Contains Nonbinding Recommendations 
 
 
Menu Labeling: Supplemental  
Guidance for Industry 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling, HFS-800 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-2373 
 
http://www.fda.gov/FoodGuidances   
 
You may submit written comments regarding this guidance at any time.  Submit electronic 
comments to http://www.regulations.gov.  Submit written comments to the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number [FDA
2011F0172] 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 
 
May 2018 
   
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Table of Contents 
1. Introduction
   
2. Background
   
3. Calorie Disclosure Signage for Self-Service Foods, Including 
 
Buffet Foods
 
4. Criteria for Distinguishing Between Menus and Marketing 
 
Materials
 
5. Methods for Providing Calorie Disclosure Information
   
6. Compliance and Enforcement
   
7. Determining Nutrient Content for Standard Menu Items
   
8. Covered Establishments
   
9. Standard Menu Items
   
10. Alcohol
   
11. References
   
 
   
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Menu Labeling: Supplemental 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page.  
 
 
1. Introduction 
 
This guidance document addresses concerns raised by stakeholders regarding the implementation 
of nutrition labeling required for foods sold in covered establishments,2 including expanded and 
new examples of alternatives to aid in compliance.  It also clarifies that there are additional 
options for complying with the labeling requirements and identifies places where FDA intends to 
be more flexible in its approach.  The guidance reflects input from stakeholders, including the 
public and industry, in response to an interim final rule (IFR) (82 FR 20825, May 4, 2017), as 
well as comments received on the draft guidance document.  The IFR also extended the 
compliance date for menu labeling, and invited comments to the docket.   
 
In addition, given extensive further analysis by FDA, Questions and Answers 5.17 and 5.18 have 
been withdrawn from our previous April 2016 guidance entitled A Labeling Guide for 
Restaurants and Retail Establishments Selling Away-From-Home Foods  Part II (Menu 
Labeling Requirements in Accordance with FDAs Food Labeling Regulations): Guidance for 
Industry.    
 
In this guidance, we address the issue of distinguishing between menus and other information 
presented to the consumer, which represents our current thinking on this topic.  This guidance 
also includes many graphical depictions in order to convey our thinking on various topics.  The 
guidance covers several topic areas including calorie disclosure signage for self-service food, 
including buffets and grab-and-go food; various methods for providing calorie disclosure 
information, including those for pizza; criteria for distinguishing between menus and marketing 
material; compliance and enforcement; reasonable basis, including the criteria for considering 
the natural variation of foods, when determining nutrition labeling; criteria for covered 
                                            
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration.  
2 21 CFR 101.11(a) defines 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 voluntarily registers with FDA to be covered by the federal menu labeling requirements.  
See generally 21 U.S.C. 343(q)(5)(H)(i). 
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establishments; and standard menu items.   
 
Finally, as a result of our further analysis of the menu labeling requirements and, in particular, 
the nutrient declaration requirements for the additional written nutrition information in 21 CFR 
101.11(b)(2)(ii)(A) that requires calories from fat be declared for standard menu items, and to 
align with the final rule, Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels, 81 FR 33742 et seq, we are advising covered establishments of our intent to exercise 
enforcement discretion regarding the calories from fat declaration requirement.  This means 
that, during this period, we do not intend to enforce this regulatory provision as it currently 
applies to calories from fat declarations.  We are taking this position because the current 
science supports a view that the type of fat is more relevant with respect to the risk of chronic 
disease than the overall caloric fat intake.3  Therefore, if a covered establishment meets all of the 
provisions of the menu labeling requirements for the additional written nutrition information in 
21 CFR 101.11(b)(2)(ii)(A), except that calories from fat is not declared, we do not intend to 
pursue actions against the covered establishment.  We are issuing this guidance consistent with 
our good guidance practices (GGP) regulation (21 CFR 10.115).  With respect to our 
enforcement discretion policy pertaining to calories from fat declarations, this part of the 
guidance is immediately effective because we have determined that prior public participation is 
not feasible or appropriate (21 CFR 10.115(g)(2)). 
 
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 FDA guidances means that something is suggested or 
recommended, but not required.  
 
2. Background  
 
On December 1, 2014, we published a final rule in the Federal Register (79 FR 71156) on 
nutrition labeling of standard menu items in restaurants and similar retail food establishments to 
implement the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act).  The menu labeling requirements are codified at Title 21 of the Code 
of Federal Regulations, section 101.11 (21 CFR 101.11).  Before these requirements, consumers 
could find nutrition information on most packaged foods; however, this labeling was not 
generally and consistently available in restaurants and similar retail food establishments that 
serve ready-to-eat, prepared food.  Providing calorie and other nutrition information for ready-to-
eat prepared foods in restaurants and similar retail food establishments will enable consumers to 
make informed and healthy dietary choices.   
 
The original compliance date for the menu labeling provisions was December 1, 2015.  On July 
10, 2015, we extended the compliance date to December 1, 2016 (80 FR 39675).  On December 
18, 2015, the Consolidated Appropriations Act (Pub. L. 114-113) was adopted.  It contained a 
                                            
3 FDAs current thinking on this issue is discussed in the preamble to the final rule titled, Food Labeling: Revision 
of the Nutrition and Supplement Facts Labels (81 FR 33742 at 33780 through 33781 (May 27, 2016) (now codified 
primarily at 21 CFR 101.9 and 101.36)). 
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provision stating that none of the funds made available under the Consolidated Appropriations 
Act could be used to implement, administer, or enforce the menu labeling final rule until one 
year after FDA issued a final guidance document regarding the rule.  We issued the final 
guidance document on May 5, 2016.  In accordance with Congresss direction, we subsequently 
set the compliance date for the rule as May 5, 2017, one year from the date of the publication of 
the guidance (81 FR 96364).  On May 4, 2017, we published an interim final rule (IFR) (82 FR 
20825) in the Federal Register extending the compliance date to May 7, 2018, in response to the 
diverse and complex set of stakeholders affected by the rule and questions they raised regarding 
the final rule and its implementation (Refs. 1, 2, 3, and 4).  The IFR provided additional time to 
support industry innovation and to ensure consistency across establishments when delivering 
nutrition information to consumers.  Our goals are to ensure that consumers are provided with 
consistent nutrition information they can use to make informed choices for themselves and their 
families, and to guide industry to clearly understand the flexible way the requirements can be 
implemented.  Comments to the draft guidance were received until January 8, 2018, and 
incorporated, as appropriate, to this supplemental guidance.  This guidance provides clarity to the 
industry on these remaining questions ahead of the new compliance date of May 7, 2018. 
 
3. Calorie Disclosure Signage for Self-Service Foods, Including 
Buffet Foods 
 
3.1.  We are a covered establishment that has a self-service buffet.  Are we required to 
have individual signs (e.g., food tags) next to each buffet item with the calorie 
declaration?  
  
Answer:  No.  You are not required to have individual signs next to each buffet item.  While the 
menu labeling final rule requires calorie information for each buffet item that is a standard menu 
item, the menu labeling final rule is flexible, and allows the calories for self-service foods and 
foods on display to be declared in a variety of ways, as long as the consumer can view the name, 
calorie declaration, and serving or unit of a particular menu item while selecting that item.  You 
could place a sign next to each item or on the sneeze guard over the item with the calorie 
declarations (21 CFR 101.11(b)(2)(iii)(A)).  However, you could also comply with the 
requirements by using a sign or placard listing the calorie declaration for multiple food items, 
along with the names of those food items.  Illustrations in Figures 1, 2, 3, 4, and 5 show 
examples of how this requirement could be implemented, including illustrating some examples 
that are currently in use by covered establishments.   
 
3.2.  What are options for declaring calories for standard menu items on a self-service 
buffet? 
 
Answer:  You may place the calorie information on a sign adjacent to, and clearly associated 
with, the food for which the calories are provided, or on a sign attached to a sneeze guard (e.g., a 
gel cling or hanging placard attached to the glass), or on a single sign or placard listing the 
calorie declaration for multiple food items along with the names of the food items as 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 (21 CFR 
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101.11(b)(2)(iii)(A)).  The illustration(s) in Figures 1, 2, 3, 4 and 5 show examples of how this 
requirement could be implemented. 
 
   
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Figure 1:  Example of declaring calories for multiple items on a self-service salad bar on a 
single sign attached to the sneeze guard. 
 
 
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Figure 2:  Close-up of a single sign attached to the sneeze guard used for declaring calories 
for multiple items on a self-service salad bar. 
 
   
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Figure 3:  Example of declaring calories for self-service foods on individual signs, such as 
permanent clear placard holders attached to the sneeze guard with paper inserts that can 
easily be interchanged.  
 
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Figure 4:  Example of declaring calories for multiple items at a self-service buffet on a 
single sign hanging below the sneeze guard. 
 
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Figure 5:  Example of declaring calories for self-service foods on individual signs using gel 
clings on the sneeze guard.  Gel clings can be moved or removed as standard menu items 
change in the buffet. 
 
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3.3.  We have several locations in our establishment where self-service food is offered.  
Are we required to post menus/menu boards at each self-service location? 
 
Answer:  No, menus and menu boards are not required at each self-service location.  The menu 
labeling final rule requires that calories be declared for self-service food or food on display (21 
CFR 101.11(b)(2)(iii)), but the rule does not require a covered establishment to create a new 
menu or menu board.  The menu labeling final rule is flexible in the options that can be used to 
declare the calories.    
 
For example, you may display the calories using individual placards or gel clings on the sneeze 
guard of a buffet or use one single sign on the buffet to list multiple items as discussed in Q&As 
3.1 and 3.2.  See Figures 6, 7, 8, and 9 for examples.  If an establishment chooses to use a single 
sign option at each self-service location throughout a store or restaurant, that single sign could 
list only the calorie declarations for each standard menu item offered only at that particular self-
service location in the store or restaurant, and would not be required to list calorie declarations 
for all standard menu items, because those declarations could be listed elsewhere in close 
proximity to selection of those standard menu items. 
 
   
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Figure 6:  Example of declaring calories for multiple self-service items on a single sign. 
 
 
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Figure 7:  Close-up example of a single sign declaring calories for multiple self-service 
items. 
 
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Figure 8:  Example of declaring calories at a self-service beverage station. 
 
   
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Figure 9:  Close-up of a sign declaring calories for a self-service beverage station. 
 
 
3.4.  If we use front-of-pack (FOP) calorie declarations (e.g., a sticker that reads 350 
cal), would signs also be needed? 
 
Answer:  If a packaged food, such as a sandwich prepared on site by the covered establishment 
bears a front-of-pack (FOP) calorie declaration (e.g., a sticker that reads 350 cal), then the FOP 
labeling would meet the calorie declaration requirements in the menu labeling final rule and 
additional signage disclosing calorie information would not be required.  We note that if calories 
are declared using FOP labeling on grab and go foods, the calories must be declared for the 
entire package as the menu labeling final rule requires that calories be declared for standard 
menu items as they are usually prepared and offered for sale (21 CFR 101.11(b)(2)(i)(A)).  See 
Figures 10 and 11.   
 
Additionally, if a packaged food bears a Nutrition Facts label or if an establishment voluntarily 
chooses to use a Nutrition Facts label that includes the nutrition information required by 21 CFR 
101.11(b)(2)(i)(A), the Nutrition Facts label would meet the menu labeling requirements for 
calorie declaration, provided that the food, including its label, can be examined by a consumer 
before purchasing the food (21 CFR 101.11(b)(2)(iii)(C)). 
 
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Figure 10:  Example of a grab-and-go food that meets the calorie declaration requirements 
using a front of pack calorie declaration (e.g., a sticker) that can be viewed by the 
consumer before purchase. 
 
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Figure 11:  Example of a grab-and-go food that meets the calorie declaration requirements 
using a front-of-pack calorie declaration (e.g., a sticker) that can be viewed by the 
consumer before purchase. 
 
 
   
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3.5.  If we declare calorie declarations on the package of our grab-and-go items, do the 
succinct statement4 and statement of availability5 have to be on every individual 
package?   
 
Answer:  No.  The succinct statement and the statement of availability may be on a separate sign 
in close proximity to the food that the customer can easily read as they are making their order 
selections (21 CFR 101.11(b)(2)(iii)(B)).  See Figures 12 and 13 for examples. 
 
Figure 12:  Example of displaying the succinct statement and statement of availability on a 
separate sign in close proximity to grab-and-go foods that the customer can easily read as 
they are making their order selections. 
 
 
 
 
                                            
4 The term succinct statement refers to the statement designed to enable consumers to understand the significance of 
the calorie information provided on menus and menu boards in the context of a total daily diet.  The statement must 
read 2,000 calories a day is used for general nutrition advice, but calorie needs vary (21 CFR 101.11(b)(2)(i)(B)). 
5 The statement of availability refers to the statement regarding the availability of additional written nutrition 
information.  This statement must read Additional nutrition information available upon request (21 CFR 
101.11(b)(2)(i)(2)(C)). 
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Figure 13:  Close up of the sign displaying the succinct statement and statement of 
availability on a separate sign in close proximity to grab-and-go foods that the customer 
can easily read as they are making their order selections. 
 
 
3.6.  Are the succinct statement providing context about calories in a daily diet and 
statement regarding the availability of additional written nutrition information 
required on every sign for self-service food? 
 
Answer:  No.  For self-service foods and foods on display, these statements may be on an 
individual sign adjacent to the food itself; on a separate, larger sign in close proximity to the food 
that the customer can easily read as he or she is making his or her order selections; or on a large 
menu board that the consumer can easily read as he or she is ordering his or her food (21 CFR 
101.11(b)(2)(iii)(B)). 
 
4. Criteria for Distinguishing Between Menus and Marketing 
Materials 
 
4.1.  Is marketing material (e.g., coupons, posters in store windows, or signs on gas 
pumps) required to bear calorie information?6  
 
Answer:  Menu or Menu Board is statutorily defined as the primary writing of the restaurant or 
other similar retail food establishment from which a consumer makes an order selection. See 21 
U.S.C. 343 (q)(5)(H)(xi).  Marketing material (e.g., pizza coupons, posters in store windows, 
signs on gas pumps, paper inserts, coupon flyers, or mail-delivered coupons) generally would not 
be considered a menu or menu board and would not require calorie declarations.  The 
applicability of the rule to marketing materials is intended to be flexible and not prescriptive.  
Written material of an establishment that does not satisfy the criteria of a primary writing from 
which a customer makes an order selection, such as a poster on a storefront, a coupon, or other 
promotional material, banners, billboards, and stanchions, would be considered a secondary 
writing of an establishment.  This includes materials available both inside and outside of the 
                                            
6 This question supersedes Questions and Answers 5.17 and 5.18 in the April 2016 Guidance; accordingly, we have 
withdrawn these two questions from the April 2016 Guidance.   
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covered establishment.  If the primary purpose of these materials is to entice customers into the 
covered establishment or entice customers to purchase a particular item, then we would not 
consider them to be a primary writing, and they would not require calorie declarations.  See 
Figures 14, 15, 16, 17 and 18 for examples of marketing materials that would not require calorie 
labeling. 
 
Figure 14:  Example of a poster or banner in a window, on a gas pump, or hanging inside a 
covered establishment that would not require a calorie declaration. 
 
Figure 15:  Example of a marketing board that would not require calorie declarations. 
 
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Figure 16:  Example of a marketing board hanging inside a covered establishment that 
would not require calorie declarations. 
 
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Figure 17:  Example of a coupon flyer that does not require calorie declarations. 
 
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Figure 18:  Example of a mail-delivered coupon that does not require calorie declarations. 
 
 
5. Methods for Providing Calorie Disclosure Information 
 
5.1.  I am concerned that adding the calories of each standard menu item adjacent to the 
name of the item will increase clutter on my menu board, or that I will have to 
reduce the type size to make all of the information fit, making the menu board more 
difficult for customers to read.  How can I meet the requirements without reducing 
the readability of my menu board?    
 
Answer:  We understand that there is variability in the way menus are designed, and the rule 
provides flexibility to address this variability.  We have provided covered establishments with 
the ability to list calorie declarations adjacent to either the name or the price of the associated 
standard menu item with the intention of providing greater flexibility to incorporate the calorie 
declarations within existing menu designs (21 CFR 101.11(b)(2)(i)(A)(1)).  In considering what 
would be adjacent and clearly associated with the menu item, we expect that the name or price 
and the calorie declaration would be displayed such that the consumer can easily determine 
which calories are posted for each standard menu item.  See Figures 19 and 20 for examples of 
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menu boards that meet the requirements for listing calorie declarations adjacent to and clearly 
associated with the menu item. 
 
5.2.  I am a quick-service/takeout establishment, and I dont have menu boards in my 
establishment.  Do I have to create menu boards  in addition to my paper menus or 
online menus? 
 
Answer:  No.  The menu labeling regulation does not mandate that establishments have menu 
boards; however, if establishments have menu boards, they must be labeled so consumers have 
access to the required nutrition information (21 CFR 101.11(b)(2)(i)(A)).  However, in lieu of 
having a menu board, you may use other alternatives such as electronic devices for customers to 
place their order (e.g., an in-store tablet or electronic kiosk).  Establishments may also use other 
options such as hand-held paper menus or laminated menus on the counter for ordering.  Thus, 
there are both innovative and simple solutions that may be used to disclose the calorie and other 
nutrition information in lieu of having a menu board.  
 
5.3.  On my menu I have standard menu items that can be combined for a special price.  
If the calorie declarations for those standard menu items are declared elsewhere on 
the menu, do I have to include the calorie declarations for the combinations? 
 
Answer:  No.  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 soup with a sandwich for 
$8.99), you do not need to also declare the calories for the combinations, provided that the 
calories for each standard menu item, including calories for each relevant size option that may be 
combined are declared elsewhere on the menu or menu board (21 CFR 
101.11(b)(2)(i)(A)(6)(iv)).  See Figures 19 and 20 for examples. 
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Figure 19:  Example of a menu or menu board that describes an opportunity for the 
consumer to combine standard menu items for a special price (and the calories for each 
standard menu item that may be combined are declared elsewhere on the menu or menu 
board). 
 
 
 
   
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Figure 20:  Example of a menu or menu board that describes an opportunity for the 
consumer to combine standard menu items for a special price (and the calories for each 
standard menu item that may be combined are declared elsewhere on the menu or menu 
board). 
 
 
5.4.  I am a covered pizza parlor that uses both online menus and menu boards in our 
establishment.  Do I have to provide calorie declarations on our menu boards within 
the establishment if we declare calories on our online menu?   
 
Answer:  Yes, even though you declare calories on your online menu, if you choose to use a 
menu board in your covered establishment you must provide calorie declarations for standard 
menu items listed on your menu board (section 403(q)(5)(H)(i) of the FD&C Act), as well as 
online menus if consumers can order online (21 CFR 101.11(b)(2)(i)(A)).   However, we note 
there is considerable flexibility in the rule regarding the options available to declare calories for 
standard menu items.  For example, in lieu of having a menu board in your establishment, you 
may use other alternatives to provide calorie information such as electronic devices for 
customers to place their order (e.g., an in-store tablet or electronic kiosk).  Establishments with 
online menus may also use other options for providing calorie information such as hand-held 
paper menus or laminated menus on the counter for ordering.  Thus, for covered establishments 
with online menus, there are both innovative and simple solutions that may be used to disclose 
the calorie and other nutrition information in the store in lieu of having a menu board.  We also 
note that establishments that do not have menu boards are not required to create menu boards.  
Furthermore, marketing boards or marketing materials can be used and would not require calorie 
declarations.  See Figures 14, 15, 16, 17, 18 and 21. 
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Figure 21:  Example of an in-store tablet where a customer can place an order and calories 
are declared before purchase.   
 
 
 
5.5.  I am a covered pizza parlor that sells build-your-own pizzas with a variety of 
options for crusts, sauces and toppings listed (i.e., the customer chooses from 4 crust 
options, 4 sauce options, and many topping options).  How should I declare calories 
for each option of my build-your-own pizzas on my menu or menu board?  
 
Answer:    In the menu labeling final rule we provided options and examples for declaring 
calories for pizzas and pizza toppings listed on a menu or menu board.  In the examples 
provided, we took the approach that there was a basic preparation of the pizza pie with a set 
amount of calories.  In accordance with menu labeling requirements, calories for toppings listed 
on a menu board must be declared (21 CFR 101.11(b)(2)(i)(A)(5)).  In the build-your-own pizzas 
scenario described in the question above, there does not appear to be a basic preparation of the 
pizza pie prior to adding the toppings.  Therefore, the calories for crust and sauce options may be 
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declared in the same manner as the toppings in this scenario.  A covered establishment may use a 
range for each crust or sauce option to represent the added calories across various sizes of the 
pizza.  In addition, crust and sauce options that have the same number of calories after rounding 
may be grouped together (21 CFR 101.11(b)(2)(i)(A)(5)(ii)).  This approach accommodates 
flexibility, while still providing the required calorie information for consumers to make informed 
dietary choices.  See Figures 22, 23, and 24 for examples. 
 
5.6.  I am a covered pizza parlor that sells build-your-own pizzas.  How should I declare 
calories for each option of my build-your-own pizzas if multiple sizes are offered 
and I want to provide calorie declarations per slice?   
 
Answer:  The calories may be declared in multiple ways.  The menu labeling final rule provides 
the flexibility to declare calories for the entire pizza or per slice, provided the number of slices 
per pie is included on the menu or menu board in a manner that clearly associates the calories per 
slice and the number of slices for each size of pie offered by the establishment (21 CFR 
101.11(b)(2)(i)(A)).   
 
Calories may be declared for each topping for each size of the pizza.  However, they may also be 
declared using a slash between the two calorie declarations for each topping where only two 
sizes of the pizza are available (e.g., adds 150/250 cal) or as a range for each topping where 
more than two sizes of the pizza are available (e.g., adds 100-250 cal).  Toppings that have the 
same number of calories after rounding may also be grouped together (21 CFR 
101.11(b)(2)(i)(A)(5)(ii)).  These options can provide greater flexibility for creating readable 
menus/menu boards.  See Figures 22  28 for examples. 
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Figure 22:  Example of declaring calories per slice for a build-your-own pizza using a 
column format. 
 
   
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Figure 23:  Example of declaring calories per slice for a build-your-own pizza using a 
string format. 
 
   
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Figure 24:  Additional example declaring calories for a build-your-own pizza using a string 
format. 
 
 
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Figure 25:  Example of declaring calories per slice for a basic preparation pizza offered 
for sale in different sizes, with the option of adding toppings listed on the menu or menu 
board, using a column format. 
Plain pizza pie (Calories per slice):  Small (6 slices) 150 cal. Medium (8 slices) 160 cal.  
Large (10 slices) 170 cal. 
Toppings  Added Cal (per slice) 
  Small  Med  Large 
Pepperoni  30  40  40 
       
Sausage  40  40  45 
       
Green Peppers, Red  0  0  5 
Peppers, or Onions 
 
Figure 26:  Example of declaring calories per pie for a basic preparation pizza offered 
for sale in different sizes, with the option of adding toppings listed on the menu or menu 
board, using a column format. 
Plain pizza pie:  Small (12) 500 cal. Medium (14) 750 cal. Large (16) 1,000 cal. 
Toppings  Added Cal 
  Small  Med  Large 
Pepperoni  200  300  400 
       
Sausage  250  350  450 
       
Green Peppers, Red  15  20  25 
Peppers, or Onions 
 
Figure 27:  Example of declaring calories per slice for a basic preparation pizza offered 
for sale in different sizes, with the option of adding toppings listed on the menu or menu 
board, using a column format. 
Plain pizza pie (Calories per slice):  Small (6 slices) 150 cal. Medium (8 slices) 160 cal.  
Large (10 slices) 170 cal. 
Toppings  Added Cal (per 
slice) 
(S/M/L pie) 
Pepperoni  30-40 
   
Sausage  40-45 
   
Green Peppers, Red  0-5 
Peppers, or Onions 
 
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Figure 28:  Example 2 of declaring calories per pie for a basic preparation pizza offered 
for sale in different sizes, with the option of adding toppings listed on the menu or menu 
board, using a column format (below, calories listed for the entire standard menu item). 
Plain pizza pie:  Small (12) 500 cal. Medium (14) 750 cal. Large (16) 1,000 cal. 
Toppings  Added Cal 
(S/M/L pie) 
Pepperoni  200-400 
   
Sausage  250-450 
   
Green Peppers, Red  15-25 
Peppers, or Onions 
 
5.7.  I am a covered establishment that serves family-style dishes, such as salads and 
pasta bowls that serve multiple people.  If I were to list the total calories on our 
menu, the calorie declaration would be very large.  Since these standard menu items 
are not divided into discrete units, may I declare the calories based only on a 
recommended serving? 
 
Answer:  In the case of multiple-serving standard menu items that are not offered for sale 
divided in discrete units (e.g., slices of pizza), the calories declared must be for the entire 
standard menu item listed on the menu or menu board as usually prepared and offered for sale 
(e.g., family-style salad:  1,000 Cal) (21 CFR 101.11(b)(2)(i)(A)).  However, you may, in 
addition to declaring the calories for the entire standard menu item, declare the number of 
suggested servings and the calories per suggested serving, but this must be in addition to 
declaring the calories for the entire standard menu item.  For example:  Family-Style Salad:   
1,200 Cal: 150 Cal/serving, 8 servings; or Family-Style Lasagna:  625 Cal/serving, 8 servings; 
5,000 Cal (21 CFR 101.11(b)(2)(i)(A)).  
 
6. Compliance and Enforcement 
 
6.1.  I am a covered establishment working to comply with menu labeling requirements.  
Will FDA work cooperatively with me to help me come into compliance?  
 
Answer:  We plan to work cooperatively with covered establishments to come into compliance 
with the menu labeling requirements.  Specifically, we plan to continue with education and 
outreach, especially in the first year, to help covered establishments achieve compliance.   
 
6.2.  How does FDA intend to approach enforcement of the menu labeling rule?  
 
Answer:  As stated in question and answer 6.1, our goal is to ensure compliance among covered 
establishments in a cooperative manner, and we do not intend to penalize or recommend the use of 
criminal penalties for minor violations.  For example, we would consider examples such as the 
following to be minor violations: 
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  Inadvertently missing a calorie declaration for a standard menu item on a buffet 
when other items are labeled; 
  Minor discrepancies in the type size/color contrast of calorie declarations, provided 
that they are readable; 
  Minimal variations or inadvertent error that would only minimally impact the calorie 
declaration or other nutrition information, such as adding extra slices of pepperoni 
on a pizza or adding an extra dollop of ketchup on a hamburger when not typically 
added; or 
  Not rounding your calorie declaration correctly in accordance with the menu 
labeling rule. 
 
Our goal is to seek compliance and to work flexibly with establishments to achieve compliance 
with menu labeling requirements.  Thus, we would allow establishments a reasonable 
opportunity to make corrections for minor violations.  For example, our typical approach 
following an inspection would be to raise any compliance concerns with the most responsible 
person (e.g., the manager or owner) at a covered establishment during a close-out inspection 
meeting or in regulatory meetings with that establishment.  If post-inspection issues remain, we 
may send a letter to the establishment asking for the firm to come into compliance.  Any 
enforcement activities we pursue will be consistent with our public health priorities.  We note 
that the range of potential enforcement tools for menu labeling is the same as for other 
misbranding actions under the FD&C Act; we did not receive any new enforcement tools 
specifically for menu labeling.   
 
6.3.  If a covered establishment misunderstands the requirements and needs to make a 
correction, is there a grace period in which to make the correction (e.g., 90 days or 
our next menu printing)? 
 
Answer:  The menu labeling final rule does not specify a grace period for covered 
establishments to make corrections to menus or menu boards.  If or when we become aware of 
menus or menu boards that are not in compliance, we will work flexibly and cooperatively with 
individual establishments making a good-faith effort to comply with the law, and will work with 
an establishment on an appropriate time-frame in which to make the correction.  Additionally, as 
discussed in Q&A 6.2, our typical enforcement strategy for labeling violations is to raise any 
compliance concerns with the most responsible person (e.g., the manager or owner) at a covered 
establishment during a close-out inspection meeting or in regulatory meetings with that 
establishment.   
 
7. Determining Nutrient Content for Standard Menu Items 
 
7.1.  We are a covered establishment that sells hot rotisserie chicken and prepared 
vegetables.  We have two different suppliers and the nutrition information is slightly 
different for the items from each supplier due to natural variation of the food.  How 
should we determine the calorie and nutrient information for our standard menu 
items?   
 
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Answer:  The menu labeling rule requires a covered establishment to have reasonable basis for 
its nutrient declarations (21 CFR 101.11(c)(1)), which provides flexibility for a covered 
establishment to take such natural variation into account when determining the calorie content 
and calorie declaration for a standard menu item.  You should take reasonable steps to determine 
calorie and nutrition information for standard menu items that may vary slightly due to natural 
variation.  We understand that the calorie content of non-uniform menu items, such as pieces of 
chicken, prepared vegetables, or whole fruit (e.g., whole apple or whole banana) vary depending 
on the size (e.g., different sized apples, bananas, or baked potatoes) and other factors, such as the 
composition of the items (e.g., chicken breast, thigh, or drumstick) or the growing conditions of 
the fruits and vegetables.  This natural variation can be taken into account as a part of your 
reasonable basis when determining your calorie counts and other nutrition information for your 
standard menu items as they are usually offered and prepared in your establishment.  For 
example, the calorie and other nutrient declarations could be based on the average values 
obtained when comparing the nutrient values of the food from different suppliers or from the 
same supplier when variations are known.   
 
7.2.  Am I required to conduct laboratory analysis to determine the nutritional content of 
my standard menu items?  If not, what are examples of a reasonable basis to 
determine the nutritional content of my standard menu items? 
 
Answer:  No.  You are not required to conduct laboratory analysis to determine the nutritional 
content of your standard menu items.  While laboratory analysis of standard menu items would 
be considered a reasonable basis for determining calorie and other nutrient information for your 
standard menu items, this is not the only reasonable basis permitted.  You may use any one of a 
number of means to arrive at these values, including: 
 
  Calculations based on nutrient databases such as the USDA National Nutrient Database 
for Standard Reference (http://ndb.nal.usda.gov/ndb/foods), or valid and appropriate trade 
association or industry databases (with or without computer software programs);  
  Calculations based on the Alcohol and Tobacco Tax and Trade Bureaus (TTBs) 
methods for determining values for the voluntary Statements of Average Analysis and 
voluntary Serving Facts statements;   
  Values listed in a cookbook;  
  Laboratory analysis of your menu items; or  
  Other reasonable means such as:  
  Use of Nutrition Facts on the labels of packaged foods that comply with the 
nutrition labeling requirements of section 403(q)(1) of the FD&C Act and 21 CFR 
101.9;  
  FDAs nutrient values for raw fruits and vegetables (Appendix C of 21 CFR part 
101; or  
  FDAs nutrient values for cooked fish (Appendix D of 21 CFR part 101).  
 
7.3.  Am I required to store the information on the reasonable basis on the premises of 
my covered establishment?   
 
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Answer:  No.  The reasonable basis information is not required to be stored on your premises.  
You may choose to maintain these records at the covered establishment or you may maintain the 
information at your corporate headquarters (if you have one) or some other location, for the 
duration of the time that the standard menu items are offered for sale at the covered establishment.  
Upon request and within a reasonable period of time, you must supply to FDA the information used 
to substantiate the required calorie and nutrient values that you use for your standard menu items 
listed on your menus, menu boards or on display, and for your written nutrition information (21 CFR 
101.11(c)(3)).  This information must include both the data and the method you used to derive these 
nutrient values, as specified in 21 CFR 101.11(c)(3).  We consider a reasonable period of time to be 
about 4-6 weeks after the request is made. 
 
7.4.  How often does a covered establishment have to recalculate their nutrition 
information for standard menu items? 
 
Answer:  A covered establishment should not need to recalculate nutrition information for menu 
items that stay the same (for example, a classic menu item such as a staple fried chicken recipe).  
In this instance, the establishment could rely on a one-time calculation, as long as that nutrition 
information remains accurate and consistent with the specific basis used to determine nutrient 
values (21 CFR 101.11(c)(2)).  Recalculation of the nutrition information would only be 
necessary if there are changes to the recipe or preparation of a standard menu item that would 
result in a change in the calorie declaration or other nutrition information.  In addition, Q&A 7.1 
provides additional information on how to calculate the calorie and nutrient information if you 
have multiple ingredient suppliers that have slightly different nutrition information due to natural 
variation. 
 
8. Covered Establishments  
 
8.1.  If establishments, which may be independently franchised, are doing business under 
the same name, selling restaurant-type food, and participate together in a marketing 
alliance (for example, independent grocery stores that participate in a marketing 
alliance, such as Bobs Co-op Grocery and Sallys Co-op Grocery, or independent 
convenience stores that have a branded fuel contract and sell gas under the same 
branded name, such as AMP gasoline), but do not sell substantially the same menu 
items from location to location, are they covered by the menu labeling 
requirements? 
 
Answer:  No.  If establishments do not sell substantially the same menu items from location to 
location, then those establishments would not be covered by the menu labeling final rule because 
they do not meet the definition of a covered establishment (21 CFR 101.11(a) and 21 U.S.C. 
343(q)(5)(H)(i)).  To be covered under the menu labeling requirements, an establishment must 
meet all 4 criteria of a covered establishment (as defined in the menu labeling final rule (21 CFR 
101.11(a))) or voluntarily register with FDA.  The menu labeling final rule defines a covered 
establishment as a restaurant or similar retail food establishment that meets the 4 criteria below: 
 
  Have 20 or more locations (with the term location referring to a fixed position or site); 
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  Be doing business under the same name (regardless of the type of ownership, such as 
individual franchises).  When the term name refers to the name of the establishment 
presented to the public, the term same includes names that are slight variations of each 
other, due to things such as the region, location, or size (e.g., ABC and ABC 
Express); 
  Sell substantially the same menu items; and 
  Sell restaurant-type foods (defined, in part, as food that is usually eaten on the premises, 
while walking away, or soon after arriving at another location).  
 
While the establishments may meet some of these requirements, where these types of marketing 
alliances or independent convenience stores that participate in branded fuel contracts do not offer 
for sale substantially the same menu items, they are not covered by the menu labeling final rule 
unless they choose to voluntarily register with FDA. 
 
8.2.  I am a convenience store that sells gas under a brand name; however, my 
convenience store operates under a different name (e.g., Bobs Corner Market).  
Am I a covered establishment because I am selling gas under a brand name that has 
more than 20 locations? 
 
Answer:  No.  As discussed in Q&A 8.1, in order to be covered under the menu labeling 
requirements, an establishment must meet all 4 criteria of a covered establishment (as defined in 
the menu labeling final rule (21 CFR 101.11(a))) or voluntarily register with FDA.  In this 
situation, we would consider the convenience store to be doing business under the name Bobs 
Corner Market.  If there are less than 20 Bobs Corner Markets, then this convenience store 
would not be covered under the menu labeling requirements in this example because it does not 
meet all 4 criteria of a covered establishment (e.g., does not have 20 or more locations).  If 
Bobs Corner Market does have 20 or more locations doing business under the same name, but 
does not offer substantially the same menu items from location to location, then this convenience 
store would also not be covered under the menu labeling requirements because it does not meet 
all 4 criteria of a covered establishment (i.e., not selling essentially the same menu items). 
 
8.3.  I am a convenience store that participates in a branded fuel contract and sells gas 
under that brand name (e.g., AMP Gasoline), and I do not have a separate name for 
my convenience store.  AMP Gasoline has at least 20 locations.  My convenience 
store has fewer than 20 locations, and it sells substantially the same menu items at 
all of its locations.  However, other convenience stores that are associated with AMP 
Gasoline do not sell substantially the same menu items as my store.  Am I a covered 
establishment because I am selling gas under a brand name that has 20 or more 
locations? 
 
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Answer:  No.  Menu labeling requirements apply to chain restaurants and similar retail food 
establishments that meet the definition of a covered establishment in 21 CFR 101.11(a).  As 
discussed in Q&A 8.1, in order to be covered under the menu labeling requirements, an 
establishment must meet all 4 criteria of a covered establishment (as defined in the menu 
labeling final rule (21 CFR 101.11(a))) or voluntarily register with FDA.  Your convenience 
store has fewer than 20 locations selling substantially the same menu items, so it does not meet 
the criteria for a covered establishment.  
 
In this example where the convenience store is attached to AMP Gasoline (and AMP Gasoline 
has at least 20 locations), whether the convenience store is a covered establishment under the 
menu labeling rule, or not, will depend on whether that convenience store is selling substantially 
the same menu items as other convenience stores attached to other AMP Gasoline locations.  The 
menu labeling final rule defines offering for sale substantially the same menu items, in part 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.  Although 
these establishments may be selling similar menu items, if they are not using the same general 
recipe and the menu items are not prepared in substantially the same way, then it is unlikely that 
these establishments are selling substantially the same menu items and these establishments are 
likely not covered.  This means that if your convenience store happens to offer menu items such 
as a hot dog sold off a roller or a coffee bar selection, common offerings in convenience stores 
generally, your operation is not transformed into a covered establishment by virtue of simply 
offering for sale items that are common in these types of stores generally.  To be covered, these 
items would need to be prepared in substantially the same way (for example, using the same 
standard procedures) and using the same general recipe with substantially the same food 
components across AMP Gasoline convenience store locations.        
 
9. Standard Menu Items 
 
9.1.  Are menu items that are not sold in more than 20 locations of a chain, but are 
standard menu items at one or more locations of that particular chain, covered 
under the menu labeling requirements?  
 
Answer:  Yes.  If a covered establishment is offering for sale a restaurant-type food that is 
routinely included on their menu or menu board or routinely offered as a self-service food or 
food on display at only one location, that item is covered under the menu labeling requirements 
because it meets the definition of a standard menu item, and thus calorie and other nutrition 
information is required (21 CFR 101.11(b)(2)(i)(A)).  For example, if one Tennessee location of 
a covered chain routinely offers a Memphis BBQ Sandwich on its menu or menu board or as a 
self-serve food or food on display, it meets the definition of a standard menu item at that 
location, even though it is not offered in any other location.  Thus, the sandwich would be 
covered under 21 CFR 101.11 and calorie and other nutrition information would be required.  
However, the menu labeling requirements do build in flexibility by exempting items that are 
daily specials, temporary/seasonal food, and food that is part of a customary market test, such 
that these items are not required to have calorie labeling (21 CFR 101.11(b)(1)(ii)(A)(1)).   
 
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9.2.  I am a covered establishment and I offer several unique items on my menu that are 
not offered in any of the other establishments within my chain.  For example, if I 
routinely sell crab cakes at only 15 of my 30 establishments, do I have to provide 
nutrition information on the crab cakes?  
 
Answer:  Yes.  See response to Q&A 9.1. 
 
9.3.  I am a covered establishment, and as part of my unique business model I offer 
Chef Creations that use extra produce as it becomes available from our produce 
department, so the ingredients routinely change and often on a daily basis.  Am I 
required to declare calories for these menu items? 
 
Answer:  No, so long as the item is not routinely offered.  The menu labeling final rule has built-
in flexibility to accommodate these specific situations by exempting items that are daily specials, 
temporary/seasonal food, and food that is part of a customary market test, such that these items 
are not required to have calorie labeling.  Thus, if the ingredients of a prepared food item vary 
depending on what ingredients a covered establishment happens to have available, the item may 
not meet the definition of a 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, for example, cabbage and tomato 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 a 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 soups ingredients differ daily.  This example 
could be applied to other examples like chicken salad.  If grapes are added to the chicken salad 
one day because of a surplus in the produce department, and grapes are not normally part of this 
standard menu item, then the chicken salad with added grapes would not meet the definition of a 
standard menu item on that day.  However, as noted above, if the establishment begins to 
routinely offer chicken salad with grapes, then that item would likely meet the definition of a 
standard menu item and would have to declare calorie and other nutrition information.   
 
10.  Alcohol 
 
10.1.  I am a covered establishment.  I list various alcoholic beverages (e.g., beers, wines, 
distilled spirits, and drinks made with distilled spirits) on my menu or menu board, 
some of which I rotate regularly to feature local or seasonal items throughout the 
year (e.g., pumpkin beer in the fall).  Am I required to declare calories for the 
alcoholic beverages listed on my menu or menu board that I offer at my 
establishment? 
 
Answer:  It depends.  For alcoholic beverages that are listed on your menu or menu board and 
meet the definition of a standard menu item, you must declare the calories and other nutrition 
information for these standard menu items (21 CFR 101.11(b)(2)(i)(A)).  This requirement also 
applies to beers that are on tap if they are also listed on your menu or menu board.  Depending 
on how these alcoholic beverage selections are listed on your menu or menu board, declaring the 
calories in a range may be appropriate. 
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However, for alcoholic beverages that are served on tap and not listed on your menu or menu 
board, these beverages are considered foods on display.  Alcoholic beverages that are foods on 
display and are not self-serve are exempt from the menu labeling requirements (21 CFR 
101.11(b)(1)(ii)(B)).  For example, beers that are served on tap, including local craft brews and 
regular offerings that are served by a bartender or another employee, would not require calorie 
and other nutrition labeling.  
 
In addition, alcoholic beverages that are listed on your menu or menu board for less than a total 
of 60 days per calendar year (e.g., pumpkin beer offered in the fall) meet the definition of a 
temporary menu item and, therefore, are exempt from menu labeling requirements (21 CFR 
101.11(b)(1)(ii)(A)).   
 
10.2.  I am a covered establishment that lists on my menu or menu board alcoholic 
beverages (e.g., beer, wine, distilled spirits, and drinks made with distilled spirits) 
that do not supply the nutritional information for their beverages.  In this situation, 
is laboratory testing my only option for figuring out nutrition information for these 
beverages? 
 
Answer:  The final rule requires an establishment to have a reasonable basis for its nutrient 
content declarations.  The final rule does not require an establishment to use a particular method 
or approach to determine nutritional content.  For example, the reasonable basis you use to 
determine the nutrient content of your standard menu items that are alcoholic beverages could 
include calculations based on nutrient databases (e.g., industry generated databases or the USDA 
National Nutrient Database for Standard Reference); calculations based on the ingredients and 
processing of the products; calculations based on TTBs methods for determining nutrient values 
for voluntary Statements of Average Analysis and voluntary Serving Facts statements; or other 
reasonable basis.  You could also use laboratory analysis as your reasonable basis; however, 
laboratory analysis is simply one of many methods  rather than the only method  that could be 
used. 
 
Further, as part of your reasonable basis, if you do not expect that a nutrient would be present in 
your food based on the ingredients and processing techniques used (e.g., many beers will not 
have fat or cholesterol) then this may be considered as part of your reasonable basis in 
determining nutrient values and laboratory analysis would not be required.   
 
Additionally, for items like alcoholic beverages where 6 or more of the required nutrients will be 
declared as zero, you have additional flexibility in how you present the additional written 
nutrition information, such as using the simplified format.  The simplified format must be 
presented in a column, list, or table, and in accordance with 21 CFR 101.11(b)(2)(ii)(B). 
 
11.  References 
 
1.  Letter from National Grocers Association to Commissioner Ostroff, dated March 28, 
2017. 
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2.  Letter from National Association of Convenience Stores to Secretary Tom Price, dated 
February 24, 2017. 
3.  Letter from Food Marketing Institute (FMI), National Association of Convenience Stores 
(NACS), National Association of Truck Stop Operators (NATSO), Society of 
Independent Gasoline Marketers of America (SIGMA) to Dominic J. Mancini, dated 
February 10, 2017. 
4.  Letter from Members of Congress to Secretary Tom Price, dated April 7, 2017. 
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