establishments that provide the number of calories contained in
standard menu items will give consumers information that is useful in
selecting more healthful food choices. FDA recognizes that individual
daily caloric needs may differ based on several factors including
gender, age, and activity level (Ref. 9 at page 13). For this reason,
it is important that consumers be able to place the calorie
declarations in the context of their individual dietary needs. As
described in section I. B of this document, nutrition labeling on
packaged foods has been required for approximately 20 years, and
consumers are familiar with and use this information. The Nutrition
Facts on packaged foods uses 2,000 calories as a reference amount on
which to base recommended intake for macro- and micronutrients for
individuals 4 years of age and older (Sec.  101.9(c)(9)). A 2,000-
calorie reference value is close to the midpoint of the range of energy
requirements for sedentary adults (1,600-2,600 cals) (Ref. 9 at page
14).
    FDA initially proposed a reference value of 2,350 for the Nutrition
Facts (55 FR 29476 at 29486); in response to comments, however, FDA
selected 2,000 as the reference value in the 1993 final rule. As stated
in the preamble to the final rule: ``The rationale for selecting 2,000
calories as opposed to other lower values varied, but reasons given
included the fact that it is consistent with widely used food plans, it

approximates the caloric requirements for postmenopausal women who are
at-risk for excessive intake of calories and fat, and it is a ``rounded
down'' value for 2,350 calories.'' FDA also noted in the preamble to
the final rule that some comments noted that ``2,000 calories is easier
to use in quick, mental calculations compared to other calorie levels
such as 1,900 or 2,350 calories.'' 58 FR 2206 at 2217.
    FDA tentatively concludes that 2,000 calories is an appropriate
reference value to include in the succinct statement. However, not
everyone should eat 2,000 calories per day. Individual caloric needs
differ depending on various factors such as age, gender, and physical
activity. For example young children and sedentary adults may have
caloric needs below 2,000 calories (1,200-1,600 calories) whereas some
adult men and active adults of either sex may need more than 2,000
calories (2,200-3,200). Considering the statutory directive and current
nutrition advice (Ref. 9), FDA tentatively concludes that, to help
ensure that the succinct statement is designed to enable consumers to
understand, in the context of a total daily diet, the significance of
the calorie information provided on menus and menu boards, certain
principles should be met:
     The statement should be succinct;
     The statement should be in plain language that consumers
can understand;
     The total caloric value should be framed appropriately so
that it is not viewed as a recommendation for daily intake for every
consumer;
     The statement should give consumers a means to compare the
calorie declaration for a menu item to total calories and;
     The statement should inform consumers that individual
needs vary.
    Using these principles and considering suggestions from the
comments, FDA developed the following statements:
     ``Using 2,000 calories per day as a reference point,
consider how the menu item you select fits within your total daily
calorie needs, which may be higher or lower depending on age, physical
activity, gender.''
     ``A 2,000 calorie daily diet is used as a general
reference point for nutrition advice. Individual calorie needs vary
depending on age, physical activity, gender.''
     ``Typical daily caloric intake for women is 1,600 to 2,000
calories, for men is 2,000 to 3,000 calories and for children (ages 4
to 14) is 1,800 to 2,500 calories. Be sure to include the calories of
the menu item you select as a part of your total daily caloric
intake.'' \4\
---------------------------------------------------------------------------

    \4\ This statement was developed for focus group testing based
on the data upon which the 2,000 calorie reference value used in the
Nutrition Facts was derived. The aim was to test a data-derived
statement that provided specific calorie ranges for various
subpopulations. More recent data from the 2010 Dietary Guidelines
suggest that these ranges should be revised; however, the difference
in numbers does not impact the objective of testing the utility and
comprehension of the statement by the focus group participants.
---------------------------------------------------------------------------

    We have also included the following statement that was suggested
from comments because we tentatively concluded that the statement
satisfied the principles described above.
     ``A 2,000 calorie daily diet is used as the basis for
general nutrition advice; however, individual calorie needs may vary.''
    FDA concludes that the above statements satisfy the principles
developed by the Agency to ensure that the succinct statement is
designed to enable consumers to understand, in the context of a total
daily diet, the significance of the calorie information provided on
menus and menu boards. FDA seeks comment on the principles developed by
the agency, including whether all the principles are needed to help
consumers understand the significance of the calorie information
provided on menus and menu boards. In addition, we have concerns about
whether consumers will understand the statements, especially those
statements that use terms such as ``reference point,'' ``fits within,''
and ``calorie needs vary.''
    When deliberating on which of the four (4) bulleted statements
listed above should be required on menu and menu boards, FDA considered
the language in each statement, our previously noted concerns with
certain phrases, the availability of space on menu boards, and the
statutory directive regarding the succinct statement. Given these
considerations, we tentatively conclude that the statement that best
addresses these considerations is ``A 2,000 calorie daily diet is used
as the basis for general nutrition advice; however, individual calorie
needs may vary.'' We are proposing in Sec.  101.11(b)(2)(i)(B) to
require this statement be posted on menus and menu boards.
    FDA seeks comment on whether this proposed statement is adequately
designed to enable the public to understand, in the context of a total
daily diet, the significance of the caloric information provided on
menus and menu boards. FDA is particularly interested in comments with
alternative suggested statements that are consistent with the
principles identified above and requests that any such statements be
accompanied by data, such as consumer research.
    Some comments stated that FDA should consider a different succinct
statement on children's menus and reference the calorie needs for
children in specific age ranges. We seek comment on whether FDA should
require a different statement on menus that are targeted to children.
Such a statement may include language such as ``The daily caloric
intake for children ---- years of age is ---- to ---- depending on
whether they are boys or girls as well as their age and level of
physical activity.'' (The blanks are to be filled in with information
on current dietary guidelines.) Comments submitted to the agency on
whether a different statement should be required or recommended for
children's menus should provide a rationale, data (e.g. consumer
research), or other information supporting such statement. The agency
is particularly interested in any consumer research that demonstrates
that the statement is understood by consumers.
    We intend to conduct consumer research to evaluate consumer
response to these statements. FDA intends to make the results of our
consumer research available to the public prior to publication of the
final rule and to allow sufficient time for interested stakeholders to
comment on the results of our research.
    Section 4205 requires that the succinct statement be posted on
menus and menu boards prominently and in a clear and conspicuous
manner. We are proposing in Sec.  101.11(b)(2)(i)(B)(1) that the
required succinct statement appear in a type size no smaller than the
smallest type size for any calorie declaration appearing on the same
menu or menu board with the same color, or in a color at least as
conspicuous, as the caloric declaration and with the same contrasting
background as the caloric declarations. FDA is proposing in Sec.
101.11(b)(2)(i)(B)(2) that for menus, the succinct statement must
appear on the bottom of each page of the menu. On menu pages that also
bear the statement regarding the availability of the written nutrition
information described in section III.C.5. of this document, the
succinct statement must appear directly above that statement of
availability. FDA is proposing in Sec.  101.11(b)(2)(i)(B)(3) that the
succinct statement appear on the bottom of menu boards, directly above
the statement of availability. FDA tentatively concludes that these
requirements will help ensure that the succinct statement is prominent,
clear, and conspicuous, as required by sections 343(q)(5)(H)(ii)(I)(bb)
and (II)(bb) (21

U.S.C. 343(q)(5)(H)(ii)(I)(bb) and (II)(bb)).
5. Nutrition Information That Must Be Made Available in a Written Form
    Section 403(q)(5)(H)(ii)(III) requires that covered establishments
must provide, in a written form and upon consumer request, the
nutrition information required under clauses (C) and (D) of section
403(q)(1) of the FD&C Act. 21 U.S.C. 343(q)(5)(H)(ii)(III). The written
nutrition information must be available on the premises of the
establishment and the establishment must post on the menu or menu board
a prominent, clear and conspicuous statement regarding the availability
of the information (21 U.S.C. 343(q)(5)(H)(ii)(III) and (IV)). FDA
requests comment on interpreting the phrase ``on the premises'' for
menus appearing on the Internet.
    a. Statement of availability. Section 403(q)(5)(H)(ii)(IV) requires
that covered establishments post on menus and menu boards a prominent,
clear, and conspicuous statement regarding the availability of the
written nutrition information (21 U.S.C. 343(q)(5)(H)(ii)(IV)).
Therefore, FDA is proposing in Sec.  101.11(b)(2)(i)(C) to require the
following statement regarding the availability of the written form of
additional nutrition information proposed in Sec.  101.11(b)(2)(ii)(A)
on menus and menu boards in covered establishments:

    Additional nutrition information available upon request.

    FDA is also proposing in Sec.  101.11(b)(2)(i)(C) that this
statement (``statement of availability'') appear in a type size no
smaller than the smallest type size for any calorie declaration
appearing on the same menu or menu board, with the same prominence,
i.e., the same color, or in a color as least as conspicuous as and in
the same contrasting background as the calorie declarations. FDA is
proposing that for menus, the statement of availability must appear on
the bottom of the first page with menu items in the same type size and
font as the calorie declaration and must appear immediately below the
succinct statement proposed in Sec.  101.11(b)(2)(i)(B). For menus with
more than two (2) pages, the statement must appear either on every page
with menu item, or on the first page, so long as a symbol (e.g.,
asterisk) follows the term ``Calories'' or ``Cal'' where it first
appears on each subsequent page, clearly referring to the statement of
availability appearing on the first page of the menu. FDA is proposing
that the statement appear on the bottom of menu boards, immediately
below the succinct statement required in Sec.  101.11(b)(2)(i)(B). FDA
tentatively concludes that this manner of providing the statement of
availability will satisfy the requirements in amended section
403(q)(5)(H)(ii)(IV) that the statement be prominent, clear, and
conspicuous. We seek comment on whether the statement of availability
will adequately inform consumers about the availability of the written
nutrition information. In addition, we seek comment on whether the
placement, font, and background requirements are appropriate to ensure
that the statement of availability is prominent, clear, and
conspicuous.
    FDA recognizes that some restaurants or similar retail food
establishments have relatively few standard menu items, and, as a
result, may have menu boards that list relatively few items in very
large font. FDA requests comment on whether it is appropriate in these
cases to tie the font size of the two statements required to appear at
the bottom of menu board to the calorie disclosures.
    b. Required nutrients. Section 403(q)(5)(H)(ii)(III) specifies that
the written form must provide ``the nutrition information required
under clauses (C) and (D) of subparagraph (1) [21 U.S.C. 343(q)(1)(C)
and (D)],'' which require declaration of the following nutrition
information:
     The total number of calories derived from any source, and
the total number of calories derived from the total fat;
     The amount of each of the following nutrients: Total fat,
saturated fat, cholesterol, sodium, total carbohydrates, complex
carbohydrates, sugars, dietary fiber, and total protein.
    FDA is proposing in Sec.  101.11(b)(2)(ii)(A) to require that the
nutrition information in written form contain the information listed
above, with two changes. The nutrition labeling requirements under
sections 403(q)(1)(C) and (D) were added to the FD&C Act by NLEA and
are the nutrients originally required to be provided in the mandatory
nutrition information for packaged foods. FDA has since revised by
regulation the nutrients required to be provided on the label or
labeling of food in relevant part by removing the complex carbohydrates
requirement from section 403(q)(1)(D) and requiring that information
regarding the amount of trans fats be included in the label or labeling
of food subject to section 403(q)(1). FDA proposes to make analogous
revisions with respect to the written form required by section
403(q)(5)(H)(ii)(III). These are explained further below.
    In addition, we note that, because section 403(q)(5)(H)(ii)(IV)
refers only to clauses (C) and (D) of section 403(q)(1), covered
establishments are currently not required to provide the information
about vitamins and minerals required to be on the labels and labeling
of foods pursuant to clause (E) of section 403(q)(1).
    c. Removal of complex carbohydrates from the requirements of
403(q)(1)(D). Section 403(q)(2)(B), which was added to the FD&C Act by
NLEA, provides that ``[i]f the Secretary determines that the
information relating to a nutrient required by subparagraph (1)(C),
(1)(D), or (1)(E) or clause (A) of this subparagraph to be included in
the label or labeling of food is not necessary to assist consumers in
maintaining healthy dietary practices, the Secretary may by regulation
remove information relating to such nutrient from such requirement.''
Pursuant to this authority, FDA removed the requirement for bearing the
amount of complex carbohydrates in the label or labeling of food, based
on a determination that for complex carbohydrates ``there was no
consensus on a clear definition for the term `complex carbohydrates' as
it relates to physiological effects, health benefits, or dietary
guidelines,'' there was a ``lack of methods for reliably determining
the amounts present,'' and without a specific definition for ``complex
carbohydrates it [was] not possible to include quantitative information
in the nutrition label that would assist consumers in maintaining
healthy dietary practices.'' (58 FR 2079 at 2101, Jan. 26, 1993); See
Sec.  101.9(c)(1) (no regulation requiring that labeling bear nutrition
information regarding complex carbohydrates). Because the agency
removed the requirement that the label or labeling of food include
information regarding ``complex carbohydrates'' from section
403(q)(1)(D), declaration of complex carbohydrates is no longer a
requirement under section 403(q)(1)(D). As a result, this proposed rule
does not include complex carbohydrates among the nutrients that must be
included in the written form required to be available to consumers
under section 403(q)(5)(H)(ii)(III). FDA also received a comment
stating that FDA should not include complex carbohydrates in the
nutrition information in written form because, among other reasons, the
amount of complex carbohydrates is not required to be included on the
Nutrition Facts of packaged foods.
    d. Addition of trans fat to the requirements of
403(q)(5)(H)(ii)(III). Section 403(q)(5)(H)(vi) provides that ``if the
Secretary determines that a nutrient,

other than a nutrient required under [section 403(q)(5)(H)(ii)(III)],
should be disclosed for the purpose of providing information to assist
consumers in maintaining healthy dietary practices, the Secretary may
require, by regulation, declaration of such nutrient in the written
form'' (21 U.S.C. 343(q)(5)(H)(vi)). Similarly, section 403(q)(2)(A)
(21 U.S.C. 343(q)(2)(A)) provides that ``[i]f the Secretary determines
that a nutrient other than a nutrient required by subparagraph (1)(C),
(1)(D), or (1)(E) should be included in the label or labeling of food
subject to subparagraph (1) for [the] purposes of providing information
regarding the nutritional value of such food that will assist consumers
in maintaining healthy dietary practices, the Secretary may by
regulation require that information relating to such additional
nutrient to be included in the label or labeling of such food.'' 21
U.S.C. 343(q)(2)(A).
    In 2003, FDA amended its regulations on nutrition labeling, through
rulemaking (68 FR 41434, July 11, 2003), to require in Sec.
101.9(c)(2)(ii) that trans fatty acids be declared in the label or
labeling of conventional foods subject to section 403(q)(1) of the FD&C
Act. In that rulemaking, FDA determined that the current scientific
evidence consistently showed that trans fats are associated with
increased low density lipoprotein (LDL)-cholesterol levels and,
therefore, that lower intakes of both saturated and trans fats are
important dietary factors in reducing the risk of coronary heart
disease (CHD) in the general population and for those at increased risk
for CHD. Further, FDA stated that the current authoritative reports at
that time, such as the 2000 Dietary Guidelines for Americans (Ref. 24
at p. 30), recommended that Americans cut back or limit the intake of
trans fats. Thus, the agency concluded that persons interested in
following these recommendations and maintaining optimal LDL-cholesterol
levels must be able to determine levels of both saturated and trans
fats in food products. Information on saturated fat content was already
available in the Nutrition Facts on the labels of certain foods. The
agency determined that the most practical way to inform consumers of
the level of trans fat in these foods was for that information to be
included in the Nutrition Facts. In the time since the final rule on
trans fat labeling was published in 2003, the scientific evidence on
trans fat has continued to support the relationship between trans fat
and risk of CHD. Authoritative reports published since 2000 have
included recommendations on the reduction of intake of trans fat. For
example, the Institute of Medicine (IOM) has stated that trans fat
consumption should be kept as low as possible while consuming a
nutritionally adequate diet (Ref. 25). Additionally, the 2010 Dietary
Guidelines for Americans recommended that trans fat intake be as low as
possible (Ref. 9 at pp. x and 25). Therefore, for the same public
health reasons that supported the requirement that the amount of trans
fat be declared on the label or labeling of conventional foods subject
to 403(q)(1) of the FD&C Act, we are proposing to require covered
establishments to declare the amount of trans fat in standard menu
items in the written form required by section 403(q)(5)(H)(ii)(III).
    e. Nutrients in insignificant amounts. FDA recognizes that some
standard menu items may contain insignificant amounts of the nutrients
required to be disclosed in the written form. See 21 U.S.C.
343(q)(5)(H)(ii)(III). Section 403(q)(5)(C) of the FD&C Act states
that: `` * * * If a food contains insignificant amounts, as determined
by the Secretary, of all the nutrients required by subparagraphs (1)
and (2) to be listed in the label or labeling of food, the requirements
of such subparagraphs shall not apply to such food if the label,
labeling or advertising of such food does not make any claim with
respect to the nutritional value of such food. If a food contains
insignificant amounts, as determined by the Secretary, of more than
one-half the nutrients required by subparagraphs (1) and (2) to be in
the label or labeling of the food, the Secretary shall require the
amounts of such nutrients to be stated in a simplified form prescribed
by the Secretary.''
    As directed by this statutory provision, FDA determined that ``[a]n
`insignificant amount' shall be defined as that amount that allows a
declaration of zero in nutrition labeling, except that for total
carbohydrates, dietary fiber, and protein, it shall be an amount that
allows a declaration of ``less than 1 gram.'' Sec.  101.9(f)(1).
Further, FDA established regulations at Sec.  101.9(j)(4) that exempt
foods that contain insignificant amounts of all the nutrients required
to be included in the declaration of nutrition information on the label
and labeling of food, provided that the food bears no nutrition claims
or other nutrition information in any context on the label, labeling or
advertising. FDA tentatively concludes that if a standard menu item
contains insignificant amounts of all of the nutrients required to be
declared in the written form pursuant to section 403(q)(5)(H)(ii)(II)
(i.e., the nutrition information required under clauses (C) and (D) of
section 403(q)(1)), a covered establishment is not required to include
nutrition information regarding such food in the written form provided
that the food does not make a nutrient content claim as defined in
Sec.  101.13 or Subpart D of part 101 or a health claim as defined in
Sec.  101.13 and permitted by regulation in Subpart E in part 101.
    In addition, FDA established regulations at Sec.  101.9(f)(1) that
allow for the use of a simplified form of nutrition information
labeling if a food contains insignificant amounts of more than one-half
of the nutrients required to be disclosed in the label or labeling of
food in sections 403(q)(1) and (2) of the FD&C Act. Specifically, Sec.
101.9(f) provides that the declaration of nutrition information may be
presented in the simplified format, set forth in the regulation, when a
food contains insignificant amounts of eight (8) or more of the
following fourteen (14) nutrients: Calories, total fat, saturated fat,
trans fat, cholesterol, sodium, total carbohydrates, dietary fiber,
sugars, protein, vitamin A, vitamin C, calcium, and iron. In addition,
Sec.  101.9(f)(2)(i) requires that the simplified format must include
information on the following nutrients: Total calories, total fat,
total carbohydrate, protein, and sodium. In the preamble to the 1993
final rule on nutrition labeling for packaged food, FDA explained that
this nutrition information is ``essential to aid consumers in learning
about the relative nutritional qualities of all foods, and it allows
them to judge the consequences of the food selections they make.'' (58
FR 2079, 2142 (Jan. 6, 1993)).
    Section 4205 provides that section 403(q)(5)(C) shall apply to any
regulations promulgated by FDA regarding the written nutrition
information required by section 403(q)(5)(H)(ii)(II). However, section
403(q)(5)(C) and Sec.  101.9(f) address some nutrients that are not
required to be declared in the written nutrition information,
specifically vitamin A, vitamin C, calcium, and iron. A covered
establishments only is required to declare, in the written form, the
nutrition information required under clauses (C) and (D) of 403(q)(1),
which does not include vitamins and minerals. See 21 U.S.C.
343(q)(5)(H)(ii)(III). Consequently, at this time, FDA tentatively
concludes that a covered establishment is required only to declare, in
the written nutrition information, ten of the fourteen nutrients
specified in Sec.  101.9(f), specifically: Calories (derived from any

source, and derived from the total fat), total fat, saturated fat,
trans fat, cholesterol, sodium, total carbohydrates, dietary fiber,
sugars, and protein. As a result, FDA tentatively concludes that if a
standard menu item contains insignificant amounts of more than one-half
of the nutrients required to be declared in the written nutrition
information under proposed Sec.  101.11(b)(2)(ii)(A), this nutrition
information may be presented in a simplified format for that standard
menu item. FDA is proposing in Sec.  101.11(b)(2)(ii)(B) that the
written nutrition information for a standard menu item offered for sale
in a covered establishment may be presented in a simplified format when
the standard menu item contains insignificant amounts of six (6) or
more of the following ten (10) nutrients: Calories, total fat,
saturated fat, trans fat, cholesterol, sodium, total carbohydrates,
dietary fiber, sugars and protein. In addition, we are proposing that
the simplified format must include information on the nutrients
required in Sec.  101.9(f)(2)(i) and (ii) (i.e., total calories, total
fat, total carbohydrate, protein, and sodium). 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 appear following the written nutrition information. (See
example in section III.B.3.e. of this document.) FDA tentatively
concludes that this nutrition information is essential to aid consumers
in learning about the relative nutritional qualities of all foods, and
it allows them to judge the consequences of the food selections they
make.
    f. Standards for determining and disclosing the nutrient content of
foods for variable menu items. Section 403(q)(5)(H)(v) requires that
FDA establish, by regulation, standards for determining and disclosing
the nutrient content for standard menu items that come in different
flavors, varieties, or combinations, but which are listed as a single
menu item, such as soft drinks, ice cream, pizza, doughnuts, or
children's combination meals (21 U.S.C. 343(q)(5)(H)(v)) (proposed to
be called ``variable menu items''). Further, this section provides that
FDA may establish these standards through means determined by the
agency, including averages, ranges or other methods. Consequently, we
considered these means in developing standards for disclosing nutrition
information in the written form for standard variable menu items, as
well as the comments. FDA considered the following options:
    Option 1. List the nutrition information for each nutrient in the
variable menu item as a range.
    For example, nutrition information for a meal that consists of a
cheeseburger, side dish (fries or salad with fat-free dressing), and
medium soft drink (diet or regular) would be provided in a written form
that provides the following information:
     Total calories: 620-1,150 calories
     Calories from fat: 220-410 calories
     Total fat: 24-46 g
     Saturated fat: 8-15 g
     Trans fat: 0-1 g
     Cholesterol: 75-90 mg
     Sodium: 1,240-1,560 mg
     Total carbohydrates: 70-155 g
     Sugars: 21-66 g
     Dietary fiber: 4-7 g
     Protein: 29-34 g
    For variable menu items with variations that contain calorie
amounts and levels of nutrients that vary widely, this type of nutrient
declaration minimally assists consumers in maintaining healthy dietary
practices, since it does not provide them with a way to determine the
nutrient levels of the particular variations they are choosing between.
The consumer may not be able to determine how to make a selection to
get fewer of the nutrients the consumer wishes to avoid and more of the
nutrients that the consumer wants to consume.
    Option 2. List the nutrition information for each component in the
variable menu item.
    Using the example described above in option 1, for a meal that
consists of a cheeseburger, side dish (fries or salad with fat-free
dressing), and medium soft drink (diet or regular), under option 2, the
covered establishment would be required to provide information for the
required nutrients for each component of the meal, i.e., the
cheeseburger, the fries, the salad with fat-free dressing, a medium
soft drink, and a diet soft drink. The declaration may appear as
follows, which includes the proposed simplified formats for the medium
cola and diet cola:
    Cheeseburger:
     Total calories 470 calories
     Calories from fat 190 calories
     Total fat 21 g
     Saturated fat 8 g
     Trans fat 1 g
     Cholesterol 75 mg
     Sodium 880 mg
     Total carbohydrate 43 g
     Sugars 10 g
     Dietary fiber 2 g
     Protein 26 g
    Medium fries:
     Total calories 420 calories
     Calories from fat 180 calories
     Total fat 20 g
     Saturated fat 3.5 g
     Trans fat 0 g
     Cholesterol 0 mg
     Sodium 500 mg
     Total carbohydrate 54 g
     Sugars 0 g
     Dietary fiber 6 g
     Protein 5 g
    Garden salad with fat-free dressing:
     Total calories 150 calories
     Calories from fat 30 calories
     Total fat: 3 g
     Saturated fat 0 g
     Trans fat 0 g
     Cholesterol 0 mg
     Sodium 340 mg
     Total carbohydrate 27 g
     Sugars 11 g
     Dietary fiber 2 g
     Protein 3 g
    Medium Cola:
     Total calories 200 calories
     Total fat 0 g
     Sodium 5 mg
     Total carbohydrate 56 g
     Sugars 56 g
     Protein 0 g
     Not a significant source of calories from fat, saturated
fat, trans fat, cholesterol, and dietary fiber.
    Medium Diet Cola:
     Total calories 0 calories
     Total fat 0 g
     Sodium 40 mg
     Total carbohydrate 0 g
     Sugars 0 g
     Protein 0 g
     Not a significant source of calories from fat, saturated
fat, trans fat, cholesterol, and dietary fiber
    This option provides the consumer with all the required nutrient
information for each component of the combination meal in a format that
facilitates quick comparisons between different menu items. This option
also likely reduces duplication, particularly for combination meals,
since most items in combination meals are likely to be available as
individual standard menu items.
    In addition, when the nutrition information for different flavors,
varieties, or components of combinations are the same, the nutrition
information for these food items would need only be listed once, with
the food items grouped together. For example:
    Raspberry or Peach Flavored Iced Tea (14 ounces):
     Total calories 5 calories
     Total fat 0 g
     Sodium 15 mg
     Total carbohydrate 1 g
     Sugars 0 g
     Protein 0 g

     Not a significant source of calories from fat, saturated
fat, trans fat, cholesterol, and dietary fiber
    For some variable menu items, the number of possible variations is
so large that providing the nutrient information required in proposed
Sec.  101.11(b)(2)(ii)(A) in written form would be impractical if FDA
required the information to be disclosed for each conceivable option.
For example, a pizza with a choice among many toppings has a very large
number of possible permutations. FDA tentatively concludes that it is
more reasonable to require written nutrition information for the basic
preparation of the pizza (e.g., plain, deep- dish 12'' pizza) and then
provide the additional written nutrition information for each possible
topping. Therefore, FDA proposes that the nutrition information
required in Sec.  101.11(b)(2)(ii)(A) must be provided for the basic
preparation of the item and, separately, for each topping or other
variable component.
    Option 3. If a standard menu item only has two variations (e.g. a
sandwich with fruit or with fries), provide both numbers for each
nutrient in each option with a forward slash between (e.g. 450/700). If
three or more options are available, provide the range in calories. For
example, for a grilled chicken sandwich with either small fries or
fruit the nutrients would be declared as:
     Total calories: 450/700 calories
     Calories from fat: 70/200 calories
     Total fat: 7/23 g
     Saturated fat: 1.5/4.5 g
     Cholesterol: 90/90 mg
     Trans fat: 0/0 g
     Sodium: 1160/1430 mg
     Total carbohydrate 63/87 g
     Sugars 27/9 g
     Dietary fiber 3/6 g
     Protein 35/38 g
    This option could result in a mixed format within the written
nutrition information, i.e., two different types of declarations, one
with numbers separated by slashes and one with numbers separated by
dashes. We question whether this approach has the potential to be
confusing to consumers due to the mixed format and if consumers would
be able to distinguish that the nutrient declarations separated by a
slash represent the actual amount of nutrients in the two options and
that the nutrients declarations separated by a dash actually represents
a range of nutrients where the actual amount of nutrients for the item
they decide to choose could be anywhere within that range.
    For the reasons described above in this section, FDA tentatively
concludes that Option 2 provides the most direct and clear information
for consumers. Consequently, we are proposing in Sec.
101.11(b)(2)(ii)(C) that for foods that come in different varieties,
flavors, and combinations, the nutrient information in the written form
required in Sec.  101.11(b)(2)(ii)(A) must be declared for each
variety, flavor, and each food component of the combination meal. For
those foods that come in different varieties, flavors, and combinations
where the number of possible variations is so large that providing the
nutrition information in written form for each permutation would be
impractical (e.g., pizza, ice cream), FDA is proposing that the
nutrition information required in Sec.  101.11(b)(2)(ii)(A) must be
provided for the basic preparation of the item and, separately, for
each topping or other variable component. The nutrition information in
written form may also be provided for every possible variation. FDA
specifically requests comment on this proposed requirement as well as
alternatives that would provide clear, truthful, and non-misleading
information to the consumers about the specific food they purchase.
    FDA is also proposing that if the calories and other nutrients are
the same for different flavors, varieties, and each substitutable
component of the combination meal, each variety, flavor, and
substitutable component of the combination meal is not required to be
listed separately. All items that have the same nutrient levels could
be listed together with the nutrient levels listed only once.
    g. Format and manner for the written nutrition information. FDA is
proposing that the nutrition information must be presented in the order
listed in proposed Sec.  101.11(2)(ii) and that the information must be
presented in a clear and conspicuous manner.
    FDA is not proposing a specific manner for providing the written
nutrition information. Instead, FDA is proposing in Sec.
101.11(2)(ii)(D) that the written nutrition information may be provided
on a counter card, sign, poster, handout, loose leaf binder, booklet,
or electronic device, such as a computer, on a menu or in any other
material that similarly permits the declaration in written form of the
required nutrient content information for all standard menu items.
    FDA's proposed approach is consistent with the many comments that
stated that the manner in which the written nutrition information is
made available should be flexible. One comment recommended that the
written nutrition information should be made available electronically
at kiosks in lieu of paper copies. Some comments recommended that the
information appear on the register tape and others recommended that it
appear on the menus themselves. A few comments stated that the
information should be allowed on food wrappers or tray liners, while
one comment opposed the use of liners and wrappers, stating that the
information should be provided immediately prior to or at the point of
purchase. FDA would not object to the use of tray liners or wrappers to
be used as a means to provide nutrition information, as long as the
tray liners or wrappers are available upon request to the consumers,
and the tray liner or wrapper contains nutrition information for all
standard menu items offered for sale at the covered establishment.
    Another comment recommended that FDA provide additional nutrition
information in Spanish and other languages depending on the region of
the country in which the retail food establishment is located. FDA
would not object to covered establishments providing information in
other languages, in addition to English. FDA notes, however, that if
the information is provided in other languages, all of the required
information must be provided in that language. This is consistent with
labeling requirements for packaged foods, except that covered
establishments in Puerto Rico may provide the information in Spanish
only. Sec.  101.15(c).
    Unlike the statutory requirements about calorie declarations, which
must be placed on menus and menu boards, there is more opportunity for
the industry to determine how best to present the written nutrition
information. In determining how to present the nutrition information in
written form, a covered establishment might consider the extensiveness
of the menu and levels of technology capability, among other factors.
Allowing flexibility in meeting the requirements of this section is
consistent with the current regulation for nutrition labeling in
restaurant foods in Sec.  101.10, which permit the disclosure of
nutrition information for foods that bear nutrient content or health
claims by various means. We request comment on whether we should be
more prescriptive in the format and manner of the declarations in order
to ensure they are useful to consumers.
    In considering whether to require more specific formats, FDA is
particularly concerned with whether there are ways to provide
information to consumers with diseases related to obesity and being
overweight. For example, we seek comment on whether

FDA should require nutrients that are particularly important for
consumers with obesity and diabetes to monitor in order to maintain
healthy dietary practices (e.g., total calories, total fat, sodium,
sugar) to be bolded or placed in a separate table of nutritional
content. In addition, FDA requests comment on whether and how
additional written nutrition information should be required to be
available on the Internet, e.g., when a covered establishment provides
a menu on its Web site.
6. Requirements for Self-Service Food and Food on Display
    a. General requirements for self-service food and food on display.
Section 403(q)(5)(H)(iii) provides that calories per food item or per
serving must be disclosed for self-service food and food on display (21
U.S.C. 343(q)(5)(H)(iii)). Covered establishments must provide this
calorie information on a sign adjacent to each food offered.
    As discussed in section III.B. of this document, FDA proposes to
define ``food on display'' as food that is visible to the customer
before the customer makes an order selection. FDA is proposing to
define ``self-service food'' as food that is available at a salad bar,
buffet line, cafeteria line, or similar self-service facility, and
self-service beverages.
    b. Display of calories for self-service foods or foods on display.
Section 403(q)(5)(H)(i) and (iii) requires that covered establishments
place adjacent to each standard menu item that is a self-service food
and food on display a sign that lists calories per displayed food item
or per serving (21 U.S.C. 343(q)(5)(H)(i) and (iii)). Some comments
stated that for foods sold at salad bars or buffet lines, the calorie
information must be near each item, and not, for example, in a pamphlet
on or near the salad bar or buffet line. One comment asserted that the
placement of signs adjacent to each food item creates a potential for
insanitary conditions, and suggested that the calorie information be
placed at the beginning of the self-service line and hung above self-
serve stations.
    FDA tentatively concludes that when a self-service food or food on
display is already accompanied by an individual sign, adjacent to the
food, that provides the food's name, price, or both, listing calories
per displayed food item or per serving on that sign satisfies the
requirement of section 403(q)(5)(H)(iii). Placing a separate sign with
calorie information adjacent to a food that is already accompanied by a
sign bearing its name, price, or both, could make it more difficult for
consumers to clearly associate the calorie information with its
corresponding self-service food or food on display. Therefore, given
FDA's authority to specify the manner of nutrient content disclosures
under section 403(q)(5)(H)(x)(bb), FDA is proposing in Sec.
101.11(b)(2)(iii) that the calorie declaration appear on the sign with
the name, price, or both, of the self-service food or food on display,
if applicable.
    FDA proposes that the calorie declaration on such a sign must state
the number of calories and use the term ``Calories'' or ``Cal,'' both
in a type size no smaller than the type size of the name or the price
of the food item whichever is smaller in the same color, or a color at
least as conspicuous as that name or price, with the same contrasting
background. FDA requests comment on whether establishments that already
provide an individual sign identifying each food on display or self-
service food with its name, price, or both should have the option of
providing a separate individual sign for each food on display or self-
service food for the calorie declaration, so long as the sign with the
calorie declaration is adjacent to and clearly associated with its
corresponding food.
    When a self-service food or food on display is not already
accompanied by an individual sign, adjacent to the food, that provides
the food's name, price, or both, FDA proposes that the covered
establishment place a sign adjacent to each food with the number of
calories per serving or per item, as appropriate, and the term
``Calories'' or ``Cal.'' FDA proposes that the calorie declaration on
these signs be clear and conspicuous, and requests comment on whether
additional or more specific formatting requirements are necessary.
    Often, self-service food or food on display is displayed per item,
such that the customer generally takes one item or is generally served
one item (e.g., a baked potato at a buffet, a cupcake at a bakery, a
cup of pudding at a cafeteria). FDA tentatively concludes that for
self-service food or food on display that is displayed per item, where
an item represents one serving, the calorie declaration should be per
item.
    For self-service food or food on display that is not displayed per
item (e.g., potato salad at a buffet or ice cream at an ice cream
parlor), FDA tentatively concludes that the calorie declaration should
be per serving. Covered establishments may use the size of the serving
utensil as the serving measure (e.g. 300 calories per single scoop of
ice cream), or they may use common household measurements (e.g., 400
calories per cup of potato salad. FDA requests comment on the
appropriate measurement units for declaring calories per serving for
self-service foods and foods on display.
    With respect to multiple-serving foods, FDA tentatively concludes
that if the food on display or self-service food is a discrete item
such as a whole rotisserie chicken, and it is sold as such, then the
calories must be displayed for the whole item. FDA would not object to
the voluntary declaration of the calories per serving as well as the
calories per food item, as long as such declaration is truthful and not
misleading. However, if individual portions of a multi-serving food on
display or self-service food are served to consumers or available for
consumers to serve themselves (e.g., cake by the slice or pizza by the
slice), then, under this proposal, the calories must be displayed per
serving.
    c. Self-serve beverages. A few comments stated that calorie
labeling for self-serve beverages, such as soft drinks, juices, shakes,
smoothies, coffees, teas, and similar drinks is difficult because of
factors including the wide range of calories per ounce of the different
types of beverages; the variability in serving size within a chain and
in different establishments; and the amount of ice dispensed for
certain beverages. The comments also stated that there is limited space
on menus and beside beverage dispensers. Some comments asserted that
the calorie declaration should be on menus or menu boards, because that
is where the consumer makes decisions; one of these comments stated
that to the extent that it is appropriate to make calorie information
available in places other than the menu or menu board, it should be
provided in a consistent manner (i.e., the calorie declarations on
menus, menu boards, and adjacent to self-service fountain machines and
other self-service beverage equipment should all be consistent and
based on the same serving size or other agreed upon unit of measure).
    The comments stated that FDA must work with covered establishments,
as well as with the beverage industry, to determine the appropriate
serving size (e.g., 12 fluid ounces) or other standard (e.g., ranges,
averages, per cup assuming one-third ice fill, etc.) on which a
reasonable approximation of beverage calorie content should be based.
Some comments recommended that FDA exempt self-service fountain
machines and other self-service beverage dispensing equipment from
displaying calorie information until FDA satisfies the FD&C Act's
requirement to

``establish by regulation standards for determining and disclosing the
nutrient content for standard menu items that come in different
flavors, varieties, or combinations, but which are listed as a single
menu item, such as soft drinks.''
    FDA recognizes that covered establishments may have different sizes
for beverages that are listed on the menu as small, medium and large.
Consumers may be confused when they order the same item (e.g., a small
cola) in two different establishments and are presented with two
different calorie declarations. For example, in one establishment, a
small cola may be 140 calories and in another establishment a small
cola is 190 calories. The difference in the calories could be based on
the fact that the two cups sold as ``small'' may have different volumes
(e.g., 12 ounces versus 16 ounces). FDA is considering whether the
amount of calories declared should be based on the number of ounces. We
anticipate that if we adopt this view in the final rule, we would not
object to the covered establishment listing the number of ounces as
part of the size declaration e.g., ``140 calories per 12 ounces
(small).'' FDA requests comment on this issue.
    Similar to the ice cream parlor that lists all of its flavors on
the menu board, some covered establishments list beverages individually
on a menu or menu board. In such situations, calorie information must
be provided in both locations, in accordance with section
403(q)(5)(H)(ii) and (iii). When a general term for a set of beverages
that includes different flavors or varieties is listed on a menu or
menu board (e.g., ``soda''), we are proposing that the calories be
declared as a range, like any other variable menu item (see proposed
Sec.  101.11(b)(2)(i)(4)). The self-service beverage dispenser itself
must have calorie declarations for each flavor or variety offered, such
that the calorie declaration is clearly associated with its
corresponding flavor or variety. For example, the restaurant may place
above each dispenser for soft drinks small signs labeled with the
amount of calories for each beverage. As with other self-service foods
or foods on display, if a self-service beverage already has an
individual, identifying sign, the calorie declaration must appear on
that identifying sign, so long as it is in a type size no smaller than
the type size of the name of the beverage with the same prominence.
    d. Applicability of 403(q)(5)(H)(ii) to self-service food and food
on display. Section 403(q)(5)(H)(i) states, ``in the case of food that
is a standard menu item * * * [the covered] establishment shall
disclose the information described in subclauses (ii) and (iii).'' The
word ``and'' between the references to subclause (ii) and subclause
(iii) indicates that for each standard menu item, including self-
service food and food on display, covered establishments should follow
requirements in section 403(q)(5)(H)(ii) as applicable and section
403(q)(5)(H)(iii) as applicable. FDA tentatively concludes that when
these self-service foods and food on display appear on menus or menu
boards, the menus or menu boards must bear the calorie declarations
required by sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa). FDA also
tentatively concludes that covered establishments must provide the
nutrition information in written form required under
403(q)(5)(H)(ii)(III) for these self-service foods and foods on
display, and the statements required by 403(q)(5)(H)(ii)(I)(bb),
(II)(bb), and (IV) on their corresponding menus and menu boards.
(1) Calorie Declarations
    As discussed above, FDA proposes to define ``menu'' or ``menu
board'' as the primary writing of the covered establishment from which
a consumer makes an order selection. Under this definition, most self-
service food and food on display would not appear on menus or menu
boards. However, some would. For example, an ice cream parlor might
list all of its flavors on a menu board and also have bulk containers
of ice cream on display and visible to customers in a display case. In
this situation, calorie declarations must be provided adjacent to the
ice cream flavors on the menu board under 403(q)(5)(H)(ii)(II)(aa) and
on signs adjacent to the individual ice cream bulk containers
themselves under 403(q)(5)(H)(iii).
    As another example, a coffee shop might have baked goods identified
by small signs adjacent to each food declaring the name and, often, the
price of each baked good. In many cases, these baked goods on display
do not appear on the establishment's menu board. Because these signs
are the only writings of the establishment from which consumers select
baked goods to order, FDA tentatively concludes that they are the
primary writings from which consumers ordering baked goods make their
order selections.
    Unlike self-service beverages such as fountain drinks that have
specific size and product options, for a narrow category of self-
service food or food on display where a general menu item corresponds
to a wide set of self-service food or food on display, a calorie
declaration adjacent to the name of the general menu item on a menu or
menu board might not be helpful to the consumer. For example, the food
choices on buffet lines are typically extensive, and the customers have
control over the portions of each food choice they serve themselves. In
addition, many buffets are all-you-can-eat. FDA notes that it would be
almost impossible for covered establishments to provide useful calorie
information for the general menu item ``lunch buffet,'' given that
there is no clearly identifiable upper bound to the amount of calories
a customer ordering the ``lunch buffet'' would consume. Therefore, FDA
tentatively concludes that it would be most useful for consumers, and
most practical for retail food establishments, if the calorie
information is provided for each individual item on the lunch buffet in
accordance with section 403(q)(5)(H)(iii), but not adjacent to the name
``lunch buffet'' on the menu or menu board. Given FDA's authority to
under section 403(q)(5)(H)(v), FDA is proposing in Sec.
101.11(b)(2)(i)(A)(4) to instead require covered establishments to
include on the menu or menu board a statement referring customers to
the self-service facility for calorie information, e.g., ``See lunch
buffet for calorie declarations.'' FDA requests comment on this
tentative conclusion.
(2) Additional Written Nutrition Information for Self-Service Food and
Food on Display
    Section 403(q)(5)(H)(ii)(III) requires certain additional nutrition
information to be available to the consumer in written form upon
request. Because section 403(q)(5)(H)(i) states that covered
establishments must disclose the information in section
403(q)(5)(H)(ii) for standard menu items, FDA tentatively concludes
that covered establishments must provide the additional written
nutrition information described in section 403(q)(5)(H)(ii)(III) for
self-service foods and food on display that are standard menu items.
    Similar to our tentative conclusion regarding calorie declarations
for general menu items such as ``lunch buffet'' discussed above, FDA
tentatively concludes that it would be most useful for consumers, and
most practical for covered establishments, if the additional written
nutrition information is provided for each individual item on the lunch
buffet, not for ``lunch buffet'' generally. This tentative conclusion
is consistent with FDA's proposal for providing additional written
nutrition information for variable menu items by component. FDA
requests comment on this tentative conclusion.

(3) Succinct Statement and Statement of Availability of Additional
Written Nutrition Information for Food on Display
    As discussed earlier, a narrow set of food on display has
identifying signs adjacent to each food item that are the primary
writings of the establishment from which consumers make order
selections. FDA recognizes that sections 403(q)(5)(H)(ii)(I)(bb),
(II)(bb), and (IV) apply to these foods under a straightforward reading
of the statute. However, the obligation to provide the two statements
related to suggested daily caloric intake and the availability of
additional written nutrition information under 403(q)(5)(H)(ii) seem to
pose difficulties, given the generally small size of these individual
signs. In addition, from a consumer's perspective, it is probably
unnecessary for these two statements to appear on every single
individual identifying sign. Lastly, FDA is instructed to ``consider *
* * space on menus and menu boards'' in promulgating these regulations
(403(q)(5)(H)(x)).
    FDA tentatively concludes that each individual sign could be
considered its own menu, but that a set of signs that are in close
proximity to each other, such as those that might identify items in a
bakery display counter, could be viewed together as the primary writing
from which consumers choose among those items to order. Therefore, FDA
is proposing in Sec.  101.11(b)(iii)(B) that covered establishments may
place the statements required under 403(q)(5)(H)(ii) on the individual
food-specific signs, but they also have the option of placing them on a
separate, larger sign, in close proximity to food on display, that can
be easily read as the consumer is making his or her order selection.
Similarly, FDA tentatively concludes that signs identifying food on
display that are the primary writing from which consumers select the
corresponding items to order and are in close proximity to a menu
board, such that the menu board can be easily read as the customer is
viewing the food on display, could be considered part of that menu
board. For example, some coffee shops offer baked goods in a display
case directly in front of the menu board. In these situations, the
statements that appear on the menu board itself under
403(q)(5)(H)(ii)(II)(bb) and (IV) would be sufficient. FDA requests
comment on these conclusions and whether additional restrictions
related to presenting these statements in these contexts are necessary.
e. Requirements for Self-Service Foods and Foods on Display That Are
Packaged Foods That Bear the Nutrition Information Required by Section
403(q)(1) of the FD&C Act and Sec.  101.9
    Some packaged food, such as bags of chips or packages of cookies,
are offered for sale in covered establishments individually or as parts
of combination meals. A packaged food that is required to bear
nutrition information on its label under 403(q)(1) of the FD&C Act and
FDA's implementing regulations at Sec.  101.9 would not be a restaurant
or restaurant-type food, because restaurant or restaurant-type food
includes only food previously exempt from those nutrition labeling
requirements. Therefore, such food would not be covered by the proposed
menu labeling requirements. However, FDA tentatively concludes that
some packaged food offered for sale in covered establishments is ``food
served in restaurants or other establishments in which food is served
for immediate consumption or that is sold for sale or use in such
establishments.'' While it happens to bear Nutrition Facts, it is not
required to do so. This food would meet the proposed definition of
``restaurant food'' and therefore would be covered by the menu labeling
requirements.
    Such packaged food already includes on its label the nutrition
information that FDA is proposing be required to be disclosed in the
written form in Sec.  101.11(b)(2)(ii). As noted in section III.B.5.
this information would include the number of calories, calories from
fat, total fat, saturated fat, cholesterol, trans fat, sodium, total
carbohydrates, sugars, dietary fiber, and total protein in the food. In
some cases, the packaged food is placed on a shelf, rack, counter, or
other area where the food can be accessed by a consumer before the
consumer purchases the food. So long as the consumer is able to examine
the nutrition information on the label of the packaged food before
purchasing the food and the food complies with the nutrition labeling
requirements set forth in 403(q)(1) of the FD&C Act and Sec.  101.9,
the label for the packaged food will provide to consumers, in written
form, the nutrition information that FDA is proposing be required in
the written nutrition information. Therefore, FDA tentatively concludes
that this type of packaged food would satisfy the requirements of Sec.
101.11(b)(2)(ii), so long as consumers are able to examine the
nutrition information on the label of the packaged food before
purchasing the food.
    In addition, the label of such packaged food includes calorie
information for the food per item or per serving. FDA tentatively
concludes that a packaged food that is a self-service food or food on
display that bears the nutrition information required by 403(q)(1) of
the FD&C Act and Sec.  101.9 satisfies the calorie disclosure
requirement for self-service food or food on display in section
403(q)(5)(H)(iii) of the FD&C Act, so long as a consumer is able to
examine the calorie information on the label prior to purchase. Covered
establishments would not be required to place signs that list calories
per displayed food item or per serving adjacent to such packaged foods.
The agency tentatively concludes that these proposals will provide
flexibility for industry without sacrificing nutrition information
provided to consumers.
    Covered establishments still would be required to post calorie
information on menus and menu boards for packaged foods that are
standard menu items listed on menus and menu boards. For example, a
covered establishment may list ``chips'' on its menu board, referring
to packaged bags of chips that are available as self-service foods or
foods on display within the establishment. In this situation, the
establishment would be required to disclose on the menu board calorie
information for the packaged chips, even though the establishment may
not be required to place a sign that lists calories per displayed food
item or per serving adjacent to the packaged chips themselves.
    In addition, if a covered establishment lists on its menu or menu
board a combination meal that includes a packaged food, the
establishment would be required to disclose the total calorie
information for the combination meal, including the packaged food. For
example, a covered establishment may list on its menu board a
combination meal that includes a soft drink, sandwich, and packaged
chips. In this case, the covered establishment would be required to
disclose on the menu board the total calorie information for the
combination meal, which would include the soft drink, sandwich, and
packaged chips, because these food items together make up the
combination meal. FDA requests comments on these proposals and
tentative conclusions.
8. Determination of Nutrient Content
    Section 403(q)(5)(H)(iv) requires that a covered establishment
``shall have a reasonable basis for its nutrient content disclosures,
including nutrient databases, cookbooks, laboratory analyses, and other
reasonable means, as described in [21 CFR 101.10] (or any successor
regulation) or in a related

guidance of the Food and Drug Administration.'' 21 U.S.C.
343(q)(5)(H)(iv). FDA is proposing in Sec.  101.11(c)(1) that nutrient
content disclosures may be determined by nutrient databases, cookbooks,
laboratory analyses, and other reasonable means, including the use of
labels on packaged foods that comply with the nutrition labeling
requirements of section 403(q)(1) of the FD&C Act and Sec.  101.9. FDA
notes that covered establishments must ensure that the nutrition
declaration is truthful and not misleading in accordance with section
403(a)(1) under the FD&C Act. Further, FDA is proposing in Sec.  101.11
that for compliance purposes, a covered establishment is required to
upon request provide information on the reasonable basis used to
determine the nutrient content disclosures for their standard menu
items, self-serve foods and foods on display. This proposed requirement
is discussed in more detail below in section E. In addition, because
the nutrients that are required to be declared in covered
establishments are a subset of those required to be declared in the
labeling of food in Sec.  101.9, FDA is proposing in Sec.  101.11 an
approach for determining compliance modeled after Sec.  101.9(g).
Proposed Sec.  101.11(c)(2) provides for two classes of nutrients for
purposes of compliance: Class I (added nutrients) and Class II
(naturally occurring (indigenous) nutrients). FDA is proposing that for
Class I protein or dietary fiber, the nutrient content of an
appropriate composite sample must be at least equal to the value for
that nutrient declared in the nutrition information in the written
form. Other requirements would include that the amount of calories,
sugars, total fat, saturated fat, trans fat, cholesterol, and sodium
contained in an appropriate composite of a standard menu item must not
be more than 20 percent in excess of the declared value. Additionally,
the amount of protein, total carbohydrates and dietary fiber contained
in an appropriate composite of a standard menu item must not be less
than 80 percent of the declared value. FDA also is proposing that for
variable menu items that disclose calories in ranges, the lowest
calorie declaration in the range would be used to determine compliance.
FDA requests comments on the appropriate variability from declared
nutrition information for compliance purposes, including whether Sec.
101.11 should mirror Sec.  101.9 in this respect.

D. Voluntary Registration for Restaurants or Similar Retail Food
Establishments That Are Not Chain Retail Food Establishments and Elect
To Be Subject to the Requirements of Section 4205

    Section 403(q)(5)(H)(ix) provides that restaurants and similar
retail food establishments not automatically subject to the
requirements of section 403(q)(5)(H) may elect to become subject to the
requirements by registering biannually with FDA (21 U.S.C.
343(q)(5)(H)(ix)). On July 23, 2010, as required by section
403(q)(5)(H)(ix), FDA published in the Federal Register a notice
(``registration notice'') specifying the terms and conditions for
implementation of voluntary registration, pending promulgation of
regulations (75 FR 43182 (July 23, 2010)).
    Section 4205 preempts State and local nutrition labeling
requirements for chain retail food establishments that are not
``identical'' to the Federal requirements, as discussed more fully in
section IV of this document (21 U.S.C. 343-1(a)(4)). Under amended
section 403A(a)(4), restaurants and similar retail food establishments
that are not chain retail food establishments but elect to become
subject to the Federal requirements by registering voluntarily with FDA
are not subject to State or local nutrition labeling requirements,
unless those State or local requirements are ``identical to'' Federal
requirements. Restaurants and similar retail food establishments that
register are subject to the requirements of amended section 403(q) and
FDA's implementing regulations to the same extent as chain retail food
establishments.
    FDA anticipates that registrations will primarily be submitted by
restaurants and similar retail food establishments with fewer than 20
locations in States and localities that have non-identical menu
labeling requirements. An authorized official would be permitted to
register multiple restaurants or similar retail establishments within a
chain on a single registration form, provided that the official is an
authorized official for all of the restaurants or similar retail food
establishments included on the form. In addition, the authorized
official of an individual restaurant or retail food establishment may
register that restaurant or retail food establishment on a single
registration form.
    FDA is proposing in Sec.  101.11(c)(2) that the authorized official
of a restaurant or similar retail food establishment as defined in
Sec.  101.11(a)(10) may register with FDA. FDA is also proposing in
Sec.  101.11(c)(2) that an authorized official may register an
individual restaurant or similar retail food establishment or multiple
restaurants or similar retail food establishments that are part of
chain on a single registration form.
    FDA is proposing in Sec.  101.11(c)(3) that authorized officials
for restaurants and similar retail food establishments must provide FDA
with the following information:
     The name, address, phone number, e-mail address, and
contact information for the authorized official;
     The name, address, and e-mail address of each restaurant
or similar retail food establishment being registered, as well as the
name and contact information for an official onsite, such as the owner
or manager, for each specific restaurant or similar retail food
establishment;
     All trade names the restaurant or similar retail food
establishment uses;
     Preferred mailing address (if different from location
address for each establishment) for purposes of receiving
correspondence; and
     Certification that the information submitted is true and
accurate, that the person or firm submitting it is authorized to do so,
and that each registered restaurant or similar retail food
establishment will be subject to the requirements of Sec.  101.11.
    FDA has created and made available at a Web site, http://www.fda.gov/menulabeling, a form (OMB No. 0910-0664) that contains
fields requesting this information. Authorized officials of restaurants
and similar retail food establishments electing to be subject to the
requirements of section 403(q)(5)(H) can obtain information to register
by visiting http://www.fda.gov/menulabeling. Registrants must use this
form to ensure that complete information is submitted.
    FDA prefers that the information be submitted by e-mail by typing
complete information into the form (PDF), saving it on the registrant's
computer, and sending it by e-mail to<EMAIL_ADDRESS>
If e-mail 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<PHONE_NUMBER> or mail it to FDA, White Oak Building 22, Room 0209,
10903 New Hampshire Ave., Silver Spring, MD 20993.
    In section 4205, Congress provided that registration must be
renewed biannually (21 U.S.C. 343(q)(5)(H)(ix)(I)). Although
``biannual'' is defined as occurring twice every year,

the word is also defined as occurring every other year. (Ref. 26). FDA
tentatively concludes that registration every other year is a more
reasonable interpretation of this requirement, because it does not seem
warranted or necessary for a restaurant or similar retail food
establishment to tell FDA every 6 months that the establishment wants
to be subject to Federal jurisdiction. Thus, FDA is proposing in Sec.
101.11(d)(5) that authorized officials must register every other year
within 60 days prior to the expiration of the establishment's current
registration with FDA, and the registration will automatically expire
if not renewed.

E. Substantiation Documentation

    Covered establishments must provide nutrient content disclosures
that are not false or misleading to comply with section 403(a)(1).
Covered establishments also must have a reasonable basis for their
nutrient content disclosures under section 403(q)(5)(H)(iv). It is
clear under section 403 that covered establishments must substantiate
the accuracy of their nutrient content disclosures and the fact that
those disclosures have a reasonable basis. Under section 701(a), FDA
has authority to issue regulations for the efficient enforcement of
FD&C Act, including sections 403(a)(1) and 403(q)(5)(H)(iv).
    Without access to substantiation documentation for a covered
establishment's nutrient content disclosures, FDA cannot efficiently
determine whether a covered establishment's nutrient content
disclosures are truthful and not misleading, as required by section
403(a)(1) of the FD&C Act. Without access to substantiation
documentation of the bases of nutrient content disclosures, the
requirement that nutrient content disclosures have reasonable bases in
particular would be unenforceable. Accordingly, FDA is proposing the
substantiation requirements in Sec.  101.11(c)(2) as necessary for the
efficient enforcement of the FD&C Act.

F. Conforming Amendments

    As a result of the amendments to the FD&C Act made by section 4205,
conforming amendments must be made in part 101 of Title 21 of the CFR.
Section 4205 amended section 403(q)(5)(A) of the FD&C Act, which
provided, in part, that the nutrition labeling requirements in section
403(q)(1)-(4) did not apply to food served in restaurants or other
establishments in which food is served for immediate consumption or
which is sold for sale or use in such establishments. It also did not
apply to food which is processed and prepared primarily in a retail
establishment, which is ready for human consumption, which is of the
type described in subclause (i), and which is offered for sale to
consumers but not for immediate human consumption in such establishment
and which is not offered for sale outside such establishment. Based on
this exemption, FDA promulgated regulations in Sec.  101.9(j) that
exempt from nutrition labeling requirements these foods, so long as
they do not bear nutrition claims or other nutrition information in any
context on the label or in labeling or advertising. Section 101.10
requires nutrition labeling for a restaurant food that bears a nutrient
content or health claim, except that information on the nutrient
amounts that are the basis for the claim may serve as the functional
equivalent of complete nutrition information.
    With the new requirements of section 403(q)(5)(H) for standard menu
items offered for sale in certain restaurants and similar retail food
establishments, provisions in Sec.  101.9(j) need to be amended. In
particular, covered establishments with annual gross sales made or
business done in sales to consumers that is not more than $500,000 or
with annual gross sales made or business done in sales of food to
consumers of not more than $50,000 are now required to provide
nutrition information under section 403(q)(5)(H). Thus, the exemption
in Sec.  101.9(j)(1) needs to be amended to reflect that, in providing
the nutrition information required under Sec.  101.11, a covered
establishment would not become subject to Sec.  101.9. In addition, the
exemptions from nutrition labeling in Sec.  101.9(j)(2) and (3) need to
be revised to exclude standard menu items sold in covered
establishments and reference the special labeling requirements for
those foods in Sec.  101.11. Similarly, Sec.  101.10 needs to be
amended to include the provision that for restaurant foods sold in
covered establishments, the information required in the written
nutrition information required by proposed Sec.  101.11(b)(2)(ii)(A)
would meet the requirements of Sec.  101.10, when applicable.
Therefore, FDA is proposing conforming amendments in Sec.  101.9(j) and
Sec.  101.10.
    FDA is proposing to exempt electronic signatures submitted to
satisfy the requirements of this proposed section from the requirement
to comply with part 11--Electronic Records; Electronic Signatures (21
CFR part 11) and proposing to amend part 11 to reflect this exemption.
We expect this exemption to facilitate the registration process for
those who voluntarily choose to register under section
403(q)(5)(H)(ix).

G. Proposed Effective Date

    FDA received several comments regarding the effective date of the
final rule that would issue based on this proposal. Many comments
suggested that FDA provide one to two years before the effective date
because covered establishments would need that much time to make the
changes necessary to comply with the regulations. One comment requested
an effective date of three years because this timeframe was needed to
defray the costs of new menu boards. Others suggested that six months
was a reasonable timeframe.
    FDA is proposing that the final rule become effective six months
from the date of its publication. Compliance is expected to yield
significant public health benefits because consumers will have calorie
and other nutrition information when they make menu choices. Because of
this benefit, the agency finds that it is reasonable to make the
requirements effective as soon as practicable. Based on the comments
and on what covered establishments will need to do to come into
compliance, the agency tentatively finds that making the final rule
effective six months after publication is practicable. FDA recognizes,
however, the potential difficulties of implementing the rule in this
timeframe, and we request comment on whether the effective date should
be extended for a greater period of time after the publication of the
final rule. We request comment on whether a nine-month or one-year
implementation timeframe would be more appropriate.

H. Compliance

    As discussed in section II of this document, FDA is proposing these
regulations under sections 201(n), 403(a), 403(q), as amended by
section 4205 of the Patient Protection and Affordable Care Act of 2010,
and 701(a) of the FD&C Act. Failure to comply with the regulations, if
adopted by the agency, will render the food misbranded under sections
201(n), 403(a), or 403(q) of the FD&C Act. Introducing, delivering for
introduction, or receiving a misbranded food in interstate commerce, or
misbranding a food while it is in interstate commerce or being held for
sale after shipment in interstate commerce, are prohibited acts under
section 301 of the FD&C Act and subject to enforcement action.

    FDA addressed the issue of enforcement of section 4205 in a draft
guidance entitled, ``Draft Guidance for Industry: Questions and Answers
Regarding Implementation of the Menu Labeling Provisions of Section
4205 of the Patient Protection and Affordable Care Act of 2010.'' The
agency announced the availability of the draft guidance in the Federal
Register on August 25, 2010 (75 FR 52426). In that draft guidance, FDA
stated that it expected to refrain from enforcing the provisions of
section 4205 that became requirements immediately upon enactment of the
law until a date that it would specify in final guidance. Based on
extensive comments on the draft guidance, however, FDA decided to
withdraw the draft guidance and to exercise enforcement discretion
until after it had completed notice and comment rulemaking (76 FR 4360
(January 25, 2011)).
    FDA seeks comment on how we should implement these regulations. In
particular, we seek comment, supported by data, concerning how much
time is needed for covered establishments to come into compliance with
the final rule, including, if possible, data on whether specific
provisions of the rule can be more quickly implemented than others (see
section V.E., below). We seek comment on whether we should provide for
staggered implementation based on the size of a chain or of a specific
franchisee. Again, any suggestions should be supported by data. Given
that FDA does not intend to enforce the self-executing provisions at
this time, we encourage our State and local partners to proceed in a
similar way.

IV. Summary of Preliminary Regulatory Impact Analysis

    The summary analysis of benefits and costs included in this
document is drawn from the detailed Preliminary Regulatory Impact
Analysis (PRIA) that is available at http://www.regulations.gov, Docket
No. FDA-2011-F-0172, and is also available on FDA's Web site at http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm.

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive
Orders 12866 and 13563, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 13563 and 12866 direct agencies to assess all costs
and benefits (both quantitative and qualitative) of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects, distributive
impacts, and equity). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility. This rule has been
designated an ``economically'' significant rule, under section 3(f)(1)
of Executive Order 12866. Accordingly, the rule has been reviewed by
the Office of Management and Budget.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Using the Small Business Administration (SBA)
definitions of small for industrial subsectors in accommodations, food
service, recreation, and retail food stores (NAICS 72, 71, 445), FDA
tentatively concludes that a significant number of firms affected by
this proposed rule are small businesses.
    Section 4205 of the Affordable Care Act and the proposed
requirements apply to chain retail food establishments, as that term is
used in this document (i.e., a restaurant or similar retail food
establishment that is part of a chain with 20 or more locations doing
business under the same name (regardless of the type of ownership of
the locations) and offering for sale substantially the same menu
items), and establishments that voluntarily register with FDA to become
subject to the requirements of section 4205. Some chain retail food
establishments may meet the SBA definitions of: Less than $7 million in
annual sales for most accommodation and food service or recreation
subsectors (NAICS 72, 71); less than $20.5 million in annual sales for
Food Service Contractors (NAICS 722310); or less than $27 million in
annual sales for supermarkets and convenience store chains (NAICS 44510
and 445120). In addition, some chain retail food establishments are
owned or operated by entities, including franchisees or cooperative
members that may meet the SBA definitions described above.
    Establishments that voluntarily register to be subject to the
Federal requirements, which may be individually owned or part of a firm
that controls establishments within a chain of less than 20 locations,
may meet the SBA definition described above. While the voluntary nature
of the registration implies that these latter firms see a positive net
benefit from becoming subject to the Federal requirements, this does
constitute a potentially significant economic impact. Therefore, the
agency tentatively concludes that the rule will have a significant
economic impact on a substantial number of small entities. This
tentative conclusion is discussed further in section V.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA expects this
proposed rule to result in 1-year expenditures that would meet or
exceed this amount. This tentative conclusion is discussed further in
section VI.
    FDA asks for comments about the data and the methods used for
estimating the regulatory impact of the proposed rule.

B. Need for This Regulation

    This proposed rule is necessary to implement Section 4205 of the
Affordable Care Act, which amends sections 403(q)(5) and 403A of the
FFDCA, and requires disclosure of calorie and other nutrition
information by covered establishments. These nutrition labeling
requirements should help consumers to make more informed choices about
the nutritional content of the food they purchase. The provision of
calorie and other nutrition information for restaurant and restaurant-
type foods, as those terms are used in this document, offered for sale
by covered establishments should help consumers limit excess calorie
intake and understand how the foods that they purchase at these
establishments fit within their daily caloric and other nutritional
needs. FDA notes as well that Executive Order 13563 specifically
directs agencies to ``identify and consider regulatory approaches that
reduce burdens and maintain flexibility and freedom of choice for the
public. These approaches include * * * disclosure requirements as well
as provision of information to the public in a form that is clear and
intelligible.''
    Economic justifications for regulatory interventions in private
markets rely on the presence of some market failure. In the case of
restaurant and restaurant-type foods, the private market is
particularly robust and competitive. Hundreds of thousands of retail
food establishments and tens of thousands of

individual firms vie for consumer dollars across the United States.
High estimates of failure rates for restaurants (Ref. 27), with
relatively steady growth rates in number of establishments (Ref. 28)
indicate that entry in the industry occurs often, and survival is hard
fought: Restaurants must be responsive to consumer needs and desires in
order to survive. The competitiveness of the industry suggests that if
a sizable fraction of consumers were willing to pay for--and
discriminate based on--the availability of nutrition information, then
the industry would provide it to them. In fact, many retail food
establishments do provide nutrition information for at least a fraction
of their offerings, either through available brochures, or,
increasingly, on the Internet. A 2006 study found that 34 percent of
the top 300 chain restaurants (by sales volume) had nutrition
information available to consumers in some form (Ref. 29).
    Notwithstanding this point, and although many of the usual market
failures that justify regulatory action, such as the existence of
market power or public goods, cannot be found here (Refs. 30 and 31),
the primary support for government intervention is an absence of
sufficient nutritional information, produced by an inadequate incentive
for restaurants to produce that information on their own. An absence of
adequate information is of course a standard market failure, justifying
disclosure requirements or provision of information in many contexts.
    In terms of explaining the inadequate incentive for restaurants to
provide sufficient nutrition information, a central reason involves
consumer demand. There are systematic biases in how consumers weigh
current or immediate benefits (from eating more, or higher calorie,
foods) against future or long-term costs (higher probability of obesity
and its co-morbidities). These biases are directly related to the
proposed requirements: The temporal disconnect inherent between food
consumption choices and their potential health costs may work against
an efficient provision of nutrition information for food (Ref. 32). A
primary issue here is that long-term risks may not be sufficiently
salient to produce adequate consumer demand for relevant information
disclosure. Without that information, consumers may fail to make
informed choices and may undervalue the future costs of excessive
calorie consumption, relative to the current benefits from such
consumption (Refs. 29, 33 and 34).
    Studies suggest that one problem involves the fact that because
food decisions are made so often, and the marginal effect of any one
meal on future obesity is small, the cumulative costs of a large number
of relevant decisions may be neglected. These studies suggest that some
or many consumers will not demand calorie information, because the
issue of calories often lacks salience, or relevance, for consumers at
the time of purchase and consumption, even though they may experience
regret about their decisions at a latter date. This tendency may
explain why consumers have not generally demanded calorie and other
nutrition information for restaurant and restaurant-type food, although
they do, at a later point in time, value that information. Furthermore,
restaurants and similar retail establishments face costs in providing
calorie and other nutrition information, including opportunity costs of
limited time and space in which to convey information to the consumer.
That is, just as a firm has to decide which possible menu items to
leave off a menu board with limited space (thus giving up the
opportunity to sell those items), it must choose which pieces of
information about its menu items it wants to convey. Adding an
additional piece of information means that a firm may need to downplay
or remove some other valuable piece of information. In addition,
providing calorie information may have complex and unintended effects
on revenue and profits as consumers respond to that information. Given
the costs and the uncertain reception of displayed calorie information
most restaurants have chosen not to display this information at the
point of purchase.
    The proposed requirements respond to the apparent market failure in
information provision stemming from existing restaurant incentives and
present-biased preferences. Specifically, the proposed requirements
provide that calorie information for standard menu items must be posted
in covered establishments. Providing this nutrition information will
likely increase the salience of the information and promote informed
choice as well. It will also likely raise consumer awareness regarding
the number of calories in restaurant and restaurant-type foods, and
thus may serve to highlight the potential future costs of additional
calorie consumption. This increased attention to the number of calories
in food offered for sale by covered establishments may then result in
an increased availability of lower calorie options, and an increased
demand for these options.

C. Summary of Costs and Benefits of the Proposed Requirements and
Regulatory Options

    In this section FDA describes the bases of benefits and costs of
the proposed requirements and summarizes the results of the detailed
PRIA.
    Benefits in response to the proposed requirements. Obesity and
overweight are major public health concerns in the United States and
among the top leading health indicators addressed by the United States
Healthy People 2020 goals. Nationally representative data have
consistently exhibited a steady increase in the prevalence of obesity
over the past three decades (Ref. 35). As noted in section I.A., 34
percent of the adult U.S. population is obese and 34 percent is
overweight (Ref. 1). In addition, about 31 percent of children and
adolescents, aged 2 to 19, are overweight or obese (Ref. 8).
    Excess body weight has many health (Ref. 36), social (Refs. 37 and
38), psychological (Refs. 39 and 40), and economic consequences (Ref.
41) for the affected individuals. Lower life expectancy, elevated risk
of diabetes, hypertension, stroke and other cardiovascular disease has
been documented to rise simultaneously with the increased prevalence of
obesity (Ref. 36). The economic impact is especially evident for
health-care costs in terms of greater health-care utilization and
higher medical expenditures (Ref. 42). More specifically, as noted,
medical expenditures attributable to overweight and obesity accounted
for more than 9 percent of the total U.S. medical expenditures in 1998,
or between $86 billion, and $147 billion (Ref. 42). Another estimate
indicates that obesity costs American families, businesses and
government approximately $117 billion in 2010 (Ref. 43).
    The primary risk factors for overweight and obesity in the general
population are overconsumption of calories (i.e., eating more calories
than are needed to maintain body weight) and physical inactivity (i.e.,
getting an amount of exercise below the amount required to burn excess
calories consumed over the amount needed to maintain body weight (Ref.
9).
    One contributor out of the complex and multi-facet set of factors
is food offered for sale by restaurants and similar retail food
establishments. The proportion of total food expenditure spent on such
foods increased from 34 percent during the 1970s up to approximately 50
percent by 2004, where it has remained through 2009 (Ref. 44). These
foods are generally high in calories, fat and portion size (Ref. 45),

and they tend to be lower in fiber and other essential nutrients such
as calcium as compared to home-prepared foods (Ref. 10).
    Restaurant food and restaurant-type food form a significant and
increasing part of U.S. diets. According to one study, ``food away from
home'' (this term is roughly comparable to restaurant and restaurant-
type foods) constituted about a third of calories consumed annually by
the average adult or child in the United States in the most recent
comprehensive published study (Ref. 10). Another study of adults found
that ``food away from home'' adds an additional 130 calories per meal,
on average, relative to a similar meal prepared at home (Ref. 46). The
difference in calorie consumption between ``food away from home'' and
food prepared at home was greater for study participants who were
overweight or obese; among those individuals, the away-from-home meals
had 240 more calories per meal relative to meals prepared at home (Ref.
46).
    Although many factors contribute to obesity, to the extent that the
proposed requirements would mitigate the prevalence of obesity and of
co-morbidities, society would gain the opportunity cost of the averted
medical expenditures and an increase in productivity from averted
debilitation and death. In addition to informing consumers about the
calorie content for restaurant and restaurant-type foods offered for
sale by covered food establishments, major predicted elements of the
consumer and industry response to this proposed rule may include:
    1. Increased awareness regarding the caloric content for foods
offered for sale by covered establishments, which may help reduce the
present-bias in preferences, and thus encourage the consumption of
lower calorie options.
    2. Increased consumer interest in lower calorie options, and
greater transparency regarding calorie content of menu items, which may
give firms an incentive to:
    a. Reduce the calorie content of existing items through
reformulation or by decreasing portion size.
    b. Provide additional items with lower calorie formulations.
    These changes may reduce consumers' caloric intake from foods sold
in covered establishments, and this reduction in caloric intake may in
turn contribute to a reduction in obesity in the U.S. population. Note
that any reduction in calorie intake in these settings may be at least
partially offset by increases in calorie intake during other meals or
snacks. This substitution of one calorie source for another has been
demonstrated in the context of menu labeling (Ref. 47) and in the
context of other attempts to modify food choices (Ref. 48). Because FDA
lacks data on how consumers will substitute between caloric sources, as
well as specific information on the responsiveness of calorie demand to
new information, the benefit estimations given here may be higher or
lower than those that will be realized if the rule is finalized as
proposed. Finally, there may be additional benefits to the extent that
consumers use the written nutrition information to make food
selections.
    Industry and consumer costs in response to the proposed
requirements. Meeting the proposed requirements will have costs for
both the industry and consumers. Typically, new costs to an industry
are borne by both consumers and firms: Prices rise to reflect new
costs, but generally not by enough to completely offset them. If the
expense of meeting the proposed requirements cause prices to increase
for some or all restaurant and restaurant-type foods offered for sale
by covered establishments, then the consumption of these foods will
fall, further reducing profits for some, or all, of these
establishments. Consumers would need to pay more for this food,
requiring some reduction in other, valued, consumption.
    One difficulty in determining the cost burden stems from the
relatively complicated ownership structures in some of the covered
sectors. Restaurants and similar retail food establishments can be
corporate-owned, franchised as part of a large or small independent
chain, or cooperatively-organized and doing business under the same
name. Data for separate firms operating under the same name, such as
franchises of a particular brand or corporate name, are difficult or
impossible to acquire. Therefore, for this analysis FDA counts affected
establishments and chains, which may in fact serve one, several, or
many, underlying firms. Except for some potential costs of nutrition
analysis, the costs of the proposed rule are analyzed at either the
chain or the establishment level, so that the overall costs are not
primarily a function of the actual number of firms affected.
    The major elements of cost for this proposed rule are:
    1. Collecting and managing records of nutritional analysis for each
standard menu item.
    2. Revising or replacing existing menus, menu boards and other
affected displays.
    3. Training employees to understand nutrition information in order
to help ensure compliance with the proposed requirements.
    Although not required by the proposed requirements, some chains or
establishments may respond to increased consumer interest on caloric
content of restaurant and restaurant-type food by reformulating
existing menu items or by introducing new, lower calorie items. While
the costs associated with formulating these items have not been
included in the cost estimation, FDA has included the cost associated
with analyzing new or reformulated items. Because the rate at which
these items are introduced may be affected by the propose requirements,
FDA requests comment and data on whether the proposed requirements will
accelerate the rate of new item introduction and how the cost of these
items may be affected by the proposed requirements.
    Finally, because they are not required by the proposal, FDA has not
included any costs associated with developing online or other
electronic calorie calculators for variable menu items. FDA requests
comment and data on the costs of these kinds of calorie tools.
    Summary of benefits and costs. We summarize the estimated costs and
benefits of the proposed requirements and some regulatory options in
Tables 5a-5b. The full analysis is provided in the detailed PRIA. Costs
of complying with the proposed requirements have been estimated for
three major areas: Cost of nutrition analysis, cost of menu and menu
board replacement, and costs of training. These costs have been
aggregated across an estimate of the total number of chains and
establishments that would be defined as covered under the proposed
rule. In the case of the proposed rule, FDA estimates that there would
be approximately 278,600 covered establishments organized under 1,640
chains. The initial mean estimated cost of complying with the proposed
requirements is $315.1 million, with an estimated mean ongoing cost of
$44.2 million. Annualized over 10 years, the mean estimated annual cost
of the proposed requirements is $76.8 million at a 3 percent discount
rate, and $82.3 million at a 7 percent discount rate. FDA has estimated
low and high annualized cost estimates for the proposed requirements of
$33.4 million and $120.5 million with a 3 percent discount rate, and
$34.9 million and $130.1 million with a 7 percent discount rate. The
bases for this wide range of cost estimates and the main drivers of
this uncertainty are collected and discussed in the detailed PRIA.
    Initial costs are estimated to be $1,100 per covered establishment.
Note

however, that this figure combines the average per establishment cost
of $1,800 per limited service eating establishments--i.e., those most
likely to have more than one menu board or major display serving as a
menu--with full service restaurants averaging less than $1,000 per
establishment. These averages do not show the very wide range of costs
that individual establishments and chains will bear, based on their
very different approaches to nutrition analysis, menu design and
overall market niche.
    FDA has not estimated the actual benefits associated with proposed
requirements. Food choice and consumption decisions are complex, and
FDA is unaware of any comprehensive data allowing accurate predictions
of the effect of the proposed requirements on consumer choice and
establishment menus. Therefore, FDA has constructed a plausible
individual effect of the proposed rule, and has conducted a break-even
analysis in order to determine the proportion of the U.S. obese adult
population that would need to attain this minimal response in order for
the proposed requirement to yield a positive net benefit. Using a 100
calorie per week reduction in intake as the benchmark effect, FDA
estimates that at least 0.06 percent of the adult obese population
would need to reach at least this benchmark in order for the rule to
break even on the primary, or mean annualized cost.

   Table 5a--Accounting Statement: Annualized Cost and Break-Even Benefit Point for the Proposed Requirements
----------------------------------------------------------------------------------------------------------------
                                      Primary        Low          High         Year       Discount      Period
                                      estimate     estimate     estimate      dollar        rate       covered
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($millions/
 year)............................                                 Not quantified
-----------------------------------
Annualized Quantified:
----------------------------------------------------------------------------------------------------------------
Qualitative: FDA estimates that at least 0.06 percent of the adult obese population would need to reduce caloric
 intake by at least 100 calories per week in order for benefits from the proposed requirements to reach a break
 even point on annualized costs (at either 3% or 7%).
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($millions/          $82.3        $34.9       $130.1         2009           7%           10
 year)............................         76.8         33.4        120.5         2009           3%           10
----------------------------------------------------------------------------------------------------------------

    Regulatory Options. In addition to a baseline, FDA has identified
five regulatory options for this proposed rule as required by Executive
Order 12866. The estimated benefits and costs of these options relative
to the proposed rule are given in Table 5b.
    (0) Baseline for the purpose of analysis--No new Federal regulatory
action.
    (1) Option 1, the proposed rule, the definition of ``restaurants or
similar retail food establishments,'' limited to retail establishments
that offer for sale restaurant or restaurant type food where the sale
of food is the primary business activity of that establishment. This
option encompasses limited- and full-service restaurants, snack bars
(including coffee shops, pastry shops, sandwich counters and similar
establishments), cafeterias, drinking places, convenience stores and
grocery stores that are chain retail food establishments as defined in
this proposed rule. The proposed rule has an effective date of six
months after the publication of the final rule.
    (2) Option 2, with requirements similar to the proposed rule, but
with ``restaurant or similar retail food establishment'' limited to
retail establishments where the sale of restaurant food or restaurant-
type food is the primary business activity. This option covers all
establishments included in Option 1, with the exception that grocery
and convenience stores would not be subject to the proposed
requirements.
    (3) Option 3, with requirements similar to the proposed rule, but
with scope broadened to include a wide variety of establishments that
serve restaurant or restaurant-type food.
    (4) Option 4, with requirements similar to the proposed rule, but
with an effective date starting three months after publication of the
final rule instead of six months after publication of the final rule.
    (5) Option 5, with requirements similar to the proposed rule, but
with an effective date starting 12 months after publication of the
final rule instead of six months after publication of the final rule.

                                       Table 5b--Summary of Estimated Annualized Compliance Costs for Each Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Proportional
                                                                                Proportional cost   dollar sales of
                                                            Primary        Low          High     Percent  discount     relative to      restaurant food
                   Summary of options                       estimate     estimate     estimate     rate  (10 year    primary estimate     relative to
                                                              (in          (in          (in           horizon)       of the proposed    primary estimate
                                                           millions)    millions)    millions)                         requirements     of the proposed
                                                                                requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Baseline)..............................................          N/A          N/A          N/A                N/A                N/A  .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 1: The Proposed Rule.............................        $76.8        $33.4       $120.5                 3%               0.0%               0.0%
                                                                 82.3         34.9        130.1                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 2: Smaller Scope.................................         65.9         29.1        103.2                 3%             -12.5%              -5.0%
                                                                 72.5         31.6        113.8                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------

Option 3: Larger Scope..................................         86.9         38.2        135.5                 3%             +13.3%             +11.2%
                                                                 92.9         39.9        145.8                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 4: Shorter Compliance Time.......................         84.2         35.8        132.4                 3%              +9.4%               0.0%
                                                                 91.0         37.8        144.0                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 5: Longer Compliance Time........................         76.2         31.9        120.5                 3%              -2.4%               0.0%
                                                                 81.6         33.2        130.1                 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA estimates that Option 2, which limits the scope of the proposed
requirements to establishments that either present themselves as
restaurants or have more than 50 percent of their floor area used for
restaurant or restaurant-type food, has a ten-year annualized cost of
between $29.1 million per year and $103.2 million per year with a 3
percent discount rate, with a primary estimate of $65.9 million.
Averaged over primary, low and high estimates, the costs of Option 2
are 12.5 percent lower than those of the proposed requirements.
Although FDA does not have adequate data on the proportion of calories
consumed at different types of establishments, as a rough estimate of
the coverage of Option 2 relative to the proposed requirements, we use
the proportion of dollar sales of restaurant or restaurant type food
relative to the establishments covered by the proposed rule. In the
case of Option 2, limiting the scope of covered establishments would
reduce the coverage of restaurant or restaurant-type food sales by 5.0
percent. These changes are discussed more fully in the detailed
analysis.
    Option 3 which considers a wider set of establishments that service
restaurant or restaurant-type foods, including lodging, transport,
entertainment, general retail and other establishments, has costs that
are 13.3 percent higher than those of the proposed requirements and
coverage of sales that is 11.2 percent higher. Option 4, which shortens
the compliance time to 3 months, has costs that are 9.4 percent higher
than the proposed, and Option 5, which lengthens compliance time to 12
months has costs that are estimated to be 2.4 percent lower. These
options do not change the set of covered establishments relative to the
proposed rule.
    Finally, although registration by firms wishing to register with
FDA in order to come under the proposed requirements and the associated
preemption from State or local regulations is voluntary, and is only
likely to occur to the extent that the costs of registration and
compliance with Federal regulation is lower than that of State or local
regulation, this registration constitutes a collection of information
under the Paperwork Reduction Act of 1995. Therefore, FDA has also
estimated the burden associated with this collection of information in
section VII of this document. For full documentation and discussion of
these estimated costs and benefits see the detailed PRIA, available at
http://www.regulations.gov, enter Docket No. FDA-2011-F-0172.

V. Initial Regulatory Flexibility Analysis

    FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities consistent with statutory objectives. FDA tentatively
concludes that this proposed rule will have a significant economic
impact on a substantial number of small entities. Although chains with
20 or more establishments will generally have total sales in excess of
SBA's small business limits, many of these establishments are actually
operated by franchisees, independent operators licensing a chain store
brand, or some other types of small business. The majority of the costs
of the proposed rule will be borne at the establishment level, in
particular, the cost of new menus and of employee training. Because of
this, many of these small businesses will be directly responsible for
meeting of the costs of compliance.
    FDA has built substantial flexibility into the proposed rule. The
wide range in cost estimates given in Section IV. of this document is a
function of the variety of approaches that business may choose to take
to comply with the proposed requirements. The proposed rule does not
prescribe the method or materials used to disclose calorie information
or other nutrition information, beyond format and style requirements.
In addition, the proposed rule does not require any employee training,
and it allows for a variety of approaches for nutritional analysis.
Therefore, businesses may choose among a wide variety of less, or more,
expensive avenues for compliance depending on their situation.
    Controllers of chain level brands have significant latitude to
impose lesser or greater costs on their associated establishments.
Examples include the extent to which franchisors may impose more
expensive menu board designs on franchisees, or the extent to which
franchisors impose training requirements. Because the proposed rule
provides flexibility for the disclosure of nutrition information in
covered establishments, the proposed rule gives small businesses (and
gives owners of chain brands) the leeway to select cheaper methods to
meet the proposed requirements, such as the use of stickers or menu
strips, or more expensive methods, such as menu redesign or
replacement.
    Tying additional flexibility to the size of the firm could mean
greater confusion for customers and competitors, because individual
establishments within very large chains might differ in how or when
they disclosed calories. Tying additional flexibility to the size of
the chain would mean that some small firms in large chains would have
less flexibility, and potentially higher costs, than large firms in
small chains. Rather than attempt to

make a division between large and small firms, FDA has attempted to
build in substantial flexibility for all firms.
    Finally, section 4205 allows restaurants and similar retail food
establishments that are not subject to the proposed requirements to
voluntarily register with FDA to become subject to the requirements. By
voluntarily registering, such an establishment is in effect indicating
that the burdens of registering, which include reporting to FDA contact
information for the authorized official and the establishment, and
being subject to the Federal requirements, is outweighed by the
benefits.

VI. Unfunded Mandates

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA has determined that
this proposed rule has met the threshold under the Unfunded Mandates
Reform Act. FDA has carried out the cost-benefit analysis in the
detailed PRIA, available at http://www.regulations.gov, enter Docket
No. FDA-2011-F-0172. The other requirements under the Unfunded Mandates
Act of 1995 include assessing the proposed rule's effects on:
     Future costs;
     Particular regions, communities, or industrial sectors;
     National productivity;
     Economic growth;
     Full employment;
     Job creation; and
     Exports.
    Note that because restaurant and restaurant-type foods are goods
that by definition are not transported over long distances,
international or interstate trade issues are not relevant here: the
imposition of regulatory costs will not cause firms to shift production
to locations that are not chain retail food establishments as the term
is used in this document. Furthermore, because the costs of the
proposed rule are low relative to the revenue generated by even the
smallest chain retail food establishments, the proposed rule will not
significantly affect employment, economic growth or national
productivity.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the
PRA). A description of these provisions is given below with an estimate
of the annual reporting, recordkeeping, and third party disclosure
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    Requirements for Nutrition Labeling for Standard Menu Items in
Restaurants and Similar Retail Food Establishments (OMB Control Nos.
0910-0664 and 0910-0665)--Revision--Section 4205 of the Affordable Care
Act, which amends sections 403(q)(5) and 403A of the FD&C Act, requires
disclosure of calorie and other nutrition information by chain retail
food establishments, as that term is used in this proposed rule. In
particular, a restaurant or similar retail food establishment with 20
or more locations doing business under the same name and offering for
sale substantially the same menu items must provide nutrition
information for standard menu items. Section 4205 became effective on
the date the law was signed, March 23, 2010. A restaurant or similar
retail food establishment that is not subject to the requirements of
section 403(q)(5)(H) may elect to become subject to the requirements of
section 403(q)(5)(H) by registering biannually with FDA. Section 4205
required FDA to publish a notice in the Federal Register within 120
days of the date of enactment of the legislation, providing information
on the terms and conditions for persons who voluntarily elect to be
subject to nutrition disclosure requirements specified in the
legislation.

A. Statutory Compliance

    To comply with the PRA and with the statutory deadline under the
provisions of section 4205 for publication of registration information,
FDA initially obtained a 6-month OMB approval of the collection of
information requirements under the emergency processing provisions of
the PRA. With OMB approval of the collection of information
requirements of section 4205, FDA took several actions: (1) Developed
an electronic form, ``Menu And Vending Machine Labeling Voluntary
Registration,'' Form FDA 3757, (2) as required by section 4205,
published a notice in the Federal Register of July 23, 2010 (75 FR
43182) (the July 23, 2010, notice) to explain how retail food
establishments and vending machine operators not otherwise subject to
the provisions of section 4205 may voluntarily elect to become subject
to them, and (3) developed and implemented the guidance entitled,
``Guidance for Industry: Questions and Answers Regarding the Effect of
Section 4205 of the Patient Protection and Affordable Care Act of 2010
on State and Local Menu and Vending Machine Labeling Laws.'' This
guidance among other things clarified section 4205's effect on State
and local menu and vending machine labeling laws, to ensure that
industry and State and local government understood the immediate
effects of the law.
    FDA has requested a 3-year approval of the information collection
requirements under the same assigned OMB Control Nos. 0910-0664 and
0910-0665. In the Federal Register of January 31, 2011, FDA published
two notices announcing the submission to OMB of the information
collection requests for No. 0910-0664 (76 FR 5384) and No. 0910-0665
(76 FR 5380). As noted, the information collection requests previously
submitted sought OMB approval of the reporting, recordkeeping, and
third party disclosure burdens of section 4205, not the provisions of
this proposed rule. With this proposed rule, FDA is submitting a
revised information collection request seeking OMB approval of the
changes caused by the proposed rule.

B. Revision of OMB Control Nos. 0910-0664 and 0910-0665 by the Proposed
Rule

    This proposed rule provides detail on how chain retail food
establishments can comply with section 403(q)(5)(H)

and how restaurant or similar retail food establishments not subject to
the requirements of section 403(q)(5)(H) can voluntarily register to
become subject to the requirements. Certain provisions of the proposed
rule revise the information collection requirements that have been
approved by OMB under OMB Control Nos. 0910-0664 and 0910-0665. First,
proposed Sec.  101.11(b) would require third party disclosure to
consumers of nutrition information by chain retail food establishments.
Second, proposed Sec.  101.11(d)(3) would require reporting of
information by restaurants and similar retail food establishments that
voluntarily register to become subject to the requirements of section
403(q)(5)(H). In addition, proposed Sec.  101.11(c)(6) would require
covered establishments to provide certain information to FDA to
substantiate the nutrition information provided to consumers. The
following analysis provides FDA's estimate of the changes caused by the
proposed rule to the previously approved annual reporting,
recordkeeping, and third party disclosure burdens.

C. Consolidation of OMB Control No. 0910-0664 Under 0910-0665

    This is a revision request in which the burden hours for the
information collection request under OMB control number 0910-0664,
``Restaurant Menu and Vending Machine Labeling: Registration for Small
Chains Under Section 4205 of the Patient Protection and Affordable Care
Act of 2010'' are being consolidated under the information collection
request assigned OMB control number 0910-0665, ``Restaurant Menu and
Vending Machine Labeling: Recordkeeping and Mandatory Third Party
Disclosure Under Section 4205 of the Patient Protection and Affordable
Care Act of 2010.'' In addition, these information collection requests
will be further revised by the proposal related to calorie declaration
for food sold in vending machines that will be separately published in
the Federal Register. The revised information collection request for
0910-0665 will be renamed ``Restaurant Menu and Vending Machine
Labeling: Registration, Recordkeeping and Mandatory Third Party
Disclosure Under Section 4205 of the Patient Protection and Affordable
Care Act of 2010.''

D. Analysis of Changes in Burden Estimates Caused by the Proposed Rule

    The analysis of burden included in this document is drawn from the
detailed PRIA that is available at http://www.regulations.gov, enter
Docket No. FDA-2011-F, and is also available on FDA's Web site at
http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm.
    Description of Respondents: The likely respondents to this
information collection are covered restaurants and similar retail food
establishments, including restaurants and similar retail food
establishments not subject to section 4205 that voluntarily register.
In this analysis, we use the term ``restaurant'' to refer to the subset
of restaurants and similar retail food establishments, as defined in
this document, that self-identify as establishments whose primary
business activity is the sale of ``meals and beverages for immediate
consumption'' in economic census surveys.
    FDA estimates the burden of this collection of information as
follows:

                       Table 6--Estimated Annual Recordkeeping Burden: Nutrition Analysis and Recording for Proposed 101.11(c)(6)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average
                                                                   Number of       Number of       Total       burden per
                      Type of respondent                         recordkeepers    records per      annual     recordkeeping  Total hours   Capital costs
                                                                                recordkeeper     records      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Restaurant Chains.............................................             514              80       41,088               4      164,352     $11,381,376
Restaurant Firms..............................................          11,560               5       57,800               4      231,200      16,010,600
Grocery and Convenience Store Chains..........................             570              40       22,800               4       91,200       6,315,600
Grocery and Convenience Store Firms...........................           2,350               5       11,750               4       47,000       3,254,750
                                                               -----------------------------------------------------------------------------------------
    Total initial hours.......................................  ..............  ..............  ...........  ..............      533,752      42,226,212
New/Reformulated items........................................           1,640              12       19,680               4       78,720       5,451,360
New chains....................................................              30              80         2400               4        9,600        $664,800
                                                               -----------------------------------------------------------------------------------------
    Total recurring hours.....................................  ..............  ..............  ...........  ..............       88,320       6,116,160
                                                               -----------------------------------------------------------------------------------------
    Total burden hours........................................  ..............  ..............  ...........  ..............      622,072  ..............