Contains Nonbinding Recommendations 
Guidance for Industry
Nutrition Labeling of Standard Menu 
Items in Restaurants and Similar Retail 
Food Establishments  
Small Entity Compliance Guide 
Additional copies are available from: 
Office of Nutrition, Labeling and Dietary Supplements 
Food Labeling and Standards Staff, HFS-820 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
College Park, MD  20740 
(Tel) 240-402-2371 
http://www.fda.gov/foodguidances 
You may submit written or electronic comments regarding this guidance at any time.  Submit 
written comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  Submit electronic 
comments to http://www.regulations.gov.  All comments should be identified with the docket 
number listed in the notice of availability that publishes in the Federal Register.  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
March 2015  Contains Nonbinding Recommendations 
 
Table of Contents 
I. Introduction
   
II. Coverage of the Rule
   
A. Establishments Covered by the Rule 
II.A.1.  Who is subject to the rule? 
II.A.2   Where can I find information about registering voluntarily to be covered by the rule? 
II.A.3.  How does the rule define restaurant or similar retail food establishment? 
II.A.4.  How does the rule define restaurant-type food? 
II.A.5.  What are some examples of foods that general would be considered restaurant-type food? 
II.A.6.  What foods would not be considered restaurant-type food? 
II.A.7.  How does the rule define location? 
II.A.8.  How does the rule define doing business under the same name? 
II.A.9.  How does the rule define offering for sale substantially the same menu items? 
B. Establishments Not Covered by the Rule 
II.B.1.  Who is not covered by the rule? 
C. Food Covered by the Rule 
II.C.1.    What foods are covered by the rule? 
II.C.2.  How does the rule define standard menu item? 
II.C.3.  How does the rule define menu or menu board? 
II.C.4.  How does the rule define food on display? 
II.C.5.  How does the rule define self-service food? 
II.C.6.  How does the rule define combination meal? 
II.C.7.  How does the rule define variable menu item? 
D.  Foods Not Covered by the Rule 
II.D.1.  What foods are not covered by the rule? 
II.D.2.  Are alcoholic beverages covered by the rule? 
II.D.3.  What terms related to foods not covered by the rule does the rule define? 
II.D.4.  How does the rule define custom order? 
II.D.5.  How does the rule define daily special? 
II.D.6.  How does the rule define food that is part of a customary market test? 
II.D.7.  How does the rule define temporary menu item? 
III.  Compliance Dates
 
III.1.  If I am subject to the rule, when must I comply with it? 
IV. Labeling Requirements for Nutrition Information
 
A. Types of Labeling Requirements 
IV.A.1.  What Labeling Requirements Does the Rule Establish for Standard Menu Items that are 
Offered for Sale in a Covered Establishment? 
B. General Format Requirements for Declaring Calories on Menus and 
Menu Boards 
IV.B.1.  How do I list the number of calories on the menu or menu board?  Contains Nonbinding Recommendations 
 
IV.B.2.  How do I declare increments of calories on the menu or menu board? 
IV.B.3.  How do I declare the term Calories or Cal on the menu or menu board? 
C.  Additional Format Requirements That Apply When Declaring Calories 
on Menus and Menu Boards for Variable Menu Items, Combination 
Meals, and Toppings 
IV.C.1.  What additional requirements apply to individual variable menu items? 
IV.C.2.  What additional requirements apply to a variable menu item that is offered for sale with the 
option of adding toppings listed on the menu or menu board? 
IV.C.3.  What additional requirements apply to a combination meal? 
IV.C.4.  What exception applies to the additional requirements for a combination meal? 
IV.C.5.  What format requirements apply for declaring calories for an individual variable menu 
item, a combination meal, and toppings as a range, if applicable? 
D.  Exception from Additional Format Requirements for Variable Menu 
Items 
IV.D.1.  What exception applies to the additional format requirements for variable menu items? 
E.  Additional Requirements that Apply to Beverages That Are Not Self-
Service 
IV.E.1.  What additional requirements apply to beverages that are not self-service? 
F.  Succinct Statement on Menus and Menu Boards to Provide Context 
About Calories in a Total Daily Diet 
IV.F.1.  What must the succinct statement say? 
IV.F.2.  What options may I use for the succinct statement on menus and menu boards targeted to 
children? 
IV.F.3.  What are the format requirements for the succinct statement? 
IV.F.4.  Where must the succinct statement appear on menus? 
IV.F.5.  Where must the succinct statement appear on menu boards? 
G.  Statement on Menus and Menu Boards Regarding the Availability of 
Additional Written Nutrition Information 
IV.G.1.  What must the statement regarding the availability of the additional written nutrition 
information say? 
IV.G.2. What are the format requirements for the statement of availability? 
IV.G.3. Where must the statement of availability appear on menus? 
IV.G.4. Where must the statement of availability appear on menu boards? 
H.  Nutrition Information That Must be Made Available in Written Form 
IV.H.1.  What nutrition information for a standard menu item must be available in written form? 
IV.H.2.  How do I present the written nutrition information? 
IV.H.3.  When do the requirements for written nutrition information not apply? 
IV.H.4.  How does the rule define insignificant amount? 
IV.H.5.  When may I use a simplified format for the written nutrition information? 
IV.H.6.  What information must the simplified format include? 
IV.H.7.  What statement must I include when I use the simplified format? 
IV.H.8.  How must I declare the written nutrition information for variable menu items? 
IV.H.9. What additional format requirements apply to written nutrition information for toppings? 
IV.H.10.  What forms may I use to provide written nutrition information?  Contains Nonbinding Recommendations 
 
I.  Requirements for Food that is Self-Service or On Display 
IV.I.1.  What nutrition information must I provide for a standard menu item that is self-service or on 
display? 
IV.I.2.  Where must I place the nutrition information for a standard menu item that is self-service or 
on display? 
IV.I.3.  What does per displayed food item mean for the purposes of the labeling requirements 
that apply to standard menu items that are self-service or on display? 
IV.I.4.  What does per serving mean for the purposes of the labeling requirements that apply to 
standard menu items that are self-service or on display? 
IV.I.5.  How must I declare the calories for a standard menu item that is self-service or on display? 
IV.I.6.  Do the requirements for the succinct statement and statement of availability apply to self-
service foods and foods on display? 
IV.I.7.  What written nutrition information must I provide for a standard menu item that is self-
service or on display? 
IV.I.8.  Do I need to provide written nutrition information for a packaged food that I offer for sale if 
the food already has a Nutrition Facts label? 
V. Determination of Nutrient Content
 
A. General Requirements 
V.A.1.  How may I determine nutrient values for standard menu items? 
V.A.2.  How do I determine if the basis I use to determine nutrition information for a standard menu 
item is reasonable? 
B. Information Substantiating Nutrient Values  
V.B.1.  What  are you required to provide to FDA to substantiate nutrient values? 
V.B.2.  If I determine nutrient values using nutrient databases, what specific information must I 
provide to FDA to substantiate nutrient values? 
V.B.3.  If I determine nutrient values using published cookbooks that contain nutritional information 
for recipes in the cookbook, what specific information must I provide to FDA to substantiate nutrient 
values? 
V.B.4.  If I determine nutrient values using laboratory analyses, what specific information must I 
provide to FDA to substantiate nutrient values? 
V.B.5.  For nutrition information provided by other reasonable means, what specific information 
must I provide to FDA to substantiate nutrient values? 
VI. Voluntary Registration to be Subject to the Federal 
Requirements
 
A. Applicability 
VI.A.1.  What establishments may voluntarily register to be subject to the requirements of the rule? 
VI.A.2.  If I voluntarily register to be subject to the requirements of the rule, do I remain subject to 
non-identical State or local nutrition labeling requirements? 
VI.A.3.  Who may register my establishment? 
VI.A.4.  How does the rule define authorized official of a restaurant or similar retail food 
establishment? 
B. General Requirements for Voluntary Registration 
VI.B.1.  What form do I use for voluntary registration? 
VI.B.2.  What registration information must an authorized official provide on Form FDA 3757? 
VI.B.3.  How does an authorized official register?  Contains Nonbinding Recommendations 
 
VI.B.4.  How often must an authorized official renew a voluntary registration to keep it active? 
VI.B.5.  Is there a cost for voluntary registration? 
VI.B.6.  Are signatures obtained in the voluntary registration subject to 21 CFR part 11? 
VII. Misbranding
 
VII.1.  What are the consequences of failing to label a standard menu item offered for sale in a 
covered establishment in accordance with 21 CFR 101.11(b) or (c)? 
  Contains Nonbinding Recommendations 
 
Guidance for Industry1 
Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments; Small Entity Compliance 
Guide  
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance. 
I.  Introduction 
On December 1, 2014, FDA (we) published a final rule entitled Food Labeling; Nutrition 
Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (the 
rule) in the Federal Register to implement the nutrition labeling provisions in section 4205 of 
the Patient Protection and Affordable Care Act of 2010 (section 4205).2  The rule is effective 
on December 1, 2015.  Section 4205 amended the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), among other things, to require restaurants and similar retail food establishments 
that are part of a chain with 20 or more locations doing business under the same name and 
offering for sale substantially the same menu items to provide calorie and other nutrition 
information for standard menu items, including food on display and self-service food.  Under 
section 4205, restaurants and similar retail food establishments not otherwise covered by the law 
may elect to become subject to the Federal requirements by registering every other year with 
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. 
 
We have prepared this Small Entity Compliance Guide in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance 
document restates in plain language the requirements set forth in 21 CFR 101.11 concerning 
nutrition labeling of standard menu items in establishments covered by the rule. We have 
organized this guidance in a question/answer format and also identify the relevant regulation in 
parentheses after each answer.  The rule is binding and has the full force and effect of law.   
 
                                                 
1 This guidance has been prepared by the Food Labeling and Standards Staff in the Office of Nutrition, Labeling and 
Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
2 The rule is codified at 21 CFR 101.11. 
  1  Contains Nonbinding Recommendations 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in our guidances means that something is suggested or 
recommended, but not required.  
 
In the remainder of this guidance, you and I refer to establishments that are subject to the 
rule. 
 
II.  Coverage of the Rule  
A.  Establishments Covered by the Rule 
II.A.1.  Who is subject to the rule?  
You are subject to the rule if you are a covered establishment.  The rule defines covered 
establishment as a restaurant or similar retail food establishment that is part of a chain with 20 
or more locations doing business under the same name (regardless of the type of ownership, 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 the rule.   
(21 CFR 101.11(a)).   
 
II.A.2 Where can I find information about registering voluntarily to be covered by the rule? 
 
See section VI of this document and 21 CFR 101.11(d) for information on how 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 rule.   
II.A.3.  How does the rule define restaurant or similar retail food establishment? 
The rule defines restaurant or similar retail food establishment as 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. 
(21 CFR 101.11(a))  
II.A.4.  How does the rule define restaurant-type food? 
The rule defines restaurant-type food as food that is: 
  (1) Usually eaten on the premises, while walking away, or soon after arriving at another 
location; and 
  (2) 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 subparagraph (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.  In other words, restaurant-type food is the subset of 
  2  Contains Nonbinding Recommendations 
 
food previously exempt from Federal nutrition labeling requirements under sections 
403(q)(5)(A)(i) and (ii) of the FD&C Act that is usually eaten on the premises of the 
establishment, while walking away, or soon after arriving at another location.  (21 CFR 
101.11(a)) 
II.A.5.  What are some examples of foods that general would be considered restaurant-type 
food? 
Examples of food that generally would be considered restaurant-type food include:  food for 
immediate consumption at a sit-down or quick service restaurant; food purchased at a drive-
through; take-out and delivery pizza, hot pizza at grocery and convenience stores that is ready to 
eat, and pizza slices from a movie theater; hot buffet food, hot soup at a soup bar, and food from 
a salad bar; foods ordered from a menu or menu board at a grocery store intended for individual 
consumption (e.g., soups, sandwiches, and salads); and self-service foods and foods on display 
that are intended for individual consumption (e.g., sandwiches, wraps, and paninis at a deli 
counter; and cookies from a mall cookie counter; bagels, donuts, and rolls offered for individual 
sale). 
II.A.6.  What foods would not be considered restaurant-type food?  
Foods that are grocery-type 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 
considered restaurant-type food.  Examples of food that generally would not be considered 
restaurant-type food include:  food bought from bulk binds 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 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 or chicken salad), either 
prepacked or packed upon consumer request; and foods that are usually further prepared before 
consuming (e.g., deli meats and cheeses).  
II.A.7.  How does the rule define location? 
The rule defines location as a fixed position or site.  
(21 CFR 101.11(a)) 
II.A.8.  How does the rule define doing business under the same name? 
The rule defines doing business under the same name as sharing the same name. The term 
name refers to the name of the establishment presented to the public.  If there is no name of the 
establishment presented to the public (e.g., an establishment with the generic descriptor 
concession stand), the term name refers to the name of the parent entity that operates the 
establishment.  When the term name refers to the name of the establishment presented to the 
public, the term same includes names that are slight variations or 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).  
(21 CFR 101.11(a))  
  3  Contains Nonbinding Recommendations 
 
II.A.9.  How does the rule define offering for sale substantially the same menu items? 
The rule defines offering for sale substantially the same menu items as 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 
self-service food or food on display.  Restaurants and similar retail food establishment 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.  
(21 CFR 101.11(a))  
 
B.  Establishments Not Covered by the Rule 
II.B.1.  Who is not covered by the rule? 
Establishments that do not meet the definition of restaurant or similar retail food establishment 
are not covered by the rule.  This means that establishments that do not offer for sale restaurant-
type food are not covered.  In addition, schools (as that term is defined in 7 CFR 210.2 or 220.2) 
are excepted from the definition of restaurant or similar retail food establishment in the rule 
and, thus, are not covered by the rule.  
(21 CFR 101.11(a)) 
 
A restaurant or similar retail food establishment is not covered by the rule if it is not a covered 
establishment  i.e., it is not: 
  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; or  
  A restaurant or similar retail food establishment that is registered to be covered under the 
rule. 
C.  Food Covered by the Rule 
II.C.1.    What foods are covered by the rule? 
The rule applies to foods that are standard menu items offered for sale in a covered 
establishment.   
(21 CFR 101.11(b)(1)(i)) 
 
II.C.2.  How does the rule define standard menu item? 
The rule defines standard menu item as 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.   
(21 CFR 101.11(a)) 
  4  Contains Nonbinding Recommendations 
 
II.C.3.  How does the rule define menu or menu board? 
The rule defines menu or menu board as 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; childrens menus; other specialty menus; 
electronic menus; and menus on the Internet.  The rule specifies that 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.  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. 
(21 CFR 101.11(a))  
II.C.4.  How does the rule define food on display? 
The rule defines food on display as restaurant-type food that is visible to the customer before 
the customer makes a selection, so long as there is not an ordinary expectation of further 
preparation by the consumer before consumption. 
(21 CFR 101.11(a)) 
II.C.5.  How does the rule define self-service food? 
The rule defines self-service food as restaurant-type food that is available at a salad bar, buffet 
line, cafeteria line, or similar self-service facility and that is served by the customers themselves.  
Self-service food also includes self-service beverages. 
(21 CFR 101.11(a)) 
II.C.6.  How does the rule define combination meal? 
The rule defines 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.  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. 
(21 CFR 101.11(a)) 
 
Examples of combination meals other than those included in the definition include: 
  A burger and fries; 
  A sandwich and a package of chips;  
  Pancakes and eggs;  
  Soup and sandwich; and  
  Sandwich and salad. 
  5  Contains Nonbinding Recommendations 
 
II.C.7.  How does the rule define variable menu item? 
The rule defines variable menu item as a standard menu item that comes in different flavors, 
varieties, or combinations, and is listed as a single menu item. 
(21 CFR 101.11(a)) 
 
Examples of variable menu items include the following items where such items are listed as 
single menu items on the menu or menu board: 
  Milkshakes, ice cream, soft drinks, and doughnuts that are available in multiple flavors; 
  Pizza prepared with a selection of crusts and toppings;  
  Chicken that may be grilled or fried; and 
  A grilled cheese sandwich that can be made with either Cheddar or Swiss cheese. 
 
D.  Foods Not Covered by the Rule 
II.D.1.  What foods are not covered by the rule?   
The labeling requirements of the rule do not apply to foods that are not standard menu items, 
including:  
  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 
  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. 
(21 CFR 101.11(b)(1)(ii)(A)(1) and(2)) 
II.D.2.  Are alcoholic beverages covered by the rule?   
Yes.  However, alcoholic beverages that are foods on display and are not self-service foods are 
not subject to the new requirements, established in 21 CFR 101.11(b)(2)(iii), for standard menu 
items that are self-service or on display. 
(21 CFR 101.11(b)(1)(ii)(B)) 
 
For example, a bottle of liquor behind a bar used to prepare mixed drinks is not subject to the 
labeling requirements in 21 CFR 101.11(b)(2)(iii) that otherwise apply to standard menu items 
that are self-service or on display.  
II.D.3.  What terms related to foods not covered by the rule does the rule define? 
The rule defines the following terms related to foods not covered by the rule: 
  Custom order 
  Daily special 
  Food that is part of a customary market test 
  Temporary menu item 
  6  Contains Nonbinding Recommendations 
 
(21 CFR 101.11(a)) 
II.D.4.  How does the rule define custom order? 
The rule defines custom order as a food order that is prepared in a specific manner based on an 
individual customers 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. 
(21 CFR 101.11(a)) 
II.D.5.  How does the rule define daily special? 
The rule defines 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 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. 
(21 CFR 101.11(a)) 
II.D.6.  How does the rule define food that is part of a customary market test? 
The rule defines food that is part of a customary market test as food that appears on a menu or 
menu board for less than 90 consecutive days in order to test consumer acceptance of the 
product. 
(21 CFR 101.11(a)) 
II.D.7.  How does the rule define temporary menu item? 
The rule defines 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.  The 60 days includes the total of consecutive and non-
consecutive days the item appears on the menu. 
(21 CFR 101.11(a)) 
 
III.  Compliance Dates   
III.1.  If I am subject to the rule, when must I comply with it?  
You must comply with the rule by December 1, 2015 if you are subject to the requirements of 
the rule on or before that date.      
   
IV. Labeling Requirements for Nutrition Information  
A.  Types of Labeling Requirements 
IV.A.1.  What Labeling Requirements Does the Rule Establish for Standard Menu Items that are 
Offered for Sale in a Covered Establishment?  
The rule establishes labeling requirements for: 
  Information that must be provided on menus and menu boards (21 CFR 101.11(b)(2)(i)).  
This includes all of the following:  
  Calories (21 CFR 101.11(b)(2)(i)(A));  
o
  7  Contains Nonbinding Recommendations 
 
  A succinct statement to enable consumers to understand, in the context of a total 
o
daily diet, the significance of the calorie information provided on menus and 
menu boards (21 CFR 101.11(b)(2)(i)(B)); and 
  A statement on menus and menu boards about the availability of additional 
o
written nutrition information (21 CFR 101.11(b)(2)(i)(C));   
  Nutrition information that must be available in written form on the premises of the 
covered establishment and provided to the customer upon request (21 CFR 
101.11(b)(2)(ii)); and 
  Standard menu items that are self-service or on display (21 CFR 101.11)(b)(2)(iii)). 
 
 
B. General Format Requirements for Declaring Calories on Menus and Menu 
Boards  
IV.B.1.  How do I list the number of calories on the menu or menu board? 
You must 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 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).   
(21 CFR 101.11(b)(2)(i)(A)) 
 
You must list the number of calories: 
  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 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.  
 (21 CFR 101.11(b)(2)(i)(A)(1)) 
 
IV.B.2.  How do I declare increments of calories on the menu or menu board? 
You must declare calories to the nearest 5-calorie increment up to and including 50 calories and 
to the nearest 10-calorie increment above 50 calories, except that you may express amounts less 
than 5 calories as zero. 
(21 CFR 101.11(b)(2)(i)(A)(2)) 
 
  8  Contains Nonbinding Recommendations 
 
IV.B.3.  How do I declare the term Calories or Cal on the menu or menu board? 
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 
o
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 
o
price; and  
  In the same contrasting background or a background at least as contrasting as that 
o
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 as the number of calories; and  
o
  In the same color and contrasting background as the number of calories.  
o
(21 CFR 101.11(b)(2)(i)(A)(3)) 
 
C.  Additional Format Requirements That Apply When Declaring Calories on 
Menus and Menu Boards for Variable Menu Items, Combination Meals, and 
Toppings 
IV.C.1.  What additional requirements apply to individual variable menu items? 
  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), you must declare the calories separately for each listed flavor or variety.  
For example, if the menu or menu board lists vanilla, chocolate, and strawberry flavors of 
ice cream, you must declare the calories separately for each of those listed flavors.  
Where flavors or varieties have the same calorie amounts (after rounding in accordance 
with 21 CFR 101.11(b)(2)(i)(A)(2)), 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.  (21 CFR 101.11(b)(2)(i)(A)(4)(i)). 
  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), you must declare the calories for each option as follows (21 CFR 
101.11(b)(2)(i)(A)(4)(ii)): 
  With a slash between the two calorie declarations where only two options are 
o
available (e.g., 150/250 calories); or  
  As a range in accordance with the requirements of 21 CFR 101.11(b)(2)(i)(A)(7) 
o
where more than two options are available (e.g., 100 - 250 calories).  
  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 
  9  Contains Nonbinding Recommendations 
 
(e.g., Grilled Cheese (Cheddar or Swiss)), you must declare the calories for each option 
as follows (21 CFR 101.11(b)(2)(i)(A)(4)(iii)): 
  With a slash between the two calorie declarations where only two options are 
o
available (e.g., 450/500 calories); or  
  As a range in accordance with the requirements of 21 CFR 101.11(b)(2)(i)(A)(7) 
o
where more than two options are available (e.g., 450 - 550 calories).  
  
IV.C.2.  What additional requirements 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): 
  You must declare the calories for the basic preparation of the menu item as listed (e.g., 
small pizza pie, single scoop ice cream).  (21 CFR 101.11(b)(2)(i)(A)(5)(i)) 
  You must declare the calories separately, 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.   
 
For example,  
 
Ice Cream Scoop:  300 cal   
 
Topping  Added Cal 
Almonds  25 
Fudge  50 
 
 
Where toppings have the same calorie amounts (after rounding in accordance with 21 
CFR 101.11(b)(2)(i)(A)(2)), 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.  (21 CFR 101.11(b)(2)(i)(A)(5)(ii)) 
  You must declare the calories for the basic preparation of the menu item 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 
21 CFR 101.11(b)(2)(i)(A)(7) 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. (21 CFR 101.11(b)(2)(i)(A)(5)(iii))     
 
For example, 
 
  10  Contains Nonbinding Recommendations 
 
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 
 
 
  If the amount of the topping included on the basic preparation of the menu item decreases 
o
based on the total number of toppings ordered for the menu item (such as is sometimes 
the case with pizza toppings), you must declare the calories for each topping as single 
values representing the calories for each topping when added to a one-topping menu item, 
specifying that the calorie declaration is for the topping when added to a one-topping 
menu item.  (21 CFR 101.11(b)(2)(i)(A)(5)(iv)) 
 
For example, 
 
Plain pizza pie (14): 750 cal  
 
Toppings  Added cal 
(single topping) 
Pepperoni  300 
Sausage  350 
Green peppers  20 
 
Also, recall that if the pizza pie comes in multiple sizes, a range could be used.  For 
example: 
 
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 
11  Contains Nonbinding Recommendations 
 
IV.C.3.  What additional requirements apply to a combination meal? 
Except as provided in 21 CFR 101.11(b)(2)(i)(A)(6)(iv) (see Question IV.C.4): 
  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), you must declare the calories for each option 
with a slash between the two calorie declarations (e.g., 350/450 calories). (21 CFR 
101.11(b)(2)(i)(A)(6)(i)) 
  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), you must declare 
the calories as a range in accordance with the requirements of 21 CFR 
101.11(b)(2)(i)(A)(7) (e.g., 350-500 calories). (21 CFR 101.11(b)(2)(i)(A)(6)(ii)) 
  When the menu or menu board includes a choice to increase or decrease the size of a 
combination meal, you must declare the calorie difference for the increased or decreased 
size: 
  With a slash between two calorie declarations (e.g., Adds 100/150 calories, 
o
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 21 CFR 101.11(b)(2)(i)(A)(7) 
o
(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. (21 
CFR 101.11(b)(2)(i)(A)(5)(iii)) 
IV.C.4.  What exception applies to the additional requirements for a combination meal? 
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 
21 CFR 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 21 CFR 
101.11(b)(2)(i)(A)(6)(i), (ii), and (iii) do not apply. (21 CFR 101.11(b)(2)(i)(A)(5)(iv)) 
 
IV.C.5.  What format requirements apply for declaring calories for an individual variable menu 
item, a combination meal, and toppings as a range, if applicable? 
When you declare calories as a range, you must use 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. 
(21 CFR 101.11(b)(2)(i)(A)(7)) 
 
For examples of declaring calories as a range, see questions IV.C.1, IV.C.2, and IV.C.3. 
 
  12  Contains Nonbinding Recommendations 
 
D.  Exception from Additional Format Requirements for Variable Menu 
Items  
IV.D.1.  What exception applies to the additional format requirements for variable menu items? 
If the variable menu item appears on the menu or menu board and is a self-service food or food 
on display, and there is no clearly identifiable upper bound to the range, e.g., all-you-can-eat 
buffet, then: 
  The menu or menu board must include a statement, adjacent to the name or price of the 
item, referring customers to the self-service facility for calorie information, e.g., See 
buffet for calorie declarations.   
  This statement must appear: 
  In a type size no smaller than the type size of the name or price of the variable 
o
menu item, whichever is smaller;   
  In the same color or a color at least as conspicuous as that used for that name or 
o
price; and 
  With the same contrasting background or a background at least as contrasting as 
o
that used for that name or price.   
(21 CFR 101.11(b)(2)(i)(A)(8)) 
 
E.  Additional Requirements that Apply to Beverages That Are Not Self-
Service 
IV.E.1.  What additional requirements apply to beverages that are not self-service? 
For beverages that are not self-service: 
  You must declare calories based on the full volume of the cup served without ice, unless 
you ordinarily dispense and offer 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 dispense a standard ice fill 
(i.e., a fixed amount of ice per cup size).   
  If you ordinarily dispense and offer for sale a standard beverage fill or dispense a 
standard ice fill, you must declare calories based on such standard beverage fill or 
standard ice fill.   
 
(21 CFR 101.11(b)(2)(i)(A)(9)) 
 
F.  Succinct Statement on Menus and Menu Boards to Provide Context About 
Calories in a Total Daily Diet 
IV.F.1.  What must the succinct statement say?  
The succinct statement must say 2,000 calories a day is used for general nutrition advice, but 
calorie needs vary. 
(21 CFR 101.11(b)(2)(i)(B)) 
 
  13  Contains Nonbinding Recommendations 
 
IV.F.2.  What options may I use for the succinct statement on menus and menu boards targeted 
to children? 
For menus and menu boards targeted to children, you may use the following options 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 4-8 
years, but calorie needs vary or 
  1,200 to 1,400 calories a day is used for general nutrition advice for children ages 4-8 
years and 1,400 to 2,000 calories a day for children ages 9-13 years, but calorie needs 
vary 
(21 CFR 101.11(b)(2)(i)(B)) 
IV.F.3.  What are the format requirements for the succinct statement? 
You must post the succinct statement: 
  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;  
  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 
(21 CFR 101.11(b)(2)(i)(B)(1)) 
IV.F.4.  Where must the succinct statement appear on menus? 
The succinct statement must appear on the bottom of each page of the menu.  On menu pages 
that also bear the statement regarding the availability of the additional written nutrition 
information, the succinct statement must appear immediately above, below, or beside that 
statement. 
(21 CFR 101.11(b)(2)(i)(B)(2)) 
 
IV.F.5.  Where must the succinct statement appear on menu boards? 
The succinct statement must appear on the bottom of the menu board, immediately above, below, 
or beside the statement regarding the availability of the additional written nutrition information. 
(21 CFR 101.11(b)(2)(i)(B)(3)) 
 
G.  Statement on Menus and Menu Boards Regarding the Availability of 
Additional Written Nutrition Information 
IV.G.1.  What must the statement regarding the availability of the additional written nutrition 
information say? 
The statement regarding the availability of the additional written nutrition information 
(statement of availability) must say Additional nutrition information available upon request.   
(21 CFR 101.11(b)(2)(i)(C))  
 
  14  Contains Nonbinding Recommendations 
 
See section IV.H of this document for more information about the written nutrition information. 
IV.G.2. What are the format requirements for the statement of availability? 
You must post the statement of availability:  
  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;  
  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 
(21 CFR 101.11(b)(2)(i)(C)(1)) 
 
IV.G.3.   Where must the statement of availability appear on menus? 
The statement of availability must appear on the bottom of the first page with menu items 
immediately above, below, or beside the succinct statement. 
(21 CFR 101.11(b)(2)(i)(C)(2))  
 
IV.G.4.  Where must the statement of availability appear on menu boards? 
The statement must appear on the bottom of the menu board immediately above, below, or 
beside the succinct statement. 
(21 CFR 101.11(b)(2)(i)(C)(3))  
 
H.  Nutrition Information That Must be Made Available in Written Form 
IV.H.1.  What nutrition information for a standard menu item must be available in written form? 
 
The following nutrition information for a standard menu item must be available in written form: 
  Total calories (cal) 
  Calories from fat (fat cal) 
  Total fat (g) 
  Saturated fat (g) 
  Trans fat (g) 
  Cholesterol (mg) 
  Sodium (mg) 
  Total carbohydrates (g) 
  Dietary fiber (g) 
  Sugars (g) 
  Protein (g) 
(21 CFR 101.11(b)(2)(ii)(A)(1)-(11))   
 
Note that Cal means calories, g means grams, and mg means milligrams. 
  15  Contains Nonbinding Recommendations 
 
IV.H.2.  How do I present the written nutrition information? 
The written nutrition information must be: 
  Available in written form on the premises of the covered establishment;  
  Provided to the customer upon request;  
  Presented in the order listed and the measurements listed above (see Question IV.H.1);  
  Presented in a clear and conspicuous manner; and 
  Presented 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. 
 
In addition:  
  Rounding of these nutrients must be in compliance with 21 CFR 101.9(c); and  
  You may use the abbreviations allowed for Nutrition Facts for certain packaged foods in 
21 CFR 101.9(j)(13)(ii)(B). 
 (21 CFR 101.11(b)(2)(ii)) 
 
IV.H.3.  When do the requirements for written nutrition information not apply? 
If a standard menu item contains insignificant amounts of all the nutrients required to be 
disclosed in 21 CFR 101.11(b)(2)(ii)(A)(1)-(11) (see Question IV.H.1), you do not have to 
include nutrition information regarding the standard menu item in the written form.  However, if 
you make a nutrient content claim or health claim, you must provide nutrition information on the 
nutrient that is the subject of the claim in accordance with 21 CFR 101.10. 
(21 CFR 101.11(b)(2)(ii)(B)) 
 
IV.H.4.  How does the rule define insignificant amount? 
The rule defines an insignificant amount 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. 
(21 CFR 101.11(b)(2)(ii)(B)(1)) 
 
IV.H.5.  When may I use a simplified format for the written nutrition information? 
You may use a simplified format for the written nutrition information for standard menu items 
that contain insignificant amounts of six or more of the required nutrients. 
(21 CFR 101.11(b)(2)(ii)(B)) 
 
IV.H.6.  What information must the simplified format include? 
The simplified format must include information, in a column, list, or table, on the following 
nutrients: 
  Total calories, total fat, total carbohydrates, protein, and sodium; and 
  Calories from fat, and any other nutrients identified in 21 CFR 101.11(b)(2)(ii)(A) that 
are present in more than insignificant amounts. 
  16  Contains Nonbinding Recommendations 
 
(21 CFR 101.11(b)(2)(ii)(B)(2)(i)-(ii)) 
 
For example, you may use the simplified format for a medium cola beverage as follows: 
 Total calories 200 calories 
 Total fat 0 g 
 Sodium 5 mg 
 Total carbohydrate 56 g 
 Sugars 56 g 
 Protein 0 g 
 Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, and dietary 
fiber. 
IV.H.7.  What statement must I include when I use the simplified format? 
If the simplified format is used, you must include 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 nutrition information and calories from fat that are present in insignificant amounts) at 
the bottom of the list of nutrients. 
(21 CFR 101.11(b)(2)(ii)(B)(3)) 
 
IV.H.8.  How must I declare the written nutrition information for variable menu items? 
For variable menu items, you must declare the written nutrition information as follows for each 
size offered for sale: 
  You must declare the written nutrition information for the basic preparation of the item 
and, separately, for each topping, flavor, or variable component. 
  For toppings, see Question IV.H.9.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, you do not have to list 
these separately.  You could list all items that have the same nutrient values together with 
the nutrient values listed only once. 
(21 CFR 101.11(b)(2)(ii)(C)(1)-(3)) 
 
For example, for a meal that consists of a cheeseburger, side dish (fries or salad with fat-free 
dressing), and medium cola soft drink (diet or regular), you would provide information for the 
required nutrients for each component of the meal, i.e., the cheeseburger, the fries, the salad with 
fat-free dressing, a medium regular cola, and a diet cola. The nutrition information for the meal 
may appear as follows, which includes the simplified formats for the medium regular cola and 
diet cola: 
 
Cheeseburger: 
 Total calories 470 calories 
 Calories from fat 190 calories 
 Total fat 21 g 
 Saturated fat 8 g 
 Trans fat 1 g 
 Cholesterol 75 mg 
  17  Contains Nonbinding Recommendations 
 
 Sodium 880 mg 
 Total carbohydrate 43 g 
 Dietary fiber 2 g 
 Sugars 10 g 
 Protein 26 g 
 
Medium fries: 
 Total calories 420 calories 
 Calories from fat 180 calories 
 Total fat 20 g 
 Saturated fat 3.5 g 
 Trans fat 0 g 
 Cholesterol 0 mg 
 Sodium 500 mg 
 Total carbohydrate 54 g 
 Dietary fiber 6 g 
 Sugars 0 g 
 Protein 5 g 
 
Garden salad with fat-free dressing: 
 Total calories 150 calories 
 Calories from fat 30 calories 
 Total fat: 3 g 
 Saturated fat 0 g 
 Trans fat 0 g 
 Cholesterol 0 mg 
 Sodium 340 mg 
 Total carbohydrate 27 g 
 Dietary fiber 2 g 
 Sugars 11 g 
 Protein 3 g 
 
Medium Regular Cola: 
 Total calories 200 calories 
 Total fat 0 g 
 Sodium 5 mg 
 Total carbohydrate 56 g 
 Sugars 56 g 
 Protein 0 g 
 Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, and dietary 
fiber. 
 
Medium Diet Cola: 
 Total calories 0 calories 
 Total fat 0 g 
 Sodium 40 mg 
  18  Contains Nonbinding Recommendations 
 
 Total carbohydrate 0 g 
 Sugars 0 g 
 Protein 0 g 
 Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, and dietary 
fiber 
 
When the nutrient values for different flavors, varieties, or components of combination meals are 
the same, the nutrient values for such food items could be listed together with the nutrient values 
listed only once. For example: 
Raspberry or Peach Flavored Iced Tea (14 ounces): 
 Total calories 5 calories 
 Total fat 0 g 
 Sodium 15 mg 
 Total carbohydrate 1 g 
 Sugars 0 g 
 Protein 0 g 
 Not a significant source of calories from fat, saturated fat, trans fat, cholesterol, and dietary 
fiber 
IV.H.9. What additional format requirements apply to 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), the nutrients for such topping must be declared as single values representing the 
nutrients for each topping when added to a one-topping menu item, specifying that the nutrient 
declaration is for the topping when added to a one-topping menu item. 
(21 CFR 101.11(b)(2)(ii)(C)(2) 
IV.H.10.  What forms may I use to provide written nutrition information? 
You may provide the written nutrition information in the following forms: 
  Counter card, sign, poster, handout, booklet, loose leaf binder; 
  Electronic device, such as a computer; 
  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. 
(21 CFR 101.11(b)(2)(ii)(D)) 
 
I.  Requirements for Food that is Self-Service or On Display 
IV.I.1.  What nutrition information must I provide for a standard menu item that is self-service or 
on display? 
You must provide: 
  Calories per displayed food item (e.g., a bagel, a slice of pizza, or a muffin); or 
  19  Contains Nonbinding Recommendations 
 
  If the food is not offered for sale in a discrete unit, calories per serving (e.g., scoop, cup), 
and 
  The service or discrete unit used to determine the calorie content (e.g., per scoop or 
per muffin)  
 (21 CFR 101.11(b)(2)(iii)(A)) 
IV.I.2.  Where must I place the nutrition information for a standard menu item that is self-service 
or on display? 
You must place the calories for self-service foods and foods on display 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. 
(21 CFR 101.11(b)(2)(iii)(A)) 
IV.I.3.  What does per displayed food item mean for the purposes of the labeling requirements 
that apply to standard menu items that are self-service or on display? 
For the purposes of the requirements for providing nutrition information for a standard menu 
item that is self-service or on display, per displayed food item means per each discrete unit 
offered for sale, for example, a bagel, a slice of pizza, or a muffin. 
(21 CFR 101.11(b)(2)(iii)(A)(1)) 
 
IV.I.4.  What does per serving mean for the purposes of the labeling requirements that apply to 
standard menu items that are self-service or on display? 
For the purposes of the requirements for providing nutrition information for a standard menu 
item that is self-service or on display, per serving means, for each food: 
  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); 
  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 
  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)). 
(21 CFR 101.11(b)(2)(iii)(A)(2)) 
 
  20  Contains Nonbinding Recommendations 
 
IV.I.5.  How must I declare the calories for a standard menu item that is self-service or on 
display? 
The following applies when you declare the calories for a standard menu item that is self-service 
or on display: 
  You must declare calories 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. 
  If you provide the calorie declaration on a sign with the foods name, price, or both, you 
must declare the calories, accompanied by the term Calories or Cal and the amount 
of the serving or displayed food item on which the calories declaration is based: 
  In a type size no smaller than the type size of the name or price of the menu item 
o
whichever is smaller;  
  In the same color, or a color that is at least as conspicuous as that used for that 
o
name or price  
  Using the same contrasting background or a background at least as contrasting as 
o
that used for that name or price.   
  If you provide the calorie declaration on a sign that does not include the foods name, 
price, or both, you must declare the calories, accompanied by the term Calories or 
Cal and the amount of the serving or displayed food item on which the calorie 
declaration is based, in a manner that is clear and conspicuous. 
  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). 
(21 CFR 101.11(b)(2)(iii)(A)(3)(i)-(iii)) 
IV.I.6.  Do the requirements for the succinct statement and statement of availability apply to self-
service foods and foods on display? 
You must provide the succinct statement required by 21 CFR 101.11(b)(2)(i)(B) and the 
statement of availability required by 21 CFR 101.11(b)(2)(i)(C) 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 as defined in 21 CFR 101.11(a).  The succinct statement 
required by 21 CFR 101.11(b)(2)(i)(B) and the statement of availability required by 21 CFR 
101.11(b)(2)(i)(C) 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 larger menu board that can be easily read as the consumer is viewing the food. 
(21 CFR 101.11(b)(2)(iii)(B)) 
IV.I.7.  What written nutrition information must I provide for a standard menu item that is self-
service or on display? 
You must provide the nutrition information in written form required by 21 CFR 101.11(b)(2)(ii), 
except for packaged food insofar as it bears nutrition labeling information required by and in 
accordance with 21 CFR 101.11(b)(2)(ii) and the packaged food, including its label, can be 
examined by a consumer before purchasing the food. 
(21 CFR 101.11(b)(2)(iii)(C)) 
  21  Contains Nonbinding Recommendations 
 
An example of a packaged food that bears the required nutrition labeling is a packaged bag of 
chips that a consumer would purchase as part of a combination meal that includes the packaged 
chips with a sandwich when the consumer can pick up the packaged chips and read the Nutrition 
Facts label before purchasing the combination meal. 
IV.I.8.  Do I need to provide written nutrition information for a packaged food that I offer for 
sale if the food already has a Nutrition Facts label? 
It depends on whether the Nutrition Facts label for the food bears the nutrition information 
required by and in accordance with 21 CFR 101.11(b)(2)(ii) and the consumer can examine the 
Nutrition Facts label before purchasing the food.  For example, you would not need to provide 
written nutrition information for a bottled soft drink (that bears the nutrition information required 
by and in accordance with 21 CFR 101.11(b)(2)(ii)) that a consumer would select from a 
refrigerated case before paying for the soft drink. However, you would need to provide written 
nutrition information for a bottled soft drink that you keep behind the counter and hand to the 
consumer after the consumer has paid for it. 
 
V. Determination of Nutrient Content  
A.  General Requirements 
V.A.1.  How may I determine nutrient values for standard menu items? 
You must have a reasonable basis for your nutrient declarations.  You may determine nutrient 
values by using any of the following: 
  Nutrient databases (with or without computer software programs);  
  Cookbooks;  
  Laboratory analysis; or 
  Other reasonable means, including: 
  Use of Nutrition Facts on labels on packaged foods that comply with the nutrition 
o
labeling requirements of section 403(q)(1) of the Federal Food, Drug, and 
Cosmetic Act and 21 CFR 101.9;  
  FDA nutrients values for raw fruits and vegetables in Appendix C of 21 CFR part 
o
101; 
  FDA nutrient values for cooked fish in Appendix D of 21 CFR part 101  
o
(21 CFR 101.11(c)(1)) 
 
For nutrient databases, you may be able to obtain information from sources such as the USDA 
National Nutrient Database for Standard Reference (http://ndb.nal.usda.gov/).   In general, you 
should use a database that has a name and version number, as you are required to provide the 
name and version of the database to FDA, within a reasonable period of time upon request, as 
part of the information required to substantiate your nutrient values (as discussed further in 
section V.B. below).  In certain cases, the version number might be the date.  Databases may be 
updated to reflect more recent data and information, and different versions of a database may 
generate different nutrient values.  If available, you should consider information on how the 
database was used including calculations or operations (e.g., worksheets or computer printouts) 
  22  Contains Nonbinding Recommendations 
 
to determine the nutrient values for the standard menu items, as you are required to provide such 
information to FDA, within a reasonable time period upon request, as part of the information 
required to substantiate your nutrient values (as discussed further in section V.B. below).   Some 
databases only provide nutrient values for certain food items such as foods typically used as 
ingredients in standard menu items; while other databases use software to compute nutrient 
values for a standard menu item prepared with several of the listed foods in varying amounts, 
taking into consideration the recipe and ingredient amounts used in the preparation.  Nutrient 
databases may be used to determine nutrient values regardless of whether they use computer 
software programs. 
 
For cookbooks, you should use one that has been published.  If available, you should consider 
information provided by the cookbook or from the author or publisher about how the nutrient 
information for the recipes was obtained, as you are required to provide such information to 
FDA, within a reasonable time period upon request, as part of the information required to 
substantiate your nutrient values (as discussed further in section V.B. below).  
 
For laboratory analyses, consider whether the laboratory provides copies of analytical 
worksheets, including the analytical method, used to determine and verify the nutrition 
information, as you are required to provide copies of such analytical worksheets to FDA, within 
a reasonable period of time upon request, as part of the information required to substantiate your 
nutrient values (as discussed further in section V.B. below).   
  
V.A.2.  How do I determine if the basis I use to determine nutrition information for a standard 
menu item is reasonable? 
You must ensure that nutrient declarations for standard menu items are accurate and consistent 
with the specific basis used to determine nutrient values.  You 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 you determined your nutrient values. 
(21 CFR 101.11(c)(2)) 
 
For example, if you determine 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, you must take reasonable steps to ensure your 
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.    
 
B. Information Substantiating Nutrient Values  
V.B.1.  What  are you required to provide to FDA to substantiate nutrient values? 
You 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.   
  23  Contains Nonbinding Recommendations 
 
V.B.2.  If I determine nutrient values using nutrient databases, what specific information must I 
provide to FDA to substantiate nutrient values? 
If you determine nutrient values using nutrient databases, the information must include the 
following: 
  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 should include the name and version of 
the computer software, if applicable;  
  The recipe or formula used as a basis for the nutrient declarations; 
  Information on: 
  The amount of each nutrient that the specified amount of each ingredient 
o
identified in the recipe contributes to the menu item; and 
  How the database was used including calculations or operations (e.g., worksheets 
o
or computer printouts) to determine the nutrient values for the standard menu 
items. 
  If this information is not available, certification attesting that the database will 
o
provide accurate results when used appropriately and that the database was used 
in accordance with its instructions;  
  A detailed listing (e.g., printout) of the nutrient values determined for each standard menu 
item;  
  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);  
  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 
  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. 
(21 CFR 101.11(c)(3)(i)(A)-(G)) 
 
Because your corporate headquarters or parent entity may conduct the nutrient analysis or make 
arrangements for the nutrient analysis, the responsible individual who certifies that the 
information contained in the nutrient analysis is complete and accurate can be employed at either 
your establishment or at your corporate headquarters or parent entity.  Whether such individual is 
employed at your establishment or at your 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. 
 
21 CFR 101.11(c)(3)(i)(F)  
 
In contrast, the responsible individual who certifies that you have taken reasonable steps to 
ensure that the method of preparation and amount of a standard menu item offered for sale 
adhere to the factors on which your nutrient values were determined must be employed by your 
  24  Contains Nonbinding Recommendations 
 
establishment, because an individual employed at your corporate headquarters or parent entity 
likely would not have a factual basis for certifying the actions of your specific establishment 
because such individual would not be present where the standard items are prepared, and, thus, 
likely could not certify the actions your establishment takes to comply with the rule. 
 
21 CFR 101.11(c)(3)(i)(G) 
V.B.3.  If I determine nutrient values using published cookbooks that contain nutritional 
information for recipes in the cookbook, what specific information must I provide to FDA to 
substantiate nutrient values? 
If you determine nutrient values using published cookbooks that contain nutritional information 
for recipes in the cookbook, the information must include the following: 
  The name, author, and publisher of the cookbook used;  
  If available, information provided by the cookbook or from the author or publisher about 
how the nutrition information for the recipes was obtained;  
  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 
  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.  (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.) 
(21 CFR 101.11(c)(3)(ii)) 
 
 
V.B.4.  If I determine nutrient values using laboratory analyses, what specific information must I 
provide to FDA to substantiate nutrient values? 
If you determine nutrient values using laboratory analyses, the information must include the 
following: 
  A copy of the recipe for the standard menu item used for the nutrient analysis; 
  The name and address of the laboratory performing the analysis;  
  Copies of the analytical worksheets, including the analytical method, used to determine 
and verify nutrition information;  
  A statement signed and dated by the 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 
  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. 
  25  Contains Nonbinding Recommendations 
 
(21 CFR 101.11(c)(3)(iii)) 
 
 
V.B.5.  For nutrition information provided by other reasonable means, what specific information 
must I provide to FDA to substantiate nutrient values? 
If you determine nutrient values using other reasonable means, the information must include the 
following: 
  A detailed description of the means used to determine the nutrition information;  
  A recipe or formula used as a basis for the nutrient determination;  
  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;  
  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 
  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. 
(21 CFR 101.11(c)(3)(iv)) 
 
VI. Voluntary Registration to be Subject to the Federal 
Requirements  
A.  Applicability 
VI.A.1.  What establishments may voluntarily register to be subject to the requirements of the 
rule? 
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 of the rule.   
(21 CFR 101.11(d)(1)) 
VI.A.2.  If I voluntarily register to be subject to the requirements of the rule, do I remain subject 
to non-identical State or local nutrition labeling requirements? 
No. Restaurants and similar retail food establishments that voluntarily register will no longer be 
subject to non-identical State or local nutrition labeling requirements. 
(21 CFR 101.11(d)(1)) 
  26  Contains Nonbinding Recommendations 
 
VI.A.3.  Who may register my establishment? 
The authorized official of a restaurant or similar retail food establishment as defined in the rule, 
which is not otherwise subject to 21 CFR 101.11(b), may register with FDA.  (We discuss who 
the authorized official can be in the next question.) 
(21 CFR 101.11(d)(2)) 
VI.A.4.  How does the rule define authorized official of a restaurant or similar retail food 
establishment? 
The rule defines 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 Federal Food, Drug, and Cosmetic Act, with FDA for the 
purposes of 21 CFR 101.11(d). 
(21 CFR 101.11(a)) 
 
B.  General Requirements for Voluntary Registration 
VI.B.1.  What form do I use for voluntary registration? 
You must use Form FDA 3757.  You can find this form at www.fda.gov/menulabeling. 
(21 CFR 101.11(d)(3) and (d)(4)) 
VI.B.2.  What registration information must an authorized official provide on Form FDA 3757? 
Authorized officials for restaurants and similar retail food establishments must provide FDA 
with the following information on Form FDA 3757: 
  The contact information (including name, address, phone number, and e-mail address) for 
the authorized official; 
  The contact information (including name, address, phone number, and e-mail address) of 
each restaurant or similar retail food establishment being registered, as well as the name 
and contact information for an official onsite, such as the owner or manager, for each 
specific restaurant or similar retail food establishment; 
  All trade names the restaurant or similar retail food establishment uses; 
  Preferred mailing address (if different from location address for each establishment) for 
purposes of receiving correspondence; and 
  Certification that the information submitted is true and accurate, that the person 
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 21 CFR 101.11. 
(21 CFR 101.11(d)(3)) 
 
VI.B.3.  How does an authorized official register? 
Authorized officials of restaurants and similar retail food establishments who elect to be subject 
to the requirements of the rule can register by visiting www.fda.gov/menulabeling.  We have 
created a form (Form 3757) that contains fields requesting the information in 21 CFR 
  27  Contains Nonbinding Recommendations 
 
101.11(d)(3) and made the form available at this web site.  Registrants must use this form to 
ensure that complete information is submitted.   
  Information should be submitted by e-mail by typing complete information into the form 
(PDF), saving it on the registrants computer, and sending it by e-mail to 
menulawregistration@fda.hhs. 
  If e-mail is not available or cannot be used, 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. 
(21 CFR 101.11(d)(4)(i)-(ii)) 
VI.B.4.  How often must an authorized official renew a voluntary registration to keep it active? 
To keep the establishments 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 establishments current registration with FDA.  Registration will automatically expire if not 
renewed.  
(21 CFR 101.11(d)(5)) 
VI.B.5.  Is there a cost for voluntary registration? 
No. 
VI.B.6.  Are signatures obtained in the voluntary registration subject to 21 CFR part 11? 
No.  Signatures obtained under 21 CFR 101.11(d) that meet the definition of electronic 
signatures in 21 CFR 11.3(b)(7) are exempt from the requirements of 21 CFR part 11. 
(21 CFR 101.11(e)) 
 
VII. Misbranding 
VII.1.  What are the consequences of failing to label a standard menu item offered for sale in a 
covered establishment in accordance with 21 CFR 101.11(b) or (c)? 
A standard menu item offered for sale in a covered establishment is 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 21 CFR 101.11(b) or (c). 
(21 CFR 101.11(f)) 
 
Penalties for misbranding food are established in the Federal Food, Drug, and Cosmetic Act, and 
violations of 21 CFR 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 
  28  Contains Nonbinding Recommendations 
 
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.   
 
  29