Document ID: FDA-2011-F-0172-0617
Agency: fda
Document Type: Rule
Title: 21 CFR Part 101 Food Labeling CFR Correction
Posted Date: 2016-11-23T05:00Z

[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Rules and Regulations]
[Pages 84459-84465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

Food Labeling

CFR Correction

0
In Title 21 of the Code of Federal Regulations, Parts 100 to 169, 
revised as of April 1, 2016, on page 50, Sec.  101.11 is added to read 
as follows:

Sec.  101.11  Nutrition Labeling of Standard Menu Items in Covered 
Establishments

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for purposes of this section:
    Authorized official of a restaurant or similar retail food 
establishment means the owner, operator, agent in charge, or other 
person authorized by the owner, operator, or agent in charge to 
register the restaurant or similar retail food establishment, which is 
not otherwise subject to section 403(q)(5)(H) of the Federal Food, 
Drug, and Cosmetic Act, with FDA for the purposes of paragraph (d) of 
this section.
    Combination meal means a standard menu item that consists of more 
than one food item, for example a meal that includes a sandwich, a side 
dish, and a drink. A combination meal may be represented on the menu or 
menu board in narrative form, numerically, or pictorially. Some 
combination meals may include a variable menu item or be a variable 
menu item as defined in this paragraph where the components may vary. 
For example, the side dish may vary among several options (e.g., fries, 
salad, or onion rings) or the drinks may vary (e.g., soft drinks, milk, 
or juice) and the customer selects which of these items will be 
included in the meal.
    Covered establishment means a restaurant or similar retail food 
establishment that is a part of a chain with 20 or more locations doing 
business under the same name (regardless of the type of ownership, 
e.g., individual franchises) and offering for sale substantially the 
same menu items, as well as a restaurant or similar retail food 
establishment that is registered to be covered under paragraph (d) of 
this section.
    Custom order means a food order that is prepared in a specific 
manner based on an individual customer's request, which requires the 
covered establishment to deviate from its usual preparation of a 
standard menu item, e.g., a club sandwich without the bacon if the 
establishment usually includes bacon in its club sandwich.
    Daily special means a menu item that is prepared and offered for 
sale on a particular day, that is not routinely listed on a menu or 
menu board or offered by the covered establishment, and that is 
promoted by the covered establishment as a special menu item for that 
particular day.
    Doing business under the same name means sharing the same name. The 
term ``name'' refers to either:
    (i) The name of the establishment presented to the public; or
    (ii) If there is no name of the establishment presented to the 
public (e.g., an establishment with the generic descriptor ``concession 
stand''), the name of the parent entity of the establishment. When the 
term ``name'' refers to the name of the establishment presented to the 
public under paragraph (i) of this definition, the term ``same'' 
includes names that are slight variations

[[Page 84460]]

of each other, for example, due to the region, location, or size (e.g., 
``New York Ave. Burgers'' and ``Pennsylvania Ave. Burgers'' or ``ABC'' 
and ``ABC Express'').
    Food on display means restaurant-type food that is visible to the 
customer before the customer makes a selection, so long as there is not 
an ordinary expectation of further preparation by the consumer before 
consumption.
    Food that is part of a customary market test means food that 
appears on a menu or menu board for less than 90 consecutive days in 
order to test consumer acceptance of the product.
    Location means a fixed position or site.
    Menu or menu board means the primary writing of the covered 
establishment from which a customer makes an order selection, 
including, but not limited to, breakfast, lunch, and dinner menus; 
dessert menus; beverage menus; children's menus; other specialty menus; 
electronic menus; and menus on the Internet. Determining whether a 
writing is or is part of the primary writing of the covered 
establishment from which a customer makes an order selection depends on 
a number of factors, including whether the writing lists the name of a 
standard menu item (or an image depicting the standard menu item) and 
the price of the standard menu item, and whether the writing can be 
used by a customer to make an order selection at the time the customer 
is viewing the writing. The menus may be in different forms, e.g., 
booklets, pamphlets, or single sheets of paper. Menu boards include 
those inside a covered establishment as well as drive-through menu 
boards at covered establishments.
    Offering for sale substantially the same menu items means offering 
for sale a significant proportion of menu items that use the same 
general recipe and are prepared in substantially the same way with 
substantially the same food components, even if the name of the menu 
item varies, (e.g., ``Bay View Crab Cake'' and ``Ocean View Crab 
Cake''). ``Menu items'' in this definition refers to food items that 
are listed on a menu or menu board or that are offered as self-service 
food or food on display. Restaurants and similar retail food 
establishments that are part of a chain can still be offering for sale 
substantially the same menu items if the availability of some menu 
items varies within the chain. Having the same name may indicate, but 
does not necessarily guarantee, that menu items are substantially the 
same.
    Restaurant or similar retail food establishment means a retail 
establishment that offers for sale restaurant-type food, except if it 
is a school as defined by 7 CFR 210.2 or 220.2.
    Restaurant-type food means food that is:
    (i) Usually eaten on the premises, while walking away, or soon 
after arriving at another location; and
    (ii) Either:
    (A) Served in restaurants or other establishments in which food is 
served for immediate human consumption or which is sold for sale or use 
in such establishments; or
    (B) Processed and prepared primarily in a retail establishment, 
ready for human consumption, of the type described in paragraph (ii)(A) 
of this definition, and offered for sale to consumers but not for 
immediate human consumption in such establishment and which is not 
offered for sale outside such establishment.
    Self-service food means restaurant-type food that is available at a 
salad bar, buffet line, cafeteria line, or similar self-service 
facility and that is served by the customers themselves. Self-service 
food also includes self-service beverages.
    Standard menu item means a restaurant-type food that is routinely 
included on a menu or menu board or routinely offered as a self-service 
food or food on display.
    Temporary menu item means a food that appears on a menu or menu 
board for less than a total of 60 days per calendar year. The 60 days 
includes the total of consecutive and non-consecutive days the item 
appears on the menu.
    Variable menu item means a standard menu item that comes in 
different flavors, varieties, or combinations, and is listed as a 
single menu item.
    (b) Requirements for nutrition labeling for food sold in covered 
establishments--(1) Applicability. (i) The labeling requirements in 
this paragraph (b) apply to standard menu items offered for sale in 
covered establishments.
    (ii)(A) The labeling requirements in this paragraph (b) do not 
apply to foods that are not standard menu items, including:
    (1) Items such as condiments that are for general use, including 
those placed on the table or on or behind the counter; daily specials; 
temporary menu items; custom orders; food that is part of a customary 
market test; and
    (2) Self-service food and food on display that is offered for sale 
for less than a total of 60 days per calendar year or fewer than 90 
consecutive days in order to test consumer acceptance.
    (B) The labeling requirements of paragraph (b)(2)(iii) of this 
section do not apply to alcoholic beverages that are foods on display 
and are not self-service foods.
    (2) Nutrition information. (i) Except as provided by paragraph 
(b)(2)(i)(A)(8) of this section, the following must be provided on 
menus and menu boards:
    (A) The number of calories contained in each standard menu item 
listed on the menu or menu board, as usually prepared and offered for 
sale. In the case of multiple-serving standard menu items, this means 
the calories declared must be for the whole menu item listed on the 
menu or menu board as usually prepared and offered for sale (e.g., 
``pizza pie: 1600 cal''); or per discrete serving unit as long as the 
discrete serving unit (e.g., pizza slice) and total number of discrete 
serving units contained in the menu item are declared on the menu or 
menu board, and the menu item is usually prepared and offered for sale 
divided in discrete serving units (e.g., ``pizza pie: 200 cal/slice, 8 
slices''). The calories must be declared in the following manner:
    (1) The number of calories must be listed adjacent to the name or 
the price of the associated standard menu item, in a type size no 
smaller than the type size of the name or the price of the associated 
standard menu item, whichever is smaller, in the same color, or a color 
at least as conspicuous as that used for the name of the associated 
standard menu item, and with the same contrasting background or a 
background at least as contrasting as that used for the name of the 
associated standard menu item.
    (2) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories, 
except that amounts less than 5 calories may be expressed as zero.
    (3) The term ``Calories'' or ``Cal'' must appear as a heading above 
a column listing the number of calories for each standard menu item or 
adjacent to the number of calories for each standard menu item. If the 
term ``Calories'' or ``Cal'' appears as a heading above a column of 
calorie declarations, the term must be in a type size no smaller than 
the smallest type size of the name or price of any menu item on that 
menu or menu board in the same color or a color at least as conspicuous 
as that used for that name or price and in the same contrasting 
background or a background at least as contrasting as that used for 
that name or price. If the term ``Calories'' or ``Cal'' appears 
adjacent to the number of calories for the standard menu item, the term 
``Calories'' or ``Cal''

[[Page 84461]]

must appear in the same type size and in the same color and contrasting 
background as the number of calories.
    (4) Additional requirements that apply to each individual variable 
menu item:
    (i) When the menu or menu board lists flavors or varieties of an 
entire individual variable menu item (such as soft drinks, ice cream, 
doughnuts, dips, and chicken that can be grilled or fried), the 
calories must be declared separately for each listed flavor or variety. 
Where flavors or varieties have the same calorie amounts (after 
rounding in accordance with paragraph (b)(2)(i)(A)(2) of this section), 
the calorie declaration for such flavors or varieties can be listed as 
a single calorie declaration adjacent to the flavors or varieties, 
provided that the calorie declaration specifies that the calorie amount 
listed represents the calorie amounts for each individual flavor or 
variety.
    (ii) When the menu or menu board does not list flavors or varieties 
for an entire individual variable menu item, and only includes a 
general description of the variable menu item (e.g., ``soft drinks''), 
the calories must be declared for each option with a slash between the 
two calorie declarations where only two options are available (e.g., 
``150/250 calories'') or as a range in accordance with the requirements 
of paragraph (b)(2)(i)(A)(7) of this section where more than two 
options are available (e.g., ``100-250 calories'').
    (iii) When the menu or menu board describes flavors or varieties 
for only part of an individual variable menu item (such as different 
types of cheese offered in a grilled cheese sandwich (e.g., ``Grilled 
Cheese (Cheddar or Swiss)''), the calories must be declared for each 
option with a slash between the two calorie declarations where only two 
options are available (e.g., ``450/500 calories'') or as a range in 
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this 
section where more than two options are available (e.g., ``450-550 
calories'').
    (5) Additional requirements that apply to a variable menu item that 
is offered for sale with the option of adding toppings listed on the 
menu or menu board. When the menu or menu board lists toppings that can 
be added to a menu item (such as pizza or ice cream):
    (i) The calories must be declared for the basic preparation of the 
menu item as listed (e.g., ``small pizza pie,'' ``single scoop ice 
cream'').
    (ii) The calories must be separately declared for each topping 
listed on the menu or menu board (e.g., pepperoni, sausage, green 
peppers, onions on pizza; fudge, almonds, sprinkles on ice cream), 
specifying that the calories are added to the calories contained in the 
basic preparation of the menu item. Where toppings have the same 
calorie amounts (after rounding in accordance with paragraph 
(b)(2)(i)(A)(2) of this section), the calorie declaration for such 
toppings can be listed as a single calorie declaration adjacent to the 
toppings, provided that the calorie declaration specifies that the 
calorie amount listed represents the calorie amount for each individual 
topping.
    (iii) The calories for the basic preparation of the menu item must 
be declared for each size of the menu item. The calories for each 
topping listed on the menu or menu board must be declared for each size 
of the menu item, or declared using a slash between the two calorie 
declarations for each topping where only two sizes of the menu item are 
available (e.g., ``adds 150/250 cal'') or as a range for each topping 
in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of 
this section where more than two sizes of the menu item are available 
(e.g., ``adds 100-250 cal''). If a slash between two calorie 
declarations or a range of calorie declarations is used, the menu or 
menu board must indicate that the variation in calories for each 
topping arises from the size of the menu item to which the toppings are 
added.
    (iv) If the amount of the topping included on the basic preparation 
of the menu item decreases based on the total number of toppings 
ordered for the menu item (such as is sometimes the case with pizza 
toppings), the calories for each topping must be declared as single 
values representing the calories for each topping when added to a one-
topping menu item, specifying that the calorie declaration is for the 
topping when added to a one-topping menu item.
    (6) Additional requirements that apply to a combination meal. 
Except as provided in paragraph (b)(2)(i)(A)(6)(iv) of this section:
    (i) When the menu or menu board lists two options for menu items in 
a combination meal (e.g., a sandwich with a side salad or chips), the 
calories must be declared for each option with a slash between the two 
calorie declarations (e.g., ``350/450 calories'').
    (ii) When the menu or menu board lists three or more options for 
menu items in a combination meal (e.g., a sandwich with chips, a side 
salad, or fruit), the calories must be declared as a range in 
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this 
section (e.g., ``350-500 calories'').
    (iii) When the menu or menu board includes a choice to increase or 
decrease the size of a combination meal, the calorie difference must be 
declared for the increased or decreased size with a slash between two 
calorie declarations (e.g., ``Adds 100/150 calories,'' ``Subtracts 100/
150 calories'') if the menu or menu board lists two options for menu 
items in the combination meal, or as a range in accordance with the 
requirements of paragraph (b)(2)(i)(A)(7) of this section (e.g., ``Adds 
100-250 calories,'' ``Subtracts 100-250 calories'') if the menu or menu 
board lists three or more options for menu items in the combination 
meal.
    (iv) Where the menu or menu board describes an opportunity for a 
consumer to combine standard menu items for a special price 
(e.g.,''Combine Any Sandwich with Any Soup or Any Salad for $8.99''), 
and the calories for each standard menu item, including each size 
option as described in paragraph (b)(2)(i)(A)(6)(iii) of this section 
if applicable, available for the consumer to combine are declared 
elsewhere on the menu or menu board, the requirements of paragraphs 
(b)(2)(i)(A)(6)(i), (ii), and (iii) of this section do not apply.
    (7) Additional format requirements for declaring calories for an 
individual variable menu item, a combination meal, and toppings as a 
range, if applicable. Calories declared as a range must be in the 
format ``xx-yy,'' where ``xx'' is the caloric content of the lowest 
calorie variety, flavor, or combination, and ``yy'' is the caloric 
content of the highest calorie variety, flavor, or combination.
    (8) Exception for a variable menu item that has no clearly 
identifiable upper bound to the range of calories: If the variable menu 
item appears on the menu or menu board and is a 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 menu item, whichever is smaller, and 
in the same color or a color at least as conspicuous as that used for 
that name or price, with the same contrasting background or a 
background at least as contrasting as that used for that name or price.
    (9) Additional requirements that apply to beverages that are not 
self-service. For beverages that are not self-service, calories must be 
declared based

[[Page 84462]]

on the full volume of the cup served without ice, unless the covered 
establishment ordinarily dispenses and offers for sale a standard 
beverage fill (i.e., a fixed amount that is less than the full volume 
of the cup per cup size) or dispenses a standard ice fill (i.e., a 
fixed amount of ice per cup size). If the covered establishment 
ordinarily dispenses and offers for sale a standard beverage fill or 
dispenses a standard ice fill, the covered establishment must declare 
calories based on such standard beverage fill or standard ice fill.
    (B) The following statement designed to enable consumers to 
understand, in the context of a total daily diet, the significance of 
the calorie information provided on menus and menu boards: ``2,000 
calories a day is used for general nutrition advice, but calorie needs 
vary.'' For menus and menu boards targeted to children, the following 
options may be used as a substitute for or in addition to the succinct 
statement: ``1,200 to 1,400 calories a day is used for general 
nutrition advice for children ages 4 to 8 years, but calorie needs 
vary.'' or ``1,200 to 1,400 calories a day is used for general 
nutrition advice for children ages 4 to 8 years and 1,400 to 2,000 
calories a day for children ages 9 to 13 years, but calorie needs 
vary.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type 
size of any calorie declaration appearing on the same menu or menu 
board and in the same color or in a color at least as conspicuous as 
that used for the calorie declarations and with the same contrasting 
background or a background at least as contrasting as that used for the 
calorie declarations.
    (2) For menus, this statement must appear on the bottom of each 
page of the menu. On menu pages that also bear the statement required 
by paragraph (b)(2)(i)(C) of this section, this statement must appear 
immediately above, below, or beside the statement required by paragraph 
(b)(2)(i)(C) of this section.
    (3) For menu boards, this statement must appear on the bottom of 
the menu board, immediately above, below, or beside the statement 
required by paragraph (b)(2)(i)(C) of this section.
    (C) The following statement regarding the availability of the 
additional written nutrition information required in paragraph 
(b)(2)(ii) of this section must be on all forms of the menu or menu 
board: ``Additional nutrition information available upon request.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type 
size of any calorie declaration appearing on the same menu or menu 
board and in the same color or in a color at least as conspicuous as 
that used for the caloric declarations, and with the same contrasting 
background or a background at least as contrasting as that used for the 
caloric declarations.
    (2) For menus, the statement must appear on the bottom of the first 
page with menu items immediately above, below, or beside the succinct 
statement required by paragraph (b)(2)(i)(B) of this section.
    (3) For menu boards, the statement must appear on the bottom of the 
menu board immediately above, below, or beside the succinct statement 
required by paragraph (b)(2)(i)(B) of this section.
    (ii) The following nutrition information for a standard menu item 
must be available in written form on the premises of the covered 
establishment and provided to the customer upon request. This nutrition 
information must be presented in the order listed and using the 
measurements listed, except as provided in paragraph (b)(2)(ii)(B) of 
this section. Rounding of these nutrients must be in compliance with 
Sec.  101.9(c). The information must be presented in a clear and 
conspicuous manner, including using a color, type size, and contrasting 
background that render the information likely to be read and understood 
by the ordinary individual under customary conditions of purchase and 
use. Covered establishments may use the abbreviations allowed for 
Nutrition Facts for certain packaged foods in Sec.  
101.9(j)(13)(ii)(B):
    (A)(1) Total calories (cal);
    (2) Calories from fat (fat cal);
    (3) Total fat (g);
    (4) Saturated fat (g);
    (5) Trans fat (g);
    (6) Cholesterol (mg);
    (7) Sodium (mg);
    (8) Total carbohydrate (g);
    (9) Dietary fiber (g);
    (10) Sugars (g); and
    (11) Protein (g).
    (B) If a standard menu item contains insignificant amounts of all 
the nutrients required to be disclosed in paragraph (b)(2)(ii)(A) of 
this section, the establishment is not required to include nutrition 
information regarding the standard menu item in the written form. 
However, if the covered establishment makes a nutrient content claim or 
health claim, the establishment is required to provide nutrition 
information on the nutrient that is the subject of the claim in 
accordance with Sec.  101.10. For standard menu items that contain 
insignificant amounts of six or more of the required nutrients, the 
declaration of nutrition information required by paragraph 
(b)(2)(ii)(A) of this section may be presented in a simplified format.
    (1) An insignificant amount is defined as that amount that allows a 
declaration of zero in nutrition labeling, except that for total 
carbohydrates, dietary fiber, and protein, it must be an amount that 
allows a declaration of ``less than one gram.''
    (2) The simplified format must include information, in a column, 
list, or table, on the following nutrients:
    (i) Total calories, total fat, total carbohydrates, protein, and 
sodium; and
    (ii) Calories from fat, and any other nutrients identified in 
paragraph (b)(2)(ii)(A) of this section that are present in more than 
insignificant amounts.
    (3) If the simplified format is used, the statement ``Not a 
significant source of __'' (with the blank filled in with the names of 
the nutrients required to be declared in the written nutrient 
information and calories from fat that are present in insignificant 
amounts) must be included at the bottom of the list of nutrients.
    (C) For variable menu items, the nutrition information listed in 
paragraph (b)(2)(ii)(A) of this section must be declared as follows for 
each size offered for sale:
    (1) The nutrition information required in paragraph (b)(2)(ii)(A) 
of this section must be declared for the basic preparation of the item 
and, separately, for each topping, flavor, or variable component.
    (2) Additional format requirements for toppings if the amount of 
the topping included on the basic preparation of the menu item 
decreases based on the total number of toppings ordered for the menu 
item (such as is sometimes the case with pizza toppings). The nutrients 
for such topping must be declared as single values representing the 
nutrients for each topping when added to a one-topping menu item, 
specifying that the nutrient declaration is for the topping when added 
to a one-topping menu item.
    (3) If the calories and other nutrients are the same for different 
flavors, varieties, and variable components of the combination meal, 
each variety, flavor, and variable component of the combination meal is 
not required to be listed separately. All items that have the same 
nutrient values could be listed together with the nutrient values 
listed only once.
    (D) The written nutrition information required in paragraph 
(b)(2)(ii)(A) of this section may be provided on a counter card, sign, 
poster, handout, booklet, loose leaf binder, or electronic device

[[Page 84463]]

such as a computer, or in a menu, or in any other form that similarly 
permits the written declaration of the required nutrient content 
information for all standard menu items. If the written nutrition 
information is not in a form that can be given to the customer upon 
request, it must be readily available in a manner and location on the 
premises that allows the customer/consumer to review the written 
nutrition information upon request.
    (iii) The following must be provided for a standard menu item that 
is self-service or on display.
    (A) Calories per displayed food item (e.g., a bagel, a slice of 
pizza, or a muffin), or if the food is not offered for sale in a 
discrete unit, calories per serving (e.g., scoop, cup), and the serving 
or discrete unit used to determine the calorie content (e.g., ``per 
scoop'' or ``per muffin'') on either: A sign adjacent to and clearly 
associated with the corresponding food; (e.g., ``150 calories per 
scoop); a sign attached to a sneeze guard with the calorie declaration 
and the serving or unit used to determine the calorie content above 
each specific food so that the consumer can clearly associate the 
calorie declaration with the food, except that if it is not clear to 
which food the calorie declaration and serving or unit refers, then the 
sign must also include the name of the food, e.g., ``Broccoli and 
cheese casserole--200 calories per scoop''; or a single sign or placard 
listing the calorie declaration for several food items along with the 
names of the food items, so long as the sign or placard is located 
where a consumer can view the name, calorie declaration, and serving or 
unit of a particular item while selecting that item.
    (1) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
displayed food item''; means per each discrete unit offered for sale, 
for example, a bagel, a slice of pizza, or a muffin.
    (2) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
serving'' means, for each food:
    (i) Per serving instrument used to dispense the food offered for 
sale, provided that the serving instrument dispenses a uniform amount 
of the food (e.g., a scoop or ladle);
    (ii) If a serving instrument that dispenses a uniform amount of 
food is not used to dispense the food, per each common household 
measure (e.g., cup or tablespoon) offered for sale or per unit of 
weight offered for sale, e.g., per quarter pound or per 4 ounces; or
    (iii) Per total number of fluid ounces in the cup in which a self-
service beverage is served and, if applicable, the description of the 
cup size (e.g., ``140 calories per 12 fluid ounces (small)'').
    (3) The calories must be declared in the following manner:
    (i) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories 
except that amounts less than 5 calories may be expressed as zero.
    (ii) If the calorie declaration is provided on a sign with the 
food's name, price, or both, the calorie declaration, accompanied by 
the term ``Calories'' or ``Cal'' and the amount of the serving or 
displayed food item on which the calories declaration is based must be 
in a type size no smaller than the type size of the name or price of 
the menu item whichever is smaller, in the same color, or a color that 
is at least as conspicuous as that used for that name or price, using 
the same contrasting background or a background at least as contrasting 
as that used for that name or price. If the calorie declaration is 
provided on a sign that does not include the food's name, price, or 
both, the calorie declaration, accompanied by the term ``Calories'' or 
``Cal'' and the amount of the serving or displayed food item on which 
the calorie declaration is based must be clear and conspicuous.
    (iii) For self-service beverages, calorie declarations must be 
accompanied by the term ``fluid ounces'' and, if applicable, the 
description of the cup size (e.g., ``small,'' ``medium'').
    (B) For food that is self-service or on display and is identified 
by an individual sign adjacent to the food itself where such sign meets 
the definition of a menu or menu board under paragraph (a) of this 
section, the statement required by paragraph (b)(2)(i)(B) of this 
section and the statement required by paragraph (b)(2)(i)(C) of this 
section. These two statements may appear on the sign adjacent to the 
food itself; on a separate, larger sign, in close proximity to the food 
that can be easily read as the consumer is making order selections; or 
on a large menu board that can be easily read as the consumer is 
viewing the food.
    (C) The nutrition information in written form required by paragraph 
(b)(2)(ii) of this section, except for packaged food insofar as it 
bears nutrition labeling information required by and in accordance with 
paragraph (b)(2)(ii) of this section and the packaged food, including 
its label, can be examined by a consumer before purchasing the food.
    (c) Determination of nutrient content. (1) A covered establishment 
must have a reasonable basis for its nutrient declarations. Nutrient 
values may be determined by using nutrient databases (with or without 
computer software programs), cookbooks, laboratory analyses, or other 
reasonable means, including the use of Nutrition Facts on labels on 
packaged foods that comply with the nutrition labeling requirements of 
section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act and Sec.  
101.9, FDA nutrient values for raw fruits and vegetables in Appendix C 
of this part, or FDA nutrient values for cooked fish in Appendix D of 
this part.
    (2) Nutrient declarations for standard menu items must be accurate 
and consistent with the specific basis used to determine nutrient 
values. A covered establishment must take reasonable steps to ensure 
that the method of preparation (e.g., types and amounts of ingredients, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (3) A covered establishment must provide to FDA, within a 
reasonable period of time upon request, information substantiating 
nutrient values including the method and data used to derive these 
nutrient values. This information must include the following:
    (i) For nutrient databases:
    (A) The name and version (including the date of the version) of the 
database, and, as applicable, the name of the applicable software 
company and any Web site address for the database. The name and version 
of a database would include the name and version of the computer 
software, if applicable;
    (B) The recipe or formula used as a basis for the nutrient 
declarations;
    (C)(1) Information on:
    (i) The amount of each nutrient that the specified amount of each 
ingredient identified in the recipe contributes to the menu item; and
    (ii) How the database was used including calculations or operations 
(e.g., worksheets or computer printouts) to determine the nutrient 
values for the standard menu items;
    (2) If the information in paragraph (c)(3)(i)(C)(1) of this section 
is not available, certification attesting that the database will 
provide accurate results when used appropriately and that the database 
was used in accordance with its instructions;
    (D) A detailed listing (e.g., printout) of the nutrient values 
determined for each standard menu item.
    (E) Any other information pertinent to the final nutrient values of 
the standard menu item (e.g., information about what might cause slight 
variations in the

[[Page 84464]]

nutrient profile such as moisture variations);
    (F) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (G) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (ii) For published cookbooks that contain nutritional information 
for recipes in the cookbook:
    (A) The name, author, and publisher of the cookbook used;
    (B) If available, information provided by the cookbook or from the 
author or publisher about how the nutrition information for the recipes 
was obtained;
    (C) A copy of the recipe used to prepare the standard menu item and 
a copy of the nutrition information for that standard menu item as 
provided by the cookbook; and
    (D) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined. (Recipes may be divided as necessary to accommodate 
differences in the portion size derived from the recipe and that are 
served as the standard menu item but no changes may be made to the 
proportion of ingredients used.)
    (iii) For laboratory analyses:
    (A) A copy of the recipe for the standard menu item used for the 
nutrient analysis;
    (B) The name and address of the laboratory performing the analysis;
    (C) Copies of analytical worksheets, including the analytical 
method, used to determine and verify nutrition information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (iv) For nutrition information provided by other reasonable means:
    (A) A detailed description of the means used to determine the 
nutrition information;
    (B) A recipe or formula used as a basis for the nutrient 
determination;
    (C) Any data derived in determining the nutrient values for the 
standard menu item, e.g., nutrition information about the ingredients 
used with the source of the nutrient information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (d) Voluntary registration to be subject to the menu labeling 
requirements--(1) Applicability. A restaurant or similar retail food 
establishment that is not part of a chain with 20 or more locations 
doing business under the same name and offering for sale substantially 
the same menu items may voluntarily register to be subject to the 
requirements established in this section. Restaurants and similar 
retail food establishments that voluntarily register will no longer be 
subject to non-identical State or local nutrition labeling 
requirements.
    (2) Who may register? The authorized official of a restaurant or 
similar retail food establishment as defined in paragraph (a) of this 
section, which is not otherwise subject to paragraph (b) of this 
section, may register with FDA.
    (3) What information is required? Authorized officials for 
restaurants and similar retail food establishments must provide FDA 
with the following information on Form FDA 3757:
    (i) The contact information (including name, address, phone number, 
and email address) for the authorized official;
    (ii) The contact information (including name, address, phone 
number, and email address) of each restaurant or similar retail food 
establishment being registered, as well as the name and contact 
information for an official onsite, such as the owner or manager, for 
each specific restaurant or similar retail food establishment;
    (iii) All trade names the restaurant or similar retail food 
establishment uses;
    (iv) Preferred mailing address (if different from location address 
for each establishment) for purposes of receiving correspondence; and
    (v) Certification that the information submitted is true and 
accurate, that the person submitting it is authorized to do so, and 
that each registered restaurant or similar retail food establishment 
will be subject to the requirements of section 403(q)(5)(H) of the 
Federal Food, Drug, and Cosmetic Act and this section.
    (4) How to register. Authorized officials of restaurants and 
similar retail food establishments who elect to be subject to 
requirements in section 403(q)(5)(H) of the Federal Food, Drug, and 
Cosmetic Act can register by visiting http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm217762.htm. FDA has 
created a form (Form 3757) that contains fields requesting the 
information in paragraph (d)(3) of this section and made the form 
available at this Web site. Registrants must use this form to ensure 
that complete information is submitted.
    (i) Information should be submitted by email by typing complete 
information into the form (PDF), saving it on the registrant's 
computer, and sending it by email to menulawregistration@fda.hhs.gov.
    (ii) If email is not available, the registrant can either fill in 
the form (PDF) and print it out (or print out the blank PDF and fill in 
the information by hand or typewriter), and either fax the completed 
form to 301-436-2804 or mail it to FDA, CFSAN Menu and Vending Machine 
Registration, White Oak Building 22, Rm. 0209, 10903 New Hampshire 
Ave., Silver Spring, MD 20993.
    (5) When to renew the registration. To keep the establishment's 
registration active, the authorized official of the restaurant or 
similar retail food establishment must register every other year within 
60 days prior to the expiration of the establishment's current 
registration with FDA. Registration will automatically expire if not 
renewed.
    (e) Signatures. Signatures obtained under paragraph (d) of this 
section that

[[Page 84465]]

meet the definition of electronic signatures in Sec.  11.3(b)(7) of 
this chapter are exempt from the requirements of part 11 of this 
chapter.
    (f) Misbranding. A standard menu item offered for sale in a covered 
establishment shall be deemed misbranded under sections 201(n), 403(a), 
403(f) and/or 403(q) of the Federal Food, Drug, and Cosmetic Act if its 
label or labeling is not in conformity with paragraph (b) or (c) of 
this section.

[79 FR 71253, Dec. 1, 2014]

[FR Doc. 2016-28367 Filed 11-22-16; 8:45 am]
 BILLING CODE 1301-00-D