 

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.’’ (See Pub. L. 111–148, Sec. 

4205(d), 124 Stat. 119, 576 (2010).) 

We interpret 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 a 

covered establishment, as defined in 

§ 101.11(a), 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 in (1) chain retail 

food establishments or (2) restaurants 

and similar retail food establishments 

not subject to the requirements of 

section 403(q)(5)(H) of the FD&C Act 

that voluntarily elect to be subject to the 

requirements by registering biannually 

under section 403(q)(5)(H)(ix). 

Otherwise, for certain food that is not 

subject to the nutrition labeling 

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

the FD&C Act, States and localities may 

establish or continue to impose 

nutrition labeling requirements. First, 

States and localities can have nutrition 

labeling requirements for food sold in 

restaurants or similar retail food 

establishments that are 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 that have not voluntarily 

registered under section 403(q)(5)(H)(ix) 

of the FD&C Act. 

Second, States and localities can have 

nutrition labeling requirements for 

foods offered for sale in other 

establishments described in sections 


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403(q)(5)(A)(i) or (ii) of the FD&C Act 

that are exempt from the nutrition 

labeling requirements of sections 

403(q)(1) to (q)(4) of the FD&C Act 

under section 403(q)(5)(A)(i) or (ii) of 

the FD&C Act, provided that such food 

is not required to have nutrition labeling 

under section 403(q)(5)(H) of the FD&C 

Act. For example, certain foods sold in 

schools and transportation carriers 

would not be required to have nutrition 

labeling under sections 403(q)(1) to 

(q)(4) of the FD&C Act (see section 

403(q)(5)(A)(i) and (ii) of the FD&C Act 

and § 101.9(j)(2) and (j)(3)), or under 

section 403(q)(5)(H) of the FD&C Act 

because these establishments are not 

covered establishments within the 

meaning of § 101.11(a). Under our 

interpretation of the Rule of 

Construction in section 4205(d)(1) of the 

ACA, nutrition labeling for food sold 

from such establishments would not be 

‘‘nutrient content disclosures of the type 

required under section 403(q)(5)(H)(viii) 

[of the FD&C Act]’’ and, therefore, 

would not be preempted. As a result, 

States and localities would be able to 

continue to require nutrition labeling for 

foods sold from establishments that are 

exempt from the nutrition labeling 

requirements of section 403(q)(1) to 

(q)(4) of the FD&C Act and not subject 

to nutrition labeling requirements of 

section 403(q)(5)(H) of the FD&C Act. 

In addition, the express preemption 

provisions of section 403(A)(a)(4) of the 

FD&C Act 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. 

The preamble to the proposed rule (76 

FR 19192 at 19229 to 19230) described 

an alternative interpretation of the 

preemption provisions of section 4205 

of the ACA that could leave less room 

for States and localities to require 

nutrition labeling for food sold in 

restaurants or similar retail food 

establishments. Under this alternative 

interpretation, State or local nutrition 

labeling requirements for food sold in 

establishments that are not ‘‘restaurants 

or similar retail food establishments,’’ 

would be ineligible for the exception to 

the preemption in section 403(A)(a)(4) 

of the FD&C Act, because that exception 

by its literal terms only covers nutrition 

labeling requirements for food offered 

for sale in certain restaurants or similar 

retail food establishments, specifically 

those not subject to the nutrition 

labeling requirements of section 

403(q)(5)(H) of the FD&C Act. Under 

this alternative interpretation, States 

and localities could not have nutrition 

labeling requirements for certain foods 

offered for sale in non-restaurants and 

similar retail food establishments unless 

they successfully petitioned us. Federal 

law provides that, upon petition, FDA 

may exempt State or local requirements 

from the express preemption provisions 

of section 403A(a)(4) of the FD&C Act 

under certain conditions. (See 21 U.S.C. 

343–1(b).) We have issued regulations at 

§ 100.1 (21 CFR 100.1) describing the 

petition process that is available to State 

and local governments to request such 

exemptions from preemption. 

In addition, under this alternative 

interpretation, there would be foods in 

certain establishments 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 us and a rulemaking was 

completed. This approach would risk 

creating a regulatory gap that would be 

inconsistent with the purposes of 

section 4205 of the ACA. 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. 

We requested comment on our 

interpretation of section 4025 of the 

ACA related to preemption, as well as 

the alternative interpretation. We also 

requested comment on the use of the 

petition process in this context and on 

other potential interpretations that 

interested persons could identify as 

appropriate given both the preemptionrelated language of section 4205 of the 

ACA and the statutory goals. 

(Comment 157) Several comments 

agreed with our interpretation of the 

preemption provisions of section 4205 

of the ACA. A few of these comments 

recommended that the final rule include 

an explicit statement that the scope of 

the law’s preemptive effect is 

coextensive with the law’s nutrition 

labeling requirements; that is, the only 

State and local provisions that are 

preempted are those that explicitly 

require the type of menu labeling set 

forth in section 4205 of the ACA at a 

covered establishment. For example, the 

comments stated that if we decide not 

to cover movie theaters, hospitals, and 

other establishments or decide to 

exempt alcohol beverages from menu 

labeling in the final rule, then States 

and localities can enact laws to cover 

them. Another comment stated that an 

express statement about preemption 

will encourage States and localities to 

pass laws that fill in the gaps and to 

pass identical laws. 

One comment disagreed with our 

proposed interpretation of the 

preemption provisions and its outcome. 

The comment stated that narrowing the 

exception for preemption is consistent 

with Congress’ purpose to preempt the 

growing patchwork of State and local 

menu labeling laws. In addition, the 

comment stated that, while the 

alternative interpretation would result 

in a ‘‘regulatory gap’’ with some 

establishments not covered by Federal, 

State, and local menu labeling laws, 

Congress could amend the FD&C Act, if 

it chose to do so. 

(Response 157) We agree with the 

comments asserting that the preemptive 

effect of the Federal menu labeling 

requirements of section 4205 of the ACA 

is limited to State and local 

requirements that impose additional or 

different nutrition labeling requirements 

for food that is covered by the Federal 

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

the FD&C Act and § 101.11. We also 

agree that the alternative interpretation 

described in the proposed rule (76 FR 

19192 at 19230) would restrict State and 

local authorities and create a regulatory 

gap that would be inconsistent with the 

purposes and language of section 4205 

of the ACA and the Federalism 

principles expressed in Executive Order 

13132. 

We disagree with the comment that 

suggested that the alternative 

interpretation is more consistent with 

congressional intent to preempt the 

‘‘patchwork’’ of State and local laws on 

menu labeling and that the solution for 

the ‘‘regulatory gap’’ under that 

interpretation would be for Congress to 

amend the FD&C Act again. Congress 

did create a uniform national menu 

labeling scheme for certain foods in 

certain facilities described in section 

4205 of the ACA. However, nothing in 

the legislative history suggests that 

Congress intended to create a category 

of foods in establishments for which 

neither the Federal Government nor 

State or local governments could require 

menu labeling. We think it is more 

consistent with the purposes of section 

4205 of the ACA, which provides 

valuable nutrition information to 

consumers, to allow State and local 

governments to require menu labeling 

for food not covered by Federal law. The 

language of section 4205(c) of the ACA 

amending section 403A of the FD&C Act 

is consistent with our final 

interpretation. This amendment 

includes an exception from preemption 

for food sold in restaurants or similar 

retail food establishments that are not 

restaurants or establishments subject to 

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

FD&C Act. 


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For these reasons, we interpret the 

provisions of section 4205 of the ACA 

related to preemption to mean that State 

and local governments may not 

establish or continue in effect nutrition 

labeling requirements for food covered 

by the Federal requirements of section 

403(q)(5)(H) of the FD&C Act and 

§ 101.11, unless the State or local 

requirements are identical to the Federal 

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

the FD&C Act and § 101.11. In other 

words, States and localities cannot have 

additional or different nutrition labeling 

requirements for food sold either from: 

(1) Chain retail food establishments; or 

(2) restaurants and similar retail food 

establishments not otherwise subject to 

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

and § 101.11 who voluntarily elect to be 

subject to those requirements by 

registering biannually with FDA in 

accordance with section 403(q)(5)(H)(ix) 

of the FD&C Act and § 101.11(d). For 

food sold in restaurants and similar 

retail establishments not subject to the 

nutrition labeling requirements of 

section 403(q)(5)(H) of the FD&C Act, 

States and localities may impose 

nutrition labeling requirements. 

(Comment 158) Several comments 

agreed with our interpretation of the 

Rule of Construction. One comment 

agreed that warning statements are not 

preempted but asked us to clarify that 

this does not mean just microbiological 

hazards. 

A few comments recommended that 

we codify the Rule of Construction. The 

comments asserted that the absence of 

codified provisions in the rule regarding 

the Rule of Construction could lead to 

confusion in properly interpreting the 

statute. The comments maintained that 

the lack of codified provisions in the 

rule for a similar Rule of Construction 

in the NLEA (see 21 U.S.C. 343–1 note) 

has led to confusion and to court 

decisions that have not taken that rule 

into account. The comments maintained 

that ensuring that the Rule of 

Construction is explicitly set out in Title 

21 of the Code of Federal Regulations 

could help to avoid similar problems 

with the menu labeling law. 

(Response 158) With respect to our 

interpretation of the Rule of 

Construction in section 4205(d) of the 

ACA, we reiterate that State or local 

requirements for statements in food 

labeling providing for warnings 

concerning food safety are not 

preempted. We agree with the comment 

that food safety in this context is not 

limited to microbiological hazards. We 

are not persuaded by the comments 

suggesting that we add a codified 

statement to § 101.11 restating the Rule 

of Construction at section 4205(d) of the 

ACA. We have highlighted the existence 

of the Rule of Construction and have 

explained our interpretation of section 

4205(d) of the ACA both in the 

preamble to the proposed rule and in 

the preamble to this final rule. We do 

not think that codifying the Rule of 

Construction in section 4205(d) in our 

regulations is needed either to prevent 

confusion in interpreting the statute or 

to assure that courts consider section 

4205(d) when appropriate. 

(Comment 159) Some comments 

asked us to address the meaning of 

‘‘identical’’ in section 403A(a)(4) of the 

FD&C Act, which excludes from 

preemption State and local 

requirements that are identical to 

Federal requirements under section 

403(q) of the FD&C Act. The comments 

recommended that the final rule 

explicitly state that ‘‘identical’’ refers to 

the effect of the law and does not mean 

that a State or local requirement must be 

identical in wording of the law. 

(Response 159) In response to the 

comments asserting that we revise the 

rule to clarify the meaning of 

‘‘identical’’ within the context of section 

403A(a)(4) of the FD&C Act, we note 

that we have already issued a regulation 

at § 100.1 that explains the meaning of 

‘‘not identical to’’ in the context of 

section 403A of the FD&C Act in 

describing the petition process available 

to State and local governments to 

request an exemption from the express 

preemption provisions of section 403A 

of the FD&C Act under section 403A(b). 

Section 100.1(c)(4) provides in relevant 

part that, within the context of section 

403A of FD&C Act, ‘‘not identical to’’ 

does not refer to the specific words in 

the State or local requirement but 

instead means that the State or local 

requirement directly or indirectly 

imposes obligations or contains 

provisions concerning the labeling of 

food that: (1) Are not imposed by or 

contained in the applicable provision 

(including any implementing 

regulation) of section 403 of the FD&C 

Act; or (2) differ from those specifically 

imposed by or contained in the 

applicable provision (including any 

implementing regulation) of section 403 

of the FD&C Act. 

Accordingly, a State or local nutrition 

labeling requirement for food covered 

by the requirements of section 

403(q)(5)(H) of the FD&C Act and 

§ 101.11 that directly or indirectly 

imposes obligations or contains labeling 

provisions that: (1) Are not imposed by 

or contained in section 403(q) of the 

FD&C Act and § 101.11; or (2) differ 

from those specifically imposed by or 

contained in section 403(q) of the FD&C 

Act and § 101.11 would be ‘‘not 

identical to’’ the Federal requirements 

and therefore would be preempted 

under section 403A(a)(4) of the FD&C 

Act. Because the meaning of the phrase 

‘‘not identical to,’’ within the context of 

section 403A of the FD&C Act, is 

already described in § 100.1 and is 

further explained here, we decline to 

revise the rule to clarify the meaning of 

‘‘identical’’ as suggested by the 

comments. 

(Comment 160) A few comments 

recommended that we support 

development of State and local laws that 

are identical. The comments 

recommended that we help the States 

and localities by making staff available 

to help assess the proposed language of 

State or local law for potential conflicts 

with Federal law and providing model 

legislation, which should be made part 

of the Model Food Code. 

(Response 160) As discussed in 

section XXIV, a State or local 

jurisdiction may establish requirements, 

identical to those established in this 

rule, in its own food codes and then 

enforce its own food codes. Whether we 

can help States and localities assess the 

proposed language of State or local law 

for potential conflicts with Federal law 

will depend on resources available at 

the time of any requests for such 

assistance. However, at this time, we do 

not expect to have resources to provide 

model legislation for use by States and 

localities. We recommend that States 

and localities who wish to establish 

requirements, in their own food codes, 

identical to those established in this 

rule adapt § 101.11 for their own use. 

(Comment 161) One comment asked 

us to describe the basis on which 

establishments that opt into the program 

can be assured that preemption applies. 

The comment asserted that if a facility 

complies with the Federal requirements 

under its food service contract as agreed 

to by the Federal Government, that 

establishment must be fully protected 

from State and local menu labeling 

action. The comment also stated that a 

facility’s compliance with the terms of 

a Federal Government contract must 

suffice as certification that the facility is 

in compliance with all FDA menu 

labeling provisions and the facility 

should be permitted to opt into our 

program without any additional 

requirements. 

(Response 161) As provided in 

403(q)(5)(H)(ix) of the FD&C Act, 

authorized officials of restaurants and 

similar retail establishments that are not 

subject to the requirements of section 

403(q)(5)(H) may elect to be subject to 

those requirements by registering 

biannually with FDA, as specified in 

§ 101.11(d). Under section 403A(a)(4) of 


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the FD&C Act, an establishment that 

‘‘complies with the voluntary provision 

of nutrition information requirements of 

403(q)(5)(H)(ix)’’ brings itself within the 

scope of Federal preemption of State 

and local laws. The comment appears 

essentially to be seeking FDA’s 

assurances that a facility’s compliance 

with the terms of a Federal contract to 

provide food services would (1) suffice 

for ‘‘opting in’’ to the voluntary program 

and (2) guarantee that State and local 

menu labeling action against the facility 

is prohibited. We decline to provide 

such assurances. The requirements for 

voluntarily ‘‘opting in’’ to be subject to 

the Federal menu labeling requirements 

are set forth in § 101.11(d). Preemption 

of certain State and local requirements 

follows from voluntarily becoming 

subject to the requirements of § 101.11. 

The effects of following the terms of 

Federal contracts to procure food 

services are outside the scope of this 

rulemaking. 

XXVIII. Environmental Impact 

We have determined under 21 CFR 

25.30(k) that this action is of a type 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. 

XXIX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

all the Web site addresses in this 

reference section, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register). 

1. Flegal, K.M., M.D. Carroll, C.L. Ogden, et 

al., ‘‘Prevalence and Trends in Obesity 

Among U.S. Adults 1999–2008,’’ Journal 

of the American Medical Association, 

303:235–241, 2010. 

2. Ogden, C.L., M.D. Carroll, L.R. Curtin, et 

al., ‘‘Prevalence of High Body Mass 

Index in U.S. Children and Adolescents, 

2007–2008,’’ Journal of the American 

Medical Association, 303:242–249, 2010. 

3. U.S. Department of Health and Human 

Services (DHHS) and USDA, ‘‘2010 

Dietary Guidelines for Americans,’’ 7th 

ed., Washington DC: U.S. Government 

Printing Office, 2010. Available at 

http://www.cnpp.usda.gov/DGAs2010- 

PolicyDocument.htm. Accessed on 

November 3, 2014. 

4. Lin, B.H., J. Guthrie, and E. Fraza ̃o. 

‘‘Nutrient Contribution of Food Away 

From Home,’’ America’s Eating Habits: 

Changes and Consequences, chapter 12, 

Elizabeth Fraza ̃o (ed.), USDA Agriculture 

Information Bulletin No. (AIB–750), pp. 

213–242, May 1999. 

5. FDA Reports & Research Internet Web 

page: ‘‘Backgrounder—Keystone Forum 

on Away-From-Home Foods: 

Opportunities for Preventing Weight 

Gain and Obesity Report,’’ Keystone 

Center, June 2006. 

6. 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/

data-products/food-expenditures.aspx. 

Accessed on November 3, 2014. 

7. Burton, S., E.H. Creyer, J. Kees, et al., 

‘‘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. 

8. FDA, ‘‘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,’’ 2010. 

9. 112th Congress, House of Representatives, 

H. Rept. 112–101, ‘‘Agriculture, Rural 

Development, Food and Drug 

Administration, and Related Agencies 

Appropriations Bill, 2012,’’ June 3, 2011. 

10. FDA, ‘‘Guidance for Industry: A Labeling 

Guide for Restaurants and Other Retail 

Establishments Selling Away-FromHome Foods,’’ April 2008. 

11. Food Marketing Trends. ‘‘U.S. Grocery 

Shopper Trends’’, 2010. 

12. Sutherland Statutes 21.4, 7th ed., 2009. 

13. 155 Cong. Rec. S5522 (May 14, 2009) 

(statement of Senator Harkin). 

14. Commissioner, New York State 

Department of Agriculture and Markets 

and Commissioner, New York State 

Department of Health. ‘‘Memorandum of 

Understanding Between the New York 

State Department of Health and the New 

York State Department of Agriculture 

and Markets Concerning the Inspection 

of Food Service Establishments and Food 

Processing Establishments’’, 2010. 

15. Webster’s Third New International 

Dictionary, p. 369, 2002. 

16. The American Heritage Online 

Dictionary. Available at http://

ahdictionary.com/word/

search.html?q=chain. Accessed on 

November 3, 2014. 

17. Merriam-Webster Dictionary. Available at 

http://www.merriam-webster.com/

dictionary/chain. Accessed on November 

3, 2014. 

18. Webster’s Third New International 

Dictionary, pp. 1327–1328, 2002. 

19. The American Heritage Online 

Dictionary. Available at http://

ahdictionary.com/word/

search.html?q=location. Accessed on 

November 3, 2014. 

20. The American Heritage Online 

Dictionary. Available at http://

ahdictionary.com/word/

search.html?q=writing. Accessed on 

November 3, 2014. 

21. Merriam-Webster Dictionary. Available at 

http://www.merriam-webster.com/

dictionary/writing. Accessed on 

November 3, 2014. 

22. Webster’s Third New International 

Dictionary, p. 2641, 2002. 

23. Merriam-Webster Dictionary. Available at 

http://www.merriam-webster.com/

dictionary/primary. Accessed on 

November 3, 2014. 

24. The American Heritage Online 

Dictionary. Available at http://

ahdictionary.com/word/

search.html?q=primary. Accessed on 

November 3, 2014. 

25. Webster’s Third New International 

Dictionary, p. 1800, 2002. 

26. 2A Sutherland Statutory Construction 

137, 7th ed., 2009. 

27. McDonald’s and North America 

Consumer and Business Insights, ‘‘DriveThru Caloric Information Online 

Customer Satisfaction Survey’’, 2011. 

28. FDA Memorandum, Chung-Tung Jordan 

Lin, to the File, ‘‘Review of Comment 

Submitted by McDonald’s USA to Docket 

No. FDA–2011–F–0172, on the Use of 

Stanchions at Drive-Through Windows 

to Disclose Calories in Standard Menu 

Items in Restaurants and Similar Retail 

Food Establishments,’’ January 27, 2012. 

29. Harkin, DeLauro Respond to Proposed 

Menu Labeling Rules. April 1, 2011. 

Available at http://

www.harkin.senate.gov/press/

release.cfm?i=332329. Accessed on 

November 3, 2014. 

30. U.S. Department of the Treasury, Alcohol 

and Tobacco Tax and Trade Bureau. TTB 

Ruling Number: 2013–2, May 28, 2013. 

31. Cunningham, S.K., The Bartender’s Black 

Book, 10th ed., 2011. 

32. Comment from Hyman, Phelps, and 

McNamara on behalf of Dominoes, 

Appendix 3, 2011. 

33. FDA Memorandum, Chung-Tung Jordan 

Lin, to the File, ‘‘Review of Comment 

Submitted by Culver Franchising 

Systems, Inc,. to Docket No. FDA–2011– 

F–0172, on the Calorie Declaration 

Option of Not Using Caloric Ranges for 

Combination Meals and Variable Menu 

Items,’’ February 29, 2012. 

34. California Health and Safety Code, 

Section 114377. 

35. New York City Health Code, Section 

81.08. 

36. Baltimore City Health Code Section 6– 

507. 

37. County Council for Montgomery County 

Maryland, Resolution No. 16–134, 2007. 

38. FDA, ‘‘Guidance for Industry: A Food 

Labeling Guide,’’ 2008. 

39. FDA, ‘‘Regulatory Procedures Manual,’’ 

chapter 4. 

40 FDA, ‘‘Regulatory Procedures Manual,’’ 

chapter 6, section 5. 

41. FDA, ‘‘State Contracts,’’ available at 

http://www.fda.gov/

ForFederalStateandLocalOfficials/

PartnershipsContracts/StateContracts/

default.htm, 2012. 

42. FDA, ‘‘Food Labeling: Nutrition Labeling 

of Standard Menu Items in Restaurants 


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and Similar Retail Food Establishments. 

Final Regulatory Impact Analysis,’’ 

Docket No. FDA–2011–F–0172, 2014. 

43. ‘‘Food Labeling: Nutrition Labeling of 

Standard Menu Items in Restaurants and 

Similar Retail Food Establishments. 

Notice of Proposed Rulemaking,’’ Docket 

No. FDA–2011–F–0172, Preliminary 

Regulatory Impact Analysis, 2011. 

44. U.S. Census Bureau. County Business 

Patterns, United States NAICS 2000– 

2008. October 18, 2010. 

45. Wootan, M.G., M. Osborn. ‘‘Availability 

of Nutrition Information From Chain 

Restaurants in the United States. 

American Journal of Preventive 

Medicine, 30(3):266–268, 2006. 

46. U.S. Census Bureau. North American 

Industry Classification System. 2007. 

October 18, 2010. 

47. Mintel Menu Insights. New Menu Items 

at Restaurants. 2010. 

48. Eastern Research Group I. Evaluation of 

Recordkeeping Costs for Food 

Manufacturers, Final Report. Sertkaya, 

A, A. Berlind, S. Erdem, editors. Contract 

No. 223–01–2461, Task Order Number 5. 

2007. 

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, 21 CFR parts 11 and 

101 are 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), the 

introductory text of paragraphs (j)(2) 

and (3), and the first sentence of 

paragraph (j)(4) to read as follows: 

§ 101.9 Nutrition labeling of food. 

* * * * * 

(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 than 

$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: 

* * * * * 

(4) Except as provided in § 101.11, 

foods that contain insignificant amounts 

of all of the nutrients and food 

components required to be included in 

the declaration of nutrition information 

under paragraph (c) of this section, 

Provided, That the food bears no 

nutrition claims or other nutrition 

information in any context on the label 

or in labeling or advertising. * * * 

* * * * * 

■ 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 the purposes of 

this section, restaurant food includes 

two categories of food. It includes 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 use in such 

establishments. It also includes food 

which is processed and prepared 

primarily in a retail establishment, 

which is ready for human consumption, 

which is of the type described in the 

previous sentence, 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. 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 

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 


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71254 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

items, as well as a restaurant or similar 

retail food establishment that is 

registered to be covered under 

paragraph (d) of this section. 

Custom order means a food order that 

is prepared in a specific manner based 

on an individual customer’s request, 

which requires the covered 

establishment to deviate from its usual 

preparation of a standard menu item, 

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 menu board 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 

‘‘name’’ refers to either: 

(i) The name of the establishment 

presented to the public; or 

(ii) If there is no name of the 

establishment presented to the public 

(e.g., an establishment with the generic 

descriptor ‘‘concession stand’’), the 

name of the parent entity of the 

establishment. When the term ‘‘name’’ 

refers to the name of the establishment 

presented to the public under paragraph 

(i) of this definition, the term ‘‘same’’ 

includes names that 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 restauranttype 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 appears on 

a menu or menu board for less than 90 

consecutive days in order to test 

consumer acceptance of the product. 

Location means a fixed position or 

site. 

Menu or menu board means the 

primary writing of the covered 

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. Determining 

whether a writing is or is part of the 

primary writing of the covered 

establishment from which a customer 

makes an order selection depends on a 

number of factors, including whether 

the writing lists the name of a standard 

menu item (or an image depicting the 

standard menu item) and the price of 

the standard menu item, and whether 

the writing can be used by a customer 

to make an order selection at the time 

the customer is viewing the writing. The 

menus may be in different forms, e.g., 

booklets, pamphlets, or single sheets of 

paper. Menu boards include those 

inside a covered establishment as well 

as drive-through menu boards at 

covered establishments. 

Offering for sale substantially the 

same menu items means offering for sale 

a significant proportion of menu items 

that use the same general recipe and are 

prepared in substantially the same way 

with substantially the same food 

components, even if 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 selfservice 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. Having the same name may 

indicate, but does not necessarily 

guarantee, that menu items are 

substantially the same. 

Restaurant or similar retail food 

establishment means a retail 

establishment that offers for sale 

restaurant-type food, except if it is a 

school as defined by 7 CFR 210.2 or 

220.2. 

Restaurant-type food means food that 

is: 

(i) Usually eaten on the premises, 

while walking away, or soon after 

arriving at another location; and 

(ii) Either: 

(A) Served in restaurants or other 

establishments in which food is served 

for immediate human consumption or 

which is sold for sale or use in such 

establishments; or 

(B) Processed and prepared primarily 

in a retail establishment, ready for 

human consumption, of the type 

described in paragraph (ii)(A) of this 

definition, and offered for sale to 

consumers but not for immediate 

human consumption in such 

establishment and which is not offered 

for sale outside such establishment. 

Self-service food means restauranttype food that is available at a salad bar, 

buffet line, cafeteria line, or similar selfservice facility and that is served by the 

customers themselves. Self-service food 

also includes self-service beverages. 

Standard menu item means a 

restaurant-type food that is routinely 

included on a menu or menu board or 

routinely offered as a self-service food 

or food on display. 

Temporary menu item means a food 

that appears on a menu or menu board 

for less than a total of 60 days per 

calendar year. The 60 days includes the 

total of consecutive and 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)(A) The labeling requirements in 

this paragraph (b) do not apply to foods 

that are not standard menu items, 

including: 

(1) Items such as condiments that are 

for general use, including those placed 

on the table or on or behind the counter; 

daily specials; temporary menu items; 

custom orders; food that is part of a 

customary market test; and 

(2) Self-service food and food on 

display that is offered for sale for less 

than a total of 60 days per calendar year 

or fewer than 90 consecutive days in 

order to test consumer acceptance. 

(B) The labeling requirements of 

paragraph (b)(2)(iii) of this section do 

not apply to alcoholic beverages that are 

foods on display and are not self-service 

foods. 

(2) Nutrition information. (i) Except as 

provided by paragraph (b)(2)(i)(A)(8) of 

this section, 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. In the case 

of multiple-serving standard menu 

items, this means the calories declared 

must be for the whole menu item listed 

on the menu or menu board as usually 

prepared and offered for sale (e.g., 

‘‘pizza pie: 1600 cal’’); or per discrete 

serving unit as long as the discrete 

serving unit (e.g., pizza slice) and total 

number of discrete serving units 

contained in the menu item are declared 

on the menu or menu board, and the 

menu item is usually prepared and 

offered for sale divided in discrete 

serving units (e.g., ‘‘pizza pie: 200 cal/ 

slice, 8 slices’’). The calories 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 type size 

of the name or the price of the 


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associated standard menu item, 

whichever is smaller, in the same color, 

or a color at least as conspicuous as that 

used for the name of the associated 

standard menu item, and with the same 

contrasting background or a background 

at least as contrasting as that used for 

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 

menu board in the same color or a color 

at least as conspicuous as that used for 

that name or price and in the same 

contrasting background or a background 

at least as contrasting as that used for 

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) Additional requirements that 

apply to each individual variable menu 

item: 

(i) When the menu or menu board 

lists flavors or varieties of an entire 

individual variable menu item (such as 

soft drinks, ice cream, doughnuts, dips, 

and chicken that can be grilled or fried), 

the calories must be declared separately 

for each listed flavor or variety. Where 

flavors or varieties have the same calorie 

amounts (after rounding in accordance 

with paragraph (b)(2)(i)(A)(2) of this 

section), the calorie declaration for such 

flavors or varieties can be listed as a 

single calorie declaration adjacent to the 

flavors or varieties, provided that the 

calorie declaration specifies that the 

calorie amount listed represents the 

calorie amounts for each individual 

flavor or variety. 

(ii) When the menu or menu board 

does not list flavors or varieties for an 

entire individual variable menu item, 

and only includes a general description 

of the variable menu item (e.g. ‘‘soft 

drinks’’), the calories must be declared 

for each option with a slash between the 

two calorie declarations where only two 

options are available (e.g., ‘‘150/250 

calories’’) or as a range in accordance 

with the requirements of paragraph 

(b)(2)(i)(A)(7) of this section where more 

than two options are available (e.g., 

‘‘100–250 calories’’). 

(iii) When the menu or menu board 

describes flavors or varieties for only 

part of an individual variable menu item 

(such as different types of cheese offered 

in a grilled cheese sandwich (e.g., 

‘‘Grilled Cheese (Cheddar or Swiss)’’), 

the calories must be declared for each 

option with a slash between the two 

calorie declarations where only two 

options are available (e.g., ‘‘450/500 

calories’’) or as a range in accordance 

with the requirements of paragraph 

(b)(2)(i)(A)(7) of this section where more 

than two options are available (e.g., 

‘‘450–550 calories’’). 

(5) Additional requirements that 

apply to a variable menu item that is 

offered for sale with the option of 

adding toppings listed on the menu or 

menu board. When the menu or menu 

board lists toppings that can be added 

to a menu item (such as pizza or ice 

cream): 

(i) The calories must be declared for 

the basic preparation of the menu item 

as listed (e.g., ‘‘small pizza pie,’’ ‘‘single 

scoop ice cream’’). 

(ii) The calories must be separately 

declared for each topping listed on the 

menu or menu board (e.g., pepperoni, 

sausage, green peppers, onions on pizza; 

fudge, almonds, sprinkles on ice cream), 

specifying that the calories are added to 

the calories contained in the basic 

preparation of the menu item. Where 

toppings have the same calorie amounts 

(after rounding in accordance with 

paragraph (b)(2)(i)(A)(2) of this section), 

the calorie declaration for such toppings 

can be listed as a single calorie 

declaration adjacent to the toppings, 

provided that the calorie declaration 

specifies that the calorie amount listed 

represents the calorie amount for each 

individual topping. 

(iii) The calories for the basic 

preparation of the menu item must be 

declared for each size of the menu item. 

The calories for each topping listed on 

the menu or menu board must be 

declared for each size of the menu item, 

or declared using a slash between the 

two calorie declarations for each 

topping where only two sizes of the 

menu item are available (e.g., ‘‘adds 

150/250 cal’’) or as a range for each 

topping in accordance with the 

requirements of paragraph (b)(2)(i)(A)(7) 

of this section where more than two 

sizes of the menu item are available 

(e.g., ‘‘adds 100–250 cal’’). If a slash 

between two calorie declarations or a 

range of calorie declarations is used, the 

menu or menu board must indicate that 

the variation in calories for each topping 

arises from the size of the menu item to 

which the toppings are added. 

(iv) If the amount of the topping 

included on the basic preparation of the 

menu item decreases based on the total 

number of toppings ordered for the 

menu item (such as is sometimes the 

case with pizza toppings), the calories 

for each topping must be declared as 

single values representing the calories 

for each topping when added to a onetopping menu item, specifying that the 

calorie declaration is for the topping 

when added to a one-topping menu 

item. 

(6) Additional requirements that 

apply to a combination meal. Except as 

provided in paragraph (b)(2)(i)(A)(6)(iv) 

of this section: 

(i) When the menu or menu board 

lists two options for menu items in a 

combination meal (e.g., a sandwich with 

a side salad or chips), the calories must 

be declared for each option with a slash 

between the two calorie declarations 

(e.g., ‘‘350/450 calories’’). 

(ii) When the menu or menu board 

lists three or more options for menu 

items in a combination meal (e.g., a 

sandwich with chips, a side salad, or 

fruit), the calories must be declared as 

a range in accordance with the 

requirements of paragraph (b)(2)(i)(A)(7) 

of this section (e.g., ‘‘350–500 calories’’). 

(iii) When the menu or menu board 

includes a choice to increase or decrease 

the size of a combination meal, the 

calorie difference must be declared for 

the increased or decreased size with a 

slash between two calorie declarations 

(e.g., ‘‘Adds 100/150 calories,’’ 

‘‘Subtracts 100/150 calories’’) if the 

menu or menu board lists two options 

for menu items in the combination 

meal, or as a range in accordance with 

the requirements of paragraph 

(b)(2)(i)(A)(7) of this section (e.g., ‘‘Adds 

100–250 calories,’’ ‘‘Subtracts 100–250 

calories’’) if the menu or menu board 

lists three or more options for menu 

items in the combination meal. 

(iv) Where the menu or menu board 

describes an opportunity for a consumer 

to combine standard menu items for a 

special price (e.g., ‘‘Combine Any 

Sandwich with Any Soup or Any Salad 

for $8.99’’), and the calories for each 

standard menu item, including each size 

option as described in paragraph 

(b)(2)(i)(A)(6)(iii) of this section if 

applicable, available for the consumer to 

combine are declared elsewhere on the 

menu or menu board, the requirements 

of paragraphs (b)(2)(i)(A)(6)(i), (ii), and 

(iii) of this section do not apply. 

(7) Additional format requirements for 

declaring calories for an individual 

variable menu item, a combination 

meal, and toppings as a range, if 


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71256 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Rules and Regulations 

applicable. Calories declared as a range 

must be in the format ‘‘xx–yy,’’ where 

‘‘xx’’ is the caloric content of the lowest 

calorie variety, flavor, or combination, 

and ‘‘yy’’ is the caloric content of the 

highest calorie variety, flavor, or 

combination. 

(8) Exception for a variable menu item 

that has no clearly identifiable upper 

bound to the range of calories: 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 type size of the name or price 

of the variable menu item, whichever is 

smaller, and in the same color or a color 

at least as conspicuous as that used for 

that name or price, with the same 

contrasting background or a background 

at least as contrasting as that used for 

that name or price. 

(9) Additional requirements that 

apply to beverages that are not selfservice. For beverages that are not selfservice, calories must be declared based 

on the full volume of the cup served 

without ice, unless the covered 

establishment ordinarily dispenses and 

offers for sale a standard beverage fill 

(i.e., a fixed amount that is less than the 

full volume of the cup per cup size) or 

dispenses a standard ice fill (i.e., a fixed 

amount of ice per cup size). If the 

covered establishment ordinarily 

dispenses and offers for sale a standard 

beverage fill or dispenses a standard ice 

fill, the covered establishment must 

declare calories based on such standard 

beverage fill or standard ice fill. 

(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: 

‘‘2,000 calories a day is used for general 

nutrition advice, but calorie needs 

vary.’’ For menus and menu boards 

targeted to children, the following 

options may be used as a substitute for 

or in addition to the succinct statement: 

‘‘1,200 to 1,400 calories a day is used for 

general nutrition advice for children 

ages 4 to 8 years, but calorie needs 

vary.’’; or ‘‘1,200 to 1,400 calories a day 

is used for general nutrition advice for 

children ages 4 to 8 years and 1,400 to 

2,000 calories a day for children ages 9 

to 13 years, but calorie needs vary.’’ 

(1) This statement must be posted 

prominently and in a clear and 

conspicuous manner in a type size no 

smaller than the smallest type size of 

any calorie declaration appearing on the 

same menu or menu board and in the 

same color or in a color at least as 

conspicuous as that used for the calorie 

declarations and with the same 

contrasting background or a background 

at least as contrasting as that used for 

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 required by paragraph 

(b)(2)(i)(C) of this section, this statement 

must appear immediately above, below, 

or beside the statement required by 

paragraph (b)(2)(i)(C) of this section. 

(3) For menu boards, this statement 

must appear on the bottom of the menu 

board, immediately above, below, or 

beside the statement required by 

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)(2)(ii) 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 type size of 

any calorie declaration appearing on the 

same menu or menu board and in the 

same color or in a color at least as 

conspicuous as that used for the caloric 

declarations, and with the same 

contrasting background or a background 

at least as contrasting as that used for 

the caloric declarations. 

(2) For menus, the statement must 

appear on the bottom of the first page 

with menu items immediately above, 

below, or beside the succinct statement 

required by paragraph (b)(2)(i)(B) of this 

section. 

(3) For menu boards, the statement 

must appear on the bottom of the menu 

board immediately above, below, or 

beside the succinct statement required 

by 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 covered 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, 

including using a color, type size, and 

contrasting background that render the 

information likely to be read and 

understood by the ordinary individual 

under customary conditions of purchase 

and use. Covered establishments may 

use the abbreviations allowed for 

Nutrition Facts for certain packaged 

foods in § 101.9(j)(13)(ii)(B): 

(A)(1) Total calories (cal); 

(2) Calories from 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); and 

(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, in a column, list, 

or table, on the following nutrients: 

(i) Total calories, total fat, total 

carbohydrates, protein, and sodium; and 

(ii) 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. 

(3) If the simplified format is used, the 

statement ‘‘Not a significant source 

of ____’’ (with the blank filled in with 

the names of the nutrients required to be 

declared in the written nutrient 

information and calories from fat that 

are present in insignificant amounts) 

must be included at the bottom of the 

list of nutrients. 

(C) For variable menu items, the 

nutrition information listed in 

paragraph (b)(2)(ii)(A) of this section 

must be declared as follows for each 

size offered for sale: 

(1) The nutrition information required 

in paragraph (b)(2)(ii)(A) of this section 


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must be declared for the basic 

preparation of the item and, separately, 

for each topping, flavor, or variable 

component. 

(2) Additional format requirements for 

toppings if the amount of the topping 

included on the basic preparation of the 

menu item decreases based on the total 

number of toppings ordered for the 

menu item (such as is sometimes the 

case with pizza toppings). The nutrients 

for such topping must be declared as 

single values representing the nutrients 

for each topping when added to a onetopping menu item, specifying that the 

nutrient declaration is for the topping 

when added to a one-topping menu 

item. 

(3) If the calories and other nutrients 

are the same for different flavors, 

varieties, and variable components of 

the combination meal, each variety, 

flavor, and variable component of the 

combination meal is not required to be 

listed separately. All items that have the 

same nutrient values could be listed 

together with the nutrient values 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 

nutrient content information for all 

standard menu items. If the written 

nutrition 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 a standard menu item that is selfservice or on display. 

(A) Calories per displayed food item 

(e.g., a bagel, a slice of pizza, or a 

muffin), or if the food is not offered for 

sale in a discrete unit, calories per 

serving (e.g., scoop, cup), and the 

serving or discrete unit used to 

determine the calorie content (e.g., ‘‘per 

scoop’’ or ‘‘per muffin’’) on either: A 

sign adjacent to and clearly associated 

with the corresponding food; (e.g., ‘‘150 

calories per scoop’’); a sign attached to 

a sneeze guard with the calorie 

declaration and the serving or unit used 

to determine the calorie content above 

each specific food so that the consumer 

can clearly associate the calorie 

declaration with the food, except that if 

it is not clear to which food the calorie 

declaration and serving or unit refers, 

then the sign must also include the 

name of the food, e.g., ‘‘Broccoli and 

cheese casserole—200 calories per 

scoop’’; or a single sign or placard 

listing the calorie declaration for several 

food items along with the names of the 

food items, so long as the sign or 

placard is located where a consumer can 

view the name, calorie declaration, and 

serving or unit of a particular item while 

selecting that item. 

(1) For purposes of paragraph 

(b)(2)(iii)(A) of this section, ‘‘per 

displayed food item’’ means per each 

discrete unit offered for sale, for 

example, a bagel, a slice of pizza, or a 

muffin. 

(2) For purposes of paragraph 

(b)(2)(iii)(A) of this section, ‘‘per 

serving’’ means, for each food: 

(i) Per serving instrument used to 

dispense the food offered for sale, 

provided that the serving instrument 

dispenses a uniform amount of the food 

(e.g., a scoop or ladle); 

(ii) If a serving instrument that 

dispenses a uniform amount of food is 

not used to dispense the food, per each 

common household measure (e.g., cup 

or tablespoon) offered for sale or per 

unit of weight offered for sale, e.g., per 

quarter pound or per 4 ounces; or 

(iii) Per total number of fluid ounces 

in the cup in which a self-service 

beverage is served and, if applicable, the 

description of the cup size (e.g., ‘‘140 

calories per 12 fluid ounces (small)’’). 

(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 increment above 

50 calories except that amounts less 

than 5 calories may be expressed as 

zero. 

(ii) If the calorie declaration is 

provided on a sign with the food’s 

name, price, or both, the calorie 

declaration, accompanied by the term 

‘‘Calories’’ or ‘‘Cal’’ and the amount of 

the serving or displayed food item on 

which the calories declaration is based 

must be in a type size no smaller than 

the type size of 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 used for that name 

or price, using the same contrasting 

background or a background at least as 

contrasting as that used for that name or 

price. If the calorie declaration is 

provided on a sign that does not include 

the food’s name, price, or both, the 

calorie declaration, accompanied by the 

term ‘‘Calories’’ or ‘‘Cal’’ and the 

amount of the serving or displayed food 

item on which the calorie declaration is 

based must be clear and conspicuous. 

(iii) For self-service beverages, calorie 

declarations must be accompanied by 

the term ‘‘fluid ounces’’ and, if 

applicable, the description of the cup 

size (e.g., ‘‘small,’’ ‘‘medium’’). 

(B) For food that is self-service or on 

display and is identified by an 

individual sign adjacent to the food 

itself where such sign meets the 

definition of a menu or menu board 

under paragraph (a) of this section, the 

statement required by paragraph 

(b)(2)(i)(B) of this section and the 

statement required by paragraph 

(b)(2)(i)(C) of this section. These two 

statements may appear on the sign 

adjacent to the food itself; on a separate, 

larger sign, in close proximity to the 

food that can be easily read as the 

consumer is making order selections; or 

on a large menu board that can be easily 

read as the consumer is viewing the 

food. 

(C) The nutrition information in 

written form required by paragraph 

(b)(2)(ii) of this section, except for 

packaged food insofar as it bears 

nutrition labeling information required 

by and in accordance with paragraph 

(b)(2)(ii) of this section and the 

packaged food, including its label, can 

be examined by a consumer before 

purchasing the food. 

(c) Determination of nutrient content. 

(1) A covered establishment must have 

a reasonable basis for its nutrient 

declarations. Nutrient values may be 

determined by using nutrient databases 

(with or without computer software 

programs), cookbooks, laboratory 

analyses, or other reasonable means, 

including the use of Nutrition Facts on 

labels on packaged foods that comply 

with the nutrition labeling requirements 

of section 403(q)(1) of the Federal Food, 

Drug, and Cosmetic Act and § 101.9, 

FDA nutrient values for raw fruits and 

vegetables in Appendix C of this part, or 

FDA nutrient values for cooked fish in 

Appendix D of this part. 

(2) Nutrient declarations for standard 

menu items must be accurate and 

consistent with the specific basis used 

to determine nutrient values. A covered 

establishment must take reasonable 

steps to ensure that the method of 

preparation (e.g., types and amounts of 

ingredients, cooking temperatures) and 

amount of a standard menu item offered 

for sale adhere to the factors on which 

its nutrient values were determined. 

(3) A covered 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 values. 

This information must include the 

following: 

(i) For nutrient databases: 

(A) The name and version (including 

the date of the version) of the database, 


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and, as applicable, the name of the 

applicable software company and any 

Web site address for the database. The 

name and version of a database would 

include the name and version of the 

computer software, if applicable; 

(B) The recipe or formula used as a 

basis for the nutrient declarations; 

(C)(1) Information on: 

(i) The amount of each nutrient that 

the specified amount of each ingredient 

identified in the recipe contributes to 

the menu item; and 

(ii) How the database was used 

including calculations or operations 

(e.g., worksheets or computer printouts) 

to determine the nutrient values for the 

standard menu items; 

(2) If the information in paragraph 

(c)(3)(i)(C)(1) of this section is not 

available, certification attesting that the 

database will provide accurate results 

when used appropriately and that the 

database was used in accordance with 

its instructions; 

(D) A detailed listing (e.g., printout) of 

the nutrient values determined for each 

standard menu item. 

(E) Any other information pertinent to 

the final nutrient values of the standard 

menu item (e.g., information about what 

might cause slight variations in the 

nutrient profile such as moisture 

variations); 

(F) A statement signed and dated by 

a responsible individual, employed at 

the covered establishment or its 

corporate headquarters or parent entity, 

who can certify that the information 

contained in the nutrient analysis is 

complete and accurate; and 

(G) A statement signed and dated by 

a responsible individual employed at 

the covered establishment certifying 

that the covered establishment has taken 

reasonable steps to ensure that the 

method of preparation (e.g., types and 

amounts of ingredients in the recipe, 

cooking temperatures) and amount of a 

standard menu item offered for sale 

adhere to the factors on which its 

nutrient values were determined. 

(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 or from the author or 

publisher about how the nutrition 

information for the recipes was 

obtained; 

(C) A copy of the recipe used to 

prepare the standard menu item and a 

copy of the nutrition information for 

that standard menu item as provided by 

the cookbook; and 

(D) A statement signed and dated by 

a responsible individual employed at 

the covered establishment certifying 

that that the covered establishment has 

taken reasonable steps to ensure that the 

method of preparation (e.g., types and 

amounts of ingredients in the recipe, 

cooking temperatures) and amount of a 

standard menu item offered for sale 

adhere to the factors on which its 

nutrient values were determined. 

(Recipes may be divided as necessary to 

accommodate differences in the portion 

size derived from the recipe and that are 

served as the standard menu item but no 

changes may be made to the proportion 

of ingredients used.) 

(iii) For laboratory analyses: 

(A) A copy of the recipe for the 

standard menu item used for the 

nutrient analysis; 

(B) The name and address of the 

laboratory performing the analysis; 

(C) Copies of analytical worksheets, 

including the analytical method, used to 

determine and verify nutrition 

information; 

(D) A statement signed and dated by 

a responsible individual, employed at 

the covered establishment or its 

corporate headquarters or parent entity, 

who can certify that the information 

contained in the nutrient analysis is 

complete and accurate; and 

(E) A statement signed and dated by 

a responsible individual employed at 

the covered establishment certifying 

that the covered establishment has taken 

reasonable steps to ensure that the 

method of preparation (e.g., types and 

amounts of ingredients in the recipe, 

cooking temperatures) and amount of a 

standard menu item offered for sale 

adhere to the factors on which its 

nutrient values were determined. 

(iv) For nutrition information 

provided by other reasonable means: 

(A) A detailed description of the 

means used to determine the nutrition 

information; 

(B) A recipe or formula used as a basis 

for the nutrient determination; 

(C) Any data derived in determining 

the nutrient values for the standard 

menu item, e.g., nutrition information 

about the ingredients used with the 

source of the nutrient information; 

(D) A statement signed and dated by 

a responsible individual, employed at 

the covered establishment or its 

corporate headquarters or parent entity, 

who can certify that the information 

contained in the nutrient analysis is 

complete and accurate; and 

(E) A statement signed and dated by 

a responsible individual employed at 

the covered establishment certifying 

that the covered establishment has taken 

reasonable steps to ensure that the 

method of preparation (e.g., types and 

amounts of ingredients in the recipe, 

cooking temperatures) and amount of a 

standard menu item offered for sale 

adhere to the factors on which its 

nutrient values were determined. 

(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: 

(i) The contact information (including 

name, address, phone number, and 

email address) for the authorized 

official; 

(ii) The contact information 

(including name, address, phone 

number, and email 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. 

(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/food/

ingredientspackaginglabeling/

labelingnutrition/ucm217762.htm. FDA 

has created a form (Form 3757) that 

contains fields requesting the 

information in paragraph (d)(3) of this 

section and made the form available at 


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this Web site. Registrants must use this 

form to ensure that complete 

information is submitted. 

(i) Information should be submitted 

by email by typing complete 

information into the form (PDF), saving 

it on the registrant’s computer, and 

sending it by email to 

menulawregistration@fda.hhs.gov. 

(ii) 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, CFSAN Menu and 

Vending Machine Registration, White 

Oak Building 22, Rm. 0209, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993. 

(5) When to renew the 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), 403(f) 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: November 19, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27833 Filed 11–25–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 11 and 101 

[Docket No. FDA–2011–F–0171] 

RIN 0910–AG56 

Food Labeling; Calorie Labeling of 

Articles of Food in Vending Machines 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: To implement the vending 

machine food labeling provisions of the 

Patient Protection and Affordable Care 

Act of 2010 (ACA), the Food and Drug 

Administration (FDA or we) is 

establishing requirements for providing 

calorie declarations for food sold from 

certain vending machines. This final 

rule will ensure that calorie information 

is available for certain food sold from a 

vending machine that does not permit a 

prospective purchaser to examine the 

Nutrition Facts Panel before purchasing 

the article, or does not otherwise 

provide visible nutrition information at 

the point of purchase. The declaration 

of accurate and clear calorie information 

for food sold from vending machines 

will make calorie information available 

to consumers in a direct and accessible 

manner to enable consumers to make 

informed and healthful dietary choices. 

This final rule applies to certain food 

from vending machines operated by a 

person engaged in the business of 

owning or operating 20 or more vending 

machines. Vending machine operators 

not subject to the rules may elect to be 

subject to the Federal requirements by 

registering with FDA. 

DATES:

Effective Date: December 1, 2016. 

Compliance Date: Covered vending 

machine operators must comply with 

the rule by December 1, 2016. See 

section III.E for more information on the 

effective and compliance dates. 

Comment Date: Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

December 31, 2014 (see section V, the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

ADDRESSES: To ensure that comments on 

the information collection are received, 

the Office of Management and Budget 

(OMB) recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—New and 

title ‘‘Information Collection Provisions 

of the final rule on Food Labeling: 

Calorie Labeling of Articles of Food in 

Vending Machines.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Y. Reese, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–2371, email: Daniel.Reese@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

Executive Summary 

Purpose and Coverage of the Final Rule 

Summary of the Major Provisions of the Final 

Rule 

Costs and Benefits 

I. Background 

II. Legal Authority 

III. Comments on the Proposed Rule, FDA 

Responses, and Description of the Final 

Rule 

A. Introduction 

B. General Comments 

C. Comments on Specific Provisions and 

Description of the Final Rule 

D. Determination of Calorie Content 

E. Effective Date 

F. Enforcement 

IV. Analysis of Impacts—Final Regulatory 

Impact Analysis 

V. Paperwork Reduction Act of 1995 

VI. Federalism 

VII. Environmental Impact 

VIII. References 

Executive Summary 

Purpose and Coverage of the Final Rule 

To help make calorie information for 

vending machine foods available to 

prospective purchasers in a direct, 

accessible, and consistent manner to 

enable them to make informed and 

healthful dietary choices, section 4205 

of the ACA and the rule require that 

vending machine operators who own or 

operate 20 or more vending machines, 

or who voluntarily elect to be covered, 

must provide calorie declarations for 

those vending machine foods for which 

the Nutrition Facts label cannot be 

examined prior to purchase or for which 

visible nutrition information is not 

otherwise provided at the point of 

purchase. 

Summary of the Major Provisions of the 

Final Rule 

• The final rule requires vending 

machine operators who own or operate 

20 or more vending machines (or who 

voluntarily register with FDA to be 

subject to the final rule) to provide 

calorie declarations for certain articles 

of food sold from vending machines. 

Æ The final rule defines a vending 

machine operator as a person or entity 

that controls or directs the function of 

the vending machine, including 

deciding which articles of food are sold 

from the machine or the placement of 

the articles of food within the vending 

machine, and is compensated for the 

control or direction of the function of 

the vending machine. 

Æ Through biannual registration, 

vending machine operators who are not 

covered by the final rule can voluntarily 

elect to become subject to it. 

• The final rule describes which 

foods are subject to the calorie 


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