Food Labeling, 84459-84465 [2016-28367]
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Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Rules and Regulations
ethnological material representing
Greece’s Byzantine culture
(approximately the 4th century through
the 15th century A.D.); and made the
necessary determinations to extend the
import restrictions for an additional five
years. Diplomatic notes have been
exchanged, reflecting the extension of
those restrictions for an additional fiveyear period. Accordingly, CBP is
amending 19 CFR 12.104g(a) to reflect
this extension of the import restrictions.
The Designated List archaeological
materials representing Greece’s cultural
heritage from the Upper Paleolithic
(beginning approximately 20,000 B.C.)
through the 15th century A.D., and
ecclesiastical ethnological material
representing Greece’s Byzantine culture
(approximately the 4th century through
the 15th century A.D.) covered by these
import restrictions is set forth in CBP
Dec. 11–25. The Agreement and
Designated List may also be found at the
following Internet Web site address:
https://eca.state.gov/cultural-heritagecenter/cultural-property-protection/
bilateral-agreements/greece.
The restrictions on the importation of
these archaeological and ecclesiastical
ethnological materials from Greece are
to continue in effect for an additional
five years. Importation of such material
continues to be restricted unless the
conditions set forth in 19 U.S.C. 2606
and 19 CFR 12.104c are met.
Inapplicability of Notice and Delayed
Effective Date
This amendment involves a foreign
affairs function of the United States and
is, therefore, being made without notice
or public procedure (5 U.S.C. 553(a)(1)).
In addition, CBP has determined that
such notice or public procedure would
be impracticable and contrary to the
public interest because the action being
taken is essential to avoid interruption
of the application of the existing import
restrictions (5 U.S.C. 553(b)(B)). For the
same reasons, a delayed effective date is
not required under 5 U.S.C. 553(d)(3).
Regulatory Flexibility Act
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Executive Order 12866
It has been determined that this rule
is not a significant regulatory action
under Executive Order 12866.
Signing Authority
This regulation is being issued in
accordance with 19 CFR 0.1(a)(1).
16:26 Nov 22, 2016
Amendment to CBP Regulations
For the reasons set forth above, part
12 of title 19 of the Code of Federal
Regulations (19 CFR part 12), is
amended as set forth below:
PART 12—SPECIAL CLASSES OF
MERCHANDISE
1. The general authority citation for
part 12 and the specific authority
citation for § 12.104g continue to read as
follows:
■
Authority: 5 U.S.C. 301; 19 U.S.C. 66,
1202 (General Note 3(i), Harmonized Tariff
Schedule of the United States (HTSUS)),
1624.
*
*
*
*
*
Sections 12.104 through 12.104i also
issued under 19 U.S.C. 2612;
*
*
§ 12.104g
*
*
*
[Amended]
2. In § 12.104g, paragraph (a), the table
is amended in the entry for Greece
(Hellenic Republic) by adding after the
phrase ‘‘CBP Dec. 11–25’’ the phrase
‘‘extended by CBP Dec. 16- 21’’.
■
R. Gil Kerlikowske,
Commissioner, U.S. Customs and Border
Protection.
Approved: November 21, 2016.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 2016–28355 Filed 11–21–16; 4:15 pm]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
Food Labeling
CFR Correction
In Title 21 of the Code of Federal
Regulations, Parts 100 to 169, revised as
of April 1, 2016, on page 50, § 101.11 is
added to read as follows:
■
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply.
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List of Subjects in 19 CFR Part 12
Cultural property, Customs duties and
inspection, Imports, Prohibited
merchandise.
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§ 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
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84459
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
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of each other, for example, due to the
region, location, or size (e.g., ‘‘New York
Ave. Burgers’’ and ‘‘Pennsylvania Ave.
Burgers’’ or ‘‘ABC’’ and ‘‘ABC
Express’’).
Food on display means restauranttype food that is visible to the customer
before the customer makes a selection,
so long as there is not an ordinary
expectation of further preparation by the
consumer before consumption.
Food that is part of a customary
market test means food that appears on
a menu or menu board for less than 90
consecutive days in order to test
consumer acceptance of the product.
Location means a fixed position or
site.
Menu or menu board means the
primary writing of the covered
establishment from which a customer
makes an order selection, including, but
not limited to, breakfast, lunch, and
dinner menus; dessert menus; beverage
menus; children’s menus; other
specialty menus; electronic menus; and
menus on the Internet. Determining
whether a writing is or is part of the
primary writing of the covered
establishment from which a customer
makes an order selection depends on a
number of factors, including whether
the writing lists the name of a standard
menu item (or an image depicting the
standard menu item) and the price of
the standard menu item, and whether
the writing can be used by a customer
to make an order selection at the time
the customer is viewing the writing. The
menus may be in different forms, e.g.,
booklets, pamphlets, or single sheets of
paper. Menu boards include those
inside a covered establishment as well
as drive-through menu boards at
covered establishments.
Offering for sale substantially the
same menu items means offering for sale
a significant proportion of menu items
that use the same general recipe and are
prepared in substantially the same way
with substantially the same food
components, even if the name of the
menu item varies, (e.g., ‘‘Bay View Crab
Cake’’ and ‘‘Ocean View Crab Cake’’).
‘‘Menu items’’ in this definition refers to
food items that are listed on a menu or
menu board or that are offered as selfservice food or food on display.
Restaurants and similar retail food
establishments that are part of a chain
can still be offering for sale substantially
the same menu items if the availability
of some menu items varies within the
chain. Having the same name may
indicate, but does not necessarily
guarantee, that menu items are
substantially the same.
Restaurant or similar retail food
establishment means a retail
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establishment that offers for sale
restaurant-type food, except if it is a
school as defined by 7 CFR 210.2 or
220.2.
Restaurant-type food means food that
is:
(i) Usually eaten on the premises,
while walking away, or soon after
arriving at another location; and
(ii) Either:
(A) Served in restaurants or other
establishments in which food is served
for immediate human consumption or
which is sold for sale or use in such
establishments; or
(B) Processed and prepared primarily
in a retail establishment, ready for
human consumption, of the type
described in paragraph (ii)(A) of this
definition, and offered for sale to
consumers but not for immediate
human consumption in such
establishment and which is not offered
for sale outside such establishment.
Self-service food means restauranttype food that is available at a salad bar,
buffet line, cafeteria line, or similar selfservice facility and that is served by the
customers themselves. Self-service food
also includes self-service beverages.
Standard menu item means a
restaurant-type food that is routinely
included on a menu or menu board or
routinely offered as a self-service food
or food on display.
Temporary menu item means a food
that appears on a menu or menu board
for less than a total of 60 days per
calendar year. The 60 days includes the
total of consecutive and nonconsecutive days the item appears on
the menu.
Variable menu item means a standard
menu item that comes in different
flavors, varieties, or combinations, and
is listed as a single menu item.
(b) Requirements for nutrition labeling
for food sold in covered
establishments—(1) Applicability. (i)
The labeling requirements in this
paragraph (b) apply to standard menu
items offered for sale in covered
establishments.
(ii)(A) The labeling requirements in
this paragraph (b) do not apply to foods
that are not standard menu items,
including:
(1) Items such as condiments that are
for general use, including those placed
on the table or on or behind the counter;
daily specials; temporary menu items;
custom orders; food that is part of a
customary market test; and
(2) Self-service food and food on
display that is offered for sale for less
than a total of 60 days per calendar year
or fewer than 90 consecutive days in
order to test consumer acceptance.
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(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’’
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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;
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fudge, almonds, sprinkles on ice cream),
specifying that the calories are added to
the calories contained in the basic
preparation of the menu item. Where
toppings have the same calorie amounts
(after rounding in accordance with
paragraph (b)(2)(i)(A)(2) of this section),
the calorie declaration for such toppings
can be listed as a single calorie
declaration adjacent to the toppings,
provided that the calorie declaration
specifies that the calorie amount listed
represents the calorie amount for each
individual topping.
(iii) The calories for the basic
preparation of the menu item must be
declared for each size of the menu item.
The calories for each topping listed on
the menu or menu board must be
declared for each size of the menu item,
or declared using a slash between the
two calorie declarations for each
topping where only two sizes of the
menu item are available (e.g., ‘‘adds
150/250 cal’’) or as a range for each
topping in accordance with the
requirements of paragraph (b)(2)(i)(A)(7)
of this section where more than two
sizes of the menu item are available
(e.g., ‘‘adds 100–250 cal’’). If a slash
between two calorie declarations or a
range of calorie declarations is used, the
menu or menu board must indicate that
the variation in calories for each topping
arises from the size of the menu item to
which the toppings are added.
(iv) If the amount of the topping
included on the basic preparation of the
menu item decreases based on the total
number of toppings ordered for the
menu item (such as is sometimes the
case with pizza toppings), the calories
for each topping must be declared as
single values representing the calories
for each topping when added to a onetopping menu item, specifying that the
calorie declaration is for the topping
when added to a one-topping menu
item.
(6) Additional requirements that
apply to a combination meal. Except as
provided in paragraph (b)(2)(i)(A)(6)(iv)
of this section:
(i) When the menu or menu board
lists two options for menu items in a
combination meal (e.g., a sandwich with
a side salad or chips), the calories must
be declared for each option with a slash
between the two calorie declarations
(e.g., ‘‘350/450 calories’’).
(ii) When the menu or menu board
lists three or more options for menu
items in a combination meal (e.g., a
sandwich with chips, a side salad, or
fruit), the calories must be declared as
a range in accordance with the
requirements of paragraph (b)(2)(i)(A)(7)
of this section (e.g., ‘‘350–500 calories’’).
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(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 selfservice food or food on display, and
there is no clearly identifiable upper
bound to the range, e.g., all-you-can-eat
buffet, then the menu or menu board
must include a statement, adjacent to
the name or price of the item, referring
customers to the self-service facility for
calorie information, e.g., ‘‘See buffet for
calorie declarations.’’ This statement
must appear in a type size no smaller
than the type size of the name or price
of the variable menu item, whichever is
smaller, and in the same color or a color
at least as conspicuous as that used for
that name or price, with the same
contrasting background or a background
at least as contrasting as that used for
that name or price.
(9) Additional requirements that
apply to beverages that are not selfservice. For beverages that are not selfservice, calories must be declared based
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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
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any calorie declaration appearing on the
same menu or menu board and in the
same color or in a color at least as
conspicuous as that used for the caloric
declarations, and with the same
contrasting background or a background
at least as contrasting as that used for
the caloric declarations.
(2) For menus, the statement must
appear on the bottom of the first page
with menu items immediately above,
below, or beside the succinct statement
required by paragraph (b)(2)(i)(B) of this
section.
(3) For menu boards, the statement
must appear on the bottom of the menu
board immediately above, below, or
beside the succinct statement required
by paragraph (b)(2)(i)(B) of this section.
(ii) The following nutrition
information for a standard menu item
must be available in written form on the
premises of the covered establishment
and provided to the customer upon
request. This nutrition information must
be presented in the order listed and
using the measurements listed, except
as provided in paragraph (b)(2)(ii)(B) of
this section. Rounding of these nutrients
must be in compliance with § 101.9(c).
The information must be presented in a
clear and conspicuous manner,
including using a color, type size, and
contrasting background that render the
information likely to be read and
understood by the ordinary individual
under customary conditions of purchase
and use. Covered establishments may
use the abbreviations allowed for
Nutrition Facts for certain packaged
foods in § 101.9(j)(13)(ii)(B):
(A)(1) Total calories (cal);
(2) Calories from fat (fat cal);
(3) Total fat (g);
(4) Saturated fat (g);
(5) Trans fat (g);
(6) Cholesterol (mg);
(7) Sodium (mg);
(8) Total carbohydrate (g);
(9) Dietary fiber (g);
(10) Sugars (g); and
(11) Protein (g).
(B) If a standard menu item contains
insignificant amounts of all the
nutrients required to be disclosed in
paragraph (b)(2)(ii)(A) of this section,
the establishment is not required to
include nutrition information regarding
the standard menu item in the written
form. However, if the covered
establishment makes a nutrient content
claim or health claim, the establishment
is required to provide nutrition
information on the nutrient that is the
subject of the claim in accordance with
§ 101.10. For standard menu items that
contain insignificant amounts of six or
more of the required nutrients, the
declaration of nutrition information
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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
ll’’ (with the blank filled in with the
names of the nutrients required to be
declared in the written nutrient
information and calories from fat that
are present in insignificant amounts)
must be included at the bottom of the
list of nutrients.
(C) For variable menu items, the
nutrition information listed in
paragraph (b)(2)(ii)(A) of this section
must be declared as follows for each
size offered for sale:
(1) The nutrition information required
in paragraph (b)(2)(ii)(A) of this section
must be declared for the basic
preparation of the item and, separately,
for each topping, flavor, or variable
component.
(2) Additional format requirements for
toppings if the amount of the topping
included on the basic preparation of the
menu item decreases based on the total
number of toppings ordered for the
menu item (such as is sometimes the
case with pizza toppings). The nutrients
for such topping must be declared as
single values representing the nutrients
for each topping when added to a onetopping menu item, specifying that the
nutrient declaration is for the topping
when added to a one-topping menu
item.
(3) If the calories and other nutrients
are the same for different flavors,
varieties, and variable components of
the combination meal, each variety,
flavor, and variable component of the
combination meal is not required to be
listed separately. All items that have the
same nutrient values could be listed
together with the nutrient values listed
only once.
(D) The written nutrition information
required in paragraph (b)(2)(ii)(A) of this
section may be provided on a counter
card, sign, poster, handout, booklet,
loose leaf binder, or electronic device
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such as a computer, or in a menu, or in
any other form that similarly permits
the written declaration of the required
nutrient content information for all
standard menu items. If the written
nutrition information is not in a form
that can be given to the customer upon
request, it must be readily available in
a manner and location on the premises
that allows the customer/consumer to
review the written nutrition information
upon request.
(iii) The following must be provided
for a standard menu item that is selfservice or on display.
(A) Calories per displayed food item
(e.g., a bagel, a slice of pizza, or a
muffin), or if the food is not offered for
sale in a discrete unit, calories per
serving (e.g., scoop, cup), and the
serving or discrete unit used to
determine the calorie content (e.g., ‘‘per
scoop’’ or ‘‘per muffin’’) on either: A
sign adjacent to and clearly associated
with the corresponding food; (e.g., ‘‘150
calories per scoop); a sign attached to a
sneeze guard with the calorie
declaration and the serving or unit used
to determine the calorie content above
each specific food so that the consumer
can clearly associate the calorie
declaration with the food, except that if
it is not clear to which food the calorie
declaration and serving or unit refers,
then the sign must also include the
name of the food, e.g., ‘‘Broccoli and
cheese casserole—200 calories per
scoop’’; or a single sign or placard
listing the calorie declaration for several
food items along with the names of the
food items, so long as the sign or
placard is located where a consumer can
view the name, calorie declaration, and
serving or unit of a particular item while
selecting that item.
(1) For purposes of paragraph
(b)(2)(iii)(A) of this section, ‘‘per
displayed food item’’; means per each
discrete unit offered for sale, for
example, a bagel, a slice of pizza, or a
muffin.
(2) For purposes of paragraph
(b)(2)(iii)(A) of this section, ‘‘per
serving’’ means, for each food:
(i) Per serving instrument used to
dispense the food offered for sale,
provided that the serving instrument
dispenses a uniform amount of the food
(e.g., a scoop or ladle);
(ii) If a serving instrument that
dispenses a uniform amount of food is
not used to dispense the food, per each
common household measure (e.g., cup
or tablespoon) offered for sale or per
unit of weight offered for sale, e.g., per
quarter pound or per 4 ounces; or
(iii) Per total number of fluid ounces
in the cup in which a self-service
beverage is served and, if applicable, the
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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
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84463
declarations. Nutrient values may be
determined by using nutrient databases
(with or without computer software
programs), cookbooks, laboratory
analyses, or other reasonable means,
including the use of Nutrition Facts on
labels on packaged foods that comply
with the nutrition labeling requirements
of section 403(q)(1) of the Federal Food,
Drug, and Cosmetic Act and § 101.9,
FDA nutrient values for raw fruits and
vegetables in Appendix C of this part, or
FDA nutrient values for cooked fish in
Appendix D of this part.
(2) Nutrient declarations for standard
menu items must be accurate and
consistent with the specific basis used
to determine nutrient values. A covered
establishment must take reasonable
steps to ensure that the method of
preparation (e.g., types and amounts of
ingredients, cooking temperatures) and
amount of a standard menu item offered
for sale adhere to the factors on which
its nutrient values were determined.
(3) A covered establishment must
provide to FDA, within a reasonable
period of time upon request,
information substantiating nutrient
values including the method and data
used to derive these nutrient values.
This information must include the
following:
(i) For nutrient databases:
(A) The name and version (including
the date of the version) of the database,
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
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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
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(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
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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 https://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
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meet the definition of electronic
signatures in § 11.3(b)(7) of this chapter
are exempt from the requirements of
part 11 of this chapter.
(f) Misbranding. A standard menu
item offered for sale in a covered
establishment shall be deemed
misbranded under sections 201(n),
403(a), 403(f) and/or 403(q) of the
Federal Food, Drug, and Cosmetic Act if
its label or labeling is not in conformity
with paragraph (b) or (c) of this section.
Provided, That the food bears no
nutrition claims or other nutrition
information in any context on the label
or in labeling or advertising. * * *
*
*
*
*
*
[FR Doc. 2016–28363 Filed 11–22–16; 8:45 am]
BILLING CODE 1301–00–D
84465
requirements for the claim. Presentation
of nutrition labeling may be in various
forms, including those provided in
§ 101.45 and other reasonable means.
[79 FR 71253, Dec. 1, 2014]
[FR Doc. 2016–28364 Filed 11–22–16; 8:45 am]
BILLING CODE 1301–00–D
[FR Doc. 2016–28367 Filed 11–22–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
21 CFR Part 101
[79 FR 71253, Dec. 1, 2014]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 330
BILLING CODE 1301–00–D
Food Labeling
21 CFR Part 101
§ 101.10 Nutrition labeling of restaurant
foods whose labels or labeling bear nutrient
content claims or health claims.
Food Labeling
CFR Correction
In Title 21 of the Code of Federal
Regulations, parts 100 to 169, revised as
of April 1, 2016, on pages 43 and 44, in
§ 101.9, paragraphs (j)(1)(i), (2)
introductory text, (3) introductory text,
and the first sentence of (j)(4) are
revised to read as follows. And, on page
50, the effective date note at the end of
§ 101.9 is removed.
■
Nutrition labeling of food.
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*
*
*
*
*
(j) * * *
(1)(i) Food offered for sale by a person
who makes direct sales to consumers
(e.g., a retailer) who has annual gross
sales made or business done in sales to
consumers that is not more than
$500,000 or has annual gross sales made
or business done in sales of food to
consumers of not more than $50,000,
Provided, That the food bears no
nutrition claims or other nutrition
information in any context on the label
or in labeling or advertising. Claims or
other nutrition information subject the
food to the provisions of this section,
§ 101.10, or § 101.11, as applicable.
*
*
*
*
*
(2) Except as provided in § 101.11,
food products that are:
*
*
*
*
*
(3) Except as provided in § 101.11,
food products that are:
*
*
*
*
*
(4) Except as provided in § 101.11,
foods that contain insignificant amounts
of all of the nutrients and food
components required to be included in
the declaration of nutrition information
under paragraph (c) of this section,
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Food and Drug Administration Review
and Action on Over-the-Counter Time
and Extent Applications
■
Food and Drug Administration
§ 101.9
RIN 0910–AH30
In Title 21 of the Code of Federal
Regulations, parts 100 to 169, revised as
of April 1, 2016, on page 50, § 101.10 is
revised to read as follows:.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2016–N–0543]
CFR Correction
Jkt 241001
Nutrition labeling in accordance with
§ 101.9 shall be provided upon request
for any restaurant food or meal for
which a nutrient content claim (as
defined in § 101.13 or in subpart D of
this part) or a health claim (as defined
in § 101.14 and permitted by a
regulation in subpart E of this part) is
made, except that information on the
nutrient amounts that are the basis for
the claim (e.g., ‘‘low fat, this meal
provides less than 10 grams of fat’’) may
serve as the functional equivalent of
complete nutrition information as
described in § 101.9. For the purposes of
this section, restaurant food includes
two categories of food. It includes food
which is served in restaurants or other
establishments in which food is served
for immediate human consumption or
which is sold for sale or use in such
establishments. It also includes food
which is processed and prepared
primarily in a retail establishment,
which is ready for human consumption,
which is of the type described in the
previous sentence, and which is offered
for sale to consumers but not for
immediate human consumption in such
establishment and which is not offered
for sale outside such establishment. For
standard menu items that are offered for
sale in covered establishments (as
defined in § 101.11(a)), the information
in the written nutrition information
required by § 101.11(b)(2)(ii)(A) will
serve to meet the requirements of this
section. Nutrient levels may be
determined by nutrient databases,
cookbooks, or analyses or by other
reasonable bases that provide assurance
that the food or meal meets the nutrient
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or Agency) is
amending its nonprescription (over-thecounter or OTC) drug regulations. This
final rule supplements the time and
extent application (TEA) process for
OTC drugs by establishing timelines and
performance metrics for FDA’s review of
non-sunscreen TEAs, as required by the
Sunscreen Innovation Act (SIA). It also
amends the existing TEA process to
include filing determination and
withdrawal provisions to make the TEA
process more efficient.
DATES: This rule is effective December
23, 2016.
ADDRESSES: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this final rule, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kristen Hardin, Center for Drug
Evaluation and Research (CDER), Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–402–4246, Kristen.Hardin@
fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose and Coverage of the Final Rule
B. Summary of the Major Provisions of the
Final Rule
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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 https://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
